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Atossa Therapeutics Streamlines EVANGELINE Breast Cancer Clinical Trial to Prioritize for 2026 NDA-Enabling Activities
Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans SEATTLE, Oct. 6, 2025
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"\n Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans\n \n \n SEATTLE, Oct. 6, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; \"Atossa\" or the \"Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer. The amended, non-registrational design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa's focus on extending operating runway and deploying capital where it is most impactful. In 2026, Atossa is concentrating its resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen.\n \n \n \n \n \n \n \n \"This amendment is about efficiency, focus, and financial discipline,\" said Steven Quay, M.D., Ph.D., Atossa's Chairman and Chief Executive Officer. \"By streamlining EVANGELINE, we are rationalizing study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data.\"\n \n Capital Allocation Highlights\n \n \n Prioritizing runway and catalysts: The amended design is expected to reduce future EVANGELINE study costs and further focus on NDA-enabling work under Atossa's 2025-2026 operating plan\n Faster, objective decision points: Cohort A patients with an initial Ki-67 of > 10% employ a pre-specified two-stage futility rule using short-interval, objective endpoints (e.g., Week-4 Ki-67 ≤10%) to enable earlier go/no-go decisions. Cohort B will be for patients with initial Ki-67 of","length":2877,"tagName":"div"}]