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Atossa Therapeutics Announces Second Quarter 2025 Financial Results and Provides a Corporate Update
FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies Required\nStrong I-SPY2 Results Reinforce Efficacy of Atossa's Monotherapy at 3-weeks\nSEATTLE, Aug. 12, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the second quarter ended June 30, 2025 and provided an update on recent company developments.\n\n \n \n \n \n \n \n\n \n\"Atossa continues to make meaningful and measurable progress across our pipeline, underscored by recent, highly constructive interactions with the FDA that further support our (Z)-endoxifen development strategy in metastatic breast cancer,\" stated Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics. \"With a strong balance sheet, we believe we are well-positioned to execute on our planned upcoming IND submission and advance our metastatic clinical program toward key value-creating milestones. We remain disciplined in our capital strategy and have deliberately chosen not to utilize our ATM facility at recent share price levels, which we believe significantly undervalue the true potential of our Company. As we progress toward multiple upcoming potential catalysts, we are confident that our focused execution, scientific rigor, and unwavering commitment to patients will demonstrate the substantial intrinsic value of Atossa and position (Z)-endoxifen to make a meaningful impact in the treatment of breast cancer.\"\nClinical & Regulatory Developments\nPositive FDA Feedback on (Z)-Endoxifen Program - In July 2025, Atossa announced it received highly constructive written feedback from the U.S. Food and Drug Administration (FDA), supporting the Company's proposed dose optimization trial in estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer and allowing the Company to meet the requirements of Project Optimus. The FDA agreed that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study and agreed with the scientific rationale for combination therapy arms (Part B) using standard-of-care agents, such as CDK4/6 inhibitors, PI3K...