ATOS Atossa Therapeutics Inc

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need, today announced a new drug development program called COVID-19 HOPE. The program uses a novel combination of two drugs that have been previously approved by the FDA for other diseases. The goal of the COVID-19 HOPE program is to develop a therapy to improve lung function and reduce the amount of time that COVID-19 patients are on ventilators. 

“The rapidly increasing number of COVID-19 patients needing mechanical ventilation is deeply worrisome, as more than one-third of these patients will never recover lung function and will die on the ventilator,” stated Dr. Steven Quay, President and CEO of Atossa Therapeutics. “The problem is confounded by the fact that hospitals may soon be facing a ventilator shortage and a vaccine could take more than a year to develop. The two drugs we intend to combine, which we call AT-H201, have been approved by the FDA for other diseases and are supported by a dozen clinical studies in close to 800 patients. We plan to quickly initiate and complete clinical studies so that we can obtain FDA approval to bring this treatment to market as soon as possible.”

Atossa has filed comprehensive provisional patent applications related to AT-H201 and intends to apply to the FDA under its Coronavirus Treatment Acceleration Program for approval to commence a clinical study.

About Atossa’s COVID-19 HOPE Program

The program is called “COVID-19 HOPE,” which is an acronym for AT-H201in COVID-19 patients for Pulmonary Evaluation. The intended primary function of the drug combination AT-H201 is to essentially mimic the function of the antibodies formed from a vaccine by blocking the ability of the virus to enter the target cells; a vaccine that may not be available for more than a year. There are five known key steps the coronavirus must take to signal the cell to open up and let the virus in. AT-H201 is being designed to function like a “chemical vaccine” by blocking all five of those steps, similar to what antibodies would be expected to do when a vaccine is administered. With AT-H201, the virus should be unable to enter the cell because its "keys" that would otherwise open the door into the cell surface, are disabled. Atossa expects that its AT-H201 drug combination can be developed more quickly than a traditional vaccine.

About the Inventor, Dr. Steven Quay

AT-H201 was invented by Dr. Steven Quay. Dr. Quay received his M.D., M.A. and Ph.D. from The University of Michigan, was a postdoctoral fellow at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-Massachusetts General Hospital, and was on the faculty of Stanford University School of Medicine for almost a decade. He has over 300 published contributions to medicine which have been cited over 9,700 times. Dr. Quay has founded six pharmaceutical companies, invented seven FDA-approved medicines, and holds 87 U.S. patents.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, potential market sizes for Atossa's drugs under development and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact: Atossa Therapeutics, Inc. Kyle Guse, CFO and General Counsel Office: 866-893-4927 kyle.guse@atossainc.com

Investor Relations Contact: Scott Gordon Core IR 377 Oak Street Concourse 2 Garden City, NY 11530 Office:516-222-2560 scottg@corprominence.com