Breathe Biologics, Inc. Announces Successful Submission of Amendment #28 for IND 19757

Oceanside, CA / April 28, 2026 /

Breathe Biologics, Inc. is pleased to report the successful submission of Amendment #28 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 product characterization, identity, and manufacturing continuity.

The Company is also pleased to note that the FDA acknowledged receipt of the submission shortly after filing.

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 19757.28
• 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.”