Atossa Therapeutics(ATOS) - 2025 Q3 - Quarterly Results

Financial Performance - Atossa Therapeutics reported total operating expenses of $9.3 million for Q3 2025, an increase of $2.9 million compared to Q3 2024[6]. - Operating expenses for the three months ended September 30, 2025, were $9,251,000, compared to $6,385,000 for the same period in 2024, representing a 45.5% increase[24]. - The net loss for the three months ended September 30, 2025, was $8,692,000, compared to a net loss of $7,230,000 for the same period in 2024[24]. - The company reported a net loss per share of $0.07 for the three months ended September 30, 2025, compared to $0.06 for the same period in 2024[24]. - Total current assets decreased from $74,457,000 as of December 31, 2024, to $55,678,000 as of September 30, 2025[22]. - Total liabilities increased from $4,967,000 as of December 31, 2024, to $8,225,000 as of September 30, 2025[22]. Research and Development - Research and Development (R&D) expenses for Q3 2025 were $4.3 million, a 73% increase from $2.5 million in Q3 2024, driven by higher spending on (Z)-endoxifen trials[8]. - Clinical and non-clinical trial expenses increased by $1.8 million for Q3 2025 compared to Q3 2024, primarily due to (Z)-endoxifen development costs[12]. - Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen, which enhances bioavailability and therapeutic integrity by bypassing stomach acid[15]. - Clinical studies involving over 700 subjects have shown that (Z)-endoxifen is well tolerated, with no maximum tolerated dose identified at doses up to 360 mg/day[15]. - The (Z)-endoxifen program is currently being evaluated in three Phase 2 studies, including one for DCIS and two for ER+/HER2- breast cancer[16]. Regulatory and Strategic Initiatives - Atossa plans to submit an Investigational New Drug (IND) application for (Z)-endoxifen in Q4 2025, aligning with FDA feedback under the Project Optimus initiative[7]. - The company has streamlined its Phase 2 EVANGELINE study to prioritize NDA-enabling activities for (Z)-endoxifen, aiming for accelerated readouts and reduced costs[3]. - The company received preliminary comments from the FDA regarding the regulatory path for (Z)-endoxifen and expects to discuss a development plan in a Type C meeting on November 17, 2025[3]. - Atossa is pursuing an accelerated regulatory path for (Z)-endoxifen, with updates on milestones expected by the end of 2025[16]. Management and Intellectual Property - Atossa appointed Janet R. Rea as Senior Vice President of R&D and Mark Daniel as Chief Financial Officer to enhance its commercialization strategy[4]. - Atossa's Israeli patent for (Z)-endoxifen was granted on July 2, 2025, reinforcing its intellectual property strategy[7]. - Atossa's intellectual property portfolio includes three recently issued U.S. patents and numerous pending applications worldwide[16].