Mink Therapeutics (INKT) Corporate presentation summary

Lead program and platform

• agenT-797 is an investigational, off-the-shelf allogeneic iNKT cell therapy; the proposed dose is one infusion of 1×10⁹ cells for severe pneumonia with moderate-to-severe ARDS.

• The platform is designed to work without HLA matching or lymphodepletion; cells are cryopreserved for on-site storage and standard IV infusion.

• iNKT cells sense CD1d-presented lipids, stress ligands and cytokines, with proposed effects spanning immune coordination, pathogen control and tissue repair.

• Programs include randomized Phase 2 agenT-797 in ARDS, Phase 1 GvHD prevention, Phase 2 oncology combinations and engineered cell candidates in development.

Clinical evidence and safety

• In an open-label Phase 1/2 study in severe viral ARDS (n=21), 30-day survival was 70% with agenT-797 versus 10% in non-randomized in-hospital controls; the comparison is not head-to-head.

• Across completed trials, 1 of 67 patients had a serious treatment-related adverse event; 3.0% had a treatment-related event above Grade 3, none led to death, and no severe CRS or ICANS was observed across programs.

• The first two Phase 2 patients were alive at day 28 after one infusion plus standard care; reported improvements included oxygenation and organ function, with one patient later off ventilation and discharged to rehabilitation.

• The Phase 2 observations are two uncontrolled cases; one serious adverse event, coagulase-negative staphylococcal bacteremia, was judged unlikely related to treatment.

Phase 2/3 development plan

• Randomized Phase 2 C-1300-02 compares agenT-797 plus standard care with standard care in severe pneumonia with moderate-to-severe ARDS; enrollment began in May 2026 in Lviv, with US site activation underway.

• Proposed adaptive design uses a 1:1 randomized Phase 2b cohort of ~124 patients, with Phase 3 sized at interim; primary endpoint is a hierarchical win ratio for day-14 survival free of VV-ECMO, then 28-day mortality.

• The presentation targets a Phase 2 interim readout in 3Q 2027, Phase 3 first patient in 4Q 2027 and potential BLA in 1Q 2029; timelines and registrational plans remain subject to FDA review.

• FDA feedback on the proposed Phase 2/3 design was expected in 2H 2026; the presentation notes FDA had not agreed that Phase 2 patients would count toward approval or that the study would be registrational.