Atossa Therapeutics Q2: FDA clears path for (Z)-Endoxifen in metastatic breast cancer.

• Atossa Therapeutics announces Q2 2025 financial results • FDA clears path for IND filing for (Z)-Endoxifen in Metastatic Breast Cancer • FDA indicates no additional toxicity studies required • Strong I-SPY2 results reinforce efficacy of Atossa's monotherapy at 3-weeks • Atossa continues to make progress in pipeline development

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company focused on developing innovative medicines for breast cancer, has released its financial results for the second quarter ended June 30, 2025. The company reported an operating loss of $9.0 million for the quarter, an increase from the $7.1 million loss in the same period of 2024. The net loss for the quarter was $8.4 million, compared to $6.0 million in the prior year. Total operating expenses rose to $9.0 million for the quarter, up from $7.1 million in Q2 2024, with research and development (R&D) expenses significantly increasing due to higher spending on clinical and non-clinical trials, compensation, and professional fees [1].

In addition to its financial results, Atossa provided updates on recent corporate developments and strategic initiatives. The company made significant progress in its clinical programs, particularly with its lead product candidate, (Z)-endoxifen. The FDA provided positive feedback, clearing the path for an Investigational New Drug (IND) application for (Z)-endoxifen in metastatic breast cancer. The I-SPY2 trial results also reinforced the efficacy of Atossa’s monotherapy at three weeks, showing promising reductions in tumor volume and favorable safety profiles [2].

Atossa continues to advance its intellectual property portfolio, with the issuance of new U.S. patents covering enteric oral formulations of (Z)-endoxifen. The company is preparing for a dose-ranging study in metastatic breast cancer, targeting an IND submission in Q4 2025. Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, highlighted the company’s progress and strategic focus, emphasizing the positive interactions with the FDA and the strong balance sheet, which positions Atossa to advance its clinical programs and achieve key milestones [1].

Looking ahead, Atossa aims to submit its IND application for (Z)-endoxifen in Q4 2025 and continue advancing its Phase 2 trials. The company is also working with the FDA on regulatory strategies for additional breast cancer indications, including adjuvant settings and high-risk populations. Atossa’s robust clinical research programs and growing intellectual property portfolio are expected to support its long-term growth and value creation [1].

References:
[1] https://www.tradingview.com/news/tradingview:99a0675ce7206:0-atossa-therapeutics-q2-2025-financial-results-and-corporate-update/
[2] https://finance.yahoo.com/news/atossa-therapeutics-announces-second-quarter-123000374.html