On May 11, 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 first quarter ended March 31, 2023 (Press release, Werewolf Therapeutics, MAY 11, 2023, View Source [SID1234631541]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the first quarter, Werewolf has focused on execution by progressing our INDUKINE pipeline and enrolling ongoing first-in-human clinical trials for our lead programs, WTX-124 and WTX-330. In addition, preclinical data presented at AACR (Free AACR Whitepaper) and published in Cancer Immunology Research continues to demonstrate the robustness of our PREDATOR platform showing that Werewolf’s conditional activation technology results in potent anti-tumor activity alongside an improved therapeutic index," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Looking ahead, in the fourth quarter we plan to share initial safety, tolerability, and preliminary efficacy data from our Phase 1/1b clinical trial of WTX-124 in solid tumor types."

"Finally, we’d like to express our deep appreciation to Reid Leonard, Ph.D., Werewolf’s Chief Operating Officer, who is retiring effective June 30, 2023, after a long and successful career in the biopharmaceutical industry. Reid is a founding member of the Werewolf Executive Team and has been instrumental in leading and advancing all aspects of organizational operations. We have benefited greatly from Reid’s significant expertise, and the strong team he has built and business process he has established will ensure continued operational excellence going forward. We wish Reid the very best in his retirement."

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 checkpoint inhibitor therapy in multiple solid tumor types.

•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 checkpoint inhibitor therapy.
•Enrollment is ongoing in monotherapy dose-escalation cohorts, and the Company anticipates reporting interim safety, tolerability and preliminary efficacy data from these monotherapy cohorts in the fourth quarter of 2023.

•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented a poster entitled "Trial in progress: a multicenter phase 1/1b dose escalation study of WTX-124 as a monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors."

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.
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented a poster entitled "Trial in progress: a first-in-human, phase 1, multicenter dose escalation and dose expansion study of WTX-330 in adult patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma."
•Also in April 2023, the Company announced the publication of preclinical data in Cancer Immunology Research Online First, demonstrating that mWTX-330 delivers IL-12 selectively to the tumor environment to inhibit tumor growth in mouse models. The preclinical data demonstrate that mWTX-330 stimulates a potent anti-tumor response in mice by activating tumor infiltrating lymphocytes and restoring the metabolic health of these lymphocytes and has the potential to minimize the toxicity previously associated with systemic IL-12 administration.

Early-Stage Pipeline:
•During the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, The Company presented a poster entitled "Generation of IL-21 INDUKINE molecules for the treatment of cancer," which featured preclinical data supporting the recent nomination of Werewolf’s third wholly owned candidate, WTX-712, a conditionally activated IL-21 INDUKINE molecule in development for treatment of cancer. Highlights of the presentation include:
◦IL-21 INDUKINE polypeptides demonstrated improved tolerability and therapeutic window in mouse syngeneic tumor models.
◦Efficacy in these tumor models was linked to expansion and activation of tumor infiltrating T cells, increased polyfunctionality in CD8+ T cells, and signs of increased activation of B cells.

Financial Results for the First Quarter of 2023:

•Cash position: As of March 31, 2023, cash and cash equivalents were $147.9 million, compared to $129.3 million as of December 31, 2022. The Company also has restricted cash and cash equivalents of $21.2 million, compared to $1.2 million as of December 31, 2022. These increases are primarily due to proceeds from the Company’s at-the-market sales facility, the drawdown of remaining capital available under its term loan agreement with Pacific Western Bank, and funding received in connection with the Company’s licensing agreement with Jazz Pharmaceuticals ("Jazz"). 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 $4.5 million for the first quarter of 2023, compared to zero 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 $11.7 million for the first quarter of 2023, compared to $10.9 million for the same period in 2022. The increase in research and development expenses was primarily due to increased personnel costs.
•General and administrative expenses: General and administrative expenses were $5.0 million for the first quarter of 2023, compared to $4.4 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increased costs to support the increasing size and complexity of Werewolf’s research, development and manufacturing activities.
•Net loss: Net loss was $12.0 million for the first quarter of 2023, compared to $15.3 million for the same period in 2022.