MiNK Therapeutics (NASDAQ:INKT) has initiated a randomized Phase 2 trial of its investigational cell therapy agenT-797 in patients with severe acute lung injury and respiratory distress, with preliminary findings expected in the second half of 2026, executives said on the company’s first-quarter earnings call.
The company plans to enroll about 90 patients, randomly assigning them equally to receive either agenT-797 or placebo alongside standard care, President and CEO Jennifer Buell said. MiNK expects to discuss the trial design and development plans with the U.S. Food and Drug Administration in the coming weeks.
MiNK reported a first-quarter net loss of approximately $2.7 million, or $0.57 per share, compared with a loss of $2.8 million, or $0.70 per share, a year earlier. It ended March with about $9.5 million in cash and expects that balance to fund operations for at least the next 12 months, including the randomized trial.
Randomized Trial Targets Severe Lung Injury
MiNK is developing agenT-797 as an off-the-shelf invariant natural killer T-cell, or iNKT, therapy. Buell said it is administered without lymphodepletion or donor-recipient HLA matching, and that approximately 100 patients have received the therapy to date.
The new trial will enroll patients who meet recognized criteria for acute respiratory distress syndrome, or ARDS, and require respiratory support. Head of Development Dr. Terese Hammond said support may range from high-flow oxygen to mechanical ventilation or extracorporeal membrane oxygenation.
The study’s endpoints include overall survival, ventilator-free days, the number of days on a ventilator and the number of days in intensive care, Buell said. She said the protocol includes a framework for a potential seamless transition into Phase 3, with the size of that portion to depend on results from the randomized Phase 2 study and regulatory discussions.
MiNK is working with First Lviv Territorial Medical Union and UNBROKEN Ukraine on the study. Buell said the Ukrainian Ministry of Health approved the trial and the FDA cleared it for dosing.
Hammond said earlier observations suggested agenT-797 could modulate inflammation while supporting immune recovery and pathogen control. Those findings have yet to be confirmed in the randomized study. The company also plans to examine biomarkers and stratify patients by inflammatory state to assess whether particular groups respond differently, Buell said.
Gastric Cancer and Immune Findings
Buell highlighted data presented in April from an investigator-sponsored Phase 2 study in heavily pretreated, checkpoint-refractory gastroesophageal cancer. She said median overall survival exceeded 23 months in a cohort that received immune therapy before chemotherapy, with several patients remaining alive years after dosing.
The study was led by Memorial Sloan Kettering investigators Dr. Yelena Janjigian and Dr. Sam Cytryn. MiNK will continue to follow patients and provide an update on next steps for its gastric cancer program, Buell said.
At the American Society of Gene & Cell Therapy conference, MiNK presented analyses of patients with cancer and ARDS who received the same donor-derived agenT-797 product. Hammond said the product was associated with different immune signaling in the two settings: tumor-killing immune activation in cancer and restoration-oriented anti-inflammatory signaling in ARDS.
Hammond also plans to present a case at the American Thoracic Society conference involving a patient with persistent coccidioidomycosis infection who received agenT-797 and ImmunityBio’s IL-15 superagonist ANKTIVA. She said the patient showed inflammatory stabilization and progressive fungal clearance following treatment, after conventional antifungal therapy and corticosteroids had not been sufficient. Buell cautioned that the company would interpret the single case conservatively.
Cash Runway and Partnerships
Principal Financial Officer Melissa Orilall said MiNK repaid approximately $5.2 million associated with an Agenus convertible note during the first quarter. The company subsequently raised approximately $3 million through its at-the-market sales agreement.
MiNK also announced a first-quarter collaboration with C-Further to advance a PRAME-targeted, T-cell receptor-engineered iNKT therapy for pediatric cancers. Buell said the arrangement provides non-dilutive support for activities needed to enable an investigational new drug application, along with potential downstream commercial participation.
Buell said MiNK has generated material for the majority of its clinical program and does not expect substantial future manufacturing cash burn. The company plans to share more about its commercial preparation alongside data from the randomized lung-injury trial.
About MiNK Therapeutics (NASDAQ:INKT)
MiNK Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell therapies for cancer. The company’s platform is based on invariant natural killer T (iNKT) cells, an immune-cell type that can recognize cancer-related targets and help stimulate broader anti-tumor immune responses. MiNK’s lead product candidate, agenT-797, is an allogeneic, or donor-derived, iNKT cell therapy designed to be developed as an off-the-shelf treatment. The candidate is being evaluated for use in oncology, including in combination with other cancer treatments such as immune checkpoint inhibitors.
