[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) This section summarizes Werewolf Therapeutics' Q2 2025 financial results and key clinical and preclinical program advancements [Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) - The WTX-330 Phase 1b/2 clinical trial is actively recruiting patients, with dosing regimen determination expected by the **end of 2025**[1](index=1&type=chunk) - The company launched WTX-1011, its first INDUCER T-cell engager development candidate targeting STEAP1 for prostate cancer treatment[1](index=1&type=chunk)[2](index=2&type=chunk) [Recent Highlights and Upcoming Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Upcoming%20Milestones) This section details progress of clinical-stage INDUKINE molecules and preclinical INDUCER candidates, outlining key milestones for 2025 [Clinical-Stage INDUKINE Molecules](index=1&type=section&id=Clinical-Stage%20INDUKINE%20Molecules) Clinical-stage INDUKINE molecules WTX-124 and WTX-330 show significant progress, with WTX-124 interim data expected in Q4 2025 [WTX-124](index=1&type=section&id=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](index=3&type=chunk) - Interim data, including tolerability, response rates, and durability for cutaneous melanoma and renal cell carcinoma patients, is expected in **Q4 2025**[3](index=3&type=chunk) - 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](index=3&type=chunk) [WTX-330](index=1&type=section&id=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](index=3&type=chunk) - The dosing regimen for WTX-330 is expected to be determined by the **end of 2025**[3](index=3&type=chunk) [Preclinical-Stage INDUCER Molecules](index=2&type=section&id=Preclinical-Stage%20INDUCER%20Molecules) Preclinical INDUCER molecule WTX-1011 shows positive progress with PREDATOR masking technology, and additional candidates are planned for H2 2025 [WTX-1011](index=2&type=section&id=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](index=8&type=chunk) - Preclinical data demonstrate that PREDATOR masking technology successfully inhibited peripheral activity and prevented cytokine release[8](index=8&type=chunk) - WTX-1011 exhibits a half-life of nearly **100 hours** in cynomolgus monkeys, with less than **0.7%** active INDUCER molecules detected peripherally[8](index=8&type=chunk) - The company expects to nominate additional INDUCER candidates in **H2 2025**[8](index=8&type=chunk) [Preclinical-Stage INDUKINE Portfolio](index=2&type=section&id=Preclinical-Stage%20INDUKINE%20Portfolio) 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](index=5&type=chunk) [Financial Results for the Second Quarter of 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%20of%202025) This section presents Werewolf Therapeutics' unaudited financial performance for Q2 2025, including statements of operations and balance sheet [Q2 2025 Financial Summary](index=2&type=section&id=Q2%202025%20Financial%20Summary) 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](index=8&type=chunk) [Condensed Consolidated Statements of Operations (unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28unaudited%29) 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)](index=4&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data%20%28unaudited%29) 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](index=2&type=section&id=About%20Werewolf%20Therapeutics) This section outlines Werewolf Therapeutics' mission, PREDATOR platform, and lead product candidates for cancer and immune-mediated diseases [Company Mission and Platform](index=2&type=section&id=Company%20Mission%20and%20Platform) 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](index=7&type=chunk) - 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](index=7&type=chunk) - INDUKINE molecules are designed to remain inactive in peripheral tissues but selectively activate within the tumor microenvironment[7](index=7&type=chunk) - 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](index=7&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides important disclaimers regarding forward-looking statements, trademark information, and company contact details [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) 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](index=9&type=chunk) - 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](index=9&type=chunk) - The company undertakes no obligation to update these forward-looking statements, and investors should not place undue reliance on them[9](index=9&type=chunk) [Trademarks](index=3&type=section&id=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](index=10&type=chunk) [Contacts](index=5&type=section&id=Contacts) Contact information is provided for investors, media, and company representatives for further communication - Investor Contact: Dan Ferry (LifeSci Advisors)[15](index=15&type=chunk) - Media Contact: Amanda Sellers (Deerfield Group)[15](index=15&type=chunk) - Company Contact: Tim Trost (Chief Financial Officer, Werewolf Therapeutics)[15](index=15&type=chunk)

Core Insights - Werewolf Therapeutics is advancing its clinical trials for WTX-124 and WTX-330, with significant milestones expected in 2025, including interim data readouts and FDA engagement [1][2][5] Clinical Development - WTX-124 is a conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, currently in a Phase 1/1b clinical trial for cutaneous melanoma and renal cell carcinoma, with interim data expected in Q4 2025 [1][5] - WTX-330, an Interleukin-12 (IL-12) INDUKINE molecule, is in a Phase 1b/2 clinical trial for advanced solid tumors, with dosing regimen determination anticipated by the end of 2025 [1][5] - The company has introduced WTX-1011, its first INDUCER T-cell engager targeting STEAP1 for prostate cancer, which has shown promising preclinical data [2][5] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of $77.6 million, down from $92.0 million as of March 31, 2025, indicating a need for careful cash management [11][15] - Research and development expenses for Q2 2025 were $13.1 million, a decrease from $15.3 million in Q2 2024, while general and administrative expenses also saw a decline [11][14] - The net loss for Q2 2025 was $18.0 million, slightly higher than the $17.2 million loss reported in the same period of 2024 [11][14]

Core Viewpoint - Werewolf Therapeutics is advancing its innovative approach to cancer treatment through conditionally activated therapeutics, specifically focusing on the WTX-124 molecule for renal cell carcinoma and other solid tumors [1][2][4]. Group 1: Company Overview - Werewolf Therapeutics, Inc. is a biopharmaceutical company focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions [4]. - The company utilizes its proprietary PREDATOR platform to create conditionally activated molecules that selectively activate in the tumor microenvironment while remaining inactive in peripheral tissues [4]. - The most advanced product candidates include WTX-124 and WTX-330, which are designed for the treatment of solid tumors and Non-Hodgkin Lymphoma, respectively [4]. Group 2: Clinical Development and Research - Dr. Randi Isaacs, Chief Medical Officer, will present at the KidneyCAN 7th Annual Kidney Cancer Research Summit, focusing on the early clinical findings of WTX-124 [1][2]. - WTX-124 is a tumor-activated IL-2 INDUKINE molecule aimed at improving the therapeutic index by maximizing anti-tumor activity while minimizing systemic side effects [2]. - The "Full Moon Moment" campaign supports ongoing national trials for WTX-124, which is actively enrolling patients with advanced or metastatic renal cell carcinoma [3]. Group 3: Clinical Trial Outcomes - Early responses in clinical trials have been reported, including a patient with cutaneous squamous cell carcinoma who has been in remission for over a year [3]. - The campaign emphasizes the potential outcomes of the INDUKINE molecules in activating tumor-killing properties within the tumor microenvironment [3].

Pipeline and Platform - Werewolf Therapeutics' INDUKINE platform delivers potent payloads with improved therapeutic index [6] - The PREDATOR platform is validated and differentiated, focusing on clinical opportunities [8] - The company's pipeline includes WTX-124 (IL-2), WTX-330 (IL-12), WTX-712 (IL-21), WTX-518 (IL-18), WTX-921 (IL-10), and IFNα INDUKINE [7] - T cell engagers INDUCER molecules, first development candidate to be nominated in 2Q25 [16] Financial Status - As of March 31, 2025, Werewolf Therapeutics had $92.0 million in cash and cash equivalents [7] - The company's cash runway extends into 4Q26 [7] - Approximately 44.9M shares outstanding as of May 2, 2025 [196] Clinical Trial Results - WTX-124 - WTX-124 monotherapy induced rapid, durable regressions of target lesions in some patients [46] - In a Phase 1/1b study, WTX-124 was generally well-tolerated as a monotherapy in the outpatient setting [42] - WTX-124 in combination with pembrolizumab demonstrated durable responses in ICI-treated patients [58] - WTX-124 dosed at 18 mg IV Q2W has a ~1.5-fold higher Cmax than HD IL-2 [64] - Peak free IL-2 exposure after WTX-124 18 mg is ~146-fold lower than HD IL-2 [64] Clinical Trial Results - WTX-330 - WTX-330 delivered 22-fold greater IL-12 to patients compared to rhIL-12 therapy [124] - Peak free IL-12 exposure after 0.024 mg/kg WTX-330 is ~5-fold lower than rhIL-12 at its MTD [127] - One patient with a confirmed PR (RECIST 1.1) and an additional seven patients with stable target lesions (n=15) [101] - WTX-330 was Generally Well Tolerated as a Monotherapy in the Outpatient Setting [97] Market Opportunity - The total market for four tumor types in WTX-124 development strategy is ~$23B [77] - Market Potential in the US in Advanced/Metastatic Melanoma ~$4.1B Spanning 1L-3L [80] - A total of ~20 additional tumor types with US revenue of ~$27B [78]

Core Insights - Werewolf Therapeutics, Inc. is focused on developing conditionally activated therapeutics aimed at enhancing the immune system for cancer treatment and other immune-mediated conditions [1][3] - The company will participate in a panel discussion at the BIO International Convention, highlighting the potential of its biologics to redefine oncology treatment paradigms [2] Company Overview - Werewolf Therapeutics utilizes its proprietary PREDATOR® platform to create therapeutics that stimulate both adaptive and innate immunity, addressing limitations of traditional immune therapies [3] - The company's leading clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [3] Clinical Trials and Initiatives - The "Full Moon Moment" initiative aims to raise awareness of ongoing clinical trials, including one for WTX-124, which has shown promising results, including a patient with cutaneous squamous cell carcinoma in remission for over a year [2] - WTX-124 is being evaluated as a single agent and in combination with immune checkpoint inhibitors across multiple tumor types [3]

Core Viewpoint - Werewolf Therapeutics, Inc. (HOWL) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, making it a valuable tool for investors [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Company Performance and Investor Sentiment - The upgrade reflects an improvement in Werewolf Therapeutics' underlying business, which is expected to drive stock appreciation as investors recognize this positive trend [5]. - Over the past three months, the Zacks Consensus Estimate for Werewolf Therapeutics has increased by 6.6%, indicating a positive revision trend [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, suggesting a strong potential for market-beating returns [9][10]. - The upgrade of Werewolf Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a favorable position for potential stock price increases in the near term [10].

Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer treatment [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, featuring CEO Daniel J. Hicklin and CMO Randi Isaacs [1][2] Company Overview - Werewolf Therapeutics leverages its proprietary PREDATOR® platform to create therapeutics that activate selectively in the tumor microenvironment while remaining inactive in peripheral tissues [3] - The company's advanced clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3] - WTX-124 is being advanced in multiple tumor types both as a single agent and in combination with immune checkpoint inhibitors, while WTX-330 is being explored for various tumor types and Non-Hodgkin Lymphoma [3]

Core Insights - The investigational drug shows promise in treating advanced cutaneous squamous cell carcinoma, with a patient experiencing no detectable cancer after 12 weeks of treatment [1][2][3] - The incidence of cutaneous squamous cell carcinoma has tripled over the past three decades, highlighting the growing burden of this disease [7] Company Insights - HonorHealth Research Institute is conducting a clinical trial for a new drug designed to activate in the tumor microenvironment, offering hope for patients with limited treatment options [1][4][5] - Werewolf Therapeutics is pioneering the development of therapeutics that stimulate the immune system, utilizing its proprietary PREDATOR® platform to create conditionally activated molecules [11] Industry Insights - Approximately 1 million Americans are diagnosed with cutaneous squamous cell carcinoma annually, with nearly 7,000 fatalities occurring when the disease becomes advanced or metastatic [6] - Current treatment options for advanced cases are limited, particularly for patients who do not respond to checkpoint inhibitors [6][9]

Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics is a clinical stage biopharmaceutical company focused on developing conditionally activated biologics for cancer and other serious diseases. The company has engineered a pipeline of cytokine prodrugs, referred to as endokines, to address therapeutic index challenges associated with potent biologics [2][3] Core Programs - The lead endokine programs include: - WTX-124 (an interleukin-2 endokine) - WTX-330 (an interleukin-12 endokine) - The company has also developed T cell engagers called inducers, designed to address therapeutic index challenges of T cell engagers [3][19] Clinical Data and Efficacy - WTX-124 has completed dose escalation for both monotherapy and combination therapy with pembrolizumab, with a determined dose of 18 mg delivered IV every two weeks [5][6] - Expansion arms are open for indications including: - Cutaneous melanoma - Renal cell carcinoma - Cutaneous squamous cell carcinoma, where a patient achieved a complete response after failing standard treatment [6][7] - The company aims for an overall response rate above 20% for monotherapy and higher for combination therapy, with enrollment progressing well [11][12] Safety Profile - The safety profile of WTX-124 has shown no hallmark toxicities associated with high-dose IL-2, allowing for outpatient delivery to a broad patient population [9][10] Regulatory Pathway - The company plans to present data to the FDA in the coming quarters, seeking insights on both monotherapy and combination data for potential registration [13][14] Future Expectations - The company anticipates presenting updated interim data in Q4 2025, with a focus on both efficacy and safety metrics [9][22] - For WTX-330, the company has completed a first-in-human trial, showing a good safety profile and antitumor activity, with plans for further studies [16][17] Inducers Platform - The inducers platform aims to mask immune cell engagement to reduce cytokine release syndrome, enhancing the therapeutic index of T cell engagers [19][20] - The company plans to announce a development candidate for the inducers platform imminently [22] Conclusion - Werewolf Therapeutics is positioned for significant developments in the coming months, with a robust pipeline and promising clinical data that could lead to regulatory advancements and potential market opportunities [24][25]

Core Insights - Werewolf Therapeutics, Inc. is focused on developing conditionally activated therapeutics to enhance the immune system for cancer treatment and other immune-mediated conditions [1][2] - The company will present data on its IL-2 and IL-12 INDUKINE molecules at the Hanson Wade Cytokine-Based Drug Development Summit, showcasing the validation of its unique immunotherapy approach [2] Company Overview - Werewolf Therapeutics is leveraging its proprietary PREDATOR platform to create therapeutics that stimulate both adaptive and innate immunity, aiming to overcome the limitations of traditional proinflammatory immune therapies [2] - The company's INDUKINE molecules are designed to remain inactive in peripheral tissues and activate selectively within the tumor microenvironment [2] - The most advanced product candidates include WTX-124 and WTX-330, which are conditionally activated IL-2 and IL-12 molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [2] Upcoming Events - Sameer Chopra, M.D., Ph.D., Vice President of Clinical Development, will speak at the summit on May 15, 2025, at 4:15 PM ET, discussing the therapeutic index improvements of proinflammatory cytokines for cancer immunotherapy [2]