Financial Performance - Total revenue for the three months ended March 31, 2025 was $0, a decrease from $0.7 million recognized in the same period of 2024 [109]. - Net loss for the three months ended March 31, 2025 was $18.1 million, compared to a net loss of $16.2 million in the same period of 2024 [108]. - Interest income decreased to $1.0 million for the three months ended March 31, 2025, down from $2.0 million in 2024, attributed to lower cash equivalents held [112]. - Interest expense increased to $1.3 million for the three months ended March 31, 2025, compared to $1.0 million in 2024, due to a higher effective interest rate under the K2HV Loan Agreement [113]. - The accumulated deficit as of March 31, 2025 was $432.7 million, with expectations of continued substantial losses in the foreseeable future [115][118]. - Net cash used in operating activities for Q1 2025 was $18.9 million, an increase of $3.7 million compared to $15.3 million in Q1 2024, primarily due to decreased revenue and increased interest expenses [137]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $18.9 million for the three months ended March 31, 2025 [136]. Research and Development - The company reported external development costs totaling $6,927,000 for the three months ended March 31, 2025, compared to $6,637,000 for the same period in 2024, reflecting an increase in investment in product candidates [98]. - Research and development expenses increased to $13.1 million for the three months ended March 31, 2025, compared to $12.9 million in 2024, primarily due to a $1.0 million increase in clinical trial costs [110]. - Research and development expenses are expected to increase substantially as the company progresses clinical trials and continues preclinical development of multiple product candidates [98]. - WTX-124 is currently in a Phase 1/1b clinical trial, with a recommended dose of 18 mg administered intravenously every two weeks, and interim data is expected to be presented in the second half of 2025 [87]. - WTX-330 completed Phase 1 clinical trials in Q1 2025, with updated safety and efficacy data presented in November 2024, and a Phase 1b/2 trial initiated in Q2 2025 [88]. - The company is developing WTX-712, WTX-518, and WTX-921, with WTX-712 showing a unique mechanism that activates tumor-specific T lymphocytes [89]. - The PREDATOR platform is being utilized to develop conditionally activated immune cell engagers, with the first INDUCER development candidate expected to be nominated in Q2 2025 [92]. Collaboration and Funding - The company has entered into a global collaboration with Jazz Pharmaceuticals for the development of the JZP898 INDUKINE molecule, with Jazz responsible for commercialization activities [93]. - The company has received $20.0 million in payments from Jazz under the Collaboration Agreement and is eligible for up to $1.255 billion in additional milestone payments [130]. - The company anticipates needing substantial additional funding to support ongoing operations and growth strategies [119]. - The company anticipates needing additional funding to complete the development of product candidates WTX-124 and WTX-330, as current cash resources are insufficient [133]. - The K2HV Loan Agreement provides up to $60.0 million in term loans, with $30.0 million received at closing and additional tranches available based on certain milestones [122]. - The term loan matures on May 1, 2028, with an interest rate of at least 10.3% or a variable rate based on the prime rate plus 1.8% [123]. - The company may consider equity or debt financing to fund operations, which could lead to dilution for shareholders or impose operational restrictions [134]. Administrative Expenses - General and administrative expenses decreased to $4.9 million for the three months ended March 31, 2025, down from $5.0 million in 2024, mainly due to a reduction in professional services fees [111]. - The company expects general and administrative expenses to increase as personnel headcount grows to support research and development activities [103]. Operational Outlook - Future revenue generation will depend on achieving various development and regulatory milestones, with potential fluctuations based on product sales and collaborations [96]. - The company’s operating expenditures will depend on the progress and costs associated with clinical trials and product development [132]. - The estimated total base rent payments for the office and laboratory lease expiring in May 2030 are approximately $12.7 million [142]. - The company did not sell any shares under the ATM Offering during the three months ended March 31, 2025, after raising $20.2 million in the previous period [139].

Corporate Overview [Company Highlights](index=3&type=section&id=Company%20Highlights) Werewolf Therapeutics is a clinical-stage biopharmaceutical company developing next-generation, conditionally activated immunotherapies, leveraging its PREDATOR® platform to create INDUKINE™ molecules with an improved therapeutic index, and is well-capitalized with a cash runway into the fourth quarter of 2026 - The company's core technology is the **PREDATOR® platform**, which creates **conditionally activated INDUKINE™ molecules** to deliver potent cytokine payloads with an **improved therapeutic index**[6](index=6&type=chunk)[8](index=8&type=chunk) - Lead clinical programs are **WTX-124 (IL-2)**, a potential **best-in-class** product for immunotherapy-sensitive tumors, and **WTX-330 (IL-12)**, a potential **first-in-class** molecule for poorly immunogenic cancers[6](index=6&type=chunk) - The company has a deep preclinical pipeline including **WTX-712 (IL-21)**, **WTX-518 (IL-18)**, **WTX-921 (IL-10)**, and **IFNα** (licensed to Jazz), as well as **INDUCER™ T cell engagers**[7](index=7&type=chunk) | Financial Metric | Value | | :--- | :--- | | Cash and Cash Equivalents (as of Mar 31, 2025) | $92.0M | | Projected Cash Runway | Into 4Q 2026 | [PREDATOR® Platform Technology](index=4&type=section&id=PREDATOR%20Platform%20Technology) The PREDATOR® platform is designed to overcome the off-target toxicity that has historically limited cytokine therapies by creating conditionally activated immunotherapies selectively delivered and activated within the tumor microenvironment (TME), thereby optimizing the therapeutic index - The platform addresses the key challenge of **systemic cytokine toxicity** by enabling **targeted delivery** to the **tumor microenvironment** and **on-target immune activation**[9](index=9&type=chunk)[13](index=13&type=chunk) - The INDUKINE™ molecule design consists of four key components: - **Blocking Domain:** Ensures peripheral inactivation for safety - **Linker:** Proprietary tumor-activated linker provides selectivity - **Native Cytokine:** Delivers a potent antitumor immune response - **Anti-HSA:** Provides half-life extension for improved exposure[15](index=15&type=chunk) Pipeline and Programs [Pipeline Overview](index=6&type=section&id=Pipeline%20Overview) The company's pipeline includes two clinical-stage assets, WTX-124 (IL-2) and WTX-330 (IL-12), and a diverse preclinical portfolio, with key upcoming milestones including Phase 1/1b data for WTX-124 in 2H25 and the nomination of the first T cell engager development candidate in 2Q25 | Program | Indication | Stage | Anticipated Milestones | | :--- | :--- | :--- | :--- | | **WTX-124 (IL-2)** | Advanced/Metastatic Solid Tumors | **Phase 1/1b** | **P1/1b** mono/combo data in 2H25; Meet with FDA | | **WTX-330 (IL-12)** | Advanced/Metastatic Solid Tumors & Lymphoma | **Phase 1b/2** | Actively enrolling in **P1b/2** clinical trial | | **WTX-712 (IL-21)** | Cancer | IND-enabling | **IND-enabling studies** ongoing | | **WTX-518 (IL-18)** | Cancer | IND-enabling | **IND-enabling studies** ongoing | | **WTX-921 (IL-10)** | Inflammatory Disease (IBD) | Discovery | **Available for partnering** | | **INDUCER Molecules** | Cancer | Discovery | First Development Candidate nomination in **2Q25** | | **JZP898 (IFNα)** | Cancer | **Phase 1** | **Phase 1** FIH study ongoing (Partnered with Jazz) | [WTX-124 (IL-2 INDUKINE Molecule)](index=7&type=section&id=WTX-124%20(IL-2%20INDUKINE%20Molecule)) WTX-124 is a conditionally activated IL-2 prodrug designed to improve upon the efficacy and severe toxicity of high-dose IL-2, with Phase 1/1b data showing it is generally well-tolerated and demonstrates durable monotherapy and combination activity in heavily pretreated, ICI-refractory patients, aiming for a fast-to-market strategy [Rationale and Preclinical Data](index=8&type=section&id=WTX-124_Rationale_and_Preclinical_Data) WTX-124 aims to expand the use of IL-2 therapy to a broader patient population by selectively releasing wild-type IL-2 in the tumor microenvironment, leading to preferential activation of antitumor CD8+ T cells over Tregs, resulting in complete tumor regressions, immune memory, and a significantly improved therapeutic window - The goal is to provide a **safer IL-2 therapy** to patients with **ICI-sensitive tumors** who are ineligible for **high-dose IL-2** due to its **severe toxicity**[21](index=21&type=chunk)[23](index=23&type=chunk)[28](index=28&type=chunk) - Preclinical studies show WTX-124 selectively releases IL-2 in the tumor, leading to a **19.8x higher ratio** of **CD8+ Tetramer+ T cells** to **Tregs** in the tumor-draining lymph node compared to vehicle[29](index=29&type=chunk)[31](index=31&type=chunk) - WTX-124 demonstrated a **therapeutic window (TW) of >20**, a **significant improvement** over recombinant IL-2 which has a **TW of <4** in preclinical models[34](index=34&type=chunk) [Clinical Trial Design and Safety](index=12&type=section&id=WTX-124_Clinical_Trial_and_Safety) The Phase 1/1b trial for WTX-124 has completed dose escalation, establishing **18mg IV Q2W** as the recommended dose for expansion (RDE) for both monotherapy and combination with pembrolizumab, demonstrating general tolerability in the outpatient setting with no evidence of severe toxicities - Dose escalation is complete, with **18mg IV Q2W** selected as the **RDE** for both **monotherapy** and **combination therapy** expansion arms, which are actively enrolling[37](index=37&type=chunk) - WTX-124 was **generally well tolerated**, with **no evidence of vascular leak syndrome (VLS)**, **≥Grade 2 cytokine release syndrome (CRS)**, or infusion reactions. **No new safety signals** were observed in combination with pembrolizumab[40](index=40&type=chunk)[42](index=42&type=chunk) - The **most frequent related TEAEs** were arthralgia, fatigue, pruritus, and eosinophilia, with the majority being **Grade 1-2**[42](index=42&type=chunk) [Clinical Efficacy](index=15&type=section&id=WTX-124_Clinical_Efficacy) WTX-124 has shown compelling antitumor activity, inducing rapid and durable monotherapy responses, including a confirmed complete response (CR) in an ICI-refractory cutaneous squamous cell carcinoma (CSCC) patient ongoing for over 18 months, and producing durable partial and complete responses in melanoma patients in combination with pembrolizumab - Monotherapy induced **objective responses** in **3 out of 16 patients** (**ORR=18.75%**) at potential RDE doses, with responses occurring **within 8 weeks**[45](index=45&type=chunk) - A patient with **ICI-refractory metastatic CSCC** achieved a **confirmed CR** that has been ongoing for **over 18 months**, including **more than a year off therapy**[47](index=47&type=chunk)[49](index=49&type=chunk) | Dose | Tumor Type | Prior Therapies | Response (Combination with Pembrolizumab) | | :--- | :--- | :--- | :--- | | 12mg | Melanoma | Pembrolizumab, Ipilimumab/nivolumab, Nivolumab | Complete Response (CR) at 36 weeks | | 12mg | Melanoma | Pembrolizumab/propranolol, TVEC | Partial Response (PR) ongoing >8 months | [Pharmacokinetics (PK), Pharmacodynamics (PD), and Strategy](index=18&type=section&id=WTX-124_PK_PD_and_Strategy) Pharmacokinetic data confirm WTX-124's improved safety with peak free IL-2 exposure approximately **146-fold lower** than high-dose IL-2, while pharmacodynamic data show dose-dependent increases in intratumoral T-cell activation, supporting a fast-to-market development strategy in priority indications targeting a total market of **~$23 billion** - Peak free IL-2 exposure after an 18mg dose of WTX-124 is **~146-fold lower** than that of high-dose IL-2, while the prodrug Cmax is **~1.5-fold higher**, demonstrating **effective systemic shielding** and **half-life extension**[61](index=61&type=chunk)[62](index=62&type=chunk) - Paired tumor biopsies showed **dose-dependent upregulation** of **T-cell activation genes** (e.g., IL2RA, GZMB, LAG3), with **combination therapy** further enhancing the effect[63](index=63&type=chunk) - The development strategy includes: 1) **Fast to Market** in 2L+ melanoma, RCC, CSCC; 2) **Indication Expansion** to other IO-sensitive tumors; 3) **Moving Upstream** to combine with SOC in earlier lines[68](index=68&type=chunk) - The initial target market size for Melanoma, CSCC, RCC, and PD-L1 ≥1% NSCLC is estimated at **~$23 billion**[70](index=70&type=chunk)[71](index=71&type=chunk) [WTX-330 (IL-12 INDUKINE Molecule)](index=24&type=section&id=WTX-330%20(IL-12%20INDUKINE%20Molecule)) WTX-330 is a conditionally activated IL-12 prodrug designed to unlock the potent effects of IL-12 for treating IO-resistant tumors by overcoming historical toxicity limitations, with Phase 1 data demonstrating a manageable safety profile and monotherapy clinical activity, including a confirmed partial response in melanoma, leading to a follow-on Phase 1b/2 trial to optimize dosing and explore activity in selected tumor types [Rationale and Preclinical Data](index=25&type=section&id=WTX-330_Rationale_and_Preclinical_Data) WTX-330 aims to be the first successful systemically administered IL-12 therapy by addressing severe toxicities, with preclinical data showing selective IL-12 delivery to the tumor, activating antitumor CD8+ T cells and other immune pathways, resulting in a **49-fold improved therapeutic window** - The primary goal is to enable **IL-12 therapy** for patients with **poorly immunogenic** or **IO-resistant tumors** by **improving its tolerability**[77](index=77&type=chunk)[79](index=79&type=chunk) - Preclinically, WTX-330 demonstrated a **49x improved therapeutic window** over a chimeric IL-12 and induced **potent antitumor activity** and **pleiotropic immune activation** in the TME[80](index=80&type=chunk)[81](index=81&type=chunk) [Phase 1 FIH Trial and Safety](index=27&type=section&id=WTX-330_Clinical_Trial_and_Safety) The first-in-human (FIH) Phase 1 trial enrolled **25 patients** with diverse solid tumors, demonstrating that WTX-330 was generally well-tolerated with primarily mild to moderate, manageable, and reversible related TEAEs consistent with IL-12's mechanism of action, leading to an expansion dose set at **0.024 mg/kg** - The **FIH trial** enrolled **25 patients**, with **44%** having received **≥4 prior lines of therapy** for metastatic disease[83](index=83&type=chunk)[86](index=86&type=chunk) - **Most frequent related TEAEs** were CRS, chills, pyrexia, and elevated liver function tests. **Grade 3/4 TEAEs** were **manageable and reversible**[90](index=90&type=chunk) - Expansion arms were opened at **0.024 mg/kg**. **Two dose-limiting toxicities (DLTs)** were observed at the higher **0.032 mg/kg** dose, but a **maximum tolerated dose (MTD) was not reached**[90](index=90&type=chunk) [Clinical Efficacy and Pharmacodynamics (PD)](index=30&type=section&id=WTX-330_Clinical_Efficacy_and_PD) WTX-330 demonstrated monotherapy clinical activity, including a confirmed partial response in a melanoma patient and stable disease in MSS colorectal cancer patients, with pharmacodynamic data from tumor biopsies confirming on-target IL-12 activity through increased expression of T/NK cell activation genes and increased T and NK cell density, even in 'cold' tumors - A **confirmed PR (RECIST 1.1)** was achieved in a **melanoma patient** who had progressed on pembrolizumab. The response lasted **16 weeks**[92](index=92&type=chunk)[96](index=96&type=chunk) - **Stable disease** was observed for **16 and 24 weeks** in **two patients** with **microsatellite-stable colorectal cancer (MSS CRC)**[92](index=92&type=chunk) - NanoString analysis of tumor biopsies showed **increased expression** of **genes related to T-cell activation** (IFNG, CD8A), **cytolytic function** (GRZMB), and **antigen presentation**, confirming **IL-12 activity** in the TME[106](index=106&type=chunk)[109](index=109&type=chunk) - Multiplexed immunofluorescence in MSS CRC patients showed **increased density** of **CD8+ T cells** and **Granzyme B+ NK cells** post-treatment[110](index=110&type=chunk)[111](index=111&type=chunk) [Pharmacokinetics (PK) and Next Steps](index=36&type=section&id=WTX-330_PK_and_Next_Steps) Pharmacokinetic analysis shows WTX-330 delivered **22-fold greater** molar exposure of IL-12 compared to recombinant IL-12's MTD, with **~5-fold lower** peak free IL-12 levels, validating its improved therapeutic index, and a follow-on Phase 1b/2 trial is actively enrolling to optimize dosing and evaluate activity in melanoma, MSS colorectal cancer, and non-Hodgkin's lymphoma - WTX-330 at **0.024 mg/kg** achieved a **~22-fold higher Cmax** than rhIL-12 at its MTD, with **~5-fold lower peak free IL-12 exposure**, demonstrating an **improved therapeutic index**[113](index=113&type=chunk)[115](index=115&type=chunk) - **Peripheral IFNγ levels**, a marker of systemic IL-12 activity and toxicity, showed a **dose-related spike** after the first dose but **decreased with subsequent doses** ('tachyphylaxis'), correlating with **improved tolerability**[116](index=116&type=chunk)[119](index=119&type=chunk) - A new **Phase 1b/2 trial** (WTX-330x2102) is actively enrolling to determine an **optimal regimen** (fixed vs. step-up dosing) and explore expansion cohorts in **melanoma**, **MSS CRC**, and **advanced NHL**[120](index=120&type=chunk)[121](index=121&type=chunk) [Preclinical Pipeline](index=40&type=section&id=Preclinical%20Pipeline) Werewolf has a deep preclinical pipeline leveraging its PREDATOR® platform, including INDUCER™ molecules (conditionally activated T cell engagers), WTX-712 (IL-21), WTX-518 (IL-18), and WTX-921 (IL-10), targeting a range of mechanisms and indications from cancer to inflammatory diseases - **INDUCER™ Molecules (T Cell Engagers):** Applying the **PREDATOR platform** to create masked T cell engagers (TCEs) to mitigate **cytokine release syndrome (CRS)** and **on-target, off-tumor toxicity**. The first development candidate is expected to be nominated in **2Q25**[128](index=128&type=chunk)[18](index=18&type=chunk) - **WTX-712 (IL-21):** An **INDUKINE molecule** designed to deliver IL-21, a pleiotropic cytokine that activates multiple immune cells and shows preclinical activity in **ICI-refractory models**. Currently in **IND-enabling studies**[133](index=133&type=chunk)[137](index=137&type=chunk) - **WTX-518 (IL-18):** An **INDUKINE molecule** designed to be resistant to the natural inhibitor IL-18BP, potentially complementing **WTX-330 (IL-12)** due to known synergy. Currently in **IND-enabling studies**[152](index=152&type=chunk)[155](index=155&type=chunk) - **WTX-921 (IL-10):** An **INDUKINE molecule** for **inflammatory bowel disease (IBD)**, designed to selectively deliver the anti-inflammatory cytokine IL-10 to inflamed tissues. The program is **available for partnership**[167](index=167&type=chunk)[169](index=169&type=chunk) Summary and Outlook [Corporate Summary and Financial Position](index=55&type=section&id=Corporate%20Summary%20and%20Financial%20Position) Werewolf Therapeutics is strategically positioned with two wholly-owned clinical programs, a deep preclinical pipeline, and a validated platform technology, maintaining a strong financial position with **$92.0 million** in cash as of March 31, 2025, providing a cash runway into the fourth quarter of 2026 to support multiple near-term, value-enhancing catalysts - The company has **two lead, wholly-owned clinical programs**: **WTX-124 (Phase 1/1b)** and **WTX-330 (Phase 1b/2)**[178](index=178&type=chunk)[180](index=180&type=chunk) - A **deep preclinical pipeline** includes **INDUKINE molecules** for **IL-21**, **IL-18**, **IL-10**, and **INDUCER T cell engagers**[180](index=180&type=chunk) | Financial Snapshot | Value | | :--- | :--- | | **Cash and Cash Equivalents** (as of Mar 31, 2025) | $92.0M | | **Cash Runway** | Into 4Q 2026 | | **Shares Outstanding** (as of May 2, 2025) | ~44.9M | [Leadership](index=56&type=section&id=Leadership) The company is led by an experienced management team with deep expertise in immunotherapy research and development, business development, and finance - Key executives include: - **Daniel J. Hicklin, PhD** (President and CEO) - **Randi E. Isaacs, MD** (Chief Medical Officer) - **Chulani Karunatilake, PhD** (Chief Technology Officer) - **Steven Bloom** (Chief Business Officer) - **Tim Trost, CPA** (Chief Financial Officer) - **William Winston, PhD** (SVP, Research)[183](index=183&type=chunk)[184](index=184&type=chunk)

– WTX-124 Phase 1/1b clinical trial on track for data readouts and interactions with the FDA in the second half of the year – – First patient dosed in the Phase 1b/2 clinical trial of WTX-330, seeking to build on the clinical activity and tolerability demonstrated in the recently completed WTX-330 first-in-human Phase 1 trial – – Company announces development of its proprietary INDUCER™ T cell engager molecules; development candidate targeted by the end of the second quarter of 2025 – – Updated cash guidanc ...

Core Insights - Werewolf Therapeutics, Inc. announced the efficacy of its IL-10 INDUKINE molecule, WTX-921, in reducing tissue damage and inflammatory cytokine production in a mouse colitis model [1][3] - The findings provide a deeper understanding of WTX-921's anti-inflammatory effects on the immune landscape in the inflamed colon [1] Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics aimed at stimulating the immune system for cancer and immune-mediated conditions [1][7] - The company utilizes its proprietary PREDATOR platform to design molecules that activate selectively in the tumor microenvironment, addressing limitations of conventional therapies [7] Product Development - WTX-921 is engineered to selectively deliver IL-10 to inflamed tissues, minimizing systemic toxicity while providing therapeutic exposure [6] - The molecule has shown potential in blocking disease-driving effector molecules and cytokines, impacting both innate and adaptive immune responses [6] Clinical Findings - The data presented at the AAI Annual Meeting indicate that WTX-921 effectively masks IL-10, preventing off-tissue effects and demonstrating efficacy in preventing weight loss and reducing Disease Activity Index (DAI) scores in a colitis model over four weeks [4][3] - The treatment resulted in decreased immune cell infiltration and reduced RNA levels of inflammatory cytokines in treated animals [4] Market Context - The CDC estimates that 7 million people worldwide had Inflammatory Bowel Disease (IBD) in 2024, highlighting the need for improved treatment options [3]

Wall Street expects a year-over-year decline in earnings on higher revenues when Werewolf Therapeutics, Inc. (HOWL) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, t ...

Core Insights - Werewolf Therapeutics, Inc. has appointed Steven Bloom as Chief Business Officer, bringing over 35 years of experience in the life sciences industry [1][2] - The company is at a pivotal moment with upcoming interim dose expansion data from the WTX-124 Phase 1/1b clinical trial, which is expected to inform regulatory discussions on potential registrational pathways [2] - Werewolf is advancing its PREDATOR platform to develop novel molecules for oncology and immunology, with a focus on minimizing patient side effects while effectively targeting tumors [3] Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics that stimulate the immune system for cancer and other immune-mediated conditions [5] - The company utilizes its proprietary PREDATOR platform to create INDUKINE molecules that activate selectively in the tumor microenvironment, aiming to overcome limitations of traditional immune therapies [5] - The lead product candidates, WTX-124 and WTX-330, are designed for the treatment of solid tumors and Non-Hodgkin Lymphoma, respectively [5] Leadership Background - Steven Bloom previously served as Chief Business Officer at Vincerx Pharma, where he led business development and corporate strategy initiatives [2] - His experience includes senior roles at various biotechnology companies and Eli Lilly, focusing on sales, marketing, and corporate affairs [2][3] - Bloom is also involved in community service as Chair of the Board of Directors of the CLL Society, which supports chronic lymphocytic leukemia patients [3] Stock Option Grant - In connection with Bloom's appointment, Werewolf's board approved a stock option grant allowing him to purchase up to 201,720 shares of common stock at the closing price on May 1, 2025 [4] - The stock option has a ten-year term, with 25% vesting on the first anniversary of his employment and the remaining 75% vesting in 36 equal monthly installments [4]

WATERTOWN, Mass., March 31, 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 Daniel J. Hicklin, Ph.D., President and Chief Executive Officer and Randi Isaacs, M.D., Chief Medical Officer, both of Werewolf Therapeutics, ...

Financial Performance - The company incurred a net loss of $70.5 million for the fiscal year ended December 31, 2024, with an accumulated deficit of $414.6 million[225]. - As of December 31, 2024, the company had cash and cash equivalents of $111.0 million, which is expected to support the development of WTX-124 and WTX-330 through dose escalation and expansion[230]. - The company has not generated any product revenue to date and does not expect to do so for several years[226]. - The company does not anticipate generating revenue from product sales for the foreseeable future and may never achieve profitability[245]. - The company’s ability to generate product revenues is not expected to occur for many years, if ever, depending on the successful development and commercialization of its product candidates[252]. Product Development and Regulatory Approval - The company is developing two product candidates, WTX-124 and WTX-330, with all other programs in discovery or preclinical stages[224]. - The success of the company's business is highly dependent on obtaining regulatory approval and successfully launching its initial product candidates, WTX-124 and WTX-330[246]. - The company has not previously submitted a Biologics License Application (BLA) or a New Drug Application (NDA) to the FDA, which may impede timely approval for its products[249]. - The regulatory approval process for the company's product candidates is expected to be expensive and uncertain, potentially taking several years[250]. - The company must demonstrate safety and efficacy through extensive clinical trials to obtain regulatory approvals for product candidates[263]. Financial and Operational Risks - The company will need to secure substantial additional funding to finance operations and complete development of its product candidates[229]. - The company faces risks related to its limited operating history and the unproven nature of its product development approach[224]. - The company may encounter unforeseen expenses and complications in achieving its business objectives[225]. - The company has no committed external source of funds, and additional financing may not be available on acceptable terms[235]. - The company is subject to operating covenants under the K2HV Loan Agreement, which could restrict its financial flexibility[237]. Clinical Trials and Development Challenges - The company may face challenges in completing preclinical studies and clinical trials, which could adversely affect its ability to obtain regulatory approvals[262]. - The company may encounter substantial delays in clinical trials, which could increase costs and limit revenue generation capabilities[266]. - Delays in patient enrollment for clinical trials could significantly increase development costs and jeopardize marketing approval timelines[277]. - Undesirable side effects from product candidates could lead to interruptions in clinical trials and affect regulatory approval outcomes[278]. - Significant variability in safety or efficacy results can occur between different clinical trials of the same product candidate, impacting development timelines and regulatory approval[265]. Market and Competitive Landscape - The company may face substantial competition from major pharmaceutical and biotechnology companies, which could hinder its ability to develop and commercialize its product candidates[296]. - The potential market opportunities for the company's product candidates are difficult to estimate and may be smaller than current estimates if assumptions prove inaccurate[304]. - Market acceptance of approved products is crucial for commercial success, with established treatments posing competition[309]. - The approval of biologics may lead to competition sooner than expected due to the Biologics Price Competition and Innovation Act, which allows for abbreviated approval pathways[311]. Intellectual Property and Legal Risks - The company relies on patent protection for its PREDATOR platform and product candidates, with the risk that competitors could develop similar technologies if patent protection is insufficient[332]. - The company may face challenges in maintaining and enforcing patent rights, which could adversely affect its competitive position and ability to commercialize products[339]. - The company may be involved in lawsuits to protect its patents, which could be expensive and time-consuming[371]. - An unfavorable outcome in litigation could result in the loss of patent rights or require the company to cease using related technology[372]. - The company may not be able to prevent misappropriation of trade secrets, especially in jurisdictions with weaker protections[372]. Regulatory Compliance and Designations - The company may seek designations such as Breakthrough Therapy, Fast Track, and Priority Review for its product candidates, but there is no guarantee of receiving these designations[417]. - Compliance with FDA regulations is critical, as violations could lead to substantial civil or criminal fines and damage awards[416]. - The company intends to implement compliance and training programs to ensure adherence to regulations regarding the promotion of products for unapproved uses[413]. - Recent guidance from the FDA allows for truthful scientific communications about unapproved uses, provided they are non-misleading and scientifically sound[413]. - The company must navigate complex regulations and guidance to ensure compliance and avoid potential sanctions[414].

Exhibit 99.1 Werewolf Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update – Full enrollment in cutaneous melanoma dose-expansion arms of Phase 1/1b clinical trial evaluating WTX-124 as monotherapy and in combination with pembrolizumab expected by the end of the first half and the second half of 2025, respectively - – Plan to meet with the FDA in the second half of 2025 to discuss potential registrational pathways for both monotherapy and combination therapy ...

– Full enrollment in cutaneous melanoma dose-expansion arms of Phase 1/1b clinical trial evaluating WTX-124 as monotherapy and in combination with pembrolizumab expected by the end of the first half and the second half of 2025, respectively – – Plan to meet with the FDA in the second half of 2025 to discuss potential registrational pathways for both monotherapy and combination therapy for WTX-124 in select indications – – Interim data from Phase 1/1b clinical trial of WTX-124 as monotherapy and in combinati ...