On March 7, 2024 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 announced financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Werewolf Therapeutics, MAR 7, 2024, View Source [SID1234640937]).

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!

"Werewolf made considerable progress in 2023, setting up 2024 as a year of execution across our pipeline," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "In the first half of this year, we plan to present additional clinical data from our Phase 1/1b clinical trial of WTX-124, including updated monotherapy data and initial combination data, which we anticipate will build on the promising signals of antitumor activity and improved therapeutic index that we observed in the data presented at SITC (Free SITC Whitepaper) last year. In addition, we plan to share data further demonstrating the performance of our platform in our preclinical programs at AACR (Free AACR Whitepaper). We also plan to share initial clinical data from WTX-330, our second clinical candidate, in the second quarter of 2024."

"Additionally, I would like to express my deep appreciation to Cindy Seidel-Dugan, Ph.D., Werewolf’s Chief Scientific Officer, who is retiring effective March 29, 2024, after a long and successful career in the biopharmaceutical industry. Cindy was a founding member of the Werewolf Executive Team and has been instrumental in establishing Werewolf’s innovative science, developing our INDUKINE technology, and shepherding our lead candidates through the discovery and IND-enabling process. We have benefited greatly from Cindy’s significant expertise, and the strong scientific leadership team she has built that will ensure continued success going forward. We wish Cindy the very best in her 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 pembrolizumab in multiple solid tumor types.

•In November 2023, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, Werewolf presented first-in-human monotherapy data from the Phase 1/1b clinical trial of WTX-124. These preliminary data established proof of mechanism for WTX-124 and proof of concept for Werewolf’s INDUKINE design hypothesis.

•In the first half of 2024, Werewolf expects to present additional interim dose-escalation data from the monotherapy dose-escalation arm, nominate a recommended dose for expansion and initiate monotherapy dose expansion arms.
•Additionally, Werewolf continues to progress combination dose escalation cohorts of the Phase 1/1b clinical trial and plans to report initial clinical data from this arm in the first half of 2024.

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 clinical trial evaluating WTX-330 as a monotherapy in patients with immunotherapy insensitive or resistant advanced or metastatic solid tumors or non-Hodgkin lymphoma. Werewolf plans to report initial data from the Phase 1 study in the second quarter of 2024.

Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, INDUKINE molecules targeting IL-21 and IL-18, respectively, for treatment of cancer.

•Werewolf plans to present preclinical data from WTX-712 and WTX-518 at the 2024 AACR (Free AACR Whitepaper) Annual Meeting on antitumor activity in the delivery of IL-21 or IL-18, respectively, to the tumor microenvironment in mouse tumor models. These programs are currently progressing through IND-enabling work.

Abstract Number: 4078
Title: WTX-712, a conditionally active IL-21 INDUKINETM molecule, induces a strong anti-tumor phenotype through a differentiated mechanism
Session Date and Time: Tuesday, April 9, 2024, from 9:00 a.m. – 12:30 p.m.
Abstract Number: 4074
Title: Discovery of WTX-518, an IL-18 pro-drug that is conditionally activated within the tumor microenvironment and induces regressions in mouse tumor models
Session Date and Time: Tuesday, April 9, 2024, from 9:00 a.m. – 12:30 p.m.

Additional Updates:

•In January 2024, Werewolf appointed Michael Atkins, M.D., to its Board of Directors. Dr. Atkins has served as a member of Werewolf’s Scientific Advisory Board since August 2018 and has more than 30 years of experience in translational and clinical research, specializing in melanoma, kidney cancer, and cancer immunotherapy.

Financial Results for the Fourth Quarter and Full Year 2023:

•Cash position: As of December 31, 2023, cash and cash equivalents were $134.3 million, compared to $129.3 million as of December 31, 2022. The Company also had restricted cash and cash equivalents of $21.2 million and $1.2 million as of December 31, 2023 and December 31, 2022, respectively. Based on updated forecasting the Company now expects that its existing cash and cash equivalents at December 31, 2023, and gross proceeds of $17.7 million under the at-the-market sales facility received from January 1, 2024 through March 1, 2024, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the second quarter of 2025.
•Collaboration revenue: Collaboration revenue was $1.5 million for the fourth quarter of 2023, compared to $7.3 million for the same period in 2022, and $19.9 million for the full year 2023, compared to $16.4 million for the same period in 2022. Collaboration revenue consists of revenue recognized from the Company’s licensing agreement with Jazz Pharmaceuticals (Jazz) and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz.

•Research and development expenses: Research and development expenses were $9.6 million for the fourth quarter of 2023, compared to $15.9 million for the same period in 2022. Research and development expenses were $41.8 million for the full year 2023, compared to $53.8 million for the full year 2022.
•General and administrative expenses: General and administrative expenses were $4.8 million for the fourth quarter of 2023, compared to $4.6 million for the same period in 2022. General and administrative expenses were $18.7 million for the full year 2023, compared to $18.7 million for the full year 2022.
•Net loss: Net loss was $12.0 million for the fourth quarter of 2023, compared to $11.9 million for the same period in 2022. Net loss was $37.4 million for the full year 2023, compared to $53.8 million for the full year 2022.