Werewolf Therapeutics(HOWL)

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Werewolf Therapeutics(HOWL) - 2025 Q2 - Quarterly Report
2025-08-14 11:11
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements and management's discussion for Q2 and H1 2025 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents Werewolf Therapeutics' unaudited condensed consolidated financial statements for Q2 and H1 2025, showing a net loss and decreased cash [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $92.6 million by June 30, 2025, driven by reduced cash, while equity fell due to net losses Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $77,596 | $110,995 | | Total current assets | $80,439 | $113,066 | | Total assets | $92,566 | $126,929 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $15,171 | $15,180 | | Total liabilities | $51,102 | $53,539 | | Accumulated deficit | $(450,659) | $(414,588) | | Total stockholders' equity | $41,464 | $73,390 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q2 2025 was $18.0 million, with H1 2025 net loss at $36.1 million, and collaboration revenue at zero Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $0 | $1,885 | | Research and development | $13,143 | $15,271 | $26,263 | $28,179 | | General and administrative | $4,399 | $4,832 | $9,270 | $9,828 | | Operating loss | $(17,542) | $(18,960) | $(35,533) | $(36,122) | | Net loss | $(17,982) | $(17,249) | $(36,071) | $(33,442) | | Net loss per share, basic | $(0.40) | $(0.40) | $(0.80) | $(0.79) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $73.4 million to $41.5 million by June 30, 2025, primarily due to the $36.1 million net loss - Total stockholders' equity declined from **$73.4 million** at December 31, 2024 to **$41.5 million** at June 30, 2025, primarily due to a net loss of **$36.1 million** for the six-month period[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $34.1 million in H1 2025, leading to a $33.7 million net decrease in cash Six Months Ended June 30, Cash Flow Summary (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,112) | $(29,474) | | Net cash used in investing activities | $0 | $(128) | | Net cash provided by financing activities | $388 | $10,539 | | **Net decrease in cash** | **$(33,724)** | **$(19,063)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details accounting policies, the conclusion of the Jazz collaboration, the K2HV loan, and the company's liquidity outlook - The company is an early-stage biopharmaceutical company pioneering therapeutics to stimulate the immune system for cancer treatment[31](index=31&type=chunk) - With **$77.6 million** in cash and cash equivalents as of June 30, 2025, the company expects to fund its operating expenses and capital expenditure requirements for at least the next twelve months, but will require additional funding thereafter[33](index=33&type=chunk) - In June 2024, the company completed its last material performance obligation under the Collaboration Agreement with Jazz Pharmaceuticals, resulting in the recognition of all remaining deferred revenue from that agreement[44](index=44&type=chunk) - In May 2024, the company repaid its loan with Pacific Western Bank and entered into a new loan agreement with K2 HealthVentures (K2HV), drawing down **$30.0 million** in gross proceeds[55](index=55&type=chunk)[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, clinical program updates for WTX-124 and WTX-330, and liquidity, confirming cash sufficiency into Q4 2026 [Overview](index=20&type=section&id=Overview) Werewolf develops conditionally activated immunotherapies, with lead candidates WTX-124 and WTX-330 in Phase 1/1b and Phase 1b/2 trials respectively - The company's most advanced product candidates, WTX-124 (IL-2) and WTX-330 (IL-12), are systemically delivered, conditionally activated INDUKINE molecules for treating various tumor types[91](index=91&type=chunk) - WTX-124 is being evaluated in a Phase 1/1b clinical trial as a monotherapy and in combination with KEYTRUDA, with plans to present interim data from expansion arms in the second half of 2025[92](index=92&type=chunk) - WTX-330 initiated a Phase 1b/2 clinical trial in Q1 2025, with the first patient dosed in Q2 2025 for the treatment of advanced or metastatic solid tumors[93](index=93&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q2 2025 saw zero revenue and decreased R&D expenses, while H1 2025 net loss increased to $36.1 million due to lower interest income Comparison of Three Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,143 | $(1,143) | | Research and development | $13,143 | $15,271 | $(2,128) | | General and administrative | $4,399 | $4,832 | $(433) | | **Net loss** | **$(17,982)** | **$(17,249)** | **$(733)** | - The **$2.1 million** decrease in Q2 2025 R&D expenses was primarily due to a **$1.8 million** decrease in manufacturing costs for WTX-330 and a **$0.5 million** decrease in personnel costs[116](index=116&type=chunk)[119](index=119&type=chunk) Comparison of Six Months Ended June 30, (in thousands) | Item | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,885 | $(1,885) | | Research and development | $26,263 | $28,179 | $(1,916) | | General and administrative | $9,270 | $9,828 | $(558) | | **Net loss** | **$(36,071)** | **$(33,442)** | **$(2,629)** | - The **$1.9 million** decrease in H1 2025 R&D expenses was mainly from a **$2.2 million** reduction in manufacturing costs and a **$0.7 million** decrease in personnel costs, partially offset by a **$0.7 million** increase in clinical trial costs for WTX-124 and WTX-330[126](index=126&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $77.6 million in cash, sufficient into Q4 2026, but requires substantial additional funding - As of June 30, 2025, the company had cash and cash equivalents of **$77.6 million**[147](index=147&type=chunk) - Management estimates that existing cash will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026[147](index=147&type=chunk) - The company has an active K2HV Loan Agreement with **$30.0 million** drawn and up to an additional **$20.0 million** available through May 1, 2026, subject to lender consent[139](index=139&type=chunk)[140](index=140&type=chunk) - The company's at-the-market (ATM) offering capacity is limited to an aggregate offering price of up to **$12.5 million** due to the "Baby Shelf Limitation" under Form S-3 rules[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is exempt from providing market risk disclosures - As a smaller reporting company, the registrant is not required to provide the information for this item[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[162](index=162&type=chunk) - There were no changes during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[163](index=163&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents other information including significant risk factors and a list of exhibits filed with the Form 10-Q [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Details risks including limited operating history, dependence on early-stage candidates, funding needs, reliance on third parties, and intense competition [Risks Related to Financial Position and Capital Requirements](index=34&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) The company faces risks from its limited operating history, accumulated deficit of $450.7 million, ongoing losses, and the need for substantial additional funding - The company has a limited operating history, an accumulated deficit of **$450.7 million** as of June 30, 2025, and expects to incur significant losses for the foreseeable future[166](index=166&type=chunk)[167](index=167&type=chunk) - Substantial additional funding is required to complete the development and commercialization of product candidates, and an inability to raise this capital could force the company to delay, reduce, or eliminate its R&D programs[170](index=170&type=chunk) - The K2HV Loan Agreement contains operating covenants that restrict the company's ability to incur future debt, pay dividends, and dispose of assets, among other limitations[177](index=177&type=chunk) [Risks Related to Discovery, Development, and Commercialization](index=38&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development,%20Regulatory%20Approval%20and%20Commercialization%20of%20Our%20Product%20Candidates) Business success depends on early-stage candidates and an unproven platform, facing risks in development, manufacturing, and intense competition - The company's business is highly dependent on the success of its initial INDUKINE and INDUCER molecules, which are in early stages of development and require significant additional development[187](index=187&type=chunk) - The PREDATOR platform approach is unproven, and there is no guarantee it will produce commercially valuable products[196](index=196&type=chunk) - Manufacturing the company's novel multi-domain biologics is complex, has never been done at commercial scale, and is subject to risks of delay or failure[200](index=200&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies developing immunotherapies, including numerous companies developing IL-2 and IL-12 based therapies[238](index=238&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) [Risks Related to Dependence on Third Parties](index=50&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Reliance on third-party CROs and CMOs for clinical trials and manufacturing, and a license agreement with Harpoon Therapeutics, poses significant operational risks - The company depends on third-party CROs to conduct preclinical studies and clinical trials and is responsible for ensuring their compliance with regulations like cGCP[259](index=259&type=chunk)[261](index=261&type=chunk) - Without its own clinical manufacturing capabilities, the company relies on third-party CMOs, exposing it to risks of supply disruption, quality issues, and regulatory non-compliance[265](index=265&type=chunk) - The company relies on a license agreement with Harpoon Therapeutics for patent rights essential to its PREDATOR platform and product candidates[285](index=285&type=chunk) [Risks Related to Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success hinges on obtaining and maintaining patent protection, which is uncertain, and managing risks of infringement claims and trade secret protection - The company's success depends on obtaining and maintaining patent protection for its PREDATOR platform and product candidates, but the scope and validity of such protection are uncertain[275](index=275&type=chunk)[276](index=276&type=chunk) - The company may face third-party claims of intellectual property infringement, which could be expensive and time-consuming to defend and could prevent or delay development efforts[309](index=309&type=chunk) - The company relies on trade secret protection for key aspects of its technology, but it cannot guarantee that these secrets will not be disclosed or independently discovered by competitors[305](index=305&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=65&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Marketing%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) Regulatory approval is expensive and uncertain, with ongoing compliance burdens, healthcare fraud laws, data privacy regulations, and potential FDA disruptions posing risks - The regulatory approval process is expensive, time-consuming, and uncertain, and the company has no experience in filing for marketing approvals[338](index=338&type=chunk) - Disruptions at the FDA and other government agencies due to funding cuts, personnel losses, or other factors could hinder the timely approval of product candidates[347](index=347&type=chunk) - The company is subject to healthcare fraud and abuse laws, which could expose it to criminal sanctions, civil penalties, and exclusion from government healthcare programs if found non-compliant[415](index=415&type=chunk) - The company must comply with complex and evolving state, national, and international privacy and data security laws, with non-compliance potentially leading to significant fines and reputational damage[425](index=425&type=chunk) [Risks Related to Business Operations and Public Company Status](index=83&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) Risks include dependence on key personnel, cybersecurity threats, stock price volatility, and increased public company compliance costs - The company is highly dependent on retaining key employees and faces fierce competition for qualified personnel in the Boston area[450](index=450&type=chunk)[451](index=451&type=chunk) - The company is exposed to risks from cyberattacks, which could lead to data loss, operational disruption, and financial loss[453](index=453&type=chunk)[454](index=454&type=chunk) - The company's stock price is volatile, and it may be delisted from Nasdaq if it fails to meet continued listing requirements, such as the minimum bid price[465](index=465&type=chunk)[467](index=467&type=chunk) - In the past, the company has identified material weaknesses in its internal control over financial reporting, which have since been fully remediated[480](index=480&type=chunk) [Item 6. Exhibits](index=91&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications - This section lists the exhibits filed with the report, including corporate governance documents, an employment agreement, and officer certifications required by the Sarbanes-Oxley Act[493](index=493&type=chunk)
Werewolf Therapeutics(HOWL) - 2025 Q2 - Quarterly Results
2025-08-14 11:06
Exhibit 99.1 Werewolf Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update – WTX-124 Phase 1/1b clinical trial on track for interim data readout in the fourth quarter of 2025, including patients in both the monotherapy and combination expansion arms of cutaneous melanoma and renal cell carcinoma – – Planning to engage with U.S. Food & Drug Administration (FDA) in the second half of 2025 to discuss potential registrational pathways for WTX-124 in advanced or metastatic cuta ...
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 (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]