Full Press Release Details
Werewolf Therapeutics Provides Business Update and Highlights 2024 Strategic Outlook
- Prioritizing development of wholly owned clinical assets, WTX-124 and WTX-330; key updates from both INDUKINETM programs anticipated in 2024 -
- WTX-124: updated interim monotherapy dose-escalation data and initial combination dose escalation
data from Phase 1/1b clinical trial expected in 1H 2024 -
- WTX-330: preliminary
dose-escalation data from Phase 1 clinical trial expected in 2Q 2024 -
- Updated cash guidance provides runway through at least the
first quarter of 2025 -
Watertown, Mass., January 8, 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, today provided a
business update and outlined its strategic outlook and expected milestones for 2024.
Werewolf outlined the following objectives as the Company s
strategic priorities for 2024:
2023 was an important year for Werewolf,
highlighted by preliminary monotherapy data from our IL-2 program that offered proof of concept for WTX-124 and for our INDUKINE design more broadly, said Daniel
J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. In 2024, we expect to share progress from our wholly owned clinical programs, with updated monotherapy data and initial combination data from
WTX-124 as well as our first look at WTX-330. In particular, for WTX-124, we hope to build upon the promising signals of
antitumor activity and improved therapeutic index that we observed in the highest dose cohort presented at SITC.
Dr. Hicklin continued,
In parallel, we expect to continue to progress our preclinical candidates through IND-enabling work to provide additional validation of the INDUKINE approach for novel targets, namely IL-21 and IL-18. Alongside this prioritization, we intend to seek partners who understand our unique conditional-activation expertise and protein engineering approach in areas
beyond Werewolf s core focus of oncology, such as inflammatory diseases, where we believe our approach is viable.
Based on these strategic priorities, Werewolf has provided the following guidance for 2024:
WTX-124: a systemically delivered, conditionally activated
Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy or in combination with checkpoint inhibitors in multiple solid tumor types.
In November 2023, Werewolf presented first-in-human monotherapy data from the
Phase 1/1b clinical trial of WTX-124 at the Society for Immunotherapy of Cancer s (SITC) 38th annual meeting. The preliminary data established proof of
concept for WTX-124 and for Werewolf s INDUKINE design hypothesis. In the first half of 2024, Werewolf plans to:
WTX-330: a systemically delivered, conditionally activated
Interleukin-12 (IL-12) INDUKINE molecule being developed in refractory and/or immunologically unresponsive tumors.
Werewolf continues to progress the Phase 1 clinical trial evaluating WTX-330 as a monotherapy in patients with
immunotherapy insensitive or resistant advanced or metastatic solid tumors or non-Hodgkin lymphoma. In 2024, Werewolf plans to report initial data from the Phase 1 clinical trial in the second quarter of 2024.
Preclinical Portfolio: includes development candidates WTX-712 and
WTX-518, INDUKINE molecules respectively targeting IL-21 and IL-18 for treatment of cancer, as well as numerous leads in
Werewolf intends to progress these programs through IND-enabling work. In 2024, Werewolf plans to:
Cash Position and Financial Guidance:
Based on updated forecasting reflecting the Company s streamlined development plans and careful cash management to date, Werewolf now expects that its
cash and equivalents will be sufficient to fund its operational expenses and capital expenditure requirements through at least the first quarter of 2025.
About Werewolf Therapeutics:
Werewolf Therapeutics, Inc.
is an innovative clinical-stage 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 product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2),
and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors. WTX-124 is in development as a monotherapy and
in combination with KEYTRUDA (pembrolizumab) in multiple solid tumor types. WTX-330 is in development as a single agent in refractory and/or
immunotherapy unresponsive or resistant advanced or metastatic solid tumors and non-Hodgkin lymphoma. 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 strategy, future operations, prospects, plans, and objectives of management; the projection of the cash runway; the expected timeline for the preclinical and
clinical development of product candidates and the availability of data from such preclinical and clinical development; the potential activity and efficacy of product candidates in preclinical studies and clinical trials; and the anticipated safety
profile of product candidates; constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words aim, anticipate, approach, believe,
contemplate, continue, could, design, designed to, engineered, 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 and 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; whether preliminary data from a clinical trial will be predictive of the results of the trial and future
clinical trials; the Company s ability to manage cash resources and obtain additional cash resources to fund the Company s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and
uncertainties identified in the Risk Factors section of the Company s most recent Form 10-Q filed with the Securities and Exchange Commission ( SEC ), and in subsequent filings the
Company may make with the 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.
VERGE Scientific Communications
Chief Business Officer
Werewolf Therapeutics