Werewolf Therapeutics(HOWL)

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Werewolf Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-14 11:00
Core Insights - Werewolf Therapeutics is advancing its clinical trials for WTX-124 and WTX-330, with significant milestones expected in 2025, including interim data readouts and FDA engagement [1][2][5] Clinical Development - WTX-124 is a conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, currently in a Phase 1/1b clinical trial for cutaneous melanoma and renal cell carcinoma, with interim data expected in Q4 2025 [1][5] - WTX-330, an Interleukin-12 (IL-12) INDUKINE molecule, is in a Phase 1b/2 clinical trial for advanced solid tumors, with dosing regimen determination anticipated by the end of 2025 [1][5] - The company has introduced WTX-1011, its first INDUCER T-cell engager targeting STEAP1 for prostate cancer, which has shown promising preclinical data [2][5] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of $77.6 million, down from $92.0 million as of March 31, 2025, indicating a need for careful cash management [11][15] - Research and development expenses for Q2 2025 were $13.1 million, a decrease from $15.3 million in Q2 2024, while general and administrative expenses also saw a decline [11][14] - The net loss for Q2 2025 was $18.0 million, slightly higher than the $17.2 million loss reported in the same period of 2024 [11][14]
Werewolf Therapeutics to Participate in the KidneyCAN 7th Annual Kidney Cancer Research Summit
Globenewswire· 2025-07-09 12:00
Core Viewpoint - Werewolf Therapeutics is advancing its innovative approach to cancer treatment through conditionally activated therapeutics, specifically focusing on the WTX-124 molecule for renal cell carcinoma and other solid tumors [1][2][4]. Group 1: Company Overview - Werewolf Therapeutics, Inc. is a biopharmaceutical company focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions [4]. - The company utilizes its proprietary PREDATOR platform to create conditionally activated molecules that selectively activate in the tumor microenvironment while remaining inactive in peripheral tissues [4]. - The most advanced product candidates include WTX-124 and WTX-330, which are designed for the treatment of solid tumors and Non-Hodgkin Lymphoma, respectively [4]. Group 2: Clinical Development and Research - Dr. Randi Isaacs, Chief Medical Officer, will present at the KidneyCAN 7th Annual Kidney Cancer Research Summit, focusing on the early clinical findings of WTX-124 [1][2]. - WTX-124 is a tumor-activated IL-2 INDUKINE molecule aimed at improving the therapeutic index by maximizing anti-tumor activity while minimizing systemic side effects [2]. - The "Full Moon Moment" campaign supports ongoing national trials for WTX-124, which is actively enrolling patients with advanced or metastatic renal cell carcinoma [3]. Group 3: Clinical Trial Outcomes - Early responses in clinical trials have been reported, including a patient with cutaneous squamous cell carcinoma who has been in remission for over a year [3]. - The campaign emphasizes the potential outcomes of the INDUKINE molecules in activating tumor-killing properties within the tumor microenvironment [3].
Werewolf Therapeutics (HOWL) Earnings Call Presentation
2025-07-01 14:08
Pipeline and Platform - Werewolf Therapeutics' INDUKINE platform delivers potent payloads with improved therapeutic index [6] - The PREDATOR platform is validated and differentiated, focusing on clinical opportunities [8] - The company's pipeline includes WTX-124 (IL-2), WTX-330 (IL-12), WTX-712 (IL-21), WTX-518 (IL-18), WTX-921 (IL-10), and IFNα INDUKINE [7] - T cell engagers INDUCER molecules, first development candidate to be nominated in 2Q25 [16] Financial Status - As of March 31, 2025, Werewolf Therapeutics had $92.0 million in cash and cash equivalents [7] - The company's cash runway extends into 4Q26 [7] - Approximately 44.9M shares outstanding as of May 2, 2025 [196] Clinical Trial Results - WTX-124 - WTX-124 monotherapy induced rapid, durable regressions of target lesions in some patients [46] - In a Phase 1/1b study, WTX-124 was generally well-tolerated as a monotherapy in the outpatient setting [42] - WTX-124 in combination with pembrolizumab demonstrated durable responses in ICI-treated patients [58] - WTX-124 dosed at 18 mg IV Q2W has a ~1.5-fold higher Cmax than HD IL-2 [64] - Peak free IL-2 exposure after WTX-124 18 mg is ~146-fold lower than HD IL-2 [64] Clinical Trial Results - WTX-330 - WTX-330 delivered 22-fold greater IL-12 to patients compared to rhIL-12 therapy [124] - Peak free IL-12 exposure after 0.024 mg/kg WTX-330 is ~5-fold lower than rhIL-12 at its MTD [127] - One patient with a confirmed PR (RECIST 1.1) and an additional seven patients with stable target lesions (n=15) [101] - WTX-330 was Generally Well Tolerated as a Monotherapy in the Outpatient Setting [97] Market Opportunity - The total market for four tumor types in WTX-124 development strategy is ~$23B [77] - Market Potential in the US in Advanced/Metastatic Melanoma ~$4.1B Spanning 1L-3L [80] - A total of ~20 additional tumor types with US revenue of ~$27B [78]
Werewolf Therapeutics to Participate in the BIO International Convention
GlobeNewswire News Room· 2025-06-12 12:00
Core Insights - Werewolf Therapeutics, Inc. is focused on developing conditionally activated therapeutics aimed at enhancing the immune system for cancer treatment and other immune-mediated conditions [1][3] - The company will participate in a panel discussion at the BIO International Convention, highlighting the potential of its biologics to redefine oncology treatment paradigms [2] Company Overview - Werewolf Therapeutics utilizes its proprietary PREDATOR® platform to create therapeutics that stimulate both adaptive and innate immunity, addressing limitations of traditional immune therapies [3] - The company's leading clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [3] Clinical Trials and Initiatives - The "Full Moon Moment" initiative aims to raise awareness of ongoing clinical trials, including one for WTX-124, which has shown promising results, including a patient with cutaneous squamous cell carcinoma in remission for over a year [2] - WTX-124 is being evaluated as a single agent and in combination with immune checkpoint inhibitors across multiple tumor types [3]
Werewolf Therapeutics (HOWL) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-05-29 17:06
Core Viewpoint - Werewolf Therapeutics, Inc. (HOWL) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, making it a valuable tool for investors [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Company Performance and Investor Sentiment - The upgrade reflects an improvement in Werewolf Therapeutics' underlying business, which is expected to drive stock appreciation as investors recognize this positive trend [5]. - Over the past three months, the Zacks Consensus Estimate for Werewolf Therapeutics has increased by 6.6%, indicating a positive revision trend [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, suggesting a strong potential for market-beating returns [9][10]. - The upgrade of Werewolf Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a favorable position for potential stock price increases in the near term [10].
Werewolf Therapeutics to Participate in the Upcoming Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer treatment [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, featuring CEO Daniel J. Hicklin and CMO Randi Isaacs [1][2] Company Overview - Werewolf Therapeutics leverages its proprietary PREDATOR® platform to create therapeutics that activate selectively in the tumor microenvironment while remaining inactive in peripheral tissues [3] - The company's advanced clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3] - WTX-124 is being advanced in multiple tumor types both as a single agent and in combination with immune checkpoint inhibitors, while WTX-330 is being explored for various tumor types and Non-Hodgkin Lymphoma [3]
HonorHealth Research Institute patient with advanced skin cancer in remission for more than a year following clinical trial of Werewolf Therapeutics' investigational novel conditionally activated IL-2 pro-drug WTX-124
GlobeNewswire News Room· 2025-05-20 20:01
Core Insights - The investigational drug shows promise in treating advanced cutaneous squamous cell carcinoma, with a patient experiencing no detectable cancer after 12 weeks of treatment [1][2][3] - The incidence of cutaneous squamous cell carcinoma has tripled over the past three decades, highlighting the growing burden of this disease [7] Company Insights - HonorHealth Research Institute is conducting a clinical trial for a new drug designed to activate in the tumor microenvironment, offering hope for patients with limited treatment options [1][4][5] - Werewolf Therapeutics is pioneering the development of therapeutics that stimulate the immune system, utilizing its proprietary PREDATOR® platform to create conditionally activated molecules [11] Industry Insights - Approximately 1 million Americans are diagnosed with cutaneous squamous cell carcinoma annually, with nearly 7,000 fatalities occurring when the disease becomes advanced or metastatic [6] - Current treatment options for advanced cases are limited, particularly for patients who do not respond to checkpoint inhibitors [6][9]
Werewolf Therapeutics (HOWL) 2025 Conference Transcript
2025-05-14 23:17
Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics is a clinical stage biopharmaceutical company focused on developing conditionally activated biologics for cancer and other serious diseases. The company has engineered a pipeline of cytokine prodrugs, referred to as endokines, to address therapeutic index challenges associated with potent biologics [2][3] Core Programs - The lead endokine programs include: - WTX-124 (an interleukin-2 endokine) - WTX-330 (an interleukin-12 endokine) - The company has also developed T cell engagers called inducers, designed to address therapeutic index challenges of T cell engagers [3][19] Clinical Data and Efficacy - WTX-124 has completed dose escalation for both monotherapy and combination therapy with pembrolizumab, with a determined dose of 18 mg delivered IV every two weeks [5][6] - Expansion arms are open for indications including: - Cutaneous melanoma - Renal cell carcinoma - Cutaneous squamous cell carcinoma, where a patient achieved a complete response after failing standard treatment [6][7] - The company aims for an overall response rate above 20% for monotherapy and higher for combination therapy, with enrollment progressing well [11][12] Safety Profile - The safety profile of WTX-124 has shown no hallmark toxicities associated with high-dose IL-2, allowing for outpatient delivery to a broad patient population [9][10] Regulatory Pathway - The company plans to present data to the FDA in the coming quarters, seeking insights on both monotherapy and combination data for potential registration [13][14] Future Expectations - The company anticipates presenting updated interim data in Q4 2025, with a focus on both efficacy and safety metrics [9][22] - For WTX-330, the company has completed a first-in-human trial, showing a good safety profile and antitumor activity, with plans for further studies [16][17] Inducers Platform - The inducers platform aims to mask immune cell engagement to reduce cytokine release syndrome, enhancing the therapeutic index of T cell engagers [19][20] - The company plans to announce a development candidate for the inducers platform imminently [22] Conclusion - Werewolf Therapeutics is positioned for significant developments in the coming months, with a robust pipeline and promising clinical data that could lead to regulatory advancements and potential market opportunities [24][25]
Werewolf Therapeutics to Participate in Hanson Wade’s 6th Annual Cytokine-Based Drug Development Summit
Globenewswire· 2025-05-13 12:00
Core Insights - Werewolf Therapeutics, Inc. is focused on developing conditionally activated therapeutics to enhance the immune system for cancer treatment and other immune-mediated conditions [1][2] - The company will present data on its IL-2 and IL-12 INDUKINE molecules at the Hanson Wade Cytokine-Based Drug Development Summit, showcasing the validation of its unique immunotherapy approach [2] Company Overview - Werewolf Therapeutics is leveraging its proprietary PREDATOR platform to create therapeutics that stimulate both adaptive and innate immunity, aiming to overcome the limitations of traditional proinflammatory immune therapies [2] - The company's INDUKINE molecules are designed to remain inactive in peripheral tissues and activate selectively within the tumor microenvironment [2] - The most advanced product candidates include WTX-124 and WTX-330, which are conditionally activated IL-2 and IL-12 molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [2] Upcoming Events - Sameer Chopra, M.D., Ph.D., Vice President of Clinical Development, will speak at the summit on May 15, 2025, at 4:15 PM ET, discussing the therapeutic index improvements of proinflammatory cytokines for cancer immunotherapy [2]
Werewolf Therapeutics (HOWL) 2025 Conference Transcript
2025-05-08 15:00
Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics was founded in 2017 with a focus on pro-inflammatory mechanisms, particularly cytokines [4][5] - The company aims to create tolerable drugs from cytokines, which have clinical activity but are associated with toxicity and poor pharmaceutical properties [5][6] - The platform developed is called the "predator platform," which utilizes fully potent wild type cytokines and protease-cleavable linkers to enhance therapeutic index and safety [8][9] Core Product Development - The most advanced product is WTX-124, which is currently in clinical trials with both monotherapy and combination therapy arms [20][21] - A flat dose of 18 mg of WTX-124 has been established for dose expansion arms, with ongoing trials in melanoma, renal cell cancer, and cutaneous squamous cell carcinoma [20][21][22] - Early data shows dramatic activity, including a complete response in a patient who failed standard care [22][23] Clinical Trial Insights - The company has demonstrated early monotherapy activity and dose-dependent biomarker responses, which were not shown by other companies [23][24] - The focus is on both monotherapy and combination therapy, with plans to present data to the FDA for potential accelerated approval [27][34] - Enrollment for the melanoma monotherapy expansion arm is expected to be completed by the end of the current quarter [27] Future Directions - The company is also developing an IL-10 for inflammatory bowel disease (IBD) and a T cell engager (TCE) platform, indicating a diversification beyond oncology [9][42][44] - The IL-12 program aims to tackle cold tumors and has shown promising preclinical results [37][38] - Werewolf is actively seeking partnerships to advance its IBD program and has previously partnered with Jazz Pharmaceuticals for another molecule [48][50] Financial Position - As of March, the company reported a cash position of $92 million, which is expected to last until the fourth quarter of 2026, covering important upcoming events [51]