Atossa Therapeutics Contracts with NYC Health + Hospitals/Metropolitan for COVID-19 HOPE Clinical Study

Study Designed to Evaluate Atossa’s Combination Therapy AT-H201 to Reduce Patient Time on a Ventilator

SEATTLE, April 27, 2020 (GLOBE NEWSWIRE) — 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 that it has contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study of Atossa’s proprietary combination drug therapy called AT-H201. The NY HOPE Study will evaluate AT-H201 in COVID-19 patients on ventilators with the goal of reducing the amount of time on ventilators.

“We are honored to be working with NYC Health + Hospitals/Metropolitan and Dr. Getaw Hassen, who are on the front lines of this unprecedented health crisis,” stated Dr. Steven Quay, President and CEO of Atossa Therapeutics. “The NY HOPE Study is a vital step in developing this new therapy for critically ill COVID-19 patients.”

“Managing patient care and ventilator use has become a major challenge,” commented Getaw Hassen, M.D., Ph.D., Emergency Physician, at NYC Health + Hospitals/Metropolitan and the principal investigator of the NY HOPE Study. “We have an urgent need for a therapy to reduce reliance on ventilators and we are looking forward to playing a key role in what could be a much-needed solution for our sickest COVID patients.”

The NY HOPE Study will assess the safety and efficacy of AT-H201 administered via inhalation in COVID-19 patients on mechanical ventilation support. Subject to FDA and IRB input, the study is currently designed as follows: Thirty-nine patients will be enrolled in the active treatment group and compared to the outcomes of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to the standard of care, while on mechanical ventilation for up to seven days and will be followed up during hospitalization and for 28 days after discharge. The primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates.

Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation and system function.

The NY HOPE Study is currently pending IRB approval and will not commence without IRB and all necessary regulatory approvals, including FDA. Atossa has filed comprehensive provisional patent applications related to AT-H201.

About Atossa’s COVID-19 HOPE Program

Atossa’s COVID-19 program is called “COVID-19 HOPE,” which is an acronym for AT-H201 in 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.

The NY HOPE Study is a critical step in determining safety and efficacy of AT-H201 and in bringing this new therapy to the market.

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.

About NYC Health + Hospitals/Metropolitan

NYC Health + Hospitals/Metropolitan is the community hospital of choice for residents of East Harlem, northern Manhattan and neighboring communities. NYC Health + Hospitals/Metropolitan provides culturally sensitive primary and specialized medical care to patients of all ages regardless of national origin, immigration status, or ability to pay. Since its founding in 1875, the hospital has been affiliated with New York Medical College, representing the oldest partnership between a hospital and a private medical school in the United States. NYC Health + Hospitals/Metropolitan is part of the NYC Health + Hospitals public health care system. For more information, please visit www.nychealthandhospitals.org/metropolitan.

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

About Dr. Quay

Steven Quay is the founder of Seattle-based Atossa Therapeutics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and COVID-19 therapeutics.

He received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, and a resident at the Harvard-MGH Hospital, and spent almost a decade on the faculty of Stanford University School of Medicine. His contributions to medicine have been cited over 9,600 times.

He has founded six startups, invented seven FDA-approved pharmaceuticals, and holds 87 US patents. Over 80 million people have benefited from the medicines he invented.

His current passions are big medical problems: stopping the COVID-19 pandemic and preventing the two million breast cancers in the world each year.

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The COVID-19 HOPE Clinical Trial​