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Werewolf Therapeutics(HOWL) - 2024 Q4 - Annual Results
2025-03-11 11:05
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 ...
Werewolf Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Globenewswire· 2025-03-11 11:00
– 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 ...
Werewolf Therapeutics to Present at the 2025 Leerink Partners Global Biopharma Conference
Globenewswire· 2025-03-04 13:00
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 ...
Werewolf Therapeutics Appoints Anil Singhal, Ph.D., to its Board of Directors
Globenewswire· 2025-02-24 12:30
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]
Werewolf Therapeutics Provides Business Update and Highlights 2025 Strategic Outlook
Globenewswire· 2025-01-13 13:00
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]
Werewolf Therapeutics(HOWL) - 2024 Q3 - Quarterly Results
2024-11-07 14:06
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]
Werewolf Therapeutics, Inc. (HOWL) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2024-08-08 13:17
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]
Werewolf Therapeutics(HOWL) - 2024 Q2 - Quarterly Report
2024-08-08 11:12
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]
Werewolf Therapeutics(HOWL) - 2024 Q2 - Quarterly Results
2024-08-08 11:07
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]
Werewolf Therapeutics Highlights Initial Safety and Efficacy Data from its Ongoing Phase 1 Clinical Trial Evaluating WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
GlobeNewswire News Room· 2024-06-25 11:00
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]