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Atossa Therapeutics (ATOS) investor relations material
Atossa Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Focused on developing proprietary medicines for oncology, especially breast cancer, with lead candidate (Z)-endoxifen in multiple clinical trials for prevention and treatment, including metastatic indications and regulatory acceleration efforts.
Announced regulatory engagement with the FDA for accelerated development of low-dose (Z)-endoxifen for breast cancer risk reduction, with positive feedback for metastatic trial design and a Type C FDA meeting request.
Appointed new leadership in R&D and finance to support late-stage development and commercial strategy.
No products are currently marketed; revenue generation is not expected until pharmaceutical programs are launched.
Financial highlights
Net loss of $8.7 million for Q3 2025 and $23.8 million for the nine months ended September 30, 2025, compared to $7.2 million and $19.2 million for the same periods in 2024.
Operating expenses increased to $9.3 million for Q3 2025 and $25.7 million for the nine months, driven by higher R&D and legal costs.
Cash and cash equivalents were $51.8 million as of September 30, 2025, down from $71.1 million at year-end 2024, with working capital of $47.5 million.
Interest income decreased to $0.6 million for Q3 and $1.9 million for the nine months, reflecting lower average cash balances.
No revenue was generated in the reported periods.
Outlook and guidance
Sufficient cash on hand to fund operations for at least the next 12 months; ongoing need to raise additional capital for future operations.
Plans to file an IND for (Z)-endoxifen in metastatic breast cancer in Q4 2025, with topline data from the pivotal study expected in 2026.
Focused on NDA-enabling activities and regulatory strategies for additional breast cancer indications, including DCIS and risk reduction.
Ongoing Nasdaq listing compliance issue due to minimum bid price; additional monitoring period in effect.
Will update shareholders on FDA meeting outcomes and potential accelerated regulatory paths by year-end 2025.
Quantify potential timeline/cost reduction from FDA alignment
How does EVANGELINE's non-registrational status impact NDA?
What is the projected operating runway with current cash?
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Next Atossa Therapeutics earnings date
Q4 202527 Mar, 2026
Next Atossa Therapeutics earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing medicines that address significant unmet medical needs in oncology, with a specific focus on breast cancer. The company's lead program is Endoxifen, an active metabolite of tamoxifen, currently in clinical trials for the treatment and prevention of breast cancer. Additionally, Atossa is working on AT-H201 for lung injury caused by cancer treatment and is involved in developing immunotherapy/chimeric antigen receptor therapy programs. The company is headquartered in Seattle, Washington, and its shares are listed on the NASDAQ.
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