Atossa Therapeutics Issues Letter to Shareholders Highlighting 2024 Accomplishments and Outlook for 2025

Core Insights - Atossa Therapeutics has made significant progress in 2024, particularly with (Z)-endoxifen, which shows promise in breast cancer prevention and treatment [1][4][16] Clinical Program Updates - The completion of the KARISMA-Endoxifen Phase 2 Study demonstrated significant reductions in mammographic breast density (MBD), with decreases of 17.3 percentage points in the 1 mg arm and 23.5 percentage points in the 2 mg arm, both statistically significant (p<0.01) [2][3] - The EVANGELINE trial has shown promising initial results, achieving the primary endpoint with 50% of patients in the 80 mg (Z)-endoxifen with goserelin group meeting target plasma concentrations [5][6] - Significant tumor suppression was observed across all dosing levels in the EVANGELINE trial, with a Ki-67 ≤10% response rate consistently above 85% [7] Intellectual Property and Financial Position - The company secured two additional U.S. patents for (Z)-endoxifen, enhancing its intellectual property portfolio and pipeline value [14] - Atossa maintains a strong cash position, allowing for efficient funding of research and development efforts while ensuring operational stability [15] Future Directions - The company aims to advance (Z)-endoxifen into registrational clinical trials in 2025, focusing on expediting its market entry [18] - Ongoing business development efforts will be amplified to ensure global access to (Z)-endoxifen [18] - Collaborations with industry leaders and advocacy groups will be deepened to broaden the impact of Atossa's work [18]