Form 8-K EXICURE, INC. For: Aug 15
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E-mailUNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 8-K
____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 15, 2022
____________________
(Exact name of Registrant as specified in its charter)
____________________
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of principal executive offices)
Registrant’s telephone number, including area code: (847 ) 673-1700
____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, 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. x
Item 2.02 Results of Operations and Financial Condition.
On August 15, 2022, Exicure, Inc. (the “Company”) issued a press release announcing its financial and operational results for the quarter ended June 30, 2022. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 2.02 in the Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 15, 2022 | EXICURE, INC. | |||||||
| By: | /s/ Elias D. Papadimas | |||||||
| Elias D. Papadimas | ||||||||
| Chief Financial Officer | ||||||||
| Exhibit 99.1 | |||||
 | |||||
Exicure, Inc. Reports Second Quarter 2022 Financial Results and Corporate Progress
Company advancing SCN9A preclinical discovery program
CHICAGO, IL. — August 15, 2022 — Exicure, Inc. (Nasdaq: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological and hair loss disorders, today reported financial results for the quarter ended June 30, 2022 and provided an update on its business strategy and corporate progress.
“Exicure continues to make progress with our preclinical SCN9A program for the treatment of pain with ongoing initial in vivo animal studies to support candidate selection in 2023,” commented Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. “We also continue to advance our partnered programs with Ipsen and AbbVie,” concluded Dr. Schroff.
Corporate Progress
Corporate highlights for the second quarter of 2022 include:
•We advanced the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022, with the goal of therapeutic candidate selection in the second half of 2023.
•We progressed work with partnered programs towards potential pre-clinical milestones in 2023.
•We actively pursued out-license opportunities for the Company’s clinical asset, cavrotolimod.
•We are continuing to pursue near-term partnering opportunities for pain and other neuroscience programs.
•On June 28, 2022, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect a one-for-thirty (1-for-30) reverse stock split of our outstanding common stock. The Amendment became effective at 5:00 p.m. Eastern Time on June 29, 2022.
◦At the effective time of the Amendment, every thirty (30) shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock, without any change in par value per share. No fractional shares of the Company’s common stock was issued to any stockholders in connection with the reverse stock split and holders of record received a cash payment in lieu of fractional shares.
◦Our common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on Thursday, June 30, 2022. The new CUSIP number for our common stock following the reverse stock split is 30205M 200.
•On May 18, 2022, we closed the previously announced $5 million private placement transaction priced at market premium.
◦We sold an aggregate of 867,369 shares of the Company’s common stock to certain accredited investors in a private placement in public equity (“PIPE”) financing at a
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purchase price of $5.81 per share, representing an approximately 45% premium to the 10-day volume weighted-average share price from May 9, 2022.
◦New investor CBI USA, Inc. led the transaction; existing investor, Abingworth LLP, also participated.
◦Net proceeds from the transaction are expected to support the Company’s advancement of its preclinical program, including the development of its SCN9A product candidate, as well as other working capital and general corporate purposes.
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and short-term investments, and restricted cash were $23.4 million as of June 30, 2022, as compared to $48.3 million as of December 31, 2021. The Company expects that its existing cash and cash equivalents, and short-term investments will enable it to fund its current operations early into the first quarter of 2023.
Revenue: Revenue was $2.5 million for the quarter ended June 30, 2022, reflecting an increase of $2.4 million from revenue of $0.1 million for the quarter ended June 30, 2021. The increase in revenue of $2.4 million is mostly due to the recognition of non-cash revenue of $1.8 million associated with the Company’s collaboration with Ipsen Biopharm Limited, as well as an increase in revenue of $0.6 million associated with the Company’s collaboration with AbbVie Inc.
Research and Development (R&D) Expense: Research and development expenses were $6.7 million for the quarter ended June 30, 2022, as compared to $10.8 million for the quarter ended June 30, 2021. The decrease in R&D expense for the three months ended June 30, 2022 of approximately $4.1 million reflects a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021.
General and Administrative (G&A) Expense: General and administrative expenses were $3.2 million for the quarter ended June 30, 2022, as compared to $3.1 million for the quarter ended June 30, 2021. The increase in G&A expense of approximately $0.1 million for the three months ended June 30, 2022 was mostly due to higher legal costs and retention award expense for current employees, partially offset by lower compensation and related costs in connection with a lower average headcount during the period resulting from the restructuring activities that were announced in December 2021, as well as lower costs for consulting, investor relations, and board fees.
Net Loss: The Company had a net loss of $7.5 million for the quarter ended June 30, 2022, as compared to a net loss of $14.3 million for the quarter ended June 30, 2021. The decrease in net loss was primarily driven by lower R&D expense and higher non-cash revenue during the period.
Going Concern: Given the Company’s current cash position, operating plans and forecasted negative cash flows from operating activities over the next twelve months, management believes there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that its unaudited condensed consolidated financial statements for the quarter ended June 30, 2022 are issued. The Company will require substantial additional financing to address the Company’s working capital and other financing needs to pursue its business strategy.
About Exicure
Exicure, Inc. is an early-stage biotechnology company developing nucleic acid therapies targeting ribonucleic acid against validated targets to neurological disorders and hair loss. The team includes a diverse scientific group with expertise in nucleic acid chemistry, drug development and neuroscience.
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Headquartered in Chicago, Illinois, the Company conducts its discovery and development efforts in-house with a dedicated 30,000 square foot facility, including rapid and automated high throughput nucleic acid synthesis and screening. For further information, see www.exicuretx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact may be deemed forward looking including, but not limited to: statements regarding the Company’s current business plans and objectives; the Company’s ability to continue to meet stock exchange listing standards; the use of proceeds of the PIPE; the substantial doubt about the Company’s ability to continue as a going concern; the Company’s requirements for substantial additional financing to address the Company’s working capital and other financing needs; the Company’s anticipated cash runway; the Company’s ability to continue to advance its strategic partnerships and the potential achievement of any clinical trial milestones pursuant to such license and collaboration agreements; the continuation of pre-clinical discovery of potential therapeutic candidates and the ability to develop, and possibly partner, product candidates for the treatment of neurological conditions; the timing and development of the Company’s preclinical pipeline and achievement of expected near- and long-term milestones, including timing of results from initial in vivo animal studies and planned therapeutic candidate selection; the potential advantages and clinical benefit of the Company’s SNA platform and advancement of SCN9A preclinical discovery; the future prospects of the Company, including of the outlicensing of its cavrotolimod program. Words such as “plans,” “expects,” “will,” “anticipates,” “continue,” “advance,” “believes,” “target,” “may,” “intend,” “could,” and other words and terms of similar meaning and expression are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. Forward-looking statements are based on management’s current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: market and other conditions; the Company’s ability to adequately finance its business and seek alternative sources of financing; the risks that the ongoing COVID-19 pandemic may disrupt the Company’s business and/or the global healthcare system (including its supply chain) more severely than it has to date or more severely than anticipated; unexpected costs, charges or expenses that reduce the Company’s capital resources; the unproven approach of the Company’s SNA platform; the Company’s preclinical programs do not advance into clinical or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many drug candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; regulatory developments; the ability of the Company to obtain or maintain its existing or future collaborations, licenses or contractual relationships and/or collaborate successfully with strategic partners; regulatory developments; exposure to litigation, including patent litigation, and/or regulatory actions; the ability of the Company to protect its intellectual property rights; the ability of the Company to comply with continued listing standards; and the impact of the completion of the Company’s previously reported internal investigation on the Company’s business and diversion of management time and attention on related issues, including any related investigations or proceedings, shareholder lawsuits, reputational harm, or the possibility that executives or other employees may resign. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 25, 2022,
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as updated by the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information or to publicly announce the results of any revisions to any of such statements to reflect future events or developments, except as required by law.
Media Contact:
Karen Sharma
MacDougall
781-235-3060
ksharma@macdougall.bio
###
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EXICURE, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2022 | December 31, 2021 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 21,198 | $ | 34,644 | |||||||
| Short-term investments | 997 | 4,497 | |||||||||
| Prepaid expenses and other assets | 2,526 | 4,525 | |||||||||
| Total current assets | 24,721 | 43,666 | |||||||||
| Property and equipment, net | 3,325 | 3,927 | |||||||||
| Right-of-use asset | 7,609 | 7,950 | |||||||||
| Other noncurrent assets | 1,300 | 9,325 | |||||||||
| Total assets | $ | 36,955 | $ | 64,868 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Current portion of long-term debt | $ | — | $ | 6,873 | |||||||
| Accounts payable | 1,593 | 3,413 | |||||||||
| Accrued expenses and other current liabilities | 3,308 | 6,464 | |||||||||
| Deferred revenue, current | 14,755 | 17,317 | |||||||||
| Total current liabilities | 19,656 | 34,067 | |||||||||
| Deferred revenue, noncurrent | 9,035 | 11,509 | |||||||||
| Lease liability, noncurrent | 7,101 | 7,404 | |||||||||
| Other noncurrent liabilities | — | 656 | |||||||||
| Total liabilities | $ | 35,792 | $ | 53,636 | |||||||
| Stockholders’ equity: | |||||||||||
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized, no shares issued and outstanding, June 30, 2022 and December 31, 2021 | — | — | |||||||||
Common stock, $0.0001 par value per share; 200,000,000 shares authorized, 4,962,231 issued and outstanding, June 30, 2022; 3,626,073 issued and outstanding, December 31, 2021 | — | — | |||||||||
| Additional paid-in capital | 187,053 | 181,301 | |||||||||
| Accumulated other comprehensive loss | (5) | (2) | |||||||||
| Accumulated deficit | (185,885) | (170,067) | |||||||||
| Total stockholders' equity | 1,163 | 11,232 | |||||||||
| Total liabilities and stockholders’ equity | $ | 36,955 | $ | 64,868 | |||||||
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EXICURE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Collaboration revenue | $ | 2,471 | $ | 79 | $ | 5,036 | $ | 1,076 | |||||||||||||||
| Total revenue | 2,471 | 79 | 5,036 | 1,076 | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development expense | 6,749 | 10,843 | 13,889 | 21,105 | |||||||||||||||||||
| General and administrative expense | 3,205 | 3,098 | 6,367 | 5,990 | |||||||||||||||||||
| Total operating expenses | 9,954 | 13,941 | 20,256 | 27,095 | |||||||||||||||||||
| Operating loss | (7,483) | (13,862) | (15,220) | (26,019) | |||||||||||||||||||
| Other income (expense), net: | |||||||||||||||||||||||
| Dividend income | 16 | 2 | 18 | 3 | |||||||||||||||||||
| Interest income | 1 | 43 | 3 | 131 | |||||||||||||||||||
| Interest expense | — | (450) | (595) | (859) | |||||||||||||||||||
| Other expense, net | (4) | (2) | (24) | (2) | |||||||||||||||||||
| Total other income (expense), net | 13 | (407) | (598) | (727) | |||||||||||||||||||
| Net loss before provision for income taxes | (7,470) | (14,269) | (15,818) | (26,746) | |||||||||||||||||||
| Provision for income taxes | — | — | — | — | |||||||||||||||||||
| Net loss | $ | (7,470) | $ | (14,269) | $ | (15,818) | $ | (26,746) | |||||||||||||||
| Basic and diluted loss per common share | $ | (1.66) | $ | (4.86) | $ | (3.71) | $ | (9.12) | |||||||||||||||
| Weighted-average basic and diluted common shares outstanding | 4,503,983 | 2,934,770 | 4,268,955 | 2,931,607 | |||||||||||||||||||
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