UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-40908 MiNK Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-2142067 ...

Mink Therapeutics (NasdaqCM:INKT) Q3 2025 Earnings Call November 14, 2025 08:30 AM ET Company ParticipantsJennifer Buell - President and CEOStefanie Perna-Nacar - Chief Communications and Government Relations OfficerChristine Klaskin - VP and Finance, Principal Financial and Accounting OfficerConference Call ParticipantsMayank Mamtani - AnalystNone - AnalystEmily Bodnar - Research AnalystOperatorGood morning and welcome to MiNK Therapeutics' Third Quarter 2025 Conference Call and Webcast. All participants w ...

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash balance of $14.3 million and raised an additional $1.2 million since the quarter end, providing a runway through 2026 [23] - The net loss for Q3 2025 was $2.9 million, or $0.65 per share, compared to a net loss of $1.8 million, or $0.46 per share, for Q3 2024 [23] - For the nine months ended September 30, 2025, the net loss was $9.9 million, or $2.39 per share, compared to $8.3 million, or $2.24 per share for the same period in 2024 [23] Business Line Data and Key Metrics Changes - The company presented updated clinical data from the ongoing trial of agenT-797, showing a median overall survival of approximately 23 months in patients with relapsed or refractory solid tumors when combined with PD-1 therapies [4] - Observations included complete remission in a patient with metastatic testicular cancer and durable partial responses in other difficult-to-treat cancers, demonstrating the potential of agenT-797 to restore immune function [5][6] Market Data and Key Metrics Changes - The company has established a strategic partnership with the University of Wisconsin Carbone Cancer Center to advance the iNKT program in immune reconstitution following stem cell transplantation [10] - The company is preparing for a global phase II trial in acute pulmonary dysfunction with multi-drug resistant infections, targeting critically ill patients [12] Company Strategy and Development Direction - The company aims to redefine immune recovery in cancer, infection, critical illness, and transplantation, focusing on innovative partnerships and disciplined capital use [9][22] - The leadership team has been strengthened with the onboarding of Dr. John Holcomb and Dr. Therese Hammond, enhancing the company's strategic direction [24] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of building public-private partnerships and emphasized the potential of iNKT cells in various therapeutic areas, including cancer and critical illness [9][22] - The company expects to have multiple clinical programs actively enrolling patients by this time next year, with early readouts emerging from ongoing studies [26] Other Important Information - The company executed an at-the-market sales agreement, leveraging a significant increase in equity price to access cash while limiting dilution to shareholders [25] - The company is preparing for a first-in-human phase I study with minimal capital impact, supported by public-private grants [11] Q&A Session Summary Question: Expansion of the combination therapy cohort - Management acknowledged the potential to expand the cohort for patients previously treated with anti-PD-1 therapies and indicated plans for a phase two study [28][29] Question: Timing for the launch of the severe pulmonary disease trial - Management confirmed that the activation phase is underway, targeting patient enrollment by early next year [32] Question: Details on GVHD and pulmonary disease trials - Management provided insights into the endpoints being evaluated, including GVHD presence and 28-day mortality, emphasizing the potential for significant clinical benefits [33][35][39]

Core Insights - MiNK Therapeutics reported significant clinical advancements and financial results for Q3 2025, highlighting durable clinical responses with its lead asset, agenT-797, and the expansion of its iNKT platform across various therapeutic areas [1][4][6] Q3 2025 Highlights - Durable clinical responses were observed in refractory solid tumors with agenT-797, including complete remissions lasting over two years and survival rates exceeding two to three years in late-stage cancers [2] - The safety profile of agenT-797 was favorable, with no reported cases of Grade 3 cytokine release syndrome (CRS) or neurotoxicity [2] - MiNK initiated a collaboration with the University of Wisconsin Carbone Cancer Center for a preclinical and Phase 1 study of agenT-797 aimed at preventing graft-versus-host disease (GvHD) in stem-cell transplant patients [2][4] Leadership Strengthening - Dr. Terese C. Hammond joined as Head of Inflammatory and Pulmonary Diseases, focusing on late-stage programs for acute respiratory distress syndrome (ARDS) and GvHD [5] - Colonel (Ret.) John B. Holcomb was appointed to the Board of Directors, bringing expertise in trauma and critical care [5] Financial Highlights - As of September 30, 2025, MiNK had approximately $14.3 million in cash and cash equivalents, an increase from $4.6 million at the end of 2024 [9][14] - The net loss for Q3 2025 was $2.9 million, or $0.65 per share, compared to a net loss of $1.8 million, or $0.46 per share for Q3 2024 [11][14] - Cash used in operations for Q3 2025 was $941,000, a decrease from $2.995 million in Q3 2024 [11] Future Catalysts - MiNK plans to initiate multiple studies and expects early clinical readouts over the next 12 months, focusing on oncology, inflammatory diseases, and critical illness [12][13] - Key upcoming milestones include the initiation of the NIH-supported Phase 1 GvHD study and early data from a Phase 2 trial in severe pulmonary inflammatory disease [15]

Durable survival and deep, lasting remissions in checkpoint-refractory, heavily pretreated cancers with median OS of ~23 months with agenT-797 plus anti-PD-1Evidence of immune activation and tumor-immune remodeling underscore agenT-797’s potential to restore responsiveness in PD-1–resistant diseaseFavorable safety and reproducible activity reinforce MiNK’s leadership in allogeneic iNKT cell therapy NEW YORK, Nov. 07, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharma ...

Core Insights - MiNK Therapeutics, Inc. is set to release its Q3 2025 financial results on November 14, 2025, before market opening [1] - The company recently presented new clinical data for its agenT-797 iNKT cell therapy at the 2025 SITC Annual Meeting, showing durable immune reconstitution and activity in patients with advanced solid tumors [2] - A conference call and webcast will be held on the same day to discuss financial results, clinical progress, and upcoming milestones [2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators [4] - The lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure [5] - The company aims to deliver durable, accessible, and globally deployable immune reconstitution therapies through a scalable manufacturing process [5]

Core Insights - MiNK Therapeutics is set to present late-breaking data on AgenT-797, an allogeneic invariant natural killer T (iNKT) cell therapy, demonstrating durable clinical activity in advanced solid tumors at the upcoming SITC meeting [1][2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision immune modulators aimed at restoring immune balance and achieving durable cytotoxic responses [4] - The company's lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently undergoing clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure [5] - MiNK's pipeline includes TCR-based and neoantigen-targeted iNKT programs, which are designed for tissue-specific immune activation, showcasing a scalable manufacturing process and broad therapeutic potential [5]

Core Insights - MiNK Therapeutics, Inc. has appointed Colonel (Ret.) John B. Holcomb, MD, FACS to its Board of Directors, enhancing its leadership as it advances iNKT cell therapies for immune-mediated diseases and public health security [1][3][4]. Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies [6]. - The company's lead asset, AGENT-797, is in clinical development for treating graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [6]. Leadership Appointment - Dr. Holcomb brings over 23 years of military experience and is recognized for his innovations in trauma care and transfusion medicine, which have significantly impacted global health protocols [2]. - His expertise is expected to guide MiNK in advancing its iNKT cell therapies into late-stage development, addressing critical health challenges such as cancer and pulmonary diseases [4][5]. Strategic Focus - The appointment of Dr. Holcomb, alongside pulmonary critical care expert Dr. Terese Hammond, underscores MiNK's commitment to tackling diseases with significant epidemiological burdens [3][5]. - MiNK aims to develop therapies that restore immune balance and drive cytotoxic immune responses across various conditions, leveraging a scalable manufacturing process [6].

Core Insights - MiNK Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing invariant natural killer T (iNKT) cell therapies and will present at the 10th Annual CAR-TCR Summit [1][2] Company Overview - MiNK Therapeutics is pioneering allogeneic iNKT cell therapies and precision-targeted immune technologies aimed at restoring immune balance and driving cytotoxic immune responses across various diseases [5] - The company's lead asset, agenT-797, is currently in clinical development for treating graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [5] - MiNK is also advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools for tumor- and tissue-specific immune activation [5] Industry Context - The CAR-TCR Summit is a significant global forum for cell therapy, gathering over 800 stakeholders, including executives, scientists, investors, and regulators [4] - The summit features over 100 speakers and multiple content tracks, showcasing breakthroughs in CAR-T, TCR, and iNKT cell therapies across oncology and autoimmune diseases [4] - Dr. Jennifer Buell, CEO of MiNK, will discuss the potential of iNKT cells in restoring immune balance in diseases with limited treatment options [3][2]

Core Insights - MiNK Therapeutics has appointed Dr. Terese C. Hammond as Head of Inflammatory and Pulmonary Diseases, which is expected to enhance the company's focus on innovative therapies for severe pulmonary and inflammatory diseases [1][3]. Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company specializing in invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies [6]. - The company's lead asset, AgenT-797, is an allogeneic iNKT cell therapy currently in clinical development for graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [6][9]. Leadership and Expertise - Dr. Hammond is a recognized leader in pulmonary and critical care medicine, with over two decades of experience and a history of advancing registration-stage programs in severe diseases [2][5]. - She has served as principal investigator on pivotal studies for major pharmaceutical companies and is the lead author of significant publications related to MiNK's iNKT cell therapy [2][3]. Clinical Programs - Dr. Hammond will lead MiNK's inflammatory and pulmonary disease portfolio, which includes a grant-supported clinical trial in GvHD and a planned late-stage trial in severe pulmonary disease [3][7]. - These programs are positioned as substantial, low-risk opportunities supported by strong biological rationale and peer-reviewed data [3]. Research and Development - iNKT therapies have shown promising results in acute respiratory distress syndrome (ARDS) and other severe pulmonary diseases, indicating a substantial opportunity for near-term pivotal advancement [4][9]. - The unique biology of iNKTs allows for a robust immune response against difficult-to-treat tumors, enhancing the potential for transformative treatment options [9].