Item 7.01 Regulation FD Disclosure

On June 1, 2022, Atossa Therapeutics, Inc. ("Atossa") submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Atossa's proprietary oral (Z)-endoxifen capsules for the pre-surgical treatment of patients with estrogen receptor positive and HER2 negative (ER+/HER2-) breast cancer. The initial investigation will be a Phase 2 study of premenopausal women with ER+/HER2- breast cancer titled "A Randomized Phase 2 Noninferiority Trial of (Z)-endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women with ER+/HER2- Breast Cancer." This study is designed to first determine a target dose for therapy and then to investigate the safety and efficacy of (Z)-endoxifen therapy for premenopausal women with ER+/HER2- breast cancer.

The FDA has 30 days to review the Atossa application. As matter of regulation no assurance can be given that the IND will go into effect within 30 days allowing Atossa to proceed with opening the study. The FDA could request that Atossa provide additional information during the review period and Atossa may not be able to provide the additional information in a timely manner or at all which could result in clinical hold or permanent delay in opening or completing the study. These are standard risks associated with typical IND submissions to the FDA.

The information in Item 7.01 shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Atossa, whether made before or after the date hereof, regardless of any general incorporation language in such filing.


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