Corporate Profile

Incentives that come with the designation include eligibility for federal grants, orphan drug tax credits, waiver of filing fees, and the potential for a seven-year marketing exclusivity period. The designation does not alter the standard regulatory requirements and process for obtaining marketing approval.

The award, stage-gated based on achievement of pre-determined milestones and deliverables, provides funding for Enalare to perform pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use.

As part of the transaction, Eagle will invest up to approximately $55 million, which is expected to occur over the next two years subject to the achievement by Enalare of certain milestones on an agreed upon timeline.

Funding from the NIH’s National Institute on Drug Abuse (NIDA) will Support Further Development of ENA001, an Agnostic Respiratory Stimulant

ENA001, an Agnostic Respiratory Stimulant, Successfully Achieved the Study Primary Endpoint and Was Shown to Be Safe and Well Tolerated

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.

Subject to FDA approval of ENA-001 for the treatment of Apnea of Prematurity, Enalare would be eligible to receive a priority review voucher that may be applied either to a subsequent product’s marketing application or sold/transferred to another company.

This Provisional Patent Application was filed with the United States Patent and Trademark Office for its lead product ENA-001 and related compounds for the reversal of respiratory depression from non-opioid central nervous system depressants, including common surgical anesthetics. Any resultant patent claiming priority to this filing will have an estimated term to 2042.

This study aims to demonstrate the ability of ENA-001 to reverse respiratory depression induced through administration of propofol, a central nervous system depressant commonly utilized globally as a surgical anesthetic.

Daniel Motto, Enalare’s Chief Operating Officer, will highlight how the successful partnership with BARDA is accelerating the development of Enalare’s lead drug candidate ENA-001 as a potential treatment for respiratory depression in both mass casualty situations and the drug overdose epidemic.

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 expanded its scientific team with the appointment of Thomas Miller, Ph.D., as Vice President of Clinical Development.

Enalare Therapeutics Inc. has received an initial contract from the Biomedical Advanced Research and Development Authority (BARDA) to support development of ENA-001.

The Company Raises $10 Million to Expand Its Operations and Prepare to Conduct Pivotal Studies of Lead Drug Candidate ENA-001.

The Addition of Dr. Coleman Further Enhances the Company’s Deep Medical, Enterprise Leadership, and Capital Markets Experience.

The Appointments of Professors Albert Dahan MD, PhD and Tong Joo (TJ) Gan MD, MHS, MBA Highlight a World Class Collection of Medical and Pharmaceutical Industry Experts.

The addition of Gino Santini, Bob Yedid, and Joe Petko Significantly Expands Company’s Pharmaceutical and Financial Markets Experience and Capabilities.

Enalare Therapeutics Inc. announced today that it has appointed pharmaceutical industry veteran Daniel Motto as its Chief Business Officer.

Enalare Therapeutics Inc. announced today that it has appointed biopharma industry veteran Herm Cukier as its Executive Chairman of the Board, President, and Chief Executive Officer.

Thomas L. Miller, Ph.D., Lynn M. Raab, MD, Thomas H. Shaffer, MS.E., Ph.D, Alfred Schweikert, Ph.D., RAC, Frank Diana, Ph.D., Prem Fort, MD, Alana S. Frum, LVTg, RVTg, BASVT, Joseph Pergolizzi, Jr., MD, Robert B. Raffa, Ph.D.

Margot Roozekrans, M.D., Rutger van der Schrier, M.D., Pieter Okkerse, M.D., Justin Hay, Ph.D., James F. McLeod, M.D., Albert Dahan, M.D., Ph.D

Joseph F. Cotten, M.D., Ph.D.

Francis J. Golder, Matthew M. Hewitt, James F. McLeod

Rutger van der Schier, Margot Roozekrans, Monique van Velzen, Albert Dahan and Marieke Niesters

J. F. McLeod, J. M. Leempoels, S. X. Peng, S. L. Dax, L. J. Myers and F. J. Golder

Northwell Health System Practicing Emergency Medicine Specialist

Stony Brook University Professor of and Chair, Department of Anesthesiology

Herm Cukier, President and Chief Executive Officer, will be presenting at the BioNJ’s Twelfth Annual BioPartnering Conference and Chief Operating Officer, Daniel Motto, will be taking questions after the presentation and meeting with potential investors and strategic partners.

Herm Cukier, President and Chief Executive Officer, presents at the BioNJ’s Eleventh Annual BioPartnering Conference.

Herm Cukier, President and CEO of Enalare Therapeutics, will provide an update on the Company’s ongoing clinical development program as well as progress on other scientific endeavors. The presentations will be available for viewing on-demand beginning on Jan. 10, 2022 via the H.C. Wainright Bioconnect Conference and the Biotech Showcase 2022 Conference platforms.

Herm Cukier, President and Chief Executive Officer, presents at the BioNJ’s Eleventh Annual BioPartnering Conference.