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]

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]

Core Insights - Werewolf Therapeutics, Inc. reported a quarterly loss of $0.43 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and a significant increase from a loss of $0.14 per share a year ago [1] - The company posted revenues of $1.14 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 42.85% and down from $8.08 million in the same quarter last year [2] - The stock has underperformed significantly, losing about 55.7% since the beginning of the year compared to the S&P 500's gain of 9% [3] Financial Performance - The earnings surprise for the recent quarter was -13.16%, and the company has not been able to beat consensus revenue estimates over the last four quarters [1][2] - The current consensus EPS estimate for the upcoming quarter is -$0.37 on revenues of $2 million, and for the current fiscal year, it is -$1.52 on revenues of $6.85 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Werewolf Therapeutics belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a relatively strong position [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Werewolf Therapeutics' stock performance [5]

Revenue and Collaboration Agreements - For the six months ended June 30, 2024, the company recognized $1.9 million in revenue from the Collaboration Agreement with Jazz Pharmaceuticals[77] - Collaboration revenue for the six months ended June 30, 2024, was $1.9 million, down $10.7 million from $12.5 million in 2023[99] - The company anticipates fluctuations in future revenue based on the achievement of development and regulatory milestones[77] Research and Development Expenses - Research and development expenses are expected to increase substantially as the company progresses its clinical trials for WTX-124 and WTX-330[80] - Research and development expenses increased to $15.3 million for the three months ended June 30, 2024, compared to $9.6 million in 2023, reflecting a rise of $5.7 million[90] - Research and development expenses increased by $5.7 million, driven by ongoing development efforts of product candidates[118] Operating Loss and Financial Performance - The operating loss for the three months ended June 30, 2024, was $(18.96) million, compared to $(6.07) million in the same period of 2023, an increase of $12.89 million[87] - The net loss for the three months ended June 30, 2024, was $(17.25) million, compared to $(5.10) million in 2023, an increase of $12.15 million[87] - The company reported a net loss of $17.2 million for the three months ended June 30, 2024, compared to a net loss of $5.1 million for the same period in 2023, with an accumulated deficit of $377.5 million as of June 30, 2024[106] External Development Costs - External development costs for WTX-330 amounted to $7.9 million for the six months ended June 30, 2024, compared to $1.2 million for the same period in 2023[80] - The company reported total external development costs of $15.9 million for the six months ended June 30, 2024, up from $9.4 million in the same period of 2023[80] Cash Flow and Financing Activities - Net cash used in operating activities for the six months ended June 30, 2024, was $29.5 million, an increase of $8.7 million compared to $20.8 million for the same period in 2023, primarily due to a decrease in revenue from collaboration agreements[118] - Net cash provided by financing activities for the six months ended June 30, 2024, was $10.5 million, significantly lower than $49.3 million for the same period in 2023[119] - The company expects to require additional funding to complete the development of WTX-124, WTX-330, and other product candidates[116] Interest Income and Expense - Interest income for the three months ended June 30, 2024, was $1.8 million, a decrease of $0.1 million from $1.9 million in 2023[93] - Interest income rose to $3.8 million for the six months ended June 30, 2024, compared to $3.5 million for the same period in 2023, driven by higher yields on cash equivalents[103] - Interest expense increased to $1.1 million for the three months ended June 30, 2024, compared to $1.0 million in 2023, reflecting a rise of $0.1 million[94] - Interest expense increased significantly to $2.1 million for the six months ended June 30, 2024, from $1.1 million in the same period of 2023, primarily due to the timing of term loan drawdowns[103] Share Issuance and Cash Position - The company sold 4,342,320 shares of common stock at an average price of $5.11 per share during the six months ended June 30, 2024, generating net proceeds of $21.1 million[112] - As of June 30, 2024, the company had cash and cash equivalents of $135.3 million and restricted cash of $1.2 million, expected to fund operations through at least Q1 2026[114] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $19.1 million for the six months ended June 30, 2024[117] Loan Agreements and Obligations - 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[109] - The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the three months ended June 30, 2024[96] - The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the six months ended June 30, 2024[105] Clinical Trials and Product Development - The company is currently evaluating WTX-124 in a Phase 1/1b clinical trial, with preliminary data from 16 patients indicating proof of mechanism and proof of concept for the INDUKINE design[74] - The company executed a Transfer Agreement in June 2024, completing all material performance obligations under the Collaboration Agreement with Jazz[77] - The company reported initial data from the Phase 1 clinical trial of WTX-330 in June 2024, with patient dosing initiated in February 2023[74] - The company has no remaining material performance obligations under the Collaboration Agreement as of June 2024[77] Future Financial Considerations - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for existing shareholders[116] - The company is actively considering collaboration arrangements for clinical development and commercialization to support its financial needs[116] - The company anticipates that the costs of obtaining marketing approval for WTX-124 and WTX-330 will significantly impact future cash flows[116] General and Administrative Expenses - General and administrative expenses increased to $9.8 million for the six months ended June 30, 2024, from $9.5 million in the same period of 2023, primarily due to a $0.3 million increase in personnel costs and a $0.4 million increase in professional services costs[102]

Financial Performance - As of June 30, 2024, cash and cash equivalents were $135.3 million, down from $139.2 million as of March 31, 2024, with sufficient funds projected to cover operational expenses through at least Q1 2026[6] - Collaboration revenue for Q2 2024 was $1.1 million, a significant decrease from $8.1 million in the same period of 2023, as the company completed its performance obligations under the collaboration agreement with Jazz Pharmaceuticals[6] - The net loss for Q2 2024 was $17.2 million, compared to a net loss of $5.1 million in Q2 2023[7] - General and administrative expenses were $4.8 million for Q2 2024, slightly up from $4.6 million in Q2 2023[7] - Total operating expenses for Q2 2024 were $20.1 million, compared to $14.1 million in Q2 2023[7] - The weighted-average common shares outstanding for Q2 2024 were 43,521,406, compared to 35,557,701 in Q2 2023[10] Research and Development - Research and development expenses increased to $15.3 million in Q2 2024, compared to $9.6 million in Q2 2023, primarily due to ongoing clinical trials for WTX-124 and WTX-330[7] - WTX-124 achieved three objective clinical responses, including one durable confirmed complete response and two partial responses in patients who were relapsed/refractory to immune checkpoint inhibitor therapy[2] - WTX-330 demonstrated an approximately 23-fold higher systemic drug concentration of IL-12 prodrug compared to previous IL-12 therapeutic strategies at a dose of 0.024 mg/kg[4] - The company anticipates updated data on WTX-124 and WTX-330 in the second half and fourth quarter of 2024, respectively, as part of ongoing clinical trials[1] Contacts - Investor contact is John Norton from Precision AQ, reachable at 212.362.1200[12] - Media contact is Amanda Sellers from Deerfield Group, reachable at 301.332.5574[12] - Company contact is Ellen Lubman, Chief Business Officer of Werewolf Therapeutics[12]