Atossa Therapeutics Reports $15.1 Million Net Loss and Increased R&D Expenses for First Half of 2025

Atossa Therapeutics, Inc. reported a net loss of $15.1 million for the six months ended June 30, 2025, compared to a net loss of $11.9 million for the same period in 2024. The company's total operating expenses increased to $16.5 million from $14.1 million year-over-year, driven primarily by higher research and development costs associated with its lead drug candidate, (Z)-endoxifen. Research and development expenses rose to $9.7 million for the six months ended June 30, 2025, up from $7.3 million in the prior year, reflecting increased spending on clinical trials and drug development.

As of June 30, 2025, Atossa had $57.9 million in cash and cash equivalents, a decrease from $71.1 million at the end of 2024. The company’s total assets also fell to $64.5 million from $76.4 million at the end of the previous fiscal year. Current liabilities increased to $6.8 million, up from $5.0 million, primarily due to higher accounts payable and accrued expenses. The accumulated deficit grew to $226.9 million from $211.8 million, indicating ongoing financial challenges as the company continues to invest heavily in its development programs without generating revenue.

Strategically, Atossa is focused on advancing its (Z)-endoxifen program, which is being developed for the treatment of breast cancer and other breast conditions. The company has received positive feedback from the FDA regarding its clinical development plan and is preparing for a potential Investigational New Drug (IND) submission targeted for the fourth quarter of 2025. The company is also exploring additional studies to assess the correlation between (Z)-endoxifen and breast cancer risk reduction, which could enhance its marketability.

Operationally, Atossa has seen an increase in its employee headcount, contributing to higher compensation expenses. The company is currently engaged in multiple clinical trials for (Z)-endoxifen, including studies for metastatic breast cancer and ductal carcinoma in situ (DCIS). The company’s strategic focus on these areas reflects its commitment to addressing significant unmet medical needs in oncology. However, Atossa acknowledges the necessity of raising additional capital to support its ongoing operations and development efforts, as it has not yet established a sustainable revenue stream.

Looking ahead, Atossa anticipates continued operating losses as it progresses through its clinical development phases. The company plans to fund its operations through a combination of public or private equity offerings, debt financing, and potential collaborations. Management believes that its current cash reserves will be sufficient to support operations for at least the next 12 months, but recognizes the need for additional funding to sustain its business strategy and meet its financial obligations.