On March 11, 2025 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, reported a business update and announced financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Werewolf Therapeutics, MAR 11, 2025, View Source [SID1234651073]).
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"Werewolf made considerable progress in 2024 with promising preliminary evidence of durable anti-tumor activity and tolerability for cytokine therapeutics as we completed the dose-escalation phase of our Phase 1/1b clinical trial in both monotherapy and in combination with pembrolizumab," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We expect to build on these promising data in 2025, targeting full enrollment in the monotherapy cutaneous melanoma dose-expansion arm of the WTX-124 Phase 1/1b clinical trial by the end of the first half of 2025, and in combination with pembrolizumab by the end of the year. These data will guide conversations with regulators on potential registrational pathways for WTX-124 in the second half of the year. We anticipate providing a clinical data readout for both monotherapy and combination data and providing an update on our plans for further clinical development of WTX-124 in the fourth quarter of 2025. In addition, our PREDATOR platform continues to demonstrate its effectiveness as we presented updated interim safety, pharmacokinetics, biomarker, and efficacy data from the WTX-330 Phase 1 clinical trial at SITC (Free SITC Whitepaper) in November, which demonstrated anti-tumor activity in patients with refractory solid tumors. A Phase 1/2 dose and regimen-finding clinical trial is expected to be initiated by the end of the first quarter of 2025, which includes expansion arms in specific indications."
Recent Highlights and Upcoming Milestones
WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
•Werewolf continues to evaluate WTX-124 as a monotherapy and in combination with pembrolizumab through the ongoing Phase 1/1b clinical trial evaluating the INDUKINE molecule in multiple solid tumor types.
•WTX-124 has shown promising monotherapy activity and an improved tolerability profile versus high dose IL-2 in heavily pretreated patients refractory to all standard-of-care therapies, including immune checkpoint inhibitors. The Company has selected 18 mg administered intravenously every two weeks (IV Q2W) as the recommended dose for monotherapy expansion arms in metastatic melanoma, renal cell carcinoma (RCC) and cutaneous squamous cell carcinoma (CSCC), as well as combination expansion arms in metastatic melanoma, RCC, and non-small cell lung cancer (NSCLC).
•Of the five previously disclosed objective responses, one monotherapy and two combination responses continue to demonstrate no evidence of disease progression, with the monotherapy complete response ongoing at greater than one year off therapy, one combination response improving from a confirmed partial response to a complete response, and both combination responses ongoing at greater than eight months.
•The cutaneous melanoma monotherapy dose-expansion arm of the Phase 1/1b clinical trial evaluating WTX-124 in a more homogeneous, less heavily pre-treated patient population is expected to be fully enrolled in the first half of 2025, and the cutaneous melanoma dose-expansion arm evaluating WTX-124 in combination with pembrolizumab is expected to be fully enrolled by the end of 2025. The Company expects to use the monotherapy and combination data to engage with regulators to discuss potential registrational pathways for WTX-124, including strategies for accelerated approval, in the second half of 2025.
•Anticipated presentation of interim data from monotherapy and combination expansion arms in the fourth quarter of 2025.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
•Presented an interim update from the Phase 1 clinical trial highlighting the tolerability profile and monotherapy efficacy signals of WTX-330 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th annual meeting in November 2024.
•On track to initiate a Phase 1/2 dose- and regimen-finding clinical trial by the end of the first quarter of 2025 to optimize the exposure of WTX-330 in the tumor microenvironment.
•Pending data from Phase 1/2 dose- and regimen-finding trial, anticipate opening expansion arms in selected tumor types.
Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, our Interleukin-21 (IL-21) and binding protein resistant Interleukin-18 (IL-18) INDUKINE molecules, respectively, for treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases.
Financial Results for the Fourth Quarter and Full Year 2024:
•Cash position: As of December 31, 2024, cash and cash equivalents were $111.0 million, compared to $134.3 million as of December 31, 2023. The Company also had restricted cash and cash equivalents of $1.2 million and $21.2 million as of December 31, 2024 and December 31, 2023, respectively. The Company believes its existing cash and cash equivalents at December 31, 2024 will be sufficient to fund operational expenses and capital expenditure requirements through at least the second quarter of 2026.
•Collaboration revenue: No collaboration was recognized during fourth quarter of 2024 due to the fact that Werewolf substantially completed its performance obligations under the collaboration agreement with Jazz Pharmaceuticals (Jazz) during the second quarter of 2024. Comparatively, collaboration revenue was $1.5 million for the fourth quarter of 2023. Collaboration revenue was $1.9 million for the full year 2024, compared to $19.9 million for the same period in 2023. Collaboration revenue consists of revenue recognized from the Company’s licensing agreement with Jazz and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $15.7 million for the fourth quarter of 2024, compared to $9.6 million for the same period in 2023. Research and development expenses were $56.4 million for the full year 2024, compared to $41.8 million for the full year 2023.
•General and administrative expenses: General and administrative expenses were $4.6 million for the fourth quarter of 2024, compared to $4.8 million for the same period in 2023. General and administrative expenses were $19.0 million for the full year 2024, compared to $18.7 million for the full year 2023.
•Net loss: Net loss was $20.4 million for the fourth quarter of 2024, compared to $12.0 million for the same period in 2023. Net loss was $70.5 million for the full year 2024, compared to $37.4 million for the full year 2023.