Werewolf Therapeutics (HOWL) BofA Securities 2025 Healthcare Conference summary

Company overview and platform

• Developing conditionally activated biologics for cancer and serious diseases, focusing on improving therapeutic index challenges with potent biologics.

• Pipeline includes cytokine prodrugs called INDUKINEs, with lead programs WTX-124 (IL-2) and WTX-330 (IL-12).

• Recently introduced conditionally activated T-cell engagers, termed inducers, using similar engineering principles.

Clinical progress and data

• WTX-124 has completed dose escalation for both monotherapy and combination with pembrolizumab; 18 mg IV every two weeks is the selected dose.

• Expansion arms are open for melanoma, renal cell carcinoma, and cutaneous squamous cell carcinoma, all in immunotherapy-pretreated patients.

• Notable complete response in a cutaneous squamous cell carcinoma patient who failed standard of care, now in CR for over a year.

• Combination studies include melanoma, kidney cancer, and PD-L1 positive non-small cell lung cancer.

Upcoming milestones and regulatory plans

• Targeting Q4 for updated interim data from both monotherapy and combination studies.

• Full enrollment in monotherapy melanoma arm expected by end of first half; combination arm by year-end.

• Plans to present data to FDA in coming quarters to discuss registration paths, including potential accelerated approval for monotherapy in checkpoint inhibitor-failed patients.

• Considering randomized controlled trials for combination with pembrolizumab in earlier lines.