On August 11, 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 second quarter ended June 30, 2022 (Press release, Werewolf Therapeutics, AUG 11, 2022, View Source [SID1234618147]).
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"Werewolf continues to advance our conditionally activated INDUKINE therapies into clinical development," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Most notably, we received FDA clearance to launch our first-in-human study of WTX-124, an IL-2 INDUKINE, for treatment of advanced solid tumors, marking our transition to a clinical-stage company. Additionally, we are planning to submit an IND for our IL-12 INDUKINE, WTX-330, in the second half of 2022. We believe that these initial candidates offer compelling opportunities not just to advance patient outcomes in their respective indications, but also to validate the distinct advantages of our platform. Importantly, we believe that we remain well-capitalized to advance clinical development for both programs as we proceed with novel discovery efforts in parallel."
Recent Highlights and Upcoming Milestones
WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule in development as monotherapy or in combination with checkpoint inhibitors in multiple solid tumor types.
During the second quarter of 2022, Werewolf received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for WTX-124. This Phase 1/1b clinical trial will evaluate WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced or metastatic solid tumors.
The Company plans to provide an update after dosing the first patient in the WTX-124 Phase 1/1b clinical trial.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule in development as monotherapy or in combination with checkpoint inhibitors in refractory and/or immunologically unresponsive tumors.
Werewolf is concluding IND-enabling work for WTX-330 and is planning to submit an IND application for this program in the second half of 2022.
Corporate:
In April 2022, Jazz Pharmaceuticals (Jazz) and Werewolf entered into a collaboration and license agreement under which Werewolf granted Jazz certain licenses to develop and commercialize WTX-613 (now known as JZP898), an Interferon alpha (IFNα) molecule. During the second quarter of 2022, Werewolf received an upfront payment of $15.0 million from Jazz and is eligible to receive up to $520.0 million in development and regulatory milestones and up to $740.0 million in commercial milestone payments, as well as a tiered, mid-single-digit percentage royalty on net sales, pending approval.
Second Quarter 2022 Financial Highlights
Cash position: As of June 30, 2022, cash and cash equivalents were $145.7 million, compared to $157.5 million as of December 31, 2021. The Company expects that its existing cash and cash equivalents will be sufficient to enable funding of its operating expenses and capital expenditure requirements through at least the fourth quarter of 2023.
Collaboration revenue: Collaboration revenue was $4.1 million for the second 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 $13.9 million for the second quarter of 2022, compared to $7.3 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 future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613, increased employee compensation costs related to increased headcount and increased contract research organization expenses incurred to support IND-enabling studies and clinical start-up activities for WTX-124 and WTX-330.
General and administrative expenses: General and administrative expenses were $5.2 million for the second quarter of 2022, compared to $3.7 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increased personnel and other costs attributable to operating as a public company.
Net loss: Net loss was $14.6 million for the second quarter of 2022, compared to $10.9 million for the same period in 2021.