MiNK shares fell 4.8% after earnings, likely reflecting the long wait for comparative evidence: the ARDS trial’s readout is expected in 2027, while U.S. dosing has not yet begun and remains targeted for before year-end. Early patient observations were encouraging but small and uncontrolled, and the pivotal-development path still depends on FDA discussions.
- The randomized Phase II ARDS study continued enrolling in Ukraine; U.S. activation is in its final stages, with dosing expected to begin before year-end.
- The company expects a comparative readout in 2027. It plans an initial randomized stage of about 124 patients, potentially expanding to as many as 300, and aims to discuss the design with the FDA before year-end.
- Management reported no major serious adverse events attributed to agenT-797 in the patients discussed. Clinicians also described improvements in fever, oxygenation and ventilator use, while emphasizing the observations involve small numbers and no comparator.
- MiNK recognized its first pre-commercial revenue from agenT-797 supplied through a paid named-patient access program in multiple countries outside the U.S.; the transcript did not disclose revenue.
- Management estimates about 93,000 U.S. patients annually in its initial target population of ventilated patients with pneumonia-associated moderate-to-severe ARDS.
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