Atossa Therapeutics (ATOS) Maxim Group’s 2024 Healthcare Virtual Summit summary

Company overview and strategic focus

• Transitioned from diagnostics to therapeutics in 2020, now focused solely on breast cancer and (Z)-endoxifen.

• (Z)-endoxifen is a potent SERM, more active than tamoxifen, with a proprietary oral formulation that bypasses liver metabolism.

• Demonstrates triple action: pure estrogen receptor antagonism, ER degradation, and PKC beta inhibition, supporting use across prevention and neoadjuvant settings.

• Six phase II trials are ongoing, with data readouts expected by year-end and into 2025.

• Well-capitalized with $79 million in cash, providing a 2.5-year runway at current burn rate.

Clinical development and trial updates

• KARISMA trial (breast density): 240 patients, last dosed in May, data expected before year-end.

• EVANGELINE trial (premenopausal women): Focused on 80 mg arm, PK run-in data due by year-end, full trial data expected in 2025.

• I-SPY platform: Monotherapy and combination arms (with abemaciclib) in neoadjuvant setting, 10 mg monotherapy data expected by year-end.

• Window of opportunity study showed 100% Ki-67 reduction and up to 37% tumor size reduction at 24 weeks.

• (Z)-endoxifen achieves therapeutic levels rapidly, unlike tamoxifen, and shows promising safety and tolerability.

Market context and regulatory environment

• Breast density is a significant risk factor; new FDA guidelines require reporting of breast density in lay terms for all mammograms.

• 50% of women have dense breasts, complicating cancer detection and increasing risk.

• Market has not fully recognized the company’s progress, possibly due to lack of high-profile data and confusion over formulation changes.

• Potential for future partnerships, especially as CDK 4/6 inhibitors approach patent expiry.

• Insider ownership has remained stable over the past 24 months.