Geron Corp Files 2023 Annual Report on Form 10-K

TL;DR

<b>Geron Corp filed its 2023 10-K, detailing financial activities and corporate structure.</b>

AI Summary

GERON CORP (GERN) filed a Annual Report (10-K) with the SEC on February 28, 2024. Geron Corporation filed its 10-K report for the fiscal year ending December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is located at 919 East Hillsdale Boulevard, Suite 250, Foster City, CA 94404. Geron Corp is incorporated in Delaware and operates within the Pharmaceutical Preparations industry (SIC 2834). The report details various financial instruments and agreements, including stock compensation plans, sales agreements, and lease agreements.

Why It Matters

For investors and stakeholders tracking GERON CORP, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Geron Corp's financial performance, operational status, and strategic initiatives for the fiscal year 2023, which is crucial for investors to assess the company's health and future prospects. The detailed disclosures within the 10-K are essential for regulatory compliance and transparency, offering stakeholders insights into the company's assets, liabilities, equity, and risk factors.

Risk Assessment

Risk Level: medium — GERON CORP shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market competition, as indicated by the numerous disclosures of agreements and plans.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Geron Corp's current financial position and potential future challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-02-28 — Filed As Of Date (FILED AS OF DATE)
• 1934 Act — SEC Act (SEC ACT)
• 000-20859 — SEC File Number (SEC FILE NUMBER)

Key Players & Entities

• GERON CORP (company) — FILER
• 0000886744 (company) — CENTRAL INDEX KEY
• DE (company) — STATE OF INCORPORATION
• 2834 (company) — STANDARD INDUSTRIAL CLASSIFICATION
• 919 EAST HILLSDALE BOULEVARD (company) — BUSINESS ADDRESS STREET 1
• FOSTER CITY (company) — BUSINESS ADDRESS CITY
• CA (company) — BUSINESS ADDRESS STATE
• 94404 (company) — BUSINESS ADDRESS ZIP

FAQ

Industry Context

Geron Corp operates in the pharmaceutical preparations industry, focusing on the development of therapies.

Regulatory Implications

The company is subject to the regulations of the U.S. Securities and Exchange Commission (SEC) as a publicly traded entity.

What Investors Should Do

1. Review Geron Corp's detailed financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section to understand potential challenges and uncertainties.
3. Examine disclosures related to stock compensation plans and other financial agreements.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-28: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This filing represents the annual 10-K report for the fiscal year 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — ge on which registered: Common Stock, $0.001 par value GERN The Nasdaq Stock Mar
• $7.0 b — Europe for imetelstat is approximately $7.0 billion, of which lower-risk MDS represen
• $3.5 billion — lower-risk MDS represents approximately $3.5 billion and relapsed/refractory MF represents a

Filing Documents

• gern-20231231.htm (10-K) — 2975KB
• gern-ex4_1.htm (EX-4.1) — 30KB
• gern-ex10_23.htm (EX-10.23) — 42KB
• gern-ex10_30.htm (EX-10.30) — 120KB
• gern-ex10_39.htm (EX-10.39) — 1482KB
• gern-ex21_1.htm (EX-21.1) — 3KB
• gern-ex23_1.htm (EX-23.1) — 10KB
• gern-ex31_1.htm (EX-31.1) — 13KB
• gern-ex31_2.htm (EX-31.2) — 13KB
• gern-ex32_1.htm (EX-32.1) — 7KB
• gern-ex32_2.htm (EX-32.2) — 7KB
• gern-ex97_1.htm (EX-97.1) — 46KB
• img43612817_0.jpg (GRAPHIC) — 200KB
• img43612817_1.jpg (GRAPHIC) — 223KB
• img43612817_2.jpg (GRAPHIC) — 211KB
• img43612817_3.jpg (GRAPHIC) — 682KB
• img43612817_4.jpg (GRAPHIC) — 192KB
• 0000950170-24-022056.txt (&nbsp;) — 16858KB
• gern-20231231.xsd (EX-101.SCH) — 1533KB
• gern-20231231_htm.xml (XML) — 2086KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 69 Item 1C. Cybersecurity 69 Item 2.

Properties

Properties 70 Item 3.

Legal Proceedings

Legal Proceedings 70 Item 4. Mine Safety Disclosures 70 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 71 Item 6. [Reserved] 71 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 71 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 82 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 82 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 116 Item 9A.

Controls and Procedures

Controls and Procedures 116 Item 9B. Other Information 117 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 117 PART III Item 10. Directors, Executive Officers and Corporate Governance 117 Item 11.

Executive Compensation

Executive Compensation 118 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 118 Item 13. Certain Relationships and Related Transactions, and Director Independence 118 Item 14. Principal Accountant Fees and Services 118 PART IV Item 15. Exhibits and Financial Statement Schedules 118 Item 16. Form 10K Summary 122

SIGNATURES

SIGNATURES 123 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, and its wholly owned subsidiaries, Geron UK Limited, a United Kingdom company, and Geron Netherlands, B.V., a Dutch company. 1 ForwardLooking Statements This annual report on Form 10K, including "Business" in Part I, Item 1 of this annual report on Form 10-K and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Part II, Item 7 of this annual report on Form 10-K, contains forwardlooking 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 forwardlooking statements. All statements other than statements of historical fact are statements that could be deemed forwardlooking statements. In some cases, forwardlooking 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 and uncertainties related to: (a) whether the U.S. Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, may have issues with the New Drug Application, or NDA, or marketing authorization application, or MAA, for imetelstat for Low or Intermediate-1 risk myelodysplastic syndromes, or lower-risk MDS, that delay or prevent approval and a potential commercial launch; (b) whether we will be able to continue to develop imetelstat or advance imetelstat to subsequent clinical trials, or that we will be able to receive regulatory approval for or successfully commerc

BUSINESS

ITEM 1. BUSINESS Company Overview We are a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases. Our lead indication for imetelstat is in lower-risk MDS. In August 2023, our NDA for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk MDS who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents, or ESAs, was accepted by the United States, or U.S., FDA, for review and assigned a Prescription Drug User Fee Act, or PDUFA, action date of June 16, 2024. In addition, the FDA has scheduled an advisory committee meeting as part of the NDA review on March 14, 2024. If imetelstat is approved for commercialization by the FDA, we anticipate commercial launch of imetelstat in lower-risk MDS in the U.S. could occur at the time of approval. In September 2023, we submitted an MAA in Europe that was validated for review by the EMA for imetelstat for the same proposed indication as in the U.S. We expect a review of the MAA could be completed in early 2025, and subject to approval by the European Commission, we believe EU commercial launch of imetelstat would occur in 2025. Our NDA and EMA submissions are based on positive data from the IMerge Phase 3 clinical trial. The trial met its primary endpoint of 8-week transfusion independence rate and a key secondary endpoint of 24-week transfusion independence rate, demonstrating highly statistically significant (i.e., p<0.001 for both) and clinically meaningful benefits with imetelstat treatment versus placebo. Furthermore, statistically significant and clinically meaningful efficacy results were observed in the trial across key subtypes, including patients who wer

View Full Filing

View this 10-K filing on SEC EDGAR