Allogene Therapeutics Files 10-K/A Amendment

TL;DR

<b>Allogene Therapeutics, Inc. has filed an amended 10-K for the fiscal year ending December 31, 2022.</b>

AI Summary

Allogene Therapeutics, Inc. (ALLO) filed a Amended Annual Report (10-K/A) with the SEC on March 14, 2024. This filing is an amendment to the 10-K for the fiscal year ended December 31, 2022. The company's central index key is 0001737287. Allogene Therapeutics, Inc. operates in the Biological Products sector. The filing covers the period from January 1, 2022, to December 31, 2022. The SEC file number for this company is 001-38693.

Why It Matters

For investors and stakeholders tracking Allogene Therapeutics, Inc., this filing contains several important signals. This amended filing provides updated financial and operational information for the 2022 fiscal year, which is crucial for investors to assess the company's current standing and future prospects. As a biotechnology company, updates to its 10-K are important for understanding its progress in drug development, regulatory milestones, and financial health.

Risk Assessment

Risk Level: low — Allogene Therapeutics, Inc. shows low risk based on this filing. The risk is low as this is an amended filing (10-K/A) which typically corrects or updates information from a previous filing, rather than introducing new material risks.

Analyst Insight

Review the specific changes and updates within this 10-K/A filing to understand any material differences from the original 10-K filing for fiscal year 2022.

Key Numbers

• 20221231 — Fiscal Year End (Conformed Period of Report)
• 20240314 — Filing Date (Filed As Of Date)
• 2022-01-01 — Period Start Date (Fiscal Year 2022)
• 2022-12-31 — Period End Date (Fiscal Year 2022)

Key Players & Entities

• Allogene Therapeutics, Inc. (company) — Filer name
• 0001737287 (company) — Central Index Key
• 2836 (regulator) — Standard Industrial Classification
• 001-38693 (regulator) — SEC File Number
• 24749619 (dollar_amount) — Film Number

FAQ

Industry Context

Allogene Therapeutics is a biotechnology company focused on developing allogeneic CAR T therapies for cancer. This sector is characterized by high R&D costs, long development cycles, and significant regulatory oversight.

Regulatory Implications

As a biotechnology company, Allogene Therapeutics is subject to stringent regulations from bodies like the FDA regarding drug development, clinical trials, and manufacturing processes.

What Investors Should Do

1. Analyze the specific amendments made in this 10-K/A filing compared to the original 10-K for FY2022.
2. Investigate any changes in financial reporting, risk factors, or business operations disclosed in the amendment.
3. Assess the impact of these amendments on the company's overall financial health and strategic outlook.

Key Dates

• 2022-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-14: Filing Date — Date the amended 10-K was filed with the SEC.

Year-Over-Year Comparison

This is an amended 10-K filing (10-K/A), indicating updates or corrections to the previously filed 10-K for the fiscal year ended December 31, 2022.

Key Financial Figures

• $0.001 — ich registered Common Stock, Par Value $0.001 Per Share ALLO The Nasdaq Stock Market
• $11.40 — rant's common stock on June 30, 2022 of $11.40 per share, as reported by The Nasdaq Gl
• $117.0 million — ock for which Overland committed to pay $117.0 million to Allogene Overland, which included an
• $40 million — ene Overland. The Company also received $40 million from Allogene Overland as partial consi

Filing Documents

• allo-20221231.htm (10-K/A) — 2262KB
• allo-20221231xex231.htm (EX-23.1) — 4KB
• allo-20221231xex311.htm (EX-31.1) — 11KB
• allo-20221231xex312.htm (EX-31.2) — 10KB
• allo-20221231xex321.htm (EX-32.1) — 6KB
• allo-20221231xex322.htm (EX-32.2) — 5KB
• allo-20221231_g1.jpg (GRAPHIC) — 207KB
• allo-20221231_g10.jpg (GRAPHIC) — 26KB
• allo-20221231_g11.jpg (GRAPHIC) — 23KB
• allo-20221231_g12.jpg (GRAPHIC) — 50KB
• allo-20221231_g2.jpg (GRAPHIC) — 276KB
• allo-20221231_g3.jpg (GRAPHIC) — 39KB
• allo-20221231_g4.jpg (GRAPHIC) — 50KB
• allo-20221231_g5.jpg (GRAPHIC) — 37KB
• allo-20221231_g6.jpg (GRAPHIC) — 44KB
• allo-20221231_g7.jpg (GRAPHIC) — 34KB
• allo-20221231_g8.jpg (GRAPHIC) — 24KB
• allo-20221231_g9.jpg (GRAPHIC) — 39KB
• 0001737287-24-000018.txt (&nbsp;) — 12431KB
• allo-20221231.xsd (EX-101.SCH) — 73KB
• allo-20221231_cal.xml (EX-101.CAL) — 75KB
• allo-20221231_def.xml (EX-101.DEF) — 413KB
• allo-20221231_lab.xml (EX-101.LAB) — 747KB
• allo-20221231_pre.xml (EX-101.PRE) — 617KB
• allo-20221231_htm.xml (XML) — 1526KB

Forward-Looking Statements

Forward-Looking Statements Table of Contents Risk Factors Summary

, Item 1A. Risk Factors

Part I, Item 1A. Risk Factors

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

Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations

, Item 8. Financial Statements and Supplementary Data

Part II, Item 8. Financial Statements and Supplementary Data

, Item 9A. Controls and Procedures

Part II, Item 9A. Controls and Procedures

, Item 15. Exhibits and Financial Statement Schedules

Part IV, Item 15. Exhibits and Financial Statement Schedules In addition to the restatement-related changes, Part II, Item 7 has been revised to (1) disclose the fact that we do not track most of our external research and development expenses by program or product candidate, and the reason therefor, and (2) provide more details about our research and development expenses for each period presented, including but not limited to internal versus external expenses as well as the nature of the expenses. In addition, all references in the Original Report to "Annual Report" and "Form 10-K" have been revised to refer to this "Amended Annual Report" and "Form 10-K/A," as applicable. In addition, in accordance with applicable SEC rules, this Amended Annual Report includes new certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 from our principal executive officer and our principal financial officer dated as of the filing date of this Amended Annual Report and an updated signature page. Except as described above, this Amended Annual Report does not amend, update or change any other items or disclosures in the Original Report and does not purport to reflect any information or events subsequent to the filing thereof. As such, this Amended Annual Report speaks only as of the date the Original Report was filed, and we have not undertaken herein to amend, supplement or update any information contained in the Original Report to give effect to any subsequent events. Among other things, forward-looking statements made in the Original Report have not been revised to reflect events, results or developments that occurred or facts that became known to us after the date of the Original Report. Accordingly, this Amended Annual Report should be read in conjunction with our filings made with the SEC subsequent to the filing of the Original Report, including any amendments to those filings. The restatement is more fully described in Note 1 of the notes to the

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 41 Item 1B. Unresolved Staff Comments 78 Item 2.

Properties

Properties 79 Item 3.

Legal Proceedings

Legal Proceedings 79 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] 81 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 93 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 94 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 129 Item 9A.

Controls and Procedures

Controls and Procedures 129 Item 9B. Other Information 132

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 132 PART III Item 10. Directors, Executive Officers and Corporate Governance 133 Item 11.

Executive Compensation

Executive Compensation 136 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 136 Item 13. Certain Relationships and Related Transactions, and Director Independence 136 Item 14. Principal Accounting Fees and Services 136 PART IV Item 15. Exhibits, Financial Statement Schedules 137 Item 16 Form 10-K Summary 139 i Table of Contents Unless the context requires otherwise, references in this report to "Allogene," "we," "us" and "our" refer to Allogene Therapeutics, Inc., and references in this report to "Servier" collectively refer to Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Amended Annual Report on Form 10-K/A contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled "Business," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations". These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: the success, cost, timing and potential indications of our product development activities and clinical trials; the timing of the initiation, enrollment and completion of planned clinical trials in the United States and foreign countries; our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; our ability to obtain funding for our operations, including funding necessary to c

Business

Item 1. Business Overview We are a clinical stage immuno-oncology company pioneering the development of genetically engineered allogeneic T cell product candidates for the treatment of cancer. We are developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. Our engineered T cells are allogeneic, meaning they are derived from healthy donors for intended use in any patient, rather than from an individual patient for that patient's use, as in the case of autologous T cells. We believe this key difference will enable us to deliver readily available treatments faster, more reliably, at greater scale, and to more patients. Chimeric antigen receptor (CAR) T cell therapy, a form of cancer immunotherapy, has emerged as a revolutionary and potentially curative therapy for patients with hematologic cancers, including refractory cancers. In 2017, the first two autologous anti-CD19 CAR T cell therapies, Kymriah, developed by Novartis International AG (Novartis), and Yescarta, developed by Kite Pharma, Inc. (Kite), were approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL) (Kymriah) and R/R large B-cell lymphoma (Yescarta). Autologous CAR T cell therapies are manufactured individually for the patient's use by modifying the patient's own T cells outside the body, causing the T cells to express CARs. The entire manufacturing process is dependent on the viability of each patient's T cells and takes approximately two to four weeks. Obtaining a manufacturing slot, collecting patient cells, and scheduling can extend the time to treatment by additional weeks. As seen in the registrational trials for Kymriah and Yescarta, up to 31% of intended patients ultimately did not receive treatment primarily due to interval complications from the underlying disease prior to delivery of therapy or manufacturing failures. Our allogeneic

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View this 10-K/A filing on SEC EDGAR