MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills cancer cellsActivates multiple immune pathways to generate potent, lasting anti-tumor activity in lung and MSS colorectal cancer models NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune ...

Financial Performance - Research and development (R&D) expenses increased 111% to $1.1 million for Q3 2025 from $0.5 million in Q3 2024, primarily due to a $1.8 million gain from liability forgiveness in 2024 that did not recur in 2025 [81]. - General and administrative (G&A) expenses rose 59% to $1.8 million for Q3 2025 from $1.2 million in Q3 2024, mainly due to increased professional fees related to the implementation of the At Market Issuance Sales Agreement [82]. - R&D expenses decreased 14% to $4.2 million for the nine months ended September 30, 2025, down from $4.9 million for the same period in 2024, attributed to reduced clinical trial costs and personnel expenses [85]. - G&A expenses increased 42% to $5.0 million for the nine months ended September 30, 2025, compared to $3.5 million in the same period in 2024, driven by higher professional fees and share-based compensation [86]. - The company reported net cash used in operating activities of $3.9 million for the nine months ended September 30, 2025, compared to $7.8 million for the same period in 2024 [97]. Clinical Trials and Product Development - The company reported a survival benefit of 75% in a Phase 1 study of agenT-797 for viral ARDS, compared to 10-22% in an in-hospital control group [77]. - The median progression-free survival for patients in the Phase 1 trial of agenT-797 exceeded six months, with approximately 30% achieving durable disease stabilization [73]. - The company plans to submit an Investigational New Drug (IND) application for MiNK-215 to the FDA in 2025, following promising preclinical data [78]. - The collaboration with ImmunoScape aims to develop next-generation T-cell receptor therapies against solid tumors, leveraging both companies' proprietary technologies [79]. - The company’s future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of its product candidates [97]. Financial Position and Funding - The company had an accumulated deficit of $154.1 million as of September 30, 2025, and expects to incur losses in the coming years as it continues product development [91]. - The company entered into a Sales Agreement to sell shares of common stock with a maximum aggregate offering price of $50.0 million, with approximately $35.2 million remaining available under the agreement as of November 13, 2025 [92]. - As of September 30, 2025, the company had a cash and cash equivalents balance of $14.3 million, and after receiving $1.2 million from stock sales, it believes this will satisfy liquidity requirements for more than one year [95]. - The company has an outstanding Note of $5.0 million in principal plus accrued interest of approximately $154,000, which is payable on or after January 1, 2026 [93]. - The company plans to seek additional funding through strategic partnerships, collaborations, and potential equity or debt financing options to support liquidity requirements [96]. Going Concern and Regulatory Status - The company has substantial doubt about its ability to continue as a going concern for a period of one year after the filing of the Quarterly Report [95]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements [100].

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]

Core Insights - MiNK Therapeutics announced updated clinical results for agenT-797, demonstrating durable survival and immune restoration in patients with advanced solid tumors resistant to existing treatments [1][2][6]. Group 1: Clinical Results - agenT-797 showed durable responses and disease stabilization in multiple checkpoint-refractory solid tumors, with median overall survival (OS) of approximately 23 months when combined with anti-PD-1 therapy [6][7]. - Complete remission lasting over two years was observed in a patient with metastatic germ cell/testicular cancer, alongside significant tumor marker normalization [7]. - The therapy demonstrated broad applicability across various solid tumors, including thymoma (OS > 39 months), gastric cancer (OS > 27 months), and cholangiocarcinoma (OS > 21 months) [7]. Group 2: Mechanism of Action - agenT-797 operates through dual killing pathways, eliminating tumor cells via TCR-dependent and TCR-independent mechanisms [7]. - The therapy reactivates immune function by activating dendritic cells, converting suppressive macrophages to pro-inflammatory states, and reactivating exhausted T cells, leading to enhanced immune responses without systemic toxicity [8]. Group 3: Safety Profile - agenT-797 was well tolerated, with no dose-limiting toxicities or severe cytokine release syndrome reported; common treatment-related adverse events included fatigue and Grade 3 anemia [8]. - The favorable safety profile supports the potential for combination and repeat-dose regimens in future studies [8]. Group 4: Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies aimed at restoring immune balance and treating various cancers and immune disorders [9][10]. - The company's lead candidate, agenT-797, is an off-the-shelf iNKT cell therapy currently in clinical trials for solid tumors and other conditions [10].

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]