Atossa Therapeutics, Inc.

For full-year 2024, Atossa reported total operating expenses of $27.6 million, down from $31.4 million in 2023. R&D expenses were $14.1 million versus $17.3 million in 2023, and G&A expenses were $13.5 million versus $14.0 million in 2023. Interest income was $4.1 million, and the company wrote off its remaining $1.7 million investment in Dynamic Cell Therapies in Q4 2024. Net loss improved to $25.5 million, or $0.20 per share, versus $30.1 million, or $0.24 per share, in 2023. The company ended the year with $71.1 million in cash and cash equivalents. No formal revenue guidance was given; management said 2025 will be focused on defining the metastatic trial design with KOLs and the FDA, with U.S. FDA discussions and execution expected over the next 4 to 6 months.

Dr. Quay framed (Z)-endoxifen as a next-generation anti-estrogen that could address adherence, resistance, tolerability, and efficacy gaps in endocrine therapy. He emphasized metastatic breast cancer as the first indication because it has high unmet need and may offer a faster regulatory path, while leaving open later expansion into prevention and neoadjuvant settings. His tone was optimistic and confident, but he repeatedly noted that key trial details are still being worked out with KOLs and the FDA.

Heather Rees said 2024 was marked by disciplined spending, with operating expenses down $3.8 million year over year to $27.6 million. R&D fell $3.2 million to $14.1 million, mainly because clinical and preclinical spending on (Z)-endoxifen was down $2.6 million, while G&A declined modestly to $13.5 million despite higher legal, investor relations, and accounting costs. She highlighted $4.1 million of interest income, the $1.7 million write-off of the Dynamic Cell Therapies investment, and year-end cash of $71.1 million, which she said provides a healthy runway to hit clinical milestones.

Analysts focused on timing and structure of the metastatic program, asking when the study might start and whether it would be Phase II or Phase III. Management said it is still early, that it is consulting KOLs first and then the FDA, and that details should become clearer over the next 4 to 6 months. Another question asked about EVANGELINE enrollment and why the monotherapy arm uses a 24-week endpoint while the combo arm uses a 4-week Ki-67 readout; management said enrollment and interim updates will come at upcoming meetings, and the endpoint difference reflects the need for an early Ki-67 look in the combination arm. A final question asked whether the metastatic effort would be pursued globally, and management said 2025 will be U.S. FDA-focused first, with Europe and Australia considered later, likely early next year.