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]

Core Insights - Werewolf Therapeutics is advancing its clinical programs with significant milestones expected in 2025, including data from ongoing trials for WTX-124 and WTX-330 [1][2][3] Clinical Development - Data from the Phase 1/1b clinical trial for WTX-124 as a monotherapy is expected in the first half of 2025, which will guide regulatory engagement for potential registrational pathways [1][2] - Combination data for WTX-124 with pembrolizumab is anticipated in the fourth quarter of 2025 [1][2] - A Phase 1/2 dose and regimen-finding clinical trial for WTX-330 is set to begin in the first quarter of 2025 [1][2][11] Financial Guidance - The company expects its cash and cash equivalents to fund operations through at least the second quarter of 2026 [8] Product Details - WTX-124 is being developed as a conditionally activated IL-2 INDUKINE molecule for multiple solid tumor types, showing promising activity and improved tolerability compared to high-dose IL-2 [4][9] - The recommended dose for WTX-124 in monotherapy expansion arms is 18 mg administered intravenously every two weeks [4] - WTX-330 is an IL-12 INDUKINE molecule aimed at treating immunotherapy-resistant cancers [2][4] Strategic Outlook - The company plans to engage with regulators regarding potential accelerated approval strategies for WTX-124 based on interim data [5] - Ongoing preclinical work will support IND-stage programs and the company seeks strategic partnerships to advance these initiatives [6][7]

Revenue and Collaboration Agreements - For the nine months ended September 30, 2024, the company recognized $1.9 million in revenue from the Collaboration Agreement with Jazz, with no revenue recognized in the three months ended September 30, 2024[79][90]. - Revenue for the nine months ended September 30, 2024, was $1.9 million, a significant decrease from $18.4 million in the same period of 2023, due to the execution of the Transfer Agreement with Jazz[99]. - The company has received $20.0 million from Jazz under the Collaboration Agreement and is eligible for up to an additional $1.255 billion in milestone payments[113]. Expenses - Research and development expenses for the three months ended September 30, 2024, increased to $12.5 million, up from $10.8 million in the same period in 2023, reflecting a rise of approximately 15.6%[89]. - The total operating expenses for the three months ended September 30, 2024, were $17.1 million, compared to $15.1 million in the same period in 2023, representing an increase of $1.98 million or 13.1%[89]. - General and administrative expenses for the three months ended September 30, 2024, were $4.6 million, up from $4.3 million in the same period of 2023, primarily due to a $0.3 million increase in professional services fees[93]. - Research and development expenses for the nine months ended September 30, 2024, were $40.7 million, compared to $32.1 million in the same period of 2023, reflecting an increase of $8.6 million[101]. - General and administrative expenses for the nine months ended September 30, 2024, were $14.4 million, up from $13.9 million in the same period of 2023, primarily due to increased professional services costs[102]. - The company anticipates that general and administrative expenses will increase in the future as personnel headcount grows to support expanding research and development activities[83]. Net Loss and Financial Position - The company reported a net loss of $16.7 million for the three months ended September 30, 2024, compared to a net loss of $8.3 million in the same period in 2023, indicating an increase in loss of approximately 101.2%[89]. - The net loss for the three months ended September 30, 2024, was $16.7 million, compared to $8.3 million for the same period in 2023, resulting in an accumulated deficit of $394.2 million as of September 30, 2024[107]. - The company expects to incur substantial and increasing expenses and net losses for the foreseeable future as it advances product candidates through clinical development[107]. - The company anticipates needing substantial additional funding to support operations and pursue growth strategies, with potential reliance on public or private equity offerings and debt financings[109]. Cash Flow and Financing Activities - Cash and cash equivalents as of September 30, 2024, were $122.8 million, with an additional $1.2 million in restricted cash, expected to fund operational expenses through at least the second quarter of 2026[114]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $41.9 million, an increase of $13.9 million from $28.0 million in the same period of 2023, primarily due to decreased revenue and increased R&D expenses[118]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $10.5 million, down from $49.4 million in the prior year[120]. - Cash provided by financing activities in 2024 included net proceeds from the ATM Offering of $21.1 million and a drawdown of $30.0 million from the K2HV Loan Agreement, offset by a $40.0 million repayment of the previous PWB term loan[120]. - The K2HV Loan Agreement provides up to $60.0 million in term loans, with $30.0 million received at closing and additional tranches available based on certain milestones[110]. - The company incurred debt issuance costs of $0.7 million in connection with the term loans, which are being amortized over the term of the K2HV Loan Agreement[111]. Clinical Development and Trials - The company is currently evaluating WTX-124 in a Phase 1/1b clinical trial, with initial efficacy data expected to be reported in the first half of 2025[76]. - WTX-330 is being evaluated in a Phase 1 clinical trial for immunotherapy-resistant advanced or metastatic solid tumors, with initial data reported in June 2024[76]. - The company has received alignment from the FDA on the comparability path for WTX-330, which is expected to be integrated into the clinical development program[76]. - The company continues to develop preclinical candidates WTX-518 and WTX-712, with promising preclinical data presented in April 2024[76]. Interest Income and Expense - Interest income decreased to $1.6 million for the three months ended September 30, 2024, compared to $2.0 million in the same period of 2023, due to lower cash equivalents held[94]. - Interest expense increased to $1.2 million for the three months ended September 30, 2024, from $1.0 million in the same period of 2023, primarily due to higher effective interest rates under the K2HV Loan Agreement[95]. - Interest expense for the nine months ended September 30, 2024, was $3.4 million, compared to $2.1 million in the same period of 2023, driven by higher effective interest rates[105]. - The company recognized interest expense of $1.3 million related to the PWB Loan Agreement during the nine months ended September 30, 2024[109]. Other Financial Information - The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the nine months ended September 30, 2024[106]. - Net cash used in investing activities for the nine months ended September 30, 2024, was $0.1 million, a decrease from $0.6 million for the same period in 2023[120]. - Total estimated base rent payments for the office and laboratory lease expiring in May 2030 are approximately $13.9 million[122]. - There were no material changes to critical accounting policies during the three and nine months ended September 30, 2024[123].

Financial Performance - As of September 30, 2024, cash and cash equivalents were $122.8 million, down from $135.3 million as of June 30, 2024, providing runway through at least the second quarter of 2026[4] - Collaboration revenue for Q3 2024 was $0, compared to $5.9 million in Q3 2023, as the company completed its obligations under the collaboration agreement with Jazz Pharmaceuticals[4] - The net loss for Q3 2024 was $16.7 million, compared to a net loss of $8.3 million in Q3 2023[5] - The total operating expenses for Q3 2024 were $17.1 million, compared to $15.1 million in Q3 2023[8] - The weighted-average common shares outstanding increased to 43,704,836 in Q3 2024 from 35,653,924 in Q3 2023[8] Research and Development - Research and development expenses increased to $12.5 million in Q3 2024 from $10.8 million in Q3 2023, primarily due to ongoing clinical trials for WTX-124 and WTX-330[5] - The company is actively enrolling patients in the Phase 1/1b clinical trial for WTX-124, with initial efficacy data expected in the first half of 2025[2] - WTX-330 demonstrated a 22-fold higher systemic prodrug exposure compared to recombinant IL-12 at its maximum tolerated dose, indicating improved therapeutic index[3] - The company plans to present interim data from the Phase 1 clinical trial of WTX-330 at the SITC Annual Meeting on November 9, 2024[3] - WTX-921, a new IL-10 INDUKINE candidate for inflammatory diseases, was added to the pipeline in October 2024, expanding the therapeutic focus beyond oncology[3] Contacts - Investor contact is John Norton from Precision AQ, reachable at 212.362.1200[10] - Media contact is Amanda Sellers from Deerfield Group, reachable at 301.332.5574[10] - Company contact is Ellen Lubman, Chief Business Officer of Werewolf Therapeutics[10]