Atossa Therapeutics, Inc. Q4 FY2024 earnings call

Key Challenges in Endocrine Therapy for Breast Cancer

• Patient adherence issues: 30%-50% of patients stop adjuvant endocrine therapy early due to side effects, fatigue, etc.
• Efficacy gaps: Not all patients get long-term benefits; resistance to endocrine therapy is a major hurdle.
• Need for better tolerability: Broader community calls for treatments with fewer side effects and higher adherence.

Introduction to (Z)-endoxifen

• Innovative next-generation anti-estrogen therapy addressing unmet needs: potent anti-estrogenic activity, enhanced potency vs older agents, resistance mitigation, tumor cell apoptosis induction.
• Versatility: Potential role across breast cancer care spectrum, including early prevention and advanced metastatic disease.

Advancement in Metastatic Breast Cancer

• Prioritizing metastatic breast cancer indication for expedited access and potential streamlined regulatory path.
• Supported by Phase I study showing robust plasma concentrations, clinical activity in endocrine-refractory patients, and Phase II study suggesting prolonged progression-free survival vs tamoxifen in certain subgroups.

EVANGELINE Trial and Other Developments

• Presented abstracts at San Antonio Breast Cancer Symposium with pharmacokinetic, tolerability data, and mammographic breast density reduction with low doses of (Z)-endoxifen.

Financial Highlights 2024

• Total operating expenses decreased to $27.6M from $31.4M; R&D expenses down to $14.1M, G&A expenses to $13.5M.
• Net loss $25.5M vs $30.1M in 2023; cash and cash equivalents $71.1M providing healthy runway.

Forward-Looking Plans

• Focus on advancing (Z)-endoxifen and other research initiatives with current cash position.
• Over next 4-6 months, consult key opinion leaders and engage with FDA regarding metastatic setting study design.
• 2025 to be U.S. FDA-focused year for finalizing trial parameters in metastatic breast cancer, with plans to consider global markets early next year.

• Risks associated with forward-looking statements, including potential differences between actual results and implied outcomes.
• Uncertainties in clinical trial progress, regulatory approvals, and market adoption of (Z)-endoxifen.

Q: Can you provide timing around when you'd be able to initiate a study in the metastatic setting and whether it's Phase II or III?

A: We are consulting with key opinion leaders now, then will transition to discussions with the FDA over the next 4-6 months. It's premature to detail exact study phase now but plan to finalize parameters in that timeframe.

Q: Update on EVANGELINE trial enrollment and primary endpoint discrepancy?

A: We'll provide updates on enrollment and interim data at upcoming meetings. The primary endpoint difference is due to early look requirements for Ki-67 values in the trial.

Q: Do you anticipate pursuing metastatic breast cancer globally?

A: We are focusing on the U.S. FDA process in 2025. Once the U.S. FDA parameters are finalized, we'll consider other major markets early next year.