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

TL;DR

<b>Xilio Therapeutics filed its 2023 10-K, detailing operations, agreements, and significant subsequent events including a major deal with Gilead Sciences.</b>

AI Summary

Xilio Therapeutics, Inc. (XLO) filed a Annual Report (10-K) with the SEC on April 1, 2024. Xilio Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located at 828 Winter Street, Waltham, MA. Key agreements include license agreements with City of Hope, Askgene, Wuxi Biologics, and F. Hoffmann-La Roche Ltd. Subsequent events include a private placement and a stock purchase agreement with Gilead Sciences, Inc. in March 2024. The filing covers the fiscal year ending December 31, 2023, with data points for common stock, retained earnings, and additional paid-in capital for 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking Xilio Therapeutics, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Xilio's financial health, operational status, and strategic partnerships as of year-end 2023. Subsequent events, particularly the March 2024 transactions with Gilead Sciences, Inc., indicate significant strategic shifts and potential future developments for the company.

Risk Assessment

Risk Level: medium — Xilio Therapeutics, Inc. shows moderate risk based on this filing. The company's financial performance and future prospects are heavily dependent on the success of its clinical development programs and strategic partnerships, which carry inherent risks typical of the biotechnology sector.

Analyst Insight

Monitor the progress and outcomes of Xilio's clinical trials and the integration of its strategic partnerships, especially the recent agreements with Gilead Sciences, to assess future growth potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-04-01 — Filing Date (Date of submission)
• 2024-03-28 — Subsequent Event Date (Private placement and Gilead stock purchase agreement)
• 2021-10-01 — Stock Incentive Plan Start Date (Xilio Stock Incentive Plan 2021)
• 2016-08-01 — License Agreement Start Date (City of Hope License Agreement)

Key Players & Entities

• Xilio Therapeutics, Inc. (company) — Filer name
• 2023-12-31 (date) — Fiscal year end
• 828 Winter Street, Waltham, MA (location) — Business address
• City of Hope (company) — License agreement partner
• Gilead Sciences, Inc. (company) — Subsequent event partner
• 2024-03-28 (date) — Subsequent event date
• F. Hoffmann-La Roche Ltd. (company) — Clinical supply agreement partner
• Wuxi Biologics (company) — License agreement partner

FAQ

Risk Factors

• Net Losses and Need for Additional Financing [high — financial]: The company has a history of net losses and expects to continue incurring net losses, requiring substantial additional funding to support its operations and development programs.
• Regulatory Approval Process [high — regulatory]: The development and commercialization of the company's product candidates are subject to extensive regulatory review and approval processes by health authorities, which are lengthy and uncertain.
• Competition [medium — market]: The biotechnology industry is highly competitive, with many companies developing therapies for similar diseases, posing a risk to market penetration and success.
• Reliance on Third-Party Manufacturers [medium — operational]: The company relies on third-party manufacturers for the production of its product candidates, creating dependence and potential supply chain risks.
• Intellectual Property Rights [medium — financial]: The company's ability to protect its intellectual property and avoid infringement claims is critical for its long-term success and competitive position.

Key Financial Figures

• $0.0001 — ch Registered Common stock, par value $0.0001 per share XLO Nasdaq Global Select
• $0.64 — hares of our common stock at a price of $0.64 per share and prefunded warrants to pur
• $0.6399 — our common stock at a purchase price of $0.6399 per prefunded warrant share, through a
• $11.3 m — the private placement of approximately $11.3 million, before deducting placement agent

Filing Documents

• xlo-20231231x10k.htm (10-K) — 2249KB
• xlo-20231231xex10d18.htm (EX-10.18) — 98KB
• xlo-20231231xex21d1.htm (EX-21.1) — 6KB
• xlo-20231231xex23d1.htm (EX-23.1) — 9KB
• xlo-20231231xex31d1.htm (EX-31.1) — 13KB
• xlo-20231231xex31d2.htm (EX-31.2) — 13KB
• xlo-20231231xex32d1.htm (EX-32.1) — 9KB
• xlo-20231231xex97.htm (EX-97) — 28KB
• xlo-20231231x10k001.jpg (GRAPHIC) — 60KB
• xlo-20231231x10k003.jpg (GRAPHIC) — 75KB
• xlo-20231231x10k004.jpg (GRAPHIC) — 47KB
• xlo-20231231x10k005.jpg (GRAPHIC) — 14KB
• xlo-20231231x10k006.jpg (GRAPHIC) — 71KB
• 0001558370-24-004530.txt (&nbsp;) — 8552KB
• xlo-20231231.xsd (EX-101.SCH) — 49KB
• xlo-20231231_cal.xml (EX-101.CAL) — 49KB
• xlo-20231231_def.xml (EX-101.DEF) — 191KB
• xlo-20231231_lab.xml (EX-101.LAB) — 475KB
• xlo-20231231_pre.xml (EX-101.PRE) — 382KB
• xlo-20231231x10k_htm.xml (XML) — 975KB

Business

Item 1. Business 5

Risk Factors

Item 1A. Risk Factors 49

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 119

Cybersecurity

Item 1C. Cybersecurity 119

Properties

Item 2. Properties 120

Legal Proceedings

Item 3. Legal Proceedings 120

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 120 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 120

[Reserved]

Item 6. [Reserved] 120

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 121

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 136

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 136

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 136

Controls and Procedures

Item 9A. Controls and Procedures 136

Other Information

Item 9B. Other Information 138

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 138 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 138

Executive Compensation

Item 11. Executive Compensation 138

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 139

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 139

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 139 PART IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 140

Form 10-K Summary

Item 16. Form 10-K Summary 142 i Table of Contents References to Xilio Unless otherwise stated, all references to "us," "our," "we," "Xilio," "Xilio Therapeutics," "the Company" and similar references in this Annual Report on Form 10-K refer to Xilio Therapeutics, Inc. and its consolidated subsidiaries. Xilio Therapeutics and its associated logos are registered trademarks of Xilio Therapeutics, Inc. Other brands, names and trademarks contained in this Annual Report on Form 10-K are the property of their respective owners. Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by words such as "aim," "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would," or the negative of these words or other comparable terminology, although not all forward-looking statements contain these identifying words. The forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about: our ability to secure sufficient additional capital in the near term or implement other strategies needed to alleviate our current doubt about our ability to continue as a going concern; our estimates regarding expenses, future revenue and capital requirements and our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents; the initiation, timing, progress and results of our research and development programs, including preclinical studies and clinical trials;

Business

Item 1. Business Overview We are a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. We are leveraging our proprietary platform to build a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines and antibodies (including bispecifics) and immune cell engagers (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers). Current I-O therapies have curative potential for patients with cancer; however, their potential is significantly curtailed by systemic toxicity that results from activity of the therapeutic molecule outside the tumor microenvironment. Our molecules are engineered to localize activity within the tumor microenvironment with minimal systemic effects, resulting in the potential to achieve enhanced anti-tumor activity and increasing the population of patients who may be eligible to receive our medicines. Our most advanced tumor-activated, clinical-stage product candidates are XTX101, an Fc-enhanced, anti-CTLA-4 monoclonal antibody, or mAb, XTX301, an interleukin 12, or IL-12, therapy, and XTX202, an interleukin 2, or IL-2, therapy. In 2023, we presented clinical data across these programs showing initial clinical validation for each of these molecules and our tumor-activated approach. In addition to our clinical-stage product candidates, we are continuing to leverage our differentiated research platform and expertise in developing tumor-activated I-O therapies to advance preclinical development for tumor-activated bispecific molecules and immune cell engager molecules (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers). XTX101

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View this 10-K filing on SEC EDGAR