Atossa Therapeutics(ATOS) Newsfilter·2025-03-25 12:00Core Viewpoint - Atossa Therapeutics is focusing on advancing its lead product candidate, (Z)-endoxifen, for the treatment of metastatic breast cancer, which is an area with significant unmet medical needs. The company believes that this approach may provide a more efficient regulatory pathway to bring the therapy to patients sooner [3][5]. Financial Performance - For the year ended December 31, 2024, Atossa reported total operating expenses of 3.8 million from 31.4 million in 2023 [7]. - Research and Development (R&D) expenses totaled 14.1 million in 2024, down from 17.3 million in 2023, reflecting a decrease in spending on (Z)-endoxifen trials [8]. - General and Administrative (G&A) expenses were 13.5 million for 2024, compared to 71.1 million in cash and cash equivalents and no debt, positioning the company favorably for future developments [1][19]. Clinical Development - The company is advancing (Z)-endoxifen as a potential next-generation therapy for metastatic breast cancer, supported by promising results from previous clinical trials [3][5]. - The Phase 2 EVANGELINE trial showed substantial tumor suppression with (Z)-endoxifen, achieving a Ki-67 response rate above 85% across dosing levels [5]. - Data from the Phase 2 KARISMA-Endoxifen study indicated that low-dose (Z)-endoxifen significantly reduced mammographic breast density, with a 1 mg dose reducing it by 17.3 percentage points and a 2 mg dose by 23.5 percentage points [5]. Strategic Focus - Atossa plans to continue engaging with the U.S. Food and Drug Administration (FDA) to pursue additional indications for (Z)-endoxifen, including breast cancer prevention and neoadjuvant therapy [5]. - The company is committed to transforming breast cancer treatment through innovative science and patient-focused solutions, with (Z)-endoxifen being central to this strategy [16][17].