Werewolf Therapeutics (HOWL) 2025 Conference May 08, 2025 10:00 AM ET Speaker0 Alright. We're gonna go ahead and get started. Welcome and good morning everyone to the second day of the Citizens Life Sciences Conference. It's my pleasure to introduce the next presenting company, Werewolf Therapeutics. Presenting for the company is Randy Isaacs, the Chief Medical Officer. Welcome Randy, thanks for joining us. Speaker1 Oh, Ren, thank you so much for having us. Speaker0 So I never know exactly who's in the audi ...

Core Insights - Werewolf Therapeutics, Inc. announced the efficacy of its IL-10 INDUKINE molecule, WTX-921, in reducing tissue damage and inflammatory cytokine production in a mouse colitis model [1][3] - The findings provide a deeper understanding of WTX-921's anti-inflammatory effects on the immune landscape in the inflamed colon [1] Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics aimed at stimulating the immune system for cancer and immune-mediated conditions [1][7] - The company utilizes its proprietary PREDATOR platform to design molecules that activate selectively in the tumor microenvironment, addressing limitations of conventional therapies [7] Product Development - WTX-921 is engineered to selectively deliver IL-10 to inflamed tissues, minimizing systemic toxicity while providing therapeutic exposure [6] - The molecule has shown potential in blocking disease-driving effector molecules and cytokines, impacting both innate and adaptive immune responses [6] Clinical Findings - The data presented at the AAI Annual Meeting indicate that WTX-921 effectively masks IL-10, preventing off-tissue effects and demonstrating efficacy in preventing weight loss and reducing Disease Activity Index (DAI) scores in a colitis model over four weeks [4][3] - The treatment resulted in decreased immune cell infiltration and reduced RNA levels of inflammatory cytokines in treated animals [4] Market Context - The CDC estimates that 7 million people worldwide had Inflammatory Bowel Disease (IBD) in 2024, highlighting the need for improved treatment options [3]

Wall Street expects a year-over-year decline in earnings on higher revenues when Werewolf Therapeutics, Inc. (HOWL) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, t ...

WATERTOWN, Mass., April 17, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced the appointment of Steven Bloom as Chief Business Officer. Mr. Bloom brings more than 35 years of experience in the life sciences industry leading ...

WATERTOWN, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body's immune system for the treatment of cancer and other immune-mediated conditions, today announced that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer and Randi Isaacs, M.D., Chief Medical Officer, both of Werewolf Therapeutics, ...

Financial Performance - The company incurred a net loss of $70.5 million for the fiscal year ended December 31, 2024, with an accumulated deficit of $414.6 million[225]. - As of December 31, 2024, the company had cash and cash equivalents of $111.0 million, which is expected to support the development of WTX-124 and WTX-330 through dose escalation and expansion[230]. - The company has not generated any product revenue to date and does not expect to do so for several years[226]. - The company does not anticipate generating revenue from product sales for the foreseeable future and may never achieve profitability[245]. - The company’s ability to generate product revenues is not expected to occur for many years, if ever, depending on the successful development and commercialization of its product candidates[252]. Product Development and Regulatory Approval - The company is developing two product candidates, WTX-124 and WTX-330, with all other programs in discovery or preclinical stages[224]. - The success of the company's business is highly dependent on obtaining regulatory approval and successfully launching its initial product candidates, WTX-124 and WTX-330[246]. - The company has not previously submitted a Biologics License Application (BLA) or a New Drug Application (NDA) to the FDA, which may impede timely approval for its products[249]. - The regulatory approval process for the company's product candidates is expected to be expensive and uncertain, potentially taking several years[250]. - The company must demonstrate safety and efficacy through extensive clinical trials to obtain regulatory approvals for product candidates[263]. Financial and Operational Risks - The company will need to secure substantial additional funding to finance operations and complete development of its product candidates[229]. - The company faces risks related to its limited operating history and the unproven nature of its product development approach[224]. - The company may encounter unforeseen expenses and complications in achieving its business objectives[225]. - The company has no committed external source of funds, and additional financing may not be available on acceptable terms[235]. - The company is subject to operating covenants under the K2HV Loan Agreement, which could restrict its financial flexibility[237]. Clinical Trials and Development Challenges - The company may face challenges in completing preclinical studies and clinical trials, which could adversely affect its ability to obtain regulatory approvals[262]. - The company may encounter substantial delays in clinical trials, which could increase costs and limit revenue generation capabilities[266]. - Delays in patient enrollment for clinical trials could significantly increase development costs and jeopardize marketing approval timelines[277]. - Undesirable side effects from product candidates could lead to interruptions in clinical trials and affect regulatory approval outcomes[278]. - Significant variability in safety or efficacy results can occur between different clinical trials of the same product candidate, impacting development timelines and regulatory approval[265]. Market and Competitive Landscape - The company may face substantial competition from major pharmaceutical and biotechnology companies, which could hinder its ability to develop and commercialize its product candidates[296]. - The potential market opportunities for the company's product candidates are difficult to estimate and may be smaller than current estimates if assumptions prove inaccurate[304]. - Market acceptance of approved products is crucial for commercial success, with established treatments posing competition[309]. - The approval of biologics may lead to competition sooner than expected due to the Biologics Price Competition and Innovation Act, which allows for abbreviated approval pathways[311]. Intellectual Property and Legal Risks - The company relies on patent protection for its PREDATOR platform and product candidates, with the risk that competitors could develop similar technologies if patent protection is insufficient[332]. - The company may face challenges in maintaining and enforcing patent rights, which could adversely affect its competitive position and ability to commercialize products[339]. - The company may be involved in lawsuits to protect its patents, which could be expensive and time-consuming[371]. - An unfavorable outcome in litigation could result in the loss of patent rights or require the company to cease using related technology[372]. - The company may not be able to prevent misappropriation of trade secrets, especially in jurisdictions with weaker protections[372]. Regulatory Compliance and Designations - The company may seek designations such as Breakthrough Therapy, Fast Track, and Priority Review for its product candidates, but there is no guarantee of receiving these designations[417]. - Compliance with FDA regulations is critical, as violations could lead to substantial civil or criminal fines and damage awards[416]. - The company intends to implement compliance and training programs to ensure adherence to regulations regarding the promotion of products for unapproved uses[413]. - Recent guidance from the FDA allows for truthful scientific communications about unapproved uses, provided they are non-misleading and scientifically sound[413]. - The company must navigate complex regulations and guidance to ensure compliance and avoid potential sanctions[414].

Exhibit 99.1 Werewolf Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update – Full enrollment in cutaneous melanoma dose-expansion arms of Phase 1/1b clinical trial evaluating WTX-124 as monotherapy and in combination with pembrolizumab expected by the end of the first half and the second half of 2025, respectively - – Plan to meet with the FDA in the second half of 2025 to discuss potential registrational pathways for both monotherapy and combination therapy ...

– Full enrollment in cutaneous melanoma dose-expansion arms of Phase 1/1b clinical trial evaluating WTX-124 as monotherapy and in combination with pembrolizumab expected by the end of the first half and the second half of 2025, respectively – – Plan to meet with the FDA in the second half of 2025 to discuss potential registrational pathways for both monotherapy and combination therapy for WTX-124 in select indications – – Interim data from Phase 1/1b clinical trial of WTX-124 as monotherapy and in combinati ...

WATERTOWN, Mass., March 04, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf, and Randi Isaacs, M.D., Chief Medical Officer of Werewolf, will p ...

Core Insights - Werewolf Therapeutics, Inc. has appointed Dr. Anil Singhal to its board of directors, enhancing its leadership team as it advances its clinical development of novel INDUKINE molecules [1][2] - Dr. Singhal brings over 30 years of experience in oncology research and development, previously serving as President and CEO of Trishula Therapeutics and Adicet Bio [2] - Concurrently, Derek DiRocco will resign from the board effective at the 2025 annual meeting, having been a valuable member since 2020 [3] Company Overview - Werewolf Therapeutics is focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions, utilizing its proprietary PREDATOR platform [4] - The company's INDUKINE molecules are designed to remain inactive in peripheral tissues and activate selectively in the tumor microenvironment, addressing limitations of conventional therapies [4] - The most advanced product candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 and Interleukin-12 molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [4]