– Initial first-in-human clinical data for IL-2 INDUKINE WTX-124 monotherapy expected in 4Q 2023 from Phase 1/1b clinical trial in advanced or metastatic solid tumors –
– Dosed first patient in Phase 1 clinical trial evaluating IL-12 INDUKINE WTX-330 in patients with advanced or metastatic solid tumors or lymphoma –
– Nominated WTX-712, a conditionally active IL-21 INDUKINE molecule targeting oncology indications; preclinical data to be presented at AACR Annual Meeting 2023 in Orlando, Florida –
– Updated cash runway guidance to fund cash flow requirements through at least 4Q 2024 –
WATERTOWN, Mass., March 23, 2023 (GLOBE NEWSWIRE) — 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, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2022.
“Werewolf enters 2023 with considerable momentum following exceptional execution across our Company in 2022. In particular, we initiated clinical trials for our two lead INDUKINE programs, WTX-124 and WTX-330, and also advanced our newest IL-21 INDUKINE pipeline candidate WTX-712,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. “This year we anticipate multiple catalysts as we progress our two clinical stage programs, WTX-124 and WTX-330, through first in human testing and expect to share initial clinical data on the safety, tolerability, and preliminary efficacy of WTX-124 in the fourth quarter. Also of note, we have extended our cash runway beyond previous guidance and through at least the fourth quarter of 2024, which provides us the opportunity to reach multiple potential value creating milestones.”
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 inhibitors in multiple solid tumor types.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in refractory and/or immunologically unresponsive tumors.
Early-Stage Pipeline:
Financial Results for the Fourth Quarter and Full Year 2022:
About Werewolf Therapeutics:
Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. We are leveraging our proprietary PREDATOR™ platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Our INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Our most advanced clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of solid tumors. We expect to advance WTX-124 in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor and WTX-330 in multiple tumor types or Non-Hodgkin Lymphoma as a single agent. To learn more visit www.werewolftx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risk and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Werewolf’s future operations, prospects, plans, the projection of the cash runway, the expected timeline for the clinical development of product candidates and availability of data from such clinical development, and the potential activity and efficacy of product candidates in preclinical and clinical trials constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “design,” “designed to,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “promise,” “should,” “target,” “will,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and the Company’s ability to submit and obtain regulatory approval for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; the Company’s ability to obtain sufficient cash resources to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; the impact of the COVID-19 pandemic on the Company’s business and operations; as well as the risks and uncertainties identified in the “Risk Factors” section of the Company’s most recent Form 10-Q and in subsequent filings the Company may make with the Securities and Exchange Commission (“SEC”). In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Werewolf Therapeutics, Inc. |
||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Revenue: | ||||||||||||
Collaboration revenue | $ | 7,283 | $ | — | $ | 16,401 | $ | — | ||||
Operating expenses: | ||||||||||||
Research and development | 15,859 | 13,400 | 53,761 | 35,269 | ||||||||
General and administrative | 4,603 | 4,484 | 18,696 | 14,818 | ||||||||
Total operating expenses | 20,462 | 17,884 | 72,457 | 50,087 | ||||||||
Operating loss | (13,179) | (17,884) | (56,056) | (50,087) | ||||||||
Other income | 1,249 | 15 | 2,246 | 104 | ||||||||
Net loss | (11,930) | (17,869) | (53,810) | (49,983) | ||||||||
Accretion of redeemable convertible preferred stock to redemption value | — | — | — | (151,942) | ||||||||
Net loss attributable to common stockholders | $ | (11,930) | $ | (17,869) | $ | (53,810) | $ | (201,925) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.39) | $ | (0.66) | $ | (1.86) | $ | (10.94) | ||||
Weighted-average common shares outstanding, basic and diluted | 30,735 | 27,270 | 28,864 | 18,455 |
Werewolf Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited) (amounts in thousands) |
||||||
December 31, 2022 | December 31, 2021 | |||||
Cash and cash equivalents | $ | 129,315 | $ | 157,531 | ||
Working capital | $ | 116,211 | $ | 149,194 | ||
Total assets | $ | 160,245 | $ | 179,250 | ||
Total deferred revenue | $ | 7,660 | $ | — | ||
Total stockholders’ equity | $ | 122,337 | $ | 152,787 |
Investor Contact:
Josh Rappaport
Stern IR
212.362.1200
Josh.rappaport@sternir.com
Media Contact:
Peg Rusconi
VERGE Scientific Communications
prusconi@vergescientific.com
Company Contact:
Ellen Lubman
Chief Business Officer
Werewolf Therapeutics
elubman@werewolftx.com
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