Breathe Biologics, Inc. Announces Successful Submission of Amendment #31 for IND 19757

Oceanside, CA / May 15, 2026 /

Breathe Biologics, Inc. announced today that the Company has submitted an additional clinical information package to the U.S. Food and Drug Administration (“FDA”) in support of the ongoing Regenerative Medicine Advanced Therapy (“RMAT”) designation review for the Company’s Umbilical Cord-Derived Mesenchymal Stem Cell (“UC-MSC”) program for Acute Respiratory Distress Syndrome (“ARDS”) under IND 19757.

The submission was provided in response to a recent FDA information request and included detailed clinical protocol materials, patient-level clinical outcome data, pulmonary stabilization analyses, mechanistic inflammatory biomarker information, and additional discussion regarding the applicability of COVID-19-associated ARDS clinical findings to broader inflammatory ARDS populations.

The Company’s response package included randomized controlled study data involving hospitalized subjects with severe COVID-19-associated ARDS and incorporated respiratory outcome measures including oxygenation-associated recovery metrics, ventilator-free days, survival outcomes, and pulmonary stabilization-related assessments.

The Company previously disclosed that the FDA informed Breathe Biologics that the RMAT request remains under active review with a decision forthcoming by May 22, 2026.

RMAT designation was established under the 21st Century Cures Act to facilitate the development and review of regenerative medicine therapies intended to treat serious or life-threatening diseases or conditions where preliminary clinical evidence indicates the potential to address unmet medical needs.

About Breathe Biologics, Inc.:
Breathe Biologics, Inc. is a regenerative medicine company focused on lung diseases using licensed and patented umbilical cord derived multi-potent mesenchymal stem cell, termed “JadiCell.”