Form 20-F IMMUTEP Ltd For: Jun 30
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
☐ | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended June 30, 2018
OR
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
OR
☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report
Commission file number 001-35428
Immutep Limited
(Exact name of Registrant as specified in its charter and translation of Registrants name into English)
Australia
(Jurisdiction of incorporation or organization)
Level 12, 95 Pitt Street, Sydney 2000, New South Wales, Australia
(Address of principal executive offices)
Marc Voigt, Chief Executive Officer
Level 12, 95 Pitt Street, Sydney, 2000 New South Wales, Australia
Phone: +61 (0)2 8315 7003 Fax: +61 (0)2 8569 1880
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class |
Name of each exchange on which registered | |
Ordinary Shares | NASDAQ Global Market (for listing purposes only) | |
American Depositary Shares, each representing 100 Ordinary Shares |
NASDAQ Global Market |
Securities registered or to be registered pursuant to Section 12(g) of the Act. None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None
Indicate the number of outstanding shares of each of the issuers classes of capital or common stock as of the close of the period covered by the Annual Report.
The number of ordinary shares outstanding as of June 30, 2018 was 3,026,082,669.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definitions of large accelerated filer, accelerated filer, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Emerging growth company | ☒ |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐ |
International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ |
Other ☐ |
If Other has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18
If this is an Annual Report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
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Material Modifications to the Rights of Security Holders and Use of Proceeds |
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Immutep Limited (previously known as Prima BioMed Ltd) was incorporated under the laws of the Commonwealth of Australia on May 21, 1987. The Company changed its name from Prima BioMed Ltd to Immutep Limited in November 2017. The principal listing of our ordinary shares is the Australian Securities Exchange, or ASX. We filed a registration statement on Form 20-F with respect to our ordinary shares with the U.S. Securities and Exchange Commission, or SEC, which was declared effective on April 12, 2012. Our American Depositary Shares, or ADSs, each of which represents 100 of our ordinary shares, are listed on the NASDAQ Global Market, or NASDAQ, under the symbol IMMP (previously PBMD). The Bank of New York Mellon acts as our depositary, and registers and delivers our ADSs. As used in this Annual Report on Form 20-F, the terms we, us, our, Immutep and the Company mean Immutep Limited and its subsidiaries, unless otherwise indicated.
FINANCIAL AND OTHER INFORMATION
Our consolidated financial statements appearing in this Annual Report on Form 20-F are prepared in Australian dollars and in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this Annual Report on Form 20-F comply with both the IFRS and Australian Accounting Standards. In this Annual Report, all references to U.S. dollars or US$ are to the currency of the United States, all references to euro, or EUR are to the currency of certain states of the European Union, and all references to Australian dollars or $ or A$ are to the currency of Australia. In this Annual Report, fiscal year refers to the period between July 1 and June 30 of the following year.
Statements made in this Annual Report on Form 20-F concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this Annual Report or to any registration statement that we previously filed, you may read the document itself for a complete description of its terms.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Except for the historical information contained in this Annual Report on Form 20-F, the statements contained in this Annual Report on Form 20-F are forward-looking statements which reflect our current view with respect to future events and financial results. We urge you to consider that statements which use the terms anticipate, believe, do not believe, expect, plan, intend, estimate, and similar expressions are intended to identify forward-looking statements and these forward-looking statements, include, without limitation, any statements relating to:
| our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products and therapies in our markets; |
| our current and future research and development activities, including clinical testing and manufacturing and the costs and timing thereof; |
| sufficiency of our cash resources; |
| our ability to commercialize products and generate product revenues |
| our ability to achieve and collect milestone and royalty payments from our collaboration partners and other contract counterparties; |
| our ability to raise additional funding when needed; |
| any statements concerning anticipated regulatory activities or licensing or collaborative arrangements, including our ability to obtain regulatory clearances; |
| our research and development and other expenses; |
| our operations and intellectual property risks; |
| our ability to remain compliant with ASX and NASDAQs continuing listing standards; and |
| any statement of assumptions underlying any of the foregoing. |
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We remind investors that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, our achievements or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed or implied by such forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information, future events or circumstances, or otherwise after the date hereof. Please see the Risk Factors section that appears in Item 3. Key Information D. Risk Factors.
ITEM 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
Not applicable.
ITEM 2. | OFFER STATISTICS AND EXPECTED TIMETABLE |
Not applicable.
ITEM 3. | KEY INFORMATION |
Our consolidated financial statements appearing in this Annual Report on Form 20-F comply with both the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, and Australian Accounting Standards, as issued by the Australian Accounting Standards Board (AASB).
The following selected consolidated financial data as of June 30, 2018 and 2017 and for the fiscal years ended June 30, 2018, 2017 and 2016 have been derived from our audited consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form 20-F. The selected consolidated financial data as of June 30, 2016, 2015, and 2014 and for the fiscal years ended June 30, 2015 and 2014 have been derived from our audited consolidated financial statements and notes thereto which are not included in this Annual Report on Form 20-F. This data should be read together with, and is qualified in its entirety by reference to, Item 5. Operating and Financial Review and Prospects as well as our consolidated financial statements and notes thereto appearing in Item 18. Financial Statements of this Annual Report on Form 20-F.
The selected financial data are presented in Australian dollars (A$) (except as otherwise noted).
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Consolidated Statement of Operations Data:
Year Ended June 30, | ||||||||||||||||||||
2018 | 2017 | 2016 | 2015 | 2014 | ||||||||||||||||
(in A$, except share amounts) | ||||||||||||||||||||
License revenue |
2,630,484 | | 175,052 | | | |||||||||||||||
Other income |
4,722,823 | 4,221,534 | 1,853,869 | 2,092,867 | 3,140,066 | |||||||||||||||
Depreciation & amortization |
(1,808,929 | ) | (1,701,615 | ) | (1,993,093 | ) | (1,341,202 | ) | (446,360 | ) | ||||||||||
Research & development and intellectual property |
(9,989,830 | ) | (7,525,744 | ) | (7,059,528 | ) | (8,952,447 | ) | (11,930,857 | ) | ||||||||||
Corporate administrative expenses |
(7,242,061 | ) | (4,346,952 | ) | (6,982,629 | ) | (5,723,106 | ) | (4,092,623 | ) | ||||||||||
Loss on foreign exchange |
| | (563,890 | ) | | | ||||||||||||||
Finance costs |
| | (8,199 | ) | (18,364,804 | ) | | |||||||||||||
Share Based Payment to strategic investor |
| | (47,468,071 | ) | | | ||||||||||||||
Changes in fair value of warrants |
(189,983 | ) | | | | | ||||||||||||||
Changes in fair value of comparability milestone |
| | (542,075 | ) | | | ||||||||||||||
Net change in fair value of convertible note liability |
(866,848 | ) | (751,816 | ) | (607,637 | ) | | | ||||||||||||
Loss on disposal of assets |
| | | (5,160 | ) | | ||||||||||||||
Loss before income tax expense |
(12,744,344 | ) | (10,104,593 | ) | (63,196,201 | ) | (32,293,852 | ) | (13,329,774 | ) | ||||||||||
Income tax (expense) / benefit |
(1,676 | ) | 737,387 | 1,181,017 | 142,156 | (13,607 | ) | |||||||||||||
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Net loss |
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | (32,151,696 | ) | (13,343,381 | ) | ||||||||||
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Loss per share basic and diluted (in A$ cents) |
(0.49 | ) | (0.41 | )* | (2.78 | )* | (2.02 | )* | (0.89 | )* | ||||||||||
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Weighted average number of ordinary shares outstanding basic and diluted |
2,608,328,140 | 2,284,360,994 | * | 2,228,477,348 | * | 1,591,280,189 | * | 1,504,675,324 | * | |||||||||||
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* | Immutep Limited and all of its wholly owned subsidiaries (the group) restated the 2014 to 2017 EPS figures to reflect the bonus element of shares issue arising from the capital raising in fiscal year 2018. |
Consolidated Balance Sheet Data:
As of June 30, | ||||||||||||||||||||
2018 | 2017 | 2016 | 2015 | 2014 | ||||||||||||||||
(in A$) | ||||||||||||||||||||
Cash and cash equivalents |
23,475,521 | 12,236,974 | 20,879,548 | 6,759,615 | 14,200,042 | |||||||||||||||
Working capital |
24,789,816 | 13,287,250 | 20,198,827 | 3,643,408 | 21,912,972 | |||||||||||||||
Net assets |
33,521,927 | 26,532,306 | 35,317,513 | 24,689,743 | 22,592,320 | |||||||||||||||
Total assets |
46,998,783 | 34,963,796 | 42,554,067 | 30,983,445 | 25,377,955 | |||||||||||||||
Long-term debt |
6,645,832 | 5,778,984 | 5,027,168 | | | |||||||||||||||
Total shareholders equity |
33,521,927 | 26,532,306 | 35,317,513 | 24,689,743 | 22,592,320 | |||||||||||||||
Contributed equity |
213,232,719 | 195,352,543 | 194,530,932 | 179,878,436 | 149,014,372 |
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Exchange Rate Information:
The following tables set forth, for the periods and dates indicated, certain information regarding the rates of exchange of A$1.00 into US$ based on the historical daily exchange rates of the Australian dollar by the Reserve Bank of Australia (RBA).
Year Ended June 30, |
At Period End | Average Rate | High | Low | ||||||||||||
US$ | US$ | US$ | US$ | |||||||||||||
2014 |
0.9420 | 0.9187 | 0.9672 | 0.8716 | ||||||||||||
2015 |
0.7680 | 0.8382 | 0.9458 | 0.7114 | ||||||||||||
2016 |
0.7426 | 0.7283 | 0.7812 | 0.6867 | ||||||||||||
2017 |
0.7692 | 0.7545 | 0.7724 | 0.7202 | ||||||||||||
2018 |
0.7391 | 0.7753 | 0.8121 | 0.7353 |
Month |
High | Low | ||||||
US$ | US$ | |||||||
April 2018 |
0.7804 | 0.7545 | ||||||
May 2018 |
0.7588 | 0.7435 | ||||||
June 2018 |
0.7664 | 0.7353 | ||||||
July 2018 |
0.7467 | 0.7360 | ||||||
August 2018 |
0.7441 | 0.7213 | ||||||
September 2018 |
0.7296 | 0.7103 |
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
The following risks relate specifically to our business and should be considered carefully. Our business, financial condition and results of operations could be harmed by any of the following risks. As a result, the trading price of our ordinary shares and our American Depositary Shares, or ADSs, could decline and the holders could lose part or all of their investment.
Risks Related to Our Business
We have a history of operating losses and may not achieve or maintain profitability in the future.
We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. For example, for the years ended June 30 2017 and 2018, we had net losses of $9.4 million and $12.7 million, respectively.
We are at an early stage in the development of pharmaceutical product candidates and their success is therefore uncertain. We focus on the development of immunotherapeutic products for the treatment of cancer and autoimmune diseases. We, and our partners, have four product candidates under development IMP321 (also known as eftilagimod alpha or efti), IMP761, IMP701 and IMP731, all of which are related to lymphocyte activation gene 3, or LAG-3, a gene linked to the regulation of T cells in immune responses.
We expect to continue to incur losses from operations for the foreseeable future and expect the costs of drug development to increase in the future as more patients are recruited to the clinical trials. In particular, we expect to continue to incur significant losses in carrying out clinical trials of IMP321 and ongoing research and preclinical development in terms of immunotherapy product candidates, such as IMP761. Because of the numerous risks and uncertainties associated with the development, manufacturing, sales and marketing of therapeutic products such as IMP321 and IMP761, we may experience larger than expected future losses and may never become profitable.
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Moreover, there is a substantial risk that we, or our development partners, may not be able to complete the development of our current product candidates or develop other pharmaceutical products. It is possible that none of them will be successfully commercialized, which would prevent us from ever achieving profitability.
We have no medicinal products approved for commercial sale and no source of consistent material revenue.
Currently, we have no products approved for commercial sale and to date have not generated material revenue from product sales. We are largely dependent on the success of our product candidates.
The LAG-3 product candidates were acquired by us through the acquisition of the French privately owned and venture capital backed company Immutep SA, a biopharmaceutical company in the rapidly growing field of Immuno-Oncology in December 2014. This acquisition significantly expanded our clinical development product portfolio to other categories of immunotherapies. It has also provided the business with partnerships with several of the worlds largest pharmaceutical companies.
We have four LAG-3 product candidates. The most advanced of the three is IMP321(INN: eftilagimod alpha). IMP321 is a recombinant protein typically used in conjunction with other therapies (e.g. chemotherapy or other immunotherapy) to amplify a patients immune response. The development and manufacturing of IMP321 is being conducted in conjunction with Eddingpharm, in China. We entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of our immune activator, IMP321 with MSDs anti-PD-1 therapy pembrolizumab in phase II clinical trials. We also entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for a Phase I clinical trial that will evaluate the clinical benefits of combining our immune stimulator, IMP321, with avelumab, a PD-L1 blocking antibody.
Our second LAG-3 product candidate is IMP701, an antagonist antibody that acts to stimulate T cell proliferation in cancer patients. IMP701 has been licensed to CoStim (Novartis), which is solely responsible for its development and manufacturing. Our third LAG-3 product candidate is IMP731, a depleting antibody that could remove T cells involved in autoimmunity. IMP731 has been licensed to GlaxoSmithKline, or GSK, which is solely responsible for its development and manufacturing. Our fourth LAG-3 product candidate is IMP761, an early stage product candidate which is being developed as our first agonist antibody of LAG-3. In addition to these products Immutep has a dedicated R&D laboratory outside Paris with ongoing research capabilities. Immutep also currently generates modest income from sales of LAG-3 research reagents.
Our ability to generate product revenue, especially through the commercialization of the LAG-3 products, depends on a number of factors, including our ability to:
| successfully complete clinical development of, and receive regulatory approval for, our product candidates; |
| set an acceptable price for our products, if approved, and obtain adequate coverage and reimbursement from third-party payors; |
| obtain commercial quantities of our products, if approved, at acceptable cost levels; and |
| successfully market and sell our products, if approved. |
There can be no assurance that our or our partners ability to develop any product candidate, will be successful or our ability to obtain the necessary regulatory approvals with respect to any of the foregoing will be successful. As a result, the prolonged inability to generate revenue may adversely impact our business operations.
The increase in expenses may adversely impact our business if our sources of funding and revenue are insufficient.
We anticipate that as the costs related to the clinical trials for IMP321 will increase, we will require additional funds to achieve our long-term goals of commercialization and further development of IMP321 and other product candidates. In addition, we will require funds to pursue regulatory applications, defend intellectual property rights, increase contracted manufacturing capacity, potentially develop marketing and sales capability and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through licensing of our assets or other arrangements with corporate partners. However, such financing, licensing opportunities or other arrangements may not be available from any sources on acceptable terms, or at all. Any shortfall in funding could result in us having to curtail or cease our operations including research and development activities, thereby harming our business, financial condition and results of operations.
In addition, because of the numerous risks and uncertainties associated with product candidate development, we are unable to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. Our expenses could significantly increase beyond current expectations if the applicable regulatory authorities require further studies in addition to those currently anticipated. In any case, even if our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of such products and there can be no guarantee that we will ever generate significant revenues.
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We will require additional financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our products or product candidates.
We have historically devoted most of our financial resources to research and development, including pre-clinical and clinical development activities. To date, we have financed a significant amount of our operations through public and private financings. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings or strategic collaborations. The amount of such future net losses, as well as the possibility of future profitability, will also depend on our success in developing and commercializing products that generate significant revenue. Our failure to become and remain profitable would depress the value of our ordinary shares or ADSs and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.
We anticipate that our expenses will increase substantially for the foreseeable future if, and as, we:
| continue our research and preclinical and clinical development of our product candidates; |
| expand the scope of our current proposed clinical studies for our product candidates; |
| initiate additional preclinical, clinical or other studies for our product candidates; |
| change or add additional manufacturers or suppliers; |
| seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; |
| seek to identify and validate additional product candidates; |
| acquire or in-license other product candidates and technologies; |
| maintain, protect and expand our intellectual property portfolio; |
| attract and retain skilled personnel; |
| create additional infrastructure to support our operations as a publicly quoted company and our product development and planned future commercialization efforts; |
| add an internal sales force; and |
| experience any delays or encounter issues with any of the above. |
Until our product candidates become commercially available, we will need to obtain additional funding in connection with the further development of our product candidates. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. As such, additional financing may not be available to us when needed, on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts or obtain funds by
entering agreements on unattractive terms. Our resource allocation decisions and the elimination of development programs may result in the failure to capitalize on profitable market opportunities. Furthermore, any additional equity fundraising in the capital markets may be dilutive for stockholders and any debt-based funding may bind us to restrictive covenants and curb our operating activities and ability to pay potential future dividends even when profitable. We cannot guarantee that future financing will be available in sufficient amounts or on acceptable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our common stock and ADSs to fall.
If we are unable to secure sufficient capital to fund our operations, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. For example, additional strategic collaborations could require us to share commercial rights to our product candidates with third parties in ways that we do not intend currently or on terms that may not be favorable to us. Moreover, we may also have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
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We may find it difficult to enroll patients in our current and any future clinical trials, and patients could discontinue their participation in our current and any future clinical trials, which could delay or prevent our current and any future clinical trials of our product candidates and make those trials more expensive to undertake.
Identifying and qualifying patients to participate in current and any future clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates. Patients may be unwilling to participate in any future clinical trials because of negative publicity from adverse events in the biotechnology industry Patients may be unavailable for other reasons, including competitive clinical trials for similar patient populations, and the timeline for recruiting patients, conducting trials and obtaining regulatory approval of potential products may be delayed. If we have difficulty enrolling a sufficient number of patients to conduct any future clinical trials as planned, we may need to delay, limit or discontinue those clinical trials. Clinical trial delays could result in increased costs, slower product development, setbacks in testing the safety and effectiveness of our technology or discontinuation of the clinical trials altogether.
We may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a trial, to complete any future clinical trials in a timely manner. Patient enrollment is affected by factors including:
| finding and diagnosing patients; |
| severity of the disease under investigation; |
| design of the clinical trial protocol; |
| size and nature of the patient population; |
| eligibility criteria for the trial in question; |
| perceived risks and benefits of the product candidate under study; |
| proximity and availability of clinical trial sites for prospective patients; |
| availability of competing therapies and clinical trials; |
| clinicians and patients perceptions of the potential advantages of the product being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; |
| patient referral practices of physicians; and |
| ability to monitor patients adequately during and after treatment. |
If we are unable to successfully develop related diagnostics for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates.
We may develop related diagnostics for some of our therapeutic product candidates. Such related diagnostics are subject to regulation by the FDA and typically to comparable foreign regulatory authorities as medical devices and typically require separate regulatory approval or clearance prior to commercialization. Marketing approval or clearance of the diagnostic will require sufficient data to support its safety and efficacy. In addition, at least in some cases, the FDA and comparable foreign regulatory authorities may require the development and regulatory approval or clearance of a related diagnostic as a condition to approving our therapeutic product candidates. While we have some, limited experience in developing diagnostics, we plan to rely in large part on third parties to perform these functions. We may seek to enter into arrangements with one or more third parties to create a related diagnostic for use with our current or future product candidates.
If we or any third parties that we engage to assist us, are unable to successfully develop or obtain marketing approval or clearance for related diagnostics for our therapeutic product candidates, or experience delays in doing so:
| the development of relevant product candidates may be delayed or impaired altogether if we are unable to appropriately select patients for enrollment in our clinical trials; |
| our relevant therapeutic product candidate may not receive marketing approval if its effective use depends on a related diagnostic in the regulatory authoritys judgment; and |
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| we may not realize the full commercial potential of any therapeutic product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients with the specific genetic alterations targeted by our therapeutic product candidates. |
If any of these events were to occur, our business would be harmed.
We are exposed to significant risks related to our ongoing research and development efforts and might not be in a position to successfully develop any product candidate. Any failure to implement our business strategy could negatively impact our business, financial condition and results of operations.
The development and commercialization of IMP321, IMP701, IMP761 and IMP731, or any other product candidate we may develop, is subject to many risks, including:
| additional clinical or pre-clinical trials may be required beyond what we currently expect; |
| regulatory authorities may disagree with our interpretation of data from our preclinical studies and clinical studies or may require that we conduct additional studies; |
| regulatory authorities may disagree with our proposed design of future clinical trials; |
| regulatory authorities may delay approval of our product candidates, thus preventing milestone payments from our collaboration partners; |
| regulatory authorities may not accept data generated at our clinical study sites; |
| we may be unable to obtain and maintain regulatory approval of our product candidate in any jurisdiction; |
| the prevalence and severity of any side effects of any product candidate could delay or prevent commercialization, limit the indications for any approved product candidate, require the establishment of a risk evaluation and mitigation strategy, or REMS, or cause an approved product candidate to be taken off the market; |
| regulatory authorities may identify deficiencies in our manufacturing processes or facilities or those of our third-party manufacturers; |
| regulatory authorities may change their approval policies or adopt new regulations; |
| the third-party manufacturers we expect to depend on to supply or manufacture our product candidates may not produce adequate supply; |
| we, or our third-party manufacturers, may not be able to source or produce current Good Manufacturing Practice (cGMP) materials for the production of our product candidates; |
| we may not be able to manufacture our product candidates at a cost or in quantities necessary to make commercially successful products; |
| we may not be able to obtain adequate supply of our product candidates for our clinical trials; |
| we may experience delays in the commencement of, enrolment of patients in and timing of our clinical trials; |
| we may not be able to demonstrate that our product candidates are safe and effective as a treatment for its indications to the satisfaction of regulatory authorities, and we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our product candidates; |
| we may not be able to maintain a continued acceptable safety profile of our products following approval; |
| we may be unable to establish or maintain collaborations, licensing or other arrangements; |
| the market may not accept our product candidates; |
| we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators marketing, sales and distribution strategy and operations will affect our profitability; |
| we may experience competition from existing products or new products that may emerge; |
| we and our licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our product candidates; and |
| we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors. |
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If any of these risks materializes, we could experience significant delays or an inability to successfully develop and commercialize IMP321, IMP761, IMP701 and IMP731, or any other product candidate we may develop, which would have a material adverse effect on our business, financial condition and results of operations.
Positive results from preclinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates.
Positive results in preclinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development or early stage clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks can be caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval. If we fail to produce positive results in our clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be negatively impacted.
We may not make acquisitions in the future, or if we do, we may not be successful in integrating the acquired company, either of which could have a materially adverse effect on our business.
We completed our acquisition of Immutep S.A.S., in December 2014 for consideration of up to US$25 million in cash and stock. Although we have completed the integration of Immuteps business into our own, we have not yet achieved, and may never achieve, the full benefit of the clinical development expectations, product portfolio enhancements or revenue generations we expected at the time of the acquisition. In addition, even if we achieve the expected benefits, we may be unable to achieve them within the anticipated time frame. Also, there may be unexpected problems in the business unrelated to the Immutep acquisition that have a negative effect on our business. If we fail to implement our business strategy, we may be unable to achieve expected results and our business, financial condition and results of operations may be materially and adversely affected.
Immutep S.A.S. is the only significant acquisition in our recent history. Identifying strategic acquisitions is part of our business plan and may become an increasingly important part of our growth. There is, however, no assurance that we will be successful in identifying, negotiating, or consummating any future acquisitions. If we fail to make any future acquisitions, our growth rate could be materially and adversely affected. Any additional acquisitions we undertake could involve the dilutive issuance of equity securities, incurring indebtedness and/or incurring large one-time expenses. In addition, acquisitions involve numerous risks, including difficulties in assimilating the acquired companys operations, the diversion of our managements attention from other business concerns, risks of entering into markets in which we have had no or only limited direct experience, and the potential loss of customers, key employees and drivers of the acquired company, all of which could have a materially adverse effect on our business and operating results. If we make acquisitions in the future, we cannot guarantee that we will be able to successfully integrate the acquired companies or assets into our business, which would have a materially adverse effect on our business, financial condition, and results of operations.
Ongoing and future clinical trials of product candidates may not show sufficient safety or efficacy to obtain requisite regulatory approvals for commercial sale.
Phase I and Phase II clinical trials are not primarily designed to test the efficacy of a product candidate but rather to test safety and to understand the product candidates side effects at various doses and schedules. Furthermore, success in preclinical and early clinical trials does not ensure that later large-scale trials will be successful nor does it predict final results. Acceptable results in early trials may not be repeated in later trials. Further, Phase III clinical trials may not show sufficient safety or efficacy to obtain regulatory approval for marketing. In addition, clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could require that the clinical trial be redone or terminated. The length of time necessary to complete clinical trials and to submit an application for marketing approval by applicable regulatory authorities may also vary significantly based on the type, complexity and novelty of the product candidate involved, as well as other factors. If we suffer any significant delays, quality issues, setbacks or negative results in, or termination of, our clinical trials, we may be unable to continue the development of our products or product candidates or generate revenue and our business may be severely harmed.
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If we do not obtain the necessary regulatory approvals we will be unable to commercialize our products.
The clinical development, manufacturing, sales and marketing of our products are subject to extensive regulation by regulatory authorities in the United States, the United Kingdom, the European Union, Australia and elsewhere. Despite the substantial time and expense invested in preparation and submission of a Biologic License Application or equivalents in other jurisdictions, regulatory approval is never guaranteed. The number, size and design of preclinical studies and clinical trials that will be required will vary depending on the product, the disease or condition for which the product is intended to be used and the regulations and guidance documents applicable to any particular product. The FDA or other regulators can delay, limit or deny approval of a product for many reasons, including, but not limited to, the fact that regulators may not approve our or a third-party manufacturers processes or facilities or that new laws may be enacted or regulators may change their approval policies or adopt new regulations requiring new or different evidence of safety and efficacy for the intended use of a product.
IMP321 and our other product candidates are undergoing clinical trials; however, successful results in the trials and in the subsequent application for marketing approval are not guaranteed. Without additional clinical trials any other product candidate in the current portfolio cannot obtain a regulatory approval. If we are unable to obtain regulatory approvals, we will not be able to generate revenue from this product candidate or any other candidate. Even if we receive regulatory approval for IMP321 or any product candidate, our profitability will depend on our ability to generate revenues from their sale or the licensing of our technology.
We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates.
Of our current pipeline product candidates, none of our drugs have been designated with orphan drug status by the FDA. Regulatory authorities in some jurisdictions, including the United States, may designate drugs or biological products for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. The FDA may also designate a product as an orphan drug if it is intended to treat a disease or condition of more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product candidate.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for such indication for that time period. The applicable period is seven years in the United States. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
While there is no guarantee, FDA orphan drug designation may provide a range of benefits, including a potential fast track process for clinical regulatory approval, potential tax credits for qualified clinical trials and an exemption from FDA application user fees.
Even if we obtain orphan drug exclusivity for a product in the United States or for additional products in the European Union, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition, and the same drug could be approved for a different condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the European Union, the European Medicines Agency, or the EMA, can approve a competitive product if the orphan drug no longer meets the criteria for orphan designation (including sufficient profitability), if the competitive product is safer, more effective or otherwise clinically superior, or if the orphan drug cannot be supplied in sufficient quantities.
Even if our product candidates receive regulatory approval, it may still face development and regulatory difficulties that may delay or impair future sales of product candidates.
Even if we or our licensing partners receive regulatory approval to sell IMP321 or any other product candidate, the relevant regulatory authorities may, nevertheless, impose significant restrictions on the indicated uses, manufacturing, labelling, packaging, adverse event reporting, storage, advertising, promotion and record keeping or impose ongoing requirements for post-approval studies. In addition, regulatory agencies subject a marketed product, its manufacturer and the manufacturers facilities to continual review and periodic inspections. Previously unknown problems with the product candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the product, and could include withdrawal of the product from the market. In addition, new statutory requirements may be enacted or additional regulations may be enacted that could prevent or delay regulatory approval of our products.
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We have limited manufacturing experience with our product candidates.
We have no manufacturing capabilities and are dependent on third parties for cost effective manufacture and manufacturing process development of the companys product candidates. Problems with third party manufacturers or the manufacturing process, or the scaling up of manufacturing activities as such may delay clinical trials and commercialization of our product candidates. To minimize the chance of these kinds of disruption, we enter into advance purchase agreements for reagents wherever possible.
Biological product candidates like IMP731, IMP701, IMP761 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.
To the extent we rely significantly on contractors, we will be exposed to risks related to the business and operational conditions of our contractors.
We are a small company, with few internal staff and limited facilities. We are and will be required to rely on a variety of contractors to manufacture and transport our products, to perform clinical testing and to prepare regulatory dossiers. Adverse events that affect one or more of our contractors could adversely affect us, such as:
| a contractor is unable to retain key staff that have been working on our product candidates; |
| a contractor is unable to sustain operations due to financial or other business issues; |
| a contractor loses their permits or licenses that may be required to manufacture our products or product candidates; or |
| errors, negligence or misconduct that occur within a contractor may adversely affect our business. |
We depend on, and will continue to depend on, collaboration and strategic alliances with third partners. To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.
An important element of our strategy for developing, manufacturing and commercializing our product candidates is entering into partnerships and strategic alliances with other pharmaceutical companies or other industry participants. For example, we currently have collaborative arrangements with Eddingpharm for the development of IMP321 for China, Hong Kong, Macau and Taiwan. Any revenues from sales of any of our partnered product candidates will depend on the success of the collaboration partner.
Any partnerships or alliance we have or may have in the future may be terminated for reasons beyond our control or we may not be able to negotiate future alliances on acceptable terms, if at all. These arrangements may result in us receiving less revenue than if it sold its products directly, may place the development, sales and marketing of its products outside of its control, may require it to relinquish important rights or may otherwise be on unfavorable terms. Collaborative arrangements or strategic alliances will also subject us to a number of risks, including the risk that:
| we may not be able to control the amount and timing of resources that our strategic partner/collaborators may devote to the product candidates; |
| strategic partner/collaborators may experience financial difficulties; |
| the failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization of our product candidates or revenue expectations; |
| products being developed by partners/collaborators may never reach commercial stage resulting in reduced or even no milestone or royalty payments; |
| business combinations or significant changes in a collaborators business strategy may also adversely affect a collaborators willingness or ability to complete their obligations under any arrangement; |
| a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and |
| collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing product candidates. |
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Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
We rely on third-party supply and manufacturing partners to manufacture and supply the materials for our research and development and preclinical and clinical study supplies. We do not own manufacturing facilities or supply sources for such materials.
There can be no assurance that our supply of research and development, preclinical and clinical development biologics and other materials will not be limited, interrupted or restricted in certain geographic regions, be of satisfactory quality or continue to be available at acceptable prices. Replacement of a third-party manufacturer could require significant effort, cost and expertise because there may be a limited number of qualified replacements.
The manufacturing process for a product candidate is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMP. In the event that any of our suppliers or manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves or enter into an agreement with another third party, which would be costly and delay any future clinical trials.
In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills or technology to another third party. These factors increase our reliance on our manufacturers and may require us to obtain a license from a manufacturer in order to have another third-party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines of the FDA and comparable foreign regulatory authorities. The delays and costs associated with the verification of a new manufacturer could increase our costs and delay the development of our product candidates.
We expect to continue to rely on third-party manufacturers for preclinical and clinical grade product candidates and if we receive regulatory approval for any product candidate. To the extent that we have existing, or enter into future, manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance. If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully. Our or a third partys failure to execute on our manufacturing requirements could adversely affect our business in a number of ways, including:
| an inability to conduct necessary preclinical studies to progress our product candidates to clinical trials; |
| an inability to initiate or continue any future clinical trials of product candidates under development; |
| delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates; |
| loss of the cooperation of a collaborator; |
| subjecting our product candidates to additional inspections by regulatory authorities; |
| requirements to cease distribution or to recall batches of our product candidates; and |
| in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products. |
We and our collaborators may disagree over our right to receive payments under our collaboration agreements, potentially resulting in costly litigation and loss of reputation.
Our ability to receive payments under our collaboration agreements depends on our ability to clearly delineate our rights under those agreements. We have out-licensed portions of our intellectual property to our collaborators with the intent that our collaborators will develop product candidates. However, a collaborator may use our intellectual property without our permission, dispute our ownership of intellectual property rights, or argue that our intellectual property does not cover, or add value to, any product candidates they develop. If a dispute arises, it may result in costly patent office procedures and litigation, and our collaborator may refuse to pay us while the dispute is ongoing. Furthermore, regardless of any resort to legal action, a dispute with a collaborator over intellectual property rights may damage our relationship with that collaborator and may also harm our reputation in the industry. Even if we are entitled to payments from our collaborators, we may not actually receive these payments, or we may experience difficulties in collecting the payments to which we believe we are entitled. After our collaborators launch commercial products containing our licensed traits, we will need to rely on the good faith of our collaborators to report to us the sales they earn from these products and to accurately calculate the payments we are entitled to, a process that will involve complicated and difficult calculations. Although we seek to address these concerns in our collaboration agreements by reserving our right to audit financial records, such provisions may not be effective.
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Our research and development efforts will be jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations.
Changes in our senior management may be disruptive to our business and may adversely affect our operations. For example, when we have changes in senior management positions, we may elect to adopt different business strategies or plans. Any new strategies or plans, if adopted, may not be successful and if any new strategies or plans do not produce the desired results, our business may suffer.
Moreover, competition among biotechnology and pharmaceutical companies for qualified employees is intense and as such we may not be able to attract and retain personnel critical to our success. Our success depends on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel, manufacturing personnel, sales and marketing personnel and on our ability to develop and maintain important relationships with clinicians, scientists and leading academic and health institutions. If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our product development and commercialization activities.
In addition, biotechnology and pharmaceutical industries are subject to rapid and significant technological change. Our product candidates may be or become uncompetitive. To remain competitive, we must employ and retain suitably qualified staff that are continuously educated to keep pace with changing technology, but may not be in a position to do so.
Future potential sales of our products may suffer if they are not accepted in the marketplace by physicians, patients and the medical community.
There is a risk that IMP321 or any other product candidate may not gain market acceptance among physicians, patients and the medical community, even if they are approved by the regulatory authorities. The degree of market acceptance of any of our approved products will depend on a variety of factors, including:
| timing of market introduction, number and clinical profile of competitive products; |
| our ability to provide acceptable evidence of safety and efficacy and our ability to secure the support of key clinicians and physicians for our products; |
| cost-effectiveness compared to existing and new treatments; |
| availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payers; |
| prevalence and severity of adverse side effects; and |
| other advantages over other treatment methods. |
Physicians, patients, payers or the medical community may be unwilling to accept, use or recommend our product candidates which would adversely affect our potential revenues and future profitability.
We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours.
The development and commercialization of pharmaceutical products is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as technology being developed at universities and other research institutions. Our competitors have developed, are developing or could develop product candidates and processes competitive with our product candidates. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community, patients and third-party payers, and any new treatments that enter the market.
There may be a significant number of products that are currently under development, and may become commercially available in the future, for the treatment of conditions for which we are developing, and may in the future try to develop, product candidates.
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Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources and experience than we have. If we successfully obtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectiveness of our products, the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position.
Competing products could present superior treatment alternatives, including by being more effective, safer, less expensive or marketed and sold more effectively than any products we may develop. Competitive products may make any products we develop obsolete or non-competitive before we recover the expense of developing and commercializing our product candidates. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.
If healthcare insurers and other organizations do not pay for our products or impose limits on reimbursement, our future business may suffer.
Our product candidates may be rejected by the market due to many factors, including cost. The continuing efforts of governments, insurance companies and other payers of healthcare costs to contain or reduce healthcare costs may affect our future revenues and profitability. In Australia and certain foreign markets the pricing of pharmaceutical products is already subject to government control. We expect initiatives for similar government control to continue in the United States and elsewhere. The adoption of any such legislative or regulatory proposals could harm our business and prospects.
Successful commercialization of our product candidates will depend in part on the extent to which reimbursement for the cost of our products and related treatment will be available from government health administration authorities, private health insurers and other organizations. Our product candidates may not be considered cost-effective and reimbursement may not be available to consumers or may not be sufficient to allow our products to be marketed on a competitive basis. Third-party payers are increasingly challenging the price of medical products and treatment. If third party coverage is not available for our products the market acceptance of these products will be reduced. Cost-control initiatives could decrease the price we might establish for products, which could result in product revenues lower than anticipated. If the price for our product candidates decreases or if governmental and other third-party payers do not provide adequate coverage and reimbursement levels our potential revenue and prospects for profitability will suffer.
We may be exposed to product liability claims which could harm our business.
The testing, marketing and sale of therapeutic products entails an inherent risk of product liability. We rely on a number of third party researchers and contractors to produce, collect, and analyze data regarding the safety and efficacy of our product candidates. We also have quality control and quality assurance in place to mitigate these risks, as well as professional liability and clinical trial insurance to cover financial damages in the event that human testing is done incorrectly or the data is analyzed incorrectly.
Notwithstanding our control procedures, we may face product liability exposure related to the testing of our product candidates in human clinical trials. If any of our products are approved for sale, we may face exposure to claims by an even greater number of persons than were involved in the clinical trials once marketing, distribution and sales of our products begin. Regardless of merit or eventual outcome, liability claims may result in:
| decreased demand for our product candidates; |
| injury to our reputation; |
| withdrawal of clinical trial participants; |
| costs of related litigation; |
| substantial monetary awards to patients and others; |
| loss of revenues; and |
| the inability to commercialize products and product candidates. |
With respect to product liability claims, we could face additional liability beyond insurance limits if testing mistakes were to endanger any human subjects. In addition, if a claim is made against us in conjunction with these research testing activities, the market price of our ordinary shares or ADSs may be negatively affected.
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We and our development partners, third-party manufacturers and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
We and our development partners, third-party manufacturers and suppliers may use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. Our operations and the operations of our third-party manufacturers and suppliers also produce hazardous waste products. National, state and local laws and regulations in the United States, Australia and other countries govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our product development and commercialization efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and any future clinical trials, regulatory approvals or product commercialization progress could be suspended.
Our status as emerging growth company may reduce the amount of information available to investors
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Accordingly, this allows us to postpone the date by which we must comply with some of the laws and regulations that are otherwise applicable to public companies and to reduce the amount of information we provide in our reports filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our ordinary shares or ADSs.
We would cease to be an emerging growth company upon the earliest of: (i) the last day of our fiscal year following the fifth anniversary of the date of the first sale of our initial U.S. public offering, which closed on July 5, 2017; (ii) the last day of the first fiscal year in which we have total annual gross revenues of at least US$1.1 billion; (iii) the date on which we are deemed to be a large accelerated filer, which means the market value of our ordinary shares (including ordinary shares represented by ADSs) that is held by non-affiliates exceeds US$700 million as of the end of the second quarter of our last completed fiscal year; and (iv) the date on which we have issued more than US$1 billion in non-convertible debt during a three-year period.
For so long as we remain an emerging growth company, we may take advantage of certain exemptions from various requirements that are applicable to public companies that are not emerging growth companies, including, but not limited to, the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting. As a result, our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting for so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected.
Risks Related to Intellectual Property
Our success depends on our ability to protect our intellectual property and our proprietary technology.
Our success is to a certain degree also dependent on our ability to obtain and maintain patent protection or where applicable, to receive/maintain orphan drug designation/status and resulting marketing exclusivity for our product candidates.
We may be materially adversely affected by our failure or inability to protect our intellectual property rights. Without the granting of these rights, the ability to pursue damages for infringement would be limited. Similarly, any know-how that is proprietary or particular to our technologies may be subject to risk of disclosure by employees or consultants despite having confidentiality agreements in place.
Any future success will depend in part on whether we can obtain and maintain patents to protect our own products and technologies; obtain licenses to the patented technologies of third parties; and operate without infringing on the proprietary rights of third parties. Biotechnology patent matters can involve complex legal and scientific questions, and it is impossible to predict the outcome of biotechnology and pharmaceutical patent claims. Any of our future patent applications may not be approved, or we may not develop additional products or processes that are patentable. Some countries in which we may sell our product candidate or license our intellectual property may fail to protect our intellectual property rights to the same extent as the protection that may be afforded in the United States or Australia. Some legal principles remain unresolved and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States, the United Kingdom, the European Union, Australia or elsewhere. In addition, the specific content of patents and patent applications that are necessary to support and interpret patent claims
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is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or in interpretations of patent laws in the United States, the United Kingdom, the European Union or elsewhere may diminish the value of our intellectual property or narrow the scope of our patent protection. Even if we are able to obtain patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. We may also fail to take the required actions or pay the necessary fees to maintain our patents.
Moreover, any of our pending applications may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, the European Patent Office, or EPO, the Australian Patent and Trademark Office and/or any patents issuing thereon may become involved in opposition, derivation, reexamination, inter partes review, post grant review, interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, and allow third parties to commercialize our technology or products and compete directly with us, without payment to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to exploit our intellectual property or develop or commercialize current or future product candidate.
The issuance of a patent is not conclusive as to the inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the U.S., the EU, Australia and elsewhere. Such challenges may result in loss of ownership or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit the duration of the patent protection of our technology and products. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
In addition, other companies may attempt to circumvent any regulatory data protection or market exclusivity that we obtain under applicable legislation, which may require us to allocate significant resources to preventing such circumvention. Such developments could enable other companies to circumvent our intellectual property rights and use our clinical trial data to obtain marketing authorizations in the EU, Australia and in other jurisdictions. Such developments may also require us to allocate significant resources to prevent other companies from circumventing or violating our intellectual property rights.
Our attempts to prevent third parties from circumventing our intellectual property and other rights may ultimately be unsuccessful.
Intellectual property rights of third parties could adversely affect our ability to commercialize our products, such that we could be required to litigate with or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not available on commercially reasonable terms.
Our commercial success may somewhat depend upon our future ability and the ability of our potential collaborators to develop, manufacture, market and sell our product candidates without infringing valid intellectual property rights of third parties.
If a third-party intellectual property right exists it may require the pursuit of litigation or administrative proceedings to nullify or invalidate the third-party intellectual property right concerned, or entry into a license agreement with the intellectual property right holder, which may not be available on commercially reasonable terms, if at all.
Third-party intellectual property right holders, including our competitors, may bring infringement claims against us. We may not be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims or otherwise resolve such claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from, or experience substantial delays in, marketing our product candidate.
If we fail to settle or otherwise resolve any such dispute, in addition to being forced to pay damages, we or our potential collaborators may be prohibited from commercializing any product candidates we may develop that are held to be infringing, for the duration of the patent term. We might, if possible, also be forced to redesign our formulations so that we no longer infringe such third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
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Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
Because we rely on third parties to manufacture our product candidates, and because we collaborate with various organizations and academic institutions on the advancement of our technology and product candidates, we may, at times, share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets. Despite these contractual provisions, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by potential competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, discovery by a third party of our trade secrets or other unauthorized use or disclosure would impair our intellectual property rights and protections in our product candidates.
In addition, these agreements typically restrict the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by us. In other cases we may share these rights with other parties. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications are required to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and applications. The USPTO and various corresponding governmental patent agencies outside of the United States require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and after a patent has issued. There are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
We may become involved in lawsuits to protect and defend our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
Competitors may infringe our patents or other intellectual property and we may inadvertently infringe the patent or intellectual property of others. To counter infringement or unauthorized use, we may be required to file claims, and any related litigation and/or prosecution of such claims can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid in whole or in part, unenforceable, or construe the patents claims narrowly allowing the other party to commercialize competing products on the grounds that our patents do not cover such products.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. The effects of patent litigation or other proceedings could therefore have a material adverse effect on our ability to compete in the marketplace.
Confidentiality and invention assignment agreements with our employees, advisors and consultants may not adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary trade secrets and/or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets and/or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. However, trade secrets and/or confidential know-how can be difficult to maintain as confidential.
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To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, advisors and consultants to enter into confidentiality and invention assignment agreements with us. However, current or former employees, advisors and consultants may unintentionally or wilfully disclose our confidential information to competitors, and confidentiality and invention assignment agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third-party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality and invention assignment agreements may vary from jurisdiction to jurisdiction.
Failure to obtain or maintain trade secrets and/or confidential know-how trade protection could adversely affect our competitive position. Moreover, our competitors may independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in obtaining such patent protection, our competitors could limit our use of our trade secrets and/or confidential know-how.
Intellectual property rights do not address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:
| Others may be able to make products that are similar to ours but that are not covered by our intellectual property rights. |
| Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights. |
| We or any of our collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license. |
| We or any of our collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or will have obtained a license. |
| It is possible that any pending patent applications that we have filed, or will file, will not lead to issued patents. |
| Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors. |
| Our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets. |
| Ownership of our patents or patent applications may be challenged by third parties. |
| The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business. |
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Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidate.
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and exploiting patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and exploiting biopharmaceutical patents is costly, time-consuming and inherently uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Such examples include:
| Nautilus, Inc. v. Biosig Instruments, Inc. (2014), where the Court imposed a stricter requirement for clarity of claim language than previously applied by the Federal Circuit, thereby making it easier to invalidate patents for insufficiently apprising the public of the scope of the invention. |
| Limelight Networks, Inc. v. Akamai Technologies, Inc. (2014), where the Court articulated a standard for inducement of infringement that makes it more difficult to establish liability for inducing infringement of a multi-step method claim that is performed by multiple parties. |
| Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), where the Court held that isolated naturally-occurring DNA is patent ineligible subject matter. |
| KSR v. Teleflex (2007), where the Court decided unanimously that the Federal Circuit Court had been wrong in taking a narrow view of when an invention is obvious and thus cannot be patented. |
| EBay Inc. v. MercExchange, LLC (2006), where the Court heightened the standard for an injunction after a finding of patent infringement. |
| Merck KGgA v. Integra Lifesciences (2004), where the Court adopted an expansive interpretation of the activities associated with regulatory approval exempt from patent infringement. |
In addition, the America Invents Act, or AIA, has been recently enacted in the United States, resulting in significant changes to the U.S. patent system. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, the combination of the U.S. Supreme Court decisions and AIA has created uncertainty with respect to the value of patents, once obtained. A few highlights of changes to U.S. patent law under the AIA are:
| Under the AIA, a patent is awarded to the first-inventor-to-file rather than the first to invent. |
| There is a new definition of prior art which removes geographic and language boundaries found in the pre-AIA law. At the same time, certain categories of secret prior art have been eliminated. |
| The AIA introduced new procedures for challenging the validity of issued patents: post-grant review and inter partes review. |
| Patent owners under the AIA may now request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent. |
| The AIA allows third parties to submit any patent, published application, or publication relevant to examination of a pending patent application with a concise explanation for inclusion during prosecution of the patent application. |
The first-inventor-to-file system and the new definitions of prior art apply to U.S. patent applications with claims having an effective filing date on or after March 16, 2013. Until at least 2034, patent practice will involve both pre-AIA and AIA laws. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to exploit our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Changes in patent law or patent jurisprudence could limit our ability to obtain new patents in the future that may be important for our business.
We may face difficulties with protecting our intellectual property in certain jurisdictions, which may diminish the value of our intellectual property rights in those jurisdictions.
The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the U.S. and the EU, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If we or our collaboration partners encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished and we may face additional competition from others in those jurisdictions.
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Some countries in Europe and China have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are, or any of our licensors is, forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position or commercial advantage may be impaired and our business and results of operations may be adversely affected.
Risks Relating to Our Securities
Our stock price is volatile and could decline significantly.
The market price of our ordinary shares historically has been, and we expect will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to us, to changes in analysts recommendations and earnings estimates, to arbitrage between our Australian-listed ordinary shares and our NASDAQ-listed ADSs, to changes in exchange rates, or to factors affecting the biopharmaceutical industry or the securities markets in general. Market fluctuations, as well as general political and economic conditions, such as a recession, interest rate or currency fluctuations, could adversely affect the market price of our securities.
For example, during the last two fiscal years, the market price for our ordinary shares on the Australian Securities Exchange and ADSs on NASDAQ has ranged from a low of A$0.020 and US$1.25, respectively, to a high of A$0.044 and US$3.30, respectively. We may experience a material decline in the market price of our shares, regardless of our operating performance. Therefore, a holder of our ordinary shares or ADSs may not be able to sell those ordinary shares or ADSs at or above the price paid by such holder for such shares or ADSs. Price declines in our ordinary shares or ADSs could result from a variety of factors, including many outside our control. These factors include:
| the results of pre-clinical testing and clinical trials by us and our competitors; |
| unforeseen safety issues or adverse side effects resulting from the clinical trials or the commercial use of our product candidate; |
| regulatory actions in respect of any of our products or the products of any of our competitors; |
| announcements of the introduction of new products by us or our competitors; |
| market conditions, including market conditions in the pharmaceutical and biotechnology sectors; |
| increases in our costs or decreases in our revenues due to unfavorable movements in foreign currency exchange rates; |
| developments or litigation concerning patents, licenses and other intellectual property rights; |
| litigation or public concern about the safety of our potential products; |
| changes in recommendations or earnings estimates by securities analysts; |
| actual and anticipated fluctuations in our quarterly operating results; |
| deviations in our operating results from the estimates of securities analysts; |
| rumors relating to us or our competitors; |
| additions or departures of key personnel; |
| changes in third-party reimbursement policies; and |
| developments concerning current or future strategic alliances or acquisitions. |
In addition, volatility and low market price of our ordinary shares and/or ADSs may adversely impact investors interest in our securities. A decline in investors interest may prompt further volatility and decrease in market price.
Our ordinary shares may be considered a penny stock under SEC regulations which could adversely affect market trading in our ADSs.
The SEC has adopted regulations which generally define penny stock to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. During the fiscal year ended June 30, 2018, our ordinary shares traded on the NASDAQ from low of US$1.25 to a high of US$3.06 per share. During the fiscal year ended June 30, 2017, our ordinary shares traded on the NASDAQ from a low of US$1.70 to a high of US$3.30 per share. Penny stock rules impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and accredited investors. The term accredited investor refers generally to institutions with assets in excess of US$5,000,000 or individuals with a net worth in excess of US$1,000,000 or annual income exceeding US$200,000 or US$300,000 jointly with their spouse in each of the prior two years.
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The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC, which provides (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the brokers or dealers duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customers account.
In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchasers written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.
These disclosure requirements may significantly burden trading in, and delay the execution of transactions in, our ADSs. Thus, if our ADSs are considered penny stock, these disclosure requirements may adversely impact market trading in our ADSs.
We may be a passive foreign investment company (PFIC) which would subject our U.S. investors to adverse tax rules.
Holders of our ADSs who are U.S. residents face income tax risks if we are a passive foreign investment company, or PFIC, which could result in a reduction in the after-tax return to a U.S. Holder of our ADSs and reduce the value of our ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income.
If we are classified as a PFIC in any year that a U.S. Holder owns ADSs, the U.S. Holder will generally continue to be treated as holding ADSs of a PFIC in all subsequent years, notwithstanding that we are not classified as a PFIC in a subsequent year. Dividends received by the U.S. Holder and gains realized from the sale of our ADSs would be taxed as ordinary income and subject to an interest charge. We urge U.S. investors to consult their own tax advisors about the application of the PFIC rules and certain elections that may help to minimize adverse U.S. federal income tax consequences in their particular circumstances.
We have never paid a dividend and we do not intend to pay dividends in the foreseeable future which means that holders of shares and ADSs may not receive any return on their investment from dividends.
To date, we have not declared or paid any cash dividends on our ordinary shares and currently intend to retain any future earnings for funding growth. We do not anticipate paying any dividends in the foreseeable future. Dividends may only be paid out of our profits. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors. Our holders of shares and ADSs may not receive any return on their investment from dividends. The success of your investment will likely depend entirely upon any future appreciation of the market price of our ordinary shares and ADSs, which is uncertain and unpredictable. There is no guarantee that our ordinary shares and ADSs will appreciate in value or even maintain the price at which you purchased your ordinary shares and ADSs.
Currency fluctuations may adversely affect the price of the ADSs relative to the price of our ordinary shares.
The price of our ordinary shares is quoted in Australian dollars and the price of our ADSs is quoted in U.S. dollars. Movements in the Australian dollar/U.S. dollar exchange rate may adversely affect the U.S. dollar price of our ADSs and the U.S. dollar equivalent of the price of our ordinary shares. In the last two years, the value of the Australian dollar remained relatively stable against the U.S. dollar. There can be no assurance, however, that this trend will continue. If the Australian dollar weakens against the U.S. dollar, the U.S. dollar price of the ADSs could decline, even if the price of our ordinary shares in Australian dollars increases or remains unchanged.
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The requirements of being a public company may strain our resources and divert managements attention and if we are unable to maintain effective internal control over financial reporting in the future, the accuracy and timeliness of our financial reporting may be adversely affected.
As a publicly-traded company, we are subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended (the Exchange Act), the Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of the NASDAQ Global Market and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file certain reports with respect to our business and results of operations. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight are required. As a result, managements attention may be diverted from other business concerns, which could adversely affect our business and results of operations.
The Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal control over financial reporting annually and disclosure controls and procedures quarterly. In particular, beginning with fiscal year ended on June 30, 2013, we have performed system and process evaluation and testing of our internal control over financial reporting to allow our management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. We have in prior fiscal years identified material weaknesses that have been remediated. If we identify material weaknesses in future periods or we are not able to comply with the requirements of Section 404 in a timely manner, our reported financial results could be restated, we could be subject to investigations or sanctions by regulatory authorities, which would require additional financial and management resources, and the market price of our stock could decline.
The listing of our securities on stock exchanges in different countries may adversely impact their liquidity.
Our ordinary shares are listed and traded on the ASX and NASDAQ and on Over The Counter markets within Germany. Price levels for our ordinary shares could fluctuate significantly on either market, independent of our share price on the other market. Investors could seek to sell or buy our shares to take advantage of any price differences between the three markets through a practice referred to as arbitrage. Any arbitrage activity could create unexpected volatility in our share prices on either exchange and the volumes of shares available for trading on either exchange. In addition, holders of shares in either jurisdiction will not be immediately
able to transfer such shares for trading on the other markets without effecting necessary procedures with our transfer agent. This could result in time delays and additional cost for our shareholders. Further, if we are unable to continue to meet the regulatory requirements for listing on the ASX and NASDAQ, we may lose our listing on any of these exchanges, which could impair the liquidity of our shares.
Risks Related to an Investment in Our ADSs
Our ADS holders are not shareholders and do not have shareholder rights.
The Bank of New York Mellon, as depositary, registers and delivers our American Depositary Shares, or ADSs. Our ADS holders will not be treated as shareholders and do not have the rights of shareholders. The depositary will be the holder of the shares underlying our ADSs. Holders of our ADSs will have ADS holder rights. A deposit agreement among us, the depositary and our ADS holders, and the beneficial owners of ADSs, sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. For a description of ADS holder rights, see Item 12. Description of Securities Other than Equity SecuritiesD. American Depositary Shares.
Our shareholders have shareholder rights. Australian law and our constitution govern shareholder rights. For a description of our shareholders rights, see Item 10. Additional InformationB. Memorandum and Articles of Association. Shareholders are entitled to our notices of general meetings and to attend and vote at our general meetings of shareholders. At a general meeting, every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote on a show of hands. Every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote per fully paid ordinary share on a poll. This is subject to any other rights or restrictions which may be attached to any shares.
Our ADS holders do not have the same voting rights as our shareholders. ADS holders may exercise voting rights with respect to the underlying ordinary shares only in accordance with the provisions of the deposit agreement. Under the deposit agreement, ADS holders vote by giving voting instructions to the depositary. Upon receipt of instructions, the depositary will try to vote in accordance with those instructions. Otherwise, ADS holders will not be able to vote unless they withdraw the ordinary shares underlying their ADSs.
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If we ask for our ADS holders instructions, the depositary will notify our ADS holders of the upcoming vote and arrange to deliver our voting materials and form of notice to them. The depositary will try, as far as practical, subject to Australian law and the provisions of the depositary agreement, to vote the shares as our ADS holders instruct. The depositary will not vote or attempt to exercise the right to vote other than in accordance with the instructions of the ADS holders. We cannot assure our ADS holders that they will learn of ordinary shareholders meetings and receive the voting materials in time to instruct the depositary or withdraw the underlying ordinary shares. This means that there is a risk that our ADS holders may not be able to exercise voting rights and there may be nothing they can do if their shares are not voted as they requested.
Our ADS holders do not have the same rights to receive dividends or other distributions as our shareholders.
Subject to any special rights or restrictions attached to a share, the directors may determine that a dividend will be payable on a share and fix the amount, the time for payment and the method for payment (although we have never declared or paid any cash dividends on our ordinary stock and we do not anticipate paying any cash dividends in the foreseeable future). Dividends may be paid on shares of one class but not another and at different rates for different classes. Dividends and other distributions payable to our shareholders with respect to our ordinary shares generally will be payable directly to them. Any dividends or distributions payable with respect to ordinary shares will be paid to the depositary, which has agreed to pay to our ADS holders the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, after deducting its fees and expenses. Our ADS holders will receive these distributions in proportion to the number of shares their ADSs represent. In addition, there may be certain circumstances in which the depositary may not pay to our ADS holders amounts distributed by us as a dividend or distribution.
There are circumstances where it may be unlawful or impractical to make distributions to the holders of our ADSs.
The deposit agreement with the depositary generally requires the depositary to convert foreign currency it receives in respect of deposited securities into U.S. dollars and distribute the U.S. dollars to ADS holders, provided the depositary can do so on a reasonable basis. If it does not convert foreign currency, the depositary may distribute the foreign currency only to those ADS holders to whom it is possible to do so. If a distribution is payable by us in Australian dollars, the depositary will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, our ADS holders may lose some of the value of the distribution. The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. This means that our ADS holders may not receive the distributions we make on our shares or any value for them if it is illegal or impractical for us to make them available.
If we fail to comply with the Nasdaq listing requirements, Nasdaq may delist the ADSs, which could limit liquidity of the ADSs and adversely affect our business and access to future capital.
The ADSs are listed on the Nasdaq Global Market under the symbol IMMP. In the past we have failed, and in the future we may again fail, to comply with the Nasdaq Global Market regulations and listing requirements as to minimum stockholders equity, minimum market value, minimum total assets and revenue, minimum bid price, minimum public float and/or other requirements, and as a result Nasdaq may initiate procedures to delist the ADSs from the Nasdaq Global Market, which may adversely affect our business.
If we fail to meet Nasdaqs continued listing rules, the ADSs may be delisted from the Nasdaq Global Market. Delisting from the Nasdaq Global Market could have an adverse effect on our business, including our ability to access future capital, and on the trading of the ADSs. If a delisting of the ADSs were to occur, the ADSs may trade in the over-the-counter market such as on the OTC Bulletin Board or on the pink sheets. The over-the-counter market is generally considered to be a less efficient market, and this could diminish investors interest in the ADSs as well as significantly impact the price and liquidity of the ADSs. Any such delisting may also adversely affect the trading of the ADSs by ADS holders, or impede them from liquidating their holdings. Delisting may also adversely impact the success of future issues of securities or the possibility to receive additional financing, particularly in the United States.
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Risks Relating to Our Location in Australia
Currency fluctuations may expose us to increased costs and revenue decreases.
Our business is affected by fluctuations in foreign exchange rates. Our expenses are denominated in Australian dollars, U.S. dollars and European euro. Last year, the Australian dollar has, as a general trend, remained stable against the U.S. dollar and European euro, whereas two years ago, the Australian dollar had appreciated against the U.S. dollar and European Euro. We conduct clinical trials in many different countries and we have manufacturing of our product candidate undertaken outside of Australia, which exposes us to potential cost increases resulting from fluctuations in exchange rates. In fiscal 2018, we made net foreign exchange gain of A$323,000 as a result of currency fluctuations. In fiscal 2017, there was a small foreign exchange gain of A$433 as a result of currency fluctuations. In fiscal 2016, we made net foreign exchange losses as a result of currency fluctuations of A$0.6 million. Currency fluctuations could, therefore, cause our costs to increase and revenues to decline.
Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.
We are incorporated in Australia and are subject to the takeovers laws of Australia. Amongst other things, we are subject to the Corporations Act 2001 (Commonwealth of Australia). Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares (including through the acquisition of ADSs) if the acquisition of that interest will lead to a persons or someone elses voting power in us increasing from 20% or below to more than 20%, or increasing from a starting point that is above 20% and below 90%. Exceptions to the general prohibition include circumstances where the person makes a formal takeover bid for us, if the person obtains shareholder approval for the acquisition or if the person acquires less than 3% of the voting power of us in any rolling six month period. Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.
Rights as a holder of ordinary shares are governed by Australian law and our Constitution which differ from the rights of shareholders under U.S. law. Holders of our ordinary shares or ADSs may have difficulty in effecting service of process in the United States or enforcing judgments obtained in the United States.
We are a public company incorporated under the laws of Australia. Therefore, the rights of holders of our ordinary shares are governed by Australian law and our Constitution. These rights differ from the typical rights of shareholders in U.S. corporations. The rights of holders of ADSs are affected by Australian law and our Constitution but are governed by U.S. law. Circumstances that under U.S. law may entitle a shareholder in a U.S. company to claim damages may also give rise to a cause of action under Australian law entitling a shareholder in an Australian company to claim damages. However, this will not always be the case. Holders of our ordinary shares or ADSs may have difficulties enforcing, in actions brought in courts in jurisdictions located outside the U.S., liabilities under U.S. securities laws. In particular, if such a holder sought to bring proceedings in Australia based on U.S. securities laws, the Australian court might consider:
| that it did not have jurisdiction; and/or |
| that it was not an appropriate forum for such proceedings; and/or |
| that, applying Australian conflict of laws rule, U.S. law (including U.S. securities laws) did not apply to the relationship between holders of our ordinary shares or ADSs and us or our directors and officers; and/or |
| that the U.S. securities laws were of a public or penal nature and should not be enforced by the Australian court. |
Holders of our ordinary shares and ADSs may also have difficulties enforcing in courts outside the U.S. judgments obtained in the U.S. courts against any of our directors and executive officers or us, including actions under the civil liability provisions of the U.S. securities laws.
As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we may follow certain home country corporate governance practices instead of certain NASDAQ requirements.
As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we are permitted to follow certain home country corporate governance practices instead of certain requirements of The NASDAQ Marketplace Rules. As an Australian company listed on the NASDAQ Global Market, we may follow home country practice with regard to, among other things, the composition of the board of directors, director nomination process, compensation of officers and quorum at shareholders meetings. In addition, we may follow Australian law instead of the NASDAQ Marketplace Rules that require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest in the company and certain acquisitions of the stock or assets of another company. As a foreign private issuer that has
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elected to follow a home country practice instead of NASDAQ requirements, we have submitted to NASDAQ a written statement from our independent counsel certifying that our practices are not prohibited by Australian laws. In addition, a foreign private issuer must disclose in Annual Reports filed with the U.S. Securities and Exchange Commission each such requirement that it does not follow and describe the home country practice followed by the issuer instead of any such requirement. Accordingly, our shareholders may not be afforded the same protection as provided under NASDAQs corporate governance rules. Please see Item 6. Directors, Senior Management and EmployeesC. Board Practices for further information.
We are exposed to differing legal and tax laws in multiple jurisdictions, including complex transfer pricing rules in Australia.
We and our subsidiaries are located in a number of jurisdictions and therefore have exposure to different legal and taxation requirements in multiple jurisdictions, which requirements are subject to change. The listed entity Immutep Limited is incorporated in, and a tax resident of, Australia. It has a number of intercompany arrangements with its subsidiaries (resident outside Australia also for tax purposes), including, for example, funding and employee sourcing arrangements. In Australia there are complex and material requirements on transfer pricing of intercompany loan arrangements with overseas entities. The multiple jurisdictional structure of the Company and its subsidiaries can expose the group to substantial compliance and taxation liabilities. While we believe we are compliant with these tax laws, there is a risk that we and our subsidiaries could be subject to tax audits (with the resulting compliance costs) or exposed to fines or penalties.
ITEM 4. | INFORMATION ON THE COMPANY |
A. History and Development of the Company
Our legal and commercial name is Immutep Limited. We were incorporated under the laws of the Commonwealth of Australia on May 21, 1987 as Prima BioMed Ltd.
In December 2014, we completed the acquisition of Immutep S.A., a French company. In December 2014, Immutep S.A. underwent a change of company organization and become known as Immutep S.A.S. In November 2017, what was then known as Prima BioMed Ltd, changed its name to Immutep Limited to reflect the new strategic direction and management of the business to primarily focus on the development of its portfolio of LAG-3 based immunotherapy assets.
Our registered office is located at Level 12, 95 Pitt Street, Sydney 2000 New South Wales, Australia and our telephone number is +61 (0)2 8315 7003. Our address on the Internet is www.immutep.com. The information on, or accessible through, our website is not part of this Annual Report on Form 20-F. We have included our website address in this Annual Report on Form 20-F solely as an inactive textual reference.
Background
Immutep is a leader in the development of LAG-3 related immunotherapeutic products. Our key product candidate is IMP321, which is a recombinant protein in clinical trials for the treatment of different types of cancers.
IMP321, based on the LAG-3 immune control mechanism could play a vital role in the regulation of the T cell immune response. IMP321, which is a soluble LAG-3Ig fusion protein, is an antigen presenting cell (APC) activator boosting T cell responses. IMP321 is currently in a Phase IIb clinical trial as a chemoimmunotherapy combination for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT 02614833) and in a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT 02676869).
Two additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by Immuteps pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
Operations Summary
Immutep has administrative offices in Sydney, Australia, New York, USA and in Berlin, Germany. With the acquisition of Immutep S.A. in December 2014 we also have a laboratory located in Paris for the conduct of research and development relating to the LAG-3 program, under which we have four product candidates: IMP321, IMP761, IMP701 and IMP731. Background IP supporting the development of LAG-3 products was licensed from Merck Serono in 2002. Development milestones and royalties are payable on earnings of IMP321, IMP701 and IMP731. Further details are provided under the intellectual property section.
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As of June 30, 2018, we employed 19 people. Our internal staff manages the Companys finances, business development, intellectual property, investor relations, oversight of manufacturing, and clinical development. We make extensive use of outside contractors and consultants to help manage and conduct manufacturing and clinical trials.
IMP321 Clinical Development
Immuteps lead program is the development of IMP321, a recombinant protein that may be used in conjunction with chemotherapy to amplify a patients immune response. IMP321 may also be administered in combination with other agents and at different doses to achieve different effects on the immune system. These alternative applications of IMP321 are the subject of various clinical programs.
Immutep is developing IMP321 jointly with Eddingpharm under a licensing agreement dated May 2013 between Immutep S.A. and Eddingpharm. Eddingpharm has the exclusive development right of the IMP321 product in China, Hong Kong, Macau and Taiwan, while the development right in other countries is retained by Immutep. Eddingpharm has paid for the past manufacture of IMP321 GMP grade material needed for the conduct of clinical trials of IMP321 but current and future costs of manufacturing of IMP321 are now Immuteps responsibility. Immutep will offer technical assistance to Eddingpharm to facilitate its application to register IMP321 in China, Hong Kong, Macau and Taiwan. Eddingpharm is also required to make further milestone payments to Immutep if IMP321 achieves specific development milestones as well as undisclosed royalties on sales. Eddingpharms co-development of IMP321 is supported by a sublicense from Immutep to the background Serono licensed IP.
In fiscal 2016, we started two new clinical trials for IMP321. The first one was Active Immunotherapy PAClitaxel (AIPAC), a Phase IIb study on IMP321s effectiveness in treating metastatic breast cancer. Meetings have taken place with the European Medicines Agency (EMA) in regard to protocol design of the AIPAC study and the EMA have shown their support of the design, although a scientific advice is not legally binding. The primary purpose of the AIPAC trial, which will have a study group of up to 226 patients in the randomized part of the study and 15 patients who have been enrolled for the safety run-in (hence up to 241 patients in total), is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint in this patient population. The second of the two clinical trials was Two ACTive Immunotherapeutics in melanoma (TACTI-mel), a Phase I study on IMP321s effectiveness in enhancing immune responses to PD-1 inhibitors in melanoma patients. The primary purpose of the TACTI-mel trial, which will have a study group of up to 24 patients, is to determine safety and dosage levels for combining the two products in future trials.
In fiscal 2017, we continued our AIPAC Phase IIb and TACTI-mel Phase I clinical trials for IMP321. Regarding AIPAC Phase IIb clinical trial, in December 2016, we announced interim data, with respect to tests of IMP321 plus paclitaxel chemotherapy, with all 15 patients in the safety run-in phase confirming previous trial results as well as the safety, pharmacokinetics and pharmacodynamics of IMP321 at both dosage levels. In January 2017, we commenced the enlarged randomised phase of its AIPAC Phase IIb clinical trial for IMP321 in breast cancer. The randomised phase entails half of the 226 patients receiving paclitaxel plus a placebo and half receiving paclitaxel in conjunction with IMP321. Regarding TACTI-mel Phase I clinical trial, in December 2016, we announced first clinical data from its TACTI-mel Phase I clinical trial for IMP321 combined with PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA®) in melanoma cancer. The results confirmed that IMP321 is safe and well tolerated at the first dose level of 1 mg, paving the way for 6 mg dosage. In January 2017, we commenced recruitment for the second cohort of six patients for its TACTI-mel melanoma trial being conducted in Australia. This second cohort was fully recruited by March 2017.
We also entered into new partnerships. In particular, in July 2016, we announced a new clinical trial investigating the intra-tumoural injection of IMP321 in collaboration with the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany. In November 2016, we announced the signing of a non-binding MOU and strategic development and manufacturing partnership it entered into with WuXi Biologics. Under the partnership, WuXi Biologics will be the exclusive clinical and commercial manufacturer for IMP321 for Immutep worldwide (excluding: China, Macau, Taiwan and Hong Kong where rights are retained by Eddingpharm, Immuteps development partner in China). In January 2017, we entered into a new collaboration with Japans CYTLIMIC, a recent spin off from NEC Corporation (NEC), to test a cancer peptide vaccine in combination with IMP321.
In fiscal 2018, we continued our AIPAC Phase IIb and TACTI-mel Phase I clinical trials for IMP321. Regarding AIPAC Phase IIb clinical trial, clinical trials sites were opened across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. Active recruiting and patients treatments are undergoing as part of the randomized and controlled phase of the study. At the end of the fiscal year, we had recruited 113 patients. First data are expected in calendar year 2019. Regarding TACTI-mel Phase I clinical trial, we reported overall encouraging interim data regarding the efficacy and safety of IMP321 combined with pembrolizumab (KEYTRUDA®). In March 2018, we expanded the clinical trial to include a fourth cohort (Part B) of six patients which evaluates 30mg of efti in combination with pembrolizumab. This cohort was fully recruited in August 2018. In May 2018, interim data for the initial three cohorts yielded an overall response rate of 61% when the response rates from the initial four cycles of pembrolizumab monotherapy are used, and an overall rate response of 33% measured from the start of the combination therapy when IMP321 was added at cycle five of pembrolizumab. Two complete responses according to RECIST have been reported from the trial, out of 18 patients. We expect to report updated data from the TACTI-mel clinical trials in November 2018.
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We also expanded our collaborative studies. In particular, the INSIGHT clinical trial was amended in September 2018, through a collaboration with Merck KGaA and Pfizer, Inc. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH will be the sponsor of the amended clinical trial which will be conducted under the existing protocol of the ongoing INSIGHT clinical study. In particular, this new collaborative study will test the safety and efficacy of IMP321 combined with Merck KGaAs and Pfizers Avelumab, which is a stimulator of the immune system to detect and fight tumor cells, with respect to advanced solid tumors.
We also entered into a new collaboration with the Monash University in Melbourne following a grant of A$360,000 in August 2017. The grant will fund a research project of the role of LAG-3 in immune responses. Furthermore, our Chinese partner EOC Pharma, an affiliate of Eddingpharm, is expected to commence a Phase I trial of IMP321 in combination with paclitaxel with respect to the treatment of metastatic melanoma in September 2018.
In March 2018, we announced that we had entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to evaluate the safety and efficacy of the combination of IMP321 and pembrolizumab (KEYTRUDA) in a new Phase II clinical trial (TACTI-002) with respect to head and neck squamous cell carcinoma (second line) and non-small cell lung carcinoma (first and second line). In July 2018, the FDA granted approval of the IND regarding TACTI-002 Phase II clinical trial which allows us to initiate the study in the United States. We expect to commence this clinical trial in the last quarter of 2018 with the first data expected in mid calendar 2019. We expect to recruit up to 110 patients across 15 centers in the United States, Europe and Australia.
IMP731 Clinical Development
A second key product candidate of Immutep is IMP731, a depleting antibody that removes T cells involved in autoimmunity. The product candidate was acquired through our acquisition of Immutep S.A.S (formerly known as Immutep S.A.) in December 2014. Immutep S.A.S obtained the exclusive intellectual property rights of IMP731 from the Institut national de la santé et de la recherche médicale (INSERM Transfert) under a commercial co-ownership and exploitation agreement dated July 2010. In return, Immutep S.A.S has the obligation to make customary milestone payments when the product achieves market authorization, plus additional minor royalty payments on sales.
The development of IMP731 was licensed to Glaxo Smith Kline (GSK) under a license and research collaboration agreement dated December 2010 between Immutep S.A.S and GSK. Under the sublicense, GSK has the exclusive development right of IMP731and will fund all the development costs and make potential milestone payments in the aggregate amount of up to £64 million as well as potential royalty payments to Immutep.
In January 2015, we collected a milestone payment from GSK for the development of GSK2831781 (derived from Immuteps IMP731 antibody) for a first time in human clinical trial. GSK announced in July 2018 that the lead indication for GSK2831781 will be ulcerative colitis with Proof of Concept data expected in 2020. A new clinical study will build on GSKs Phase I clinical trial of the product candidate in psoriasis, which was completed in March 2018.
More information about the phase I clinical trial can be found at www.clinicaltrials.gov by searching for NCT02195349.
IMP701 Clinical Development
The third key product candidate of Immutep is IMP701, an antagonist (blocking) antibody targeting the LAG-3 molecule with potential application in the treatment of cancer. It is designed to block the negative signal in cytotoxic T cells, which may stop T cells from responding to the cancer. The product candidate was acquired through ours acquisition of Immutep S.A.S in December 2014.
The development of IMP701 was licensed to CoStim Pharmaceuticals under an exclusive license and collaboration agreement dated September 2012 between Immutep and CoStim. Under the license, CoStim has the exclusive development right of IMP701, in consideration for the obligation to fund all the development costs and to make milestone and royalty payments to Immutep S.A.S.
In February 2014, CoStim became a wholly owned subsidiary of Novartis, but the obligations of the Agreement remained with CoStim.
In August 2017 we received a milestone payment of US$1,000,000 from Novartis relating to our IMP701 LAG-3 antibody.
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Novartis currently has three active trials for its LAG525 (derived from Immuteps IMP701 antibody), with a fourth trial expected to commence soon.
More information about this clinical trial can be found at www.clinicaltrials.gov by searching for NCT02460224.
IMP761 Preclinical Development
On January 3, 2017 we announced a new early stage product candidate to be known as IMP761, developed in our laboratory in Paris, and believed to be the first agonist antibody of LAG-3. IMP761, our fourth LAG-3 related product candidate, is our first agonist antibody related to LAG-3. The product candidate is not partnered and in early preclinical development (in vitro and in vivo studies). No GMP grade material has been produced yet. In September 2018 we announced that we would commence cell line development and associated manufacturing steps to progress the development of IMP761.
Research Reagents used in the Development of LAG-3 Products
Our French subsidiary, Immutep S.A.S. manufactures, sells and distributes research reagents used by scientists in the research of LAG-3 products. In the fiscal year ending 30 June 2018, the business generated A$ 987,000 of revenue for Immutep S.A.S. The reagents are manufactured by Immutep S.A.S. and distributed through third party distributers. These third parties include Adipogen, Cytlimic Inc and Enzo.
The research reagents were originally manufactured and sold based on background licensed technology from Serono. Since 2016, the relevant patents have expired and Immutep therefore has no further obligation to make royalty payments on these sales to Serono under the licensing agreement dated December 2002 between Immutep and Serono.
CVac (Clinical Development for the Treatment of Ovarian Cancer Patients in Remission)
Prior to the acquisition of Immutep S.A., the lead program of Prima BioMed, was CVac for the treatment of epithelial ovarian cancer patients who were in complete second remission. This disease represents a significant unmet medical need due to the high relapse rates and high morbidity associated with the disease.
After completing a strategic review of the assets after acquiring Immutep S.A. in December 2014, Immutep Limited decided to consolidate the CVac clinical trial program and seek a development partner. In May 2016 Immutep entered into a sale and exclusive licensing agreement with Sydys Corporation, Inc., a New York-based company that has been repurposed as a clinical stage biotechnology company in order to develop the CVac assets. The shares of Sydys are publicly traded in the United States.
Under the terms of the agreement, Sydys licensed Immuteps CVac related assets, including manufacturing protocols, clinical data from Phase I and Phase II trials, patents and know-how. Immutep will also sell certain assets including some equipment and inventory to Sydys. In return, Immutep received a 9.9% equity stake in Sydys at the time of closing as consideration for the assets being transferred. Given the significant capital requirements for conducting clinical trials, no upfront payment was received. However, should CVac be successfully commercialized, Immutep could receive over A$400 million (US$293 million) in development, regulatory and commercial milestone payments payable for achievement of set commercial sales targets, in addition to low single digit royalties on sales. As Sydys possessed no significant cash reserves at the time of the transaction and is currently a one product company, there are significant risks associated with this transaction, such as the inability of Sydys to raise sufficient funds in order to develop and commercialize CVac.
Intellectual Property
As of June 30, 2018, Immutep owns, co-owns or licenses a total of 13 patent families. One patent family is in-licensed from Merck Serono and covers the background LAG-3 intellectual property (refer to the following paragraph for further details). The Merck Serono family expired on July 23, 2018 and four other in-licensed Merck Serono families covering the background LAG-3 intellectual property expired during fiscal years 2015-2018.
On the December 9, 2002, Ares Trading SA (a fully owned subsidiary of Serono, now Merck Serono) and Immutep S.A. entered into an exclusive Licence Agreement for the development of the LAG-3 technology. The license covers use of background patents and know-how necessary for the development of certain LAG-3 products. Confidential milestones and royalties are payable to Serono while the patent or know-how license is in force. As the license is exclusive it provides a greater level of protection to the development of LAG-3 products. The license is sub-licensable and has been sublicensed in Agreements with GSK, Co-Stim and Eddingpharm. Improvements to the technology and new developments in intellectual property covered by the license are the property of Immutep S.A.
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In addition to the patent family in-licensed from Merck Serono, Immutep owns or co-owns patent families which collectively cover its candidates IMP321, IMP731, IMP701 and IMP761.
In addition to patent protection for all of our assets, we rely on unpatented trade secrets, know-how and other confidential information as well as proprietary technological innovation and expertise that are protected in part by confidentiality and invention assignment agreements with our employees, advisors and consultants.
Patent matters in biotechnology are highly uncertain and involve complex legal and factual questions. The availability and breadth of claims allowed in biotechnology and pharmaceutical patents cannot be predicted. Statutory differences in patentable subject matter may limit the protection Immutep can obtain on some or all of their licensed inventions or prevent us from obtaining patent protection either of which could harm our business, financial condition and results of operations. Since patent applications are not published until at least 18 months from their first filing date and the publication of discoveries in the scientific literature often lags behind actual discoveries, we cannot be certain that we, or any of our licensors, were the first creator of inventions covered by pending patent applications, or that we or our licensors, were the first to file patent applications for such inventions. Additionally, the grant and enforceability of a patent is dependent on a number of factors that may vary between jurisdictions. These factors may include the novelty of the invention, the requirement that the invention not be obvious in the light of prior art (including prior use or publication of the invention), the utility of the invention and the extent to which the patent clearly describes the best method of working the invention. In short, this means that claims granted in various territories may vary and thereby influence commercial outcomes.
While we have applied and will continue to file for protection as appropriate for our therapeutic products and technologies, we cannot be certain that any future patent applications filed by the company, or licensed to us, will be approved, or that Immutep will develop additional proprietary products or processes that are patentable or that we will be able to license any other patentable products or processes. Immutep cannot be certain that others will not independently develop similar products or processes, duplicate any of the products or processes developed or being developed by the company or licensed to us, or design around the patents owned or licensed by us, or that any patents owned or licensed by us will provide us with competitive advantages.
Furthermore, we cannot be certain that patents held by third parties will not prevent the commercialization of products incorporating the technology developed by us or licensed to us, or that third parties will not challenge or seek to narrow, invalidate or circumvent any of the issued, pending or future patents owned or licensed by us.
Our commercial success will also depend, in part, on our ability to avoid infringement of patents issued to others. If a court determines that we were infringing any third party patents, we could be required to pay damages, alter our products or processes, obtain licenses or cease certain activities. We cannot be certain that the licenses required under patents held by third parties would be made available on terms acceptable to us or at all. To the extent that we are unable to obtain such licenses, we could be foreclosed from the development, export, manufacture or commercialization of the product requiring such license or encounter delays in product introductions while we attempt to design around such patents, and any of these circumstances could have a material adverse effect on our business, financial condition and results of operations. We may have to resort to litigation to enforce any patents issued or licensed to us or to determine the scope and validity of third party proprietary rights. Such litigation could result in substantial costs and diversion of effort by us. We may have to participate in opposition proceedings before the Australian Patent and Trademark Office or another foreign patent office, or in interference proceedings declared by the United States Patent and Trademark Office, to determine the priority of invention for patent applications filed by competitors. Any such litigation interference or opposition proceeding, regardless of outcome, could be expensive and time consuming, and adverse determinations in any such proceedings could prevent us from developing, manufacturing or commercializing our products and could have a material adverse effect on our business, financial condition and results of operations.
CVac is a registered trade mark in Australia, Europe, New Zealand, China, and the UAE. The CVac trade mark registrations are owned by the Company and have been licensed to Sydys. See Item 4. Information on the Company B BackgroundCVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission for more information.
During the course of fiscal year 2018, the Company filed a trademark application for IMMUTEP in Australia and also an International (Madrid) trademark application for IMMUTEP designating United States, Europe (EU), China and Japan, claiming priority from the Australian application. The Australian, United States and European applications have now proceeded to registration, and the Chinese and Japanese applications are pending.
Moreover, in fiscal 2018, we added four new patents (i) one patent granted in Japan relating to IMP321, (ii) one patent in Europe relating to IMP321, (iii) a patent granted in Japan relating to IMP731 and (iv) a patent granted in the United States relating to IMP701.
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Patent Portfolio
The following table presents our portfolio of patents and patent applications, including their status (as at June 30, 2018) and title.
Patent Family |
Title |
Status |
Expires | |||
356 (Serono) |
Use of MHC Class II ligands as adjuvant for vaccination and of LAG-3 in cancer treatment | Granted Europe x2, Canada x2, Israel, Japan, Korea, Singapore, Australia, China, Hong Kong, Mexico, US x2 | expired on July 23, 2018 | |||
400 (IGRD and Paris XI) |
Molecules binding to Glu-Pro motifs, therapeutical compositions containing them and their applications | Granted Europe | 2021 | |||
500 (Immutep S.A.S.) |
Vaccine composition comprising a class II MHC ligand couples with an antigen, method for the preparation and the use thereof | Granted Canada, Europe, Japan | 2025 | |||
550 (Immutep S.A.S. & INSERM) |
Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease | Pending China, US (x2), Europe Granted US, Canada, Europe and Japan (x2) |
2028 | |||
600 (Immutep S.A.S.) |
Compositions containing LAG-3 and cells that secrete GM-CSF and the methods of use | Granted US | 2028 | |||
650 (Immutep S.A.S.) |
Use of recombinant LAG-3 or the derivatives thereof for eliciting monocyte immune response |
Pending China, Europe (x2) and US Granted Australia, Europe (x2), Japan (x2) and US |
2028 | |||
660 (Immutep S.A.S.) |
Combined preparations for the treatment of cancer |
Pending in Australia, China, Europe, Japan, Korea, US and Hong Kong | 2034 | |||
670 (Immutep S.A.S.) |
Combination of IMP321 and a checkpoint inhibitor | Pending in Europe, Russia, US, Canada, Mexico, Australia, New Zealand, China, Korea, Japan, Brazil, India and Israel |
2036 | |||
700 (Immutep S.A.S. & Novartis) |
Antibody molecules to LAG-3 and uses thereof | National phase in 50 countries Granted US, Iraq and Lebanon |
2035 | |||
710 (Immutep S.A.S. & Novartis) |
Combination therapies comprising antibody molecules to LAG-3 | Pending in Europe and US | 2036 | |||
761 (Immutep S.A.S.) |
Anti-LAG-3 antibodies | Pending in Europe, Russia, US, Canada, Mexico, Brazil, Australia, New Zealand, China, Korea, Japan, India, Israel, Indonesia, Malaysia, Philippines, Singapore, Nigeria and South Africa |
2036 | |||
800 (Immutep S.A.S.) |
Binding assay | Pending PCT application | 2037 | |||
Family 3 |
||||||
(Burnet Institute) |
Method of producing dendritic cells pulsed with MFP | Granted in US | 2022 |
Competition
We expect to face competition from other pharmaceutical or biotech companies and academic institutions that have or are developing products or product candidates intended for the same indications for which our product candidates are being developed. These potentially competitive products include LAG-3 antibodies, checkpoint activators/inhibitors, cell therapies and other cancer treatments. We believe the competitive position of Immutep in the face of such competition will be driven by a number of factors including the safety and efficacy of IMP321 or our other product candidates compared with competitor products, the price value analysis, adoption by patients and physicians, timing of entry into the market in each indication, and the timing of regulatory approvals and influence of regulatory approvals. The need to continuously improve and optimize manufacturing costs is also expected to be crucial to remaining competitive.
Current treatments for metastatic breast cancer include chemotherapies/cytotoxics, parp inhibitors, angiogenesis inhibitors and immunotherapies. The competitive space for checkpoint inhibitors, including LAG-3, is constantly growing. IMP321 is a first in class agonist fusion protein that is an antigen presenting cell activator (immune activator) with limited direct competition. The Company believes there is significant potential for combining an immune activator with other treatment modalities including chemotherapies and checkpoint inhibitors to achieve enhanced therapeutic benefit.
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There are a number of companies developing antagonist LAG-3 antibodies, such as IMP701 that are more advanced than that being developed by Novartis but the safety and efficacy of these candidates remains to be seen. As far as we are aware, there are currently no other companies developing depleting LAG-3 antibodies such as IMP731 other than our partner, GSK. Our new early stage product candidate IMP761 is being developed as the first ever agonist antibody of LAG-3. It is mechanistically distinct from any of the known LAG-3 antibodies.
Regulatory Authorities
Our ongoing research and development, clinical, and manufacturing activities of our pharmaceutical products are subject to extensive regulation by numerous governmental authorities, including (i) in Australia, principally the Therapeutics Goods Administration, or TGA; (ii) in the United States, principally the Food and Drug Administration, or FDA; and (iii) in Europe, principally the European Medicines Agency, or EMEA.
United States
Government oversight of the pharmaceutical industry is usually classified into pre-approval and post-approval categories. Most of the therapeutically significant innovative products marketed today are the subject of New Drug Applications, or NDAs, or Biologics License Applications, or BLAs. Pre-approval activities, based on these detailed applications, are used to assure the product is safe and effective before marketing.
In the United States, The Centre for Biologics Evaluation and Research, or CBER, is the FDA organization responsible for vaccines, blood and biologics evaluation and approval. The FDA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. After the product is approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities by FDAs field investigators and analysts.
Federal Food, Drug and Cosmetic Act and Public Health Service Act
Prescription drug and biologic products are subject to extensive pre- and post-market regulation by the FDA, including regulations that govern the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, advertising and promotion of such products under the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations. The process of obtaining FDA approval and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial time and financial resources. Failure to comply with applicable FDA or other requirements may result in refusal to approve pending applications, a clinical hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total suspension of production or withdrawal of the product from the market. FDA approval is required before any new drug or biologic, including a new use of a previously approved drug, can be marketed in the United States. All applications for FDA approval must contain, among other things, information relating to safety and efficacy, stability, manufacturing, processing, packaging, labeling and quality control.
Biologic License Applications (BLAs)
The FDAs BLA approval process generally involves:
| completion of preclinical laboratory and animal testing in compliance with the FDAs good laboratory practice, or GLP, regulations; |
| submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin in the United States; |
| performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product for each intended use; |
| satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDAs Current Good Manufacturing Practices, or cGMP regulations; and |
| submission to and approval by the FDA of a BLA. |
The manufacturing and quality, as well as preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot guarantee approval of our product candidates will be granted on a timely basis, if at all. Preclinical tests include laboratory evaluation of toxicity and immunogenicity in animals. The results of preclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND application to the FDA. In such a case, the IND
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sponsor and the FDA must resolve any outstanding concerns. Further, an independent institutional review board, or IRB, covering each medical center proposing to conduct clinical trials must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations, which include requirements that all research subjects provide informed consent and that all clinical studies be conducted under the supervision of one or more qualified investigators.
For purposes of a BLA submission and approval, human clinical trials are typically conducted in the following sequential phases, which may overlap:
| Phase I: Trials are initially conducted in a limited population of healthy human subjects or patients to test the product candidate for safety and dose tolerance. Absorption, metabolism, distribution, and excretion testing is generally performed at this stage. |
| Phase II: Trials are generally controlled, explorative therapeutic trials in which the drug is studied in a limited patient population with the disease or medical condition for which the drug is intended to be used in order to identify possible adverse effects and safety risks, to determine the initial efficacy, dose tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more extensive Phase III clinical trials. |
| Phase III: These are commonly referred to as pivotal studies. When Phase II evaluations demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically-dispersed clinical trial sites. Generally, replicate evidence of safety and effectiveness needs to be demonstrated in two adequate and well-controlled Phase III clinical trials of a product candidate for a specific indication. These studies are intended to establish the overall risk/benefit ratio of the product candidate and provide adequate basis for product labeling. |
| Phase IV: In some cases, the FDA may condition approval of a BLA on the sponsors agreement to conduct additional clinical trials to further assess the product candidates safety, purity and potency after BLA approval. Such post-approval trials are typically referred to as Phase IV clinical trials. |
Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events. Concurrent with clinical studies, sponsors usually complete additional animal studies and must also develop additional information about the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. Moreover, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
The results of product development, preclinical studies and clinical trials, along with the aforementioned manufacturing information, are submitted to the FDA as part of a BLA. BLAs must also contain extensive manufacturing information. Under the Prescription Drug User Fee Act, or PDUFA, the FDA agrees to specific goals for BLA review time through a two-tiered classification system, Standard Review and Priority Review. Standard Review is applied to products that offer, at most, only minor improvement over existing marketed therapies. Standard Review BLAs have a goal of being completed within a ten-month timeframe, although a review can take a significantly longer amount of time. A Priority Review designation is given to products that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes the FDA to review a BLA is six months. The FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations.
The FDA may deny approval of a BLA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. Once issued, product approval may be withdrawn by the FDA if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, Risk Evaluation and Mitigation Strategies, or REMS, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs. Products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, approval of a new or supplemental BLA may be required, which may involve conducting additional preclinical studies and clinical trials.
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Other U.S. Regulatory Requirements
After approval, products are subject to extensive continuing regulation by the FDA, which include company obligations to manufacture products in accordance with GMP, maintain and provide to the FDA updated safety and efficacy information, report adverse experiences with the product, keep certain records and submit periodic reports, obtain FDA approval of certain manufacturing or labelling changes and comply with FDA promotion and advertising requirements and restrictions. Failure to meet these obligations can result in various adverse consequences, both voluntary and FDA-imposed, including product recalls, withdrawal of approval, restrictions on marketing, and the imposition of civil fines and criminal penalties against the BLA holder. In addition, later discovery of previously unknown safety or efficacy issues may result in restrictions on the product, manufacturer or BLA holder.
We, and any manufacturers of our products, are required to comply with applicable FDA manufacturing requirements contained in the FDAs GMP regulations. GMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation. The manufacturing facilities for our products must meet GMP requirements. We, and any third-party manufacturers, are also subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.
With respect to post-market product advertising and promotion, the FDA imposes a number of complex regulations on entities that advertise and promote pharmaceuticals, which include, among others, standards for direct-to-consumer advertising, promoting products for uses or in patient populations that are not described in the products approved labelling (known as off-label use), industry-sponsored scientific and educational activities, and promotional activities involving the Internet. Failure to comply with FDA requirements can have negative consequences, including adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors and civil or criminal penalties. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.
Changes to some of the conditions established in an approved application, including changes in indications, labelling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs.
Adverse event reporting and submission of periodic reports is required following FDA approval of a BLA. The FDA also may require post-marketing testing, known as Phase IV testing, risk mitigation strategies, and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.
European Union
In addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials vary greatly from country to country.
Under European Union regulatory systems, we must submit and obtain authorization for a clinical trial application in each member state in which we intend to conduct a clinical trial. After we have completed our clinical trials, we must obtain marketing authorization before we can market our product. We may submit applications for marketing authorizations either under a centralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states.
The European Medicines Agency, or EMA, is a body of the European Union located in London. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The EMA is involved in the scientific evaluation of medicines that fall within the scope of the centralized procedure. Like the FDA there is a harmonization between regulators and the EMA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. Additionally, after the product is approved and marketed, the EMA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities.
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Australia
In Australia, the relevant regulatory body responsible for the pharmaceutical industry is the Therapeutics Goods Administration, or TGA. As with the EMA and FDA there is a harmonization and collaboration between regulatory authorities. The TGA requires notification of all clinical trials via an electronic submission of a Clinical Trial Notification (CTN) prior to commencing the clinical trial.
Third-Party Payer Coverage and Reimbursement
Although our product candidate has not been commercialized for any indication, if they are approved for marketing, commercial success of our product candidate will depend, in part, upon the availability of coverage and reimbursement from third-party payers at the federal, state and private levels.
Inflation and Seasonality
Management believes inflation has not had a material impact on our operations or financial condition. Management further believes that our operations are not currently subject to seasonal influences due to our current lack of marketed products. Moreover, cancer and autoimmune diseases, which are the targets of our product candidates, are not seasonal diseases. Accordingly, once we have marketed products, management does not expect that our business will be subject to seasonal influences.
Manufacturing and Raw Materials
Immutep has no manufacturing capabilities and is dependent on third parties for cost effective manufacture and manufacturing process development of their product candidates. Problems with third party manufacturers or the manufacturing process as such may delay or jeopardize clinical trials and commercialization of Immuteps product candidates.
Biological product candidates like IMP731, IMP761, IMP701 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly negatively impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.
Below is a list of the current subsidiaries of Immutep, including our ownership percentage, its date of formation and its jurisdiction. These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States and expand our operations in Australia.
Subsidiary |
Ownership |
Date of Formation/Acquisition |
Jurisdiction | |||
Immutep U.S., Inc. |
100% | April 2010 (formed) | Delaware, United States | |||
Immutep GmbH |
100% | September 2010 (formed) | Germany | |||
Immutep Australia Pty Ltd |
100% | November 2011 (formed) | Australia | |||
Immutep IP Pty Ltd |
100% | November 2011 (formed) | Australia | |||
Immutep S.A.S. |
100% | December 2014 (acquired) | France |
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D. Property, Plants and Equipment
We own computer equipment, office furniture and laboratory equipment, which is primarily placed at our own offices and laboratories.
Office Location |
Lease expiry date | |
Sydney, Australia |
October 31, 2019 | |
Paris, France |
June 30, 2019 | |
Berlin, Germany |
February 2, 2019 | |
Leipzig, Germany |
December 31, 2018 | |
New York, USA |
February 28, 2019 |
ITEM 4A. | UNRESOLVED STAFF COMMENTS |
None.
ITEM 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
Overview
We are a development stage enterprise at an early stage in the development of our product candidate. We have incurred net losses since inception and expect to incur substantial and increasing losses for the next several years as we expand our research and development activities and move our product candidate into later stages of development. The process of carrying out the development of our products to later stages of development may require significant additional research and development expenditures, including pre-clinical testing and clinical trials, as well as for obtaining regulatory approval. To date, we have funded our operations primarily through the sale of equity securities, proceeds from the exercise of options, grants and interest income. For details of the business overview, see Item 4. Information on the CompanyB. Business Overview.
We are exposed to foreign currency risk via trade and other payables we hold. We are required to make certain payments in U.S. dollars, European Euro and other currencies. See Note 2. Financial Risk Management(a) Market Risk to our notes to the financial statements for a further discussion of market risk and sensitivity analysis.
Critical Accounting Policies and Estimates
Estimates and judgements are continually evaluated and are based on historical experience and other factors, including expectations of future events that may have a financial impact on the entity and that are believed to be reasonable under the circumstances.
We make estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.
Income taxes
Deferred tax assets relating to carried forward tax losses and taxable temporary differences have not been recognised since we are currently in a loss making position and unable to generate taxable income to utilise the carried forward tax losses and taxable temporary differences. The utilisation of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. We are subject to income taxes in Australia and jurisdictions where it has foreign operations. Significant judgement is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The Company estimates its tax liabilities based on the Companys understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.
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Development
The consolidated entity has expensed all internal development expenditure incurred during the year as the costs relate to the initial expenditure for development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the current stage of development. It was considered appropriate to expense the development costs as they did not meet the criteria to be capitalized under AASB 138 Intangible Assets (IAS 38).
Going concern
We have experienced significant recurring operating losses and negative cash flows from operating activities since its inception. As at June 30, 2018, the Company holds cash and cash equivalents of A$23,475,521 (2017: A$12,236,974 ). In line with the Companys financial risk management, the directors have carefully assessed the financial and operating implications of the above matters, including the expected cash outflows of ongoing research and development activities of the Company over the next 12 months. Based on this consideration, the directors are of the view that the Company will be able to pay its debts as and when they fall due for at least 12 months following the date of these financial statements and that it is appropriate for the financial statements to be prepared on a going concern basis.
Monitoring and addressing the ongoing cash requirements of the Company is a key focus of the directors. This involves consideration of alternative future capital raising initiatives and an active engagement with potential retail and institutional investors alike.
Amortization of intellectual property
Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.
Costs include only those costs directly attributable to the acquisition of the intellectual property. An assets carrying amount is written down immediately to its recoverable amount if the assets carrying amount is greater than its estimated recoverable amount.
Results of Operations
Comparison of Fiscal Year Ended June 30, 2018 to Fiscal Year Ended June 30, 2017
Revenue
Revenue from ordinary activities increased from nil in FY2017 to A$2.63 million in FY2018, which is attributed to milestone payments received from the Companys partners. In particular, in August 2017, the company received a US$1 million milestone payment from Novartis relating to the development of IMP701, and in Jan 2018, the Company received a US$1 million milestone payment from EOC Pharma relating to the development of IMP321 in China.
Other Income
Other income increased by A$0.5 million to A$ 4.7 million for FY2018 from A$4.2 million for FY2017. The increase was primarily attributable to a A$0.2 million increase in miscellaneous income from the LAG-3 research material sales and a A$0.3 million increase in foreign exchange gain recognised in the fiscal year of 2018.
In March 2018, Immutep received a A$0.7 million cash rebate from the Australian Federal Governments R&D tax incentive program, which was provided in respect of expenditure incurred on eligible research and development activities conducted in FY2017 and mainly related to our TACTI-mel trial being conducted in Australia. In addition, Immutep has recognised approximately A$0.7 million grant income from the Australian Federal Governments R&D tax incentive program.
The Companys French subsidiary has also benefited from cash grants of 0.9 million (approximately A$1.35 million) from the French Crédit dImpôt Recherche scheme (received in August 2017) for the eligible research and development expenditures incurred in the 2016 calendar year in Europe. The French subsidiary has also recognised A$2.5 million grant income from the French Crédit dImpôt Recherche scheme for the expenditure incurred on eligible research and development activities conducted in FY2018. Miscellaneous income increased by A$ 0.2 million to A$1.0 million for FY2018 from A$0.8 million for FY2017. This increase was primarily attributable to sales growth of manufactured product used in research.
Interest income for FY2018 was A$ 0.18 million versus A$0.10 million for FY2017. The increase was due to an increase in the level of cash held on term deposits and a reduction in interest rates.
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Research & Development and Intellectual Property Expenses
Research and development and intellectual property expenses increased by A$2.5 million to A$10.0 million for FY2018 from A$7.5 million for FY2017. The significant increase was primarily due to the increase in R&D expenses following patient recruitment for our two IMP321 related clinical trials, AIPAC and TACTI-mel, and the development of our new product candidate IMP761.
Corporate Administrative Expenses
Corporate administrative expenses for FY2018 were A$7.2 million compared to A$4.3 million in FY2017. This increase of A$2.9 million was primarily due to an (i) increase of A$0.6 million in salary expense as a result of increased headcount, (ii) an increase in non-cash expenses including A$1.4 million in employee share-based payments and (iii) A$0.5 million in transaction costs relating to the US capital raising.
Depreciation and Amortization Expenses
Depreciation and amortization expenses increased to A$1.8 million for FY2018 from A$1.7 million for FY2017. This was mainly due to the foreign currency translation difference.
Net change in fair value of convertible note liability
The net change in fair value of the convertible note liability was A$0.9 million for FY2018 compared to A$0.8 million for FY2017. The increase was attributable to the liability component of the convertible note being measured at fair value.
Net Loss
Whilst the loss after tax for FY2018 of A$12,746,020 was higher compared to A$9,367,206 for FY2017, mainly due to non-cash expenses, the operating cash outflows reduced year on year from $8.5 million in FY2017 to $7.8 million in FY2018.
Comparison of Fiscal Year Ended June 30, 2017 to Fiscal Year Ended June 30, 2016
Other Income
Other income increased by A$2.3 million to A$4.2 million for FY2017 from A$1.9 million for FY2016. The increase was primarily attributable to A$2.4 million higher grant income from the Australian and French governments recognised in the fiscal year of 2017.
In April Immutep received a A$0.5 million cash rebate from the Australian Federal Governments R&D tax incentive program, which was provided in respect of expenditure incurred on eligible research and development activities conducted in FY2016 and mainly related to our TACTI-mel trial being conducted in Australia. The company has also benefited from cash grants of 0.6 million (approximately A$0.9 million) from the French Crédit dImpôt Recherche scheme (received in February 2017) for the eligible R&D expenditures incurred in the calendar year 2015 in Europe. In addition, Immutep has recognised approximately A$0.6 million grant income from the Australian Federal Governments R&D tax incentive program and A$1.3 million (received in August 2017) from French Crédit dImpôt Recherche scheme for the expenditure incurred on eligible research and development activities conducted in the fiscal year of 2017 and the calendar year of 2016, respectively.
Miscellaneous income increased by A$0.1 million to A$0.8 million for FY2017 from A$0.7 million for FY2016. This increase was primarily attributable to sales growth of manufactured product used in research.
Interest income for FY2017 was A$0.1 million versus A$0.3 million for FY2016. The decrease was due to a decrease in the level of cash held on term deposits and a reduction in interest rates.
Research & Development and Intellectual Property Expenses
Research and development and intellectual property expenses increased by A$0.4 million to A$7.5 million for FY2017 from A$7.1 million for FY2016. The slight increase was expected and was primarily due to the increase in R&D expenses due to patient recruitment for our two IMP321 related clinical trials, AIPAC and TACTI-mel, and the development of our new product candidate IMP761.
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Corporate Administrative Expenses
Corporate administrative expenses for FY2017 was A$4.3 million compared to A$7.0 million in FY2016. This decrease of A$2.7 million was primarily due to a decrease of A$1.2 million in finance, legal and consulting expenses, a decrease of A$0.4 million in labour expenses, and a decrease of A$1.2 million in employee share-based payment expenses in FY2017 compared to the prior period.
Depreciation and Amortization Expenses
Depreciation and amortization expenses decreased to A$1.7 million for FY2017 from A$2.0 million for FY2016. This was due to certain intellectual property assets and the plant & equipment of CVac being written off during the fiscal year of 2016.
Finance cost
Finance costs were A$0 for FY2017 compared to A$0.01 million for FY2016. The interest expense incurred in the fiscal year of 2016 related to other borrowings which were repaid in August 2015.
Changes in fair value of comparability milestone
Changes in fair value of the comparability milestone were A$0 for FY2017 compared to A$0.5 million for FY2016. This amount related to a payment into a retention account on the acquisition of Immutep which was measured at fair value through the profit and loss.
Net change in fair value of convertible note liability
The net change in fair value of the convertible note liability was A$0.8 million for FY2017 compared to A$0.6 million for FY2016. The increase was attributable to the liability component of the convertible note being measured at fair value.
Net Loss
Net loss decreased to A$9.4 million for the fiscal year of 2017 from A$62.0 million for the fiscal year of 2016. This decrease was primarily due to the accounting treatment for a share based payment to a strategic investor where A$47.5 million was expensed in FY2016. The amount represents the difference between the accounting fair value of convertible notes and warrants issued to Ridgeback Capital Investments and the cash received, which was expensed on grant date.
New Accounting Standards and Interpretations Not Adopted
New and amended standards adopted by the Company
Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2018 reporting periods and have not been early adopted by the company. The companys assessment of the impact of these new standards and interpretations is set out below:
(i) | AASB 15 (IFRS 15) Revenue from Contracts with CustomersThe AASB has issued a new standard for the recognition of revenue. This will replace AASB 118 (IAS 18) which covers revenue arising from the sale of goods and the rendering of services and AASB 111 (IAS 11) which covers construction contracts. The new standard is based on the principle that revenue is recognized when control of a good or service transfers to a customer. The standard permits either a full retrospective or a modified retrospective approach for the adoption. It applies to annual reporting periods commencing on or after 1 January 2018. The impact of the new standard on the financial statements when applied to future periods will depend on the Companys sources of revenues at the time of adoption of the new standard. The impact of the new standard on the financial statements when applied to future periods will depend on our sources of revenues at the time of adoption of the new standard. Immutep currently has limited sources of revenue as it is still in the research and development phase and has assessed that the new revenue standard will have minimal impact. Immutep plans to use the modified retrospective approach for the adoption. |
(ii) | AASB 9 (IFRS 9) Financial InstrumentsAASB 9 (IFRS 9) addresses the classification, measurement and derecognition of financial assets and financial liabilities, introduces new rules for hedge accounting and a new impairment model for financial assets. It applies to annual reporting periods commencing on or after 1 January 2018. Management has assessed the impact of the new standard on the financial statements when applied to future periods and expects it to have limited impact. |
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(iii) | AASB 16 (IFRS 16) LeasesThe AASB 16 (IFRS 16) has issued a new standard for the accounting of leases. The new standard will predominantly affect lessees, with almost all leases brought onto the balance sheet. It applies to annual reporting periods commencing on or after 1 January 2019. Management has yet to fully assess the impact of the new standard on the financial statements when applied to future periods, although the Company currently has no significant off-balance sheet lease commitments. |
There are no other standards and interpretations that are not yet effective and that are expected to have a material impact on the Company in the current or future reporting periods and on foreseeable future transactions.
B. Liquidity and Capital Resources
Since our inception, our operations have mainly been financed through the issuance of equity securities. Additional funding has come through convertible loans, operating grants and interest earned from cash on term deposit.
Equity Issuances
The following table summarizes our issuances of ordinary shares for cash, share-based payments and executive and employee compensation in the last five fiscal years.
Fiscal Year |
Number of Shares/Options |
Net Proceeds | ||||||||||
(in A$) | ||||||||||||
Ordinary Shares share purchase plan |
2014 | 85,562,503 | 6,845,001 | |||||||||
Ordinary Shares private placement, repayment of convertible loans and exercise of performance rights and options |
2015 | 522,785,260 | 7,744,648 | |||||||||
Ordinary Shares private placement, share purchase plan and exercise of performance rights and options |
2016 | 310,136,343 | 13,761,075 | |||||||||
Ordinary Shares exercise of performance rights and options |
2017 | 18,111,994 | 1 | |||||||||
Ordinary Shares private placement, share purchase plan and exercise of performance rights and options |
2018 | 946,339,731 | 16,968,200 |
Capital Requirements
As of June 30, 2018, we had year-end cash and cash equivalents of A$23.5 million. We anticipate that our current cash and cash equivalents will be sufficient to fund our operations for more than 12 months from the date of this filing. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue one or more of our clinical trials or our operations.
We anticipate that we will require substantial additional funds in order to achieve our long-term goals and complete the research and development of our current product candidates. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our product candidate and sales of our product candidate have commenced. We therefore expect to continue to incur substantial losses in the near future. Our future capital requirements are difficult to forecast and will depend on many factors, including:
| the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
| the scope, results and timing of preclinical studies and clinical trials; |
| the costs and timing of regulatory approvals; and |
| the costs of establishing sales, marketing and distribution capabilities. |
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Cash Flows
The following table summarizes our cash flows for the periods presented:
Fiscal Year Ended June 30, | ||||||||||||
2018 | 2017 | 2016 | ||||||||||
A$ | A$ | A$ | ||||||||||
Net cash used in operating activities |
(7,776,703 | ) | (8,506,798 | ) | (11,309,691 | ) | ||||||
Net cash provided by (used in) investing activities |
(11,893 | ) | (6,644 | ) | 102,575 | |||||||
Net cash provided by (used in) financing activities |
18,404,567 | (8,532 | ) | 25,720,284 | ||||||||
Net increase (decrease) in cash and cash equivalents |
10,615,971 | (8,521,974 | ) | 14,513,168 | ||||||||
Effect of exchange rate on cash and cash equivalents |
622,576 | (120,600 | ) | (393,235 | ) | |||||||
Cash and cash equivalents at beginning of period |
12,236,974 | 20,879,548 | 6,759,615 | |||||||||
Cash and cash equivalents at end of period |
23,475,521 | 12,236,974 | 20,879,548 |
Operating Activities
Net cash used in operating activities was A$7.8 million, A$8.5 million, and A$11.3 million during fiscal years 2018, 2017 and 2016, respectively. Payments to suppliers and employees account for almost all of the amounts above for R&D and administrative purposes. Payments to suppliers and employees increased by A$2.8 million during fiscal year 2018 primarily due to due to the increase in research and development activities with patient recruitment for our two IMP321 related clinical trials, AIPAC and TACTI-mel, and the development of our new product candidate IMP761.
During fiscal years 2018, 2017 and 2016, our payments to suppliers and employees were offset by license revenue received of A$2.6 million, A$ nil and A$0.2 million, respectively, interest income received of A$0.1 million, A$0.1 million, and A$0.3 million, respectively, and grant income received of A$ 2.0 million, A$1.4 million, and A$0.9 million, respectively.
Investing Activities
Net cash used in investing activities was A$11,893 during fiscal year 2018, while net cash used in investing activities was A$6,644 during fiscal year 2017 and net cash provided by investing activities was A$0.1 million during fiscal year 2016. The net cash outflow for fiscal year 2018 and 2017 was due to the purchase of plant and equipment. The cash inflow in fiscal year 2016 was a result of the sale of plant and equipment.
Financing Activities
Net cash provided by financing activities during fiscal year 2018 was A$18.4 million, while net cash used in financing activities was A$8,532 for fiscal years 2017 and Net cash provided by financing activities during fiscal year 2016 was A$25.7 million. Net cash used in or provided by financing activities during (i) fiscal 2018 was primarily attributable to the US capital raising(A$5.2 million), Share placement(A$6.9 million) and Securities Purchase Agreement (A$6.3 million), (ii) fiscal 2017 was primarily attributable to the exercise of performance rights, (iii) fiscal 2016 was primarily due to the issue of shares attributable to a share purchase plan (A$10 million) and attributable to private placements to institutional investors (A$3.8 million) and the issue of convertible notes (A$13.7 million), which matures on August 4, 2025 and accrue interest at a rate of 3% per annum which may also be converted into shares.
At June 30, 2018 we had A$23.5 million in cash and cash equivalents compared with 2017, where we had A$12.2 million in cash and cash equivalents. At June 30, 2016, we had A$20.9 million in cash and cash equivalents.
C. Research and Development, Patents and Licenses
For a description of our research and development programs and activities, see Item 4. Information on the CompanyB. Business OverviewBackground. For a description of the amount spent during each of the last three fiscal years on company-sponsored research and development activities, as well as the four components of research and development expenses, see Item 5. Operating and Financial Review and ProspectsA. Operating ResultsResults of Operations.
We are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research or commercialization efforts.
Our research and development expenditure is our primary expenditure. Increases or decreases in research and development expenditure are attributable to the level of clinical trial activity and the amount of expenditure on those trials. The main clinical trials are the ongoing AIPAC 226 patient Phase IIb study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 as an adjuvant to a standard chemotherapy treatment regimen of paclitaxel and our pilot Phase I TACTI-mel study for 24 patients with unresectable or metastatic melanoma who are being dosed with IMP321 in combination with KEYTRUDA® (pembrolizumab).
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It is expected that our R&D expenses will increase as we continue to progress our ongoing clinical trials with IMP321, as well as commence the recently announced trials with our partners. Expenses will also increase as we continue to progress the pre-clinical development of IMP761.
E. Off-Balance Sheet Arrangements
During fiscal years 2018, 2017 and 2016, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
F. Tabular Disclosure of Contractual Obligations
As of June 30, 2018, our contractual obligations were as set forth below:
Payments Due by Period | ||||||||||||
Contractual maturities of financial liabilities |
Less than 6 months |
More than 5 years |
Total contractual cash flows |
|||||||||
$ | $ | $ | ||||||||||
Non-Derivatives |
||||||||||||
Trade and other payables |
3,663,849 | | 3,663,849 | |||||||||
Convertible note liability |
| 17,876,076 | 17,876,076 | |||||||||
|
|
|
|
|
|
|||||||
3,663,849 | 17,876,076 | 21,539,925 | ||||||||||
|
|
|
|
|
|
We have agreements with clinical sites and contract research organizations. We make payments to these sites and organizations based upon the number of patients enrolled and the period of follow-up in the trial.
Special note regarding forward-looking statements
This Annual Report contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and section 21E of the U.S. Securities Exchange Act of 1934, as amended, including assumptions, anticipations, expectations and forecasts concerning the Companys future business plans, products, services, financial results, performance, future events and information relevant to our business, industries and operating environments. When used in this document, the words
anticipate, believe, estimate, assume, could, should, expect and similar expressions, as they relate to the Company or its management are intended to identify forward-looking environments. Such statements reflect the current views of management with respect to future events and are subject to certain risks, uncertainties and assumptions. The forward-looking statements contained herein represent a good-faith assessment of our future performance for which we believe there is a reasonable basis. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expresses or implied by such forward-looking statements, including, among others, adverse changes or uncertainties in economic conditions that affect the markets we serve and the risks as described in Item 3D. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
These forward-looking statements represent our view only as of the date they are made and we disclaim any obligation to update forward-looking statements contained herein, except as may be otherwise required by law.
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ITEM 6. | DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES |
A. Directors and Senior Management
The following table sets forth our directors and senior management, their age and the positions they held as of September 1, 2018.
Name |
Age |
Position | ||
Russell Howard, Ph.D. (1) |
68 | Chairman and Non-Executive Chairman | ||
Pete Meyers (3) |
48 | Deputy Chairman and Non-Executive Director | ||
Grant Chamberlain (2) |
47 | Non-Executive Director | ||
Marc Voigt |
45 | Executive Director, Chief Executive Officer, Chief Financial Officer and Chief Business Officer | ||
Frédéric Triebel |
63 | Chief Scientific Officer & Chief Medical Officer | ||
Deanne Miller |
41 | Chief Operating Officer, General Counsel & Company Secretary |
(1) | Chair of the Remuneration Committee and member of the Audit & Risk Committee. |
(2) | Member of the Remuneration Committee and Audit & Risk Committee. |
(3) | Chair of the Audit & Risk Committee and member of the Remuneration Committee. |
Dr. Russell Howard, Ph.D. Dr. Russell Howard is an Australian scientist, executive manager and entrepreneur. He was a pioneer in molecular parasitology and commercialization of DNA Shuffling. He is an inventor of 9 patents and has over 150 scientific publications. After his PhD in biochemistry from the University of Melbourne, he held positions at several research laboratories, including the National Institutes of Health in the USA where he gained tenure. In industry, Dr. Howard worked at Schering-Ploughs DNAX Research Institute in Palo Alto, CA; was the President and Scientific Director of Affymax, Inc. and co-founder and CEO of Maxygen, Inc. After its spin-out from GlaxoWellcome, as Maxygens CEO, Dr. Howard led its IPO on NASDAQ and a secondary offering, raising US$ 260 million. Maxygen developed and partnered dozens of technology applications and products over 12 years of his tenure as CEO. After leaving Maxygen in 2008, he started the Cleantech company Oakbio, Inc. And remains involved in several innovative companies in the USA and Australia. He is currently Executive Chairman of NeuClone Pty Ltd.
Mr. Pete Meyers. Pete Meyers is currently the Chief Financial Officer of Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX). From May 2016 to January 2017, Mr. Meyers served as the Chief Financial Officer of Motif BioSciences Inc. (NASDAQ: MTFB; AIM: MTFB), where he led the execution of the companys November 2016 US IPO. From August 2013 to March 2016, Mr. Meyers served as Chief Financial Officer and Treasurer of TetraLogic Pharmaceuticals Corporation (NASDAQ: TLOG), where he led the execution of the companys December 2013 IPO and subsequent acquisition of Shape Pharmaceuticals, Inc. Prior to his role at TetraLogic, Mr. Meyers spent 18 years in health care investment banking, holding positions of increasing responsibility at Dillon, Read &Co., Credit Suisse First Boston LLC and, most recently, as Co-Head of Global Health Care Investment Banking at Deutsche Bank Securities Inc. Mr. Meyers is the Chairman and President of The Thomas M. Brennan Memorial Foundation, Inc. He earned a Bachelor of Science degree in Finance from Boston College and a Master of Business Administration degree from Columbia Business School.
Mr. Grant Chamberlain. Mr Chamberlain is a principal of One Ventures, one of Australias leading venture capital firms. He has over 20 years experience in investment banking and has advised on many of the largest mergers and acquisitions transactions in Australia during that time. Mr Chamberlain was Head of Mergers & Acquisitions and Financial Sponsors Australia at Bank of America Merrill Lynch until June 2017 and prior to joining Bank of America Merrill Lynch in 2013, Mr Chamberlain held senior positions at Nomura Australia and Deutsche Bank. He began his career as a corporate lawyer at Freehill Hollingdale & Page. Mr Chamberlain earned a Bachelor of Laws with Honours and a Bachelor of Commerce from the University of Melbourne.
Mr. Marc Voigt. Marc has more than 18 years of experience in the financial and biotech industry, having joined the Immutep team in 2011 as the General Manager, European Operations based in Berlin, Germany. In May 2012, he became Immutep s Chief Business Officer and in November 2012 its Chief Financial Officer, as well as continuing to focus on its European operations. He was then promoted to the role of Chief Executive Officer of Immutep in July 2014. Having started his career at the Allianz Group working in pension insurances and funds, he moved to net.IPO AG, a publicly-listed boutique investment bank in Frankfurt where he was focused on IPOs and venture capital investments. Marc then worked for a number of years as an investment manager for a midsize venture capital fund based in Berlin, specializing in healthcare. He also gained considerable operational experience while serving in different management roles with Revotar Biopharmaceuticals, Caprotec Bioanalytics and Medical Enzymes AG respectfully, where he handled several successful licensing transactions and financing rounds.
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Dr. Frédéric Triebel , MD Ph.D., Dr Triebel is our Chief Scientific Officer and Chief Medical Officer and has been with the Company since December 2014, following the completion of the acquisition of Immutep S.A. Dr Triebel was the scientific founder of Immutep S.A. (2001) and served as the Scientific and Medical Director at Immutep from 2004. Before starting Immutep S.A., he was Professor in Immunology at Paris University. While working at Institut Gustave Roussy (IGR), a large cancer center in Paris, he discovered the LAG-3 gene in 1990 and continued working on this research program since then, identifying the functions and medical usefulness of this molecule. He headed a research group at IGR while also being involved in the biological follow-up of cancer patients treated in Phase I/II immunotherapy trials. He was Director of an INSERM Unit from 1991 to 1996. First trained as a clinical hematologist, Prof. Triebel holds a Ph.D. in immunology (Paris University) and successfully developed several research programs in immunogenetics and immunotherapy, leading to 144 publications and 16 patents.
Ms. Deanne Miller. Ms. Miller joined the Company as General Counsel and Company Secretary in October 2012 and was promoted to the role of Chief Operating Officer in November 2016. She has broad commercial experience having held legal, investment banking, regulatory compliance and tax advisory positions, including, Legal Counsel at RBC Investor Services, Associate Director at Westpac Group, Legal & Compliance Manager at Macquarie Group, Regulatory Compliance Analyst at the Australian Securities and Investment Commission, and Tax Advisor at KPMG. She has a Combined Bachelor of Laws (Honours) and Bachelor of Commerce, Accounting and Finance (double major) from the University of Sydney. She is admitted as a solicitor in NSW and member of the Law Society of NSW.
Remuneration Principles
Remuneration of all executive and non-executive directors and officers is determined by the Remuneration Committee.
We are committed to remunerating senior executives and executive directors in a manner that is market-competitive and consistent with Best Practice including the interests of shareholders. Remuneration packages are based on fixed and variable components, determined by the executives position, experience and performance, and may be satisfied via cash or equity.
Non-executive directors are remunerated out of the aggregate amount approved by shareholders and at a level that is consistent with industry standards. Non-executive directors do not receive performance based bonuses and prior shareholder approval is required to participate in any issue of equity. No retirement benefits are payable other than statutory superannuation, if applicable.
Our remuneration policy is not directly based on our financial performance, rather on industry practice, given we operate in the biotechnology sector and our primary focus is research activities with a long term objective of developing and commercializing the research and development results.
We envisage our performance in terms of earnings will remain negative while we continue in the research and development phase.
The purpose of a performance bonus is to reward individual performance in line with our objectives. Consequently, performance based remuneration is paid to an individual where the individuals performance clearly contributes to a successful outcome. This is regularly measured in respect of performance against key performance indicators.
We use a variety of key performance indicators to determine achievement, depending on the role of the executive being assessed. These include:
| Successful contract negotiations. |
| Achievement of research project milestones within scheduled time and/or budget. |
| Our share price reaching a targeted level on the ASX over a period of time. |
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Executive Compensation
The following table sets forth all of the compensation awarded to, earned by or paid to each individual who served as directors and executive officers in fiscal 2018.
June 30, 2018 |
Short-term Benefits | Post Employment Benefits |
Long- term Benefits |
Share-based Payments |
Total | |||||||||||||||||||||||||||||||
Cash salary and fees A$ |
Cash bonus A$ |
Non Monetary A$ |
Super- annuation A$ |
Long service leave A$ |
Termi- nation benefits A$ |
Executive Performance rights A$ |
Options issued A$ |
A$ | ||||||||||||||||||||||||||||
Non-Executive Directors |
||||||||||||||||||||||||||||||||||||
Dr. R. Howard |
90,000 | | | | | | | | 90,000 | |||||||||||||||||||||||||||
Mr. P. Meyers |
| | 136,007 | 1,2 | | | | | | 136,007 | ||||||||||||||||||||||||||
Mr. M. Voigt |
400,566 | 101,970 | | | | | 836,591 | 4,5 | | 1,339,127 | ||||||||||||||||||||||||||
Mr G Chamberlain |
| | 138,387 | 3 | | | | | | 138,387 | ||||||||||||||||||||||||||
Ms L Turnbull6, AO |
57,300 | | | 5,443 | | | | | 62,743 | |||||||||||||||||||||||||||
Mr A Wong7 |
32,215 | | | 3,060 | | | | | 35,275 | |||||||||||||||||||||||||||
Other Key Management Personnel |
| |||||||||||||||||||||||||||||||||||
Dr. F. Triebel |
261,721 | 9,620 | | | | | 514,991 | 4,5 | | 786,332 | ||||||||||||||||||||||||||
Ms. D. Miller |
218,333 | 75,000 | 27,867 | 11,429 | | | 388,656 | 4,5 | | 721,285 | ||||||||||||||||||||||||||
|
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|
1 | Mr Pete Meyers was issued 7,720,588 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 14 November 2014. |
The first tranche of his performance rights vested to him i.e. 1,715,686 converted to ordinary shares immediately after the shareholder approval was received. (Being for service from date of appointment to 30 September 2014). The second tranche of 2,573,529 performance rights vested on 1 October 2015. (Being for service from 1 October 2014 to 30 September 2015); The third tranche of 2,573,529 performance rights vested on 1 October 2016. (Being for service from 1 October 2015 to 30 September 2016); The final 857,844 vested on 1 October 2017. (Being for service from 1 October 2016 to 31 January 2017).
2 | Mr Pete Meyers was issued 10,023,350 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 25 November 2016. |
The first tranche of his performance rights (1,814,249 rights) vested on 1 October 2017. (Being for service from 1 February 2017 to 30 September 2017). The second tranche of 2,736,367 performance rights is due to vest on 1 October 2018. (Being for service from 1 October 2017 to 30 September 2018); The third tranche of 2,736,367 performance rights is due to vest on 1 October 2019. (Being for service from 1 October 2018 to 30 September 2019); The final 2,736,367 will vest on 1 October 2020. (Being for service from 1 October 2019 to 30 September 2020).
3 | Mr G Chamberlain was issued 13,272,356 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 17 November 2017. |
The first tranche of his performance rights (4,739,293 rights) is due to vest on 1 October 2018. (Being for service from 21 August 2017 to 30 September 2018). The second tranche of 4,266,531 performance rights is due to vest on 1 October 2019. (Being for service from 1 October 2018 to 30 September 2019); The third tranche of 4,266,531 performance rights is due to vest on 1 October 2020. (Being for service from 1 October 2019 to 30 September 2020).
4 | Performance Rights issued in prior years vested as follows: |
| 1/3 vested on 5 August, 2015 to Mr M Voigt and Ms D Miller and on 31 January 2016 for Dr F Triebel. |
| 1/3 vested on 5 August, 2016 to Mr M Voigt, Ms D Miller and Dr F Triebel. |
| 1/3 vested on 5 August, 2017 to Mr M Voigt, Ms D Miller and Dr F Triebel. |
5 | The Performance Rights issued to Mr M Voigt, Ms D Miller and Dr F Triebel on 4 December 2017 vested as follows: |
| 1/3 vested on 4 December 2017 to Mr M Voigt, Ms D Miller and Dr F Triebel. |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
For vesting details of the other Performance Rights please refer to Share-based compensation below.
6 | Ms L Turnbull resigned on November 17, 2017. |
7 | Mr A Wong resigned on November 17, 2017. |
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Service Agreements
The following members of key personnel have service agreements as at 30 June 2018 as follows:
Mr. Marc Voigt |
Chief Executive Officer, Chief Business Officer and Chief Financial Officer | |
Agreement commenced: | July 9, 2014 | |
Details | The initial term is for a period of 3 years and has been extended to 6 years Each party is to provide at least 6 months notice of its intention to extend the term of the contract. The contract can be terminated by the company giving 12 months notice or by Marc giving 6 months notice.
Immutep may make payments in lieu of the period of notice, or for any unexpired part of that notice period. | |
Base salary including superannuation | 250,000. | |
Dr. Frédéric Triebel |
Chief Scientific Officer & Chief Medical Officer | |
Agreement commenced: | October 01, 2014 | |
Details | Each of the parties may terminate the employment contract and the present Amendment, subject to compliance with the law and the CBA and notably to a 6-month notice period as set forth in the CBA.
The party which fails to comply with the notice period provisions shall be liable to pay the other an indemnity equal to the salary for the remainder of the notice period.
Dr Triebel is subject to a non-competition clause which shall apply for 12 months, starting on the last effective day of work, and covers the territory of European Union. A non-competition indemnity of 33% of the average monthly gross basic remuneration paid to Dr Triebel within 12 months preceding the notification of the termination will be paid on a monthly basis to the Employee during the entirety of the non-competition period, unless the Company releases Dr Triebel from such non-competition clause, in which case the payment period will be 3 months. | |
Base salary including superannuation | 170,000 | |
Ms. Deanne Miller |
Chief Operating Officer, General Counsel & Company Secretary | |
Agreement commenced: | October 13, 2012 | |
Details | The agreement can be terminated with 6 months notice. The termination terms are payment of base salary in lieu of notice period. | |
Base salary including superannuation | A$240,900 |
Executive Incentive Plan
A new Executive Incentive Plan, or EIP, was approved by shareholders at the Annual General Meeting in November 2015.The key terms of the EIP are as follows:
Operation
The Board is responsible for administering the EIP in accordance with the EIP Rules. A grant of performance rights and/or options under the EIP will be subject to both the EIP Rules and the terms and conditions of the specific grant.
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Eligibility
The EIP is open to employees (including Directors employed in an executive capacity) of the Company who are invited by the Board to participate in the EIP. The EIP is not open to non-executive directors of the Company. All non-executive directors are ineligible to participate in any current employee incentive scheme of the Company. The Board may invite employees to apply for performance rights and/or options under the EIP in its absolute discretion.
Grant
No payment is required on the grant of a performance right and no exercise price is payable upon the performance right vesting. No payment is required on the grant of an option. The exercise price of an option will be determined by the Board in its discretion and specified in the participants invitation letter.
Vesting
The vesting of a performance right will be conditional on the satisfaction of any performance conditions attaching to the performance right. Performance conditions will be determined by the Board in its discretion and specified in the participants invitation letter. Where relevant performance conditions are met, then the performance right will vest and be automatically be exercised into Shares. The vesting of an option will be conditional on the satisfaction of any performance conditions attaching to the option. Performance conditions will be determined by the Board in its discretion and specified in the participants invitation letter.
Where a participant ceases to be an employee of the Company because of total and permanent disability, death, or any other circumstance determined by the Board in its discretion, the Board may determine that any of the performance rights and/or options granted to a participant will vest, whether or not any performance conditions attaching to the performance right and/or option have been met. Notwithstanding this and subject to the ASX Listing Rules:
(i) | the Board may vest some or all of a participants performance rights and/or options even if a performance condition has not been met, if the Board considers that to do so would be in the interests of the Company; and |
(ii) | the vesting of a participants performance rights and/or options may be made subject to further conditions as determined by the Board. |
Lapse of Performance Rights and Options
All performance rights and options that have not vested on or before the fifth anniversary of their grant date will automatically lapse. Performance rights and options will also lapse if the applicable performance conditions attaching to them are not met within a
prescribed period determined by the Board in its discretion. If a participant ceases to be an employee of the Company (other than in the circumstances referred to above), the participants performance rights and/or options will lapse automatically on cessation of the participants employment unless the Board determines otherwise within 60 days of the date of cessation of the participants employment.
Conversion
A participant may at any time request the Board to convert any or all of the participants unvested performance rights to Options, or vice versa, at a rate of conversion determined by the Board in its absolute discretion. Any converted performance rights or Options will be subject to the same terms and conditions of the original performance rights or options (as applicable) granted to the participant unless otherwise determined by the Board in its discretion.
Dealing with Performance Rights and Options
Performance rights and options are not transferable, except on the participants death, to their legal personal representative.
Shares
Each performance right will entitle a participant to one share upon vesting. Each option will entitle a participant upon vesting to subscribe for one share at the exercise price specified by the Board in the participants invitation letter. Shares issued as a result of the vesting of a performance right or vesting and exercise of an option will rank equally with the shares currently on issue.
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Table of Contents
Maximum Number of Performance Rights and Options
The Board may grant such number of performance rights and/or options under the EIP as the Board determines so long as no limit specified, imposed or calculated by any relevant policy or guideline of ASIC, including any regulatory guide, class order or condition for relief, is exceeded.
Takeovers
If the event of a takeover bid (as defined in the Corporations Act), a participants performance rights and options will vest immediately to the extent that the performance conditions attaching to those performance rights and/or options have been satisfied and the remaining performance rights and/or options will lapse.
Reconstruction of Capital
If the Company makes a bonus issue, then a participant will become entitled to a proportionately greater number of shares on vesting of the performance rights and/or options held, as if the performance rights and/or options had vested before the bonus issue. If there is any other form of capital reconstruction, the number of performance rights and/or options will be adjusted in accordance with the ASX Listing Rules. A participant is not entitled to participate in any new issue of securities in the Company other than as described above.
Amendment of Incentive Plan
Subject to the ASX Listing Rules, the Board may amend the rules of the EIP, but no amendment may materially reduce the rights of participants generally in respect of the performance rights and/or options granted to them, except an amendment made primarily to enable compliance with the law governing or regulating the EIP, to correct a manifest error or mistake, to take into account changes in development in taxation law or to enable compliance with the Corporations Act or the ASX Listing Rules.
Details of bonuses and share-based compensation
The percentage of the available bonus or grant that was paid, or that vested, in the financial year, and the percentage that was forfeited because the person did not meet the vesting criteria is set out below.
Name |
Cash bonus | Share-based compensation benefits (performance rights) | ||||||||||||||||||||||||||||||
Paid | For-feited | Year |
No Granted |
Value of rights at grant date |
Vested | Number of rights vested/ excercised during the year |
Value of rights at exercise date******** |
For-feited | Financial years in which rights may vest |
|||||||||||||||||||||||
% | % | $ | % | $ | % | |||||||||||||||||||||||||||
Mr P Meyers |
| | 2014* | 7,720,588 | 285,662 | 100.00 | |
857,844 1,814,249 |
|
19,730 | |
|
2015, 2016, 2017 & 2018 2018, 2019, 2020 & 2021 |
| ||||||||||||||||||
2017** | 10,233,350 | 384,616 | 18.10 | 41,728 | ||||||||||||||||||||||||||||
Mr M Voigt |
| | 2014*** 2016**** 2017******* |
|
16,323,529 20,000,000 50,000,000 |
|
|
623,051 940,000 1,200,000 |
|
|
24.92 100.00 33.33 |
|
|
6,666,666 16,666,667 |
|
|
173,333 416,667 |
|
|
|
2016, 2018 & 2019 2016, 2017 & 2018 2018, 2019 & 2020 |
| ||||||||||
Mr F Triebel |
| | 2016***** 2017****** |
|
11,486,326 35,000,000 |
|
|
470,000 805,000 |
|
|
58.07 33.33 |
|
|
4,819,660 11,666,666 |
|
|
125,311 291,667 |
|
|
|
2016, 2017 & 2018 2018, 2019 & 2020 |
| ||||||||||
Ms D Miller |
| | 2014*** 2016**** 2017****** |
|
6,127,451 12,000,000 25,000,000 |
|
|
265,375 564,000 575,000 |
|
|
40.00 100.00 33.33 |
|
|
4,000,000 8,333,334 |
|
|
104,000 208,333 |
|
|
|
2016, 2018 & 2019 2016, 2017 & 2018 2018, 2019 & 2020 |
|
* | 7,720,588 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 14 November 2014. |
The first tranche of his performance rights vested to him i.e. 1,715,686 converted to ordinary shares immediately after the shareholder approval was received. (Being for service from date of appointment to 30 September 2014). The second tranche of 2,573,529 performance rights vested on 1 October 2015. (Being for service from 1 October 2014 to 30 September 2015); The third tranche of 2,573,529 performance rights vested on 1 October 2016. (Being for service from 1 October 2015 to 30 September 2016); The final 857,844 vested on 1 October 2017. (Being for service from 1 October 2016 to 31 January 2017).
** | 10,023,350 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 25 November 2016. |
The first tranche of his performance rights vested on 1 October 2017. (Being for service from 1 February 2017 to 30 September 2017). The second tranche of 2,736,367 performance rights is due to vest on 1 October 2018. (Being for service from 1 October 2017 to 30 September 2018); The third tranche of 2,736,367 performance rights is due to vest on 1 October 2019. (Being for service from 1 October 2018 to 30 September 2019); The final 2,736,367 will vest on 1 October 2020. (Being for service from 1 October 2019 to 30 September 2020).
| 75% to vest on 2 October, 2017 |
| 25% to vest on 1 October, 2018 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
**** | Performance rights were granted under the EIP. Long term incentive performance rights vest in three tranches as follows: |
| 1/3 vested on 5 August, 2015 |
| 1/3 vested on 5 August, 2016 |
| 1/3 vested on 5 August, 2017 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
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***** | Performance rights were granted under the EIP. 1,486,326 short term incentive performance rights vested on 5 August 2017 subject to meeting pre-determined KPIs. 10,000,000 long term incentive performance rights vest in three tranches as follows: |
| 1/3 vested on 31 January, 2016 |
| 1/3 vested on 5 August, 2016 |
| 1/3 vested on 5 August, 2017 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
****** | Performance rights were granted under the EIP. Long term incentive performance rights vest in three tranches as follows: |
| 1/3 vested on 1 December, 2017 |
| 1/3 to vest on 1 December, 2018 |
| 1/3 to vest on 1 December, 2019 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period and meeting pre-determined KPIs. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
******** | Performance rights were granted under the EIP. Long term incentive performance rights vest in three tranches as follows: |
| 1/3 vested on 1 December, 2017 |
| 1/3 to vest on 1 December, 2018 |
| 1/3 to vest on 1 December, 2019 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each persons employment contract.
******** | The value at the exercise date of performance rights that were granted as part of remuneration and were exercised during the year has been determined as the intrinsic value of the performance rights at that date. |
Equity instruments held by key management personnel
The tables below show the number of:
(i) | Options over ordinary shares in the company; |
(ii) | Performance rights over ordinary shares in the company; |
(iii) | Shares in the company that were held during the financial year by key management personnel of the group, including their close family members and entities related to them. |
There were no shares granted during the reporting period as compensation.
(i) Options holdings
2018 |
Balance at start of the year |
Granted | Exercised | Other Changes1 |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Options over ordinary shares |
||||||||||||||||||||||||||||
Dr Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr Pete Meyers |
| | | | | | | |||||||||||||||||||||
Mr Marc Voigt |
643,629 | | | (643,629 | ) | | | | ||||||||||||||||||||
Mr Grant Chamberlain |
| | | | | | | |||||||||||||||||||||
Ms Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr Albert Wong |
| | | | | | | |||||||||||||||||||||
Ms Deanne Miller |
121,212 | | | (121,212 | ) | | | | ||||||||||||||||||||
Dr Frédéric Triebel2 |
24,000,600 | | | | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
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24,765,441 | | | (764,841 | ) | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
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1 | The above options lapsed during the year ended 30 June 2018. |
2 | This amount represents warrants which were issued to Dr Frédéric Triebel upon the acquisition of Immutep. |
(ii) Performance Rights holdings
2018 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Performance rights over ordinary shares |
||||||||||||||||||||||||||||
Dr Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr Pete Meyers |
10,881,194 | | (2,672,093 | ) | | 8,209,101 | | 8,209,101 | ||||||||||||||||||||
Mr Marc Voigt |
18,921,569 | 50,000,000 | (23,333,333 | ) | | 45,588,236 | | 45,588,236 | ||||||||||||||||||||
Mr Grant Chamberlain |
| 13,272,356 | | | 13,272,356 | | 13,272,356 | |||||||||||||||||||||
Ms Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr Albert Wong |
| | | | | | | |||||||||||||||||||||
Ms Deanne Miller |
7,676,471 | 25,000,000 | (12,333,334 | ) | | 20,343,137 | | 20,343,137 | ||||||||||||||||||||
Dr Frédéric Triebel |
4,819,660 | 35,000,000 | (16,486,326 | ) | | 23,333,334 | | 23,333,334 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
42,298,894 | 123,272,356 | (54,825,086 | ) | | 110,746,164 | | 110,746,164 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Table of Contents
(iii) | Ordinary Share holdings |
2018 |
Balance at start of the year |
Received during the year on exercise of performance rights |
Received during the year on the exercise of options |
Other changes during the year |
Balance at end of the year |
|||||||||||||||
Ordinary shares |
||||||||||||||||||||
Dr Russell Howard |
| | | | | |||||||||||||||
Mr Pete Meyers |
6,862,744 | 2,672,093 | | | 9,534,837 | |||||||||||||||
Mr Marc Voigt |
|
18,271,960 45 |
* |
|
23,333,333 |
|
|
|
|
|
|
|
|
41,605,293 45 |
| |||||
Mr Grant Chamberlain |
| | | | | |||||||||||||||
Ms Lucy Turnbull, AO** |
20,359,576 | | | (20,359,576 | ) | | ||||||||||||||
Mr Albert Wong** |
3,837,500 | | | (3,837,500 | ) | | ||||||||||||||
Ms Deanne Miller |
8,243,572 | 12,333,334 | | (808,488 | ) | 19,768,418 | ||||||||||||||
Dr Frédéric Triebel |
15,978,049 | 16,486,326 | | | 32,464,375 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ordinary shares |
73,553,401 | 54,825,086 | | (25,005,564 | ) | 103,372,923 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ADR |
45 | | | | 45 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
* | American Depository Receipts (ADR) traded on the NASDAQ. |
** | At the date of resignation, the shareholding balance for Ms Lucy Turnbull and Mr Albert Wong are 20,359,576 shares and 3,837,500 shares respectively. The changes during the year is not the actual disposal of the shares. It represents derecognition due to the fact that they ceased to be directors of the company. |
Shares under option
Unissued ordinary shares of Immutep Limited under option at the date of this report are as follows:
Date options granted |
Expiration Date |
Exercise Price | Number | Listed/Unlisted Options | ||||||||
12 December 2014 |
12 December 2018 |
$ | 0.05019 | 147,628,500 | Unlisted | |||||||
5 August 2015 |
4 August 2020 |
$ | 0.0237 | 371,445,231 | Unlisted | |||||||
30 October 2015 |
30 October 2020 |
$ | 0.057 | 793,103 | Unlisted | |||||||
7 March 2016 |
7 March 2021 |
$ | 0.040 | 1,026,272 | Unlisted | |||||||
5 August 2015 |
4 August 2025 |
$ | 0.025 | 8,475,995 | Unlisted | |||||||
4 July 2017 |
5 January 2023 |
US$ | 0.025 | * | 197,345,100 | * | Listed on NASDAQ | |||||
|
|
|||||||||||
726,714,201 | ||||||||||||
|
|
No option holder has any right under the options to participate in any other share issue of the Company or any other entity.
* | 1 American Depository Shares (ADS) listed on NASDAQ equals 100 ordinary shares listed on ASX thus the number of warrants on issue has been grossed up and the exercise price adjusted accordingly in the above table to be comparable. |
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Number of securities issued under the EIP since the date of last approval
Set out below are summaries of options granted under the EIP up to June 30, 2018.
Grant Date |
Expiry Date |
Exercise Price |
Balance at Start of the Period |
Issued During the Period |
Exercised During the Period |
Lapsed During the Period |
Balance at End of the Period |
|||||||||||||||||
December 23, 2013 |
June 30, 2018 | The Options are exercisable at an exercise price of A$ 0.0774 per Share at any time after vesting and prior to 5pm on June 30, 2018 (Expiry Date). | 1,515,752 | | | (1,515,752 | ) | | ||||||||||||||||
January 24, 2014 |
June 30, 2018 | The Options are exercisable at an exercise price of A$ 0.0774 per Share at any time after vesting and prior to 5pm on June 30, 2018 (Expiry Date). | 165,116 | | | (165,116 | ) | |
Set out below are summaries of STI and LTI performance rights granted under the EIP up to June 30, 2018.
2018 Grant date |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
|||||||||||||||||||||
September 19, 2014 |
0.044 | 2,757,353 | | | | 2,757,353 | | |||||||||||||||||||||
September 19, 2014 |
0.044 | 919,118 | | | | 919,118 | | |||||||||||||||||||||
November 14, 2014 |
0.038 | 9,191,177 | | | | 9,191,177 | | |||||||||||||||||||||
November 14, 2014 |
0.040 | 3,063,725 | | | | 3,063,725 | | |||||||||||||||||||||
August 5, 2015 |
0.047 | 14,000,001 | | (14,000,001 | ) | | | | ||||||||||||||||||||
October 1, 2015 |
0.060 | 600,000 | | | | 600,000 | | |||||||||||||||||||||
October 1, 2015 |
0.061 | 200,000 | | | | 200,000 | | |||||||||||||||||||||
March 7, 2016 |
0.041 | 1,486,326 | | (1,486,326 | ) | | | | ||||||||||||||||||||
February 10, 2017 |
0.035 | 1,634,375 | | (1,634,375 | ) | | | | ||||||||||||||||||||
August 2, 2017 |
0.020 | | 3,900,000 | | | 3,900,000 | | |||||||||||||||||||||
November 17, 2017 |
0.024 | | 50,000,000 | (16,666,667 | ) | | 33,333,333 | | ||||||||||||||||||||
November 28, 2017 |
0.023 | | 15,000,000 | | | 15,000,000 | 15,000,000 | |||||||||||||||||||||
November 29, 2017 |
0.023 | | 60,000,000 | (20,000,000 | ) | | 40,000,000 | | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total |
|
33,852,075 | 128,900,000 | (53,787,369 | ) | | 108,964,706 | 15,000,000 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Introduction
Our Board of Directors is elected by and accountable to our shareholders. It currently consists of four directors, including three non-executive directors, of which one is the non-executive Chairman of our Board of Directors. The Chairman of our Board of Directors is responsible for the management of the Board of Directors and its functions.
Election of Directors
Directors are elected at our annual general meeting of shareholders. Under our Constitution, a director, other than a managing director, must not hold office for more than three years or beyond the third annual general meeting following his appointment (whichever is the longer period) without submitting himself for re-election. Our Board of Directors has the power to appoint any person to be a director, either to fill a vacancy or as an additional director (provided that the total number of directors does not exceed the maximum allowed by law), and any director so appointed may hold office only until the next annual general meeting when he or she shall be eligible for election.
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The appointment and expiration dates of each director in office at the date of this report is as follows:
Name |
Position |
Year first appointed |
Current term expires | |||
Russell Howard |
Non-Executive Director |
2013 | November 2018 | |||
Pete Meyers |
Non-Executive Director |
2014 | November 2020 | |||
Grant Chamberlain |
Non-Executive Director |
2017 | November 2020 | |||
Marc Voigt |
Managing Director, CEO |
2014 | N/A (managing director exempt from election under constitution and Australian corporate law |
Corporate Governance
ASX Corporate Governance Principles
In Australia there are no defined corporate governance structures and practices that must be observed by a company listed on the ASX, except that entities of a certain size are required to have audit and remuneration committees and in some instances trading policies for key management personnel. Instead, the ASX Corporate Governance Council has published the Corporate Governance Principles and Recommendations, which contains what are called the Recommendations which articulate eight core principles which are intended to provide a reference point for companies about their corporate governance structures and practices. Under ASX listing Rule 4.10.3, companies are required to attach a copy (or the URL page on its website) of the Companys corporate governance statement (which has been approved by the Board) and provide a statement in their Annual Report to shareholders disclosing the extent to which they have followed the Recommendations in the reporting period and where they have not followed all the Recommendations, identify the Recommendations that have not been followed, and the reasons for not following them and what (if any) alternative governance practices it adopted in lieu of the recommendations during that period . It is not mandatory to follow the Recommendations. We believe we are in material compliance with the Recommendations. Set forth below are the material provisions of the Recommendations together with the reasons, where applicable, for variations therefrom.
1. | Lay solid foundations for management and oversight. Companies should establish and disclose the respective roles and responsibilities of board and management and how their performance is monitored and evaluated. During the year ended June 30, 2018, we varied from the Recommendations in the following area: |
| At present the Board does not have a formal diversity policy as recommended by the ASX Corporate Governance Councils Principles and Recommendations. The Board believes that the Company does not have a workforce size which is significant enough to require a formal diversity policy. A diversity policy will be formalised as the Company develops and grows. At present the Board ensures that appropriate procedures and measures are introduced and responsibilities delegated to the Remuneration committee to ensure that the both the Boards and the Companys diversity objectives are met. |
2. | Structure the Board to add value. Companies should have a board of an effective composition, size, and commitment to adequately discharge its responsibilities and duties effectively. During the year ended June 30, 2018, we varied from the Recommendations in the following area: |
| The Board believes that we are not of a size, nor are our financial affairs of such complexity, to justify the establishment of a Nomination Committee of the Board of Directors. All matters which might be properly dealt with by a Nomination Committee are considered by the full Board of Directors. The Board considers the necessity to establish a Nomination Committee annually. |
3. | Promote ethical and responsible decision-making. Companies should act ethically and responsibly. |
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4. | Safeguard integrity in corporate reporting. Companies should have formal and rigorous processes to independently verify and safeguard the integrity of their corporate reporting. |
5. | Make timely and balanced disclosure. Companies should make timely and balanced disclosure of all matters concerning it that a reasonable person would expect to have a material effect on the price or value of its securities. |
6. | Respect the rights of shareholders. Companies should respect the rights of shareholders by providing them with appropriate information and facilities to allow them the effective exercise of those rights. |
7. | Recognize and manage risk. Companies should establish a sound system of risk management and periodically review the effectiveness of that internal control. |
8. | Remunerate fairly and responsibly. Companies should ensure that the level and composition of remuneration is sufficient and reasonable and that its relationship to performance is clear. |
Non-Executive and Independent Directors
Australian law does not require a company to appoint a certain number of independent directors to its board of directors or audit committee. However, under the Corporate Governance Principles and Recommendations, the ASX recommends, but does not require, that a ASX-listed company have a majority of independent directors on its board of directors and that the audit committee be comprised of independent directors, within the meaning of the rules of the ASX. Our Board of Directors currently has four directors, of which three are non-executive directors within the meaning of the Corporate Governance Principles and Recommendations, and our audit committee consists of four such non-executive directors. Accordingly, we currently comply with the Recommendations.
Under NASDAQ Marketplace Rules, in general a majority of our Board of Directors must qualify as independent directors within the meaning of the NASDAQ Marketplace Rules and our audit committee must have at least three members and be comprised only of independent directors, each of whom satisfies the respective independence requirements of NASDAQ and the U.S. Securities and Exchange Commission.
The Board of Directors does not have regularly scheduled meetings at which only independent directors are present. The Board of Directors does meet regularly and independent directors are expected to attend all such meetings. Our practices are consistent with the Recommendations, in that the Recommendations do not provide that independent directors should meet separately from the Board of Directors.
Our Board of Directors has determined that each of Pete Meyers, Grant Chamberlain and Russell Howard qualifies as an independent director under the requirements of the ASX, NASDAQ Marketplace Rules and U.S. Securities and Exchange Commission.
Committees of the Board of Directors
Audit Committee. NASDAQ Marketplace Rules require us to establish an audit committee comprised of at least three members, each of whom is financially literate and satisfies the respective independence requirements of the U.S. Securities and Exchange Commission and NASDAQ and one of whom has accounting or related financial management expertise at senior levels within a company.
Our Audit Committee assists our Board of Directors in overseeing the accounting and financial reporting processes of our company and audits of our financial statements, including the integrity of our financial statements, compliance with legal and regulatory requirements, our independent public accountants qualifications and independence, the performance of our internal audit function and independent public accountants, and such other duties as may be directed by our Board of Directors. The Audit Committee is also required to assess risk management.
Our Audit Committee currently consists of three board members, each of whom satisfies the independence requirements of the U.S. Securities and Exchange Commission, NASDAQ Marketplace Rules and ASX Rules. Our Audit Committee is currently composed of Russell Howard, Pete Meyers and Grant Chamberlain. The audit committee meets at least two times per year.
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Remuneration Committee. Our Board of Directors has established a Remuneration Committee, which is comprised solely of independent directors, within the meaning of NASDAQ Marketplace Rules. The Remuneration Committee is responsible for reviewing the salary, incentives and other benefits of our directors, senior executive officers and employees, and to make recommendations on such matters for approval by our Board of Directors. The Remuneration Committee is also responsible for overseeing and advising our Board of Directors with regard to the adoption of policies that govern our compensation programs. Russell Howard, Pete Meyers and Grant Chamberlain are the current members of the Remuneration Committee, each of whom qualifies as an independent director within the meaning of NASDAQ Marketplace Rules.
Nominations Committee. Our Board of Directors has not established a Nominations Committee. The Recommendations provide that the Nominations Committee of a company should have a charter that clearly sets out its roles and responsibilities, composition, structure, membership requirements and the procedures for inviting non-committee members to attend meetings. We have not established a Nominations Committee as we do not believe the size of our financial affairs justify the establishment of a separate committee at this time.
Corporate Governance Requirements Arising from Our U.S. Listing the Sarbanes-Oxley Act of 2002, SEC Rules and the Nasdaq Global Market Marketplace Rules.
Our shares in the form of ADRs are quoted on the Nasdaq Global Market. The Sarbanes-Oxley Act of 2002, as well as related new rules subsequently implemented by the SEC, require companies which are considered to be foreign private issuers in the U.S., such as us, to comply with various corporate governance practices. In addition, Nasdaq has made certain changes to its corporate governance requirements for companies that are listed on the Nasdaq Global Market. These changes allow us to follow Australian home country corporate governance practices in lieu of the otherwise applicable Nasdaq corporate governance standards, as long as we disclose each requirement of Rule 5600 that we do not follow and describe the home country practice we follow in lieu of the
relevant Nasdaq corporate governance standards. We intend to take all actions necessary to maintain compliance with applicable corporate governance requirements of the Sarbanes-Oxley Act of 2002, rules adopted by the SEC and listing standards of Nasdaq. We follow Australian corporate governance practices in lieu of the corporate governance requirements of the Nasdaq Marketplace Rules in respect of:
| Nasdaq requirement under Rule 5620(c) that a quorum consist of holders of 33 1/3% of the outstanding ordinary shares The ASX Listing Rules do not have an express requirement that each issuer listed on ASX have a quorum of any particular number of the outstanding ordinary shares, but instead allow a listed issuer to establish its own quorum requirements. Our quorum is currently two persons who are entitled to vote. We believe this quorum requirement is consistent with the requirements of the ASX and is appropriate and typical of generally accepted business practices in Australia. |
| The Nasdaq requirements under Rules 5605(b)(1) and (2) relating to director independence, including the requirements that a majority of the board of directors must be comprised of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors are present The Nasdaq and ASX definitions of what constitute an independent director are not identical and the requirements relating to the roles and obligations of independent directors are not identical. The ASX, unlike Nasdaq, permits an issuer to establish its own materiality threshold for determining whether a transaction between a director and an issuer affects the directors status as independent and it does not require that a majority of the issuers board of directors be independent, as long as the issuer publicly discloses this fact. In addition, the ASX does not require that the independent directors have regularly scheduled meeting at which only independent directors are present. We believe that our Board composition is consistent with the requirements of the ASX and that it is appropriate and typical of generally accepted business practices in Australia. |
| We have relied on and expect to continue to rely on an exemption from the requirement that our independent directors meet regularly in executive sessions under Nasdaq Listing Rules. The ASX Listing Rules and the Corporations Act do not require the independent directors of an Australian company to have such executive sessions and, accordingly, we seek to claim this exemption. |
| The Nasdaq requirements under Rules 5605(d) that compensation of an issuers officers must be determined, or recommended to the Board for determination, either by a majority of the independent directors, or a compensation committee comprised solely of independent directors, and that director nominees must either be selected, or recommended for the Boards selection, either by a majority of the independent directors, or a nominations committee comprised solely of independent directors. The Nasdaq compensation committee requirements are not identical to the ASX remuneration and nomination committee requirements. Issuers listed on the ASX are recommended under applicable listing standards to establish a remuneration committee consisting of a majority of independent directors and an independent chairperson, or publicly disclose that it has not done so. We have a Remuneration Committee that is consistent with the requirements of the ASX and which we believe is appropriate and typical of generally accepted business practices in Australia. |
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| We have relied on and expect to continue to rely on an exemption from the requirement prescribed by Nasdaq Listing Rules that issuers obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions, private placements of securities, or the establishment or amendment of certain stock option, purchase or other compensation plans. Applicable Australian law and the ASX Listing Rules differ from Nasdaq requirements, with the ASX Listing Rules providing generally for prior shareholder approval in numerous circumstances, including (i) issuance of equity securities exceeding 15% (or 25% under certain circumstances) of our issued share capital in any 12-month period (but, in determining the 15% limit, securities issued under an exception to the rule or with shareholder approval are not counted), (ii) issuance of equity securities to related parties (as defined in the ASX Listing Rules) and (iii) issuances of securities to directors or their associates under an employee incentive plan. Due to differences between Australian law and rules and the Nasdaq shareholder approval requirements, we seek to claim this exemption. |
Directors Service Contracts
For details of directors service contracts providing for benefits upon termination of employment, see Item 6. Directors, Senior Management and EmployeesB. CompensationService Agreements.
Indemnification of Directors and Officers
Our Constitution provides that, we may indemnify a person who is, or has been, an officer of our company, to the full extent permissible by law, out of our property against any liability incurred by such person as an officer in defending proceedings, whether civil or criminal, and whatever their outcome.
In addition, our Constitution provides that to the extent permitted by law, we may pay, or agree to pay, a premium in respect of a contract insuring a person who is or has been an officer of our company or one of our subsidiaries against any liability:
| incurred by the person in his or her capacity as an officer of our company or a subsidiary of our company, and |
| for costs and expenses incurred by that person in defending proceedings relating to that person acting as an officer of Immutep, whether civil or criminal, and whatever their outcome. |
We maintain a directors and officers liability insurance policy. We have established a policy for the indemnification of our directors and officers against certain liabilities incurred as a director or officer, including costs and expenses associated in successfully defending legal proceedings.
As of June 30, 2018, we had 19 employees. Of such employees, 12 were employed in research and development, one in intellectual property management and 6 in general management and administration. Of these 19 employees, 4 were located in Australia, 5 were located in France, 9 were located in Germany and one was located in the US. As at the end of fiscal years 2016 and 2017 we had 22 and 17 employees, respectively. The number of employees increased by approximately 12% during fiscal year 2018. The increase is mainly due to the increased research and development activities with patient recruitment for our two IMP321 related clinical trials.
Each of our full-time employees has entered into an agreement with a term of employment of between one to four years or for an unlimited term. We also engage part-time employees. We may only terminate the employment of any of our employees in accordance with the relevant employees contract of employment.
Our standard contract of employment for full time and part-time employees provides that we can terminate the employment of an employee without notice for serious misconduct or with between one to three months notice without cause (as set out in the relevant employees contract of employment). We can terminate the employment of a casual employee without notice. For a summary of the key terms of employment of each of our senior management, see Item 6. Directors, Senior Management and EmployeesB. CompensationService Agreements.
For a description of arrangements involving the employees in the capital of the company, including any arrangement that involves the issue or grant of options or shares or securities of the company, see Item 6. Directors, Senior Management and EmployeesB. CompensationGlobal Employee Share Option Plan, Employee Share Option Plan and Executive Incentive Plan.
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Table of Contents
Beneficial Ownership of Senior Management and Directors
Beneficial ownership is determined in accordance with the rules of the U.S. Securities and Exchange Commission, and generally includes voting or investment power with respect to securities. Ordinary shares relating to options currently exercisable or exercisable within 60 days of the date of the above table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table below have sole voting and investment power with respect to all shares shown as beneficially owned by them.
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Table of Contents
The following table sets forth certain information as of June 30, 2018 regarding the beneficial ownership of our ordinary shares by each of our directors and senior management and by all of our directors and senior management as a group. The shares are beneficially owned, held directly or via an entity related to the individual. The percentages shown are based on 3,026,082,669 ordinary shares issued and outstanding as of June 30, 2018.
Name |
Number of Ordinary Shares Beneficially Owned |
Percentage of Ownership |
||||||
Russell Howard |
| | ||||||
Pete Meyers |
9,534,837 | * | ||||||
Marc Voigt |
|
41,605,293 4,500 |
** |
1.38 | % | |||
Grant Chamberlain |
| | ||||||
Deanne Miller |
19,768,418 | * | ||||||
Frédéric Triebel |
32,464,375 | 1.07 | % | |||||
All directors and executive officers as a group (6 persons) Ordinary shares |
|
103,372,923 4,500 |
** |
3.42 | % |
* | Less than 1%. |
** | Held in the form of 45 ADSs listed on the NASDAQ Global Market. |
ITEM 7. | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
One shareholder, Australian Ethical Investment Limited (Australian Ethical) owned more than 5% or more of our ordinary shares as at June 30, 2018. Australian Ethical held 202,380,952 ordinary shares, representing 7.43% of the total issued share capital of the Company on March 14, 2018. The shareholding balance of Australian Ethical changed to 192,199,218 on August 31, 2018, representing 6.35% of the total issued share capital of the Company as at August 31, 2018. On September 26, 2018, the shareholding balance of Australian Ethical changed to 153,530,938, representing 5.07% of the total issued share capital. On September 28, Australian Ethical ceased to be a major shareholder as its shareholding balance changed to 149,502,725, representing 4.93% of the total issued share capital.
The ordinary shares are registered in the name of its custodian National Nominees Limited, with Australian Ethical being the underlying holder and entitled to be registered as the holder. Each share ranks pari passu with existing ordinary shares and entitles the holder to one vote. The voting rights of Australian Ethical are no different than the voting rights of other holders of our ordinary shares.
As of June 30, 2018, there were 10,823 holders of record of our ordinary shares, of which 8 holders, holding approximately 0.772% of our ordinary shares, had registered addresses in the United States. These numbers are not representative of the number of beneficial holders of our shares nor are they representative of where such beneficial holders reside, as many of these ordinary shares were held of record by brokers or other nominees. The majority of trading by our U.S. investors is done by means of ADSs that are held of record by HSBC Custody Nominees (Australia) Ltd, which held 28.76% of our ordinary shares as of August, 15th, 2018.
To our knowledge, we are not directly or indirectly controlled by another corporation, by any foreign government or by any other natural or legal person severally or jointly. There are no agreements known to us, the operation of which may at a subsequent date result in a change in control of Immutep. All shareholders have the same voting rights.
We operate inter-company loan accounts with our wholly owned subsidiaries. All inter-company transactions and loan balances are eliminated on consolidation.
During fiscal 2018, in addition to Directors fees, consultancy fees of A$49,500 for post directorship executive duties were paid to Barton Place Pty Ltd, a corporation in which Albert Wong has a beneficial interest.
During fiscal 2017 and fiscal 2016 there were no related party transactions.
C. Interests of Experts and Counsel
Not applicable.
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Table of Contents
ITEM 8. | FINANCIAL INFORMATION |
A. Consolidated Statements and Other Financial Information
Our audited consolidated financial statements for the fiscal years ending June 30, 2016, 2017 and 2018 are included in Item 18 of this Annual Report on Form 20-F, which is found immediately following the text of this Annual Report on Form 20-F. The audit report of PricewaterhouseCoopers as of June 30, 2018 and 2017, and for each of the three years in the period ended June 30, 2018, is included therein immediately preceding the financial statements.
Legal Proceedings
We are not involved in any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings and those involving any third party, which may have, or have had in the recent past, significant effects on our financial position or profitability. The company is not involved in any governmental proceedings pending or known by us to be contemplated.
Dividend Distribution Policy
We have never paid cash dividends to our shareholders. We intend to retain future earnings for use in our business and do not anticipate paying cash dividends on our ordinary shares in the foreseeable future. Any future dividend policy will be determined by the Board of Directors and will be based upon various factors, including our results of operations, financial condition, current and anticipated cash needs, future prospects, contractual restrictions and other factors as the Board of Directors may deem relevant. There is no assurance that dividends will ever be paid. See Special Note Regarding Forward Looking Statements.
No significant changes occurred since the date of the annual financial statements.
ITEM 9. | THE OFFER AND LISTING |
Our ordinary shares have traded on the ASX under the symbol PRR from our initial public offering on July 9, 2001 until the company changed its name from Prima BioMed to Immutep Limited in November 2017. With effect from 1 December 2017, the Company now trades on the ASX under the symbol IMM. The ADSs have traded on the NASDAQ Global Market under the symbol PBMD from April 16, 2012 and following the change of name of Prima BioMed Ltd to Immutep Limited, now trade under the symbol IMMP. Each ADS represents 100 ordinary shares. The following table sets forth, for the periods indicated, the high and low market quotations for our ordinary shares as quoted on the ASX and on the NASDAQ Global Market.
Per Ordinary Share (A$) | Per ADS (US$) | |||||||||||||||
High | Low | High | Low | |||||||||||||
A$ | A$ | US$ | US$ | |||||||||||||
Fiscal Year Ended June 30, | ||||||||||||||||
2014 |
0.11 | 0.03 | 11.43 | 2.73 | ||||||||||||
2015 |
0.19 | 0.02 | 21.60 | 1.40 | ||||||||||||
2016 |
0.09 | 0.04 | 6.00 | 2.40 | ||||||||||||
2017 |
0.04 | 0.03 | 3.30 | 1.70 | ||||||||||||
2018 |
0.04 | 0.02 | 3.06 | 1.25 | ||||||||||||
Fiscal Year Ended June 30, 2017: | ||||||||||||||||
First Quarter |
0.04 | 0.04 | 3.30 | 2.67 | ||||||||||||
Second Quarter |
0.04 | 0.03 | 3.26 | 1.70 | ||||||||||||
Third Quarter |
0.04 | 0.03 | 3.24 | 2.10 | ||||||||||||
Fourth Quarter |
0.04 | 0.03 | 2.79 | 1.88 | ||||||||||||
Fiscal Year Ended June 30, 2018: | ||||||||||||||||
First Quarter |
0.03 | 0.02 | 2.22 | 1.40 | ||||||||||||
Second Quarter |
0.04 | 0.02 | 2.85 | 1.25 | ||||||||||||
Third Quarter |
0.03 | 0.02 | 2.45 | 1.60 | ||||||||||||
Fourth Quarter |
0.04 | 0.02 | 3.06 | 1.70 | ||||||||||||
Month Ended: | ||||||||||||||||
April 2018 |
0.03 | 0.02 | 1.99 | 1.70 | ||||||||||||
May 2018 |
0.04 | 0.02 | 2.92 | 1.81 | ||||||||||||
June 2018 |
0.04 | 0.03 | 3.06 | 2.15 | ||||||||||||
July 2018 |
0.04 | 0.03 | 2.75 | 2.33 | ||||||||||||
August 2018 |
0.04 | 0.03 | 2.94 | 2.35 | ||||||||||||
September 2018 |
0.05 | 0.03 | 3.93 | 2.52 |
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For a description of the rights of our ADSs, see Item 12. Description of Securities Other Than Equity SecuritiesD. American Depositary Shares.
On December 28, 2016, we changed the ordinary share-to-ADS ratio from 30:1 to 100:1. Per ADS sale prices for dates prior to such change are adjusted to give effect to such change.
Not applicable.
Our ordinary shares are listed and traded on the Australian Securities Exchange Ltd., or ASX, on the NASDAQ Global Market where our ordinary shares in the form of ADSs are traded on the NASDAQ Global Market.
Not applicable.
Not applicable.
Not applicable.
ITEM 10. | ADDITIONAL INFORMATION |
Not applicable.
B. Memorandum and Articles of Association
General
Our constituent document is a Constitution. The Constitution is subject to the terms of the Listing Rules of ASX Limited and the Corporations Act 2001. The Constitution may be amended or repealed and replaced by special resolution of shareholders, which is a resolution of which notice has been given and that has been passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution.
Purposes and Objects
As a public company we have all the rights, powers and privileges of a natural person. Our Constitution does not provide for or prescribe any specific objects or purposes.
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The Powers of the Directors
Under the provision of our Constitution our directors may exercise all the powers of our company in relation to:
Members Approval to Significant Changes
The directors must not make a significant change (either directly or indirectly) to the nature and scale of our activities except after having disclosed full details to ASX in accordance with the requirements of the Listing Rules of the ASX and the directors must not sell or otherwise dispose of the main undertaking of our company without the approval of shareholders in general meeting in accordance with the requirements of the Listing Rules.
Interested Directors
A director may not vote in respect of any contract or arrangement in which the director has, directly or indirectly, any material interest according to our Constitution. Such director must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being considered. However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal interest.
Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of certain interests or conflicts of interests and prohibits directors from voting on matters in which they have a material personal interest and from being present at the meeting while the matter is being considered. In addition, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision of related party benefits to our directors.
Directors compensation
Our directors are paid remuneration for their services as directors (but excluding any remuneration payable to a director under any executive services contract with us or one of our related bodies corporate) which is determined in a general meeting of shareholders. The aggregate, fixed sum for directors remuneration is to be divided among the directors in such proportion as the directors themselves agree and in accordance with our Constitution. The fixed sum remuneration for directors may not be increased except at a general meeting of shareholders and the particulars of the proposed increase are required to have been provided to shareholders in the notice convening the meeting. In addition, executive directors may be paid remuneration as employees of Immutep.
Fees payable to our non-executive directors must be by way of a fixed sum and not by way of a commission on or a percentage of profits or operating revenue. Remuneration paid to our executive directors must also not include a commission or percentage of operating revenue.
Pursuant to our Constitution, any director who performs services that in the opinion of our board of directors, are outside the scope of the ordinary duties of a director may be paid extra remuneration, which is determined by our board of directors.
In addition to other remuneration provided in our Constitution, all of our directors are entitled to be paid by us for reasonable travel accommodation and other expenses incurred by the directors in attending general meetings, board meetings, committee meetings or otherwise in connection with our business.
In addition, in accordance with our Constitution, a director may be paid a retirement benefit as determined by our board of directors subject to the limits set out in the Corporations Act and the ASX Listing Rules which broadly restrict our ability to pay our officers a termination benefit in the event of a change of control of the Company or our subsidiaries as well as impose requirements for shareholder approval to be obtained to pay certain retirement benefits to our officers.
Borrowing powers exercisable by Directors
Pursuant to our Constitution, the management and control of our business affairs are vested in our board of directors. Our board of directors has the power to raise or borrow money, and charge any of our property or business or any uncalled capital, and may issue debentures or give any other security for any of our debts, liabilities or obligations or of any other person, in each case, in the manner and on terms it deems fit.
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Retirement of Directors
Pursuant to our Constitution and the ASX Listing Rules, one-third of our directors, other than the managing director, must retire from office at every annual general meeting. If the number of directors is not a multiple of three, then the number nearest, to but not exceeding, one-third must retire from office. The directors who retire in this manner are required to be the directors or director longest in office since last being elected. A director, other than the director who is the Chief Executive Officer, must retire from office at the conclusion of the third annual general meeting after which the director was elected. Retired directors are eligible for a re-election to the board of directors unless disqualified from acting as a director under the Corporations Act or our Constitution.
Rights Attached to Our Ordinary Shares
The concept of authorized share capital no longer exists in Australia and as a result, our authorized share capital is unlimited. All our outstanding ordinary shares are validly issued, fully paid and non-assessable. The rights attached to our ordinary shares are as follows:
Dividend Rights.
The directors may declare that a dividend be paid to the members according to the shareholders pro rata shareholdings and the directors may fix the amount, the time for payment and the method of payment. No dividend is payable except in accordance with the Corporations Act as amended from time to time and no dividend carries interest as against the Company.
Voting Rights.
Holders of ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders. Such voting rights may be affected by the grant of any special voting rights to the holders of a class of shares with preferential rights that may be authorized in the future.
The quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. A meeting adjourned for lack of a quorum generally is adjourned to the same day in the following week at the same time and place. At the reconvened meeting, the required quorum consists of any two members present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. The meeting is dissolved if a quorum is not present within 15 minutes from the time appointed for the meeting.
An ordinary resolution, such as a resolution for the declaration of dividends, requires approval by the holders of a majority of the voting rights represented at the meeting, in person, by proxy, or by written ballot and voting thereon. Under our Constitution, a special resolution, such as amending our Constitution, approving any change in capitalization, winding-up, authorization of a class of shares with special rights, or other changes as specified in our Constitution, requires approval of a special majority, representing the holders of no less than 75% of the voting rights represented at the meeting in person, by proxy or by written ballet, and voting thereon.
Rights in Our Profits.
Our shareholders have the right to share in our profits distributed as a dividend and any other permitted distribution.
Rights in the Event of Liquidation.
In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion to the capital at the commencement of the liquidation paid up or which ought to have been paid up on the shares held by them respectively. This right may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights, such as the right in winding up to payment in cash of the amount then paid up on the share, and any arrears of dividend in respect of that share, in priority to any other class of shares.
Directors may make calls
Our Constitution provides that subject to the terms on which the shares have been issued directors may make calls on a shareholder for amounts unpaid on shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment. Shares represented by the ADSs issued in our initial public offering in the United States were fully paid and are not subject to calls by directors.
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Changing Rights Attached to Shares
According to our Constitution, the rights attached to any class of shares, unless otherwise provided by the terms of the class, may be varied with either the written consent of the holders of not less than 75% of the issued shares of that class or the sanction of a special resolution passed at a separate general meeting of the shares of that class.
Annual and Extraordinary Meetings
Our directors must convene an annual meeting of shareholders at least once every calendar year, within five months of our last fiscal year-end balance sheet data. Notice of at least 28 days prior to the date of the meeting is required. A general meeting may be convened by any director, or one or more shareholders holding in the aggregate at least 5% of our issued capital. A general meeting must be called not more than 21 days after the request is made. The meeting must be held not later than two months after the request is given.
Limitations on the Rights to Own Securities in Our Company
Subject to certain limitations on the percentage of shares a person may hold in our company, neither our Constitution nor the laws of the Commonwealth of Australia restrict in any way the ownership or voting of shares in our company.
Changes in Our Capital
Pursuant to the Listing Rules, our directors may in their discretion issue securities to persons who are not related parties of our company, without the approval of shareholders, if such issue, when aggregate with securities issued by our company during the previous 12 month period would be an amount that would not exceed 15% of our issued capital at the commencement of the 12 month period. Other allotments of securities require approval by an ordinary resolution of shareholders.
In March 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with Merck Sharp & Dohme B.V (MSDBV) and MSD International GmbH (MSDIG) to evaluate the combination of our lead immunotherapy product candidate eftilagimod alpha (efti) with MSDBVs and MSDIGs anti-PD-1 therapy KEYTRUDA® in a new clinical trial that will evaluate the combination in several different solid tumours. The planned Phase II clinical trial, referred to as TACTI-002, will evaluate the safety and efficacy of this novel immunotherapy combination in patients with non-small cell lung cancer, head and neck cancer, or ovarian cancer. The TACTI-002 clinical trial will be a Phase II, Simon two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Up to 120 patients across the three indications are planned to be treated in medical centres in Europe and the United States with the trial expected to commence in the second half of 2018. The trial combines two immuno-oncology treatments with complementary mechanisms of action, analogous to releasing the brakes and pushing the accelerator of the bodys immune system at two different positions in the cancer immunity cycle. Our efti is a first-in-class antigen presenting cell activator which stimulates cancer-fighting T cells, while KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells.
Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Cash Transaction Reports Agency, which monitors such transaction, and amounts on account of potential Australian tax liabilities may be required to be withheld unless a relevant taxation treaty can be shown to apply.
The Foreign Acquisitions and Takeovers Act 1975
Under Australian law, in certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of the shares in an Australian company without approval from the Australian Treasurer. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act, or the Takeovers Act.
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Under the Foreign Acquisitions and Takeovers Act, as currently in effect, any foreign person, together with associates, or parties acting in concert, is prohibited from acquiring 20% or more of the shares in any company having total assets of A$261 million or more (or A$1,134 million or more in case of U.S. investors). Associates is a broadly defined term under the Takeovers Act 1975 and includes the following, but not limited to:
| spouses, lineal ancestors and descendants, and siblings; |
| partners, officers of companies, the company, employers and employees, and corporations; |
| their shareholders related through substantial shareholdings or voting power; |
| corporations whose directors are controlled by the person, or who control a person; and |
| associations between trustees and substantial beneficiaries of trust estates. |
In addition, a foreign person may not acquire shares in a company having total assets of A$261 million or more (or A$1,134 million or more in case of U.S. investors) if, as a result of that acquisition, the total holdings of all foreign persons and their associates will exceed 40% in aggregate without the approval of the Australian Treasurer. If the necessary approvals are not obtained, the Treasurer may make an order requiring the acquirer to dispose of the shares it has acquired within a specified period of time. The same rule applies if the total holdings of all foreign persons and their associates already exceeds 40% and a foreign person (or its associate) acquires any further shares, including in the course of trading in the secondary market of the ADSs. At present, we do not have total assets of A$261 million or more. At this time, our total assets do not exceed any of the above thresholds and therefore no approval would be required from the Australian Treasurer. Nonetheless, should our total assets exceed the threshold in the future, we would will be mindful of the number of ADS that can be made available, and monitor the 40% aggregate shareholding threshold for foreign persons (together with the associates) to ensure that it will not be exceeded subject to the Australian Treasurers approval.
Each foreign person seeking to acquire holdings in excess of the above caps (including their associates, as the case may be) would need to complete an application form setting out the proposal and relevant particulars of the acquisition/shareholding. The Australian Treasurer then has 30 days to consider the application and make a decision. However, the Australian Treasurer may extend the period by up to a further 90 days by publishing an interim order. The Australian Treasurer has issued a guideline titled Australias Foreign Investment Policy which provides an outline of the policy. As for the risk associated with seeking approval, the policy provides that the Treasurer will reject an application if it is contrary to the national interest.
If the level of foreign ownership exceeds 40% at any time, we would be considered a foreign person under the Takeovers Act. In such event, we would be required to obtain the approval of the Australian Treasurer for our company, together with our associates, to acquire (i) more than 15% of an Australian company or business with assets totaling over A$261 million (or A$1,134 if the investor is a non-government entity from a partner agreement country); or (ii) any direct or indirect ownership in Australian residential real estate and certain non-residential real estate.
The percentage of foreign ownership in our company would also be included determining the foreign ownership of any Australian company or business in which it may choose to invest. Since we have no current plans for any such acquisition and do not own any property, any such approvals required to be obtained by us as a foreign person under the Takeovers Act will not affect our current or future ownership or lease of property in Australia.
Our Constitution does not contain any additional limitations on a non-residents right to hold or vote our securities.
Australian law requires the transfer of shares in our company to be made in writing. No stamp duty will be payable in Australia on the transfer of ADSs.
The following is a discussion of Australian and United States tax consequences material to our shareholders. To the extent that the discussion is based on tax legislation which has not been subject to judicial or administrative interpretation, the views expressed in the discussion might not be accepted by the tax authorities in question or by court. The discussion is not intended, and should not be construed, as legal or professional tax advice and does not exhaust all possible tax considerations.
Holders of our ADSs should consult their own tax advisors as to the United States, Australian or other tax consequences of the purchase, ownership and disposition of ADSs, including, in particular, the effect of any foreign, state or local taxes.
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E.1. AUSTRALIAN TAX CONSEQUENCES
In this section we discuss the material Australian tax considerations that apply to non-Australian tax residents with respect to the acquisition, ownership and disposal of the absolute beneficial ownership of ADSs, which are evidenced by ADSs. This discussion is based upon existing Australian tax law as of the date of this Annual Report, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian income tax law which may be important to particular investors in light of their individual investment circumstances, such as ADSs or shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the purchase, ownership and disposition of the ADSs or shares.
Nature of ADSs for Australian Taxation Purposes
Holders of our ADSs are treated as the owners of the underlying ordinary shares for Australian income tax and capital gains tax purposes. Therefore, dividends paid on the underlying ordinary shares will be treated for Australian tax purposes as if they were paid directly to the owners of ADSs, and the disposal of ADSs will be treated for Australian tax purposes as the disposal of the underlying ordinary shares. In the following analysis we discuss the application of the Australian income tax and capital gains tax rules to non-Australian resident holders of ADSs.
Taxation of Dividends
Australia operates a dividend imputation system under which dividends may be declared to be franked to the extent they are paid out of company profits that have been subject to income tax. Fully franked dividends are not subject to dividend withholding tax. Dividends that are not franked or are partly franked and are paid to non-Australian resident stockholders are subject to dividend withholding tax, but only to the extent the dividends are not franked.
Dividends paid to a non-resident stockholder are subject to withholding tax (a) except to the extent they have been franked and (b) at 30%, unless the stockholder is a resident of a country with which Australia has a double taxation agreement.
In accordance with the provisions of the Double Taxation Convention between Australia and the United States, the maximum rate of Australian tax on any unfranked portion of a dividend to which a resident of the United States is beneficially entitled is 15%, where the U.S. resident holds less than 10% of the voting rights in our company, or 5% where the U.S. resident holds 10% or more of the voting rights in our company. Special rules apply to Regulated Investment Companies and Real Estate Investment Trusts that hold shares and receive dividends. The Double Taxation Convention between Australia and the United States does not apply to limit the tax rate on dividends where the ADSs are effectively connected to a permanent establishment or a fixed base carried on by the owner of the ADSs in Australia through which the stockholder carries on business or provides independent personal services, respectively.
Tax on Sales or other Dispositions of SharesCapital Gains Tax
Australian capital gains derived by non-Australian residents in respect of the disposal of capital assets that are not taxable Australian property will be disregarded. Non-Australian resident stockholders will not be subject to Australian capital gains tax on the capital gain made on a disposal of our shares, unless they, together with associates, hold 10% or more of our issued capital, tested either at the time of disposal or over any continuous 12 month period in the 24 months prior to disposal, and the value of our shares at the time of disposal is principally attributable to Australian real property assets.
Australian capital gains tax applies to net capital gains at a taxpayers marginal tax rate but for certain stockholders a discount capital gain may apply if the shares have been held for 12 months or more. For individuals, this discount is 50%. Net capital gains are calculated after reduction for capital losses (including certain prior year capital losses), which may only be offset against capital gains.
Tax on Sales or other Dispositions of SharesStockholders Holding Shares on Revenue Account
Some non-Australian resident stockholders may hold shares on revenue rather than on capital account, for example, share traders. These stockholders may have the gains made on the sale or other disposal of the shares included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.
Non-Australian resident stockholders assessable under these ordinary income provisions in respect of gains made on shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 29% for non-Australian resident individuals. Some relief from the Australian income tax may be available to such non-Australian resident stockholders under the Double Taxation Convention between the United States and Australia, for example, because the stockholder does not have a permanent establishment in Australia.
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To the extent an amount would be included in a non-Australian resident stockholders assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the stockholder would not be subject to double tax on any part of the income gain or capital gain.
Dual Residency
If a stockholder were a resident of both Australia and the United States under those countries domestic taxation laws, that stockholder may be subject to tax as an Australian resident. If, however, the stockholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, the Australian tax applicable would be limited by the Double Taxation Convention. Stockholders should obtain specialist taxation advice in these circumstances.
Stamp Duty
A transfer of shares of a company listed on the Australian Stock Exchange is not subject to Australian stamp duty except in some circumstances where the listed company holds substantial real property and/or real property interests.
Australian Death Duty
Australia does not have estate or death duties. No capital gains tax liability is realized upon the inheritance of a deceased persons shares. The disposal of inherited shares by beneficiaries, may, however, give rise to a capital gains tax liability.
Goods and Services Tax
The issue or transfer of shares will not incur Australian goods and services tax and does not require a stockholder to register for Australian goods and services tax purposes.
Research and Development Tax Incentives
The Australian Government tax incentive scheme, introduced on July 1, 2011, replaces the former R&D Tax Concession scheme for research and development activities in income years commencing on or after July 1, 2011. Subject to certain exclusions, the new scheme provides benefits for eligible research and development activities (R&D activities). Such eligible R&D activities include but are not limited to:
| Core activities, which are experimental activities whose outcome is not known or cannot be determined in advance, but can only be determined by applying a systematic progression of work; |
| Core activities must be conducted for the purpose of generating new knowledge (including new knowledge in the form of new or improved processes and materials); or |
| Supporting activities that are directly related and designed to support core activities and are usually required in order for the core activities to take place. |
Under the R&D Tax incentive scheme, entities will be entitled to either (i) a 43.5% refundable tax offset for eligible companies with an aggregated turnover of less than $20 million per annum; or (ii) a non-refundable 40% tax offset for all other eligible companies. Where our turnover is less than $20 million, we anticipate being entitled to claim a 43.5% refundable tax offset for costs relating to eligible R&D activities during the year.
E.2 UNITED STATES FEDERAL INCOME TAX CONSEQUENCES
The following is a summary of material U.S. federal income tax consequences that generally apply to U.S. Holders (as defined below) who hold ADSs as capital assets within the meaning of Section 1221 of the Internal Revenue Code of 1986, as amended (the Code). This summary is based on the Code, its legislative history, final, temporary and proposed United States Treasury regulations promulgated thereunder, published rulings and court decisions, and the bilateral income tax convention between Australia and the United States (the Treaty), all as in effect on the date hereof and all of which are subject to change, or changes in interpretation, either prospectively or retroactively. This discussion does not address all of the tax consequences relating to the purchase, ownership, and disposition of ADSs, and does not take into account U.S. Holders who may be subject to special rules, including: financial institutions, insurance companies, , tax-exempt organizations, real estate investment trusts, regulated investment companies, grantor trusts, non-resident aliens of the United States or taxpayers whose functional currency is not the U.S. dollar, persons who hold the ADSs through partnerships or other pass-through entities, persons who acquired their ADSs through the exercise or cancellation of any employee stock options or otherwise as compensation for their services, investors that actually or constructively own 10% or more
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of our shares, dealers or traders in securities or currencies, certain former citizens or long-term residents of the United States, dual resident corporations, persons that generally mark their securities to market for United States federal income tax purposes, persons who are residents of Australia for Australian income tax purposes, and investors holding ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction. This summary does not address the Medicare tax imposed on certain investment income, any state, local and foreign tax considerations or any U.S. federal estate, gift or alternative minimum tax considerations relevant to the purchase, ownership and disposition of our ADSs. In addition, this discussion is based in part upon representations of the depositary and the assumption that each obligation in the deposit agreement and any related agreements will be performed according to its terms.
If a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes owns ADSs, the U.S. federal income tax treatment of its partners will generally depend upon the status of the partner and the activities of the partnership. A partnership should consult its tax advisors regarding the U.S. federal income tax consequences applicable to it and its partners of the purchase, ownership and disposition of ADSs.
For purposes of this summary, the term U.S. Holder means a beneficial owner of ADSs that is for U.S. federal income tax purposes: an individual who is a citizen or resident of the United States; a corporation that is created or organized in or under the laws of the United States or any political subdivision thereof; an estate whose income is subject to U.S. federal income tax regardless of its source; or a trust if (a) a court within the United States is able to exercise primary supervision over administration of the trust, and one or more U.S. persons have the authority to control all substantial decisions of the trust or (b) it has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
Distributions
For U.S. federal income tax purposes, a U.S. Holder of ADSs will be treated as owning the ordinary shares underlying the ADSs. Subject to the passive foreign investment company rules discussed below, the gross amount of any distribution received by a U.S. Holder with respect to our ordinary shares or ADSs, including the amount of any Australian taxes withheld therefrom, will be included in gross income as a dividend to the extent the distribution is paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Distributions in excess of our earnings and profits will be treated first as a non-taxable return of capital to the extent of a U.S. Holders tax basis in the ADSs and thereafter will be treated as gain from the sale or exchange of the ADSs. We have not maintained and do not plan to maintain calculations of earnings and profits for U.S. federal income tax purposes. As a result, a U.S. Holder may need to include the entire amount of any such distribution in income as a dividend. Dividends will not however be eligible for the dividends received deduction generally allowed to corporate shareholders with respect to dividends received from U.S. corporations.
The U.S. dollar value of any distribution on the ADSs made in Australian dollars generally should be calculated by reference to the spot exchange rate between the U.S. dollar and the Australian dollar in effect on the date the distribution is actually or constructively received by the U.S. Holder regardless of whether the Australian dollars so received are in fact converted into U.S. dollars. A U.S. Holder who receives payment in Australian dollars and converts those Australian dollars into U.S. dollars at an exchange rate other than the rate in effect on such day may have a foreign currency exchange gain or loss, which would generally be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.
Subject to complex limitations and certain holding period requirements, a U.S. Holder may elect to claim a credit for Australian tax withheld from distributions against its U.S. federal income tax liability. The limitations set out in the Code include computational rules under which foreign tax credits allowable with respect to specific classes of income cannot exceed the U.S. federal income taxes otherwise payable with respect to each such class of income. Dividends generally will be treated as foreign-source passive category
income for U.S. foreign tax credit purposes or in the case of certain U.S. Holders as foreign source general category income. A U.S. Holder that does not elect to claim a U.S. foreign tax credit may instead claim a deduction for Australian tax withheld.
Subject to certain limitations, dividends received by a non-corporate U.S. Holder are subject to tax at a reduced maximum tax rate of 20 percent if the dividends are qualified dividends. Dividends are qualified dividends if: (a)(i) the issuer is entitled to benefits under the Treaty or (ii) the shares are readily tradable on an established securities market in the United States and (b) certain other requirements are met. We believe that we are entitled to benefits under the Treaty and that the ADSs currently are readily tradable on an established securities market in the United States. However, no assurance can be given that the ADSs will remain readily tradable. However, the reduced rate does not apply to dividends if we are a PFIC in the year prior to or the year in which the dividend is paid. As noted below, we believe there is a risk that we are a PFIC.
The U.S. Treasury has expressed concerns that intermediaries in the chain of ownership between the holder of an ADS and the issuer of the security underlying the ADS may be taking actions that are inconsistent with the claiming of foreign tax credits for U.S. Holders of ADSs. Such actions would also be inconsistent with the claiming of the reduced rate of tax, described above, applicable to dividends received by certain non-corporate holders. Accordingly, the analysis of the creditability of Australian taxes and the availability of the reduced tax rate for dividends received by certain non-corporate holders, each described above, could be affected by actions taken by intermediaries in the chain of ownership between the holder of an ADS and our Company.
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Disposition of ADSs
If you sell or otherwise dispose of ADSs, you will recognize gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the U.S. dollar value of the amount realized on the sale or other disposition and your adjusted tax basis in the ADSs. Subject to the passive foreign investment company rules discussed below, such gain or loss generally will be capital gain or loss and will be long-term capital gain or loss if you have held the ADSs for more than one year at the time of the sale or other disposition. In general, any gain that you recognize on the sale or other disposition of ADSs will be gain from U.S. sources for purposes of the foreign tax credit limitation; losses will generally be allocated against U.S. source income. The deduction of capital losses is subject to certain limitations under the Code.
In the case of a cash-basis U.S. Holder who receives Australian dollars in connection with the sale or other disposition of ADSs, the amount realized will be calculated based on the U.S. dollar value of the Australian dollars received as determined by reference to the spot rate in effect on the settlement date of such exchange. A U.S. Holder who receives payment in Australian dollars and converts Australian dollars into U.S. dollars at a conversion rate other than the rate in effect on the settlement date may have foreign currency exchange gain or loss that would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.
An accrual-basis U.S. Holder may elect the same treatment required of cash-basis taxpayers with respect to a sale or disposition of ADSs, provided that the election is applied consistently from year to year. Such election may not be changed without the consent of the Internal Revenue Service (IRS). In the event that an accrual-basis U.S. Holder does not elect to be treated as a cash-basis taxpayer (pursuant to the Treasury regulations applicable to foreign currency transactions), such U.S. Holder may have foreign currency gain or loss for U.S. federal income tax purposes because of differences between the U.S. dollar value of the currency received prevailing on the trade date and the settlement date. Any such currency gain or loss would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes. However, if foreign currency is converted into U.S. dollars on the date received by the U.S. Holder, a cash-basis or electing accrual-basis U.S. Holder should not recognize any gain or loss on such conversion.
Passive Foreign Investment Companies
There is a risk that we may be a passive foreign investment company(PFIC), for U.S. federal income tax purposes. Our treatment as a PFIC could result in a reduction in the after-tax return to the U.S. Holders of our ADSs and may cause a reduction in the value of such securities.
For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset which produces passive income. Passive income generally includes dividends, interest, royalties, rents, annuities and the excess of gains over losses from the disposition of assets which produce passive income. Based on the composition of our assets and income, we believe that we should not be treated as a PFIC for U.S. federal income tax purposes with respect to our 2018 taxable year. However, the determination of PFIC status is a factual determination that must be made annually at the close of each taxable year and therefore, there can be no certainty as to our status in this regard until the close of the current or any future taxable year. Changes in the nature of our income or assets or a decrease in the trading price of our ADSs may cause us to be considered a PFIC in the current or any subsequent year. If we were a PFIC in any year during a U.S. Holders holding period for our ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S. Holder owned the ADSs.
Under the default PFIC excess distribution regime, if we are a PFIC in any taxable year during which a U.S. Holder owns ADSs, such U.S. Holder could be liable for additional taxes and interest charges upon (i) certain distributions by us (generally any distribution paid during a taxable year that is greater than 125 percent of the average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holders holding period for the ADSs), and (ii) any gain realized on a sale, exchange or other disposition, including a pledge, of the ADSs, whether or not we continue to be a PFIC for the year of the disposition. In these circumstances, the tax will generally be determined by allocating such distributions or gain ratably over the U.S. Holders holding period for the ADSs. The amount allocated to the current taxable year and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income (rather than capital gain) earned in the current taxable year. The amount allocated to other taxable years will be taxed at the highest applicable marginal rates for the year and an interest charge at the rate applicable to underpayments of tax will also be imposed on the amount of taxes allocated to such other taxable years.
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An indirect shareholder may be taxed on a distribution paid to the direct owner of a PFIC and on a disposition of the stock indirectly owned. Indirect shareholders are strongly urged to consult their tax advisors regarding the application of these rules.
If we are a PFIC and subsequently cease to be a PFIC in a future year, a U.S. Holder may avoid the continued application of the tax treatment described above by electing to be treated as if it sold its ADSs on the last day of the last taxable year in which we were a PFIC. Any gain would generally be recognized and subject to tax under the excess distribution regime described above. Loss would not be recognized. A U.S. Holders basis in its ADSs would be increased by the amount of gain, if any, recognized on the deemed sale. A U.S. Holder would be required to treat its holding period for its ADSs as beginning on the day following the last day of the last taxable year in which we were a PFIC.
If the ADSs are considered marketable stock and if a U.S. Holder properly elects to mark-to-market its ADSs in a timely fashion, the U.S. Holder would not be subject to tax under the excess distribution regime described above. Instead, the U.S. Holder would generally include in income any excess of the fair market value of the ADSs at the close of each tax year over the adjusted tax basis of the ADSs. If the fair market value of the ADSs had depreciated below the adjusted basis at the close of the tax year, the U.S. Holder would be entitled to deduct the excess of the adjusted basis of the ADSs over their fair market value at that time. However, such deductions generally would be limited to the net mark-to-market gains, if any, the U.S. Holder included in income with respect to such ADSs in prior years. Income recognized and deductions allowed under the mark-to-market provisions, as well as any gain or loss on the disposition of ADSs with respect to which the mark-to-market election is made, is treated as ordinary income or loss (except that loss is treated as capital loss to the extent the loss exceeds the net mark-to-market gains, if any, that a U.S. Holder included in income with respect to such ordinary shares in prior years). However, gain or loss from the disposition of ADSs (as to which a mark-to-market election was properly made) in a year in which we are no longer a PFIC, will be capital gain or loss. Our ordinary shares or ADSs will be marketable stock as long as they remain regularly traded on a national securities exchange, such as the Nasdaq, or a foreign securities exchange regulated by a governmental authority of the country in which the market is located and which meets certain requirements, including that the rules of the exchange effectively promote active trading of listed stocks. If such stock is traded on such a qualified exchange or other market, such stock generally will be regularly traded for any calendar year during which such stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter, but no assurances can be given in this regard. Our ordinary shares are traded on the ASX, which may qualify as an eligible foreign securities exchange for this purpose. Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. Holder may continue to be subject to the PFIC rules with respect to its such holders indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes, including shares in any of our subsidiaries that are treated as PFICs.
A U.S. Holder of ADSs will not be able to avoid the tax consequences described above by electing to treat us as a qualified electing fund. In general, a qualified electing fund is, with respect to a U.S. person, a PFIC if the U.S. person has elected to include its proportionate share of a companys ordinary earnings and net capital gains in U.S. income on an annual basis. A qualified electing fund election can only be made with respect to us if we provide U.S. Holders with certain information on an annual basis and we do not intend to prepare the information that U.S. Holders would need to make the qualified electing fund election.
Backup Withholding and Information Reporting
Payments in respect of ADSs may be subject to information reporting to the IRS and to U.S. backup withholding tax at a rate equal to the fourth lowest income tax rate applicable to individuals (which, under current law, is 24%). Backup withholding will not apply, however, if a U.S. Holder (i) is a corporation, (ii) satisfies an applicable exemption, or (iii) furnishes correct taxpayer identification.
Backup withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a U.S. Holders U.S. tax liability, and a U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS.
F. Dividends and Paying Agents
Not applicable.
Not applicable.
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We are subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, as applicable to foreign private issuers as defined in Rule 3b-4 under the Exchange Act. As a foreign private issuer, we are exempt from certain provisions of the Exchange Act. Accordingly, our proxy solicitations are not subject to the disclosure and procedural requirements of regulation 14A under the Exchange Act, transactions in our equity securities by our officers and directors are exempt from reporting and the short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we file with the U.S. Securities and Exchange Commission an Annual Report on Form 20-F containing financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting firm, and we submit reports to the U.S. Securities and Exchange Commission on Form 6-K containing (among other things) press releases and unaudited financial information for the first six months of each fiscal year. We post our Annual Report on Form 20-F on our website promptly following the filing of our Annual Report with the U.S. Securities and Exchange Commission. The information on our website is not incorporated by reference into this Annual Report.
This document and the exhibits thereto and any other document we file pursuant to the Exchange Act may be inspected without charge and copied at prescribed rates at the U.S. Securities and Exchange Commission public reference room at 100 F Street, N.E., Room 1580, Washington D.C. 20549. You may obtain information on the operation of the Securities and Exchange Commissions public reference room in Washington, D.C. by calling the U.S. Securities and Exchange Commission at 1-800-SEC-0330.
The U.S. Securities and Exchange Commission maintains a website at www.sec.gov that contains reports, proxy and information statements and other information regarding registrants that make electronic filings with the U.S. Securities and Exchange Commission using its EDGAR (Electronic Data Gathering, Analysis, and Retrieval) system.
The documents concerning our company which are referred to in this document may also be inspected at our office located at Level 12, 95 Pitt Street, Sydney New South Wales 2000, Australia.
We currently have the following subsidiaries:
| Immutep USA Inc, a 100% owned subsidiary of Immutep Limited, incorporated in the State of Delaware in the United States. |
| Immutep GmbH, a 100% owned subsidiary of Immutep Limited, incorporated in Germany. |
| Immutep Australia Pty Ltd, a 100% owned subsidiary of Immutep Limited, incorporated in Australia. |
| Immutep IP Pty Ltd, a 100% owned subsidiary of Immutep Limited, incorporated in Australia. |
| Immutep S.A.S., a 100% owned subsidiary of Immutep Limited, incorporated in France |
These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States.
ITEM 11. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Our cash and cash equivalents consist primarily of cash and money market funds. We invest our excess cash and cash equivalents in interest-bearing accounts and term deposits with banks in Australia. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of Australian interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation.
We conduct our activities predominantly in Australia. However, we are exposed to foreign currency risk via trade and other payables we hold. We are required to make certain payments in U.S. dollars, European Euro and other currencies. See Note 2. Financial Risk Management(a) Market Risk to our notes to the financial statements for a further discussion of market risk and sensitivity analysis.
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Our exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollar, was as follows:
June 30, 2018 | June 30, 2017 | |||||||||||||||
USD | EUR | USD | EUR | |||||||||||||
Cash in bank |
7,788,802 | 2,163,426 | 712,680 | 7,449,288 | ||||||||||||
Trade and other receivables |
| 2,541,056 | | 5,024 | ||||||||||||
Trade and other payables |
(1,226,364 | ) | (315,485 | ) | (135,820 | ) | (858,305 | ) |
ITEM 12. | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
Not applicable.
Not applicable.
Not applicable.
The following are fees and charges that a holder of our ADSs may have to pay to the Bank of New York Mellon, as depositary:
Persons depositing or withdrawing ordinary shares or ADS holders must pay: |
For: | |
US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs) |
Issuance of ADSs, including issuances resulting from a distribution of ordinary shares or rights or other property Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | |
US$0.05 (or less) per ADS |
Any cash distribution to ADS holders | |
A fee equivalent to the fee that would be payable if securities distributed to an ADS holder had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs, i.e., US$5.00 or less per 100 ADSs (or portion of 100 ADSs) |
Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders | |
US$0.05 (or less) per ADSs per calendar year |
Depositary services | |
Registration or transfer fees |
Transfer and registration of ordinary shares on our ordinary share register to or from the name of the depositary or its agent when an ADS holder deposits or withdraws ordinary shares | |
Expenses of the depositary |
Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
converting foreign currency to U.S. dollars | |
Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or ordinary share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes |
As necessary | |
Any charges incurred by the depositary or its agents for servicing the deposited securities |
As necessary |
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The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.
The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary makes no representation that the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at that time or that the method by which that rate will be determined will be the most favorable to ADS holders, subject to the depositarys obligations under the deposit agreement. The methodology used to determine exchange rates used in currency conversions is available upon request to the depositary.
ADS holders are responsible for any taxes or other governmental charges payable on its ADSs or on the deposited securities represented by any of its ADSs. The depositary may refuse to register any transfer ADSs or allow an ADS holder to withdraw the deposited securities represented by its ADSs until such taxes or other charges are paid. It may apply payments owed to an ADS holder or sell deposited securities represented by an ADS holders ADSs to pay any taxes owed and such ADS holder will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to the holders of ADSs holder any proceeds, or send to the holders of ADSs any property, remaining after it has paid the taxes.
ITEM 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
Not applicable.
ITEM 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
Not applicable.
ITEM 15. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of June 30, 2018, as required by Rule 13a-15(b) under the Exchange Act. Based on that evaluation, our management has concluded that, as of June 30, 2018, our disclosure controls and procedures were effective.
Managements Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2018 based on the criteria set forth in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control Integrated Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2018.
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This Annual Report does not include an attestation report of the Companys registered public accounting firm as we are an emerging growth company.
Inherent Limitations on Effectiveness of Controls
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) for the fiscal year ended June 30, 2018 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 16. | RESERVED |
Not applicable.
ITEM 16A. | AUDIT COMMITTEE FINANCIAL EXPERT |
Pete Meyers is a member of our board of directors and serves on our audit committee. Our board has determined that Pete Meyers is an audit committee financial expert and satisfies the independence requirements of the U.S. Securities and Exchange Commission, the NASDAQ Marketplace Rules and ASX Rules.
ITEM 16B. | CODE OF ETHICS |
We have adopted a code of conduct that applies to our directors, chief executive officer and all senior financial officers of our company, including the chief financial officer, chief accounting officer or controller, or persons performing similar functions. The code of conduct is publicly available as attachment C to our Board Charter on our website at www.immutep.com. Written copies are available upon request. If we make any substantive amendment to the code of conduct or grant any waivers, including any implicit waiver, from a provision of the code of conduct, we will disclose the nature of such amendment or waiver on our website.
ITEM 16C. | PRINCIPAL ACCOUNTANT FEES AND SERVICES |
We retained PricewaterhouseCoopers as our independent registered public accounting firm. Set forth below is a summary of the fees paid to PricewaterhouseCoopers for services provided in fiscal years 2018 and 2017.
PricewaterhouseCoopers
Fiscal 2018 A$ |
Fiscal 2017 A$ |
|||||||
Audit fees |
258,570 | 434,250 | ||||||
|
|
|
|
|||||
Total |
258,570 | 434,250 | ||||||
|
|
|
|
Pre-Approval Policies and Procedures
Our Audit Committee has adopted policies and procedures for the pre-approval of audit and non-audit services rendered by our independent registered public accounting firm. Pre-approval of an audit or non-audit service may be given as a general pre-approval, as part of the audit committees approval of the scope of the engagement of our independent registered public accounting firm, or on an individual basis. Any proposed services exceeding general pre-approved levels also requires specific pre-approval by our audit committee. The policy prohibits retention of the independent registered public accounting firm to perform the prohibited non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the rules of the Securities and Exchange Commission, and also requires the audit committee to consider whether proposed services are compatible with the independence of the registered public accounting firm.
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ITEM 16D. | EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
Not applicable.
ITEM 16E. | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
Not applicable
ITEM 16F. | CHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT |
Not applicable.
ITEM 16G. | CORPORATE GOVERNANCE |
Under NASDAQ Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home country corporate governance practices instead of certain provisions of the NASDAQ Stock Market Rules. A foreign private issuer that elects to follow a home country practice instead of any such NASDAQ rules must submit to NASDAQ, in advance, a written statement from an independent counsel in such issuers home country certifying that the issuers practices are not prohibited by the home countrys laws. We submitted such a written statement to NASDAQ. See Item 6. Directors, Senior Management and EmployeesC. Board PracticesCorporate Governance Requirements Arising from our U.S. Listingthe Sarbanes-Oxley Act of 2002, SEC Rules and the Nasdaq Global Market Marketplace Rules for a summary of such differences.
ITEM 16H. | MINE SAFETY DISCLOSURE |
Not applicable.
ITEM 17. | FINANCIAL STATEMENTS |
We have elected to furnish financial statements and related information specified in Item 18.
ITEM 18. | FINANCIAL STATEMENTS |
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Immutep Ltd
Index to Consolidated Financial Statements
F-1
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|
To the Board of Directors and Shareholders of Immutep Limited
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Immutep Limited and its subsidiaries as of June 30, 2018 and June 30, 2017, and the related consolidated statements of comprehensive income, changes in equity and cash flows for each of the three years in the period ended June 30, 2018, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Immutep Limited and its subsidiaries as of June 30, 2018 and June 30, 2017, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2018 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board and in conformity with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board.
Basis for Opinion
These consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers
PricewaterhouseCoopers
Sydney, Australia
19 October 2018
We have served as the Companys auditor since 2011.
F-2
Table of Contents
IMMUTEP LIMITED
(in Australian dollars, except number of shares)
June 30, | ||||||||||||
Note | 2018 A$ |
2017 A$ |
||||||||||
ASSETS |
||||||||||||
Current Assets |
||||||||||||
Cash and cash equivalents |
7 | 23,475,521 | 12,236,974 | |||||||||
Current receivables |
8 | 3,431,994 | 2,194,016 | |||||||||
Other current assets |
9 | 1,735,664 | 1,488,268 | |||||||||
|
|
|
|
|||||||||
Total Current Assets |
28,643,179 | 15,919,258 | ||||||||||
|
|
|
|
|||||||||
Non-Current Assets |
||||||||||||
Plant and equipment |
10 | 26,449 | 24,202 | |||||||||
Intangibles |
11 | 18,329,155 | 19,020,336 | |||||||||
|
|
|
|
|||||||||
Total Non-Current Assets |
18,355,604 | 19,044,538 | ||||||||||
|
|
|
|
|||||||||
TOTAL ASSETS |
46,998,783 | 34,963,796 | ||||||||||
|
|
|
|
|||||||||
Current Liabilities |
||||||||||||
Trade and other payables |
13 | 3,663,849 | 2,588,781 | |||||||||
Employee benefits |
16 | 189,514 | 43,227 | |||||||||
|
|
|
|
|||||||||
Total Current Liabilities |
3,853,363 | 2,632,008 | ||||||||||
|
|
|
|
|||||||||
Non-Current Liabilities |
||||||||||||
Convertible note liability |
15 | 6,645,832 | 5,778,984 | |||||||||
Warrant liability |
14 | 2,945,358 | | |||||||||
Employee benefits |
17 | 32,303 | 20,498 | |||||||||
Deferred tax liability |
12 | | | |||||||||
|
|
|
|
|||||||||
Total Non-Current Liabilities |
9,623,493 | 5,799,482 | ||||||||||
|
|
|
|
|||||||||
TOTAL LIABILITIES |
13,476,856 | 8,431,490 | ||||||||||
|
|
|
|
|||||||||
NET ASSETS |
33,521,927 | 26,532,306 | ||||||||||
|
|
|
|
|||||||||
EQUITY |
||||||||||||
Contributed equity |
18 | 213,232,719 | 195,352,543 | |||||||||
Reserves |
19 | 64,874,040 | 63,018,575 | |||||||||
Accumulated losses |
19 | (244,584,832 | ) | (231,838,812 | ) | |||||||
|
|
|
|
|||||||||
Equity attributable to the owners of Immutep Limited |
33,521,927 | 26,532,306 | ||||||||||
|
|
|
|
|||||||||
TOTAL EQUITY |
33,521,927 | 26,532,306 | ||||||||||
|
|
|
|
The above consolidated balance sheets should be read in conjunction with the accompanying notes
F-3
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IMMUTEP LIMITED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in Australian dollars, except number of shares)
Years ended June 30, | ||||||||||||||||
Note | 2018 A$ |
2017 A$ |
2016 A$ |
|||||||||||||
Revenue |
||||||||||||||||
License revenue. |
2,630,484 | | 175,052 | |||||||||||||
Other income |
||||||||||||||||
Miscellaneous income |
1,008,678 | 800,460 | 702,743 | |||||||||||||
Grant income |
3,214,441 | 3,316,273 | 887,083 | |||||||||||||
Net gain on foreign exchange |
322,518 | 433 | | |||||||||||||
Interest income |
177,186 | 104,368 | 264,043 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total revenue and other income |
7,353,307 | 4,221,534 | 2,028,921 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Expenses |
||||||||||||||||
Research & development and intellectual property |
5 | (9,989,830 | ) | (7,525,744 | ) | (7,059,528 | ) | |||||||||
Corporate administrative expenses |
5 | (7,242,061 | ) | (4,346,952 | ) | (6,982,629 | ) | |||||||||
Depreciation and amortization expenses |
5 | (1,808,929 | ) | (1,701,615 | ) | (1,993,093 | ) | |||||||||
Share Based Payment to strategic investor |
15 | | | (47,468,071 | ) | |||||||||||
Loss on foreign exchange |
5 | | | (563,890 | ) | |||||||||||
Net finance cost |
5 | | | (8,199 | ) | |||||||||||
Changes in fair value of comparability milestone |
5 | | (542,075 | ) | ||||||||||||
Net loss on fair value movement of warrants |
14 | (189,983 | ) | | | |||||||||||
Changes in fair value of convertible note liability |
15 | (866,848 | ) | (751,816 | ) | (607,637 | ) | |||||||||
|
|
|
|
|
|
|||||||||||
Loss before income tax expense |
(12,744,344 | ) | (10,104,593 | ) | (63,196,201 | ) | ||||||||||
Income tax(expense)/ benefit |
6 | (1,676 | ) | 737,387 | 1,181,017 | |||||||||||
|
|
|
|
|
|
|||||||||||
Loss after income tax expense for the year |
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | ||||||||||
Other Comprehensive Income/(Loss) |
||||||||||||||||
Items that may be reclassified to profit or loss |
||||||||||||||||
Exchange differences on the translation of foreign operations |
1,329,119 | (271,696 | ) | 306,997 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Other comprehensive income/(loss) for the year net of tax |
1,329,119 | (271,696 | ) | 306,997 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total comprehensive loss for the year |
(11,416,901 | ) | (9,638,902 | ) | (61,708,187 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Loss for the year is attributable to: |
||||||||||||||||
Owners of Immutep Ltd |
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Total comprehensive loss for the year is attributable to: |
||||||||||||||||
Owners of Immutep Ltd |
(11,416,901 | ) | (9,638,902 | ) | (61,708,187 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
(11,416,901 | ) | (9,638,902 | ) | (61,708,187 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Cents | Cents (Restated) | Cents (Restated) | ||||||||||||||
Basic loss per share |
29 | (0.49 | ) | (0.41 | ) | (2.78 | ) | |||||||||
Diluted loss per share |
29 | (0.49 | ) | (0.41 | ) | (2.78 | ) |
The above consolidated statements of comprehensive income should be read in conjunction with the accompanying notes
F-4
Table of Contents
IMMUTEP LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in Australian dollars, except number of shares)
Years Ended June 30, | ||||||||||||||||
Note | 2018 A$ |
2017 A$ |
2016 A$ |
|||||||||||||
Cash flows related to operating activities |
||||||||||||||||
Payments to suppliers and employees (inclusive of GST) |
(13,572,384 | ) | (10,818,557 | ) | (13,336,202 | ) | ||||||||||
Miscellaneous income |
1,005,375 | 800,460 | 702,743 | |||||||||||||
License revenue |
2,630,484 | | 175,052 | |||||||||||||
Interest received |
127,033 | 104,368 | 264,043 | |||||||||||||
Tax received / (paid) |
(1,676 | ) | 21,643 | (2,410 | ) | |||||||||||
Grant income |
2,035,997 | 1,385,288 | 887,083 | |||||||||||||
Payment for security deposit |
(1,532 | ) | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows used in operating activities |
28 | (7,776,703 | ) | (8,506,798 | ) | (11,309,691 | ) | |||||||||
|
|
|
|
|
|
|||||||||||
Cash flows related to investing activities |
||||||||||||||||
Proceeds from disposal of plant and equipment |
| | 129,705 | |||||||||||||
Payments for plant and equipment |
(11,893 | ) | (6,644 | ) | (27,130 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows provided by (used in) investing activities |
(11,893 | ) | (6,644 | ) | 102,575 | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash flows related to financing activities* |
||||||||||||||||
Proceeds from issue of shares and options |
18 | 16,968,200 | 1 | 13,761,075 | ||||||||||||
Proceeds from issue of warrants |
14 | 2,755,375 | | | ||||||||||||
Proceeds from issue of convertible notes |
15 | | | 13,750,828 | ||||||||||||
Repayment of borrowings |
| | (1,508,473 | ) | ||||||||||||
Share issue transaction costs |
18 | (825,521 | ) | (8,533 | ) | (283,146 | ) | |||||||||
Finance cost of warrants |
(493,487 | ) | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows provided by (used in) financing activities |
18,404,567 | (8,532 | ) | 25,720,284 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net (decrease) increase in cash and cash equivalents |
10,615,971 | (8,521,974 | ) | 14,513,168 | ||||||||||||
Effect of exchange rate on cash and cash equivalents |
622,576 | (120,600 | ) | (393,235 | ) | |||||||||||
Cash and cash equivalents at the beginning of the year |
12,236,974 | 20,879,548 | 6,759,615 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Cash and cash equivalents at the end of the year |
7 | 23,475,521 | 12,236,974 | 20,879,548 | ||||||||||||
|
|
|
|
|
|
*Non-cash investing and financing activities relate mainly to the following:
| Fair value movement of convertible notes disclosed in Note 15 to the financial statements |
| Fair value movement of warrant liability disclosed in Note 14 to the financial statements |
| Exercise of vested performance rights for no cash consideration disclosed in Note 19 to the financial statements |
The above consolidated statements of cash flows should be read in conjunction with the accompanying notes
F-5
Table of Contents
IMMUTEP LIMITED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(in Australian dollars, except number of shares)
Consolidated |
Issued Equity A$ |
Reserves A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
Balance at July 1, 2015 |
179,878,436 | 5,267,729 | (160,456,422 | ) | 24,689,743 | |||||||||||
Other comprehensive income for the year, net of tax |
| 306,997 | | 306,997 | ||||||||||||
Loss after income tax expense for the year |
| | (62,015,184 | ) | (62,015,184 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total comprehensive income/(loss) for the year |
| 306,997 | (62,015,184 | ) | (61,708,187 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Transactions with owners in their capacity as owners: |
||||||||||||||||
Contributions of equity, net of transaction costs |
13,477,930 | | | 13,477,930 | ||||||||||||
Issue of convertible notes |
| 9,331,297 | | 9,331,297 | ||||||||||||
Share based payment |
| 82,242 | | 82,242 | ||||||||||||
Share based payment to strategic investor |
| 47,468,071 | | 47,468,071 | ||||||||||||
Employee share based payment |
| 1,976,417 | | 1,976,417 | ||||||||||||
Exercise of vested performance rights |
1,174,566 | (1,174,566 | ) | | | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at June 30, 2016 |
194,530,932 | 63,258,187 | (222,471,606 | ) | 35,317,513 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Consolidated |
Issued Equity A$ |
Reserves A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
Balance at July 1, 2016 |
194,530,932 | 63,258,187 | (222,471,606 | ) | 35,317,513 | |||||||||||
Other comprehensive loss for the year, net of tax |
| (271,696 | ) | | (271,696 | ) | ||||||||||
Loss after income tax expense for the year |
| | (9,367,206 | ) | (9,367,206 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total comprehensive loss for the year |
| (271,696 | ) | (9,367,206 | ) | (9,638,902 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Transactions with owners in their capacity as owners: |
||||||||||||||||
Contributions of equity, net of transaction costs |
(8,532 | ) | | | (8,532 | ) | ||||||||||
Employee share based payment |
| 862,227 | | 862,227 | ||||||||||||
Exercise of vested performance rights |
830,143 | (830,143 | ) | | | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at June 30, 2017 |
195,352,543 | 63,018,575 | (231,838,812 | ) | 26,532,306 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Consolidated |
Issued Equity A$ |
Reserves A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
Balance at July 1, 2017 |
195,352,543 | 63,018,575 | (231,838,812 | ) | 26,532,306 | |||||||||||
Other comprehensive income for the year, net of tax |
| 1,329,119 | | 1,329,119 | ||||||||||||
Loss after income tax expense for the year |
| | (12,746,020 | ) | (12,746,020 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total comprehensive income/( loss) for the year |
| 1,329,119 | (12,746,020 | ) | (11,416,901 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Transactions with owners in their capacity as owners: |
||||||||||||||||
Contributions of equity, net of transaction costs |
16,142,679 | | | 16,142,679 | ||||||||||||
Employee share based payment |
| 2,263,843 | | 2,263,843 | ||||||||||||
Exercise of vested performance rights |
1,737,497 | (1,737,497 | ) | | | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at June 30, 2018 |
213,232,719 | 64,874,040 | (244,584,832 | ) | 33,521,927 | |||||||||||
|
|
|
|
|
|
|
|
The above consolidated statements of changes in equity should be read in conjunction with the accompanying notes
F-6
Table of Contents
IMMUTEP LIMITED
NOTES TO THE FINANCIAL STATEMENTS
(in Australian dollars, unless otherwise noted)
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
As approved in the November 2017 Annual General Meeting, the name of the Company was changed from Prima BioMed Limited to Immutep Limited with effect from 1 December 2017. The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all years presented, unless otherwise stated. The financial statements are for the consolidated entity consisting of the Company and its subsidiaries.
(a) Basis of preparation
These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (AASB) and the Corporations Act 2001. Immutep Limited is a for-profit entity for the purpose of preparing the financial statements.
(i) Compliance with IFRS
The consolidated financial statements of the Immutep Limited group also comply with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
(ii) New and amended standards adopted by the group
None of the new standards and amendments to standards that are mandatory for the first time for the financial year beginning July 1, 2017 affected any of the amounts recognized in the current period or any prior periods.
(iii) Historical cost convention
The financial statements have been prepared under the historical cost convention, except for, where applicable, financial assets and liabilities (including derivative financial instruments), which are subsequently remeasured to fair value with changes in fair value recognized in profit or loss.
(iv) Critical accounting estimates
The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entitys accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in note 3.
(v) Authorisation of financial statements
The financial statements were authorised for issue, in accordance with a resolution of directors, on October 19, 2018. The directors have the power to amend and reissue the financial report.
(b) Principles of consolidation
Subsidiaries are all entities (included structured entities) over which the group has control. The group controls an entity when the group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the group. They are deconsolidated from the date that control ceases.
Intercompany transactions, balances and unrealized gains on transactions between group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the group.
(c) Segment reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision maker. The chief operating decision maker (CODM), who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors.
F-7
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(d) Foreign currency translation
(i) Functional and presentation currency
Items included in the financial statements of each of the groups entities are measured using the currency of the primary economic environment in which the entity operates (the functional currency). The consolidated financial statements are presented in Australian dollars, which is the Immutep Limiteds functional and presentation currency.
(ii) Transactions and balances
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss, except when they are deferred in equity as qualifying cash flow hedges and qualifying net investment hedges or are attributable to part of the net investment in a foreign operation.
Foreign exchange gains and losses that relate to borrowings are presented in the income statement, within finance costs. All other foreign exchange gains and losses are presented separately in the income statement on a net basis.
Non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair value through profit or loss are recognized in profit or loss as part of the fair value gain or loss and translation differences on non-monetary assets such as equities classified as available-for-sale financial assets are recognized in other comprehensive income.
(iii) Group companies
The results and financial position of foreign operations (none of which has the currency of a hyperinflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:
| assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet |
| income and expenses for each income statement and statement of comprehensive loss are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions), and |
| all resulting exchange differences are recognized in other comprehensive income. |
On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings and other financial instruments designated as hedges of such investments, are recognized in other comprehensive income. When a foreign operation is sold or any borrowings forming part of the net investment are repaid, the associated exchange differences are reclassified to profit or loss, as part of the gain or loss on sale.
(e) Revenue recognition
Revenue is measured at the fair value of the consideration received or receivable.
The group recognizes revenue when the amount of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria have been met for each of the groups activities as described below. The group bases its estimates on historical results, taking into consideration the type of customer, the type of transaction and the specifics of each arrangement.
(i) License revenue
License revenue is recognized on receipt or where there is reasonable assurance that the license revenue will be received.
F-8
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(e) Revenue recognition (continued)
Other income
(i) Interest income
Interest income is recognized as interest accrues using the effective interest method. This is a method of calculating the amortized cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.
(ii) Grant income
Grants from the governments, including Australian Research and Development Rebates and Development Rebates, Frances Crédit dImpôt Recherche, and Saxony Development Bank (Sächsische Aufbaubank) from Germany, are recognized at their fair value when there is a reasonable assurance that the grant will be received and the Company will comply with all attached conditions. Government grants relating to operating costs are recognized in the Statements of Comprehensive Income as grant income.
(iii) Miscellaneous income
a. | Research collaboration income |
The group receives income from undertaking research collaborations with are recognized when the services have been provided.
b. | Research material sales |
The group receives income from the sale of materials supplied to other researchers in order to conduct further studies on LAG-3 technologies. Income is recognized at the point at which the ownership of material is transferred to third parties.
(f) Income tax
The income tax expense or benefit for the period is the tax payable on the current periods taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Companys subsidiaries operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.
Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, deferred tax liabilities are not recognized if they arise from the initial recognition of goodwill.
Deferred income tax is also not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized or the deferred income tax liability is settled.
Deferred tax assets are recognized for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilize those temporary differences and losses. Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount and tax bases of investments in foreign operations where the Company is able to control the timing of the reversal of the temporary differences and it is probable that the differences will not reverse in the foreseeable future.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities and when the deferred tax balances relate to the same taxation authority.
F-9
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(f) Income tax (continued)
Current tax assets and tax liabilities are offset where the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously.
Immutep Limited and its wholly-owned Australian controlled entities have implemented the tax consolidation legislation. As a consequence, these entities are taxed as a single entity and the deferred tax assets and liabilities of these entities are set off in the consolidated financial statements.
Current and deferred tax is recognized in profit or loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.
(g) Business combinations
The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments or other assets are acquired. The consideration transferred for the acquisition of a subsidiary comprises the fair value of the assets transferred, liabilities incurred to the former owners of the acquired business and the equity interests issued by the group. The consideration transferred also includes the fair value of any asset or liability resulting from a contingent consideration agreement, and the fair value of any pre-existing equity interest in the subsidiary.
Identifiable assets acquired and liabilities and contingent liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date. The group recognizes and non-controlling interest in the acquired entity on an acquisition-by-acquisition basis either at fair value or at the non-controlling interests proportionate share of the acquired entitys net identifiable assets.
Acquisition-related costs are expensed as incurred.
The excess of the consideration transferred and the amount of any non-controlling interests in the acquiree over the fair value of the Groups share of the net identifiable assets acquired is recorded as goodwill. If those amounts are less than the fair value of the net identifiable assets of the subsidiary acquired and the measurement of all amounts has been reviewed, the difference is recognized directly in profit and loss as a bargain purchase.
Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate used is the entitys incremental borrowing rate, being the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and conditions.
Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are subsequently remeasured to fair value with changes in fair value recognized in profit or loss.
If the business combination is achieved in stages, the acquisition date carrying value of the acquirers previously held equity interest in the acquiree is remeasured to fair value at the acquisition date. Any gains or losses arising from such remeasurement are recognized in profit and loss.
(h) Impairment of assets
Goodwill and intangible assets that have a definite useful life are subject to amortization and tested annually for impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the assets carrying amount exceeds its recoverable amount.
The recoverable amount is the higher of an assets fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from other assets or groups of assets (cash-generating units). Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at the end of each reporting period.
F-10
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(i) Cash and cash equivalents
For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value, and bank overdrafts. Bank overdrafts are shown within borrowings in current liabilities in the balance sheet.
(j) Current receivables
Current receivables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less provision for impairment. Amount receivable in relation to Goods and Services Tax (GST) and Value Added Tax (VAT) are due from the local taxation authorities and recorded based on the amount of GST and VAT paid on purchases. They are presented as current assets unless collection is not expected for more than 12 months after the reporting date.
Collectability of current receivables is reviewed on an ongoing basis. Receivables which are known to be uncollectible are written off by reducing the carrying amount. An allowance account is used when there is objective evidence that the group will not be able to collect all amounts due.
(k) Investments and other financial assets
Investments and other financial assets are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets at fair value through profit or loss. They are subsequently measured at either amortized cost or fair value depending on their classification. Classification is determined based on the purpose of the acquisition and subsequent reclassification to other categories is restricted.
Financial assets are derecognized when the rights to receive cash flows from the financial assets have expired or have been transferred and the consolidated entity has transferred substantially all the risks and rewards of ownership.
Loans and receivables
Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are carried at amortized cost using the effective interest rate method. Gains and losses are recognized in profit or loss when the asset is derecognized or impaired, as well as through the amortization process.
Impairment of financial assets
The group assesses at the end of each reporting period whether there is any objective evidence that a financial asset or group of financial assets is impaired. Objective evidence includes significant financial difficulty of the issuer or obligor; a breach of contract such as default or delinquency in payments; the lender granting to a borrower concessions due to economic or legal reasons that the lender would not otherwise do; it becomes probable that the borrower will enter bankruptcy or other financial reorganization; the disappearance of an active market for the financial asset; or observable data indicating that there is a measurable decrease in estimated future cash flows.
The amount of the impairment allowance for loans and receivables carried at amortized cost is the difference between the assets carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate. If there is a reversal of impairment, the reversal cannot exceed the amortized cost that would have been recognized had the impairment not been made and is reversed to profit or loss.
(l) Plant and equipment
Plant and equipment is stated at historical cost less depreciation. Historical cost includes expenditure that is directly attributable to the acquisition of the items.
Depreciation on other assets is calculated using the straight-line method to allocate their cost, net of their residual values, over their estimated useful lives as follows:
| Computers 3 years |
| Plant and equipment 3-5 years |
| Furniture 3-5 years |
F-11
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(l) Plant and equipment (continued)
The assets residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period.
An assets carrying amount is written down immediately to its recoverable amount if the assets carrying amount is greater than its estimated recoverable amount (note 1(h)).
Gains and losses on disposals are determined by comparing proceeds with carrying amount. These are included in profit or loss.
(m) Intangible assets
(i) Intellectual property
Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents, which averages 14 years. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.
Costs include only those costs directly attributable to the acquisition of the intellectual property. An assets carrying amount is written down immediately to its recoverable amount if the assets carrying amount is greater than its estimated recoverable amount (note 1(h)).
(ii) Research and development
Research expenditure on internal projects is recognized as an expense as incurred. Costs incurred on development projects (relating to the design and testing of new or improved products) are recognized as intangible assets when it is probable that the project will, after considering its commercial and technical feasibility, be completed and generate future economic benefits and its costs can be measured reliably. The expenditure that could be recognized comprises all directly attributable costs, including costs of materials, services, direct labor and an appropriate proportion of overheads. Other expenditures that do not meet these criteria are recognized as an expense as incurred.
As the Company has not met the requirement under the standard to capitalize costs in relation to development, these amounts have been expensed.
Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. Capitalized development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight line basis over its useful life.
(iii) Goodwill
Goodwill is measured as described in (note 1(g)). Goodwill on acquisitions of subsidiaries is included in intangible assets. Goodwill is not amortized but it is tested for impairment annually or more frequently if events or changes in circumstances indicate that it might be impaired, and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold.
(n) Trade and other payables
These amounts represent liabilities for goods and services provided to the group prior to the end of financial year which are unpaid.
The amounts are unsecured and are usually paid within 30 days of recognition. Trade and other payables are presented as current liabilities unless payment is not due within 12 months from the reporting date. They are recognized initially at their fair value and subsequently remeasured at amortized cost using the effective interest method.
F-12
Table of Contents
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(o) Compound instruments
Convertible notes, including the attached options and warrants, issued to Ridgeback Capital Investments are accounted for as share based payments when the fair value of the instruments are higher than the consideration received, representing intangible benefits received from the strategic investor. The difference between the fair value and consideration received at issuance of the convertible notes and attached options and warrants is recognised immediately in profit and loss as a share-based payment charge.
If options or warrants contain a settlement choice between cash or shares, this settlement choice constitutes a compound feature of the convertible notes, which triggers the separation of debt and equity components to be accounted for separately. The liability component is measured at fair value at initial recognition and subsequent changes in fair value are recognised in profit and loss. The difference between the fair value of the convertible notes and the liability component at inception is accounted as an equity element and not remeasured subsequently.
(p) Finance costs
Finance costs are expensed in the period in which they are incurred.
(q) Employee benefits
(i) Short-term obligations
Liabilities for wages and salaries, including non-monetary benefits and accumulating annual leave that are expected to be settled wholly within 12 months after the end of the period in which the employees render the related service are recognized in respect of employees services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. Liabilities for non-accumulating sick leave are recognized when the leave is taken and measured at the rates paid or payable.
(ii) Other long-term employee benefit obligations
The liabilities for long service leave and annual leave that are not expected to be settled wholly within 12 months after the end of the period in which the employees render the related service are measured at the present value of expected future payments to be made in respect of services provided by employees up to the end of the reporting period using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the end of the reporting period of corporate bonds with terms and currencies that match, as closely as possible, the estimated future cash outflows. Remeasurements as a result of experience adjustments and changes in actuarial assumptions are recognized in profit or loss. The obligations are presented as current liabilities in the balance sheet if the entity does not have an unconditional right to defer settlement for at least twelve months after the reporting period, regardless of when the actual settlement is expected to occur.
(iii) Retirement benefit obligations
The group does not maintain a group superannuation plan. The group makes fixed percentage contributions for all Australian resident employees to complying third party superannuation funds. The group has no statutory obligation and does not make contributions on behalf of its resident employees in the USA and Germany. The groups legal or constructive obligation is limited to these contributions. Contributions to complying third party superannuation funds are recognized as an expense as they become payable.
(iv) Share-based payments
Share-based compensation benefits are provided to employees via the Executive Incentive Plan (EIP). Information relating to these schemes is set out in note 30.
The fair value of performance rights and options granted under the EIP are recognized as an employee benefits expense with a corresponding increase in equity. The total amount to be expensed is determined by reference to the fair value of the options granted, which includes any market performance conditions and the impact of any non-vesting conditions but excludes the impact of any service and non-market performance vesting conditions.
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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Non-market vesting conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each period, the entity revises its estimates of the number of options that are expected to vest based on the non-marketing vesting conditions. It recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to equity.
(v) Termination benefits
Termination benefits are payable when employment is terminated before the normal employment contract expiry date. The group recognizes termination benefits when it is demonstrably committed to terminating the employment of current employees.
(vi) Bonus plan
The group recognizes a liability and an expense for bonuses. The group recognizes a provision where contractually obliged or where there is a past practice that has created a constructive obligation.
(r) Contributed equity
Ordinary shares are classified as equity.
Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.
(s) Earnings per share
(i) Basic earnings per share
Basic earnings per share is calculated by dividing:
| the profit or loss attributable to owners of the Company |
| by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the year. Bonus elements have been included in the calculation of the weighted average number of ordinary shares and has been retrospectively applied to the prior financial year. |
(ii) Diluted earnings per share
Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account:
| the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares, and |
| the weighted average number of additional ordinary shares that would have been outstanding assuming the conversion of all dilutive potential ordinary shares. |
(t) Goods and Services Tax and other similar taxes (GST)
Revenues, expenses and assets are recognized net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is recognized as part of the cost of acquisition of the asset or as part of the expense.
Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the balance sheet.
Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the taxation authority, are presented as operating cash flows.
Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.
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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(u) New Accounting Standards and Interpretations not yet mandatory or early adopted
Certain new accounting standards and interpretations have been published that are not mandatory for June 30, 2018 reporting periods and have not been early adopted by the company. The companys assessment of the impact of these new standards and interpretations is set out below:
(i) | AASB 15 (IFRS 15) Revenue from Contracts with CustomersThe AASB has issued a new standard for the recognition of revenue. This will replace AASB 118 (IAS 18) which covers revenue arising from the sale of goods and the rendering of services and AASB 111 (IAS 11) which covers construction contracts. The new standard is based on the principle that revenue is recognised when control of a good or service transfers to a customer. The standard permits either a full retrospective or a modified retrospective approach for the adoption. It applies to annual reporting periods commencing on or after 1 January 2018. The impact of the new standard on the financial statements when applied to future periods will depend on the Groups sources of revenues at the time of adoption of the new standard. The Group currently has limited sources of revenue as it is still in the research and development phase and has assessed that the new revenue standard will have minimal impact. The Group plans to use the modified retrospective approach for the adoption. |
(ii) | AASB 9 (IFRS 9) Financial InstrumentsAASB 9 (IFRS 9) addresses the classification, measurement and derecognition of financial assets and financial liabilities, introduces new rules for hedge accounting and a new impairment model for financial assets. It applies to annual reporting periods commencing on or after 1 January 2018. Management has assessed the impact of the new standard on the financial statements when applied to future periods and expects it to have limited impact. |
(iii) | AASB 16 (IFRS 16) LeasesThe AASB 16 (IFRS 16) has issued a new standard for the accounting of leases. The new standard will predominantly affect lessees, with almost all leases brought onto the balance sheet. It applies to annual reporting periods commencing on or after 1 January 2019. Management has yet to fully assess the impact of the new standard on the financial statements when applied to future periods, although the Group currently has no significant off-balance sheet lease commitments. |
There are no other standards and interpretations that are not yet effective and that are expected to have a material impact on the Group in the current or future reporting periods and on foreseeable future transactions.
(v) Parent entity financial information
The financial information for the parent entity, Immutep Limited, disclosed in note 31 has been prepared on the same basis as the consolidated financial statements, except as set out below.
(i) Investments in subsidiaries, associates and joint venture entities
Investments in subsidiaries are accounted for at cost in the financial statements of Immutep Limited.
(ii) Tax consolidation legislation
Immutep Limited and its wholly-owned Australian controlled entities have implemented the tax consolidation legislation. The head entity, Immutep Limited, and the controlled entities in the tax consolidated group account for their own current and deferred tax amounts. These tax amounts are measured as if each entity in the tax consolidated group continues to be a stand-alone taxpayer in its own right.
The entities have also entered into a tax funding agreement under which the wholly-owned entities fully compensate for any current tax payable assumed and are compensated by the head entity for any current tax receivable and deferred tax assets relating to unused tax losses or unused tax credits that are transferred to the head entity under the tax consolidation legislation. The funding amounts are determined by reference to the amounts recognized in the wholly-owned entities financial statements.
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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(v) Parent entity financial information (continued)
The amounts receivable/payable under the tax funding agreement are due upon receipt of the funding advice from the head entity, which is issued as soon as practicable after the end of each financial year. The head entity may also require payment of interim funding amounts to assist with its obligations to pay tax instalments. Assets or liabilities arising under tax funding agreements with the tax consolidated entities are recognized as current amounts receivable from or payable to other entities in the group. Any difference between the amounts assumed and amounts receivable or payable under the tax funding agreement are recognized as a contribution to (or distribution from) wholly-owned tax consolidated entities.
(iii) Share-based payments
The grant by the company of options over its equity instruments to the employees of subsidiary undertakings in the group is treated as a capital contribution to that subsidiary undertaking. The fair value of employee services received, measured by reference to the grant date fair value, is recognized over the vesting period as an increase to investment in subsidiary undertakings, with a corresponding credit to equity.
NOTE 2. FINANCIAL RISK MANAGEMENT
The groups activities expose it to a variety of financial risks: market risk (including currency risk), credit risk and liquidity risk. The groups overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the financial performance of the group. The group may use derivative financial instruments such as foreign exchange contracts to hedge certain risk exposures. Derivatives are exclusively used for hedging purposes, i.e. not as trading or other speculative instruments. The group hedges its foreign exchange risk exposure arising from future commercial transactions and recognized assets and liabilities using forward contracts or natural hedging. The group uses different methods to measure different types of risk to which it is exposed. These methods include sensitivity analysis and cash flow forecasting in the case of foreign exchange and aging analysis for credit risk.
Risk management is carried out by senior management under policies approved by the board of directors. Management identifies, evaluates and hedges financial risks in close co-operation with the groups operating units. The board provides the principles for overall risk management, as well as policies covering specific areas, such as foreign exchange risk, interest rate risk, credit risk, use of derivative financial instruments and non-derivative financial instruments, and investment of excess liquidity.
(a) Market risk
Foreign exchange risk
The group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US dollar and Euro. Foreign exchange risk arises from future commercial transactions and recognized assets and liabilities denominated in a currency that is not the entitys functional currency. The risk is measured using sensitivity analysis and cash flow forecasting.
Management has set up a policy to manage the companys exchange risk within the group companies. The group hedges its foreign exchange risk exposure arising from future commercial transactions and recognized assets and liabilities using forward contracts or natural hedging.
The group considers using forward exchange contracts to cover anticipated cash flow in USD and Euro periodically, as derivatives held for trading and measured through the statement of comprehensive income. This policy is reviewed regularly by directors from time to time. There were no outstanding foreign exchange contracts as at June 30, 2018 and June 30, 2017.
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NOTE 2. FINANCIAL RISK MANAGEMENT (continued)
The groups exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollar, was as follows:
June 30, 2018 | June 30, 2017 | |||||||||||||||
USD | EUR | USD | EUR | |||||||||||||
Cash in bank |
7,788,802 | 2,163,426 | 712,680 | 7,449,288 | ||||||||||||
Trade and other receivables |
| 2,541,056 | | 5,024 | ||||||||||||
Trade and other payables |
(1,226,364 | ) | (315,485 | ) | (135,820 | ) | (858,305 | ) |
Sensitivity
Based on the financial assets and liabilities held at June 30, 2018, had the Australian dollar weakened/ strengthened by 10% against the US dollar with all other variables held constant, the groups post-tax loss for the year would have been $656,244 lower/$656,244 higher (2017 $57,686 lower/$57,686 higher).
Based on the financial instruments held at June 30, 2018, had the Australian dollar weakened/ strengthened by 10% against the Euro with all other variables held constant, the groups post-tax loss for the year would have been $438,900 lower/$438,900 higher lower (2017 $659,601 lower/$659,601 higher), mainly as a result of foreign exchange gains/losses on translation of Euro denominated financial instruments.
Any changes in post-tax loss will have an equivalent change to equity.
The US warrants financial liability will be equity-based settled upon exercise of the US warrants. However, as the exercise will be done with an exercise price in US dollars, there is a foreign exchange risk due to the subsequent translation to Australian dollars.
Currently the groups exposure to other foreign exchange movements is not material.
(b) Credit risk
Credit risk is managed on a group basis. Credit risk arises from cash and cash equivalents, derivative financial instruments and deposits with banks. For banks, only independently rated parties with a minimum rating of A according to ratings agencies are accepted.
The credit quality of financial assets that are neither past due nor impaired can be assessed by reference to external credit ratings:
June 30, 2018 | June 30, 2017 | |||||||
$ | $ | |||||||
Cash at bank and short-term bank deposits |
||||||||
Minimum rating of A |
23,475,521 | 12,236,974 |
(c) Liquidity risk
Prudent liquidity risk management implies maintaining sufficient cash to meet obligations when due. At the end of the reporting period the group held deposits at call of $ 23,475,521 (2017: $12,236,974) that are expected to readily generate cash inflows for managing liquidity risk. Management monitors rolling forecasts of the groups liquidity reserve cash and cash equivalents (note 7) on the basis of expected cash flows. In addition, the groups liquidity management policy involves projecting cash flows in major currencies and considering the level of liquid assets necessary to meet these.
As outlined in Note 3, the companys monitoring of its cash requirements extends to the consideration of potential capital raising strategies and an active involvement with its institutional and retail investor base.
Maturities of financial liabilities
The tables below analyze the groups financial liabilities into relevant maturity groupings based on their contractual maturities for:
(a) | all non-derivative financial liabilities, and |
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NOTE 2. FINANCIAL RISK MANAGEMENT (continued)
(b) | net and gross settled derivative financial instruments for which the contractual maturities are essential for an understanding of the timing of the cash flows. |
The amounts disclosed in the table are the contractual undiscounted cash flows. Balances due within 12 months equal their carrying balances as the impact of discounting is not significant.
Contractual maturities of financial liabilities At June 30, 2018 |
Less than 6 months $ |
More than 5 years $ |
Total contractual cash flows $ |
Carrying Amount (assets) / liabilities $ |
||||||||||||
Non-Derivatives |
||||||||||||||||
Trade and other payables |
3,663,849 | | 3,663,849 | 3,663,849 | ||||||||||||
Convertible note liability (refer note 15) |
| 17,876,076 | 17,876,076 | 6,645,832 | ||||||||||||
3,663,849 | 17,876,076 | 21,539,925 | 10,309,681 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Contractual maturities of financial liabilities At June 30, 2017 |
Less than 6 months $ |
More than 5 years $ |
Total contractual cash flows $ |
Carrying Amount (assets) / liabilities $ |
||||||||||||
Non-Derivatives |
||||||||||||||||
Trade and other payables |
2,588,781 | | 2,588,781 | 2,588,781 | ||||||||||||
Convertible note liability (refer note 15) |
| 17,876,076 | 17,876,076 | 5,778,984 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
2,588,781 | 17,876,076 | 20,464,857 | 8,367,765 | |||||||||||||
|
|
|
|
|
|
|
|
(d) Fair value measurements
The following table presents the groups financial assets and financial liabilities measured and recognized at fair value at June 30, 2018 and June 30, 2017 on a recurring basis:
At June 30, 2018 |
Level 1 $ |
Level 2 $ |
Level 3 $ |
Total $ |
||||||||||||
Liabilities |
||||||||||||||||
Convertible note liability |
| | 6,645,832 | 6,645,832 | ||||||||||||
Warrant liability |
| 2,945,358 | | 2,945,358 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total liabilities |
| 2,945,358 | 6,645,832 | 9,591,190 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At June 30, 2017 |
Level 1 $ |
Level 2 $ |
Level 3 $ |
Total $ |
||||||||||||
Liabilities |
||||||||||||||||
Convertible note liability |
| | 5,778,984 | 5,778,984 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total liabilities |
| | 5,778,984 | 5,778,984 | ||||||||||||
|
|
|
|
|
|
|
|
(i) Valuation techniques used to determine fair values
Level 1: The fair value of financial instruments trade in active markets (such as publicly traded derivatives, and trading and available-for-sale securities) is based on quoted (unadjusted) market prices at the end of the reporting period. The quoted market price used for financial assets held by the group is the current bid price. These instruments are included in level 1.
Level 2: The fair value of financial instruments that are not traded in an active market (for example over-the-counter derivatives) is determined using valuation techniques. These valuation techniques maximize the use of observable market data where it is available and rely as little as possible on entity specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2
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NOTE 2. FINANCIAL RISK MANAGEMENT (continued)
Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for unlisted equity securities.
Specific valuation techniques used to value financial instruments include:
| The use of quoted market prices or dealer quotes for similar instruments |
| The fair value of interest rate swaps is calculated as the present value of the estimated future cash flows based on observable yield curves |
| The fair value of forward foreign exchange contracts is determined using forward exchange rates at the balance sheet date |
| The fair value of the remaining financial instruments is determined using discounted cash flow analysis. |
(ii) Fair value measurements using value techniques
For US warrant valuation inputs under Level 2, please refer to Note 14.
| There are no financial instruments as at 30 June 2018 under Level 1. |
| Level 2 financial instruments consist of warrant liabilities. Refer to Note 14 for details of fair value measurement. |
| Level 3 financial instruments consist of convertible notes. Refer to Note 15 for details of fair value measurement. |
(iii) Valuation inputs and relationships to fair value
The following table summarizes the quantitative information about the significant inputs used in level 3 fair value measurements:
Description |
Fair value at June 30, 2018 $ |
Unobservable inputs |
Range of inputs | |||||||
Convertible note |
6,645,832 | Face value | $ | 13,750,828 | ||||||
Interest rate of note | 3 | % | ||||||||
Risk adjusted interest rate | 15 | % |
(iv) Valuation process
The convertible note was valued using a discounted cash flow model.
NOTE 3. CRITICAL ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS
Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that may have a financial impact on the entity and that are believed to be reasonable under the circumstances.
The group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.
F-19
Table of Contents
NOTE 3. CRITICAL ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS (continued)
Income taxes
Deferred tax assets relating to carried forward tax losses and taxable temporary differences have not been recognized since the group is currently in a loss making position and unable to generate taxable income to utilize the carried forward tax losses and taxable temporary differences. The utilization of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. The group is subject to income taxes in Australia and jurisdictions where it has foreign operations. Significant judgement is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The group estimates its tax liabilities based on the groups understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.
Development
The consolidated entity has expensed all internal development expenditure incurred during the year as the costs relate to the initial expenditure for development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the current stage of development. It was considered appropriate to expense the development costs as they did not meet the criteria to be capitalized under AASB 138 (IAS 38) Intangible Assets.
Going Concern
The Group has experienced significant recurring operating losses and negative cash flows from operating activities since its inception. As at 30 June 2018, the Group holds cash and cash equivalents of $23,475,521 (2017: $12,236,974). In line with the Companys financial risk management, the directors have carefully assessed the financial and operating implications of the above matters, including the expected cash outflows of ongoing research and development activities of the Group over the next 12 months. Based on this consideration, the directors are of the view that the Group will be able to pay its debts as and when they fall due for at least 12 months following the date of these financial statements and that it is appropriate for the financial statements to be prepared on a going concern basis.
Monitoring and addressing the ongoing cash requirements of the Group is a key focus of the directors. This involves consideration of alternative future capital raising initiatives and an active engagement with potential retail and institutional investors alike.
Amortization of intellectual property
Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.
Costs include only those costs directly attributable to the acquisition of the intellectual property. An assets carrying amount is written down immediately to its recoverable amount if the assets carrying amount is greater than its estimated recoverable amount (note 1(h)).
F-20
Table of Contents
NOTE 4. SEGMENT REPORTING
Identification of reportable operating segments
Operating segments are reported in a manner consistent with internal reports which are reviewed and used by Management and the Board of Directors (who are identified as the Chief Operating Decision Makers (CODM)). The Group operates in one operating segment, being Cancer Immunotherapy.
Operating segment information
June 30, 2018 |
Cancer Immunotherapy A$ |
Unallocated A$ |
Consolidated A$ |
|||||||||
Revenue |
||||||||||||
License revenue |
2,630,484 | | 2,630,484 | |||||||||
Other income |
||||||||||||
Miscellaneous income |
1,008,678 | | 1,008,678 | |||||||||
Grant income |
3,214,441 | | 3,214,441 | |||||||||
Other income |
| 322,518 | 322,518 | |||||||||
Interest income |
| 177,186 | 177,186 | |||||||||
Total revenue and other income |
6,853,603 | 499,704 | 7,353,307 | |||||||||
Segment Result |
(13,054,065 | ) | 309,721 | (12,744,344 | ) | |||||||
Profit/(loss) before income tax expense |
(13,054,065 | ) | 309,721 | (12,744,344 | ) | |||||||
Income tax benefit |
| (1,676 | ) | |||||||||
|
|
|||||||||||
Loss after income tax expense |
(12,746,020 | ) | ||||||||||
|
|
|||||||||||
Total segment assets |
46,998,783 | | 46,998,783 | |||||||||
Total segment liabilities |
13,476,856 | | 13,476,856 | |||||||||
June 30, 2017 |
Cancer Immunotherapy A$ |
Unallocated A$ |
Consolidated A$ |
|||||||||
Revenue |
||||||||||||
License revenue |
| | | |||||||||
Other income |
| | | |||||||||
Miscellaneous income |
800,460 | | 800,460 | |||||||||
Grant income |
3,316,273 | | 3,316,273 | |||||||||
Other income |
| 433 | 433 | |||||||||
Interest income |
| 104,368 | 104,368 | |||||||||
Total revenue and other income |
4,116,733 | 104,801 | 4,221,534 | |||||||||
Segment Result |
(10,209,394 | ) | 104,801 | (10,104,593 | ) | |||||||
Profit/(loss) before income tax expense |
(10,209,394 | ) | 104,801 | (10,104,593 | ) | |||||||
Income tax benefit |
737,387 | |||||||||||
|
|
|||||||||||
Loss after income tax expense |
(9,367,206 | ) | ||||||||||
|
|
|||||||||||
Total segment assets |
34,963,796 | | 34,963,796 | |||||||||
Total segment liabilities |
8,431,490 | | 8,431,490 |
F-21
Table of Contents
NOTE 4. SEGMENT REPORTING (continued)
June 30, 2016 |
Cancer Immunotherapy A$ |
Unallocated A$ |
Consolidated A$ |
|||||||||
Revenue |
||||||||||||
License revenue |
175,052 | | 175,052 | |||||||||
Other income |
||||||||||||
Miscellaneous income |
702,743 | | 702,743 | |||||||||
Grant income |
887,083 | | 887,083 | |||||||||
Interest income |
| 264,043 | 264,043 | |||||||||
Total revenue and other income |
1,764,878 | 264,043 | 2,028,921 | |||||||||
Segment Result |
(63,460,244 | ) | 264,043 | (63,196,201 | ) | |||||||
Profit/(loss) before income tax expense |
(63,460,244 | ) | 264,043 | (63,196,201 | ) | |||||||
Income tax benefit |
1,181,017 | |||||||||||
|
|
|||||||||||
Loss after income tax expense |
(62,015,184 | ) | ||||||||||
|
|
|||||||||||
Total segment assets |
42,554,067 | | 42,554,067 | |||||||||
Total segment liabilities |
7,236,554 | | 7,236,554 |
NOTE 5. EXPENSES
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Loss before income tax includes the following specific expenses: |
||||||||||||
Research & Development and Intellectual Property |
||||||||||||
Research and development |
8,972,321 | 6,991,151 | 6,382,377 | |||||||||
Intellectual property management |
1,017,509 | 534,593 | 677,151 | |||||||||
|
|
|
|
|
|
|||||||
Total Research & Development and Intellectual Property |
9,989,830 | 7,525,744 | 7,059,528 | |||||||||
|
|
|
|
|
|
|||||||
Corporate administrative expenses |
||||||||||||
Auditors remuneration |
258,570 | 234,250 | 441,741 | |||||||||
Directors fee and employee expenses |
1,703,671 | 1,103,512 | 1,643,294 | |||||||||
Employee share-based payment expenses |
2,263,843 | 862,227 | 1,976,417 | |||||||||
US warrants transaction costs |
493,487 | | | |||||||||
Administrative expenses |
2,522,490 | 2,146,963 | 2,921,177 | |||||||||
|
|
|
|
|
|
|||||||
Total corporate administrative expenses |
7,242,061 | 4,346,952 | 6,982,629 | |||||||||
|
|
|
|
|
|
|||||||
Depreciation |
||||||||||||
Plant and equipment |
1,917 | 3,680 | 168,924 | |||||||||
Computers |
7,814 | 8,867 | 10,676 | |||||||||
Furniture and fittings |
893 | 1,394 | 2,775 | |||||||||
|
|
|
|
|
|
|||||||
Total depreciation |
10,624 | 13,941 | 182,375 | |||||||||
|
|
|
|
|
|
|||||||
Amortization |
||||||||||||
Patents |
| | 61,881 | |||||||||
Intellectual Property Assets R&D |
1,798,305 | 1,687,674 | 1,748,837 | |||||||||
|
|
|
|
|
|
|||||||
Total amortization |
1,798,305 | 1,687,674 | 1,810,718 | |||||||||
|
|
|
|
|
|
|||||||
Total depreciation and amortization |
1,808,929 | 1,701,615 | 1,993,093 | |||||||||
|
|
|
|
|
|
|||||||
(Gain)/loss on disposal of assets |
||||||||||||
Plant and equipment |
| | (18,493 | ) | ||||||||
|
|
|
|
|
|
|||||||
Finance expenses |
||||||||||||
Interest expenses |
| | 8,199 | |||||||||
Other finance expenses |
| |||||||||||
|
|
|
|
|
|
|||||||
Finance expense |
| | 8,199 | |||||||||
|
|
|
|
|
|
|||||||
Net change in fair value of convertible note liability |
866,848 | 751,816 | 607,637 | |||||||||
|
|
|
|
|
|
|||||||
Net change in fair value of warrants |
189,983 | | | |||||||||
|
|
|
|
|
|
|||||||
Loss on foreign exchange |
| | 563,890 | |||||||||
|
|
|
|
|
|
|||||||
Changes in fair value of comparability milestone |
| | 542,075 | |||||||||
|
|
|
|
|
|
|||||||
Share Based Payment to strategic investor |
| | 47,468,071 | |||||||||
|
|
|
|
|
|
F-22
Table of Contents
NOTE 6. INCOME TAX EXPENSE
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Current tax |
||||||||||||
Current tax on profits for the year |
1,676 | (43,193 | ) | 3,121 | ||||||||
|
|
|
|
|
|
|||||||
Total current tax expense |
1,676 | (43,193 | ) | 3,121 | ||||||||
|
|
|
|
|
|
|||||||
Deferred income tax |
||||||||||||
Increase in deferred tax assets (note 12) |
(103,660 | ) | (419,460 | ) | (921,463 | ) | ||||||
Decrease in deferred tax liabilities (note 12) |
103,660 | (274,734 | ) | (262,675 | ) | |||||||
|
|
|
|
|
|
|||||||
Total deferred tax (benefit)/expense |
| (694,194 | ) | (1,184,138 | ) | |||||||
|
|
|
|
|
|
|||||||
Income tax (benefit)/expense |
1,676 | (737,387 | ) | (1,181,017 | ) | |||||||
|
|
|
|
|
|
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Numerical reconciliation of income tax expense to prima facie tax payable |
||||||||||||
Loss before income tax expense |
(12,744,344 | ) | (10,104,593 | ) | (63,196,201 | ) | ||||||
Tax at the Australian tax rate of 27.5% (2017 27.5% and 2016: 30%) |
(3,504,695 | ) | (2,778,763 | ) | (18,958,860 | ) | ||||||
Tax effect amounts which are not deductible/(taxable) in calculating taxable income: |
||||||||||||
Non-deductible share based payments |
807,896 | 234,385 | 14,858,019 | |||||||||
Other non-deductible expenses |
2,962,323 | 628,111 | 598,016 | |||||||||
Non-assessable income |
(883,971 | ) | (911,975 | ) | (266,125 | ) | ||||||
Capital listing fee |
(79,152 | ) | (64,120 | ) | (90,305 | ) | ||||||
Difference in overseas tax rates* |
828,289 | 811,346 | 1,184,138 | |||||||||
|
|
|
|
|
|
|||||||
130,690 | (2,081,016) | (2,675,117) | ||||||||||
Net adjustment to deferred tax assets and liabilities for tax losses and temporary differences not recognized |
(129,014 | ) | 1,343,629 | 1,494,100 | ||||||||
|
|
|
|
|
|
|||||||
Income tax (benefit)/expense** |
1,676 | (737,387 | ) | (1,181,017 | ) | |||||||
|
|
|
|
|
|
* | Difference in overseas tax rate is as a result of reduced corporate income tax rate of 15% applicable to the Immutep subsidiary in France. |
** | Income tax expense /(benefit) relates to tax payable in the United States and for the prior year movement in deferred tax assets and liabilities for the French subsidiary. |
F-23
Table of Contents
NOTE 6. INCOME TAX EXPENSE (continued)
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Deferred tax assets not recognized |
||||||||||||
Deferred tax assets not recognized comprises temporary differences attributable to: |
||||||||||||
Carried forward tax losses benefit |
34,854,437 | 30,987,750 | 32,044,352 | |||||||||
Temporary differences |
27,366 | 57,955 | 438,284 | |||||||||
|
|
|
|
|
|
|||||||
Total deferred tax assets not recognized |
34,881,803 | 31,045,705 | 32,482,636 | |||||||||
|
|
|
|
|
|
The above potential tax benefit, which includes tax losses and temporary differences has not been recognized in the consolidated balance sheet as the recovery of this benefit is not probable. There is no expiration date for the tax losses carried forward. The estimated amount of cumulative tax losses at June 30, 2018 was $126,743,409 (2017 $112,682,727). Utilization of these tax losses is dependent on the parent entity satisfying certain tests at the time the losses are recouped.
NOTE 7. CASH AND CASH EQUIVALENTS
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Cash on hand |
422 | 130 | ||||||
Cash at bank |
5,932,433 | 11,972,345 | ||||||
Cash on deposit |
17,542,666 | 264,499 | ||||||
|
|
|
|
|||||
23,475,521 | 12,236,974 | |||||||
|
|
|
|
The above cash and cash equivalent are held in AUD, USD, and Euro. The interest rates on these deposits range from 0% to 2.73% in 2018 (0% to 2.05% in 2017).
NOTE 8. CURRENT RECEIVABLES
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
GST receivable |
170,926 | 187,273 | ||||||
Grant and other receivables |
3,261,068 | 2,006,743 | ||||||
|
|
|
|
|||||
3,431,994 | 2,194,016 | |||||||
|
|
|
|
Due to the short term nature of these receivables, the carrying value is assumed to be their fair value at June 30, 2018. No receivables were impaired or past due.
NOTE 9. OTHER CURRENT ASSETS
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Prepayments* |
1,646,579 | 604,687 | ||||||
Capital raising costs |
| 846,180 | ||||||
Security deposit |
38,843 | 37,311 | ||||||
Accrued interest |
50,242 | 90 | ||||||
|
|
|
|
|||||
1,735,664 | 1,488,268 | |||||||
|
|
|
|
* | Prepayments are in relation to the deposits paid to organizations involved in the clinical trials. |
F-24
Table of Contents
NOTE 10. NON-CURRENT ASSETS PLANT AND EQUIPMENT
Plant and Equipment A$ |
Computers A$ |
Furniture and fittings A$ |
Total A$ |
|||||||||||||
At June 30, 2016 |
||||||||||||||||
Cost or fair value |
511,195 | 41,971 | 8,064 | 561,230 | ||||||||||||
Accumulated depreciation |
(496,104 | ) | (28,212 | ) | (5,414 | ) | (529,730 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
15,091 | 13,759 | 2,650 | 31,500 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Year ended June 30, 2017 |
||||||||||||||||
Opening net book amount |
15,091 | 13,759 | 2,650 | 31,500 | ||||||||||||
Exchange differences |
(171 | ) | (229 | ) | (46 | ) | (446 | ) | ||||||||
Additions |
| 7,089 | | 7,089 | ||||||||||||
Disposals |
| | | | ||||||||||||
Depreciation charge |
(3,680 | ) | (8,867 | ) | (1,394 | ) | (13,941 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Closing net book amount |
11,240 | 11,752 | 1,210 | 24,202 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At June 30, 2017 |
||||||||||||||||
Cost or fair value |
510,188 | 48,919 | 8,030 | 567,137 | ||||||||||||
Accumulated depreciation |
(498,948 | ) | (37,167 | ) | (6,820 | ) | (542,935 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
11,240 | 11,752 | 1,210 | 24,202 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Year ended June 30, 2018 |
||||||||||||||||
Opening net book amount |
11,240 | 11,752 | 1,210 | 24,202 | ||||||||||||
Exchange differences |
638 | 314 | 26 | 978 | ||||||||||||
Additions |
1,312 | 10,581 | | 11,893 | ||||||||||||
Disposals |
| | | | ||||||||||||
Depreciation charge |
(1,917 | ) | (7,814 | ) | (893 | ) | (10,624 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Closing net book amount |
11,273 | 14,833 | 343 | 26,449 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At June 30, 2018 |
||||||||||||||||
Cost or fair value |
524,746 | 61,585 | 8,475 | 594,806 | ||||||||||||
Accumulated depreciation |
(513,473 | ) | (46,752 | ) | (8,132 | ) | (568,357 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
11,273 | 14,833 | 343 | 26,449 | ||||||||||||
|
|
|
|
|
|
|
|
F-25
Table of Contents
NOTE 11. NON-CURRENT ASSETS INTANGIBLES
Patents A$ |
Intellectual Property Assets A$ |
Goodwill A$ |
Total A$ |
|||||||||||||
At June 30, 2016 |
||||||||||||||||
Cost or fair value |
1,915,671 | 23,451,000 | 109,962 | 25,476,633 | ||||||||||||
Accumulated amortization |
(1,915,671 | ) | (2,709,263 | ) | | (4,624,934 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
| 20,741,737 | 109,962 | 20,851,699 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Year ended June 30, 2017 |
||||||||||||||||
Opening net book amount |
| 20,741,737 | 109,962 | 20,851,699 | ||||||||||||
Exchange difference |
| (143,689 | ) | (143,689 | ) | |||||||||||
Amortization charge |
| (1,687,674 | ) | | (1,687,674 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Closing net book amount |
| 18,910,374 | 109,962 | 19,020,336 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At June 30, 2017 |
||||||||||||||||
Cost or fair value |
1,915,671 | 23,343,253 | 109,962 | 25,368,886 | ||||||||||||
Accumulated amortization |
(1,915,671 | ) | (4,432,879 | ) | | (6,348,550 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
| 18,910,374 | 109,962 | 19,020,336 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Year ended June 30, 2018 |
||||||||||||||||
Opening net book amount |
| 18,910,374 | 109,962 | 19,020,336 | ||||||||||||
Exchange difference |
| 1,107,124 | | 1,107,124 | ||||||||||||
Amortization charge |
| (1,798,305 | ) | | (1,798,305 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Closing net book amount |
| 18,219,193 | 109,962 | 18,329,155 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At June 30, 2018 |
||||||||||||||||
Cost or fair value |
1,915,671 | 24,786,169 | 109,962 | 26,789,097 | ||||||||||||
Accumulated amortization |
(1,915,671 | ) | (6,566,976 | ) | | (8,459,942 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book amount |
| 18,219,193 | 109,962 | 18,329,155 | ||||||||||||
|
|
|
|
|
|
|
|
(i) Amortization methods and useful lives
The group amortizes intangible assets with a limited useful life using the straight-line method over the following periods:
| Patents, trademark and licenses 13 21 years |
| Intellectual property assets 13 14 years |
NOTE 12. DEFERRED TAX BALANCES
(i) Deferred tax assets
The balance comprises temporary differences attributable to:
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Tax losses |
2,732,866 | 2,836,526 | ||||||
|
|
|
|
|||||
Total deferred tax assets |
2,732,866 | 2,836,526 | ||||||
Set-off of deferred tax liabilities pursuant to set-off provisions |
(2,732,866 | ) | (2,836,526 | ) | ||||
|
|
|
|
|||||
Net deferred tax liabilities |
| | ||||||
|
|
|
|
F-26
Table of Contents
NOTE 12. DEFERRED TAX BALANCES (continued)
(ii) Deferred tax liabilities
The balance comprises temporary differences attributable to:
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Intangible assets |
2,732,866 | 2,836,526 | ||||||
|
|
|
|
|||||
Total deferred tax liabilities |
2,732,866 | 2,836,526 | ||||||
Set-off of deferred tax liabilities pursuant to set-off provisions |
(2,732,866 | ) | (2,836,526 | ) | ||||
|
|
|
|
|||||
Net deferred tax liabilities |
| | ||||||
|
|
|
|
(iii) Movements in deferred tax balances
Tax Losses A$ |
Intangible Assets A$ |
Total A$ |
||||||||||
Movement |
||||||||||||
At June 30, 2017 |
2,836,526 | (2,836,526 | ) | | ||||||||
(Charged)/credited |
||||||||||||
to profit or loss |
(103,660 | ) | 103,660 | | ||||||||
|
|
|
|
|
|
|||||||
At June 30, 2018 |
2,732,866 | (2,732,866 | ) | | ||||||||
|
|
|
|
|
|
NOTE 13. CURRENT LIABILITIES TRADE AND OTHER PAYABLES
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Trade payables |
1,615,381 | 1,138,753 | ||||||
Other payables and accruals |
2,048,468 | 1,450,028 | ||||||
|
|
|
|
|||||
3,663,849 | 2,588,781 | |||||||
|
|
|
|
NOTE 14. NON-CURRENT LIABILITIES US WARRANT LIABILITY
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Warrants fair value at issue date |
2,755,375 | | ||||||
Fair value movements |
189,983 | | ||||||
|
|
|
|
|||||
Balance at 30 June 2018 |
2,945,358 | | ||||||
|
|
|
|
In July 2017, the Company completed its first US capital raise after it entered into a securities purchase agreement with certain accredited investors for the company to issue American Depositary Shares (ADSs) and Warrants of the Company for cash consideration totaling $6,561,765. In this private placement, the Company agreed to issue unregistered warrants to purchase up to 1,973,451 of its ADSs. The warrants have an exercise price of US$2.50 per ADS, are exercisable immediately and will expire on 5 January 2023. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant.
F-27
Table of Contents
NOTE 14. NON-CURRENT LIABILITIES US WARRANT LIABILITY (continued)
The US warrants represent a written option to exchange a fixed number of the Groups own equity instruments for a fixed amount of cash that is denominated in a foreign currency (US dollars) and is classified as a derivative financial liability in accordance with AASB 132. The US warrants liability is initially recorded at fair value at issue date and subsequently measured at fair value through profit and loss at each reporting date. Capital raising costs have been allocated proportionately between issued capital and the US warrants in accordance with their relative fair values.
Fair value of warrants
The warrants granted are not traded in an active market and the fair value has thus been estimated by using the Black-Scholes pricing model based on the following assumptions. Key terms of the warrants are included above. The following assumptions were based on observable market conditions that existed at the issue date and at 30 June 2018:
Assumption | At issue date | At 30 June 2018 | Rationale | |||
Historic volatility | 58.0% | 55.4% | Based on 12-month historical volatility data for the Company | |||
Exercise price | US$2.50 | US$2.50 | As per subscription agreement | |||
Share price | US$2.17 | US$2.38 | Closing share price on valuation date from external market source | |||
Risk-free interest rate | 1.930% | 2.730% | Based on the US Government securities yields which match the term of the warrant | |||
Dividend yield | 0.0% | 0.0% | Based on the Companys nil dividend history | |||
Fair value per warrant | US$1.0716 A$1.3962 |
US$1.1031 A$1.4900 |
Determined using Black-Scholes models with the inputs above | |||
Fair value | A$2,755,375 | A$2,945,358 | Fair value of 1,973,451 warrants |
NOTE 15. NON CURRENT LIABILITIES CONVERTIBLE NOTE
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Convertible note at fair value at beginning of reporting period |
5,778,984 | 5,027,168 | ||||||
Net change in fair value |
866,848 | 751,816 | ||||||
|
|
|
|
|||||
Convertible note at fair value at end of reporting period |
6,645,832 | 5,778,984 | ||||||
|
|
|
|
On May 11, 2015, the Company entered into a subscription agreement with Ridgeback Capital Investments (Ridgeback) to invest in Convertible Notes and Warrants of the Company for cash consideration totaling $13,750,828, which was subject to shareholder approval at an Extraordinary General Meeting. Shareholder approval was received on July 31, 2015.
The 13,750,828 Convertible Notes issued have a face value of $1.00 per note which are exercisable at a price of $0.02 per share, mature on August 4, 2025 and accrue interest at a rate of 3% per annum which may also be converted into shares. Conversions may occur during the period (i) at least 3 months after the Issue Date and (ii) at least 15 business days prior to the maturity date into 50 ordinary shares of the Company per note (subject to customary adjustments for rights or bonus issues, off market buybacks, issues at less than current market price, share purchase plan, dividend reinvestment plan at a discount, return of capital or dividend or other adjustment). If a change of control event, delisting event or event of default has occurred, Ridgeback may elect to convert the notes into shares or repayment of principal and interest. The Convertible Notes rank at least equal with all present and future unsubordinated and unsecured debt obligations of the Company and contain customary negative pledges regarding financial indebtedness, dividend payments, related party transaction and others.
8,475,995 Warrants were granted to Ridgeback which are exercisable at a price of $0.025 per share on or before August 4, 2025. 371,445,231 Warrants were granted to Ridgeback which are exercisable at a price of $0.0237 per share on or before 4 August 2020. All warrants may be settled on a gross or net basis and the number of warrants or exercise price may be adjusted for a pro rata issue of shares, a bonus issue or capital reorganization. The Warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant.
F-28
Table of Contents
NOTE 15. NON CURRENT LIABILITIES CONVERTIBLE NOTE (continued)
(i) Fair value of convertible notes
The following assumptions were used to determine the initial fair value of the debt component of the convertible note which were based on market conditions that existed at the grant date:
Assumption |
Convertible notes |
Rationale | ||||
Historic volatility |
85.0 | % | Based on the Companys historical volatility data | |||
Share price |
$ | 0.051 | Closing market share price on July 31, 2015 | |||
Risk free interest rate |
2.734 | % | Based on Australian Government securities yields which match the term of the convertible note | |||
Risk adjusted interest rate |
15.0 | % | An estimate of the expected interest rate of a similar non-convertible note issued by the company | |||
Dividend yield |
0.0 | % | Based on the Companys nil dividend history | |||
Risk free rate |
2.734 | % | Based on 10 year Australian Government securities yield |
The fair value of the convertible note is allocated between a financial liability for the traditional note component of the convertible note and into equity which represents the conversion feature. The traditional note component of the convertible note was initially recorded at fair value of $4.4m, based on the present value of the contractual cash flows of the note discounted at 15%. After initial recognition, the liability component of the convertible note has been measured at fair value as required by AASB 2 (IFRS 2). The remaining value of the convertible note was allocated to the conversion feature and recognized as equity.
Note Liability |
Conversion feature Equity |
|||||||
Fair value at issuance |
4,419,531 | 41,431,774 | ||||||
Fair value movements |
2,226,301 | | ||||||
|
|
|
|
|||||
Balance at June 30, 2018 |
6,645,832 | 41,431,774 | ||||||
|
|
|
|
NOTE 16. CURRENT LIABILITIES EMPLOYEE BENEFITS
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Annual leave |
189,514 | 43,227 | ||||||
|
|
|
|
The current provision for employee benefits is in relation to accrued annual leave and covers all unconditional entitlements where employees have completed the required period of service. The entire amount of the provision is presented as current, since the group does not have an unconditional right to defer settlement for any of these obligations.
NOTE 17. NON CURRENT LIABILITIES EMPLOYEE BENEFITS
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Long service leave |
32,303 | 20,498 | ||||||
|
|
|
|
F-29
Table of Contents
NOTE 18. CONTRIBUTED EQUITY
Consolidated | ||||||||||||
Note | June 30, 2018 A$ |
June 30, 2017 A$ |
||||||||||
Fully paid ordinary shares |
18(a) | 203,570,765 | 185,690,589 | |||||||||
Options over ordinary shares listed |
9,661,954 | 9,661,954 | ||||||||||
|
|
|
|
|||||||||
213,232,719 | 195,352,543 | |||||||||||
|
|
|
|
(a) Ordinary Shares
June 30, 2018 | June 30, 2017 | |||||||||||||||||||
Note | No. | A$ | No. | A$ | ||||||||||||||||
At the beginning of reporting period |
2,079,742,938 | 185,690,589 | 2,061,630,944 | 184,868,978 | ||||||||||||||||
Shares issued during year |
18(b) | 889,880,270 | 16,968,200 | | | |||||||||||||||
Exercise of options and warrants (Shares issued during the year) |
18(b) | 56,459,461 | 1,737,497 | 18,111,994 | 830,144 | |||||||||||||||
Transaction costs relating to share issues |
| (825,521 | ) | | (8,533 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
At reporting date |
3,026,082,669 | 203,570,765 | 2,079,742,938 | 185,690,589 | ||||||||||||||||
|
|
|
|
|
|
|
|
(b) Shares issued
2018 Details |
Number | Issue Price A$ |
Total A$ |
|||||||||
Shares issued under Securities Purchase Agreement |
263,126,800 | 0.01 | 3,806,390 | |||||||||
Performance rights exercised (transfer from share-based payment reserve) |
56,459,461 | 0.03 | 1,737,497 | |||||||||
Share placement |
326,192,381 | 0.021 | 6,850,040 | |||||||||
Shares issued under Securities Purchase Agreement |
300,561,089 | 0.021 | 6,311,770 | |||||||||
|
|
|
|
|||||||||
946,339,731 | 18,705,697 | |||||||||||
|
|
|
|
F-30
Table of Contents
NOTE 18. CONTRIBUTED EQUITY (continued)
(b) Shares issued (continued)
2017 Details |
Number | Issue Price A$ |
Total A$ |
|||||||||
Performance rights exercised(transfer from share-based payment reserve) |
18,111,991 | 0.05 | 830,143 | |||||||||
Options exercised |
3 | 0.20 | 1 | |||||||||
|
|
|
|
|||||||||
18,111,994 | 830,144 | |||||||||||
|
|
|
|
Ordinary shares
Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the company in proportion to the number of and amounts paid on the shares held.
The fully paid ordinary shares have no par value and the company does not have a limited amount of authorized capital.
On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.
Options
Information relating to the Companys Global Employee Share Option Plan, including details of options issued, exercised and lapsed during the financial year and options outstanding at the end of the reporting period, is set out in note 30.
Unlisted Options
Expiration Date |
Exercise Price | Number | ||||||
December 12, 2018 |
$ | 0.05019 | 147,628,500 | |||||
August 4, 2020 |
$ | 0.0237 | 371,445,231 | |||||
October 30, 2020 |
$ | 0.057 | 793,103 | |||||
March 7, 2021 |
$ | 0.04 | 1,026,272 | |||||
August 4, 2025 |
$ | 0.025 | 8,475,995 | |||||
November 5, 2023 |
USD 0.025 | 197,345,100 | * | |||||
|
|
|||||||
Total |
726,714,201 | |||||||
|
|
* | 1 American Depository Shares (ADS) listed on NASDAQ equals 100 ordinary shares listed on ASX thus the number of warrants on issue has been grossed up and the exercise price adjusted accordingly in the above table to be comparable. |
Share buy-back
There is no current on-market share buy-back.
Capital risk management
The consolidated entitys objectives when managing capital are to safeguard its ability to continue as a going concern, so that they can continue to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital.
In order to maintain or adjust the capital structure, the consolidated entity may adjust the amount of dividends paid to shareholders, return capital to shareholders, issue new shares or sell assets to reduce debt.
The consolidated entity would look to raise capital when an opportunity to invest in a business or company was seen as value adding relative to the current parent entitys share price at the time of the investment. The consolidated entity is not actively pursuing additional investments in the short term as it continues to integrate and grow its existing businesses in order to maximize synergies.
F-31
Table of Contents
NOTE 19. EQUITY RESERVES AND RETAINED EARNINGS
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
(a) Reserves |
||||||||
Options issued reserve |
19,116,205 | 19,116,205 | ||||||
Conversion feature of convertible note reserve |
41,431,774 | 41,431,774 | ||||||
Foreign currency translation reserve |
1,096,368 | (232,751 | ) | |||||
Share-based payment reserve |
3,229,693 | 2,703,347 | ||||||
|
|
|
|
|||||
64,874,040 | 63,018,575 | |||||||
|
|
|
|
|||||
Movement in options issued reserve were as follows: |
||||||||
Opening balance |
19,116,205 | 19,116,205 | ||||||
|
|
|
|
|||||
Ending balance |
19,116,205 | 19,116,205 | ||||||
|
|
|
|
|||||
Movements in conversion feature of convertible note reserve: |
||||||||
Opening balance |
41,431,774 | 41,431,774 | ||||||
|
|
|
|
|||||
Ending balance |
41,431,774 | 41,431,774 | ||||||
|
|
|
|
|||||
Movement in foreign currency translation reserve were as follows: |
||||||||
Opening balance |
(232,751 | ) | 38,945 | |||||
Currency translation differences arising during the year |
1,329,119 | (271,696 | ) | |||||
|
|
|
|
|||||
Ending balance |
1,096,368 | (232,751 | ) | |||||
|
|
|
|
|||||
Movement in share-based payment reserve were as follows: |
||||||||
Opening balance |
2,703,347 | 2,671,263 | ||||||
Employee options issued during the year |
2,263,843 | 862,227 | ||||||
Exercise of vested performance rights |
(1,737,497 | ) | (830,143 | ) | ||||
|
|
|
|
|||||
Ending balance |
3,229,693 | 2,703,347 | ||||||
|
|
|
|
|||||
(b) Accumulated losses |
||||||||
Movement in accumulated losses were as follows: |
||||||||
Opening balance |
(231,838,812 | ) | (222,471,606 | ) | ||||
Net loss for the year |
(12,746,020 | ) | (9,367,206 | ) | ||||
|
|
|
|
|||||
Balance |
(244,584,832 | ) | (231,838,812 | ) | ||||
|
|
|
|
(c) Nature and purpose of reserves
(i) Options issued reserve
On August 4, 2015 warrants were granted to Ridgeback Capital Investments. 8,475,995 Warrants were granted which are exercisable at a price of $0.025 per share on or before August 4, 2025. 371,445,231 Warrants were granted which are exercisable at a price of $0.0237 per share on or before August 4, 2020. All warrants may be settled on a gross or net basis and the number of warrants or exercise price may be adjusted for a pro rata issue of shares, a bonus issue or capital reorganisation. The Warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. For further information, refer to note 15.
In December 2014, the Company issued 200,000,000 warrants at an exercise price of $0.05019 to the vendors of Immutep S.A. The options expire on October 2, 2017 and December 12, 2018. Each option and warrant is exercisable for one ordinary share in the capital of the Company. For the year ended 30 June 2018 and 2017 no warrants were exercised by vendors of Immutep S.A., and as at June 30, 2016, 52,371,500 warrants were exercised by the vendors of Immutep S.A. The options held are exercisable at any time before its expiry date.
F-32
Table of Contents
NOTE 19. EQUITY RESERVES AND RETAINED EARNINGS (continued)
(ii) Conversion feature of convertible note reserve
This amount relates to the conversion feature of the convertible note issued to Ridgeback Capital Investments which has been measured at fair value as required by AASB 2 (IFRS 2). For further information, refer to note 15.
(iii) Foreign currency translation reserve
Exchange differences arising on translation of the foreign controlled entity a recognized in other comprehensive loss as described in note 1(d) and accumulated in a separate reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is disposed of.
(iv) Share-based payments reserve
The share-based payments reserve is used to recognize the grant date fair value of options and performance rights issued to employees but not exercised. For a reconciliation of movements in the share-based payment reserves refer to note 30.
NOTE 20. DIVIDENDS
There were no dividends paid or declared during the current or previous fiscal year.
F-33
Table of Contents
NOTE 21. KEY MANAGEMENT PERSONNEL DISCLOSURES
(a) Directors and key management personnel compensation
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Short-term employee benefits |
1,521,119 | 1,256,272 | 1,300,140 | |||||||||
Long-term employee benefits |
11,429 | 6,879 | 5,817 | |||||||||
Post-employment benefits |
36,370 | 38,184 | 42,471 | |||||||||
Share-based payments |
1,740,238 | 637,637 | 1,824,643 | |||||||||
|
|
|
|
|
|
|||||||
3,309,156 | 1,938,972 | 3,173,071 | ||||||||||
|
|
|
|
|
|
(b) Equity instrument disclosures relating to key management personnel
(i) Options provided as remuneration and shares issued on exercise of such options
For details of options provided as remuneration and shares issued on the exercise of such options, together with terms and conditions of the options, please refer to note 30.
(ii) Shareholding
The numbers of shares in the company held during the financial year by each director of and other key management personnel of the group, including their personally related parties, are set out below. There were no shares granted during the reporting period as compensation.
2018 |
Balance at start of the year |
Received during the year on exercise of performance rights |
Received during the year on the exercise of options |
Other changes during the year |
Balance at end of the year |
|||||||||||||||
Ordinary shares |
||||||||||||||||||||
Dr Russell Howard |
| | | | | |||||||||||||||
Mr Pete Meyers |
6,862,744 | 2,672,093 | | | 9,534,837 | |||||||||||||||
Mr Marc Voigt |
|
18,271,960 45 |
* |
|
23,333,333 |
|
|
|
|
| |
41,605,293 45 |
| |||||||
Mr Grant Chamberlain |
| | | | | |||||||||||||||
Ms Lucy Turnbull, AO** |
20,359,576 | | | (20,359,576 | ) | | ||||||||||||||
Mr Albert Wong** |
3,837,500 | | | (3,837,500 | ) | | ||||||||||||||
Ms Deanne Miller |
8,243,572 | 12,333,334 | | (808,488 | ) | 19,768,418 | ||||||||||||||
Dr Frédéric Triebel |
15,978,049 | 16,486,326 | | | 32,464,375 | |||||||||||||||
Total ordinary shares |
73,553,401 | 54,825,086 | | (25,005,564 | ) | 103,372,923 | ||||||||||||||
Total ADR |
45 | | | | 45 |
* | American Depository Receipts (ADR) traded on the NASDAQ |
** | At the date of resignation, the shareholding balance for Ms Lucy Turnbull and Mr Albert Wong are 20,359,576 shares and 3,837,500 shares respectively. The changes during the year is not the actual disposal of the shares. It represents derecognition due to the fact that they ceased to be directors of the company. |
F-34
Table of Contents
NOTE 21. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)
June 30, 2017 |
Balance at start of the year |
Received during the year on the exercise of performance rights |
Received during the year on the exercise of options |
Other changes during the year |
Balance at end of the year |
|||||||||||||||
Ordinary shares |
||||||||||||||||||||
Ms. Lucy Turnbull, AO |
20,359,576 | | | | 20,359,576 | |||||||||||||||
Mr. Albert Wong |
3,837,500 | | | | 3,837,500 | |||||||||||||||
Dr. Russell Howard |
| | | | | |||||||||||||||
Mr. Pete Meyers |
4,289,215 | 2,573,529 | | | 6,862,744 | |||||||||||||||
Mr. Marc Voigt |
|
11,605,293 150 |
* |
|
6,666,667 |
|
|
|
|
|
(105 |
)* |
|
18,271,960 45 |
* | |||||
Ms. Deanne Miller |
4,950,980 | 4,000,000 | | (707,408 | ) | 8,243,572 | ||||||||||||||
Dr. Frédéric Triebel |
12,644,716 | 3,333,333 | | | 15,978,049 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ordinary shares |
57,687,280 | 16,573,529 | | (707,408 | ) | 73,553,401 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ADSs |
150 | | | (105 | ) | 45 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
* | American Depositary Shares (ADSs) traded on the NASDAQ. The change is due to the change of ADS ration from 30:1 to 100:1 during the fiscal year 2017. |
June 30, 2016 |
Balance at start of the year |
Received during the year on the exercise of performance rights |
Received during the year on the exercise of options |
Other changes during the year |
Balance at end of the year |
|||||||||||||||
Ordinary shares |
||||||||||||||||||||
Ms. Lucy Turnbull, AO |
20,059,576 | | | 300,000 | 20,359,576 | |||||||||||||||
Mr. Albert Wong |
3,537,500 | | | 300,000 | 3,837,500 | |||||||||||||||
Dr. Russell Howard |
| | | | | |||||||||||||||
Mr. Pete Meyers |
1,715,686 | 2,573,529 | | | 4,289,215 | |||||||||||||||
Mr. Marc Voigt |
|
870,000 150 |
* |
|
10,735,293 |
|
|
|
|
|
|
|
|
11,605,293 150 |
* | |||||
Ms. Deanne Miller |
20,924 | 6,450,980 | | (1,520,924 | ) | 4,950,980 | ||||||||||||||
Dr. Frédéric Triebel |
9,311,383 | 3,333,333 | | | 12,644,716 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ordinary shares |
35,515,069 | 23,093,135 | | (920,924 | ) | 57,687,280 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total ADSs |
150 | | | | 150 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
* | American Depositary Shares (ADSs) traded on the NASDAQ |
F-35
Table of Contents
NOTE 21. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)
(iii) Option holdings
The number of options over ordinary shares in the parent entity held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:
June 30, 2018 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Options over ordinary shares |
||||||||||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
| | | | | | | |||||||||||||||||||||
Mr. Marc Voigt1 |
643,629 | | | (643,629 | ) | | | | ||||||||||||||||||||
Mr Grant Chamberlain |
| | | | | | | |||||||||||||||||||||
Ms Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr Albert Wong |
| | | | | | | |||||||||||||||||||||
Ms. Deanne Miller1 |
121,212 | | | (121,212 | ) | | | | ||||||||||||||||||||
Dr Frédéric Triebel2 |
24,000,600 | | | | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
24,765,441 | | | (764,841 | ) | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 | The above options lapsed during the year ended 30 June 2018. |
2 | This amount represents warrants which were issued to Dr Frédéric Triebel upon the acquisition of Immutep. |
June 30, 2017 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Options over ordinary shares |
||||||||||||||||||||||||||||
Ms. Lucy Turnbull, AO1 |
4,439,894 | | | (4,439,894 | ) | | | | ||||||||||||||||||||
Mr. Albert Wong |
| | | | | | | |||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
| | | | | | | |||||||||||||||||||||
Mr. Marc Voigt1 |
721,754 | | | (78,125 | ) | 643,629 | 643,629 | | ||||||||||||||||||||
Ms. Deanne Miller |
121,212 | | | | 121,212 | 121,212 | | |||||||||||||||||||||
Dr Frédéric Triebel |
24,000,600 | | | | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
29,283,460 | | | (4,518,019 | ) | 24,765,441 | 24,765,441 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 | The above options lapsed during the year ended 30 June 2017. |
June 30, 2016 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Options over ordinary shares |
||||||||||||||||||||||||||||
Ms. Lucy Turnbull, AO |
4,439,894 | | | | 4,439,894 | 4,439,894 | | |||||||||||||||||||||
Mr. Albert Wong |
| | | | | | | |||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
| | | | | | | |||||||||||||||||||||
Mr. Marc Voigt1 |
1,171,754 | | | (450,000 | ) | 721,754 | 721,754 | | ||||||||||||||||||||
Ms. Deanne Miller |
121,212 | | | | 121,212 | 121,212 | | |||||||||||||||||||||
Dr Frédéric Triebel |
24,000,600 | | | | 24,000,600 | 24,000,600 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
29,733,460 | | | (450,000 | ) | 29,283,460 | 29,283,460 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 | The above options lapsed during the year ended 30 June 2016. |
F-36
Table of Contents
NOTE 21. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)
(iv) Performance rights holdings
The number of performance rights over ordinary shares in the parent entity held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:
June 30, 2018 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Rights over ordinary shares |
| | | | | | | |||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
10,881,194 | | (2,672,093 | ) | | 8,209,101 | | 8,209,101 | ||||||||||||||||||||
Mr. Marc Voigt |
18,921,569 | 50,000,000 | (23,333,333 | ) | | 45,588,236 | | 45,588,236 | ||||||||||||||||||||
Mr Grant Chamberlain |
| 13,272,356 | | | 13,272,356 | | 13,272,356 | |||||||||||||||||||||
Ms Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr Albert Wong |
| | | | | | | |||||||||||||||||||||
Ms. Deanne Miller |
7,676,471 | 25,000,000 | (12,333,334 | ) | | 20,343,137 | | 20,343,137 | ||||||||||||||||||||
Dr. Frédéric Triebel |
4,819,660 | 35,000,000 | (16,486,326 | ) | | 23,333,334 | | 23,333,334 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
42,298,894 | 123,272,356 | (54,825,086 | ) | | 110,746,164 | | 110,746,164 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2017 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Rights over ordinary shares |
||||||||||||||||||||||||||||
Ms. Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr. Albert Wong |
| | | | | | | |||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
3,431,373 | 10,023,350 | (2,573,529 | ) | | 10,881,194 | | 10,881,194 | ||||||||||||||||||||
Mr. Marc Voigt |
25,588,236 | | (6,666,667 | ) | | 18,921,569 | | 18,921,569 | ||||||||||||||||||||
Ms. Deanne Miller |
11,676,471 | | (4,000,000 | ) | | 7,676,471 | | 7,676,471 | ||||||||||||||||||||
Dr. Frédéric Triebel |
8,152,993 | | (3,333,333 | ) | | 4,819,660 | | 4,819,660 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
48,849,073 | 10,023,350 | (16,573,529 | ) | | 42,298,894 | | 42,298,894 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2016 |
Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
Rights over ordinary shares |
||||||||||||||||||||||||||||
Ms. Lucy Turnbull, AO |
| | | | | | | |||||||||||||||||||||
Mr. Albert Wong |
| | | | | | | |||||||||||||||||||||
Dr. Russell Howard |
| | | | | | | |||||||||||||||||||||
Mr. Pete Meyers |
6,004,902 | | (2,573,529 | ) | | 3,431,373 | | 3,431,373 | ||||||||||||||||||||
Mr. Marc Voigt |
16,323,529 | 20,000,000 | (10,735,293 | ) | | 25,588,235 | | 25,588,236 | ||||||||||||||||||||
Ms. Deanne Miller |
6,127,451 | 12,000,000 | (6,450,980 | ) | | 11,676,471 | | 11,676,471 | ||||||||||||||||||||
Dr. Frédéric Triebel |
| 11,486,326 | (3,333,333 | ) | | 8,152,993 | | 8,152,993 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
28,455,882 | 43,486,326 | (23,093,135 | ) | | 48,849,072 | | 48,849,073 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-37
Table of Contents
NOTE 22. REMUNERATION OF AUDITORS
During the year the following fees were paid or payable for services provided by the auditor of the parent entity, its related practices and non-related audit firms
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Audit fees PricewaterhouseCoopers Australia |
||||||||||||
Audit or review of the financial report |
258,570 | 234,250 | 232,000 | |||||||||
Other audit and assurance services in relation to regulatory filings overseas |
| 200,000 | 209,741 | |||||||||
|
|
|
|
|
|
|||||||
Total remuneration of PricewaterhouseCoopers Australia |
258,570 | 434,250 | 441,741 | |||||||||
|
|
|
|
|
|
NOTE 23. CONTINGENT LIABILITIES
There were no material contingent liabilities in existence at June 30, 2018 and June 30, 2017.
NOTE 24. COMMITMENTS FOR EXPENDITURE
Consolidated | ||||||||
30 June 2018 $ |
30 June 2017 $ |
|||||||
Lease commitmentsoperating |
||||||||
Committed at the reporting date but not recognised as liabilities, payable: |
||||||||
Within one year |
117,562 | | ||||||
One to five years |
21,600 | | ||||||
139,162 | |
Operating lease commitments includes contracted amounts for leases of premises under non-cancellable operating leases expiring within two years. On renewal, the terms of the leases are renegotiated.
F-38
Table of Contents
NOTE 25. RELATED PARTY TRANSACTIONS
Parent entity
Immutep Limited is the parent entity.
Subsidiaries
Interests in subsidiaries are set out in note 26.
Key management personnel
Disclosures relating to key management personnel are set out in note 21.
Transactions with related parties
The following transaction occurred with related parties:
Consolidated | ||||||||
30 June 2018 $ |
30 June 2017 $ |
|||||||
In addition to Directors fees, Consultancy fees for post directorship executive duties were paid to Barton Place Pty Ltd, a corporation in which Albert Wong has a beneficial interest |
49,500 | |
Receivable from and payable to related parties
There were no trade receivables from or trade payables due to related parties at the reporting date.
Loans to/from related parties
There were no loans to or from related parties at the reporting date.
NOTE 26. SUBSIDIARIES
The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 1:
|
Equity holding | |||||||||
Name of entity |
Country of incorporation |
June 30, 2018 % |
June 30, 2017 % |
|||||||
Immutep U.S., Inc |
United States | 100.00 | 100.00 | |||||||
PRR Middle East FZ LLC |
United Arab Emirates | 100.00 | 100.00 | |||||||
Immutep GmbH |
Germany | 100.00 | 100.00 | |||||||
Immutep Australia Pty Ltd |
Australia | 100.00 | 100.00 | |||||||
Immutep IP Pty Ltd |
Australia | 100.00 | 100.00 | |||||||
Immutep S.A.S. |
France | 100.00 | 100.00 |
F-39
Table of Contents
NOTE 27. EVENTS OCCURRING AFTER THE REPORTING DATE
On July 31, 2018, the company received approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for eftilagimod alpha (efti or IMP321), a LAG-3Ig fusion protein.
On August 7, 2018 the company announced the grant of Canadian patent no. 2,685,584 entitled Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease.
On August 21, 2018 the company announced that it had received a 1,221,906 cash rebate from the French Government under its Crédit dImpôt Recherche scheme (CIR).
On September 24, 2018, the company announced that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc., to evaluate the combination of Immuteps lead immunotherapy product candidate eftilagimod alpha (efti or IMP321) with avelumab.
During the period from September 27, 2018 to October 5, 2018, the company received USD 1.05 million of proceeds from the exercising of ADS Warrants by the US investors.
NOTE 28. RECONCILIATION OF LOSS AFTER INCOME TAX TO NET CASH USED IN OPERATING ACTIVITIES
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Loss after income tax expense for the year |
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | ||||||
Adjustments for: |
||||||||||||
Depreciation and amortization |
1,808,929 | 1,701,615 | 1,993,093 | |||||||||
Add back share based payments |
2,263,843 | 862,227 | 2,058,659 | |||||||||
Changes in fair value of US investor warrant |
189,983 | | | |||||||||
US warrants transaction costs |
493,487 | | | |||||||||
Non-cash share based payment to strategic investor |
| | 47,468,071 | |||||||||
Changes in fair value of comparability milestone |
| | 542,075 | |||||||||
Add back (gain) on disposal of assets |
| | (18,493 | ) | ||||||||
Add back Non-cash finance expenses |
| | | |||||||||
Unrealized (gain)/loss on exchange through the profit and loss |
(401,557 | ) | (218,567 | ) | 844,864 | |||||||
Net change in fair value of convertible note liability |
866,848 | 751,816 | 607,637 | |||||||||
Change in operating assets and liabilities: |
||||||||||||
(Increase) in current receivables |
(1,237,978 | ) | (2,025,716 | ) | (394,922 | ) | ||||||
Decrease/(increase) in other operating assets |
(247,396 | ) | (865,245 | ) | 324,983 | |||||||
(Decrease)/increase in trade and other payables |
1,075,067 | 1,377,141 | (1,491,882 | ) | ||||||||
Increase/(decrease) in employee benefits |
158,091 | (7,120 | ) | (45,165 | ) | |||||||
(Decrease)/increase in income tax payable |
| (21,549 | ) | 712 | ||||||||
(Decrease) in deferred tax liability |
| (694,194 | ) | (1,184,139 | ) | |||||||
|
|
|
|
|
|
|||||||
Net cash used in operating activities |
(7,776,703 | ) | (8,506,798 | ) | (11,309,691 | ) | ||||||
|
|
|
|
|
|
F-40
Table of Contents
NOTE 29. EARNINGS PER SHARE
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Loss after income tax attributable to the owners of Immutep Limited |
(12,746,020 | ) | (9,367,206 | ) | (62,015,184 | ) | ||||||
|
|
|
|
|
|
|||||||
Number | Number (Restated)* |
Number (Restated)* |
||||||||||
Weighted average number of ordinary shares used in calculating basic earnings per share |
2,608,328,140 | 2,284,360,994 | 2,228,477,348 | |||||||||
|
|
|
|
|
|
|||||||
Weighted average number of ordinary shares used in calculating diluted earnings per share |
2,608,328,140 | 2,284,360,994 | 2,228,477,348 | |||||||||
|
|
|
|
|
|
|||||||
Cents | Cents (Restated)* |
Cents (Restated)* |
||||||||||
Basic earnings per share |
(0.49 | ) | (0.41 | ) | (2.78 | ) | ||||||
Diluted earnings per share |
(0.49 | ) | (0.41 | ) | (2.78 | ) |
* | The Group updated the 2017 and 2016 EPS figure to reflect the bonus shares issue arising from the capital raising in fiscal year 2018. |
The following table summarizes the convertible notes, performance rights, listed options and unlisted options that were not included in the calculation of weighted average number of ordinary shares because they are anti-dilutive for the periods presented.
Consolidated | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Listed options |
| | 77,378,693 | |||||||||
Unlisted options |
529,369,101 | 531,049,969 | 531,049,969 | |||||||||
Convertible notes |
797,171,907 | 727,075,050 | 706,476,966 | |||||||||
Performance rights |
108,964,706 | 33,852,075 | 51,310,083 | |||||||||
Non-executive director rights |
21,481,457 | 10,881,194 | 3,431,373 | |||||||||
US warrants* |
197,345,100 | | | |||||||||
|
|
|
|
|
|
* | 1 American Depository Shares (ADS) listed on NASDAQ equals 100 ordinary shares listed on ASX thus the number of warrants on issue has been grossed up. |
NOTE 30. SHARE-BASED PAYMENTS
a) Executive Incentive Plan (EIP)
Equity incentives are granted under the Executive Incentive Plan (EIP) which was approved by shareholders at the 2015 Annual General Meeting. In light of our increasing operations globally the Board reviewed the Companys incentive arrangements to ensure that it continued to retain and motivate key executives in a manner that is aligned with members interests. As a result of that review, an umbrella EIP was adopted to which eligible executives are invited to apply for the grant of performance rights and/or options. Equity incentives granted in accordance with the EIP Rules are designed to provide meaningful remuneration opportunities and will reflect the importance of retaining a world-class management team. The Company endeavors to achieve simplicity and transparency in remuneration design, whilst also balancing competitive market practices in France, Germany, and Australia. The company grants Short Term Incentives (STIs) and Long Term Incentives (LTIs) under the EIP.
F-41
Table of Contents
NOTE 30. SHARE-BASED PAYMENTS (continued)
(a) Executive Incentive Plan (EIP) (continued)
Set out below are summaries of all STI and LTI performance rights granted under the EIP excluding the performance rights issued to non-executive directors:
2018 Grant date |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
|||||||||||||||||||||
September 19, 2014 |
0.044 | 2,757,353 | | | | 2,757,353 | | |||||||||||||||||||||
September 19, 2014 |
0.044 | 919,118 | | | | 919,118 | | |||||||||||||||||||||
November 14, 2014 |
0.038 | 9,191,177 | | | | 9,191,177 | | |||||||||||||||||||||
November 14, 2014 |
0.040 | 3,063,725 | | | | 3,063,725 | | |||||||||||||||||||||
August 5, 2015 |
0.047 | 14,000,001 | | (14,000,001 | ) | | | | ||||||||||||||||||||
October 1, 2015 |
0.060 | 600,000 | | | | 600,000 | | |||||||||||||||||||||
October 1, 2015 |
0.061 | 200,000 | | | | 200,000 | | |||||||||||||||||||||
March 7, 2016 |
0.041 | 1,486,326 | | (1,486,326 | ) | | | | ||||||||||||||||||||
February 10, 2017 |
0.035 | 1,634,375 | | (1,634,375 | ) | | | | ||||||||||||||||||||
2 August 2017 |
0.020 | | 3,900,000 | | | 3,900,000 | | |||||||||||||||||||||
November 17, 2017 |
0.024 | | 50,000,000 | (16,666,667 | ) | | 33,333,333 | | ||||||||||||||||||||
November 28, 2017 |
0.023 | | 15,000,000 | | | 15,000,000 | 15,000,000 | |||||||||||||||||||||
November 29, 2017 |
0.023 | | 60,000,000 | (20,000,000 | ) | | 40,000,000 | | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total |
33,852,075 | 128,900,000 | (53,787,369 | ) | | 108,964,706 | 15,000,000 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
2017 Grant date |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
|||||||||||||||||||||
September 19, 2014 |
0.044 | 5,422,794 | | | (2,665,441 | ) | 2,757,353 | | ||||||||||||||||||||
September 19, 2014 |
0.044 | 1,807,598 | | | (888,480 | ) | 919,118 | | ||||||||||||||||||||
November 14, 2014 |
0.038 | 9,191,177 | | | | 9,191,177 | | |||||||||||||||||||||
November 14, 2014 |
0.040 | 3,063,725 | | | | 3,063,725 | | |||||||||||||||||||||
August 5, 2015 |
0.047 | 28,000,001 | | (14,000,000 | ) | | 14,000,001 | | ||||||||||||||||||||
October 1, 2015 |
0.060 | 600,000 | | | | 600,000 | | |||||||||||||||||||||
October 1, 2015 |
0.061 | 200,000 | | | | 200,000 | | |||||||||||||||||||||
December 29, 2015 |
0.050 | 1,538,462 | | (1,538,462 | ) | | | | ||||||||||||||||||||
March 7, 2016 |
0.041 | 1,486,326 | | | | 1,486,326 | | |||||||||||||||||||||
February 10, 2017 |
0.035 | | 1,634,375 | | | 1,634,375 | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total |
51,310,083 | 1,634,375 | (15,538,462 | ) | (3,553,921 | ) | 33,852,075 | | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The fair value at grant date for Short Term Incentive (STI) performance rights are determined using a Black-Scholes option pricing model that takes into account the exercise price, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.
The model inputs for STI performance rights granted during the year ended June 30, 2018 included:
Grant date | August 2, 2017 | November 17, 2017 | November 28, 2017 | November 29, 2017 | ||||||||||||
Share price at grant date |
$ | 0.020 | $ | 0.024 | $ | 0.023 | $ | 0.023 | ||||||||
Expected price volatility of the Companys shares |
49% | 73% | 74% | 74% | ||||||||||||
Expected dividend yield |
Nil | Nil | Nil | Nil | ||||||||||||
Risk-free interest rate |
1.75% | 1.79% | 1.88% | 1.73% |
F-42
Table of Contents
NOTE 30. SHARE-BASED PAYMENTS (continued)
(a) | Executive Incentive Plan (EIP) (continued) |
The model inputs for STI performance rights granted during the year ended June 30, 2017 included:
Grant date |
February 10, 2017 |
|||
Share price at grant date |
$ | 0.035 | ||
Expected price volatility of the Companys shares |
54% | |||
Expected dividend yield |
Nil | |||
Risk-free interest rate |
1.80% |
The model inputs for STI performance rights granted during the year ended June 30, 2016 included:
Grant date |
August 5, 2015 |
December 29, 2015 |
March 7, 2016 |
|||||||||
Share price at grant date |
$ | 0.047 | $ | 0.050 | $ | 0.041 | ||||||
Expected price volatility of the Companys shares |
167% | 169% | 169% | |||||||||
Expected dividend yield |
Nil | Nil | Nil | |||||||||
Risk-free interest rate |
2.03% | 1.97% | 2.14% |
The fair value at grant date for 42,000,000 long term incentives issued on August 5, 2015 are determined using a Black Scholes option pricing model that takes into account the exercise price, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.
The model inputs for these performance rights granted included:
Grant date | August 5, 2015 | |||
Measurement period |
August 5, 2015 to August 5, 2017 | |||
Share price at grant date |
$ | 0.047 | ||
Expected price volatility of the Companys shares |
162% | |||
Expected dividend yield |
Nil | |||
Risk-free interest rate |
1.95% |
The fair value at grant date for long term incentives are determined using an Up and in Call Barrier Option Pricing Model.
The model inputs for performance rights granted during the year ended June 30, 2016 included:
Grant date |
August 5, 2015 | October 1, 2015 | ||||||
Measurement period tranche 1 |
|
August 5, 2015 to October 2, 2017 |
|
October 1, 2015 to October 2, 2017 |
||||
Measurement period tranche 2 |
|
August 5, 2015 to October 2, 2018 |
|
October 1, 2015 to October 2, 2018 |
||||
Barrier price |
|
CAGR 20% per annum over |
|
|
CAGR 20% per annum over measurement period |
|||
Share price at grant date |
$ | 0.047 | $ | 0.058 | ||||
Expected price volatility of the Companys shares |
120% | 120% | ||||||
Expected dividend yield |
Nil | Nil | ||||||
Risk-free interest rate |
2.12% | 1.94% |
F-43
Table of Contents
NOTE 30. SHARE-BASED PAYMENTS (continued)
(a) Executive Incentive Plan (EIP) (continued)
Set out below are summaries of options granted under the EIP:
2018 Grant date |
Expiry date |
Exercise |
Balance at |
Granted |
Exercised |
Forfeited during |
Balance at |
Vested
and | ||||||||
December 23, 2013 |
June, 30, 2018 | 0.0774 | 1,515,752 | | | (1,515,752) | | | ||||||||
January 24, 2014 |
June, 30, 2018 | 0.0774 | 165,116 | | | (165,116) | | | ||||||||
|
|
|
|
|
| |||||||||||
Total |
1,680,868 | | | (1,680,868) | | | ||||||||||
|
|
|
|
|
| |||||||||||
Weighted average |
0.0774 | | ||||||||||||||
2017 Grant date |
Expiry date |
Exercise |
Balance at |
Granted |
Exercised |
Forfeited during |
Balance at |
Vested
and | ||||||||
December 23, 2013 |
June, 30, 2018 | 0.0774 | 1,515,752 | | | | 1,515,752 | 1,515,752 | ||||||||
January 24, 2014 |
June, 30, 2018 | 0.0774 | 165,116 | | | | 165,116 | 165,116 | ||||||||
|
|
|
|
|
| |||||||||||
Total |
1,680,868 | | | | 1,680,868 | 1,680,868 | ||||||||||
|
|
|
|
|
| |||||||||||
Weighted average exercise price |
0.0774 | 0.0774 | ||||||||||||||
2016 Grant date |
Expiry date |
Exercise |
Balance at |
Granted |
Exercised |
Forfeited during |
Balance at |
Vested
and | ||||||||
December 23, 2013 |
June, 30, 2018 | 0.0774 | 1,515,752 | | | | 1,515,752 | 1,515,752 | ||||||||
January 24, 2014 |
June, 30, 2018 | 0.0774 | 165,116 | | | | 165,116 | 165,116 | ||||||||
|
|
|
|
|
| |||||||||||
Total |
1,680,868 | | | | 1,680,868 | 1,680,868 | ||||||||||
|
|
|
|
|
| |||||||||||
Weighted average exercise price |
0.0774 | 0.0774 |
No options expired during the periods covered by the above tables.
Fair value of options granted
No options were granted during the year ended June 30, 2018 (2017 Nil). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.
F-44
Table of Contents
NOTE 30. SHARE-BASED PAYMENTS (continued)
(b) Performance rights issued to non-executive directors with shareholders approval
At the 2017 annual general meeting, shareholders approved the issue of 13,272,356 performance rights to Mr Grant Chamberlain in lieu of cash for his services as a non-executive director. When exercisable, each performance right is convertible into one ordinary share. The weighted average remaining contractual life of performance rights outstanding at the end of the period was less than 1.2 years.
Set out below are summaries of performance rights granted with shareholders approval.
2018 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
||||||||||||||||||||||||
November 14, 2014 |
Director rights | 0.037 | 857,844 | | (857,844 | ) | | | | |||||||||||||||||||||||
November 25, 2016 |
Director rights | 0.038 | 10,023,350 | | (1,814,249 | ) | | 8,209,101 | | |||||||||||||||||||||||
November 17, 2017 |
Director rights | 0.024 | | 13,272,356 | | | 13,272,356 | | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total |
10,881,194 | 13,272,356 | (2,672,093 | ) | | 21,481,457 | | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
2017 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
||||||||||||||||||||||||
November 14, 2014 |
Director rights | 0.037 | 3,431,373 | | (2,573,529 | ) | | 857,844 | | |||||||||||||||||||||||
November 25, 2016 |
Director rights | 0.038 | | 10,023,350 | | | 10,023,350 | | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total |
3,431,373 | 10,023,350 | (2,573,529 | ) | | 10,881,194 | | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
2016 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
||||||||||||||||||||||||
November 14, 2014 |
Director rights | 0.037 | 6,004,902 | | (2,573,529 | ) | | 3,431,373 | | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total |
6,004,902 | | (2,573,529 | ) | | 3,431,373 | | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of performance rights granted
The fair value at grant date for the performance rights issued to non-executive directors with shareholders approval are determined using a Black-Scholes option pricing model that takes into account the exercise price, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.
The model inputs for STI performance rights granted during the year ended 30 June 2018 included:
Grant date |
17 November 2017 | |||
Share price at grant date |
$0.024 | |||
Expected price volatility of the Companys shares |
73% | |||
Expected dividend yield |
Nil | |||
Risk-free interest rate |
1.79% |
F-45
Table of Contents
NOTE 30. SHARE-BASED PAYMENTS (continued)
(b) Performance rights issued to non-executive directors with shareholders approval (continued)
The model inputs for STI performance rights granted during the year ended June 30, 2017 included:
Grant date |
25 November 2016 | |||
Share price at grant date |
$ | 0.037 | ||
Expected price volatility of the Companys shares |
56% | |||
Expected dividend yield |
Nil | |||
Risk-free interest rate |
1.92% |
(c) Options issued to other parties
During the financial year ended June 30, 2016, options were issued to Ridgeback Capital Investments and Trout Group LLC and these are exercisable at June 30, 2018.
Set out below is a summary of the options granted to both parties:
2018 Grant date |
Expiry date | Exercise price |
Balance at start of the year |
Granted during the year |
Exercised during the year |
Forfeited during the year |
Balance at end of the year |
Vested and exercisable at end of the year |
||||||||||||||||||||||
Number | Number | Number | Number | Number | Number | |||||||||||||||||||||||||
July 31, 2015 | August 5,2020 | 0.0237 | 371,445,231 | | | | 371,445,231 | 371,445,231 | ||||||||||||||||||||||
July 31, 2015 | August 5, 2021 | 0.025 | 8,475,995 | | | | 8,475,995 | 8,475,995 | ||||||||||||||||||||||
October 30, 2015 | October 30, 2020 | 0.057 | 793,103 | | | | 793,103 | 793,103 | ||||||||||||||||||||||
March 7, 2016 | March 7, 2021 | 0.040 | 1,026,272 | | | | 1,026,272 | 1,026,272 | ||||||||||||||||||||||
Total | 381,740,601 | | | | 381,740,601 | 381,740,601 |
Fair value of options granted
There were no options granted during the year ended June 30, 2018 (2017 nil). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.
(d) Warrants issued to US investors
In July 2017, the Company completed its first US capital raise. In this private placement, the Company agreed to issue unregistered warrants to purchase up to 1,973,451 ADSs. Please refer to note 14 for more details.
(e) Expenses arising from share-based payment transactions
Total expenses arising from share-based payment transactions recognized during the period as part of employee benefit expense were as follows:
Consolidated | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Employee share-based payment expense |
2,263,843 | 862,227 | ||||||
|
|
|
|
|||||
2,263,843 | 862,227 | |||||||
|
|
|
|
Share-based payment transactions with employees are recognised during the period as a part of corporate administrative expenses.
F-46
Table of Contents
NOTE 31. PARENT ENTITY INFORMATION
Set out below is the supplementary information about the parent entity.
Statement of comprehensive loss
Parent | ||||||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
June 30, 2016 A$ |
||||||||||
Loss after income tax |
(14,687,752 | ) | (8,526,159 | ) | (61,973,221 | ) | ||||||
|
|
|
|
|
|
|||||||
Total comprehensive loss |
(14,687,752 | ) | (8,526,159 | ) | (61,973,221 | ) | ||||||
|
|
|
|
|
|
Statement of financial position
Parent | ||||||||
June 30, 2018 A$ |
June 30, 2017 A$ |
|||||||
Total current assets |
23,589,353 | 13,220,743 | ||||||
Total non current assets |
18,698,068 | 20,936,849 | ||||||
|
|
|
|
|||||
Total assets |
42,287,421 | 34,157,592 | ||||||
|
|
|
|
|||||
Total current liabilities |
615,027 | 1,189,848 | ||||||
Total non current liabilities |
10,630,814 | 6,482,571 | ||||||
|
|
|
|
|||||
Total liabilities |
11,245,841 | 7,672,419 | ||||||
|
|
|
|
|||||
Equity |
||||||||
Contributed equity |
213,232,719 | 195,352,543 | ||||||
Reserves |
64,615,312 | 63,251,328 | ||||||
Accumulated losses |
(246,806,451 | ) | (232,118,699 | ) | ||||
|
|
|
|
|||||
Total equity |
31,041,580 | 26,485,173 | ||||||
|
|
|
|
Parent company financial information is presented in order to meet the disclosure requirements of Australian Accounting Standards, which permits investments in subsidiaries to be measured at cost.
Guarantees of financial support
There are no guarantees entered into by the parent entity.
Contingent liabilities of the parent entity
Refer to note 23 for details in relation to contingent liabilities as at June 30, 2018 and June 30, 2017.
Capital commitments Property, plant and equipment
The parent entity did not have any capital commitments for property, plant and equipment at as June 30, 2018 and June 30, 2017.
F-47
Table of Contents
ITEM 19. | EXHIBITS |
The following exhibits are filed as part of this Annual Report on Form 20-F:
EXHIBIT INDEX
Table of Contents
* | Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been submitted separately with the Securities and Exchange Commission. |
+ | Indicates management contract or compensatory plan. |
| Confidential treatment requested. Confidential information omitted and filed separately with the Securities and Exchange Commission. |
# | Filed herewith. |
In accordance with SEC Release Nos. 33-8238 and 34-47986, Final Rule: Managements Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, and the instructions to Form 20-F, the certifications furnished in Exhibits 13.1 and 13.2 hereto are deemed to accompany this Annual Report on Form 20-F and will not be deemed filed for purpose of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the U.S. Securities Act of 1933, as amended, or the U.S. Securities Exchange Act of 1934, as amended, except to the extent that we specifically incorporates it by reference.
Table of Contents
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
Immutep LTD |
/s/ Marc Voigt |
By: Marc Voigt Title: Chief Executive Officer, Chief Financial Officer and Chief Business Officer |
Date: October 19, 2018
Exhibit 4.14
EXECUTION COPY
**** INDICATES CONFIDENTIAL MATERIAL OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT AND FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION SEPARATELY WITH A REQUEST
FOR CONFIDENTIAL TREATMENT.
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
by and among
Merck Sharp & Dohme B.V., MSD International GmbH, and
Immutep Limited
Dated: March 12, 2018
Confidential material omitted and filed separately with the Commission.
TABLE OF CONTENTS
Page | ||||||||
1. |
Definitions |
1 | ||||||
2. |
Scope of the Agreement |
8 | ||||||
2.1. | Generally |
8 | ||||||
2.2. | Manufacturing Delay |
8 | ||||||
2.3. | Compound Commitments |
8 | ||||||
2.4. | Delegation of Obligations |
9 | ||||||
2.5. | Compounds |
9 | ||||||
3. |
Conduct of the Study |
9 | ||||||
3.1. | Sponsor |
9 | ||||||
3.2. | Performance |
9 | ||||||
3.3. | Debarred Personnel; Exclusions Lists |
9 | ||||||
3.4. | Regulatory Matters. |
10 | ||||||
3.5. | Documentation |
10 | ||||||
3.6. | Copies |
10 | ||||||
3.7. | Sample Testing |
10 | ||||||
3.8. | Ownership and Use of Clinical Data |
11 | ||||||
3.9. | Regulatory Submission |
12 | ||||||
3.10. | Joint Development Committee; Alliance Managers |
12 | ||||||
3.11. | Final Study Report |
13 | ||||||
3.12. | Relationship |
13 | ||||||
3.13. | Licensing |
13 | ||||||
3.14. | Subsequent Study |
13 | ||||||
4. |
Protocol and Informed Consent; Certain Covenants |
13 | ||||||
4.1. | Protocol |
13 | ||||||
4.2. | Informed Consent |
14 | ||||||
4.3. | Financial Disclosure |
14 | ||||||
4.4. | Transparency Reporting |
15 | ||||||
5. |
Adverse Event Reporting |
15 | ||||||
5.1. | Pharmacovigilance Agreement |
15 | ||||||
5.2. | Transmission of SAEs |
16 | ||||||
6. |
Term and Termination |
16 | ||||||
6.1. | Term |
16 | ||||||
6.2. | Merck Termination for Safety |
16 | ||||||
6.3. | Termination for Material Breach |
16 |
Confidential material omitted and filed separately with the Commission.
6.4. | Termination for Patient Safety |
16 | ||||||||
6.5. | Termination for Regulatory Action; Other Reasons |
16 | ||||||||
6.6. | Termination related to AntiCorruption Obligations |
17 | ||||||||
6.7. | Return of Merck Compound |
17 | ||||||||
6.8. | Survival |
17 | ||||||||
6.9. | No Prejudice |
17 | ||||||||
6.10. | Confidential Information |
17 | ||||||||
6.11. | Manufacturing Costs |
18 | ||||||||
7. |
Costs of Study |
18 | ||||||||
8. |
Supply and Use of the Compounds |
18 | ||||||||
8.1. | Supply of the Compounds |
18 | ||||||||
8.2. | Clinical Quality Agreement |
18 | ||||||||
8.3. | Minimum Shelf Life Requirements |
19 | ||||||||
8.4. | Provision of Compounds |
19 | ||||||||
8.5. | Labeling and Packaging; Use, Handling and Storage |
19 | ||||||||
8.6. | Product Specifications |
20 | ||||||||
8.7. | Changes to Manufacturing |
20 | ||||||||
8.8. | Product Testing; Noncompliance |
20 | ||||||||
8.9. | Investigations |
21 | ||||||||
8.10. | Shortage; Allocation |
22 | ||||||||
8.11. | Records; Audit Rights |
22 | ||||||||
8.12. | Quality |
22 | ||||||||
8.13. | Quality Control |
22 | ||||||||
8.14. | Audits and Inspections |
22 | ||||||||
8.15. | Recalls |
22 | ||||||||
8.16. | VAT |
22 | ||||||||
9. |
Confidentiality |
23 | ||||||||
9.1. | Confidential Information |
23 | ||||||||
9.2. | Inventions |
23 | ||||||||
9.3. | Personal Identifiable Data |
23 | ||||||||
10. |
Intellectual Property |
24 | ||||||||
10.1. | Joint Ownership and Prosecution |
24 | ||||||||
10.2. | Inventions Owned by Company |
25 | ||||||||
10.3. | Inventions Owned by Merck |
26 |
Confidential material omitted and filed separately with the Commission.
ii
10.4. | Mutual Freedom to Operate for Combination Inventions |
27 | ||||||||
10.5. | Ownership of Other Inventions |
27 | ||||||||
11. |
Reprints; Rights of CrossReference |
28 | ||||||||
12. |
Publications; Press Releases |
28 | ||||||||
12.1. | Clinical Trial Registry |
28 | ||||||||
12.2. | Publication |
28 | ||||||||
12.3. | Press Releases |
28 | ||||||||
13. |
Representations and Warranties; Disclaimers |
29 | ||||||||
13.1. | Due Authorization |
29 | ||||||||
13.2. | Compounds |
29 | ||||||||
13.3. | Results |
29 | ||||||||
13.4. | AntiCorruption |
29 | ||||||||
13.5. | DISCLAIMER |
31 | ||||||||
14. |
Insurance; Indemnification; Limitation of Liability |
31 | ||||||||
14.1. | Insurance |
31 | ||||||||
14.2. | Indemnification |
31 | ||||||||
14.3. | LIMITATION OF LIABILITY |
32 | ||||||||
15. |
Use of Name |
33 | ||||||||
16. |
Force Majeure |
33 | ||||||||
17. |
Entire Agreement; Amendment; Waiver |
33 | ||||||||
18. |
Assignment and Affiliates |
34 | ||||||||
19. |
Invalid Provision |
34 | ||||||||
20. |
No Additional Obligations |
34 | ||||||||
21. |
Governing Law; Dispute Resolution |
34 | ||||||||
22. |
Notices |
34 | ||||||||
23. |
Relationship of the Parties |
35 | ||||||||
24. |
Counterparts and Due Execution |
35 | ||||||||
25. |
Construction |
36 |
Appendices
Appendix A Protocol Synopsis
Appendix B Supply of Compound Appendix
C Initial Press Release
Schedules
Schedule I Data Sharing and Sample Testing Schedule
Confidential material omitted and filed separately with the Commission.
iii
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this Agreement), is entered into as of March 12, 2018 (the Effective Date), by and between Merck Sharp & Dohme B.V., having a place of business at Waarderweg 39, 2031 BN Haarlem, Netherlands (MSDBV), MSD International GmbH, having a place of business at Weystrasse 20, 6000 Luzern 6, Switzerland (MSDIG, and, collectively with MSDBV, Merck), and Immutep Limited, having a place of business at Level 12, 95 Pitt Street, Sydney, NSW, Australia 2000 (Company). Merck and Company are each referred to herein individually as Party and collectively as Parties.
RECITALS
A. Each of MSDBV and MSDIG holds intellectual property rights with respect to the Merck Compound (as defined below).
B. Company holds intellectual property rights in and is developing the Company Compound (as defined below) for the treatment of certain tumor types.
C. Merck is developing the Merck Compound for the treatment of certain tumor types.
D. Company desires to sponsor a clinical trial in which the Company Compound and the Merck Compound would be dosed concurrently or in combination.
E. Merck and Company, consistent with the terms of this Agreement, desire to collaborate as more fully described herein, including by providing the Merck Compound and the Company Compound for the Study (as defined below).
NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as follows:
1. Definitions.
For all purposes of this Agreement, the capitalized terms defined in this Article 1 and throughout this Agreement shall have the meanings herein specified.
1.1. Affiliate means, with respect to either Party, a firm, corporation or other entity that, now or hereafter, directly or indirectly owns or controls said Party, or, now or hereafter, is owned or controlled by said Party, or is under common ownership or control with said Party. The word control as used in this definition means (a) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity or (b) possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise.
1.2. Agreement means this agreement, as amended by the Parties from time to time, and as set forth in the preamble.
Confidential material omitted and filed separately with the Commission.
1.3. Alliance Manager has the meaning set forth in Section 3.10.3.
1.4. Applicable Law means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administration (FDA), national regulatory authorities, the European Medicines Agency (EMA) and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union (each a Regulatory Authority and collectively, Regulatory Authorities), and including cGMP and GCP (each as defined below); all data protection requirements such as those specified in the EU Data Protection Directive and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996 (HIPAA); export control and economic sanctions regulations which prohibit the shipment of United States-origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives; laws and regulations governing payments to healthcare providers; and any United States or other countrys or jurisdictions successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing.
1.5. Business Day means any day other than a Saturday, Sunday, or a day on which commercial banks located in the country where the applicable obligations are to be performed are authorized or required by law to be closed.
1.6. cGMP means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.
1.7. Clinical Data means all data (including raw data) and results generated by or on behalf of either Party or at either Partys direction, or by or on behalf of the Parties together or at their direction, in the course of each such Partys performance of the Study; provided however, that Clinical Data does not include Sample Testing Results.
1.8. Clinical Quality Agreement has the meaning set forth in Section 8.2.
1.9. CMC means Chemistry Manufacturing and Controls as such term of art is used in the pharmaceutical industry.
1.10. Combination means the use or method of using the Company Compound and the Merck Compound in concomitant or sequential administration.
1.11. Company has the meaning set forth in the preamble.
1.12. Company Background Patents has the meaning set forth in Section 10.4.1.
1.13. Company Class Compound means ****.
Confidential material omitted and filed separately with the Commission.
2
1.14. Company Compound means eftilagimod alpha (IMP321), ****.
1.15. Company Inventions has the meaning set forth in Section 10.2.
1.16. Compounds means the Company Compound and the Merck Compound. A Compound means either the Company Compound or the Merck Compound, as applicable.
1.17. Confidential Information means any information, Know-How or other proprietary information or materials furnished to one Party (Receiving Party) by or on behalf of the other Party (Disclosing Party) in connection with this Agreement, except to the extent that such information or materials: (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party, as demonstrated by competent evidence; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or (e) was subsequently developed by the Receiving Party without use of the Disclosing Party Confidential Information, as demonstrated by competent evidence.
1.18. Continuing Party has the meaning set forth in Section 10.1.3.
1.19. Control or Controlled means, with respect to particular information or intellectual property, that the applicable Party owns or has a license to such information or intellectual property and has the ability to grant a right, license or sublicense to the other Party as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.
1.20. CTA means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial.
1.21. Data Sharing and Sample Testing Schedule means the schedule attached hereto as Schedule I.
1.22. Defending Party has the meaning set forth in Section 14.2.3.
1.23. Delivery with respect to the Merck Compound has the meaning set forth in Section 8.4.1, and with respect to the Company Compound, the meaning set forth in Section 8.4.2.
1.24. Direct Manufacturing Costs has the meaning set forth in Section 6.11.
1.25. Disclosing Party has the meaning set forth in the definition of Confidential Information.
Confidential material omitted and filed separately with the Commission.
3
1.26. Disposition Package has the meaning set forth in Section 8.8.1.
1.27. Effective Date has the meaning set forth in the preamble.
1.28. EMA has the meaning set forth in the definition of Applicable Law.
1.29. Exclusions List has the meaning set forth in the definition of Violation.
1.30. FDA has the meaning set forth in the definition of Applicable Law.
1.31. Filing Party has the meaning set forth in Section 10.1.3.
1.32. Final Study Report has the meaning set forth in Section 3.11.
1.33. Force Majeure has the meaning set forth Section 16.
1.34. GAAP has the meaning set forth in Section 6.11.
1.35. GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.
1.36. Government Official means: (a) any officer or employee of a government or any department, agency or instrument of a government; (b) any Person acting in an official capacity for or on behalf of a government or any department, agency, or instrument of a government; (c) any officer or employee of a company or business owned in whole or part by a government; (d) any officer or employee of a public international organization such as the World Bank or United Nations; (e) any officer or employee of a political party or any Person acting in an official capacity on behalf of a political party; and/or (f) any candidate for political office; who, when such Government Official is acting in an official capacity, or in an official decision- making role, has responsibility for performing regulatory inspections, government authorizations or licenses, or otherwise has the capacity to make decisions with the potential to affect the business of either of the Parties.
1.37. HIPAA has the meaning set forth in the definition of Applicable Law.
1.38. IND means any Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an Investigational Medicinal Product Dossier filed or to be filed with Regulatory Authorities in the European Union.
1.39. Indirect Manufacturing Costs has the meaning set forth in Section 6.11.
1.40. Inventions means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together, (a) in the design or performance of the Study, (b) through use of unpublished Clinical Data or (c) through use of Sample Testing Results that are shared between the Parties pursuant to the Data Sharing & Sample Testing Schedule.
Confidential material omitted and filed separately with the Commission.
4
1.41. Joint Development Committee or JDC has the meaning set forth in Section 3.10.1.
1.42. Joint Patent Application has the meaning set forth in Section 10.1.3.
1.43. Joint Patent means a patent, extension, registration, supplementary protection certificate or the like that issues from a Joint Patent Application.
1.44. Jointly Owned Invention has the meaning set forth in Section 10.1.1.
1.45. Know-How means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.
1.46. Liability has the meaning set forth in Section 14.2.1.
1.47. Manufacture, Manufactured, or Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.
1.48. Manufacturers Release or Release has the meaning ascribed to such term in the Clinical Quality Agreement.
1.49. Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.
1.50. Merck has the meaning set forth in the preamble.
1.51. Merck Background Patents has the meaning set forth in Section 10.4.2.
1.52. Merck Compound means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, ****.
1.53. Merck Inventions has the meaning set forth in Section 10.3.
1.54. NDA means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
Confidential material omitted and filed separately with the Commission.
5
1.55. Non-Conformance means, with respect to a given unit of Compound, (a) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound or (b) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.3. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.
1.56. Non-Filing Party has the meaning set forth in Section 10.1.3.
1.57. Other Party has the meaning set forth in Section 14.2.3.
1.58. Opting-out Party has the meaning set forth in Section 10.1.3.
1.59. Party has the meaning set forth in the preamble.
1.60. PD-1 Antagonist means ****.
1.61. Person means any individual, sole proprietorship, partnership, corporation, business trust, joint stock company, trust, unincorporated organization, association, limited liability company, institution, public benefit corporation, joint venture, entity or governmental entity.
1.62. Pharmacovigilance Agreement has the meaning set forth in Section 5.1.
1.63. Project Manager has the meaning set forth in Section 3.10.1.
1.64. Protocol means the written documentation that describes the Study and sets forth specific activities to be performed as part of the conduct of the Study.
1.65. Receiving Party has the meaning set forth in the definition of Confidential Information.
1.66. Regulatory Approvals means, with respect to a Compound, any and all permissions (other than the Manufacturing approvals) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration, importation and distribution of such Compound in the United States, Europe or other applicable jurisdictions for use in the Study.
1.67. Regulatory Authorities has the meaning set forth in the definition of Applicable Law.
1.68. Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).
Confidential material omitted and filed separately with the Commission.
6
1.69. Related Agreements means the Pharmacovigilance Agreement and the Clinical Quality Agreement.
1.70. Right of Reference means the right of reference defined in 21 CFR 314.3(b), including with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Partys Compound, only to the extent necessary for the conduct of the Study in such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder.
1.71. SAEs has the meaning set forth in Section 5.2.
1.72. Samples means biological specimens collected from subjects participating in the Study, including urine, blood and tissue samples.
1.73. Sample Testing means the analyses to be performed by each Party using the applicable Samples, as described in the Data Sharing and Sample Testing Schedule.
1.74. Sample Testing Results means those data and results arising from the Sample Testing performed by a Party.
1.75. Specifications means, with respect to a given Compound, the set of requirements for such Compound as set forth in the Clinical Quality Agreement.
1.76. Study means the Phase I/II clinical trials described in the Protocol to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the concomitant and/or sequenced administration of the combination of the Merck Compound and the Company Compound in patients with ovarian, head and neck or non-small cell lung cancers.
1.77. Study Completion has the meaning set forth in Section 3.11.
1.78. Subcontractors has the meaning set forth in Section 2.4.
1.79. Subsequent Study has the meaning set forth in Section 3.14.1.
1.80. Term has the meaning set forth in Section 6.1.
1.81. Third Party means any Person or entity other than Company, Merck or their respective Affiliates.
1.82. Toxicity & Safety Data means all clinical adverse event information and/or patient-related safety data included in the Clinical Data, as more fully described in the Pharmacovigilance Agreement.
Confidential material omitted and filed separately with the Commission.
7
1.83. VAT has the meaning set forth in Section 8.16.
1.84. Violation means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party performing activities hereunder) has been: (a) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (b) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for Award Management (http://www.sam.gov); or (c) listed by any US Federal agency as being suspended, proposed for debarment, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) ((a), (b) and (c) collectively the Exclusions Lists).
2. Scope of the Agreement.
2.1. Generally. Each Party shall: (a) contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party.
2.2. Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound as contemplated by this Agreement.
2.3. Compound Commitments.
2.3.1. Company agrees to Manufacture and supply the Company Compound for purposes of the Study in accordance with Article 8, and Company hereby represents and warrants to Merck that, at the time of Delivery of the Company Compound, such Company Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections.
2.3.2. Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections.
2.3.3. Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, for clarity, Company shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4).
Confidential material omitted and filed separately with the Commission.
8
2.4. Delegation of Obligations. Each Party shall have the right to delegate any portion of its obligations hereunder as follows: (a) to such Partys Affiliates; (b) to Third Parties that are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) ****; and (d) upon the other Partys prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as Subcontractors. Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Each Party shall ensure that each of its Affiliates and Subcontractors performs such Partys obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates and Subcontractors that are required to be provided to the other Party under this Agreement.
2.5. Compounds. This Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, nor does it create any obligation on the part of Company to provide the Company Compound for any activities other than the Study.
3. Conduct of the Study.
3.1. Sponsor. Company shall act as the sponsor of the Study under its existing IND for the Company Compound with a Right of Reference to the IND of the Merck Compound, as necessary, as further described in Section 3.4; provided, however, that in no event shall Company file an additional IND for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests an additional IND for the Study the Parties shall meet and mutually agree on an approach to address such requirement.
3.2. Performance. Company shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.
3.3. Debarred Personnel; Exclusions Lists. Notwithstanding anything to the contrary contained herein, Company shall not employ or subcontract with any Person that is excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs for the performance of the Study or any other activities under this Agreement or the Related Agreements. Company hereby certifies that it has not employed or otherwise used in any capacity and will not employ or otherwise use in any capacity, the services of any Person suspended, proposed for debarment, or debarred under United States law, including 21 USC 335a, or any foreign equivalent thereof, in performing any portion of the Study or other activities under this Agreement or the Related Agreements and that Company has, as of the Effective Date, screened itself, and its officers and directors, against the Exclusions Lists and that it has informed Merck whether it or any of its officers or directors has been in Violation. Company shall promptly notify Merck in writing if any such suspension, proposed debarment, debarment or Violation occurs or comes to its attention, and shall, with respect to any Person so suspended, proposed for debarment, debarred or in Violation, promptly remove such Person from performing in any capacity related to the Study or otherwise related to activities under this Agreement or the Related Agreements.
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3.4. Regulatory Matters. Company shall: (a) obtain, prior to initiating the Study, all Regulatory Approvals from all Regulatory Authorities, ethics committees and/or institutional review boards with jurisdiction over the Study prior to initiating the Study; and (b) follow all directions from any such Regulatory Authorities, ethics committees and/or institutional review boards. Merck shall (a) reasonably assist the Company relating to the Companys interaction with, and efforts to obtain and maintain approvals from, Regulatory Authorities, ethics committees and/or institutional review boards, in each case for the Study, and (b) have the right (but not the obligation) to participate in any discussions (including meetings) with a Regulatory Authority regarding matters related to the Study and the Merck Compound and to collaborate on questions posed to Regulatory Authorities regarding design and conduct of the Study. If a Right of Reference is necessary, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority if needed to effectuate the Right of Reference. ****. Merck shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound INDs and CTAs to provide data access to Company sufficient to support conduct of the Study. If Mercks CTA is not available in a given country, Merck will file its CMC data with the Regulatory Authority for such country, referencing Companys CTA as appropriate (****).
3.5. Documentation. In connection with the Study, Company shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law. Company shall provide to Merck all Study information and documentation reasonably requested by Merck to enable Merck to (a) comply with any of its legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, related to the Merck Compound and (b) determine whether the Study has been performed in accordance with this Agreement.
3.6. Copies. Company shall provide to Merck copies of all Clinical Data, in electronic form or other mutually agreeable alternate form and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that a complete copy of the Clinical Data shall be provided to Merck no later than **** days following Study Completion. Company shall ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Merck.
3.7. Sample Testing.
3.7.1. Company shall provide Samples to Merck as specified in the Protocol or as agreed to by the Joint Development Committee. Each Party shall (a) use the Samples only for the Sample Testing and (b) conduct the Sample Testing solely in accordance with the Data Sharing and Sample Testing Schedule and the Protocol.
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3.7.2. Merck shall own ****.
3.7.3. Company shall own ****.
3.7.4. Except to the extent otherwise agreed in a writing signed by authorized representatives of each Party, each Party may use and disclose the Sample Testing Results owned by the other Party and shared by such other Party in accordance with the Data Sharing and Sample Testing Schedule solely for the purposes of ****.
3.8. Ownership and Use of Clinical Data.
3.8.1. All Clinical Data shall be ****. Company shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, Company shall grant Merck access to all Clinical Data.
3.8.2. Notwithstanding the foregoing, before publication of the Clinical Data in accordance with Article 12, ****; provided, however, that the foregoing shall not limit or restrict either Partys ability to (i) use or disclose the Clinical Data as may be necessary to comply with Applicable Law or with such Partys internal policies and procedures with respect to pharmacovigilance and adverse event reporting or (ii) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety.
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3.9. Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to ****.
3.10. Joint Development Committee; Alliance Managers.
3.10.1. The Parties shall form a joint development committee (the Joint Development Committee or JDC) made up of an equal number of representatives of Merck and Company, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party may appoint or replace its representatives to the JDC at any time upon notice to the other Party. The JDC will review and finalize the Protocol in accordance with Section 4.1. Each Party shall designate a project manager (the Project Manager) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study and shall be a member of the JDC. Other JDC members will be agreed by both Parties.
3.10.2. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, Companys Project Manager shall provide an update in writing to Mercks Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study.
3.10.3. In addition to a Project Manager, each Party shall designate an alliance manager (the Alliance Manager), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Executive Officer for Company. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Company shall have final decision-making authority with respect to issues related to Company Compound.
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3.11. Final Study Report. Company shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have **** after receipt of such draft to provide comments thereon. Company shall consider in good faith any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Company shall deliver to Merck a final version of the final study report promptly following finalization thereof (the Final Study Report). Study Completion shall occur upon database lock of the Study results.
3.12. Relationship. Notwithstanding anything in this Agreement to the contrary, each Party acknowledges and agrees that: ****.
3.13. Licensing. ****.
3.14. Subsequent Study.
3.14.1 ****.
3.14.2 ****.
4. Protocol and Informed Consent; Certain Covenants.
4.1. Protocol. A synopsis of the initial Protocol and the draft statistical analysis plan for the Study have been agreed to by the Parties as of the Effective Date and are attached hereto as Appendix A. Through the JDC, Company shall (a) provide a draft of the Protocol (and any subsequent revisions thereof) to Merck for Mercks review and comment, (b) consider in good faith any changes to the draft of the Protocol requested by Merck, and (c) incorporate any changes requested by Merck with respect to Merck Compound. Company shall submit the draft Protocol to the JDC for final approval. To the extent the JDC cannot agree unanimously regarding the contents of the Protocol for final approval: (i) Company shall have final decision- making authority with respect to matters in the Protocol related to the Company Compound; (ii) Merck shall have final decision-making authority with respect to matters in the Protocol related to the Merck Compound (including with respect to the quantities and/or presentations of Merck Compound to be provided for the Study and/or the timing for Delivery thereof); and (iii) all other matters in respect of the Protocol on which the JDC cannot agree shall be resolved in accordance with Section 3.10.3. Once the final Protocol has been approved in accordance with this Section 4.1, any material changes to such approved final Protocol (other than material changes relating solely to the Company Compound) and any changes to the final Protocol (whether or not material) relating to the Merck Compound shall require Mercks prior written consent. Any such proposed changes will be sent in writing to Mercks Project Manager and Mercks Alliance Manager.
4.1.1. Notwithstanding anything to the contrary contained herein, Merck, in its sole discretion, shall have the sole right to determine the dose and dosing regimen for the Merck Compound and shall have the final decision on all matters relating to the Merck Compound (including quantities of Merck Compound to be supplied pursuant to Article 8) and any information regarding the Merck Compound included in the Protocol.
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4.1.2. Notwithstanding anything to the contrary contained herein, Company, in its sole discretion, shall have the sole right to determine the dose and dosing regimen for the Company Compound and shall have the final decision on all matters relating to the Company Compound (including quantities of Company Compound to be supplied pursuant to Article 8) and any information regarding the Company Compound included in the Protocol.
4.2. Informed Consent. Company shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the Merck Compound shall be provided to Company by Merck). Any proposed changes to such form that relate to the Merck Compound, including Sample Testing of the Merck Compound, shall be subject to Mercks prior written consent. Any such proposed changes will be sent in writing to Mercks Project Manager and Mercks Alliance Manager. Merck will provide such consent, or a written explanation for why such consent is being withheld, within **** Business Days after Merck receives a copy of Companys requested changes.
4.3. Financial Disclosure. Company shall (a) track and collect financial disclosure information from all clinical investigators involved in the Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents. Prior to the initiation of clinical activities under the Study, but in any event within **** days after the Effective Date, the Parties shall determine whether Company shall track and collect from all clinical investigators involved in the Study separate certification and/or disclosure forms for each of Merck and Company or one (1) combined certification and/or disclosure form for both Merck and Company. For purposes of this Section 4.3, the term clinical investigators shall have the meaning set forth in Part 54.2(d) of Title 21 of the United States Code of Federal Regulations.
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4.4. Transparency Reporting.
4.4.1. With respect to any annual reporting period in which Company is not an entity that is required to make a Transparency Report under Applicable Law, Company will: (a) notify Merck, in writing, within **** days after the commencement of such reporting period that Company is not so required; and (b) during such reporting period Company will track and provide to Merck data regarding indirect payments or other transfers of value by Company to such health care professionals to the extent such payments or other transfers of value were required, instructed, directed or otherwise caused by Merck pursuant to this Agreement in the format requested by Merck and provided on a basis to be agreed upon by both Parties. Company represents and warrants that any data provided by Company to Merck pursuant to Section 4.4.1(b) above will be complete and accurate to the best of Companys knowledge.
4.4.2. With respect to any annual reporting period in which Company is required to make a Transparency Report under Applicable Law, Company will provide to Merck, in writing, Companys point of contact for purposes of receiving information from Merck pursuant to this Section 4.4, along with such contacts full name, email address, and telephone number. Company may update such contact from time to time by notifying Merck in writing pursuant to Section 22 (Notices). Where applicable, Merck will provide to such Company contact all information regarding the value of the Merck Compound provided for use in the Study required for such reporting. In the event that the value of the Merck Compound provided pursuant to this Section 4.4.2 changes, Merck shall notify Company of such revised value and the effective date thereof.
4.4.3. For purposes of this Section 4.4, Transparency Report means a transparency report in connection with reporting payments and other transfers of value made to health care professionals, including, without limitation, investigators, steering committee members, data monitoring committee members, and consultants in connection with the Study in accordance with reporting requirements under Applicable Law, including, without limitation, the Physician Payment Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code, or a Partys applicable policies.
5. Adverse Event Reporting.
5.1. Pharmacovigilance Agreement. Company will be solely responsible for compliance with all Applicable Laws pertaining to safety reporting for the Study and related activities. The Parties (or their respective Affiliates) will execute a pharmacovigilance agreement (the Pharmacovigilance Agreement) prior to the initiation of clinical activities under the Study to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews. In the event of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall control. The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the Merck Compound and Company Compound in the Study, consistent with Applicable Law. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities.
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5.2. Transmission of SAEs. Company will transmit to Merck all serious adverse events (SAEs) as follows:
5.2.1. For drug-related fatal and life-threatening SAEs, Company will send a processed case (on a CIOMS-1 form in English) within **** calendar days after receipt by Company of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Company will send a processed case (on a CIOMS-1 form in English) within **** calendar days after receipt by Company of such SAEs.
6. Term and Termination.
6.1. Term. The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until **** (the Term).
6.2. Merck Termination for Safety. In the event that Merck in good faith believes that the Merck Compound is being used in the Study in an unsafe manner and notifies Company in writing of the grounds for such belief, and Company fails to promptly incorporate changes into the Protocol requested by Merck to address such issue or to otherwise address such issue reasonably and in good faith, Merck may terminate this Agreement and the supply of the Merck Compound immediately upon written notice to Company.
6.3. Termination for Material Breach. Either Party may terminate this Agreement if the other Party commits a material breach of this Agreement, and such material breach continues for **** days after receipt of written notice thereof from the non-breaching Party; provided that if such material breach cannot reasonably be cured within **** days, the breaching Party shall be given a reasonable period of time to cure such breach; provided further, that if such material breach is incapable of cure, then the notifying Party may terminate this Agreement effective after the expiration of such **** day period.
6.4. Termination for Patient Safety. If either Party determines in good faith, based on a review of the Clinical Data, Sample Testing Results or other Study-related Know-How or other information, that the Study may unreasonably affect patient safety, such Party shall promptly notify the other Party of such determination. The Party receiving such notice may propose modifications to the Study to address the safety issue identified by the other Party and, if the notifying Party agrees, shall act to implement immediately such modifications; provided, however, that if the notifying Party, in its sole discretion, believes that there is imminent danger to patients, such Party need not wait for the other Party to propose modifications and may instead terminate this Agreement immediately upon written notice to such other Party. Furthermore, if the notifying Party, in its sole discretion, believes that any modifications proposed by the other Party will not resolve the patient safety issue, such Party may terminate this Agreement effective upon written notice to such other Party.
6.5. Termination for Regulatory Action; Other Reasons. Either Party may terminate this Agreement immediately upon written notice to the other Party in the event that any Regulatory Authority takes any action, or raises any objection, that prevents the terminating Party from complying with its obligations under this Agreement (including, but not limited to,
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supplying its Compound for purposes of the Study). Additionally, either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party in the event that it determines in its sole discretion to withdraw any applicable Regulatory Approval for its Compound or to discontinue development of its Compound, for medical, scientific or legal reasons.
6.6. Termination related to Anti-Corruption Obligations. Either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party, if such other Party fails to perform any of its obligations under Section 13.4 or breaches any representation or warranty contained in Section 13.4. Except as set forth in Section 6.11, the non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 6.6.
6.7. Return of Merck Compound. In the event that this Agreement is terminated, or in the event Company remains in possession (including through any Affiliate or Subcontractor) of Merck Compound at the time this Agreement expires, Company shall, at Mercks sole discretion, promptly either return or destroy all unused Merck Compound pursuant to Mercks instructions. If Merck requests that Company destroy the unused Merck Compound, Company shall provide written certification of such destruction.
6.8. Survival. The provisions of Sections 3.4 through 3.9 (inclusive), 3.14, 6.7 through 6.11 (inclusive), 8.5.2, 8.11, 8.14 through 8.16 (inclusive), 13.4.6, 14.2, and 14.3, and Articles 1, 5, 9 through 12 (inclusive), 17, and 20 through 25 (inclusive) shall survive the expiration or termination of this Agreement.
6.9. No Prejudice. Termination of this Agreement shall be without prejudice to any claim or right of action of either Party against the other Party for any prior breach of this Agreement.
6.10. Confidential Information. Upon termination of this Agreement, each Party and its Affiliates shall promptly return to the Disclosing Party or destroy any Confidential Information of the Disclosing Party (other than Clinical Data, Sample Testing Results and Inventions) furnished to the Receiving Party by the Disclosing Party; provided, however that the Receiving Party may retain one copy of such Confidential Information in its confidential files, solely for purposes of exercising the Receiving Partys rights hereunder, satisfying its obligations hereunder or complying with any legal proceeding or requirement with respect thereto, and provided further that the Receiving Party shall not be required to erase electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information so long as such electronic files are (a) maintained only on centralized storage servers (and not on personal computers or devices), (b) not accessible by any of its personnel (other than its information technology specialists), and (c) are not otherwise accessed subsequently except with the written consent of the Disclosing Party or as required by law or legal process. Such retained copies of Confidential Information shall remain subject to the confidentiality and non-use obligations herein.
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6.11. Manufacturing Costs. In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, ****.
7. Costs of Study.
The Parties agree that: **** in connection with the Study.
8. Supply and Use of the Compounds.
8.1. Supply of the Compounds. Subject to the terms and conditions of this Agreement, each of Company and Merck will use commercially reasonable efforts to supply, or cause to be supplied, the quantities of its respective Compound as are set forth in Appendix B, on the timelines set forth in Appendix B, in each case for use in the Study. If the Protocol is changed in accordance with Article 4 in such a manner that may affect the quantities of Compound to be provided or the timing for providing such quantities, the Parties shall amend Appendix B to reflect any changes required to be consistent with the Protocol. Each Party shall also provide to the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that a Party is: (a) not supplying its Compound in accordance with the terms of this Agreement, then the other Party shall have no obligation to supply its Compound; or (b) allocating under Section 8.9, then the other Party may allocate proportionally.
8.2. Clinical Quality Agreement. Within **** days after the Effective Date of this Agreement, but in any event before any supply of Merck Compound hereunder, the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in
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the Study (the Clinical Quality Agreement). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control. The Clinical Quality Agreement shall, among other things: (a) detail classification of any Compound found to have a Non-Conformance; (b) include criteria for Manufacturers Release and related certificates and documentation; (c) include criteria and timeframes for acceptance of Merck Compound; (d) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (e) include provisions governing the recall of Compounds.
8.3. Minimum Shelf Life Requirements. Each Party shall use commercially reasonable efforts to supply its Compound hereunder with an adequate remaining shelf life at the time of Delivery to meet the Study requirements.
8.4. Provision of Compounds.
8.4.1. Merck will deliver the Merck Compound **** (INCOTERMS 2010) to Companys, or its designees, location as specified by Company (Delivery with respect to such Merck Compound). ****.
8.4.2. Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Company Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Company Compound supplied hereunder. Company shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the Delivery of a given quantity of the Company Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
8.5. Labeling and Packaging; Use, Handling and Storage.
8.5.1. The Parties obligations with respect to the labeling and packaging of the Compounds are as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, Merck shall provide the Merck Compound to Company in the form of ****.
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8.5.2. Company shall: (a) use the Merck Compound solely for purposes of performing the Study; (b) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (c) label, use, store, transport, handle and dispose of the Merck Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all instructions of Merck. Company shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck Compound, and in particular shall not analyze the Merck Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.
8.6. Product Specifications. A certificate of analysis shall accompany each shipment of the Merck Compound to Company. Upon request, Company shall provide Merck with a certificate of analysis covering each shipment of Company Compound used in the Study.
8.7. Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site, provided that such changes shall be in accordance with the Clinical Quality Agreement.
8.8. Product Testing; Noncompliance.
8.8.1. After Manufacturers Release. After Manufacturers Release of the Merck Compound and concurrently with Delivery of the Compound to Company, Merck shall provide Company with such certificates and documentation as are described in the Clinical Quality Agreement (Disposition Package). Company shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company shall be solely responsible for taking all steps necessary to determine that Merck Compound or Company Compound, as applicable, is suitable for release before making such Merck Compound or Company Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the Merck Compound. Company shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Company shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Company hereunder.
8.8.2. Non-Conformance.
(a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.
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(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Company, then unless otherwise agreed to by the Parties, Merck shall, at its own expense, replace such Merck Compound as is found to have a Non- Conformance (with respect to Merck Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be ****. In the event Merck Compound is lost or damaged by Company after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to Company; provided that ****. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Company.
(c) Company shall be responsible for, and Merck shall have no obligation or liability with respect to, any Company Compound supplied hereunder that is found to have a Non-Conformance. Company shall, at its own expense, replace any Company Compound as is found to have a Non-Conformance (with respect to Company Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Merck with respect to any Company Compound that is found to have a Non- Conformance at the time of Delivery shall be ****; provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
8.8.3. Resolution of Discrepancies. Disagreements regarding any determination of Non-Conformance by Company shall be resolved in accordance with the provisions of the Clinical Quality Agreement.
8.9. Investigations. The process for investigations of any Non-Conformance shall be handled in accordance with the Clinical Quality Agreement.
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8.10. Shortage; Allocation. In the event that a Partys Compound is in short supply such that a Party reasonably believes in good faith that it will not be able to fulfill its supply obligations hereunder with respect to its Compound, such Party will provide prompt written notice to the other Party thereof (including the shipments of Compound hereunder expected to be impacted and the quantity of its Compound that such Party reasonably determines it will be able to supply) and the Parties will promptly discuss such situation (including how the quantity of Compound that such Party is able to supply hereunder will be allocated within the Study). In such event, the Party experiencing such shortage shall (i) use its commercially reasonable efforts to remedy the situation giving rise to such shortage and to take action to minimize the impact of the shortage on the Study, and (ii) ****.
8.11. Records; Audit Rights. Company shall keep complete and accurate records pertaining to its use and disposition of Merck Compound (including its storage, shipping (cold chain) and chain of custody activities) and, upon request of Merck, shall make such records open to review by Merck for the purpose of conducting investigations for the determination of Merck Compound safety and/or efficacy and Companys compliance with this Agreement with respect to the Merck Compound.
8.12. Quality. Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this Agreement.
8.13. Quality Control. Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound, and for validation, documentation and release of its Compound and such other quality assurance and quality control procedures as are required by the Specifications, cGMPs and the Clinical Quality Agreement.
8.14. Audits and Inspections. The Parties audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.
8.15. Recalls. Recalls of the Compounds shall be governed by the terms of the Clinical Quality Agreement.
8.16. VAT.
(a) It is understood and agreed between the Parties that any payments made and any other consideration given under this Agreement are each exclusive of any value added or similar tax (VAT), which shall be added thereon as applicable and at the relevant rate. Subject to Section 8.16(b), where VAT is properly charged by the supplying Party and added to a payment made or other consideration provided (as applicable) under this Agreement, the Party making the payment or providing the other consideration (as applicable) will pay the amount of VAT properly chargeable only on receipt of a valid tax invoice from the supplying Party issued in accordance with the laws and regulations of the country in which the VAT is chargeable. Each Party agrees that it shall provide to the other Party any information and copies of any documents within its Control to the extent reasonably requested by the other Party for the purposes of (i) determining the amount of VAT chargeable on any supply made under this Agreement, (ii) establishing the place of supply for VAT purposes, or (iii) complying with its VAT reporting or accounting obligations.
Confidential material omitted and filed separately with the Commission.
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(b) Where one Party or its Affiliate (the First Party) is treated as making supply of goods or services in a particular jurisdiction (for VAT purposes) for no consideration, and the other Party or its Affiliate (the Second Party) is treated as receiving such supply in the same jurisdiction, thus resulting in an amount of VAT being properly chargeable on such supply, the Second Party shall only be obliged to pay to the First Party the amount of VAT properly chargeable on such supply (and no other amount). The Second Party shall pay such VAT to the First Party on receipt of a valid VAT invoice from the First Party (issued in accordance with the laws and regulations of the jurisdiction in which the VAT is properly chargeable). Each Party agrees to (i) use its reasonable efforts to determine and agree the value of the supply that has been made and, as a result, the corresponding amount of VAT that is properly chargeable and (ii) provide to the other Party any information or copies of documents in its Control as are reasonably necessary to evidence that such supply will take, or has taken, place in the same jurisdiction (for VAT purposes).
9. Confidentiality.
9.1. Confidential Information. Subject to Section 13.4.8, Company and Merck agree to hold in confidence any Confidential Information provided by or on behalf of the other Party, and neither Party shall use Confidential Information of the other Party except to fulfill such Partys obligations under this Agreement or exercising its rights. Without limiting the foregoing, the Receiving Party may not, without the prior written permission of the Disclosing Party, disclose any Confidential Information of the Disclosing Party to any Third Party except to the extent disclosure (i) is required by Applicable Law; (ii) is pursuant to the terms of this Agreement; or (iii) is necessary for the conduct of the Study, and in each case ((i) through (iii)) provided that the Receiving Party shall provide reasonable advance notice to the Disclosing Party before making such disclosure. For the avoidance of doubt, Company may, without Mercks consent, disclose Confidential Information to clinical trial sites and clinical trial investigators performing the Study, the data safety monitoring and advisory board relating to the Study, and Regulatory Authorities working with Company on the Study, in each case to the extent necessary for the performance of the Study and provided that such Persons (other than governmental entities) are bound by an obligation of confidentiality at least as stringent as the obligations contained herein.
9.2. Inventions. ****.
9.3. Personal Identifiable Data. All Confidential Information containing personal identifiable data shall be handled in accordance with all data protection and privacy laws, rules and regulations applicable to such data.
Confidential material omitted and filed separately with the Commission.
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10. | Intellectual Property. |
10.1. Joint Ownership and Prosecution.
10.1.1. All rights to all Inventions relating to, or covering, **** (each a Jointly Owned Invention) shall be owned jointly by Company and Merck. Merck hereby assigns to Company an undivided one-half interest in, to and under the Jointly Owned Inventions that are invented or created solely by Merck or by Persons having an obligation to assign such rights to Merck. Company hereby assigns to Merck an undivided one- half interest in, to and under any Jointly Owned Inventions that are invented or created solely by Company or by Persons having an obligation to assign such rights to Company. For those countries where a specific license is required for a joint owner of a Jointly Owned Invention to practice such Jointly Owned Invention in such countries: (a) Merck hereby grants to Company a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Mercks right, title and interest in and to all Jointly Owned Inventions to use such Inventions in accordance with the terms of this Agreement; and (b) Company hereby grants to Merck a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Companys right, title and interest in and to all Jointly Owned Inventions to use such Inventions in accordance with the terms of this Agreement. For clarity, the terms of this Agreement do not provide Company or Merck with any rights, title or interest or any license to the other Partys intellectual property except as necessary to conduct the Study and as expressly provided under this Agreement, including as set forth in Section 10.4.
10.1.2. Each Party shall have the right to freely exploit each Jointly Owned Invention both within and outside the scope of the Study, without accounting to or any other obligation to the other Party; provided, however, that Merck may not ****, and Company may not ****.
10.1.3. Promptly following the Effective Date, but in any event as soon as practicable after the discovery of a Jointly Owned Invention, patent representatives of each of the Parties shall meet (in person or by telephone) to discuss the patenting strategy for any Jointly Owned Inventions that may arise. In particular, the Parties shall discuss which Party will file and prosecute a patent application (including any provisional, substitution, divisional, continuation, continuation in part, reissue, renewal, reexamination, extension, supplementary protection certificate and the like) in respect of any Jointly Owned Invention (each, a Joint Patent Application) and whether the Parties wish to appoint counsel that is mutually acceptable to the Parties. In any event, the Parties shall consult and reasonably cooperate with one another in the preparation, filing, prosecution (including prosecution strategy) and maintenance of such patent application and shall equally share the expenses associated with the Joint Patent Applications and any corresponding Joint Patents. In the event that one Party (the Filing Party) wishes to file a patent application for a Jointly Owned Invention and the other Party (the Non-Filing
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Party) does not want to file a patent application for such Jointly Owned Invention or does not want to file in a particular country, the Non-Filing Party shall execute in a timely manner and at the Filing Partys reasonable expense an assignment of such Jointly Owned Invention to the Filing Party (in such country or all countries, as applicable) and any additional documents as may be reasonably necessary to allow the Filing Party to file and prosecute such patent application. If a Party (the Opting-out Party) wishes to discontinue the prosecution and maintenance (or sharing in the costs with respect thereto) of a Joint Patent Application or Joint Patent (in one or more countries), the other Party, at its sole option (the Continuing Party), may continue such prosecution and maintenance. In such event, the Opting-out Party shall execute in a timely manner and at the Continuing Partys reasonable expense an assignment of such Joint Patent Application or Joint Patent to the Continuing Party (in such country or all countries, as applicable) and any additional documents as may be necessary to allow the Continuing Party to prosecute and maintain such Joint Patent Application or Joint Patent. Any Jointly Owned Invention, Joint Patent Application or Joint Patent so assigned shall thereafter be owned solely by the Continuing Party or Filing Party (as applicable), shall no longer be considered jointly owned, and the Non-Filing Party or Opting-out Party (as applicable) shall have no right to practice under such Joint Patent Application or Joint Patent in the applicable country or countries.
10.1.4. Except as expressly provided in Section 10.1.3 and in furtherance and not in limitation of Section 9.1, each Party agrees to make no patent application based on the other Partys Confidential Information, and to give no assistance to any Third Party for such application, without the other Partys prior written authorization.
10.1.5. Company shall have the first right to initiate legal action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from misappropriation by any Third Party, where **** or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that Company fails to initiate or defend such action within thirty (30) days after being first notified of such infringement, Merck shall have the right to do so at its sole expense. Merck shall have the first right to initiate legal action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from misappropriation by any Third Party, where **** or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that Merck fails to initiate or defend such action within thirty (30) days after being first notified of such infringement, Company shall have the right to do so at its sole expense. The Parties shall cooperate in good faith to coordinate legal action to enforce all Joint Patents against infringement, and to protect all Jointly Owned Inventions from misappropriation, by any Third Party where **** or to defend any declaratory judgment action relating thereto, and shall share the costs and expenses of such litigation equally.
10.1.6. ****.
10.2. Inventions Owned by Company. Notwithstanding anything to the contrary contained in Section 10.1, the Parties agree that all rights to Inventions relating ****, or covering ****, ****, regardless of whether such Invention or improvement was invented solely by Company or Merck or jointly by the Parties, are the exclusive property of Company (Company Inventions). Company shall be entitled to file and prosecute in its own name relevant patent applications and to own resultant patent rights for any Company Invention. For the avoidance of doubt, any Invention ****, is a Company Invention. Merck hereby assigns its right, title and interest to any and all Company Inventions to Company.
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10.3. Inventions Owned by Merck. Notwithstanding anything to the contrary contained in Section 10.1, the Parties agree that all rights to Inventions relating ****, or covering ****, ****, regardless of whether such Invention or improvement was invented solely by Merck or Company or jointly by the Parties, are the exclusive property of Merck (Merck Inventions). Merck shall be entitled to file and prosecute in its own name relevant patent applications and to own resultant patent rights for any Merck Invention. For the avoidance of doubt, any Invention ****, even where the ****, is a Merck Invention. Company hereby assigns its right, title and interest to any and all Merck Inventions to Merck.
10.4. Mutual Freedom to Operate for Combination Inventions.
10.4.1. Company License to Merck. Company hereby grants to Merck a non- exclusive, worldwide, royalty-free, fully paid-up, transferable and sublicensable license to any patent Controlled by Company that **** (the Company Background Patents) solely for ****; provided, however, that in no event shall Merck have the right to exploit Company Background Patents to sell the Company Compound or any Company Class Compound, either alone or as part of a combination (including the Combination).
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10.4.2. Merck License to Company. Merck hereby grants to Company a non- exclusive, worldwide, royalty-free, fully paid-up, transferable and sublicensable license to any patent Controlled by Merck that **** (the Merck Background Patents) solely for ****; provided, however, that in no event shall Company have the right to exploit Merck Background Patents to sell the Merck Compound or any PD-1 Antagonist, either alone or as part of a combination (including the Combination).
10.4.3. No Other Rights. For clarity, the terms of this Section 10.4 do not provide Merck or Company with any rights, title or interest or any license to the other Partys intellectual property rights which ****.
10.4.4. Termination. Any and all licenses granted under this Section 10.4 shall ****.
10.5. Ownership of Other Inventions. ****.
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11. | Reprints; Rights of Cross-Reference. |
Consistent with applicable copyright and other laws, each Party may use, refer to, and disseminate reprints of scientific, medical and other published articles and materials from journals, conferences and/or symposia relating to the Study that disclose the name of a Party, provided, however, that such use does not constitute an endorsement of any commercial product or service by the other Party.
12. | Publications; Press Releases. |
12.1. Clinical Trial Registry. Company shall register the Study with the Clinical Trials Registry located at www.clinicaltrials.gov and is committed to timely publication of the results following Study Completion, after taking appropriate action to secure intellectual property rights (if any) arising from the Study. The publication of the results of the Study will be in accordance with the Protocol.
12.2. Publication. Each Party shall use reasonable efforts to publish or present scientific papers dealing with the Study in accordance with accepted scientific practice. The Parties agree that prior to submission of the results of the Study for publication or presentation or any other dissemination of such results including oral dissemination, the publishing Party shall invite the other to comment on the content of the material to be published, presented, or otherwise disseminated according to the following procedure:
12.2.1. At least **** days prior to submission for publication of any paper, letter or any other publication, or **** days prior to submission for presentation of any abstract, poster, talk or any other presentation, the publishing Party shall provide to the other Party the full details of the proposed publication, presentation, or dissemination in an electronic version (cd-rom or email attachment). Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation/dissemination for an additional **** days in order to allow for actions to be taken to preserve rights for patent protection.
12.2.2. The publishing Party shall give reasonable consideration to any request by the other Party made within the periods mentioned in Section 12.2.1 to modify the publication and the Parties shall work in good faith and in a timely manner to resolve any issue regarding the content for publication.
12.2.3. The publishing Party shall remove all Confidential Information of the other Party before finalizing the publication.
12.3. Press Releases. Within **** days following the Effective Date, Company will issue a press release substantially in the form attached hereto as Appendix C. Unless otherwise required by Applicable Law, neither Party shall make any other public announcement concerning this Agreement without the prior written consent of the other Party. To the extent a Party desires to make such public announcement, such Party shall provide the other Party with a draft thereof at least **** Business Days prior to the date on which such Party would like to make the public announcement. Notwithstanding any language in this Agreement to the contrary, nothing in this Agreement shall prohibit either Party from making disclosure related this Agreement or the Study to the extent such disclosure is required by Applicable Law or applicable stock exchange listing rules, provided that the disclosing Party provides reasonable advance notice to the other Party prior to making such disclosure and, at the request of such other Party, cooperates with such other Party in limiting the scope of such disclosure.
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13. | Representations and Warranties; Disclaimers. |
13.1. Due Authorization. Each of Company and Merck represents and warrants to the other that: (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) this Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.
13.2. Compounds.
13.2.1. Company Compound. Company hereby represents and warrants to Merck that: (a) Company has the full right, power and authority to grant all of the licenses granted to Merck under this Agreement; and (b) Company Controls the Company Compound.
13.2.2. Merck Compound. Merck hereby represents and warrants to Company that: (a) Merck has the full right, power and authority to grant all of the licenses granted to Company under this Agreement; and (b) Merck Controls the Merck Compound.
13.3. Results. Company does not undertake that the Study shall lead to any particular result, nor is the success of the Study guaranteed. Neither Party shall be liable for any use that the other Party may make of the Clinical Data nor for advice or information given in connection therewith.
13.4. Anti-Corruption.
13.4.1. In performing their respective obligations hereunder, the Parties acknowledge that the corporate policies of Company and Merck and their respective Affiliates require that each Partys business be conducted within the letter and spirit of the law. By signing this Agreement, each Party agrees to conduct the business contemplated herein in a manner that is consistent with all Applicable Law, including the Stark Act, Anti-Kickback Statute, Sunshine Act, and the U.S. Foreign Corrupt Practices Act, good business ethics, and its ethics and other corporate policies and agrees to abide by the spirit of the other Partys guidelines, which may be provided by such other Party from time to time.
13.4.2. Specifically, each Party represents and warrants that it has not, and covenants that it, its Affiliates, and its and its Affiliates directors, employees, officers, and anyone acting on its behalf, will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.
Confidential material omitted and filed separately with the Commission.
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13.4.3. Neither Party shall contact, or otherwise knowingly meet with, any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement, without the prior written approval of the other Party, except where such meeting is consistent with the purpose and terms of this Agreement and in compliance with Applicable Law.
13.4.4. Each Party represents and warrants that it (a) is not excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs; and (b) has not employed or subcontracted with any Person for the performance of the Study who is excluded, debarred, suspended, proposed for suspension or debarment, or is in Violation or otherwise ineligible for government programs.
13.4.5. Each Party represents and warrants that, except as disclosed to the other in writing prior to the Effective Date, such Party: (a) does not have any interest that directly or indirectly conflicts with its proper and ethical performance of this Agreement; (b) shall maintain arms length relations with all Third Parties with which it deals for or on behalf of the other in performance of this Agreement; and (c) has provided complete and accurate information and documentation to the other Party, the other Partys Affiliates and its and their personnel in the course of any due diligence conducted by the other Party for this Agreement, including disclosure of any officers, employees, owners or Persons directly or indirectly retained by such Party in relation to the performance of this Agreement who are Government Officials or relatives of Government Officials. Each Party shall make all further disclosures to the other Party as are necessary to ensure the information provided remains complete and accurate throughout the Term. Subject to the foregoing, each Party agrees that it shall not hire or retain any Government Official to assist in its performance of this Agreement, with the sole exception of conduct of or participation in clinical trials under this Agreement, provided that such hiring or retention shall be subject to the completion by the hiring or retaining Party of a satisfactory anti-corruption and bribery (e.g., FCPA) due diligence review of such Government Official. Each Party further covenants that any future information and documentation submitted to the other Party as part of further due diligence or a certification shall be complete and accurate.
13.4.6. Each Party shall have the right during the Term, and for a period of two (2) years following termination of this Agreement, to conduct an investigation and audit of the other Partys activities, books and records, to the extent they relate to that other Partys performance under this Agreement, to verify compliance with the terms of this Section 13.4. Such other Party shall cooperate fully with such investigation or audit, the scope, method, nature and duration of which shall be at the sole reasonable discretion of the Party requesting such audit.
13.4.7. Each Party shall use commercially reasonable efforts to ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in all material respects. Each Party further represents, warrants and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures. Each Party shall maintain a system of internal accounting controls reasonably designed to ensure that no off-the-books or similar funds or accounts will be maintained or used in connection with this Agreement.
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13.4.8. Each Party agrees that in the event that the other Party believes in good faith that there has been a possible violation of any provision of Section 13.4, such other Party may make full disclosure of such belief and related information needed to support such belief at any time and for any reason to any competent government bodies and agencies, and to anyone else such Party determines in good faith has a legitimate need to know.
13.4.9. Each Party shall comply with its own ethical business practices policy and any corporate integrity agreement (if applicable) to which it is subject, and shall conduct its Study-related activities in accordance with Applicable Law. Each Party shall ensure that all of its employees involved in performing its obligations under this Agreement are made specifically aware of the compliance requirements under this Section 13.4. In addition, each Party shall ensure that all such employees participate in and complete mandatory compliance training to be conducted by each Party, including specific training on anti-bribery and corruption, prior to his/her performance of any obligations or activities under this Agreement. Each Party shall certify its continuing compliance with the requirements under this Section 13.4 on a periodic basis during the Term in such form as may be reasonably specified by the other Party.
13.4.10. Each Party shall have the right to terminate this Agreement immediately upon violation of this Section 13.4 in accordance with Section 6.6.
13.5. DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN, MERCK MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE MERCK COMPOUND, AND COMPANY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE COMPANY COMPOUND.
14. | Insurance; Indemnification; Limitation of Liability. |
14.1. Insurance. Each Party warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification obligations assumed herein. Upon request, a Party shall provide evidence of such insurance.
14.2. Indemnification.
14.2.1. Indemnification by Company. Company agrees to ****.
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14.2.2. Indemnification by Merck. Merck agrees to ****.
14.2.3. Procedure. The obligations of Merck and Company under this Section 14.2 are conditioned upon the delivery of written notice to Merck or Company, as the case might be, of any potential Liability within a reasonable time after a Party becomes aware of such potential Liability. The indemnifying Party will have the right to assume the defense of any suit or claim related to the Liability (using counsel reasonably satisfactory to the indemnified Party) if it has assumed responsibility for the suit or claim in writing; provided that the indemnified Party may assume the responsibility for such defense to the extent the indemnifying Party does not do so in a timely manner). The indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. The Party controlling such defense (the Defending Party) shall keep the other Party (the Other Party) advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the Other Party with respect thereto. The Defending Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Other Party, which shall not be unreasonably withheld. The Defending Party, but solely to the extent the Defending Party is also the indemnifying Party, shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Other Party from all liability with respect thereto or that imposes any liability or obligation on the Other Party without the prior written consent of the Other Party.
14.2.4. Study Subjects. Company shall not offer compensation on behalf of Merck to any Study subject or bind Merck to any indemnification obligations in favor of any Study subject. Merck shall not offer compensation on behalf of Company to any Study subject or bind Company to any indemnification obligations in favor of any Study subject.
14.3. LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY UNDER ANY THEORY FOR, NOR SHALL ANY INDEMNIFIED PARTY HAVE THE RIGHT TO RECOVER, ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES OR ANY PUNITIVE DAMAGES OR ANY LOST PROFIT, LOST SALE OR LOST OPPORTUNITY DAMAGES (WHETHER SUCH CLAIMED DAMAGES ARE DIRECT OR INDIRECT), WHETHER ARISING DIRECTLY OR INDIRECTLY OUT OF (A) THE MANUFACTURE OR USE OF ANY COMPOUND SUPPLIED HEREUNDER OR (B) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT OR ANY REPRESENTATION, WARRANTY OR COVENANT CONTAINED IN OR MADE PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION SHALL NOT APPLY (I) TO DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER OR (II) WITH RESPECT TO DAMAGES ARISING OUT OF OR RELATED TO A PARTYS BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO USE, DISCLOSURE, LICENSE, ASSIGNMENT OR OTHER TRANSFER OF CLINICAL DATA, CONFIDENTIAL INFORMATION, JOINTLY- OWNED INVENTIONS AND SAMPLE TESTING RESULTS.
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15. | Use of Name. |
Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other trade name, trademark or logo of the other Party for any purpose in connection with the performance of this Agreement without the other Partys prior written consent.
16. | Force Majeure. |
If, in the performance of this Agreement, one of the Parties is prevented, hindered or delayed by reason of any cause beyond such Partys reasonable control (e.g., war, riots, fire, strike, acts of terror, governmental laws), such Party shall be excused from performance to the extent that it is necessarily prevented, hindered or delayed (Force Majeure). The non- performing Party shall notify the other Party of such Force Majeure within **** days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance will be of no greater scope and no longer duration than is necessary and the non- performing Party shall use commercially reasonable efforts to remedy its inability to perform.
17. | Entire Agreement; Amendment; Waiver. |
This Agreement, together with the Appendices and Schedules hereto and the Related Agreements, constitutes the sole, full and complete agreement by and between the Parties with respect to the subject matter of this Agreement, and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded by this Agreement. In the event of a conflict between a Related Agreement and this Agreement, the terms of this Agreement shall control. No amendments, changes, additions, deletions or modifications to or of this Agreement shall be valid unless reduced to writing and signed by the Parties hereto. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
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18. | Assignment and Affiliates. |
Neither Party shall assign or transfer this Agreement without the prior written consent of the other Party; provided, however, that either Party may assign all or any part of this Agreement to one or more of its Affiliates without the other Partys consent, and any and all rights and obligations of either Party may be exercised or performed by its Affiliates, provided that such Affiliates agree to be bound by this Agreement.
19. | Invalid Provision. |
If any provision of this Agreement is held to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision. In lieu of the illegal, invalid or unenforceable provision, the Parties shall negotiate in good faith to agree upon a reasonable provision that is legal, valid and enforceable to carry out as nearly as practicable the original intention of the entire Agreement.
20. | No Additional Obligations. |
Company and Merck have no obligation to renew this Agreement or apply this Agreement to any clinical trial other than the Study. Nothing in this Agreement obligates the Parties to enter into any other agreement (other than the Related Agreements) at this time or in the future.
21. | Governing Law; Dispute Resolution. |
21.1. The Parties shall attempt in good faith to settle all disputes arising out of or in connection with this Agreement in an amicable manner. Any claim, dispute or controversy arising out of or relating to this Agreement, including the breach, termination or validity hereof or thereof, shall be governed by and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law principles.
21.2. Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties.
22. | Notices. |
All notices or other communications that are required or permitted hereunder shall be in writing and delivered personally, sent by facsimile (and promptly confirmed by personal delivery or overnight courier), or sent by internationally-recognized overnight courier addressed as follows:
If to Company, to: Immutep Limited
Attention: ****
Level 12
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95 Pitt Street
Sydney, NSW, Australia 2000
With a copy (which shall not constitute notice) to:
****
If to Merck, to:
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands Attention:
Director
****
-and-
****
With copies (which shall not constitute notice) to:
****
****
****
23. | Relationship of the Parties. |
The relationship between the Parties is and shall be that of independent contractors, and does not and shall not constitute a partnership, joint venture, agency or fiduciary relationship. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or take any actions, that are binding on the other Party, except with the prior written consent of the other Party to do so. All Persons employed by a Party will be the employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
24. | Counterparts and Due Execution. |
This Agreement and any amendment may be executed in any number of counterparts (including by way of facsimile or electronic transmission), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or printers. When executed by the Parties, this Agreement shall constitute an original instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or printers. For clarity, facsimile signatures and signatures transmitted via PDF shall be treated as original signatures.
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25. | Construction. |
Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders, and the word or is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including as used herein shall be deemed to be followed by the phrase without limitation or like expression. The term will as used herein means shall. The terms hereof, hereto, herein and hereunder and words of similar import when used in this Agreement refer to this Agreement as a whole and no to any particular provision of this Agreement. References to Article, Section, Appendix or Schedule are references to the numbered sections of this Agreement and the appendices attached to this Agreement, unless expressly stated otherwise. Except where the context otherwise requires, references to this Agreement shall include the appendices attached to this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction will be applied against either Party hereto.
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IN WITNESS WHEREOF, the respective representatives of the Parties have executed this Agreement as of the Effective Date.
Immutep Limited | ||
By: |
| |
| ||
Name | ||
| ||
Title | ||
Merck Sharp & Dohme B.V. | ||
By: |
| |
| ||
Name | ||
| ||
Title | ||
MSD International GmbH | ||
By: |
| |
| ||
Name | ||
| ||
Title |
Appendix A
PROTOCOL SUMMARY
2017-11-20
TACTI-basket synops
IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
Clinical Trial Protocol
Study title: |
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Sponsor: |
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Protocol No. |
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Protocol date: |
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STATEMENT OF CONFIDENTIALITY
This document contains scientific and commercial information proprietary to Prima BioMed that is privileged or confidential and is intended solely for the purpose of this clinical investigation. It should be kept secure and its contents should not be disclosed to any third party without the prior written consent of Prima BioMed.
Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
STUDY TITLE
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SPONSOR
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COUNTRIES
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STUDY RATIONALE
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
STUDY OBJECTIVES
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
STUDY ENDPOINTS
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STUDY DESIGN
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
STUDY POPULATION
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
INVESTIGATIONAL PRODUCT, DOSE AND MODE OF ADMINISTRATION
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DURATION OF THE STUDY
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STATISTICAL ANALYSIS
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
Table 1: Schedule of Assessments (Part A + Part B + Part C)
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Confidential material omitted and filed separately with the Commission.
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IMP321-P015 Clinical Trial Protocol Synopsis 20th November 2017 (Version 1.1) |
CONFIDENTIAL AND PROPRIETARY Prima BioMed |
List of Footnotes
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Confidential material omitted and filed separately with the Commission.
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Appendix B
SUPPLY OF COMPOUND1
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Appendix C
INITIAL PRESS RELEASE
MSD FINAL
20180306 Immutep -
ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP)
[ ] March 2018
IMMUTEP ENTERS INTO CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT WITH MSD
SYDNEY, AUSTRALIA - Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company) has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Immuteps lead immunotherapy product candidate eftilagimod alpha (efti or IMP321) with MSDs anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a new clinical trial that will evaluate the combination in several different solid tumours.
The planned Phase II clinical trial, referred to as TACTI-002 (Two ACTive Immunotherapies), will evaluate the safety and efficacy of this novel immunotherapy combination in patients with non-small cell lung cancer (NSCLC), head and neck cancer, or ovarian cancer. The TACTI-002 clinical trial will be a Phase II, Simon two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Up to 120 patients across the three indications are planned to be treated in medical centres in Europe and the United States with the trial expected to commence in the second half of 2018.
We are extremely pleased to be collaborating with MSD, one of the worlds leading immuno-oncology companies said Marc Voigt, CEO of Immutep. This clinical trial will evaluate a novel combination of two complementary immuno-oncology treatments in three cancer indications simultaneously, which could lead to more rapid drug development subject to successful outcomes. The data generated thus far from our ongoing TACTI-mel clinical trial has supported our hypothesis that there is a compelling therapeutic synergy in administering efti in combination with another immuno-oncology treatment. This new Phase II clinical trial significantly builds on the momentum we are delivering in the evaluation of efti in cancer, with two Phase I clinical trials and now two Phase II clinical trials in our program for 2018.
The trial combines two immuno-oncology treatments with complementary mechanisms of action, analogous to releasing the brakes and pushing the accelerator of the bodys immune system at two different positions in the cancer immunity cycle. Immuteps efti is a first-in-class antigen presenting cell (APC) activator which stimulates cancer-fighting T cells, while KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells.
About Immutep
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.
Immuteps current lead product is eftilagimod alpha (efti or IMP321), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Eftilagimod alpha, alone or in combination with other therapeutics, has completed early Phase II trials as an APC activator boosting T cell responses for cancer chemo-immunotherapy. Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immuteps large pharmaceutical partners.
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Immutep is listed on the Australian Stock Exchange (IMM), and on the NASDAQ (IMMP) in the U.S.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
For further information please visit www.immutep.com or contact:
U.S. Investors:
Jay Campbell, Vice President of Business Development and Investor Relations, Immutep Limited
+1 (917) 860-9404; [email protected]
Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS
+61 2 8234 0105; [email protected]
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Schedule I
DATA SHARING AND SAMPLE TESTING SCHEDULE
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Exhibit 12.1
Certification of the Chief Executive Officer and Chief Financial Officer as required by
Rule 13a-14(a) of the Securities Exchange Act of 1934
I, Marc Voigt, certify that:
1. | I have reviewed this annual report on Form 20-F of Immutep Limited; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
4. | I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the companys disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the companys internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the companys internal control over financial reporting; and |
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5. | I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the companys auditors and the audit committee of the companys board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the companys ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the companys internal control over financial reporting. |
Date: October 19, 2018
/s/ Marc Voigt |
Marc Voigt |
Chief Executive Officer |
Chief Financial Officer |
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Exhibit 13.1
Certification of the Chief Executive Officer and Chief Financial Officer as required by
Rule 13a-14(b) of the Securities Exchange Act of 1934
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Marc Voigt, Chief Executive Officer and Chief Financial Officer of Immutep Limited (the Company), hereby certifies that, to the best of his knowledge:
1. | The Companys Annual Report on Form 20-F for the period ended June 30, 2018, to which this Certification is attached as Exhibit 13.1 (the Annual Report), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
2. | The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: October 19, 2018
/s/ Marc Voigt |
Marc Voigt |
Chief Executive Officer |
Chief Financial Officer |
This certification accompanies the Form 20-F to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Immutep Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 20-F), irrespective of any general incorporation language contained in such filing.
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 15.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form F-3 (No. 333-211702 and 333-221021) of Immutep Limited (previously known as Prima BioMed Ltd) of our report dated October 19, 2018 relating to the financial statements, which appears in this Form 20-F.
/s/ PricewaterhouseCoopers
Sydney, Australia
October 19, 2018
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