Core Insights - MiNK Therapeutics presented new data on the role of invariant natural killer T (iNKT) cells in idiopathic pulmonary fibrosis (IPF) at the Emerging Cell Therapies Meeting, indicating a significant depletion of iNKT cells in patients with end-stage IPF [1][2][3] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision-targeted immune technologies [6] - The company's lead candidate, agenT-797, is designed to restore immune balance and is currently in clinical development for conditions such as GvHD, solid tumors, and severe pulmonary inflammation [6][7] Research Findings - The data presented by Dr. Terese Hammond showed that iNKT cells are significantly depleted in lung-associated lymph nodes of patients with advanced IPF, suggesting a loss of natural immunoregulatory mechanisms that may contribute to persistent inflammation and fibrotic remodeling [2][5] - The findings support the potential of iNKT cell replenishment strategies to restore immune balance and aid tissue repair in fibrotic lung diseases, expanding MiNK's platform relevance into chronic fibrotic and senescence-associated indications [3][8] Disease Context - IPF is a progressive and fatal lung disease characterized by irreversible lung scarring and a median survival of 3–5 years, affecting approximately 100,000 patients in the U.S. with 30,000–40,000 new diagnoses annually [4] - There are currently no approved treatments that can reverse fibrosis or restore immune balance in IPF, highlighting a significant unmet medical need [4]

Non-dilutive public-private funded trial with NIAID STTR & Mary Gooze Clinical Trial and Translation AwardExpands iNKT platform into transplantation with an off-the-shelf, HLA-independent, lymphodepletion-free experimental therapy in patients at risk for GvHD NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic invariant natural killer T (allo-iNKT) cell therapies, today announced the upcoming initi ...

Core Insights - MiNK Therapeutics, Inc. is initiating a Phase 1 clinical trial for its lead therapy, agenT-797, aimed at patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) [1][2] Group 1: Clinical Trial Details - The trial will assess the safety, tolerability, and preliminary efficacy of agenT-797 in reducing graft-versus-host disease (GvHD), relapse, and other complications in high-risk leukemia and blood cancer patients [2] - The study is led by Dr. Hongtao Liu and co-investigator Dr. Kalyan V. G. Nadiminti from the University of Wisconsin School of Medicine and Public Health [2] Group 2: Funding and Support - The development of agenT-797 is supported by two public-private funding awards: an NIH STTR grant from NIAID and a philanthropic clinical grant, the Mary Gooze Clinical Trial Award [3] - The Mary Gooze Clinical Trial Award funds enrollment, immune monitoring, and operations for the Phase 1 trial, while also supporting mechanistic research on iNKT cells [5] Group 3: Therapeutic Potential - GvHD is a significant cause of morbidity and mortality post-HSCT, affecting up to 50% of recipients, and agenT-797 aims to address this issue without the cytotoxic burden of lymphodepleting conditioning regimens [4] - iNKT cells are positioned to suppress inflammatory responses while maintaining anti-leukemia activity, making them suitable for this therapeutic approach [4] Group 4: Company Overview - MiNK Therapeutics specializes in allogeneic invariant natural killer T (iNKT) cell therapies and aims to develop next-generation immune reconstitution therapies [7][8] - AgenT-797 is designed to be an off-the-shelf, donor-derived therapy that does not require HLA matching or lymphodepletion, enhancing its accessibility for patients [9]

Clinical Trials and Research - MiNK Therapeutics reported a median overall survival of approximately 23 months for patients receiving agenT-797 in combination with PD-1 therapies, significantly exceeding the expected survival of under six months in a refractory setting [7]. - The company observed a complete remission in a patient with metastatic testicular cancer lasting over two years following a single infusion of agenT-797 combined with PD-1 blockade [26]. - The company is preparing for a global Phase II trial in acute pulmonary dysfunction, with the study expected to launch within weeks [19]. - The Phase I study of agenT-797 demonstrated durable activity across various tumor types, with nearly half of patients having failed PD-1 ligand inhibitors [25]. - The primary endpoint for the pulmonary disease trial will be 28-day mortality, with additional secondary and exploratory endpoints being established [71]. - The company anticipates launching the severe pulmonary disease trial with the first patient targeted for enrollment by early Q1 of next year [54]. - The GvHD trial is funded through a partnership with government collaborators and aims to improve engraftment success without the need for cytotoxic lymphodepletion [60]. - The GvHD program aims for a significant reduction in GvHD incidence, targeting a 50% improvement or more, which would be substantially beneficial [63]. - MiNK Therapeutics aims to redefine immune recovery in cancer and critical illness, focusing on reeducating the immune system rather than suppressing it [35]. - The company is actively engaging with the FDA to ensure rapid development pathways for its clinical programs [64]. Financial Performance - The cash balance at the end of Q3 2025 was $14.3 million, with an additional $1.2 million raised since the quarter end, providing a runway through 2026 [36]. - 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 [36]. - For the nine months ended September 30, 2025, the net loss was $9.9 million or $2.39 per share, compared to a net loss of $8.3 million or $2.24 per share for the same period in 2024 [38]. - The company executed an at-the-market sales agreement, leveraging a more than 700% increase in equity price, which extended the cash runway through 2026 [42]. - The company is exploring nondilutive financing options to expand its manufacturing infrastructure beyond current capabilities [76]. Partnerships and Collaborations - The company has established a strategic partnership with the University of Wisconsin to advance its iNKT program in immune reconstitution following stem cell transplantation [15]. - The company is leveraging public-private partnerships, including support from the Department of Defense and NIH, to advance its clinical programs with minimal capital impact [17]. - Discussions are ongoing with collaborators in both the private and public sectors to leverage substantial scale and interest [79]. Manufacturing and Production - The company is currently able to produce 1 billion cells per donor, which provides substantial cost advantages and the ability to stockpile materials for trials [76]. - The cells have demonstrated stability for almost 3 years, indicating potential for continued production at scale [77]. - The company is preparing for future opportunities based on the current stability of their products [77].

Core Insights - MiNK Therapeutics has published new preclinical data for MiNK-215, a next-generation CAR-iNKT therapy targeting FAP-positive cancer-associated fibroblasts to enhance antitumor immunity [1][4] - MiNK-215 is designed to overcome barriers in solid tumors by eliminating immunosuppressive stroma and enhancing immune activation through IL-15 secretion [2][3] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders [5] - The company aims to restore immune balance and drive durable cytotoxic responses through its proprietary iNKT platform [5] Product Details - MiNK-215 targets FAP-positive cancer-associated fibroblasts, which contribute to the immunosuppressive tumor microenvironment, thereby allowing immune cells to infiltrate and attack cancer cells [7][8] - The therapy is characterized as an "off-the-shelf" solution, enabling scalable manufacturing and immediate delivery for patients with solid tumors resistant to existing treatments [3][4] Preclinical Findings - MiNK-215 has shown the ability to remodel the tumor microenvironment, activate dendritic cells, and re-polarize macrophages to a pro-inflammatory state, enhancing immune response in preclinical models [8] - The therapy has demonstrated potent and lasting anti-tumor activity in models of lung and MSS colorectal cancer [7][8]

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].

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 ongoing trial of agenT-797, an allo off-the-shelf iNKT cell therapy, showed 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 a patient demographic that mirrors U.S. demographics [12] Company Strategy and Development Direction - MiNK Therapeutics is focused on advancing its iNKT Cell Therapy platform and has become the most clinically advanced company in developing allogeneic iNKT cells [8] - The company aims to redefine immune recovery in various conditions, including cancer, infection, critical illness, and transplantation, through innovative partnerships and disciplined capital use [9][22] 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 to transform treatment in critical illness and transplantation [9][22] - The company expects to have multiple clinical programs actively enrolling patients by this time next year, with early readouts emerging from GVHD and pulmonary cohorts [28] 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 [26] - The leadership team has been strengthened with the onboarding of Dr. John Holcomb and Dr. Therese Hammond, enhancing the company's clinical and operational capabilities [25] Q&A Session Summary Question: Expansion of the combination therapy cohort - Management indicated plans to expand the cohort for the combination therapy with PD-1, with a focus on patients who have failed prior PD-1 therapy, and will announce an expanded cohort moving into a phase two study [33][34] Question: Timing for the severe pulmonary disease trial - The company is in the activation phase and aims to dose the first patient by early next year, with efforts to initiate patient enrollment imminently [38] Question: Details on GVHD and pulmonary inflammation trials - Management provided insights into the GVHD trial, emphasizing endpoints such as GVHD presence or absence and the potential for significant improvements in patient outcomes [44][46] - For the pulmonary disease trial, the primary endpoint will be 28-day mortality, with a focus on patients with severe pneumonia and hypoxemic respiratory failure [51]

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].