Atossa Therapeutics, Inc. Files for Swedish Regulatory Approval to Initiate a Phase 2 Study of Oral Endoxifen to Reduce Mamm...

Atossa Therapeutics, Inc. (Nasdaq:

ATOS

), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that it has filed with the Swedish Medical Product Agency and the Institutional Review Board to initiate a Phase 2 study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States. Studies conducted by others have shown that MBD increases the risk of developing breast cancer, and reducing MBD can reduce the incidence of breast cancer.

“This is an important milestone in the development of our oral Endoxifen product. Regulatory approval is necessary to commence the Phase 2 randomized, double-blinded, placebo-controlled study in Stockholm, which will include approximately 1,000 pre-menopausal women with MBD who will receive daily doses of Endoxifen or placebo for six months. We expect the Medical Product Authority will respond within 30 days and that the IRB approval will follow in the second quarter,” commented Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO.

Atossa has established both primary and secondary sources of manufacturing for the clinical supply of its oral Endoxifen capsules.  With over three years of experience manufacturing and supplying the oral Endoxifen capsules for its completed clinical studies, Atossa believes adequate drug supply will be available to support this Phase 2 study.

The primary objective of the study is to determine if breast density changes compared to placebo and among different doses, with secondary endpoints to assess and characterize safety and tolerability. South General Hospital in Stockholm will be conducting this study at multiple sites, after having recently completed the company’s Phase 2 study of its topical form of Endoxifen. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

About Atossa Therapeutics

Atossa Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 with respect to fulvestrant, 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 Form 10-K and 10-Q, each as amended and supplemented from time to time.

Atossa Therapeutics Company Contact:

Atossa Therapeutics, Inc.Kyle GuseCFO and General Counsel(O) [e-mail]

Investor Relations Contact:Scott GordonCoreIR377 Oak StreetConcourse 2Garden City, NY 11530Office: [e-mail]