Aug 13, 2026 earnings call — AgenT-797 randomized Phase Two and access program
Moved agenT-797 into a randomized phase two and started a run-in scheduled for about 10 patients, reporting initial day 28 observations.
EPS $-0.62 (est $-0.60)
Key quotes
"We moved agenT-797 into a randomized phase two study in patients with acute lung injury and ARDS."
"Second, this is a paid program. MiNK receives payment for products supplied on a per patient basis."
"It does not require apheresis, does not require patient-specific manufacturing, HLA matching, or lymphodepletion."
Analyst Q&A 2
ARDS run-in patients and profile
Q (Emily Bodnar · H.C. Wainwright): Asked how many patients were in the run-in, their baseline characteristics, how they would have done on standard of care, and whether the observed day-28 survival was due to agenT-797.
A: They said the run-in was scheduled for about 10 patients. These were adults with hypoxia and pneumonia meeting the global ARDS definition; the first two treated included a 41-year-old female with poorly controlled diabetes and pneumococcal sepsis. Management called the results preliminary and unrandomized, and noted that ARDS patients with complex, multi-drug resistant infections normally have "somewhere between a 30% and 50% chance of mortality" in the first 28 days, so 28-day survival in that setting is provocative.
"In this study, we have a run-in scheduled for about 10 patients." — Jennifer Buell (CEO)
Enrollment pace, patient differences, and programs
Q (Mayank Mamtani · B. Riley): Asked how many patients have been dosed and randomized in the randomized portion, the enrollment rate in Ukraine and expected U.S. enrollment, and whether patient phenotypes differ. Also asked about phase III population/randomization, DoD/BARDA involvement, and the Brazil paid program rationale and pricing/demand.
A: They said the study is underway in Ukraine and expanding into the U.S., but they have not given specific enrollment numbers. They expect preliminary randomized Phase II readouts in the first half of 2027, expect "between four to eight patients per site per month" when sites are fully active, have an active center in Ukraine and U.S. sites starting enrollment in September, and noted Ukraine patients commonly have multi-drug resistant pathogens while the U.S. profile may differ. They said Phase III population would be comparable to Phase II with a primary endpoint of 28-day mortality and secondary endpoints like ventilator-free days and immune measures; they would not yet detail government interactions, and said the Brazil program launched due to physician demand and fast regulators, is active with patients, and pricing will be disclosed later.
"We expect to have our preliminary readouts from the randomized phase two portion of the study in the first half of 2027." — Jennifer Buell (CEO)