Atossa Therapeutics Announces Second Quarter 2025 Financial Results and Provides a Corporate Update

Core Insights - Atossa Therapeutics has received positive feedback from the FDA regarding its (Z)-endoxifen program for metastatic breast cancer, indicating no additional toxicity studies are required and supporting the company's planned IND submission [3][4][6] - The company reported strong results from the I-SPY2 trial, demonstrating the efficacy of (Z)-endoxifen as a monotherapy, with significant reductions in Ki-67 levels, a key biomarker for cancer cell proliferation [4][11] - Atossa is strategically focused on advancing its clinical programs while maintaining a strong balance sheet, avoiding the use of its ATM facility at current undervalued share prices [2][6] Clinical & Regulatory Developments - The FDA's feedback supports Atossa's proposed dose optimization trial in ER+/HER2- metastatic breast cancer, allowing the initiation of the monotherapy arm and combination therapy arms [3] - Atossa plans to file an IND application in Q4 2025, aligning with FDA's Project Optimus initiative [3][6] Clinical Trial Readouts & Scientific Validation - In the I-SPY2 trial, 95% of subjects completed at least 75% of planned dosing, with a median Ki-67 reduction from 10.5% to 5% by Week 3 [4] - The median functional tumor volume decreased by 77.7% from baseline to surgery, indicating significant tumor response [4] Financial Overview - Total operating expenses for Q2 2025 were $9.0 million, an increase from $7.1 million in Q2 2024, driven by higher R&D costs related to (Z)-endoxifen trials [6][20] - Research and development expenses rose to $5.5 million for Q2 2025, up from $3.6 million in Q2 2024, reflecting increased spending on clinical trials [7][20] Intellectual Property & Patent Portfolio - Atossa holds a robust intellectual property portfolio, including recent patents related to (Z)-endoxifen formulations, which provide substantial protection for its lead program [15] - The company is currently facing post-grant challenges on two patents but remains confident in defending its intellectual property [7][15] Strategic Outlook & Upcoming Milestones - Key upcoming milestones include the IND submission for (Z)-endoxifen and advancing enrollment in ongoing Phase 2 trials [6][15] - Atossa is also exploring regulatory strategies for additional breast cancer indications beyond metastatic cases [6][15]