Fate Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Fate Therapeutics Inc. filed its 2023 10-K report detailing its fiscal year-end operations and financial standing.</b>

AI Summary

FATE THERAPEUTICS INC (FATE) filed a Annual Report (10-K) with the SEC on February 26, 2024. Fiscal year ended December 31, 2023, reported. Company address: 12278 Scripps Summit Drive, San Diego, CA 92131. Phone number: 858.875.1803. SIC code: 2836 (Biological Products, Not Including Diagnostic Substances). Filing type: 10-K.

Why It Matters

For investors and stakeholders tracking FATE THERAPEUTICS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Fate Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information within the filing, including financial statements and risk factors, is essential for stakeholders to make informed investment decisions and understand the company's regulatory and market landscape.

Risk Assessment

Risk Level: medium — FATE THERAPEUTICS INC shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology sector, facing significant risks related to clinical trial success, regulatory approvals, and market adoption of its products.

Analyst Insight

Investors should carefully review the risk factors section of the 10-K to understand the specific challenges and uncertainties Fate Therapeutics faces in developing and commercializing its cell-based therapeutics.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-02-26 — Filed As Of Date (Submission date)
• 001-36076 — SEC File Number (Filing identifier)
• 2836 — SIC Code (Industry classification)

Key Players & Entities

• FATE THERAPEUTICS INC (company) — Filer
• 2023-12-31 (date) — Fiscal Year End
• 2024-02-26 (date) — Filed As Of Date
• 12278 SCRIPPS SUMMIT DRIVE (address) — Business Address
• SAN DIEGO (city) — Business Address
• CA (state) — Business Address
• 92131 (zip_code) — Business Address
• 858.875.1803 (phone_number) — Business Phone

FAQ

Industry Context

Fate Therapeutics operates in the biotechnology sector, focusing on the development of cell-based therapeutics for cancer and other serious diseases.

Regulatory Implications

The company is subject to regulations by the Food and Drug Administration (FDA) and other health authorities regarding the development, testing, and marketing of its therapeutic products.

What Investors Should Do

1. Analyze the financial statements for revenue, expenses, and cash flow.
2. Review the risk factors section for potential challenges and uncertainties.
3. Examine any disclosed executive compensation details.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-26: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This filing represents the annual report for the fiscal year ending December 31, 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value FATE NASDAQ Global Market

Filing Documents

• fate-20231231.htm (10-K) — 2819KB
• fate-ex10_41.htm (EX-10.41) — 30KB
• fate-ex10_42.htm (EX-10.42) — 223KB
• fate-ex14_1.htm (EX-14.1) — 69KB
• fate-ex23_1.htm (EX-23.1) — 5KB
• fate-ex31_1.htm (EX-31.1) — 11KB
• fate-ex31_2.htm (EX-31.2) — 12KB
• fate-ex32_1.htm (EX-32.1) — 7KB
• fate-ex32_2.htm (EX-32.2) — 7KB
• fate-ex97_1.htm (EX-97.1) — 58KB
• img142887423_0.jpg (GRAPHIC) — 45KB
• img142887423_1.jpg (GRAPHIC) — 18KB
• img142887423_2.jpg (GRAPHIC) — 60KB
• 0000950170-24-020158.txt (&nbsp;) — 11657KB
• fate-20231231.xsd (EX-101.SCH) — 1617KB
• fate-20231231_htm.xml (XML) — 1879KB

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS 3 PART I Item 1.

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 36 Item 1B. Unresolved Staff Comments 78 Item 1C. Cybersecurity 78 Item 2.

Properties

Properties 78 Item 3.

Legal Proceedings

Legal Proceedings 78 Item 4. Mine Safety Disclosures 79 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 80 Item 6. [Reserved] 80 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 81 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 92 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 93 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 118 Item 9A.

Controls and Procedures

Controls and Procedures 118 Item 9B. Other Information 119 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 119 PART III 120 Item 10. Directors, Executive Officers and Corporate Governance 120 Item 11.

Executive Compensation

Executive Compensation 120 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 120 Item 13. Certain Relationships and Related Transactions, and Director Independence 120 Item 14. Principal Accounting Fees and Services 120 PART IV Item 15. Exhibits and Financial Statement Schedules 121 Item 16. Form 10-K Summary 121

SIGNATURES

SIGNATURES 126 Table of Contents RISK FACTO R SUMMARY Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading "Risk Factors" and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the Securities and Exchange Commission (SEC) before making investment decisions regarding our common stock. Development of our product candidates will require substantial additional funding, which, if available, may cause dilution to our stockholders, and without which we will be unable to complete preclinical or clinical development of, or obtain regulatory approval for, our product candidates, and we may not be able to secure adequate funding on acceptable terms or on a timely basis. Our product candidates and programs represent novel therapeutic approaches to treating cancer and autoimmune disease, and our product candidates may cause undesirable side effects or have other properties that could delay or halt their preclinical or clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences. If we fail to complete the preclinical or clinical development of, or to obtain regulatory approval for, our product candidates on a timely basis or at all, our business would be significantly harmed. Our proprietary induced pluripotent stem cell (iPSC) product platform enables the production of next-generation product candidates, and we have multiple iPSC-derived NK cell and T-cell product candidates currently undergoing clinical development. We may elect to deprioritize or discontinue the clinical development of one or more of our product candidates for any number of reasons, including

Business

ITEM 1. Business Overview We are a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of programmed cellular immunotherapies to patients with cancer and autoimmune diseases. Our development of programmed cellular immunotherapies is based on a simple notion: we believe that better cell therapies start with better cells. To create better cell therapies, we have pioneered a therapeutic approach that we generally refer to as cell programming: we create and engineer human induced pluripotent stem cells (iPSCs) to incorporate novel synthetic controls of cell function; we generate a clonal master iPSC line for use as a renewable source of cell manufacture; and we direct the fate of the clonal master iPSC line to produce our cell therapy product candidate. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, we believe clonal master iPSC lines can be used to mass produce multiplexed-engineered, cellular immunotherapies which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with standard-of-care therapies, and can have significant patient reach. Utilizing our proprietary iPSC product platform, we are advancing off-the-shelf, multiplexed-engineered natural killer (NK) cell and T-cell product candidates which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients for the treatment of cancer and autoimmune disease. We have a deep pipeline of iPSC-derived, chimeric antigen receptor (CAR)-targeted NK cell and T-cell product candidates currently under development with multiple clinical trials ongoing: Program Indication CAR Target(s) # of Synthetic Controls Development Stage Partner Oncology - Hematologic Malignancies FT819 B-cell Malignancies CD19 2 Phase 1 FT522 B

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View this 10-K filing on SEC EDGAR