Werewolf Therapeutics Inc.'s (HOWL:NASDAQ) WTX-124 was shown, in initial clinical trial results, to have a favorable safety profile, reported H.C. Wainwright & Co. analyst Dr. Andres Maldonado in an October 31 research note.
"WTX-124's initial safety profile looks to be in complete divergence of native IL-2 therapies and represents a step forward in derisking Werewolf's masking technology (PREDATOR platform)," Maldonado wrote.
Conference Call on Nov. 3
These first data became available through the release of abstracts for the in-progress annual meeting of the Society for Immunotherapy of Cancer (SITC).
Werewolf management will review the WTX-124 data to be presented at SITC at 8:30 a.m. EDT on Friday, November 3, 2023, in a conference call.
495% Return Implied
H.C. Wainwright maintained its US$15 per share target price on the Massachusetts-headquartered biopharma company, trading now at about US$2.52 per share in comparison. The gap between these prices suggests a potential return for investors that is significant: 495%.
Werewolf is a Buy.
About the Data
These first results are from the monotherapy dose-escalation cohorts in the ongoing Phase 1/1b study of WTX-124, an interleukin-2 (IL-2) Indukine molecule, in solid tumors. Doses were 1 milligram (1 mg), 3 mg, and 6 mg.
Data, cut off on June 22, 2023, is for 11 patients. Of these, four had nonsmall cell lung cancer, three had cutaneous melanoma, and two had renal cell carcinoma.
"In line with our positive thesis towards Werewolf's masking technology, investors garnered a first small positive look at the potential of systemically delivering a masked native IL-2 cytokine to patients," Maldonado wrote.
Better Safety Profile
Trial results indicated that no dose-limiting toxicities were reported, Maldonado relayed. Treatment-related adverse effects (TRAEs) occurred in 26% of patients but were not severe and categorized as Grade 1 or 2. The most common TRAEs were fatigue and arthralgias, with three patients reporting each.
The analyst noted that this paucity of TRAEs overall and severe TRAEs is unusual for IL-2 therapies, Maldonado noted. He indicated that initial studies by Rosenberg et al. done in 1985 of native IL-2 reported rates of 80−100% for each TRAE plus the occurrence of 15 additional severe TRAEs.
IL-2 therapies have caused high rates of neurologic toxicities and cytokine storm symptoms, such as pulmonary edema, noted Maldonado. Less severe capillary leak syndrome occurred in some patients systemically treated with aldesleukin, for instance. None of these TRAEs was reported with WTX-124 treatment in the first data set.
"We believe it's clear that WTX-124 is exhibiting dose-proportional pharmacokinetics, which thus far has yielded low levels of active IL-2—which is responsible for the improvement of the safety profile," the analyst purported.
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Disclosures H.C. Wainwright & Co., Werewolf Therapeutics Inc., October 31, 2023
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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Andres Y. Maldonado, PhD and Andrew S. Fein , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Werewolf Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Werewolf Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Werewolf Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Werewolf Therapeutics, Inc. as of the date of this research report.
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