Werewolf Therapeutics develops conditionally activated therapeutics engineered to stimulate the immune system for cancer and other immune-mediated conditions. News about HOWL centers on the company’s PREDATOR platform, INDUKINE molecules, INDUCER T cell engager work, and programs such as WTX-124 and WTX-330.
Recurring updates include clinical and preclinical data presentations, FDA regulatory designations, operating and financial results, program licensing or asset-rights activity, capital-structure actions, shareholder voting matters, and corporate-strategy updates tied to the company’s oncology-focused development pipeline.
Werewolf Therapeutics (NASDAQ: HOWL) announced that the U.S. FDA granted Fast Track Designation for WTX-124, its conditionally activated IL-2 INDUKINE therapy, for potential treatment of locally advanced or metastatic cutaneous melanoma after standard-of-care immunotherapy.
WTX-124 is being evaluated in a Phase 1/1b open-label, multicenter study including single-agent and pembrolizumab combination arms (NCT05479812). The company said the designation was based on prior melanoma patients who showed clinically meaningful anti-tumor activity with a tolerable safety profile. Werewolf expects to share preliminary Phase 1/1b data in Q4 2025 and plans FDA engagement on potential registration strategy.
Werewolf Therapeutics (Nasdaq: HOWL) announced three poster presentations at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, Nov 5-9, 2025, in National Harbor, Maryland.
Posters cover: sequential administration of IL-2 and IL-12 INDUKINE molecules (Abstract 861) on Nov 7; development of masked conditional T cell engagers (Abstract 964) on Nov 8; and pharmacokinetics of IL-2 INDUKINE prodrug WTX-124 (Abstract 862) on Nov 8. All presentations in Poster Hall (Exhibit Halls A and B1).
Werewolf Therapeutics (NASDAQ:HOWL), a biopharmaceutical company focused on developing conditionally activated therapeutics for cancer treatment, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference.
The company's leadership, including CEO Daniel J. Hicklin, Ph.D. and CMO Randi Isaacs, M.D., will engage in a fireside chat on September 8, 2025, at 2:00 PM EDT. The presentation will be accessible via webcast on the company's investor relations website, with a replay available for approximately 90 days.
Werewolf Therapeutics (NASDAQ:HOWL) has provided a comprehensive Q2 2025 update, highlighting progress across its clinical and preclinical pipeline. The company's lead candidate, WTX-124, is advancing with interim data expected in Q4 2025 for both monotherapy and combination treatments in melanoma and renal cell carcinoma patients. Werewolf plans FDA discussions regarding potential registration pathways in H2 2025.
The company also announced WTX-1011, its first INDUCER™ T-cell engager targeting STEAP1 for prostate cancer, demonstrating promising preclinical results. Additionally, their WTX-330 Phase 1b/2 trial continues enrollment, with dosing regimen determination expected by year-end.
Financially, Werewolf reported $77.6 million in cash as of June 30, 2025, with runway extending into Q4 2026. Q2 2025 showed a net loss of $18.0 million, with R&D expenses at $13.1 million and G&A expenses at $4.4 million.
Werewolf Therapeutics (NASDAQ: HOWL) announced its participation in the KidneyCAN 7th Annual Kidney Cancer Research Summit on July 17-18, 2025, in Boston. Chief Medical Officer Dr. Randi Isaacs will present on the company's WTX-124, a tumor-activated IL-2 INDUKINE molecule, during the Biotech Showcase session.
The presentation will highlight how WTX-124 aims to improve upon traditional high-dose IL-2 therapy for renal cell carcinoma (RCC) by maximizing anti-tumor activity while reducing systemic side effects. The company's ongoing "Full Moon Moment" campaign supports clinical trials, with notable success including a patient with cutaneous squamous cell carcinoma achieving remission for over a year.
Werewolf Therapeutics (NASDAQ: HOWL), a biopharmaceutical company focused on developing conditionally activated therapeutics for cancer immunotherapy, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's President and CEO Daniel J. Hicklin, Ph.D., along with Chief Medical Officer Randi Isaacs, M.D., will engage in a fireside chat on June 5, 2025, at 4:20 PM EDT.
The conference is scheduled for June 3-5, 2025. Interested parties can access a live webcast of the presentation through the company's investor relations website, with a replay available for approximately 90 days after the event.
Werewolf Therapeutics (NASDAQ: HOWL) announced its participation in the Hanson Wade's 6th Annual Cytokine-Based Drug Development Summit in Boston on May 15-16, 2025. Dr. Sameer Chopra, VP of Clinical Development, will present on May 15 at 4:15 PM ET, discussing "Tumor-activated INDUKINE Molecules: Improving the Therapeutic Index of Proinflammatory Cytokines for Cancer Immunotherapy." The presentation will showcase data from first-in-human clinical trials of IL-2 and IL-12 INDUKINE molecules, which have validated the company's approach to developing conditionally activated therapeutics for cancer treatment.