Enalare Files Additional Patent Application for Lead Compound ENA-001 - Enhancing Potential Global Exclusivity Through 2042

Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has filed a Provisional Patent Application with the United States Patent and Trademark Office directed to parenteral formulations of ENA-001 and related compounds. The patent application encompasses the Company's developmental formulation candidates for its future proposed clinical trials. Any resultant patent claiming priority to this filing will have an estimated term to 2042.

Enalare is developing multiple agnostic respiratory stimulant products with the potential to improve standard of care for millions of patients. In 2021, Enalare formed a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of an intramuscular formulation (IM) for its lead compound, ENA-001, to treat life-threatening respiratory depression in both mass casualty and everyday community drug overdose situations.

"We are pleased to have successfully advanced our formulation development activities and to have filed another new patent application for ENA-001," stated Daniel Motto, Enalare's Chief Operating Officer. "We thank the team at BARDA for their partnership on the intramuscular formulation and look forward to further advancing the development of this potential life-saving product."

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. 75A50121C00044.

About ENA-001

Enalare's lead compound, ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant.  The compound has a unique mechanism of action that affects ventilation via the peripheral chemoreceptor pathway in the carotid bodies.  The compound utilizes the body's own ventilation control system to beneficially influence breathing and has been shown to be effective and well-tolerated in four previously completed human studies.  The Company is currently conducting a breakthrough study evaluating the ability of ENA-001 to reverse the respiratory depressive effects of propofol, a commonly utilized anesthetic in surgical procedures.

About Enalare Therapeutics Inc.

Enalare Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions, including post-operative respiratory depression, community drug overdose, and apnea of prematurity. The Company is planning to initiate additional clinical studies for ENA-001 across multiple indications in the coming year, including for Apnea of Prematurity for which it has received the designation of Rare Pediatric Disease by the FDA.



Morgan Wagner
Enalare Investor Relations

Source: Enalare Therapeutics Inc.