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MiNK Therapeutics Reports Second Quarter 2026 Financial Results and Reports Observations from Randomized Phase 2 Trial of agenT-797 in Acute Lung Injury

• First patients treated in randomized Phase 2 trial C-1300-02 were alive at Day 28, with improved oxygenation, infection control, and liberation from ventilator and vasopressor support

• Serum and bronchoalveolar lavage analyses showed reduced inflammatory markers and biologic changes associated with immune recovery and tissue repair; no major serious adverse events were attributed to agenT-797

• First paid international named-patient access program established for physicians to request access to agenT-797, subject to per-patient regulatory authorization; building cross-border infrastructure and access to an off-the-shelf cell therapy

NEW YORK, NY — August 13, 2026 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, today reported financial results for the second quarter ended June 30, 2026, and provided an update on the clinical advancement of its lead candidate, agenT-797.

The second quarter marked MiNK's transition from single-arm clinical experience to randomized clinical validation. The Company dosed its first patient in C-1300-02 within days of Ministry of Health authorization in Ukraine, and has since reported Day 28 observations in ventilated, critically ill patients treated in an active conflict environment — a pace made possible by a therapy that ships from inventory and requires no apheresis, patient-specific manufacturing, HLA matching, or lymphodepletion.

“This quarter reflects the transition of our iNKT platform from scientific thesis to clinical execution,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “Severe lung injury remains one of the largest unresolved problems in medicine, with no approved therapy shown to reduce mortality. Our randomized study in acute lung injury and ARDS gives us an opportunity to test that thesis prospectively while also demonstrating an important practical advantage of agenT-797. It is an off-the-shelf therapy that can be rapidly deployed without patient-specific manufacturing, HLA-matching or lymphodepletion. As our programs advance, we are building a body of clinical evidence around the potential of iNKT cells to restore immune function across therapeutic areas.”

Second Quarter 2026 and Recent Highlights

Randomized Phase 2 Trial in Acute Lung Injury and ARDS

• Targets a high-mortality unmet need in critical care. Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care, with mortality exceeding 40-50% and no approved therapies shown to reduce mortality.i Critically ill patients often deteriorate because severe lung injury can trigger broader immune dysfunction, including impaired pathogen control, infection susceptibility, and organ dysfunction.

• Randomized Phase 2 dosing initiated in May 2026. MiNK began dosing at First Lviv Territorial Medical Union in Lviv, Ukraine, in collaboration with UNBROKEN Ukraine, within days of receiving Ministry of Health authorization. C-1300-02 (NCT07615010) is evaluating agenT-797 plus standard of care versus placebo plus standard of care in adults with acute lung injury and moderate-to-severe hypoxemic respiratory failure meeting Global ARDS Definition criteria. The study is being conducted under an active U.S. IND.

• Initial Day 28 observations presented at the Military Health System Research Symposium (MHSRS). Dr. Terese C. Hammond, M.D., Head of Inflammatory and Pulmonary Diseases at MiNK, presented initial observations with co-authors from First Lviv Territorial Medical Union. The initial agenT-797–treated patients were alive and afebrile at Day 28, with improved oxygenation and liberation from ventilator and vasopressor support. Microbiologic findings indicated control of baseline infections. Serum and bronchoalveolar lavage analyses showed reduced inflammatory markers and biologic changes associated with immune recovery, epithelial repair and pulmonary vascular recovery. No major serious adverse events were attributed to agenT-797 in these initial patients.

• U.S. expansion in progress. Enrollment continues in Lviv, and activation of U.S. clinical centers is underway. Additional data are expected in early 2027.

Paid International Named-Patient Access

• First paid international access program established. MiNK is collaborating with Orphan Drug Consulting (ODC) to support physician-initiated requests for agenT-797 for individually identified patients. The program expands access for patients with serious unmet medical need and provides MiNK with program revenue for product supplied. Each request is initiated by the treating physician and remains subject to case-by-case Br

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MiNK Therapeutics Reports First Quarter 2026 Financial Results and Advances iNKT Cell Therapy Platform Into Randomized Clinical Validation

• Randomized Phase 2 trial initiated for agenT-797 in severe acute lung injury and respiratory distress, with preliminary data expected in the second half of 2026

• AACR and ASGCT presentations showcase durable survival and context-dependent iNKT activity in cancer and inflammatory lung disease

• Non-dilutive collaborations expand MiNK’s platform and potentiate meaningful commercial revenue potential, while preserving focus on lead clinical programs

• Company continues disciplined execution with reduced operating burn and focused advancement of high-priority programs

• New clinical data to be presented at the ATS conference on May 20, 2026

NEW YORK, NY — May 15, 2026 (Globe Newswire) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today reported financial results for the first quarter ending March 31, 2026, and provided a corporate update.

“MiNK entered 2026 focused on converting a growing body of clinical and translational evidence into prospective validation,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “During the first quarter and subsequent period, we advanced agenT-797 into a randomized Phase 2 study in acute lung injury and critical illness, presented data that further support the context-dependent biology of iNKT cells, and continued to expand the platform through selective, non-dilutive collaborations. This is the next phase of MiNK’s strategy: disciplined clinical execution, rigorous translational validation, and capital-efficient expansion of a broadly deployable cell therapy platform.”

Dr. Buell continued, “What continues to distinguish agenT-797 is both its biology and its practicality. As an off-the-shelf iNKT cell therapy administered without lymphodepletion or HLA matching, agenT-797 is designed for settings where immune dysfunction drives poor outcomes and where speed, tolerability and deployability matter. We believe this is particularly relevant in severe acute lung injury and critical illness, where patients often face a cascade of respiratory failure, secondary infection and organ dysfunction with limited therapeutic options.”

Recent Business and Development Highlights

agenT-797 Advanced into Randomized Phase 2 Clinical Evaluation in Acute Lung Injury and Critical Illness

MiNK initiated a randomized Phase 2 clinical trial evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with severe acute lung injury and critical

illness, including moderate to severe acute hypoxemic respiratory failure due to severe pneumonia, who meet Global ARDS criteria and are admitted to the ICU. The study is being designed with a seamless Phase 2/3 operational framework intended to support efficient transition into later-stage development if findings from the randomized Phase 2 portion are prospectively confirmed.

The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation. Preliminary data are expected in the second half of 2026.

Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million patients globally and approximately 200,000 patients annually in the United States, accounting for nearly 25% of mechanically ventilated ICU patients. Mortality remains high, approximately 40% to 50%, and there are currently no approved pharmacologic therapies shown to reduce mortality in ARDS. The trial is designed to prospectively evaluate agenT-797 in a clearly defined, critical care population where ventilator-free days, secondary infection, respiratory recovery and survival can be assessed within clinically meaningful and regulatory-aligned endpoints.

Recent Data at AACR and ASGCT Strengthen the Biologic Rationale for Context-Dependent iNKT Activity

Recent clinical and translational presentations at the American Association for Clinical Research (AACR) Annual Meeting and the American Society of Gene and Cell Therapy Meeting (ASGCT) reinforced the potential of MiNK’s iNKT platform to generate disease-relevant immune activity across distinct clinical settings.

In PD-1 refractory gastroesophageal cancer, investigator-sponsored Phase 2 data showed disease control and longer-term survival in a subset of heavily pretreated patients, supported by evidence of immune activation and tumor microenvironment remodeling. The study achieved a 77% disease control rate, with long-term survival beyond 20 months observed in a subset of patients with immune-induction prior to chemother

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MiNK Therapeutics Reports Q4 and Full Year 2025 Results; Phase 2 Programs Advance with Impactful Non-Dilutive Momentum

• ARDS / hypoxemic pneumonia Phase 2 trial initiation 1H 2026; early data by year end; market opportunity of ~200,000–300,000 patients annually in US/EU

• C-Further Consortium collaboration adds to growing non-dilutive funding for PRAME-TCR iNKT in pediatric oncology

• NIH STTR grant and Mary Gooze philanthropic award fully fund graft-versus-host disease (GVHD) preclinical data with clinical trial launch in 1H 2026

• Keystone Symposia data report iNKT depletion in end-stage Pulmonary Fibrosis (IPF); underscores pipeline expansion

• Portfolio focused on high-value immune restoration with multiple 2026 clinical catalysts

NEW YORK, NY — March 31, 2026 (Globe Newswire) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2025.

“2025 was a foundational year in which we sharpened our focus on immune restoration in auto-immune and inflammatory diseases and began to see the power of strategic, non-dilutive partnerships accelerate our progress,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “We are deliberately building a pipeline where iNKT cells address serious auto-immune and inflammatory conditions — from acute critical care in ARDS to chronic fibrotic disease in IPF and immune dysregulation in GVHD. The C-Further collaboration, together with the NIH NIAID STTR grant and Mary Gooze philanthropic award secured in 2025 for our GVHD program, reflects growing recognition of our platform’s potential. We enter 2026 with strong momentum and multiple near-term opportunities to demonstrate clinical value.”

Terese Hammond, MD, Head of Pulmonary and Inflammatory Diseases at MiNK, added: “There is a clear continuum from acute inflammation and autoimmune dysregulation to chronic fibrotic diseases like IPF and even immune-resistant cancers. MiNK’s iNKT platform is uniquely suited to address this spectrum because of its ability to deliver context-dependent immune modulation — activating anti-tumor responses in cancer while restoring balance and suppressing harmful inflammation in acute and chronic lung disease.”

2025 Achievements and 2026 Milestones

Pulmonary & Critical Care: Large Market Opportunity with Near-Term Catalysts

agenT-797 advances in randomized Phase 2 in hypoxemic pneumonia/ARDS, a severe inflammatory condition affecting ~200,000–300,000 patients annually in the U.S. and major European markets. With mortality rates of 30–40% and no approved disease-modifying

therapies, ARDS represents a substantial commercial opportunity with strong government and biodefense alignment.

• Phase 2 clinical readouts planned for 2H 2026

• Expanded development into end stage pulmonary fibrosis (IPF)

• Data presented at Keystone Symposia demonstrated significant iNKT cell depletion in end-stage IPF

• Strategic discussions to advance agent-797 in IPF are actively underway

Oncology: Durable Responses in Checkpoint-Resistant Tumors

Data presented at SITC 2025 reinforced agenT-797’s ability to deliver durable clinical benefit in heavily pretreated, checkpoint-refractory solid tumors.

• Median OS in R/R cancers exceeded 23 months in combo with commercial PD-1 therapy

• Complete remissions lasting beyond two years, long-term survival across multiple tumors

• Translational analyses showed iNKT cells actively reprogramming the tumor microenvironment through dendritic cell activation, macrophage repolarization, and reinvigoration of exhausted T cells

Transplantation: Externally Funded GVHD Program Advancing

NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID) supports development and evaluation of agenT-797 in preclinical models while The Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison directly funds enrollment, immune monitoring, and operations for the Phase 1.

• Trial is advancing through university approval with first dosing expected May 2026

• Preliminary clinical data expected 2H 2026

• Program represents clinically meaningful opportunity with minimal capital burden.

Expanding Pipeline: Targeting Resistance and Expanding Reach

• PRAME-TCR-engineered iNKT advancing under the C-Further Consortium collaboration

o Collaboration provides up to $1.1 million in non-dilutive funding plus meaningful double-digit percentage revenue share.

Leadership and Operational Readiness

• Dr. Terese Hammond appointed Head of Pulmonary and Inflammatory Diseases

• Col. (Ret.) John Holcomb, MD added to the Board of Directors and Scientific Advisory Board

• Melissa Orilall appointed Principal Financial Officer

•