Core Insights - Werewolf Therapeutics, Inc. announced initial results from a Phase 1 clinical trial evaluating WTX-330, a conditionally activated interleukin-12 (IL-12) INDUKINE™ molecule, as a monotherapy for patients with immunotherapy-insensitive or resistant locally advanced or metastatic solid tumors or non-Hodgkin lymphoma [18] Group 1: Clinical Trial Results - WTX-330 demonstrated therapeutically relevant exposure levels of systemically delivered IL-12 prodrug with improved tolerability compared to historical data for rhIL-12 [2][20] - Early dose-escalation data showed encouraging clinical activity, including an unconfirmed partial response in a metastatic melanoma patient and stable disease in two patients with microsatellite stable colorectal cancer [14][20] - The study had dosed eleven patients in dose escalation with three cohorts: 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), and 0.032 mg/kg (n=5) [14] Group 2: Mechanism and Technology - WTX-330 is designed to deliver fully active IL-12 selectively into the tumor microenvironment through targeted intratumoral activation, potentially broadening the therapeutic window [4][7] - The INDUKINE™ technology allows for the stimulation of both adaptive and innate immunity while remaining inactive in peripheral tissues [7] Group 3: Safety and Tolerability - Patients exhibited mild to moderate treatment-related toxicities, primarily associated with the first dose, with no Grade 4 or Grade 5 adverse events reported [20] - Two patients experienced reversible dose-limiting toxicities at the 0.032 mg/kg dose level, indicating a manageable safety profile [20] Group 4: Future Developments - The company plans to present further safety, biomarker, and antitumor activity results from patients enrolled in expansion arms at a medical meeting in the fourth quarter of 2024 [3][19] - Expansion arms have been opened to evaluate 0.024 mg/kg of WTX-330 in patients with immune checkpoint inhibitor-sensitive solid tumors [20]

Core Insights - Werewolf Therapeutics announced new clinical data from the Phase 1/1b trial of WTX-124, a conditionally activated IL-2 molecule, at the 2024 ASCO Annual Meeting [1][2] - The trial aims to evaluate WTX-124 in patients with advanced or metastatic solid tumors who have previously failed checkpoint inhibitor therapy [2][3] Clinical Trial Results - WTX-124 demonstrated clinical activity with three objective responses, including one durable confirmed complete response [3][4] - The recommended dose for expansion (RDE) for WTX-124 monotherapy was set at 18 mg administered intravenously every two weeks [6] - The combination of WTX-124 with pembrolizumab was well-tolerated, showing enhanced immune activation in tumors [3][10] Future Development Plans - The company has opened three expansion arms for WTX-124 in advanced or metastatic renal cell carcinoma, cutaneous melanoma, and cutaneous squamous cell carcinoma [6] - Ongoing dose escalation studies for WTX-124 in combination with pembrolizumab are planned, with an RDE expected to be selected in Q3 2024 [6] - The company intends to engage with regulators regarding potential registrational pathways for WTX-124, including accelerated approval strategies [6] Presentation and Webcast - The findings will be presented in a poster session at ASCO and a webcast is scheduled for June 3, 2024, to review the clinical results [1][7]

WATERTOWN, Mass., May 23, 2024 (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 announced the upcoming presentation of clinical data from dose-escalation arms of the Phase 1/1b trial evaluating WTX-124, its conditionally activated Interleukin-2 (IL-2) INDUKINE™ molecule, as m ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________________________________________________________________ FORM 10-Q ______________________________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Exhibit 99.1 Werewolf Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update – Company announces cash runway extension through at least the first quarter of 2026 — Watertown, Mass., May 3, 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 and other immune-mediated ...

— Company to present an update of its ongoing monotherapy and combination Phase 1/1b trial of WTX-124 in advanced or metastatic solid tumors at ASCO — — Company plans to present interim, first-in-human clinical data from the ongoing Phase 1 trial of WTX-330 in the second quarter of 2024 — — Multiple presentations of preclinical data demonstrate the potential of the PREDATORTM platform, including in immunology-based diseases — — Company announces cash runway extension through at least the first quarter o ...

Company to present an update of its ongoing monotherapy and combination Phase 1/1b study of WTX-124 in advanced or metastatic solid tumors WATERTOWN, Mass., April 24, 2024 (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 announced that an abstract providing an update of the Co ...

Investors might want to bet on Werewolf Therapeutics, Inc. (HOWL) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. ...

WATERTOWN, Mass., April 04, 2024 (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 announced the publication of an abstract for an upcoming poster presentation at IMMUNOLOGYTM 2024, the annual meeting of the American Association of Immunologists (AAI) taking place May 3-7 in C ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-40366 ______________________________________________________________________________________ WEREWOLF THERAPEUTICS, INC. ______________________________________________________________________________________ FORM 10-K ______________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...