Werewolf Therapeutics Announces Q3 2024 Financial Results and Business Update

Werewolf Therapeutics, Inc., an innovative biopharmaceutical firm, has provided an update on its business and financial performance for the third quarter ending September 30, 2024. The company, which is developing conditionally activated therapeutics to stimulate the immune system for cancer and other immune-mediated conditions, reported significant progress in its key programs.

The latest developments include continued advancement of its pipeline led by WTX-124 and WTX-330. WTX-124, a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, is being evaluated both as a monotherapy and in combination with pembrolizumab across multiple solid tumor types. Werewolf has initiated monotherapy expansion arms, enrolling patients with metastatic melanoma, renal cell carcinoma (RCC), and cutaneous squamous cell carcinoma (CSCC) who have not responded to immune checkpoint inhibitor therapy. The company is also testing WTX-124 in combination with pembrolizumab for metastatic melanoma, RCC, and non-small cell lung cancer (NSCLC).

Preliminary data from these studies have shown encouraging results. Two metastatic melanoma patients treated with a 12 mg combination dose of WTX-124 and pembrolizumab showed confirmed partial responses and have remained progression-free for over seven months. Additionally, a patient with advanced CSCC treated with 12 mg monotherapy achieved a complete response and has been in remission for over a year. Werewolf plans to share further data from the monotherapy expansion arms in the first half of 2025, which will help define the future development strategy of WTX-124.

WTX-330, another systemically delivered INDUKINE molecule targeting Interleukin-12 (IL-12), is undergoing a Phase 1 clinical trial for advanced or metastatic solid tumors and non-Hodgkin lymphoma. The company is set to present updated interim safety and efficacy data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas. Earlier data indicated a favorable therapeutic index with systemic WTX-330 administration, demonstrating clinical activity at generally well-tolerated doses and a significantly higher systemic prodrug exposure compared to recombinant IL-12 at its maximum tolerated dose. The upcoming presentation will further detail safety, pharmacokinetics, biomarkers, and clinical activity, including additional patients treated since the initial data cut-off.

In October 2024, Werewolf introduced WTX-921, a new IL-10 INDUKINE development candidate aimed at treating inflammatory bowel disease and potentially other inflammatory diseases. This addition broadens the company's PREDATOR™ platform beyond oncology. The company will also present preclinical data on how different INDUKINE molecules, including IL-2, IL-12, IL-18, and IL-21, drive anti-tumor efficacy via unique mechanisms at the SITC Annual Meeting.

Financially, Werewolf reported a cash position of $122.8 million as of September 30, 2024, down from $135.3 million at the end of June 2024. The company projects that its current cash and equivalents will sustain its operational expenses and capital requirements through at least the second quarter of 2026. No collaboration revenue was recognized in the third quarter of 2024 due to the completion of performance obligations under a previous agreement with Jazz Pharmaceuticals. Research and development expenses increased to $12.5 million for the third quarter of 2024, up from $10.8 million for the same period in 2023, driven by ongoing development efforts for WTX-124 and WTX-330. General and administrative expenses were $4.6 million, slightly higher than the $4.3 million reported in the third quarter of 2023. The net loss for the third quarter of 2024 was $16.7 million, compared to $8.3 million in the same period the previous year.

Werewolf Therapeutics is committed to pioneering the development of novel therapeutics designed to stimulate the body's immune response to treat cancer and other immune-mediated conditions. Leveraging its proprietary PREDATOR® platform, the company aims to address the limitations of conventional proinflammatory immune therapies with conditionally activated molecules that selectively activate in the tumor microenvironment. Currently, the company's most advanced product candidates, WTX-124 and WTX-330, are being developed for the treatment of various solid tumors and non-Hodgkin Lymphoma.