MiNK Therapeutics NASDAQ: INKT said it is advancing its off-the-shelf invariant natural killer T cell therapy platform into a randomized clinical program for severe acute lung injury and acute respiratory distress syndrome, while also reporting first-quarter 2026 financial results that management said support at least 12 months of operating runway.
On the company’s first-quarter conference call, President and Chief Executive Officer Dr. Jennifer Buell said MiNK has recently presented data across multiple scientific meetings, including findings in pulmonary fibrosis, refractory gastric cancer and mechanistic work involving its lead iNKT cell therapy candidate, AGENT-797.
Buell said the company’s broader focus is developing off-the-shelf iNKT cell therapies for diseases involving “immune failure, inflammatory injury, and impaired pathogen control.” She noted that AGENT-797 has been administered without lymphodepletion or HLA matching, and said approximately 100 patients have been treated to date with what the company has observed as a favorable safety profile.
ARDS Trial Moves Into Randomized Testing
MiNK announced the initiation of a randomized phase II clinical trial evaluating AGENT-797 in combination with standard of care versus placebo plus standard of care in patients with severe acute lung injury and respiratory distress identified using globally recognized ARDS criteria.
Buell said the trial has been designed with endpoints and infrastructure that could support a “seamless phase II/III pathway” if early findings are prospectively confirmed. She said MiNK expects to speak with the U.S. Food and Drug Administration in the coming weeks regarding the trial design and development plans.
During the question-and-answer session, Buell said the randomized phase II portion is expected to enroll about 90 patients, randomized one-to-one between AGENT-797 plus standard of care and placebo plus standard of care. She said the phase III portion would be informed by effect estimates observed in the randomized part of the trial.
The company identified endpoints including overall survival, ventilator-free days, number of ventilator days and days in the ICU. Buell said MiNK expects early readouts relatively quickly in this setting and anticipates presenting preliminary findings in the second half of 2026.
Buell said ARDS affects an estimated 3 million people globally and about 200,000 people annually in the U.S., accounting for about 25% of mechanically ventilated ICU patients. She said mortality remains high, with approximately 40% to 50% of patients dying from the disease.
Ukraine Collaboration and Critical Care Focus
MiNK is conducting work through a partnership with First Kyiv Territorial Medical Union in Ukraine. Buell said the study has been approved by the Ministry of Health of Ukraine and has cleared the FDA for dosing.
Buell said the collaboration provides an opportunity to evaluate iNKT-based cell therapies in patients with critical illness, including trauma-associated respiratory failure, multi-drug resistant pathogens, chronic inflammatory issues and downstream fibrosis. She said the ability to deliver a cryopreserved allogeneic therapy rapidly without lymphodepletion or HLA matching is “operationally important” in acute-care settings.
Dr. Terese Hammond, MiNK’s head of development and a practicing pulmonary critical care physician, said the patients targeted in the trial include those requiring high-flow oxygen, non-invasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation. She said these patients can present with hyperinflammatory disease or later evolve into immunologically exhausted states involving impaired pathogen clearance, secondary infection, prolonged ventilator dependence, fibrosis and multi-organ dysfunction.
Hammond said AGENT-797 appeared in earlier observations to function across both inflammatory and immune-exhausted scenarios. “It’s not simply inflammatory improvement that we see through using these cells,” she said, describing the observations as a combination of inflammatory modulation, immune recovery and pathogen control.
Gastric Cancer and Mechanistic Data
Buell reviewed data presented at the American Association for Cancer Research meeting from a phase II investigator-sponsored study in gastroesophageal cancer led by Memorial Sloan Kettering investigators Dr. Yelena Janjigian and Dr. Sam Spiteri. The patient population was described as heavily pretreated and checkpoint refractory.
Buell said the company observed prolonged survival in patients who received induction immune therapy prior to chemotherapy. She said median overall survival extended beyond 23 months in the immune-primed cohort, and several patients remained alive years after dosing. She characterized that outcome as unusual in refractory gastric cancer, while noting that follow-up continues to mature.
MiNK also highlighted translational findings presented at the American Society for Gene & Cell Therapy. Buell said Dr. Yan Sun from the company’s team presented analyses showing different immune outputs from the same donor-derived AGENT-797 product depending on disease context. In cancer, Buell said the biology showed Th1-oriented cytotoxic immune activation, while in severe lung injury it shifted toward restoration-associated immune signaling.
Hammond said ARDS patients treated with the same donor-derived AGENT-797 product showed restoration-oriented anti-inflammatory cytokine signaling, including interleukin-4 and interleukin-13. In oncology patients, she said the cytokine profile differed, with pro-inflammatory Th1-associated interferon gamma activation and cytotoxic immune engagement.
Fungal Infection Work With ANKTIVA
MiNK also discussed findings to be presented at the American Thoracic Society conference involving AGENT-797 in combination with N-803, also known as ANKTIVA, an IL-15 superagonist associated with ImmunityBio.
Hammond said she will present a case involving persistent Coccidioides immitis infection treated with AGENT-797 and ANKTIVA. She said the case involved immune dysfunction and persistent inflammatory injury where conventional antifungal therapy and corticosteroids had not been sufficient. Following treatment, she said MiNK observed evidence of inflammatory stabilization and progressive fungal pathogen clearance.
In response to an analyst question, Buell said the ATS presentation would provide more detail on the company’s work with ImmunityBio and the rationale for the combination. Hammond described fungal pneumonia, including Valley fever, as an increasing threat and said antifungal treatments do not work for all patients.
First-Quarter Financial Results
Principal Financial Officer Melissa Orilall said MiNK ended 2025 with approximately $13.4 million in cash and cash equivalents and completed repayment of approximately $5.2 million associated with the Agenus convertible note during the first quarter of 2026. She said the company raised approximately $3 million through its at-the-market sales agreement during the quarter, ending March 31, 2026, with approximately $9.5 million in cash.
Orilall said the company’s current operating plan provides runway for at least the next 12 months, including initiation and continued execution of the randomized ARDS clinical trial.
MiNK reported a first-quarter net loss of approximately $2.7 million, or $0.57 per share, compared with a net loss of approximately $2.8 million, or $0.70 per share, in the same period of 2025.
Buell said MiNK has generated material needed for the majority of its clinical program and does not expect “substantial manufacturing burn” prospectively. She also pointed to a first-quarter collaboration with C-Further to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers, which she said provides non-dilutive support for IND-enabling activities and potential downstream commercial participation.
About MiNK Therapeutics NASDAQ: INKT
MiNK Therapeutics, Inc is a clinical-stage biotechnology company developing exosome-based immunotherapies for the treatment of solid tumors. The company's proprietary platform isolates and engineers naturally occurring extracellular vesicles, or exosomes, to deliver therapeutic payloads—such as mRNA, proteins and modulatory factors—directly into the tumor microenvironment. By leveraging the innate cell‐to‐cell communication properties of exosomes, MiNK aims to reprogram immune cells and overcome immune suppression within solid tumors.
MiNK's preclinical pipeline features multiple lead candidates designed to repolarize tumor‐associated macrophages and boost T cell–mediated tumor clearance.
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