WATERTOWN, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (Nasdaq: HOWL) (the “Company” or “Werewolf”), an innovative biopharmaceutical company 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 will explore a full range of strategic alternatives to advance its promising platform and drug development pipeline to maximize stockholder value. The Comp ...

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgency to invest now [1][13] - The energy demands of AI technologies are significant, with data centers consuming as much energy as small cities, leading to concerns about power grid strain and rising electricity prices [2][3] Investment Opportunity - A specific company is highlighted as a critical player in the AI energy sector, owning essential energy infrastructure assets that are poised to benefit from the increasing energy demands of AI [3][7] - This company is not a chipmaker or cloud platform but is positioned to profit from the surge in electricity demand driven by AI data centers [3][6] Market Position - The company is described as a "toll booth" operator in the AI energy boom, collecting fees from energy exports and benefiting from the onshoring trend due to tariffs [5][6] - It has a unique footprint in nuclear energy, which is crucial for America's future power strategy, and is capable of executing large-scale engineering projects across various energy sectors [7][8] Financial Health - The company is noted for being completely debt-free and holding a significant cash reserve, amounting to nearly one-third of its market capitalization [8][10] - It also possesses a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth engines without high premiums [9][10] Market Sentiment - There is a growing interest from Wall Street in this company, as it is seen as undervalued compared to its potential, trading at less than seven times earnings excluding cash and investments [10][11] - The company is recognized for delivering real cash flows and owning critical infrastructure, making it an attractive investment opportunity in the context of the AI revolution [11][12]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: US Biopharmaceuticals - **Performance**: Biopharma ended 2025 positively with NBI up 32% and DRG up 21%, outperforming SPX at 17% [1] - **Outlook for 2026**: Optimism exists despite macro concerns like inflation and tariffs, with easing drug pricing worries, increased M&A activity, new product cycles, and modest expectations positioning the sector favorably [1] Core Insights and Arguments - **Valuation**: Biotech/Pharma P/E multiples are around 19x, which is lower compared to Financials at 18x and Utilities at 20x, indicating potential undervaluation [1] - **Catalysts**: Companies like Insmed (+152%), BridgeBio (+179%), and Travere (+119%) have shown strong performance driven by value-driving catalysts [1] Company-Specific Highlights Insmed - **Performance**: Insmed was a top performer in 2025, driven by Brinsupri's launch and TPIP's phase 2 results [2] - **2026 Outlook**: Continued upside is expected as Brinsupri's uptake alleviates skepticism over the $5B NCFB opportunity [2] BridgeBio - **Focus for 2026**: The debate will center around Attruby, with positive channel checks suggesting potential for accelerated sales [2] - **Key Data**: Anticipation for PROPEL3 readout in January, which could significantly impact the stock [10] Travere - **Performance**: Outperformance in 2025 attributed to commercial success in IgAN [3] - **Approval Outlook**: Filspari's potential approval for FSGS is a major debate, with FDA signals indicating a favorable outlook [9] Cytokinetics - **Market Entry**: Myqorzo's approval for oHCM is expected to face challenges in market execution against established competitors [15][40] - **Upcoming Data**: ACACIA readout in 2Q26 is crucial for assessing the drug's competitive position [19] Tyra - **Expansion**: Tyra is expanding dabogratinib's development into LG-UTUC, which could offer greater regulatory flexibility and market opportunity [43] - **Market Potential**: Management believes an oral option could be a game changer in a relatively underserved market [43] Acumen - **Pipeline Development**: Acumen's EBD program is expected to provide optionality, with initial non-clinical data anticipated early in 2026 [13] - **Key Event**: ALTITUDE-AD is a defining event for Acumen, with expectations for significant data to outperform competitors [33] Additional Important Insights - **M&A Activity**: The biopharma sector is seeing increased M&A activity as companies prepare for patent expirations [1] - **Regulatory Environment**: The FDA's involvement in various drug approvals and feedback mechanisms is crucial for shaping market expectations [9][10] - **Investor Sentiment**: There remains a cautious sentiment among investors, particularly regarding the approval of new drugs and their market uptake [9][19] This summary encapsulates the key points from the conference call, highlighting the overall industry outlook, company-specific developments, and critical upcoming events that could influence market dynamics in the biopharmaceutical sector.

Core Insights - Biotech companies experienced significant gains in after-hours trading, driven by investor interest despite limited news catalysts [1] Company Updates - GH Research PLC (GHRS) saw the largest increase, rising 22.36% to $16.20 ahead of a key update on its Investigational New Drug Application (IND) for GH001 with the FDA, scheduled for January 5, 2026 [2] - Phathom Pharmaceuticals, Inc. (PHAT) increased by 5.03% to $16.50, with the rise attributed to investor positioning rather than new announcements [3] - Forte Biosciences, Inc. (FBRX) gained 3.56%, closing at $24.45, continuing its upward trend in the biotech sector without any new updates [3] - OKYO Pharma Limited (OKYO) advanced 5.38% to $2.35, influenced by prior disclosures regarding share acquisitions by its Executive Chairman [4] - Zai Lab Limited (ZLAB) rose 5.60% to $18.30, reflecting ongoing investor interest in international biotech firms [5] - LifeMD, Inc. (LFMD) added 3.15% to $3.60, with no corporate updates released [5] - Werewolf Therapeutics, Inc. (HOWL) climbed 3.58% to $0.67, indicating speculative interest in smaller-cap biotech stocks [6] - Corvus Pharmaceuticals, Inc. (CRVS) increased by 7.24% to $7.85, extending its upward momentum without any new announcements [6]

Core Insights - Werewolf Therapeutics is advancing its pipeline with a focus on INDUKINE programs and the INDUCER T cell engager platform, seeking strategic partnerships for further development of WTX-124 and WTX-330 [1][2] Pipeline Updates - WTX-124 has shown a 30% overall response rate as a monotherapy in advanced or metastatic cutaneous melanoma patients, with a favorable tolerability profile [4] - WTX-330 demonstrated additional antitumor activity and a highly favorable tolerability profile in its Phase 1b/2 trial, building on previous Phase 1 data [4][6] - Upcoming data updates for WTX-124 and WTX-330 are expected in the first half of 2026, with the completion of the Phase 1/1b clinical trial for WTX-124 anticipated [7] Clinical Data Highlights - WTX-124 achieved a 21% objective response rate in heavily pretreated advanced melanoma patients, with a 30% response rate in those who previously responded to immunotherapy [5] - Tumor regression was observed in approximately 33% of tumors across various cancer types treated with WTX-124 [5] - WTX-330's initial data indicated a confirmed partial response in metastatic gall bladder cancer, with a 45% reduction in tumor target lesions [12] Development Strategy - The company plans to file IND applications for two INDUCER candidates, WTX-1011 and WTX-2022, by mid-2027, targeting STEAP1 and CDH6-expressing cancers respectively [4][8] - Werewolf's INDUCER molecules aim to improve therapeutic index and reduce off-tumor toxicity, leveraging a proprietary masking approach and novel linker technology [8] Company Overview - Werewolf Therapeutics is focused on developing therapeutics that stimulate the immune system for cancer treatment, utilizing its PREDATOR platform to create conditionally activated INDUKINE and INDUCER molecules [9]

Core Insights - Several biotech and life sciences companies experienced significant gains in after-hours trading on November 26, indicating strong investor interest despite a quiet news cycle [1] Company Summaries - Modular Medical, Inc. (MODD) shares increased by 11.51% to $0.4380 after a previous decline of 1.80% at the close, following the IRB approval for its Pivot insulin delivery system study announced on November 17 [2] - Standard BioTools Inc. (LAB) saw a 4.90% rise to $1.50 after a 0.70% gain during regular trading, following a strategic collaboration with Molecular Instruments announced on November 19 [3] - Werewolf Therapeutics, Inc. (HOWL) rose 4.39% to $1.0199 after a strong 7.33% gain during regular trading, reflecting continued investor optimism despite no new updates [4] - Cogent Biosciences, Inc. (COGT) climbed 6.09% to $42.85 in after-hours trading, building on a 1.69% rise during regular trading, indicating strong investor confidence in its pipeline [5] - Longeveron Inc. (LGVN) shares increased by 4.59% to $0.6772, extending gains from a 7.02% rise during regular trading, with upcoming presentation of Alzheimer's study results at CTAD 2025 highlighting ongoing research [6] - AbCellera Biologics Inc. (ABCL) gained 3.85% to $3.78 after a 0.55% increase during regular trading, reflecting renewed investor interest in its antibody discovery platform [7]

Core Insights - Werewolf Therapeutics presented preclinical data at the 2025 Society for Immunotherapy of Cancer's Annual Meeting, showcasing advancements in their INDUCER™ T Cell Engager Platform designed to enhance safety and efficacy in cancer treatment [1][2][3] Group 1: Technology and Innovation - The proprietary PREDATOR platform utilizes clinically validated protease-cleavable linkers for tumor-selective activation, leading to the development of three clinical-stage INDUKINE candidates [2][6] - The INDUCER molecules employ a novel masking strategy that prevents systemic T cell activation and cytokine release, activating only in the presence of human tumor tissue [5][6] - A sequential dosing regimen of mWTX-330 (IL-12) followed by WTX-124 (IL-2) demonstrated superior tumor-killing ability compared to either drug alone, indicating a complementary immune mechanism [5][6] Group 2: Clinical Data and Findings - Real-time pharmacokinetic data confirmed WTX-124's selective activation in tumors, with minimal active cytokine released in the plasma, validating the prodrug design [5][6] - The sequential administration strategy enhances antitumor activity while improving tolerability, suggesting a potent and translatable therapeutic strategy [5][6] - The localized release of IL-2 in the tumor environment increased the infiltration of NK and CD8+ T cells, as well as the production of effector cytokines like IFNg [5][6] Group 3: Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics to stimulate the immune system for cancer treatment, with advanced candidates WTX-124 and WTX-330 targeting solid tumors [6]

Core Insights - Werewolf Therapeutics presented preclinical data at the 2025 Society for Immunotherapy of Cancer's Annual Meeting, showcasing advancements in their INDUCER™ T Cell Engager Platform designed to enhance safety and efficacy in cancer treatment [1][2][3] Group 1: Technology and Platform - The proprietary PREDATOR platform utilizes clinically validated protease-cleavable linkers for tumor-selective activation, leading to the development of three clinical-stage INDUKINE candidates [2][6] - The INDUCER molecules employ a novel masking strategy that prevents systemic T cell activation and cytokine release, activating only in the presence of human tumor tissue [5][6] Group 2: Preclinical Findings - A sequential dosing regimen of mWTX-330 (IL-12) followed by WTX-124 (IL-2) demonstrated superior tumor-killing ability in preclinical models, suggesting enhanced immune response and tolerability [5][6] - Real-time pharmacokinetic data confirmed that WTX-124 selectively activates within tumors, with minimal active cytokine released into the plasma, validating the prodrug design [5][6] Group 3: Company Overview - Werewolf Therapeutics focuses on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions, with advanced candidates WTX-124 and WTX-330 targeting solid tumors [6]

Financial Performance - The company reported external development costs totaling $20.98 million for the nine months ended September 30, 2025, compared to $22.61 million for the same period in 2024, indicating a decrease of approximately 7.2%[98] - No revenue was recognized during the nine months ended September 30, 2025, compared to $1.9 million recognized in the same period of 2024[117] - The accumulated deficit as of September 30, 2025 was $467.0 million, indicating the total losses incurred since inception[125] - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[127] - The company anticipates substantial and increasing expenses and net losses as it advances product candidates through clinical development, leading to a significant increase in its accumulated deficit[128] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $3.7 million, a decrease from $10.5 million for the same period in 2024[148] Research and Development - Research and development expenses for WTX-124 were $13.09 million for the nine months ended September 30, 2025, up from $8.67 million in the same period of 2024, reflecting a year-over-year increase of approximately 51.9%[98] - Research and development expenses for the nine months ended September 30, 2025 were $37.9 million, down from $40.7 million in 2024, a decrease of $2.8 million[118] - Research and development expenses for the three months ended September 30, 2025 were $11.6 million, a decrease of $0.9 million from $12.5 million in the same period of 2024[109] - The company is developing additional INDUKINE candidates, including WTX-712, WTX-518, and WTX-921, with preclinical data presented at the AACR Annual Meeting in April 2024[91] - The company plans to release interim data from the WTX-124 monotherapy and combination expansion arms in the fourth quarter of 2025[87] - The company has initiated a Phase 1b/2 clinical trial for WTX-330, with an update on the clinical trial expected in the fourth quarter of 2025[88] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025 were $51.3 million, a decrease of $3.9 million from $55.1 million in 2024[116] - General and administrative expenses are expected to fluctuate based on the operating needs of the business, including support for research and development activities[102] - General and administrative expenses for the three months ended September 30, 2025 were $4.1 million, down from $4.6 million in 2024, reflecting a decrease of $0.5 million[111] Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $65.7 million, which is expected to be insufficient to fund operations for at least twelve months[141] - The company incurred net cash used in operating activities of $49.3 million for the nine months ended September 30, 2025, compared to $41.9 million for the same period in 2024, reflecting an increase of $7.3 million[146] - The company entered into the K2HV Loan Agreement, providing up to $60.0 million in term loans, with $30.0 million received at closing[132] - The term loan under the K2HV Loan Agreement matures on May 1, 2028, with a variable interest rate starting at 10.3%[133] - The company expects to continue funding operations through equity and/or debt financing until it can generate substantial revenue from product sales[143] - The repayment of all amounts outstanding under the PWB Loan Agreement resulted in a repayment of $10.7 million in term loans[148] Interest Income and Expense - Interest income decreased to $0.7 million for the three months ended September 30, 2025, down from $1.6 million in 2024, primarily due to lower balances in money market accounts[112] - Interest expense increased to $1.3 million for the three months ended September 30, 2025, compared to $1.2 million in 2024, attributed to a higher effective interest rate under the K2HV Loan Agreement[113] - Interest expense for the nine months ended September 30, 2025 was $3.9 million, compared to $3.4 million in 2024, reflecting an increase of $0.5 million[122] Other Financial Information - The company has substantial doubt about its ability to continue as a going concern for at least twelve months from the date of the financial statements issued[95] - The company has received $20.0 million in payments from Jazz under the Collaboration Agreement and is eligible for up to an additional $1.255 billion in milestone payments[140] - The company sold 2,360,186 shares of common stock at an average price of $1.71 per share for net proceeds of $3.6 million during the nine months ended September 30, 2025[139] - The company recognized a total loss on extinguishment of debt of $0.6 million during the second quarter of 2024[131] - Total estimated base rent payments for the office and laboratory lease expiring in May 2030 are approximately $11.5 million[151] - There were no material changes to the company's critical accounting policies during the three and nine months ended September 30, 2025[153]

Clinical Trials - WTX-124 received Fast Track Designation from the FDA for treating locally advanced or metastatic cutaneous melanoma, with interim data and feedback expected in Q4 2025 [3] - Enrollment in the Phase 1/1b clinical trial for WTX-124 is expected to be completed by Q1 2026, with a recommended dose of 18 mg administered intravenously every two weeks [3] - WTX-330 is actively enrolling in a Phase 1b/2 clinical trial, with an update expected in Q4 2025 [8] - The company plans to nominate a differentiated target candidate for WTX-1011 by year-end 2025 [2] Financial Performance - Cash and cash equivalents as of September 30, 2025, were $65.7 million, down from $77.6 million as of June 30, 2025, sufficient to fund operations into Q4 2026 [8] - Research and development expenses for Q3 2025 were $11.6 million, a decrease from $12.5 million in Q3 2024 [8] - General and administrative expenses for Q3 2025 were $4.1 million, down from $4.6 million in Q3 2024 [8] - Net loss for Q3 2025 was $16.4 million, compared to a net loss of $16.7 million in Q3 2024 [8] - Total operating expenses for Q3 2025 were $15.7 million, compared to $17.1 million in Q3 2024 [13] - Total stockholders' equity as of September 30, 2025, was $29.6 million, down from $73.4 million as of December 31, 2024 [15]