Form 8-K GERON CORP For: Feb 25
UNITED 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): February 25, 2015
GERON
CORPORATION
(Exact name of
registrant as specified in its charter)
| Delaware | 0-20859 | 75-2287752 |
| (State or other jurisdiction | (Commission File Number) | (IRS Employer |
| of incorporation) | Identification No.) |
149 COMMONWEALTH DRIVE,
SUITE 2070
MENLO PARK, CALIFORNIA 94025
(Address of principal executive offices, including
zip code)
(650)
473-7700
(Registrants
telephone number, including area code)
N/A
(Former name or former address, if changed since
last report)
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition
Geron Corporation (the Company or Geron) is furnishing this information under Item 2.02 of Form 8-K.
The information in this Current Report, including Exhibit 99.1, is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section. The information in this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Exchange Act.
On March 3, 2015, the Company issued a press release announcing its financial results for the three and twelve months ended December 31, 2014. A copy of the press release is attached as Exhibit 99.1.
Item 2.05 Costs Associated with Exit or Disposal Activities
In light of the projected reduced operational demands on the Company as a result of the recently announced exclusive collaboration and license agreement (the “Collaboration Agreement”) with Janssen Biotech, Inc. (“Janssen”), on March 3, 2015, the Company announced an organizational resizing to reduce its workforce from 39 to 21 positions, representing a reduction of approximately 46% of the Companys workforce. The Company expects the majority of the reduction in its workforce to be completed by the end of the third quarter of 2015.
In connection with the foregoing change to the Companys business, the Company anticipates it will incur aggregate restructuring charges of approximately $1.9 million, of which approximately $1.5 million will be paid in cash during 2015. The aggregate projected restructuring charges represent one-time termination benefits, comprised principally of severance, benefit continuation costs, outplacement services and non-cash stock-based compensation expense, associated with the elimination of 18 positions. The majority of these charges are expected to be recognized in the first half of 2015. The Company may incur other charges and will record these expenses in the appropriate period as they are determined.
The aggregate expected restructuring charges to be incurred or cash expenditures to be paid by the Company in connection with the reduction in workforce and the timing thereof are subject to a number of assumptions, and actual results may differ materially from those originally anticipated. The Company may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, the foregoing change to the Companys business.
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers |
Departure of Director
On March 3, 2015, Thomas Hofstaetter, Ph.D., a Class I member of the Companys Board of Directors (the Board), notified the Company of his decision to retire from the Board effective as of May 18, 2015, the date of the Companys next annual meeting of stockholders. Until his retirement from the Board, Dr. Hofstaetter will continue to serve on the Compensation Committee of the Board.
2
Compensatory Arrangements of Certain Officers
On February 25, 2015, the Compensation Committee of the Board approved: (a) annual base salaries for 2015 and (b) cash performance bonuses for 2014 for the following principal financial officer and named executive officers of the Company:
| Name and Current Position | Salary Increase (%) |
Salary Increase ($) |
2015
Base Salary |
2014
Cash Bonus |
| Olivia K. Bloom,
Executive Vice President, Finance, Chief Financial Officer and Treasurer |
3% | $10,950 | $375,950 | $190,530 |
| Melissa A. Kelly Behrs,
Executive Vice President, Business Development and Portfolio & Alliance Management |
3% | $10,560 | $362,560 | $188,496 |
| Andrew J. Grethlein,
Ph.D., Executive Vice President, Development and Technical Operations |
3% | $11,370 | $390,370 | $197,838 |
| Stephen N. Rosenfield, J.D., Executive Vice President, General Counsel and Corporate Secretary | 3% | $9,360 | $321,360 (1) | $162,864 |
| (1) | Reflects Mr. Rosenfields continued employment by the Company at 80% time. |
On March 3, 2015, the Board approved the annual base salary for 2015 and cash performance bonus for 2014 for the following principal executive officer:
| Name and Current Position | Salary Increase (%) |
Salary Increase ($) |
2015
Base Salary |
2014
Cash Bonus |
| John A. Scarlett,
M.D., President, Chief Executive Officer and Director |
3% | $17,595 | $604,095 | $422,280 |
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. | Description | |||
| 99.1 | Press release dated March 3, 2015. | |||
3
Safe Harbor Statement
This Current Report on Form 8-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this Current Report related to the timing of implementation and completion of actions related to the Companys reduction in workforce and expected charges and cash expenditures related to this restructuring and the timing thereof, constitute forward-looking statements. Words such as expects, will, may, anticipates, intends, and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Companys current plans, assumptions, beliefs, and expectations. Forward-looking statements involve risks and uncertainties. The Companys actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to the Companys ability to resize its workforce to the extent currently anticipated; the impact of the workforce reduction on the Companys business; unanticipated expenses and charges not currently contemplated or litigation that may occur as a result of the reduction in workforce; the uncertain, time-consuming and expensive product development and regulatory process, including whether Geron and Janssen will succeed in overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges in the development and commercialization of imetelstat; the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the Collaboration Agreement for any reason; the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat; Gerons dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the Collaboration Agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the Collaboration Agreement and the clinical development or commercialization of imetelstat could be delayed or terminated; whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; whether imetelstat can be applied to any or to multiple hematologic malignancies; the need for future capital; and general business and economic conditions. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Gerons periodic reports filed with the Securities and Exchange Commission under the heading Risk Factors, including Exhibit 99.1 of Gerons Current Report on Form 8-K filed on November 13, 2014. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
4
SIGNATURE
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.
GERON CORPORATION | ||
| Date: March 3, 2015 | By: | /s/ Stephen N. Rosenfield |
| Stephen N. Rosenfield | ||
| Executive Vice President, General | ||
| Counsel and Corporate Secretary | ||
5
EXHIBIT INDEX
| Exhibit | Description | |||
| 99.1 | Press release dated March 3, 2015. | |||
EXHIBIT 99.1
Press Release Dated March 3, 2015
Geron Corporation Reports Fourth Quarter and Annual 2014 Financial Results and Recent Events
Organizational Resizing Also Announced
Conference Call Scheduled for 4:30 p.m. EST Today, March 3
MENLO PARK, Calif., March 3, 2015 -- Geron Corporation (Nasdaq: GERN) today reported financial results for the fourth quarter and year ended December 31, 2014 and recent events.
Fourth Quarter 2014 Results
Net loss for the fourth quarter of 2014 was $8.9 million, or $0.06 per share, compared to $9.3 million, or $0.07 per share, for the comparable 2013 period. Revenues for the fourth quarter of 2014 were $178,000 compared to $225,000 for the comparable 2013 period. The company ended 2014 with $170.6 million in cash and investments, which included receipt of an upfront payment of $35.0 million for the license rights granted by the company to Janssen Biotech, Inc. (Janssen) under the exclusive collaboration and license agreement (the Collaboration Agreement) entered into between the parties in November 2014, which has been recorded as deferred revenue as of December 31, 2014.
Total operating expenses for the fourth quarter of 2014 were $9.2 million compared to $9.5 million for the comparable 2013 period. Research and development expenses for the fourth quarter of 2014 were $4.4 million compared to $5.1 million for the comparable 2013 period. General and administrative expenses for the fourth quarter of 2014 were $4.8 million compared to $4.0 million for the comparable 2013 period. Operating expenses for the 2013 fourth quarter also included restructuring charges of $430,000 in connection with the companys decisions to discontinue its discovery research programs and close its research laboratory facility in 2013.
The decrease in research and development expenses for the fourth quarter of 2014, compared to the same period in 2013, primarily reflects lower manufacturing costs for imetelstat drug product and reduced clinical trial expenses for the imetelstat trials in hematologic myeloid malignancies. The increase in general and administrative expenses for the fourth quarter of 2014, compared to the same period in 2013, primarily reflects the net result of higher non-cash stock-based compensation expense, increased legal fees for the purported lawsuits filed against the company and transaction costs associated with the Collaboration Agreement with Janssen, partially offset by transaction costs associated with the closing of the stem cell divestiture transaction in October 2013.
Interest and other income for the fourth quarter of 2014 was $100,000 compared to $115,000 for the comparable 2013 period. The decrease in interest and other income for the fourth quarter of 2014, compared to the same period in 2013, primarily reflects the net result of a gain on the sale of excess laboratory equipment in connection with the closure of the companys research laboratory facility in 2013, partially offset by higher interest income due to increased cash and investment balances with the receipt of $96.8 million in net cash proceeds from the underwritten public offering completed in February 2014.
Year-End 2014 Results
Net loss for 2014 was $35.7 million, or $0.23 per share, compared to $38.4 million, or $0.30 per share, for 2013. License fee and royalty revenues for 2014 and 2013 were $1.2 million and $1.3 million, respectively.
Total operating expenses for 2014 were $37.5 million compared to $40.2 million for 2013. Research and development expenses for 2014 were $20.7 million compared to $23.2 million for 2013. General and administrative expenses for 2014 were $16.8 million compared to $15.6 million for 2013. Year-to-date operating expenses for 2013 also included restructuring charges of $1.5 million.
The decrease in research and development expenses for 2014 compared to 2013 primarily reflects the net result of lower clinical trial expenses with the wind-down of the imetelstat trials in solid tumors and GRN1005 trials in patients with brain metastases and reduced personnel-related and other research costs resulting from previous restructurings and the discontinuation of the companys discovery research programs, partially offset by higher costs for the manufacturing of imetelstat drug product. The increase in general and administrative expenses for 2014 compared to 2013 primarily reflects the net result of higher non-cash stock-based compensation expense, increased legal fees for the purported lawsuits filed against the company and transaction costs associated with the Collaboration Agreement with Janssen, partially offset by reduced patent fees and transaction costs associated with the closing of the stem cell divestiture transaction.
Interest and other income was $373,000 for 2014 compared to $951,000 for 2013. The decrease in interest and other income for 2014 compared to 2013 primarily reflects the net result of a gain on the sale of excess laboratory equipment in 2013, partially offset by higher interest income due to increased cash and investment balances in 2014.
Recent Company Events
| ● | On October
31, 2014, the U.S. Food and Drug
Administration (FDA) removed the full clinical hold on the companys
investigational new drug application for imetelstat. In addition, the FDA
stated that the companys proposed clinical development plan for
imetelstat that is focused on high-risk myeloid malignancies, such as
myelofibrosis (MF), is acceptable. |
| ● |
On November 13, 2014, the company entered into the Collaboration Agreement with Janssen to develop and commercialize imetelstat, the companys telomerase inhibitor product candidate, worldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the Collaboration Agreement, the company received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. Development of imetelstat will proceed under a mutually agreed clinical development plan, which is expected to include Phase 2 studies in MF and myelodysplastic syndromes (MDS) as initial studies, additional registration studies in MF and MDS, and exploratory Phase 2 and potential follow-on Phase 3 studies in acute myelogenous leukemia (AML). The company expects the Initial Phase 2 MF Study to be initiated in mid-2015 followed later by the Initial Phase 2 MDS Study to be initiated at the end of 2015. Development costs for these two studies will be shared between Janssen and Geron on a 50/50 basis. Prior to initiation of the Initial Phase 2 MF Study, both investigational new drug applications for imetelstat and the sponsorship of the MF Pilot Study being conducted by Dr. Tefferi will be transferred from Geron to Janssen. The primary transition activities related to the imetelstat program are expected to be completed by mid-2015. Given projected reduced operational demands as a result of the collaboration with Janssen, the company is conducting an organizational resizing which will reduce its workforce from 39 to 21 positions. In connection with this action, the company expects to incur restructuring charges of approximately $1.9 million, the majority of which will be recognized in the first half of 2015. Approximately $1.5 million of these charges is expected to be paid in cash during 2015. The company expects the resizing will reduce the companys personnel-related costs by approximately $5.0 million on an annualized basis. |
| ● |
On December 4, 2014, preclinical data from
the laboratory of Steven Lane, M.D., Ph.D., QIMR Berghofer Medical
Research Institute, that demonstrated activity of the companys telomerase
inhibitor drug, imetelstat, on leukemic stem cells from AML was published
in the journal Cell Stem
Cell. The preclinical study
showed the role of telomerase in AML disease initiation and progression
and the company believes the data may provide preclinical proof-of-concept
to support future clinical development of imetelstat in
AML. |
| ● |
In December 2014, five presentations describing clinical and non-clinical data on imetelstat were made at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. |
| o | Monitoring of CALR
Allele Burden in Patients with Essential Thrombocythemia Treated with
Imetelstat, a Telomerase Inhibitor, Reveals Rapid and Substantial
Molecular Responses (Abstract #408) |
| o | Imetelstat, a
Telomerase Inhibitor, Therapy for Myelofibrosis: A Pilot Study (Abstract
#634) |
| o | Effects of Imetelstat
on CD34+ Cells of Patients with Myelofibrosis (Abstract
#1879) |
| o | Inhibition of
Telomerase with Imetelstat is Detrimental to Leukemia Stem Cells in Acute
Myeloid Leukemia (AML) (Abstract #2322) |
| o | Imetelstat (GRN163L), a Telomerase Inhibitor Selectively Affects Malignant Megakaryopoiesis in Myeloproliferative Neoplasms (MPN) (Abstract #4582) |
Conference Call
At 4:30 p.m. EST on March 3, 2015, Gerons management will host a conference call to discuss the companys fourth quarter and annual results as well as recent events.
Participants can access the conference call live via telephone by dialing 877-703-6107 (U.S.); 857-244-7306 (international). The passcode is 28650149. A live audio-only webcast is also available at http://edge.media-server.com/m/p/bu63s9fe/lan/en. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through April 3, 2015.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) Gerons potential receipt of development, regulatory and sales milestones, as well as royalties on potential future sales of imetelstat commercialized under the Collaboration Agreement; (ii) timing of planned and potential clinical trials of imetelstat to be conducted under the Collaboration Agreement, including the Initial Phase 2 MF Study and the Initial Phase 2 MDS Study, and other potential activities under the Collaboration Agreement; (iii) the safety and efficacy of imetelstat; (iv) Gerons transfer of the imetelstat INDs to Janssen; (v) financial projections and expectations, including incurring restructuring charges of approximately $1.9 million in 2015, cash expenditures of approximately $1.5 million in 2015 and projected reduction in personnel-related costs by approximately $5.0 million on an annualized basis; (vi) intellectual property protection; and (vii) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) the uncertain, time-consuming and expensive product development and regulatory process, including whether Geron and Janssen will succeed in overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges in the development and commercialization of imetelstat; (ii) the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the Collaboration Agreement for any reason; (iii) the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat; (iv) Gerons dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the Collaboration Agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the Collaboration Agreement and the clinical development or commercialization of imetelstat could be delayed or terminated; (v) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (vi) whether imetelstat can be applied to any or to multiple hematologic malignancies; (vii) whether Geron encounters unanticipated challenges in transferring the imetelstat INDs to Janssen in a timely manner, or at all; (viii) unanticipated expenses or charges resulting from the resizing, and (ix) the need for future capital. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Gerons periodic reports filed with the Securities and Exchange Commission under the heading Risk Factors, including Exhibit 99.1 of Gerons Current Report on Form 8-K filed on November 13, 2014. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
CONTACT:
Kevin Eng,
Ph.D.
Investor and Media
Relations
650-473-7765
[email protected]
[email protected]
Financial table follows.
GERON
CORPORATION
CONDENSED
STATEMENTS OF OPERATIONS
| UNAUDITED | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| (In thousands, except share and per share data) | 2014 | 2013 | 2014 | 2013 | ||||||||||||
| Revenues: | ||||||||||||||||
| License fees and royalties | $ | 178 | $ | 225 | $ | 1,153 | $ | 1,283 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,351 | 5,089 | 20,707 | 23,155 | ||||||||||||
| Restructuring charges | | 430 | | 1,462 | ||||||||||||
| General and administrative | 4,838 | 3,981 | 16,758 | 15,624 | ||||||||||||
| Total operating expenses | 9,189 | 9,500 | 37,465 | 40,241 | ||||||||||||
| Loss from operations | (9,011 | ) | (9,275 | ) | (36,312 | ) | (38,958 | ) | ||||||||
| Unrealized (loss) gain on derivatives | (15 | ) | (109 | ) | 351 | (316 | ) | |||||||||
| Interest and other income | 100 | 115 | 373 | 951 | ||||||||||||
| Interest and other expense | (21 | ) | (12 | ) | (82 | ) | (56 | ) | ||||||||
| Net loss | $ | (8,947 | ) | $ | (9,281 | ) | $ | (35,670 | ) | $ | (38,379 | ) | ||||
| Basic and diluted net loss per share: | ||||||||||||||||
| Net loss per share | $ | (0.06 | ) | $ | (0.07 | ) | $ | (0.23 | ) | $ | (0.30 | ) | ||||
| Shares used in computing net loss per share | 157,145,361 | 129,084,200 | 153,540,341 | 128,380,800 | ||||||||||||
CONDENSED BALANCE SHEETS
| (In thousands) | December
31, 2014 |
December
31, 2013 | ||||
| Current assets: | ||||||
| Cash, cash equivalents and restricted cash | $ | 43,062 | $ | 13,785 | ||
| Current marketable securities | 108,645 | 52,234 | ||||
| Other current assets | 1,699 | 1,038 | ||||
| Total current assets | 153,406 | 67,057 | ||||
| Noncurrent marketable securities | 18,932 | | ||||
| Property and equipment, net | 173 | 92 | ||||
| Deposits and other assets | | 195 | ||||
| $ | 172,511 | $ | 67,344 | |||
| Current liabilities1 | $ | 41,799 | $ | 7,587 | ||
| Stockholders equity | 130,712 | 59,757 | ||||
| $ | 172,511 | $ | 67,344 | |||
###
|
1 Balance as of December 31, 2014 includes $35.0 million in deferred revenue resulting from the upfront payment received under the collaboration with Janssen in December 2014. |
