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MiNK starts randomized Phase 2 trial in acute lung injury

Tickers INKTIBRX

MiNK reported first quarter 2026 results and said cash and cash equivalents were approximately $9.5 million at March 31, 2026. Preliminary data from the trial are expected in the second half of 2026.

Key facts

Companies
MiNK Therapeutics, Inc. (NASDAQ: INKT), ImmunityBio, Inc. (NASDAQ: IBRX)
News type
Company Updates
Primary source
MiNK Therapeutics, Inc. 8-K (2026-05-15)
A researcher pipetting in a biology laboratory. Photo: Aidar Turlanov, CC BY 4.0, via Wikimedia Commons. The picture shows the field, not the companies named.

MiNK Therapeutics, Inc. (NASDAQ: INKT) reported financial results for the first quarter ended March 31, 2026, in a release furnished with a Form 8-K on May 15, 2026. The company said it had moved its lead candidate, agenT-797, into a randomized Phase 2 study in acute lung injury, with preliminary data expected in the second half of 2026.

The randomized Phase 2 trial

The trial compares agenT-797 plus standard of care 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. The study uses a seamless Phase 2/3 operational framework, which the company said is intended to support a transition into later-stage development if findings are prospectively confirmed. The trial has received authorization from the Ukraine Ministry of Health and is supported by an active U.S. IND. Activation of U.S. sites remains subject to FDA clearance.

The release says 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 approximately 40% to 50%, and no approved pharmacologic therapy has been shown to reduce mortality in ARDS.

Biologic data from AACR and ASGCT

At the AACR Annual Meeting, MiNK reported investigator-sponsored Phase 2 data in PD-1 refractory gastroesophageal cancer. The study achieved a 77% disease control rate among heavily pretreated patients. Long-term survival beyond 20 months was observed in a subset of patients who had immune induction before chemotherapy. Those patients also had longer progression-free survival, with median PFS of 6.9 months versus 3.5 months for patients treated without induction.

Translational analyses presented at ASGCT showed that the same off-the-shelf agenT-797 product was associated with a TH1 pro-inflammatory signature in solid tumor patients and a TH2 anti-inflammatory signature in ARDS patients.

Collaborations and funding

MiNK announced a collaboration with C-Further, an international pediatric oncology therapeutics consortium enabled by Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity, to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers. It provides up to approximately $1.1 million in non-dilutive aggregate funding for IND-enabling development, with potential meaningful double-digit downstream commercial revenue participation. MiNK also advances a graft-versus-host disease program supported by NIH STTR funding and the Mary Gooze philanthropic award.

Financial results

MiNK ended the first quarter of 2026 with approximately $9.5 million in cash and cash equivalents, compared with approximately $13.4 million as of December 31, 2025. During the quarter, it completed repayment of approximately $5.2 million associated with the Agenus convertible note, then raised approximately $3.0 million through its at-the-market sales agreement during the three months ended March 31, 2026. The net loss for the quarter was approximately $2.7 million, or $0.57 per share, compared with approximately $2.8 million, or $0.70 per share, for the same period in 2025.

The 2025 annual report showed research and development expense of $5.8 million, compared with $6.3 million for 2024, and net cash used in operations of $5.9 million for 2025.

Upcoming presentation

MiNK will present clinical data featuring agenT-797 at the American Thoracic Society (ATS) International Conference 2026 on May 20, 2026. The presentation covers N-803 and agenT-797 in unresolving Coccidioides immitis infection and will be given by Terese Hammond, M.D., in collaboration with ImmunityBio (NASDAQ: IBRX).

The risks ahead

MiNK ended the quarter with about $9.5 million in cash, down from about $13.4 million at the end of 2025, after it repaid about $5.2 million on the Agenus convertible note and raised about $3.0 million through its at-the-market agreement. The quarterly net loss was about $2.7 million, and the release does not say how long the cash will last. The company says preliminary trial data are expected in the second half of 2026, and U.S. sites remain subject to FDA clearance. The collaboration funding is up to approximately $1.1 million, for IND-enabling development of the pediatric program. On the science, the gastroesophageal cancer data come from an investigator-sponsored study. The release gives no patient numbers or p-values for the 77% disease control rate, and it says the longer survival was seen in a subset, not the whole group.

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