MiNK Therapeutics (NASDAQ:INKT) said it initiated dosing in a randomized Phase II trial of its allogeneic invariant natural killer T-cell therapy, agenT-797, for patients with acute lung injury and acute respiratory distress syndrome, or ARDS, during the second quarter of 2026.
The company also launched its first international paid named-patient access program in Brazil and reported a second-quarter net loss of $3.1 million, narrower than the $4.2 million loss reported a year earlier.
Phase II ARDS Study Begins in Ukraine
Buell said the first patient was dosed within days of authorization from Ukraine’s Ministry of Health. The program is designed around an off-the-shelf cell therapy that does not require patient-specific manufacturing, HLA matching, apheresis or lymphodepletion.
“A cell therapy cannot change critical care if it cannot reach the patients in time,” Buell said, pointing to the logistical challenges of treating critically ill, mechanically ventilated patients in an active conflict zone.
MiNK presented early day-28 observations from the first two treated patients at the Military Health System Research Symposium. According to the company, both patients were alive and fever-free at day 28, with improved oxygenation, resolution of ARDS, return to spontaneous breathing and liberation from vasopressor support. MiNK also reported microbiologic control of baseline infections, lower inflammatory markers in serum and bronchial lavage samples, and biological changes associated with immune recovery, epithelial repair and pulmonary vascular recovery.
No major serious adverse events were attributed to agenT-797 in the initial patients, according to MiNK.
However, Buell emphasized that the observations came from a small, non-comparative run-in cohort and should not be overinterpreted. The company plans for roughly 10 patients in the run-in phase before advancing the randomized portion of the study.
Terese Hammond, MiNK’s head of inflammatory and pulmonary diseases, said the first two patients had multidrug-resistant pneumonia at or shortly after intubation. She said patients with moderate-to-severe ARDS and complex infections can face 28-day mortality rates of about 30% to 50%, but noted that the company’s findings remain preliminary and unrandomized.
Enrollment Plans and Potential Regulatory Path
Enrollment is continuing in Lviv, while MiNK expects U.S. sites to begin enrolling in September. Buell said the company has not disclosed the number of patients enrolled or randomized to date. It expects preliminary data from the randomized Phase II portion in the first half of 2027.
The company expects enrollment rates of four to eight patients per site per month when all selected sites are active, according to Buell. She also said MiNK is preparing to seek a meeting with the Food and Drug Administration in the coming weeks to discuss potentially transitioning from the randomized Phase II trial into a seamless Phase III study.
MiNK said the Phase II trial’s primary endpoint includes 28-day mortality, with secondary measures including ventilator-free days, pathogen control and immune reconstitution. Buell said Phase II results could support a sample-size re-estimation for a later-stage study.
Management said the patient population in Ukraine may differ from that expected at U.S. sites because of the prevalence of multidrug-resistant organisms in conflict zones. Hammond cited pan-resistant Klebsiella, Acinetobacter and Pseudomonas among the organisms affecting patients in Ukraine and European hospitals.
Brazil Named-Patient Program Launched
MiNK also established a paid named-patient access program in Brazil, working with Orphan Drug Consulting and local partners. The program permits physicians to request agenT-797 for individually identified patients with serious unmet medical needs, subject to case-by-case regulatory authorization.
Buell said Brazil was selected following physician inquiries and the pace of local regulatory processes. She said the program is active and has enrolled patients after the quarter’s close, with financial details expected in the company’s third-quarter update. MiNK did not disclose pricing.
The company said the program is not a commercial launch or marketing authorization, and is not intended to replace clinical trial participation. Patients eligible for Study C-1300-02 will be directed to the trial, while named-patient requests must originate with treating physicians and receive local regulatory authorization.
MiNK said the initiative provides payment on a per-patient basis and helps establish infrastructure for regulatory submissions, importation, product logistics and pharmacovigilance across borders. Management said it expects the program to expand into additional territories as regulatory processes are completed.
Financial Results
Principal Financial Officer Melissa Orilall said MiNK ended the second quarter with $8.8 million in cash and cash equivalents, compared with $9.5 million at March 31, 2026, and $3.4 million at year-end 2025.
- Second-quarter net loss was $3.1 million, or $0.62 per share, compared with a $4.2 million loss, or $1.06 per share, in the prior-year period.
- Net loss for the first six months of 2026 was $5.9 million, or $1.20 per share, compared with $7 million, or $1.76 per share, a year earlier.
- Cash used in operations was $2.1 million during the quarter, compared with $1.6 million in the second quarter of 2025.
Orilall attributed the increase in operating cash use to launching the randomized trial, activating the Lviv site, completing regulatory work in Ukraine, dosing initial patients and preparing U.S. sites. Buell said the company has maintained a lean operating footprint and continues to prioritize non-dilutive funding, including externally funded graft-versus-host disease and pediatric programs.
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.
