Adicet Bio, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Adicet Bio, Inc. has filed its 2023 10-K report detailing its fiscal year-end operations and financial standing.</b>

AI Summary

Adicet Bio, Inc. (ACET) filed a Annual Report (10-K) with the SEC on March 19, 2024. Adicet Bio, Inc. filed its 2023 Form 10-K on March 19, 2024, reporting on its fiscal year ended December 31, 2023. The company's principal executive offices are located at 200 Berkeley Street, 19th Floor, Boston, MA 02116. Adicet Bio, Inc. was formerly known as resTORbio, Inc., with a name change effective October 24, 2017. The filing includes information on various financial instruments, including common stock, stock options, restricted stock units, and warrants. Key dates mentioned include a sales agreement in November 2022 and a subsequent event related to common stock on January 22, 2024.

Why It Matters

For investors and stakeholders tracking Adicet Bio, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Adicet Bio's financial health, operational activities, and strategic direction for the fiscal year 2023, crucial for investors to assess the company's performance and future prospects. The detailed financial disclosures, including information on equity, debt, and various financial instruments, are essential for understanding the company's capital structure and potential risks.

Risk Assessment

Risk Level: medium — Adicet Bio, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by the nature of its business and the mention of various financial instruments and agreements.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Adicet Bio's current financial position and future development pipeline.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-19 — Filing Date (Date the 10-K was filed)
• 001-38359 — SEC File Number (SEC file number for Adicet Bio, Inc.)
• 2017-10-24 — Name Change Date (Date of former company name change)
• 2024-01-22 — Subsequent Event Date (Date of a subsequent event concerning common stock)

Key Players & Entities

• Adicet Bio, Inc. (company) — Filer name and subject of the report
• resTORbio, Inc. (company) — Former name of Adicet Bio, Inc.
• 200 Berkeley Street, 19th Floor, Boston, MA 02116 (company) — Business and mailing address
• 2023-12-31 (date) — Conformed period of report
• 2024-03-19 (date) — Filed as of date
• Jefferies LLC (company) — Mentioned in relation to pre-funded warrants and subsequent events
• Regeneron Pharmaceuticals Incorporation (company) — Mentioned in relation to a maximum period
• 2024-01-22 (date) — Subsequent event date related to common stock

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the Federal Food, Drug, and Cosmetic Act, which impacts its product development and commercialization efforts.
• Need for Additional Funding [high — financial]: Adicet Bio has a history of net losses and expects to incur significant expenses in the future, requiring substantial additional funding to continue operations.
• Reliance on Key Personnel [medium — operational]: The success of the company depends on its ability to attract and retain highly qualified scientific and management personnel.
• Competition [medium — market]: The biotechnology industry is highly competitive, with many companies developing similar therapies, posing a risk to Adicet Bio's market position.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share ACET The Nasdaq Global Ma
• $2.43 — 6.7 million based on a closing price of $2.43 per share as quoted by The Nasdaq Globa

Filing Documents

• acet-20231231.htm (10-K) — 2446KB
• acet-ex10_39.htm (EX-10.39) — 366KB
• acet-ex19_1.htm (EX-19.1) — 127KB
• acet-ex23_1.htm (EX-23.1) — 4KB
• acet-ex31_1.htm (EX-31.1) — 16KB
• acet-ex31_2.htm (EX-31.2) — 16KB
• acet-ex32_1.htm (EX-32.1) — 8KB
• acet-ex97_1.htm (EX-97.1) — 35KB
• img18334421_0.jpg (GRAPHIC) — 2KB
• img104831930_0.jpg (GRAPHIC) — 74KB
• img104831930_1.jpg (GRAPHIC) — 83KB
• img104831930_2.jpg (GRAPHIC) — 78KB
• img104831930_3.jpg (GRAPHIC) — 81KB
• img110885244_0.jpg (GRAPHIC) — 89KB
• img110885244_1.jpg (GRAPHIC) — 44KB
• 0000950170-24-033482.txt (&nbsp;) — 11956KB
• acet-20231231.xsd (EX-101.SCH) — 2102KB
• acet-20231231_htm.xml (XML) — 1427KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 37 Item 1B. Unresolved Staff Comments 87 Item 1C. Cybersecurity 87 Item 2.

Properties

Properties 87 Item 3.

Legal Proceedings

Legal Proceedings 87 Item 4. Mine Safety Disclosures 88 PART II 89 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 89 Item 6. [ Reserved ] 89 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 90 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 100 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 101 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 101 Item 9A.

Controls and Procedures

Controls and Procedures 101 Item 9B. Other Information 102 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 102 PART III 103 Item 10. Directors, Executive Officers and Corporate Governance 103 Item 11.

Executive Compensation

Executive Compensation 103 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 103 Item 13. Certain Relationships and Related Transactions, and Director Independence 103 Item 14. Principal Accountant Fees and Services 103 PART IV 104 Item 15. Exhibits and Financial Statement Schedules 104 Item 16. Form 10-K Summary 136 ii SPECIAL NOTE REGARDING FORWARD-LOO KING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Annual Report on Form 10-K, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: the timing of and our ability to execute our clinical trials for ADI-001 in autoimmune indications and non-Hodgkin's lymphoma (NHL), including the ability to successfully complete our Phase 1 clinical trial in NHL and initiate a Phase 1 clinical trial in lupus nephritis (LN) and additional potential autoimmune indications; our expectations regarding our additional internal gamma delta T cell therapy programs in preclinical development, including ADI-270, and our ability to develop other product candidates in our research pipeline; our expectations regarding the availability, timing and announcement of data from our Phase 1 clinical trials for ADI-001; our expectations for ADI-270 as a

B usiness

Item 1. B usiness. Overview We are a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. We are advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. Our allogeneic "off-the-shelf" manufacturing process is designed to allow product from unrelated donors to be stored and sold on demand to treat patients without inducing a graft versus host immune response. This is in contrast to products based on alpha beta T cells, which either must be manufactured for each patient from his or her own T cells, or require significant gene editing to manufacture if the T cells are derived from donors that are unrelated to the patient. Our lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20, is being developed for the potential treatment of autoimmune diseases and relapsed or refractory aggressive B cell non-Hodgkin's lymphoma (NHL). Our pipeline also includes our lead preclinical candidate, ADI-270, an armored gamma delta CAR T cell product candidate targeting renal cell carcinoma, with potential for other CD70+ solid tumor and hematological malignancies indications. Our pipeline has several additional internal gamma delta T cell therapy programs in discovery and preclinical development for both hematological malignancies and solid tumors. We expect to continue to develop product candidates in autoimmune diseases and cancer based on our gamma delta T cell platform using either previously validated antigens or those that we identify and target using CAR and other technology. We plan to

View Full Filing

View this 10-K filing on SEC EDGAR