Atossa Therapeutics Reports $23.8 Million Net Loss and Increased R&D Expenses for Nine Months Ended September 30, 2025

Atossa Therapeutics, Inc. reported a net loss of $23.8 million for the nine months ended September 30, 2025, compared to a net loss of $19.2 million for the same period in 2024. The company's total operating expenses increased to $25.7 million from $20.5 million year-over-year, driven primarily by higher research and development (R&D) costs, which rose to $15.0 million from $10.7 million. General and administrative expenses also saw an increase, totaling $10.7 million compared to $9.8 million in the prior year. The company did not generate any revenue during this period, maintaining its focus on developing its lead product candidate, (Z)-endoxifen, for breast cancer treatment.

The financial position of Atossa has changed significantly since the end of 2024, with total assets decreasing to $58.0 million from $76.4 million. Cash and cash equivalents fell to $51.8 million from $71.1 million, reflecting the company's ongoing investment in R&D and operational activities. Current liabilities increased to $8.2 million from $5.0 million, primarily due to higher accounts payable and accrued expenses. The company's accumulated deficit also widened to $235.6 million from $211.8 million.

Strategically, Atossa has made notable advancements in its clinical development programs. The company is pursuing an accelerated regulatory strategy for (Z)-endoxifen, having requested a Type C meeting with the FDA to discuss its development plan. This initiative aims to potentially shorten the timeline for filing a New Drug Application (NDA) for (Z)-endoxifen, which is being developed for both breast cancer treatment and risk reduction. The company has also initiated a Phase 2 study for (Z)-endoxifen in patients with ductal carcinoma in situ (DCIS) and is exploring its use in neoadjuvant treatment settings for estrogen receptor-positive breast cancer.

Operationally, Atossa's employee headcount has increased, contributing to higher compensation expenses. The company is actively engaged in clinical trials, with significant investments in drug development costs. As of September 30, 2025, Atossa's cash reserves are expected to support its operations for at least the next year, although management acknowledges the need for additional capital to fund ongoing and future projects. The company plans to explore various funding avenues, including public or private equity offerings and potential collaborations, to ensure it can continue its development efforts without interruption.