Werewolf Therapeutics(HOWL) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights This section summarizes Werewolf Therapeutics' Q2 2025 financial results and key clinical and preclinical program advancements Executive Summary Werewolf Therapeutics reported Q2 2025 financial results, highlighting clinical and preclinical program advancements and upcoming WTX-124 interim data - Interim data from the WTX-124 Phase 1/1b clinical trial is expected in Q4 2025, including monotherapy and combination therapy expansion cohort data for cutaneous melanoma and renal cell carcinoma patients[1][2] - The company plans to communicate with the U.S. Food and Drug Administration (FDA) in H2 2025 to discuss potential registration pathways for WTX-124 in advanced or metastatic cutaneous melanoma[1][2] - The WTX-330 Phase 1b/2 clinical trial is actively recruiting patients, with dosing regimen determination expected by the end of 2025[1] - The company launched WTX-1011, its first INDUCER T-cell engager development candidate targeting STEAP1 for prostate cancer treatment[1][2] Recent Highlights and Upcoming Milestones This section details progress of clinical-stage INDUKINE molecules and preclinical INDUCER candidates, outlining key milestones for 2025 Clinical-Stage INDUKINE Molecules Clinical-stage INDUKINE molecules WTX-124 and WTX-330 show significant progress, with WTX-124 interim data expected in Q4 2025 WTX-124 WTX-124, an IL-2 INDUKINE molecule, is actively recruiting patients in expansion cohorts, with interim data and regulatory discussions planned for H2 2025 - All expansion cohorts of the WTX-124 Phase 1/1b clinical trial are actively recruiting patients at a recommended dose of 18 mg intravenously every two weeks[3] - Interim data, including tolerability, response rates, and durability for cutaneous melanoma and renal cell carcinoma patients, is expected in Q4 2025[3] - The company expects to engage with regulatory authorities in H2 2025 to discuss potential registration pathways for WTX-124 in advanced or metastatic cutaneous melanoma[3] WTX-330 WTX-330, an IL-12 INDUKINE molecule, is actively recruiting patients for its Phase 1b/2 clinical trial, with dosing regimen expected by year-end 2025 - WTX-330 is actively recruiting patients in its Phase 1b/2 clinical trial for locally advanced or metastatic solid tumors[3] - The dosing regimen for WTX-330 is expected to be determined by the end of 2025[3] Preclinical-Stage INDUCER Molecules Preclinical INDUCER molecule WTX-1011 shows positive progress with PREDATOR masking technology, and additional candidates are planned for H2 2025 WTX-1011 WTX-1011, a potential first-in-class anti-STEAP1 T-cell engager, demonstrates improved therapeutic index and suppressed peripheral activity in preclinical studies - WTX-1011 is a potential first-in-class conditionally activated anti-STEAP1 T-cell engager designed to improve the therapeutic index, targeting STEAP1 expressed in prostate cancer with limited normal tissue expression[8] - Preclinical data demonstrate that PREDATOR masking technology successfully inhibited peripheral activity and prevented cytokine release[8] - WTX-1011 exhibits a half-life of nearly 100 hours in cynomolgus monkeys, with less than 0.7% active INDUCER molecules detected peripherally[8] - The company expects to nominate additional INDUCER candidates in H2 2025[8] Preclinical-Stage INDUKINE Portfolio Werewolf Therapeutics' preclinical INDUKINE portfolio, including WTX-712, WTX-518, and WTX-921, is available for collaborative development - Werewolf Therapeutics' preclinical-stage INDUKINE molecules WTX-712 (IL-21), WTX-518 (IL-18), and WTX-921 (IL-10, for inflammatory bowel disease and other inflammatory conditions) are all available for collaborative development[5] Financial Results for the Second Quarter of 2025 This section presents Werewolf Therapeutics' unaudited financial performance for Q2 2025, including statements of operations and balance sheet Q2 2025 Financial Summary As of June 30, 2025, Werewolf Therapeutics held $77.6 million in cash, sufficient to fund operations through Q4 2026, with decreased R&D and G&A expenses Key Financial Metrics for Q2 2025 | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :---------- | | Research and Development Expenses | 13.1 | 15.3 | -14.4% | | General and Administrative Expenses | 4.4 | 4.8 | -8.3% | | Net Loss | 18.0 | 17.2 | +4.7% | Cash and Cash Equivalents | Date | Amount (Millions USD) | | :----------- | :-------------------- | | June 30, 2025 | 77.6 | | March 31, 2025 | 92.0 | - The company expects its existing cash and cash equivalents as of June 30, 2025, to be sufficient to fund operating expenses and capital expenditure requirements through Q4 2026[8] Condensed Consolidated Statements of Operations (unaudited) Werewolf Therapeutics reported no collaboration revenue in Q2 and H1 2025, with decreased R&D and G&A expenses, but a slightly expanded net loss Condensed Consolidated Statements of Operations (unaudited) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Three Months Ended June 30, 2024 (Thousands USD) | Six Months Ended June 30, 2025 (Thousands USD) | Six Months Ended June 30, 2024 (Thousands USD) | | :------------------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Collaboration revenue | $ — | $ 1,143 | $ — | $ 1,885 | | Research and development expenses | 13,143 | 15,271 | 26,263 | 28,179 | | General and administrative expenses | 4,399 | 4,832 | 9,270 | 9,828 | | Total operating expenses | 17,542 | 20,103 | 35,533 | 38,007 | | Operating loss | (17,542) | (18,960) | (35,533) | (36,122) | | Other (expense) income | (440) | 1,711 | (538) | 2,680 | | Net loss | $ (17,982) | $ (17,249) | $ (36,071) | $ (33,442) | | Net loss per common share, basic (USD) | $ (0.40) | $ (0.40) | $ (0.80) | $ (0.79) | | Net loss per common share, diluted (USD) | $ (0.40) | $ (0.43) | $ (0.80) | $ (0.82) | | Weighted-average common shares outstanding, basic | 44,981,746 Shares | 43,521,406 Shares | 44,904,880 Shares | 42,564,342 Shares | | Weighted-average common shares outstanding, diluted | 44,981,746 Shares | 44,043,184 Shares | 44,904,880 Shares | 42,825,231 Shares | Selected Condensed Consolidated Balance Sheet Data (unaudited) As of June 30, 2025, Werewolf Therapeutics' cash, working capital, and total assets decreased from December 31, 2024, impacting stockholders' equity Selected Condensed Consolidated Balance Sheet Data (unaudited) | Metric | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :------------------------------------------- | :------------------------------ | :-------------------------------- | | Cash and cash equivalents | $ 77,596 | $ 110,995 | | Working capital | $ 65,268 | $ 97,886 | | Total assets | $ 92,566 | $ 126,929 | | Total notes payable, net of discount and issuance costs | $ 27,105 | $ 26,095 | | Total stockholders' equity | $ 41,464 | $ 73,390 | About Werewolf Therapeutics This section outlines Werewolf Therapeutics' mission, PREDATOR platform, and lead product candidates for cancer and immune-mediated diseases Company Mission and Platform Werewolf Therapeutics develops engineered conditionally activated therapies to stimulate the immune system for cancer and immune-mediated diseases via its PREDATOR platform - Werewolf Therapeutics is a biopharmaceutical company focused on developing conditionally activated therapies to stimulate the immune system for cancer and immune-mediated diseases[7] - The company utilizes its PREDATOR platform to design INDUKINE and INDUCER molecules, aiming to stimulate both adaptive and innate immunity to address limitations of conventional pro-inflammatory immunotherapies[7] - INDUKINE molecules are designed to remain inactive in peripheral tissues but selectively activate within the tumor microenvironment[7] - Lead clinical-stage candidates include WTX-124 (IL-2) and WTX-330 (IL-12) INDUKINE molecules for solid tumors, and the first INDUCER development candidate, WTX-1011, targeting STEAP1 for prostate cancer[7] Additional Information This section provides important disclaimers regarding forward-looking statements, trademark information, and company contact details Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements involving significant risks and uncertainties regarding company strategy, operations, product development, and financial projections - This press release contains forward-looking statements concerning company strategy, future operations, product development timelines, regulatory interactions, potential activity and safety of product candidates, and cash flow projections[9] - Actual results may differ materially due to inherent uncertainties in product development, availability and timing of clinical trial results, regulatory approvals, and the company's ability to manage cash resources[9] - The company undertakes no obligation to update these forward-looking statements, and investors should not place undue reliance on them[9] Trademarks WEREWOLF, PREDATOR, INDUKINE, INDUCER, and associated logos are trademarks or registered trademarks of Werewolf Therapeutics, Inc - WEREWOLF, the WEREWOLF logo, PREDATOR, INDUKINE, INDUCER, and other related graphics and logos are trademarks or registered trademarks of Werewolf Therapeutics, Inc. in the U.S. and other countries[10] Contacts Contact information is provided for investors, media, and company representatives for further communication - Investor Contact: Dan Ferry (LifeSci Advisors)[15] - Media Contact: Amanda Sellers (Deerfield Group)[15] - Company Contact: Tim Trost (Chief Financial Officer, Werewolf Therapeutics)[15]