Atossa Therapeutics, Inc. reported a net loss of $34.8 million for the fiscal year ending December 31, 2025, an increase from a loss of $25.5 million in the previous year. The company's total operating expenses rose to $37.1 million, up from $27.6 million in 2024, primarily driven by increased research and development (R&D) costs associated with its lead drug candidate, (Z)-endoxifen. R&D expenses reached approximately $21.2 million, reflecting a 50% increase from $14.1 million in 2024, largely due to heightened spending on clinical trials. The company has not yet established a source of ongoing revenue, and as of December 31, 2025, it held $41.3 million in cash and cash equivalents.
In terms of strategic developments, Atossa is advancing (Z)-endoxifen, a selective estrogen receptor modulator currently in Phase 2 clinical trials for breast cancer and other conditions. The company has received both Rare Pediatric Disease and Orphan Drug designations from the FDA for (Z)-endoxifen in the treatment of Duchenne Muscular Dystrophy (DMD). These designations may provide strategic benefits, including potential market exclusivity and a Priority Review Voucher for future applications. The company is also exploring the drug's applications in other rare diseases, such as McCune-Albright Syndrome.
Operationally, Atossa has been focusing on expanding its clinical trials. The ongoing Karisma study, which evaluates (Z)-endoxifen's effectiveness in reducing mammographic breast density, fully enrolled 240 participants in November 2023, with top-line data expected in the first half of 2026. Additionally, the EVANGELINE study is assessing (Z)-endoxifen as a neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer, with enrollment ongoing and results anticipated in 2026. The company has also initiated the RECAST study, which aims to evaluate the potential for active surveillance in patients with ductal carcinoma in situ.
Looking ahead, Atossa's ability to continue operations is contingent on securing additional capital, as it has not yet generated revenue from its pharmaceutical programs. The company plans to raise funds through equity sales and other financing methods, but it faces uncertainty regarding market conditions and investor interest. The management has expressed that substantial doubt exists about the company's ability to continue as a going concern if it cannot secure adequate funding. The company is also navigating a complex regulatory environment, with potential impacts from macroeconomic factors such as inflation and geopolitical instability affecting its operations and funding strategies.
About ATOSSA THERAPEUTICS, INC.
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary medicines for breast cancer and related conditions. Its lead product candidate, oral (Z)-endoxifen, a selective estrogen receptor modulator, targets prevention and treatment of estrogen receptor-positive breast cancer. The company advances drug candidates through clinical trials, leveraging third-party manufacturing and research partnerships, and aims to address unmet medical needs in oncology with patented therapies for a global patient base.
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