0001193125-26-124396
SEC filingAtossa Therapeutics, Inc. (ATOS), a clinical-stage biopharmaceutical company, reported a net loss of $34.8 million for FY 2025 ended December 31, 2025, compared to $25.5 million in FY 2024, driven by increased research and development expenses of $21.2 million (up from $14.1 million) and general and administrative expenses of $16.0 million, totaling operating expenses of $37.1 million. No revenue was generated, consistent with its pre-commercial stage focused on (Z)-endoxifen development for breast cancer and rare diseases. Operating loss was $37.1 million, with interest income of $2.4 million partially offsetting losses, resulting in a loss before taxes of $34.8 million. Basic and diluted EPS was -$4 per share on 8.6 million weighted average shares. Balance sheet shows $41.3 million in cash and equivalents, $45.6 million total current assets, and $47.6 million total assets, with $39.4 million stockholders' equity. Net cash used in operations was $29.8 million, indicating a net decrease in cash of $29.8 million. Management states existing cash funds operations for the next 12 months but additional capital is needed long-term amid ongoing Phase 2 trials like Karisma-(Z)-endoxifen and I-SPY 2.
Atossa Therapeutics reported a FY 2025 net loss of $34.8 million, up from $25.5 million in FY 2024, primarily due to higher operating expenses totaling $37.1 million (R&D $21.2 million, G&A $16.0 million). Operating loss was $37.1 million, mitigated slightly by $2.4 million interest income. No revenue was recorded as the company remains in clinical development for (Z)-endoxifen. EPS was -$4 basic and diluted on 8.6 million weighted average shares. Cash burn intensified with $29.8 million used in operations. Total assets stood at $47.6 million, with $41.3 million cash supporting near-term runway.
No revenue generated in FY 2025, consistent with clinical-stage status. Company focuses on (Z)-endoxifen Phase 2 trials (Karisma, I-SPY 2, RECAST DCIS, EVANGELINE) without commercial products. No segment or geographic revenue breakdown disclosed.
Not applicable due to absence of revenue. Operating loss margin effectively -100% on zero revenue. Expenses rose YoY: R&D from $14.1 million to $21.2 million (+50%), G&A to $16.0 million, reflecting clinical trial investments. Stock-based compensation $2.6 million contributed to costs.
Net cash used in operating activities $29.8 million, driven by $34.8 million net loss adjusted for $2.6 million stock compensation and working capital changes (e.g., prepaid materials +$983K, accounts payable +$3.6M). Investing outflow -$23K (property purchases). No financing inflows. Ending cash $41.3 million (plus $110K restricted), total current assets $45.6M, liabilities $8.3M (mostly current). Equity $39.4M, accumulated deficit -$246.6M.
Cash sufficient for planned operations next 12 months; long-term needs additional capital via equity sales or borrowing. ATM offering up to $50M initiated Feb 2026. Priorities: Phase 2 data readouts (Karisma H1 2026, I-SPY/EVANGELINE H2 2026), FDA designations for DMD/MAS, patent portfolio (24 issued, 141 pending). Risks include capital needs, trial delays, IP challenges, going concern doubt.