On August 10, 2023 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 a business update and provided financial results for the second quarter ended June 30, 2023 (Press release, Werewolf Therapeutics, AUG 10, 2023, View Source [SID1234634224]).

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"Throughout the second quarter, we have continued advancing our INDUKINE pipeline with ongoing enrollment of our first-in-human clinical trials for WTX-124 and WTX-330, our two lead programs," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We look towards the fourth quarter, when we anticipate sharing initial safety, tolerability, pharmacokinetics and biomarker data from our Phase 1/1b trial of WTX-124 in multiple solid tumors. Additionally, we are pleased that Jazz Pharmaceuticals has announced the Investigational New Drug (IND) application clearance of JZP898 (formerly WTX-613), an engineered IFNα INDUKINE molecule. Werewolf continues to operate from a position of financial strength with a cash runway projected to carry us through at least the fourth quarter of 2024."

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 KEYTRUDA (pembrolizumab) in multiple solid tumors.

•Werewolf is progressing Study WTX-124×2101, its Phase 1/1b, multi-center, open-label clinical trial evaluating WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care, including prior checkpoint inhibitor therapy.
•Enrollment is ongoing in monotherapy dose-escalation and combination therapy cohorts, and the Company anticipates reporting initial safety, tolerability, pharmacokinetics and biomarker data from monotherapy dose escalation in the fourth quarter of 2023.

WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in refractory and/or immunologically unresponsive tumors.

•Werewolf is progressing Study WTX-330×2101, its Phase 1, multi-center, open-label trial evaluating WTX-330 as a monotherapy in patients with immunotherapy insensitive or resistant advanced or metastatic solid tumors or non-Hodgkin lymphoma. Enrollment is ongoing in dose-escalation.

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JZP898 (Formerly WTX-613): an engineered IFNα INDUKINE pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells.

•In April 2022, Werewolf entered into an exclusive global collaboration and license agreement with Jazz Pharmaceuticals under which Werewolf is responsible for certain pre-clinical development and other development activities with respect to JZP898.
•Jazz Pharmaceuticals recently disclosed that in July 2023, JZP898 received Investigational New Drug (IND) application clearance.

Financial Results for the Second Quarter of 2023:

•Cash position: As of June 30, 2023, cash and cash equivalents were $137.5 million, compared to $147.9 million as of March 31, 2023. The Company also had restricted cash and cash equivalents of $21.2 million as of June 30, 2023, and March 31, 2023, respectively. The Company expects that its existing cash and cash equivalents, together with anticipated collaboration revenue, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the fourth quarter of 2024.

•Collaboration revenue: Collaboration revenue was $8.1 million for the second quarter of 2023, compared to $4.1 million for the same period in 2022. Collaboration revenue is related to partial recognition 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 $9.6 million for the second quarter of 2023, compared to $13.9 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease in the costs incurred with contract manufacturing associated with WTX-124 and WTX-330 and favorable adjustments recognized during the quarter upon the closeout of completed purchase orders.
•General and administrative expenses: General and administrative expenses were $4.6 million for the second quarter of 2023, compared to $5.2 million for the same period in 2022. The decrease in general and administrative expenses was primarily due to reduced insurance premiums and decreased utilization of outside advisors.
•Net loss: Net loss was $5.1 million for the second quarter of 2023, compared to $14.6 million for the same period in 2022.