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Safety Profile of New IL-2 Molecule Better Than Like Drugs'
Research Report

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First clinical data of this investigational interleukin-2 cytokine show it lacks the degree and rates of adverse events typically seen with treatments of this kind, noted an H.C. Wainwright & Co. report.

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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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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Disclosures H.C. Wainwright & Co., Werewolf Therapeutics Inc., October 31, 2023

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

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.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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