Atossa Therapeutics(US:ATOS)2025-09-08 20:02Atossa Therapeutics FY Conference Summary Company Overview - Company: Atossa Therapeutics (NasdaqCM: ATOS) - Lead Asset: Zinhoxifen, a novel drug for breast cancer treatment Key Points Product Differentiation - Zinhoxifen is a pure form of (Z)-endoxifen, which is derived from tamoxifen, offering efficacy with fewer side effects [2][5] - It has unique properties: it blocks estrogen receptor interaction and stimulates receptor degradation, unlike other drugs that only block [2][3] - Higher doses of Zinhoxifen activate a different apoptotic pathway (PKC beta), enhancing its cancer-fighting capabilities [3] Clinical Trial Insights - Clinical trials involving approximately 700 women showed a reduced incidence of vasomotor symptoms (e.g., hot flashes) compared to tamoxifen [5][6] - Higher levels of (Z)-endoxifen correlated with fewer hot flashes, indicating a potentially better safety profile [6] - Zinhoxifen is being explored for both prevention (1-4 mg) and treatment of metastatic breast cancer (20-80 mg) [7][8] Metastatic Breast Cancer - Initial data from trials at the National Cancer Institute and Mayo Clinic indicated a 25% clinical response rate and 50% partial response rate in patients resistant to current therapies [9] - The iSpy 2 trial is underway, combining Zinhoxifen with the CDK4/6 inhibitor abemaciclib, showing promising recruitment [11][12] Regulatory and Development Plans - Atossa is preparing for an IND filing under the FDA's Project Optimus, focusing on optimal dosing strategies [14][20] - The iSpy 2 trial aims to assess biological activity and tumor shrinkage in high-risk breast cancer patients [21] Market Opportunity - Approximately 1.7 million women currently take tamoxifen, indicating a significant market for Zinhoxifen, especially due to its better tolerance [27] - Pricing strategies suggest that Zinhoxifen could be positioned between $6,000 to $20,000 per year for prevention, contrasting with higher costs for metastatic treatments [28] Upcoming Milestones - Key upcoming events include data from the low-dose program in December and the initiation of the high-dose Project Optimus trial [29] Additional Insights - The FDA's recent requirement for mammogram results to include breast density information may increase awareness and demand for preventive treatments like Zinhoxifen [24][25] - The potential for Zinhoxifen to reduce side effects associated with current therapies could enhance patient compliance and market acceptance [26] This summary encapsulates the critical aspects of Atossa Therapeutics' conference, highlighting the innovative approach of Zinhoxifen in breast cancer treatment and the company's strategic direction in clinical development and market positioning.