On May 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 quarter ended March 31, 2022 (Press release, Werewolf Therapeutics, MAY 10, 2022, View Source [SID1234614048]).
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"To date in 2022, we have successfully executed against corporate and strategic objectives, most notably, signing a collaboration and licensing agreement with Jazz Pharmaceuticals for the global development and commercialization of WTX-613," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Beyond supporting our conviction in the power of our innovative PREDATOR platform and the viability of WTX-613 as a next-generation IFNα for treatment of cancer, this agreement provides important access to non-dilutive capital, which, together with our updated term loan facility, extends our cash runway through at least the fourth quarter of 2023. Further, we remain on track as we advance towards clinical development for WTX-124 and WTX-330, while progressing our broader research portfolio in parallel."
First Quarter 2022 and Recent Business Highlights
Entered into exclusive global license and collaboration agreement with Jazz Pharmaceuticals to develop WTX-613: In April 2022, Jazz and Werewolf announced that they entered into a licensing agreement under which Jazz has acquired exclusive global development and commercialization rights to Werewolf’s investigational candidate WTX-613, an IFN⍺2b cytokine pro-drug, currently in preclinical development for a range of cancer types. 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. Pending approval, Werewolf is eligible to receive a tiered, mid-single-digit percentage royalty on net sales of WTX-613. Jazz is responsible for funding all preclinical and IND-enabling activities conducted by Werewolf for WTX-613 and is responsible for the submission of an investigational new drug application for WTX-613 and all subsequent clinical development and commercialization activities.
Presented preclinical data on two lead INDUKINE molecules at AACR (Free AACR Whitepaper): In April 2022, Werewolf presented promising preclinical data on its IL-2 and IL-12 INDUKINE molecules, WTX-124 and WTX-330, during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. WTX-124 demonstrated high tumor selectivity and generated significant anti-tumor activity in a CD8+ T cell-dependent manner, and the WTX-330 surrogate demonstrated significant expansion of the therapeutic
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window compared to recombinant IL-12 and generated potent anti-tumor immunity in multiple syngeneic tumor models.
Published preclinical data demonstrating efficacy of WTX-124 in delivering IL-2 selectively to the tumor microenvironment: In March 2022, Werewolf announced the publication of preclinical data for its lead molecule, WTX-124, in peer-reviewed Cancer Immunology Research. The article entitled, "Discovery of a conditionally activated IL-2 that promotes anti-tumor immunity and induces tumor regression," includes preclinical data that highlights WTX-124’s design in delivering IL-2 selectively to the tumor microenvironment where it stimulates a potent anti-tumor immune response.
Entered into $40.0 million term loan facility: In April 2022, Werewolf entered into an amended term loan facility with Pacific Western Bank (PWB), which provides access to up to $40.0 million across two tranches, $20.0 million of which is available at Werewolf’s discretion and $20.0 million upon the acceptance by the U.S. Food and Drug Administration of two investigational new drug application submissions on or before March 31, 2023.
First Quarter 2022 Financial Highlights
•Cash position: As of March 31, 2022, cash and cash equivalents were $143.7 million, compared to $157.5 million as of December 31, 2021. This quarter-end balance does not reflect $15.0 million upfront proceeds received in April from the collaboration agreement with Jazz. The Company expects that its existing cash and cash equivalents, together with the upfront payment from the Jazz agreement as well as access to the $20.0 million first tranche of its term loan agreement with PWB, will be sufficient to enable the funding of its operating expenses and capital expenditure requirements through at least the fourth quarter of 2023.
•Research and development expenses: Research and development expenses were $10.9 million for the first quarter of 2022, compared to $4.8 million for the same period in 2021. The increase in research and development expenses was primarily due to increased manufacturing, contract research organization, and personnel expenses incurred to advance the Company’s product candidates WTX-124, WTX-330 and WTX-613 and expand research and development activities.
•General and administrative expenses: General and administrative expenses were $4.4 million for the first quarter of 2022, compared to $2.6 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increased personnel, professional services, and other operating costs attributable to operating as a public company.
•Net loss: Net loss was $15.3 million for the first quarter of 2022, compared to $7.4 million for the same period in 2021.