– 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]

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]

Exhibit 99.1 Werewolf Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update – Positive data from ongoing Phase 1/1b clinical trial of WTX-124 presented at American Society of Clinical Oncology (ASCO) Annual Meeting – – Encouraging signs of clinical activity at tolerable doses disclosed from ongoing Phase 1 clinical trial of WTX-330 – – Updated data on WTX-124 in combination with pembrolizumab and opening of expansion arms anticipated in the second half of 2024 – – Update on ...

Core Insights - The administration of WTX-330 has shown therapeutically relevant exposure levels of IL-12 prodrug with improved tolerability compared to historical data for rhIL-12 [1][2] - The company is focused on advancing a pipeline of next-generation immunostimulatory medicines, with preliminary clinical data indicating promising tolerability and efficacy signals in heavily pretreated patients with late-stage solid tumors [1][3] Clinical Trial Results - As of June 12, 2024, eleven patients with relapsed or refractory solid tumors have been dosed in dose escalation cohorts, with doses of 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), and 0.032 mg/kg (n=5) [1] - At the 0.024 mg/kg dose, WTX-330 demonstrated a 23-fold higher systemic drug concentration of IL-12 prodrug compared to previous IL-12 strategies, with low free IL-12 levels across all dose levels [2] - One patient with metastatic melanoma achieved an unconfirmed partial response after treatment with 0.024 mg/kg WTX-330, with no evidence of disease on biopsy [2] - Two patients with microsatellite stable colorectal cancer achieved stable disease, with one showing evidence of tumor biomarker activity [2] Immune Response and Tolerability - Evidence of robust activation of immune biomarkers, including increased antitumor CD8+ T and NK cell expansion, was observed in patients with stable disease [2] - All patients experienced mild to moderate treatment-related toxicities, primarily associated with the first dose, with no Grade 4 or Grade 5 adverse events reported [2] - Two patients experienced reversible dose-limiting toxicities at the 0.032 mg/kg dose level, including Grade 3 mucositis and Grade 3 AST increase [2] Future Developments - The company has opened two expansion arms for further evaluation of WTX-330 in patients with immune checkpoint inhibitor-sensitive solid tumors [2][3] - Additional results are anticipated in the fourth quarter of 2024, with a focus on safety, biomarker, and antitumor activity [3] Company Overview - Werewolf Therapeutics is pioneering the development of therapeutics designed to stimulate the immune system for cancer treatment, leveraging its proprietary PREDATOR® platform [5] - The company's INDUKINE™ molecules are engineered to remain inactive in peripheral tissues and activate selectively in the tumor microenvironment [5][10]