GERON CORPORATION (Exact Name of Registrant As Specified in Its Charter)
Total Page:16
File Type:pdf, Size:1020Kb
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2019 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 0-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) Delaware 75-2287752 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 149 Commonwealth Drive, Suite 2070, Menlo Park, CA 94025 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (650) 473-7700 Securities registered pursuant to Section 12(b) of the Act: Title of each class: Trading symbol(s): Name of each exchange on which registered: Common Stock, $0.001 par value GERN The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. 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, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company 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. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes No The aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant was approximately $262,459,000 based upon the closing price of the registrant’s common stock on June 28, 2019 on the Nasdaq Global Select Market. The calculation of the aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant excludes shares of common stock held by each officer, director and stockholder that the registrant concluded were affiliates on that date. This determination of affiliate status is not necessarily a conclusive determination for other purposes. As of March 2, 2020, there were 200,344,809 shares of common stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE: Form 10-K Document Parts Portions of the Registrant’s definitive proxy statement for the 2020 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days of the Registrant’s fiscal year ended December 31, 2019 III TABLE OF CONTENTS Page PART I Item 1. Business .............................................................................................................................................. 4 Item 1A. Risk Factors ........................................................................................................................................ 26 Item 1B. Unresolved Staff Comments............................................................................................................... 63 Item 2. Properties ............................................................................................................................................ 63 Item 3. Legal Proceedings............................................................................................................................... 64 Item 4. Mine Safety Disclosures ..................................................................................................................... 64 PART II Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases 64 of Equity Securities........................................................................................................................ Item 6. Selected Financial Data....................................................................................................................... 65 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations............. 65 Item 7A. Quantitative and Qualitative Disclosures About Market Risk............................................................ 78 Item 8. Financial Statements and Supplementary Data................................................................................... 78 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure............. 108 Item 9A. Controls and Procedures ..................................................................................................................... 108 Item 9B. Other Information ............................................................................................................................... 111 PART III Item 10. Directors, Executive Officers and Corporate Governance ................................................................. 111 Item 11. Executive Compensation .................................................................................................................... 111 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder 112 Matters ........................................................................................................................................... Item 13. Certain Relationships and Related Transactions, and Director Independence ................................... 112 Item 14. Principal Accounting Fees and Services............................................................................................. 112 PART IV Item 15. Exhibits, Financial Statement Schedules ............................................................................................ 112 Item 16. Form 10-K Summary .......................................................................................................................... 115 SIGNATURES.................................................................................................................................... 116 In this report, unless otherwise indicated or the context otherwise requires, “Geron,” “the registrant,” “we,” “us,” and “our” refer to Geron Corporation, a Delaware corporation. 2 Forward-Looking Statements This annual report on Form 10-K, including “Business” in Part I, Item 1 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7, contains forward-looking statements that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause the results of Geron Corporation, or Geron or the Company, to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “expects,” “plans,” “intends,” “will,” “should,” “projects,” “believes,” “predicts,” “anticipates,” “estimates,” “potential,” or “continue” or the negative thereof or other comparable terminology. The risks and uncertainties referred to above include, without limitation, risks related to uncertainty of non-clinical and clinical trial results or regulatory approvals or clearances, the future development of imetelstat, including any future efficacy or safety results that may cause the benefit-risk profile of imetelstat to become unacceptable, our need for additional capital to support the development and commercialization of imetelstat and to otherwise grow our business, transition of the imetelstat program to us, establishing and maintaining imetelstat manufacture and supply, enforcement of our patent and proprietary rights, managing our business growth, litigation risks, the effects of any health epidemics, potential competition and other risks that are described herein and that are otherwise described from time to time in our Securities and Exchange Commission reports including, but not limited to, the factors described in Part I, Item 1A, “Risk Factors,” of this annual report on Form 10-K. Geron assumes no obligation for and except as required by law, disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. Calculation of Aggregate Market Value of Non-Affiliate Shares