Atossa Therapeutics issues letter to shareholders

Atossa Therapeutics announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company’s President and Chief Executive Officer: “2023 marked another year of significant progress for Atossa. There are now four Phase 2 trials underway investigating our proprietary-endoxifen, with primary data expected from two of these trials in the second half of this year. We also initiated important research with Weill Cornell Medicine that could fundamentally transform treatment options for patients diagnosed with one of the most aggressive and deadly forms of breast cancer. Our study that is furthest along is the Phase 2 Karisma-Endoxifen trial, which reached full enrollment in November 2023… Simply put, breast density is a health crisis. Almost half of the women in the world over the age of 40 have dense breasts and this condition not only makes mammograms far less effective, but it also significantly increases the likelihood that a woman will develop breast cancer in their lifetime. Adding to the issue is the fact that there are currently no approved treatments to reduce breast density… Late last year we announced a second breast cancer prevention study, which is investigating (Z)-endoxifen in women diagnosed with Ductal Carcinoma In Situ. Participants receive six months of treatment with the intent of determining their suitability for long-term active surveillance without surgery…. In the continuum of invasive breast cancer, our mammographic breast density and DCIS trials are prevention studies. We also have two ongoing Phase 2 trials investigating (Z)-endoxifen in the neoadjuvant treatment setting, which is the window of time between the diagnosis and the primary treatment…. Our EVANGELINE study is much larger with an enrollment target of 175 patients. Another important distinction is that patients in the EVANGELINE study are being treated with a higher daily dose of (Z)-endoxifen. As we communicated last year, the study commenced with a 40mg pharmacokinetic (PK) run-in cohort…Beyond the progress made in our four ongoing Phase 2 studies this year, we also initiated important research with Weill Cornell Medicine to study the potential of inducing estrogen receptor expression in triple-negative breast cancer… As important as 2023 was for our Company, 2024 promises to be an opportunity for unparalleled progress. Fortunately, we are well positioned to take advantage of the opportunities that lie ahead… As we continue to believe that our current share price and the long-term prospects of our business present an attractive and strategic buying opportunity, the Atossa Board of Directors recently extended the share repurchase program authorization through December 31, 2024. The authorization continues to be for the purchase up to $10 million of our common stock, inclusive of purchases made in 2023.”