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

TL;DR

<b>Werewolf Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

Werewolf Therapeutics, Inc. (HOWL) filed a Annual Report (10-K) with the SEC on March 7, 2024. Werewolf Therapeutics, Inc. filed its 2023 Form 10-K on March 7, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. Key dates include the Jazz Collaboration Agreement, with activity noted in April 2022 and July 2023. The company is incorporated in Delaware and headquartered in Watertown, MA.

Why It Matters

For investors and stakeholders tracking Werewolf Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Werewolf Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, crucial for investors assessing the company's progress and future prospects. The detailed financial data and risk factors outlined in the report are essential for understanding the company's current market position, potential challenges, and investment risks.

Risk Assessment

Risk Level: medium — Werewolf Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by the 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Werewolf Therapeutics' operational performance and future growth potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period end date)
• 2024-03-07 — Filing Date (Date the 10-K was filed)
• 2023-01-01 — Fiscal Year Start (Reporting period start date)

Key Players & Entities

• Werewolf Therapeutics, Inc. (company) — Filer name
• HOWL (company) — Ticker symbol
• 200 Talcott Avenue, 2nd Floor, Watertown, MA 02472 (company) — Business address
• Jazz Collaboration Agreement (company) — Specific agreement mentioned

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive government regulation, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The biotechnology and pharmaceutical markets are highly competitive, with potential for rapid technological advancements and new product introductions.
• Clinical Trial Risks [high — operational]: The success of the company's drug candidates depends on the outcome of clinical trials, which are inherently uncertain and can face delays or failures.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-07: 10-K Filing Date — Official submission date of the annual report.

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 filing provides the core financial and operational data for Werewolf Therapeutics for the fiscal year 2023.)

Fiscal Year End

The last day of a company's accounting year. (Indicates the period covered by the financial statements in the 10-K.)

Key Financial Figures

• $0.0001 — ange on which registered Common Stock, $0.0001 par value per share HOWL The Nasdaq Gl

Filing Documents

• howl-20231231.htm (10-K) — 1809KB
• a12312023ex1022.htm (EX-10.22) — 43KB
• a12312023ex231.htm (EX-23.1) — 3KB
• a12312023ex311.htm (EX-31.1) — 10KB
• a12312023ex312.htm (EX-31.2) — 10KB
• a12312023ex321.htm (EX-32.1) — 7KB
• a12312023ex97.htm (EX-97) — 20KB
• howl-20231231_g1.jpg (GRAPHIC) — 65KB
• howl-20231231_g2.jpg (GRAPHIC) — 37KB
• howl-20231231_g3.jpg (GRAPHIC) — 54KB
• 0001785530-24-000012.txt (&nbsp;) — 8012KB
• howl-20231231.xsd (EX-101.SCH) — 53KB
• howl-20231231_cal.xml (EX-101.CAL) — 74KB
• howl-20231231_def.xml (EX-101.DEF) — 238KB
• howl-20231231_lab.xml (EX-101.LAB) — 671KB
• howl-20231231_pre.xml (EX-101.PRE) — 477KB
• howl-20231231_htm.xml (XML) — 802KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 34 Item 1B. Unresolved Staff Comments 87 Item 1C. Cybersecurity 87 Item 2.

Properties

Properties 88 Item 3.

Legal Proceedings

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

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 99 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 99 Item 9. Change in and Disagreements with Accountants on Accounting and Financial Disclosure 99 Item 9A.

Controls and Procedures

Controls and Procedures 99 Item 9B. Other Information 101 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 101 PART III Item 10. Directors, Executive Officers and Corporate Governance 101 Item 11.

Executive Compensation

Executive Compensation 101 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 101 Item 13. Certain Relationships and Related Transactions, and Director Independence 102 Item 14. Principal Accountant Fees and Services 102 PART IV Item 15. Exhibit and Financial Statement Schedules 103 Item 16. Form 10-K Summary 103

SIGNATURES

SIGNATURES EXHIBIT INDEX Table of Contents References to Werewolf Throughout this Annual Report on Form 10-K, or Annual Report, the "Company," "Werewolf," "Werewolf Therapeutics," "we," "us," "our," and similar references, except where the context requires otherwise, refer to Werewolf Therapeutics, Inc. and its consolidated subsidiary, and "board of directors" refers to the board of directors of Werewolf Therapeutics, Inc. Cautionary Note Regarding Forward-Looking Statements and Industry Data This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act, that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words "aim," "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," "would," or the negative of these words or other 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 initiation, timing, progress and results of our research and development programs, preclinical studies and ongoing and planned clinical trials, including the anticipated timing of data announcements; our estimates regarding expenses, capital requirements, need for additional financing and the period over which we believe our existing cash and cash equivalents will be sufficient to fund our operating

Business

Item 1. Business Company Overview We are an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body's immune system for the treatment of cancer. We are leveraging our proprietary PREDATOR platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Our INDUKINE molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment, or TME. Our most advanced clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of multiple tumor types. We are currently conducting a Phase 1/1b clinical trial to evaluate the safety and tolerability of WTX-124 in patients with immunotherapy sensitive advanced or metastatic solid tumors as a single agent and in combination with pembrolizumab, and a Phase 1 clinical trial to evaluate the safety and tolerability of WTX-330 in patients with advanced or metastatic solid tumors or lymphoma resistant to checkpoint inhibitors or for which checkpoint inhibitors are not approved. We have licensed the worldwide right to develop and commercialize JZP898, formerly WTX-613, a differentiated, conditionally activated interferon alpha, or IFN, INDUKINE molecule, to Jazz Pharmaceuticals Ireland Limited, or Jazz. We have also nominated two development candidates, WTX-712 and WTX-518. WTX-712 is a systemically delivered, conditionally activated Interleukin-21 (IL-21) INDUKINE molecule that is being developed to minimize the severe toxicities that have been observed with recombinant IL-21 therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors in refractory and/or immunologically unresponsive tumors. WTX-51

View Full Filing

View this 10-K filing on SEC EDGAR