On November 10, 2022 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, reported financial results for the third quarter ended September 30, 2022 (Press release, Werewolf Therapeutics, NOV 10, 2022, View Source [SID1234623746]).
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"Werewolf continues to deliver against key corporate objectives with notable pipeline progress highlighted by our transition into a clinical-stage company," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "During the third quarter, we initiated the first-in-human clinical trial of our lead program, WTX-124, for treatment of advanced solid tumors. In addition, we have received IND clearance from the FDA for WTX-330, our IL-12 program, which puts us on track to have two actively enrolling clinical trials in 2023. Finally, Werewolf remains well-capitalized with runway that we project will carry us through at least the second quarter of 2024, which supports the development plans for both clinical programs and continued value creation for our early-stage pipeline assets."
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.
•During the third quarter of 2022, Werewolf announced the initiation of patient dosing in its Phase 1/1b clinical trial evaluating WTX-124 (WTX-124×2101), the Company’s lead INDUKINE molecule, targeting IL-2 for the treatment of solid tumors. The Phase 1/1b clinical trial is a first-in-human, multi-center, open-label trial evaluating WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with immunosensitive advanced or metastatic solid tumors who have failed standard of care, including checkpoint inhibitor therapy.
•Werewolf is actively enrolling patients in monotherapy dose-escalation cohorts in Study WTX-124×2101. The Company anticipates reporting preliminary interim data from this study in the fourth quarter of 2023. These data are expected to provide initial safety and activity profiles of WTX-124.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed as monotherapy in relapsed/refractory and/or immunologically resistant or unresponsive tumors.
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•Following submission in the third quarter of 2022, Werewolf received clearance from the U.S. Food and Drug Administration (FDA) of its IND application for WTX-330. The Company has begun activating sites for a Phase 1 clinical trial (WTX-330×2101) evaluating the safety and tolerability of WTX-330 monotherapy in patients with advanced or metastatic tumors which are either immunotherapy resistant or unresponsive.
Third Quarter 2022 Financial Highlights
•Cash position: As of September 30, 2022, cash and cash equivalents decreased to $140.5 million, compared to $157.5 million as of December 31, 2021. Based on updated forecasting, the Company has extended its runway to project that its existing cash and cash equivalents, together with anticipated collaboration revenue and access to the term loan agreement with Pacific Western Bank, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the second quarter of 2024.
•Collaboration revenue: Collaboration revenue was $5.0 million for the third quarter of 2022, compared to zero for the same period in 2021. Collaboration revenue is related to amortization of the $15.0 million upfront payment received in April 2022 upon the execution of Werewolf’s licensing agreement with Jazz and costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $13.1 million for the third quarter of 2022, compared to $9.8 million for the same period in 2021. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and current and future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613 and increased employee compensation costs related to increased headcount.
•General and administrative expenses: General and administrative expenses were $4.4 million for the third quarter of 2022, compared to $4.0 million for the same period in 2021.
•Net loss: Net loss was $11.9 million for the third quarter of 2022, compared to $13.8 million for the same period in 2021.