Fast Track Designation underscores the promise of Werewolf’s INDUKINE™ platform WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced that the Company has received Fast Track Designation for the use of WTX-124 for the potential treatment of patients with locally adv ...

WATERTOWN, Mass., Oct. 03, 2025 (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 and other immune-mediated conditions, today announced that three posters will be presented at the upcoming Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting, taking place November 5-9, 20 ...

WATERTOWN, Mass., Oct. 03, 2025 (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 and other immune-mediated conditions, today announced that three posters will be presented at the upcoming Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting, taking place November 5-9, 20 ...

At 7:50 a.m. ET on Friday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading highe ...

Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

Technical Analysis - Werewolf Therapeutics, Inc. (HOWL) has reached a key level of support, with its 50-day simple moving average crossing above its 200-day simple moving average, indicating a "golden cross" [1] - A golden cross is a bullish chart pattern that suggests a potential breakout, formed when a stock's short-term moving average surpasses a longer-term moving average [2] Stock Performance - Over the past four weeks, HOWL has gained 15.4%, indicating positive momentum [3] - The stock currently holds a 3 (Hold) rating on the Zacks Rank, suggesting it may be poised for further breakout [3] Earnings Expectations - Recent earnings expectations for HOWL show two upward revisions compared to none lower over the past 60 days, with the Zacks Consensus Estimate also moving up [3] - Positive earnings estimate revisions further support the bullish outlook for the stock [4]

Summary of Werewolf Therapeutics FY Conference Call Company Overview - **Company**: Werewolf Therapeutics (NasdaqGS:HOWL) - **Focus**: Leader in conditional activation immunotherapies, specifically through the INDUKINE and INDUCER platforms [3][1] Core Insights and Arguments - **Differentiation in Technology**: - Utilizes native cytokines without mutations, specifically native IL-2, to reduce systemic toxicity [3][4] - Employs protease-cleavable linkers that do not rebind after cleavage, enhancing specificity in tumor microenvironments [4][5] - Achieved a high therapeutic index and a safety profile distinct from traditional high-dose IL-2 therapies, which often require intensive monitoring due to toxicity [9][10] - **Clinical Data and Efficacy**: - WTX-124 shows promising clinical data with a recommended dose of 18 mg for both monotherapy and combination therapy with pembrolizumab [11][12] - Demonstrated anti-tumor activity in melanoma and cutaneous squamous cell carcinoma, with a notable complete response in a patient resistant to previous therapies [12][13] - Plans to expand trials into renal cell carcinoma and non-small cell lung cancer [12][14] - **Regulatory Pathway**: - Anticipates discussions with the FDA regarding a monotherapy trial for advanced metastatic melanoma, emphasizing the need for effective treatments in this area [16][17] - **Future Developments**: - Development of WTX-330, an IL-12 INDUKINE, which has shown outpatient delivery potential and activity in melanoma and colorectal cancer [18][19] - Ongoing business development activities for T-cell engager programs, with expectations for a second nomination by the end of the year [21][23] Important but Overlooked Content - **Cytokine Misconceptions**: - There is a persistent misconception that cytokines can be delivered systemically without modulating efficacy. Werewolf Therapeutics believes their approach allows for effective local action while minimizing systemic toxicity [24][25] - **Upcoming Catalysts**: - Key upcoming events include FDA meetings, data releases for WTX-124, and the nomination of a second INDUKINE development candidate by year-end [26][26] This summary encapsulates the key points discussed during the conference call, highlighting Werewolf Therapeutics' innovative approaches, clinical advancements, and future plans in the immunotherapy landscape.

Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer and immune-mediated conditions [3] Group 1: Company Overview - Werewolf Therapeutics is leveraging its proprietary PREDATOR platform to design INDUKINE™ and INDUCER™ molecules that enhance both adaptive and innate immunity [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 also being explored in various solid tumor types [3] Group 2: Upcoming Events - Daniel J. Hicklin, Ph.D., President and CEO, and Randi Isaacs, M.D., Chief Medical Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1] - A live webcast of the presentation will be available, with an archived replay accessible for approximately 90 days post-event [2]

[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)

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) This section summarizes Werewolf Therapeutics' Q2 2025 financial results and key clinical and preclinical program advancements [Executive Summary](index=1&type=section&id=Executive%20Summary) Werewolf Therapeutics reported Q2 2025 financial results, highlighting clinical and preclinical program advancements and upcoming WTX-124 interim data - Interim data from the WTX-124 Phase 1/1b clinical trial is expected in **Q4 2025**, including monotherapy and combination therapy expansion cohort data for cutaneous melanoma and renal cell carcinoma patients[1](index=1&type=chunk)[2](index=2&type=chunk) - The company plans to communicate with the U.S. Food and Drug Administration (FDA) in **H2 2025** to discuss potential registration pathways for WTX-124 in advanced or metastatic cutaneous melanoma[1](index=1&type=chunk)[2](index=2&type=chunk) - The WTX-330 Phase 1b/2 clinical trial is actively recruiting patients, with dosing regimen determination expected by the **end of 2025**[1](index=1&type=chunk) - The company launched WTX-1011, its first INDUCER T-cell engager development candidate targeting STEAP1 for prostate cancer treatment[1](index=1&type=chunk)[2](index=2&type=chunk) [Recent Highlights and Upcoming Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Upcoming%20Milestones) This section details progress of clinical-stage INDUKINE molecules and preclinical INDUCER candidates, outlining key milestones for 2025 [Clinical-Stage INDUKINE Molecules](index=1&type=section&id=Clinical-Stage%20INDUKINE%20Molecules) Clinical-stage INDUKINE molecules WTX-124 and WTX-330 show significant progress, with WTX-124 interim data expected in Q4 2025 [WTX-124](index=1&type=section&id=WTX-124) WTX-124, an IL-2 INDUKINE molecule, is actively recruiting patients in expansion cohorts, with interim data and regulatory discussions planned for H2 2025 - All expansion cohorts of the WTX-124 Phase 1/1b clinical trial are actively recruiting patients at a recommended dose of **18 mg intravenously every two weeks**[3](index=3&type=chunk) - Interim data, including tolerability, response rates, and durability for cutaneous melanoma and renal cell carcinoma patients, is expected in **Q4 2025**[3](index=3&type=chunk) - The company expects to engage with regulatory authorities in **H2 2025** to discuss potential registration pathways for WTX-124 in advanced or metastatic cutaneous melanoma[3](index=3&type=chunk) [WTX-330](index=1&type=section&id=WTX-330) WTX-330, an IL-12 INDUKINE molecule, is actively recruiting patients for its Phase 1b/2 clinical trial, with dosing regimen expected by year-end 2025 - WTX-330 is actively recruiting patients in its Phase 1b/2 clinical trial for locally advanced or metastatic solid tumors[3](index=3&type=chunk) - The dosing regimen for WTX-330 is expected to be determined by the **end of 2025**[3](index=3&type=chunk) [Preclinical-Stage INDUCER Molecules](index=2&type=section&id=Preclinical-Stage%20INDUCER%20Molecules) Preclinical INDUCER molecule WTX-1011 shows positive progress with PREDATOR masking technology, and additional candidates are planned for H2 2025 [WTX-1011](index=2&type=section&id=WTX-1011) WTX-1011, a potential first-in-class anti-STEAP1 T-cell engager, demonstrates improved therapeutic index and suppressed peripheral activity in preclinical studies - WTX-1011 is a potential first-in-class conditionally activated anti-STEAP1 T-cell engager designed to improve the therapeutic index, targeting STEAP1 expressed in prostate cancer with limited normal tissue expression[8](index=8&type=chunk) - Preclinical data demonstrate that PREDATOR masking technology successfully inhibited peripheral activity and prevented cytokine release[8](index=8&type=chunk) - WTX-1011 exhibits a half-life of nearly **100 hours** in cynomolgus monkeys, with less than **0.7%** active INDUCER molecules detected peripherally[8](index=8&type=chunk) - The company expects to nominate additional INDUCER candidates in **H2 2025**[8](index=8&type=chunk) [Preclinical-Stage INDUKINE Portfolio](index=2&type=section&id=Preclinical-Stage%20INDUKINE%20Portfolio) Werewolf Therapeutics' preclinical INDUKINE portfolio, including WTX-712, WTX-518, and WTX-921, is available for collaborative development - Werewolf Therapeutics' preclinical-stage INDUKINE molecules WTX-712 (IL-21), WTX-518 (IL-18), and WTX-921 (IL-10, for inflammatory bowel disease and other inflammatory conditions) are all available for collaborative development[5](index=5&type=chunk) [Financial Results for the Second Quarter of 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%20of%202025) This section presents Werewolf Therapeutics' unaudited financial performance for Q2 2025, including statements of operations and balance sheet [Q2 2025 Financial Summary](index=2&type=section&id=Q2%202025%20Financial%20Summary) As of June 30, 2025, Werewolf Therapeutics held **$77.6 million** in cash, sufficient to fund operations through Q4 2026, with decreased R&D and G&A expenses Key Financial Metrics for Q2 2025 | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :---------- | | Research and Development Expenses | 13.1 | 15.3 | -14.4% | | General and Administrative Expenses | 4.4 | 4.8 | -8.3% | | Net Loss | 18.0 | 17.2 | +4.7% | Cash and Cash Equivalents | Date | Amount (Millions USD) | | :----------- | :-------------------- | | June 30, 2025 | 77.6 | | March 31, 2025 | 92.0 | - The company expects its existing cash and cash equivalents as of June 30, 2025, to be sufficient to fund operating expenses and capital expenditure requirements through **Q4 2026**[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations (unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28unaudited%29) Werewolf Therapeutics reported no collaboration revenue in Q2 and H1 2025, with decreased R&D and G&A expenses, but a slightly expanded net loss Condensed Consolidated Statements of Operations (unaudited) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Three Months Ended June 30, 2024 (Thousands USD) | Six Months Ended June 30, 2025 (Thousands USD) | Six Months Ended June 30, 2024 (Thousands USD) | | :------------------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Collaboration revenue | $ — | $ 1,143 | $ — | $ 1,885 | | Research and development expenses | 13,143 | 15,271 | 26,263 | 28,179 | | General and administrative expenses | 4,399 | 4,832 | 9,270 | 9,828 | | Total operating expenses | 17,542 | 20,103 | 35,533 | 38,007 | | Operating loss | (17,542) | (18,960) | (35,533) | (36,122) | | Other (expense) income | (440) | 1,711 | (538) | 2,680 | | Net loss | $ (17,982) | $ (17,249) | $ (36,071) | $ (33,442) | | Net loss per common share, basic (USD) | $ (0.40) | $ (0.40) | $ (0.80) | $ (0.79) | | Net loss per common share, diluted (USD) | $ (0.40) | $ (0.43) | $ (0.80) | $ (0.82) | | Weighted-average common shares outstanding, basic | 44,981,746 Shares | 43,521,406 Shares | 44,904,880 Shares | 42,564,342 Shares | | Weighted-average common shares outstanding, diluted | 44,981,746 Shares | 44,043,184 Shares | 44,904,880 Shares | 42,825,231 Shares | [Selected Condensed Consolidated Balance Sheet Data (unaudited)](index=4&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data%20%28unaudited%29) As of June 30, 2025, Werewolf Therapeutics' cash, working capital, and total assets decreased from December 31, 2024, impacting stockholders' equity Selected Condensed Consolidated Balance Sheet Data (unaudited) | Metric | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :------------------------------------------- | :------------------------------ | :-------------------------------- | | Cash and cash equivalents | $ 77,596 | $ 110,995 | | Working capital | $ 65,268 | $ 97,886 | | Total assets | $ 92,566 | $ 126,929 | | Total notes payable, net of discount and issuance costs | $ 27,105 | $ 26,095 | | Total stockholders' equity | $ 41,464 | $ 73,390 | [About Werewolf Therapeutics](index=2&type=section&id=About%20Werewolf%20Therapeutics) This section outlines Werewolf Therapeutics' mission, PREDATOR platform, and lead product candidates for cancer and immune-mediated diseases [Company Mission and Platform](index=2&type=section&id=Company%20Mission%20and%20Platform) Werewolf Therapeutics develops engineered conditionally activated therapies to stimulate the immune system for cancer and immune-mediated diseases via its PREDATOR platform - Werewolf Therapeutics is a biopharmaceutical company focused on developing conditionally activated therapies to stimulate the immune system for cancer and immune-mediated diseases[7](index=7&type=chunk) - The company utilizes its PREDATOR platform to design INDUKINE and INDUCER molecules, aiming to stimulate both adaptive and innate immunity to address limitations of conventional pro-inflammatory immunotherapies[7](index=7&type=chunk) - INDUKINE molecules are designed to remain inactive in peripheral tissues but selectively activate within the tumor microenvironment[7](index=7&type=chunk) - Lead clinical-stage candidates include WTX-124 (IL-2) and WTX-330 (IL-12) INDUKINE molecules for solid tumors, and the first INDUCER development candidate, WTX-1011, targeting STEAP1 for prostate cancer[7](index=7&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides important disclaimers regarding forward-looking statements, trademark information, and company contact details [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This press release contains forward-looking statements involving significant risks and uncertainties regarding company strategy, operations, product development, and financial projections - This press release contains forward-looking statements concerning company strategy, future operations, product development timelines, regulatory interactions, potential activity and safety of product candidates, and cash flow projections[9](index=9&type=chunk) - Actual results may differ materially due to inherent uncertainties in product development, availability and timing of clinical trial results, regulatory approvals, and the company's ability to manage cash resources[9](index=9&type=chunk) - The company undertakes no obligation to update these forward-looking statements, and investors should not place undue reliance on them[9](index=9&type=chunk) [Trademarks](index=3&type=section&id=Trademarks) WEREWOLF, PREDATOR, INDUKINE, INDUCER, and associated logos are trademarks or registered trademarks of Werewolf Therapeutics, Inc - WEREWOLF, the WEREWOLF logo, PREDATOR, INDUKINE, INDUCER, and other related graphics and logos are trademarks or registered trademarks of Werewolf Therapeutics, Inc. in the U.S. and other countries[10](index=10&type=chunk) [Contacts](index=5&type=section&id=Contacts) Contact information is provided for investors, media, and company representatives for further communication - Investor Contact: Dan Ferry (LifeSci Advisors)[15](index=15&type=chunk) - Media Contact: Amanda Sellers (Deerfield Group)[15](index=15&type=chunk) - Company Contact: Tim Trost (Chief Financial Officer, Werewolf Therapeutics)[15](index=15&type=chunk)