ATOS News & Events

Atossa Therapeutics announced that it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,363,638 shares of its common stock, par value 18c per share, Series A warrants to purchase up to 1,363,638 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,638 shares of Common Stock and accompanying Series Warrants in a registered direct offering. The Series Warrants will be exercisable six months following the date of issuance. The Series A warrants will expire on the five one-half year anniversary of the date of issuance. The short-term Series B warrants will expire on the two year anniversary of the date of issuance. The closing of the offering is expected to occur on or about June 12. The aggregate gross proceeds to the company from the offering are expected to be approximately $4.5M before deducting the placement agent's fees and other estimated offering expenses payable by the company. The potential additional gross proceeds to the company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12M. Rodman & Renshaw is acting as the exclusive placement agent for the offering.

Atossa Therapeutics announced that it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,363,638 shares of its common stock, par value $0.18 per share. Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

"During the quarter, we made meaningful progress advancing our (Z)-endoxifen development strategy across both oncology and rare disease indications," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and CEO. "We continued to advance (Z)-endoxifen in the clinic for the treatment of breast cancer, while also generating data to support its potential in rare diseases, including Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome. Importantly, we secured both Orphan Drug and Rare Pediatric Disease designations from the FDA for (Z)-endoxifen in DMD, and subsequently we've received Rare Pediatric Disease designation from the FDA for McCune-Albright Syndrome, reinforcing the potential of our programs in areas of high unmet need. Building on this momentum, we remain focused on identifying additional indications where our platform can deliver meaningful therapeutic benefit to patients with limited treatment options." Dr. Quay continued, "Our balance sheet remains strong, positioning us to continue to execute across our strategic plans, and deliver value to shareholders in upcoming quarters."

Atossa Therapeutics announced the publication of results from the KARISMA Endoxifen trial in the Journal of the National Cancer Institute. The Phase 2 study evaluated daily oral Endoxifen and demonstrated that low-dose Endoxifen significantly reduced MBD, a key risk factor for breast cancer. The article highlighted data from a study funded by Atossa. The study evaluated placebo, 1 mg, and 2 mg Endoxifen administered daily for six months in 240 healthy premenopausal women enrolled through the Swedish national mammography screening program. Elevated MBD is an established risk factor for breast cancer and a recognized pharmacodynamic marker of response to endocrine risk-reduction therapy. In the KARISMA Endoxifen trial, both the 1 mg and 2 mg Endoxifen dose levels produced statistically significant reductions in MBD compared with placebo. The 1 mg dose reduced MBD by 19.3% vs. placebo, while the 2 mg dose reduced MBD by 26.5% vs. placebo. These reductions were comparable to those previously reported with standard-dose tamoxifen, but were achieved using direct administration of Endoxifen, the most therapeutically active metabolite of tamoxifen. Both levels demonstrated a favorable tolerability profile. Adverse events were generally vasomotor in nature, consistent with those previously reported for tamoxifen.