Breathe Biologics, Inc. Announces Successful Submission of Amendment #29 for IND 19757

Oceanside, CA / May 08, 2026 /
Breathe Biologics, Inc. is pleased to report the successful submission of Amendment #29 to IND 19757 with the U.S. Food and Drug Administration.

This amendment was prepared and submitted in eCTD format under Breathe Biologics as current sponsor of the IND and included responses to recent Agency requests for additional information relating to observed improvements in oxygenation and clinical stabilization as preliminary clinical evidence.

This submission provided summary clinical data supporting observed improvements in oxygenation and clinical stabilization, including patient population, follow-up duration, and key clinical outcomes.

Management believes this filing represents another important step in the continued advancement of the JadiCell™ program for Acute Respiratory Distress Syndrome (ARDS), while further strengthening the regulatory record under Breathe Biologics sponsorship.

The Company remains focused on:

• Ongoing dialogue with FDA regarding IND 19757.29
• Advancement of Regenerative Medicine Advanced Therapy (RMAT) related matters
• Evaluation of manufacturing and development partnerships
• Positioning the program for future clinical progress

We appreciate the continued support of our shareholders and stakeholders as we work to unlock the value of this important platform.

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.”