Atossa reports Q3 2026 results, outlines CVR tied to future priority review voucher

Atossa Therapeutics reported third quarter 2026 financial results and a corporate update on November 10, 2026. CEO Steven Quay said the company continued to advance (Z)-endoxifen toward several near-term milestones, including anticipated FDA clearance of its IND applications in Duchenne Muscular Dystrophy and McCune-Albright Syndrome in early 2027.¹ The company said it anticipates IND clearance from the FDA for (Z)-endoxifen in MAS and DMD by early 2027, with initiation of Phase 2 clinical trials expected in 2027.¹

On the data front, Atossa said the Karisma trial was completed and results finalized in the clinical study report, which the company plans to present at the San Antonio Breast Cancer Symposium in December 2026 and publicize afterward.¹ The company also said it anticipates topline data from the Phase 2 EVANGELINE study of (Z)-endoxifen plus goserelin in premenopausal women with ER+/HER2- breast cancer in the second quarter of 2027, after enrollment was completed in the second quarter of 2026.¹ Separately, enrollment in the (Z)-endoxifen plus elagolix and (Z)-endoxifen plus abemaciclib arms of the Phase 2 I-SPY2 study is complete, with select data to be presented at SABCS in December 2026.¹

On corporate structure, Atossa entered a new rights agreement on October 8, 2026, under which CVR holders will be entitled, in aggregate, to 25% of net proceeds from the sale or other monetization of the first qualifying FDA priority review voucher awarded to Atossa, subject to a maximum aggregate payment of $50 million.¹ The company cautioned that no PRV has been awarded to Atossa, and there is no assurance it will receive or monetize one or that any CVR payment will be made.¹

On finances, total operating expenses were $5.9 million for the third quarter and $24.5 million for the first nine months of 2026, down from $9.3 million and $25.7 million in the comparable 2025 periods.¹