Atossa Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Corporate Update

Core Insights - Atossa Therapeutics is advancing its development of (Z)-endoxifen for breast cancer, with plans for an Investigational New Drug (IND) submission and a focus on commercialization by 2026 [1][2][3] Clinical & Regulatory Developments - The company has requested a Type C meeting with the FDA to discuss regulatory strategies for (Z)-endoxifen aimed at accelerating its development for breast cancer risk reduction [3] - Atossa has streamlined its Phase 2 EVANGELINE study to prioritize activities that could enable a New Drug Application (NDA) in 2026 [3] - Janet R. Rea has been appointed as Senior Vice President of R&D to oversee (Z)-endoxifen programs, while Mark Daniel has been named CFO to lead financial strategies [3] - PSI has been selected as the Contract Research Organization (CRO) for a pivotal dose-ranging study of (Z)-endoxifen in metastatic breast cancer [3] Financial Performance - Total operating expenses for Q3 2025 were $9.3 million, an increase from $6.4 million in Q3 2024, with R&D expenses rising significantly due to increased trial activities [6][7] - Research and development expenses for the three months ended September 30, 2025, were $5.4 million, up 57% from $3.4 million in the same period in 2024 [7] - General and administrative expenses also increased to $3.9 million for Q3 2025, compared to $3.0 million in Q3 2024, primarily due to higher professional fees [9] Intellectual Property & Patent Portfolio - Atossa has made progress in its global intellectual property strategy, including the issuance of an Israeli patent for (Z)-endoxifen [8] - The company is currently facing post-grant challenges on two patents but remains confident in defending its intellectual property [8] Strategic Outlook & Upcoming Milestones - Atossa is focused on executing its breast cancer development strategy, with key upcoming deliverables including the IND submission and ongoing Phase 2 trials [6][13] - The company aims to provide updates on its regulatory path and milestones by the end of 2025 [13]