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

TL;DR

<b>Instil Bio, Inc. has filed its 2023 10-K, providing a comprehensive overview of its financial health and operational status.</b>

AI Summary

Instil Bio, Inc. (TIL) filed a Annual Report (10-K) with the SEC on March 21, 2024. Instil Bio, Inc. filed its 2023 Form 10-K on March 21, 2024, reporting on its fiscal year ended December 31, 2023. The filing details the company's financial position, business operations, and risk factors. Key financial data for the fiscal year 2023 is presented, including balance sheet items and equity components. The report includes information on assets such as laboratory equipment, buildings, and assets held for sale. It also references restructuring plans and potential geographic concentration risks for cash and cash equivalents.

Why It Matters

For investors and stakeholders tracking Instil Bio, Inc., this filing contains several important signals. This 10-K filing is crucial for investors to understand Instil Bio's financial performance and strategic direction over the past fiscal year. The detailed risk factors and financial data will help stakeholders assess the company's stability and future prospects in the biotechnology sector.

Risk Assessment

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

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to assess Instil Bio's long-term viability and potential for growth.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the 10-K report)
• 2024-03-21 — Filing Date (Date the 10-K was filed with the SEC)
• 2836 — SIC Code (Standard Industrial Classification for Biological Products)

Key Players & Entities

• Instil Bio, Inc. (company) — Filer of the 10-K report
• 2023 (date) — Fiscal year end
• 2024-03-21 (date) — Filing date
• 2836 (dollar_amount) — Standard Industrial Classification for Biological Products
• Dallas, TX (location) — Company business and mailing address

FAQ

Risk Factors

• Regulatory Risks [medium — regulatory]: The company is subject to extensive government regulation, which can impact its operations and product development.
• Market Competition [medium — market]: The biotechnology market is highly competitive, with potential for new entrants and rapid technological advancements.
• Operational Challenges [medium — operational]: The company may face challenges in manufacturing, supply chain management, and scaling operations.
• Financing Risks [high — financial]: The company may require significant additional funding to support its research, development, and commercialization efforts.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-21: 10-K Filing Date — Indicates when the annual report was submitted to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This is the primary document Instil Bio uses to report its annual financial results and business overview.)

Restructuring Plan

A plan implemented by a company to reorganize its business operations, often to improve efficiency or profitability. (Indicates Instil Bio may be undergoing significant operational changes.)

Key Financial Figures

• $0.000001 — ange on which registered Common Stock, $0.000001 par value per share TIL The Nasdaq Stoc
• $11.02 — Nasdaq Stock Market on June 30, 2023 of $11.02 per share. Indicate the number of shar

Filing Documents

• til-20231231.htm (10-K) — 1580KB
• amendedandrestatedcertific.htm (EX-3.1) — 46KB
• exhibit106amendedandrestat.htm (EX-10.6) — 20KB
• a-23ex231consentofdeloitte.htm (EX-23.1) — 2KB
• a-23ex311certificationofpr.htm (EX-31.1) — 18KB
• a-23ex312certificationofpr.htm (EX-31.2) — 18KB
• a-23ex321certificationceo2.htm (EX-32.1) — 7KB
• a-23ex322certificationcfo2.htm (EX-32.2) — 7KB
• exhibit971clawbackpolicy.htm (EX-97.1) — 39KB
• 0001789769-24-000036.txt (&nbsp;) — 7802KB
• til-20231231.xsd (EX-101.SCH) — 42KB
• til-20231231_cal.xml (EX-101.CAL) — 91KB
• til-20231231_def.xml (EX-101.DEF) — 253KB
• til-20231231_lab.xml (EX-101.LAB) — 610KB
• til-20231231_pre.xml (EX-101.PRE) — 456KB
• til-20231231_htm.xml (XML) — 998KB

Risk Factors

Item 1A. Risk Factors 18

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 82

Cybersecurity

Item 1C. Cybersecurity 82

Properties

Item 2. Properties 84

Legal Proceedings

Item 3. Legal Proceedings 84

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 84 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 85

Reserved

Item 6. Reserved 85

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

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 86

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 97

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 98

Changes In and Disagreement With Accountants on Accounting and Financial Disclosure

Item 9. Changes In and Disagreement With Accountants on Accounting and Financial Disclosure 125

Controls and Procedures

Item 9A. Controls and Procedures 125

Other Information

Item 9B. Other Information 127

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 127 Part III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 128

Executive Compensation

Item 11. Executive Compensation 128

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 128

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 128

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 128 Part IV

Exhibits, Financial Statement Schedules

Item 15. Exhibits, Financial Statement Schedules 129

Form 10-K Summary

Item 16. Form 10-K Summary 131

Signatures

Signatures 132 1 Part I

Business

Item 1. Business. Overview We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. We seek to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need. Our first such program is an engineered tumor infiltrating lymphocyte, or TIL, cell therapy for the treatment of cancer, which we acquired in 2020. We intend to evaluate and explore additional opportunities to in-license promising therapeutic candidates. Using our Co-Stimulatory Antigen Receptor, or CoStAR, platform we generated ITIL-306, a genetically modified TIL targeting folate receptor alpha, or FR, which was previously our lead product candidate. These modified TILs, or CoStAR-TILs, provide potent costimulation to T cells within the tumor microenvironment by expressing novel CoStAR molecules which bind to tumor associated antigens, such as FR. In October 2022, we announced the successful dosing of the first patient with non-small cell lung cancer, or NSCLC, in a Phase 1 clinical trial of ITIL-306 in the United States, ITIL-306-201. In 2023, we closed our U.S. manufacturing and clinical trial operations, ceased enrollment in the ITIL-306-201 clinical trial and pivoted our manufacturing and clinical operations to the UK with the expectation of commencing another phase 1 clinical trial of ITIL-306 in the United States and United Kingdom, ITIL-306-202, in 2023. In January 2024, we announced that we plan to close our UK manufacturing and clinical trial operations. As a result, we have ceased all ITIL-306 Phase 1 clinical trial activities. In January 2024, we announced that we entered into an agreement with a third-party to develop an autologous FR CoStAR-TIL, or the Collaboration Product, for potential open-label investigator-initiated trials, or IITs, in NSCLC in China. Initial feasibility studies for the Collaboration Product have been completed and, assuming continued collaboration progress, the next steps would

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View this 10-K filing on SEC EDGAR