Atossa Therapeutics(ATOS) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total operating expenses for 2024 were $27.6 million, down from $31.4 million in 2023, a decrease of $3.8 million [29] - R&D expenses declined by $3.2 million from $17.3 million in 2023 to $14.1 million in 2024, primarily due to reduced spending on (Z)-endoxifen trials [30] - Net loss for 2024 was $25.5 million or $0.20 per share, compared to $30.1 million or $0.24 per share in 2023 [34] - The company closed the year with $71.1 million in cash and cash equivalents, providing a healthy runway for advancing (Z)-endoxifen and other research initiatives [34] Business Line Data and Key Metrics Changes - The focus remains on the lead program (Z)-endoxifen, which is positioned as a next-generation anti-estrogen therapy for breast cancer [12][17] - The company aims to address significant unmet needs in endocrine therapy for breast cancer, including patient adherence and drug resistance [10][11] Market Data and Key Metrics Changes - The company is prioritizing the metastatic breast cancer indication for (Z)-endoxifen, which is a clinical setting of high unmet need [19] - Clinical investigations have shown a clinical benefit rate of approximately 26% in patients with endocrine refractory ER-positive HER2-negative metastatic breast cancer [21] Company Strategy and Development Direction - The company plans to advance (Z)-endoxifen in metastatic breast cancer first, potentially leading to a more streamlined path to regulatory approval [19][26] - There is a commitment to continue dialogue with the FDA regarding the potential for (Z)-endoxifen in earlier disease settings [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of (Z)-endoxifen to transform breast cancer treatment, especially in metastatic disease where new options are urgently needed [36] - The company remains focused on executing research and regulatory strategies to meet clinical milestones [27] Other Important Information - The company reported a write-off of $1.7 million related to its investment in dynamic cell therapies, which ceased operations in Q4 2024 [33] - Professional fees increased by $1.8 million year-over-year, primarily due to higher legal and investor relation costs [32] Q&A Session Summary Question: Timing for initiating a study in the metastatic setting - Management is consulting with key opinion leaders and plans to discuss details with the FDA over the next four to six months [39][40] Question: Update on EVANGELINE trial enrollment and data - Updates on enrollment and interim data results will be provided at upcoming meetings; the primary endpoint difference is due to requirements for early Ki-67 value assessments [43] Question: Pursuing global markets for metastatic breast cancer - The focus is currently on the U.S. FDA process, with plans to consider other major markets in early 2026 [48]