Atossa Therapeutics (ATOS) Corporate presentation summary

Market opportunity and strategic focus

• Multi-billion dollar opportunity in the estrogen receptor positive breast cancer market, with additional rare disease indications targeted.

• Lead candidate (Z)-endoxifen is a potent SERM/SERD in Phase 2 trials, showing broad utility across breast cancer and rare diseases.

• Robust intellectual property portfolio with global protections and a strong financial position with over a year of runway and no debt.

• Experienced leadership and world-renowned scientific advisors support development and strategy.

(Z)-Endoxifen clinical and mechanistic highlights

• (Z)-endoxifen is 30x to 100x more potent than tamoxifen, does not require liver metabolism, and is effective against ESR1 mutants.

• Demonstrates superior anti-tumor activity, induces apoptosis, and degrades estrogen receptors.

• Improved safety and tolerability profile may enhance patient adherence.

• Promising early efficacy in neoadjuvant clinical studies, with high response rates and tumor shrinkage.

Clinical development and pipeline

• Multiple ongoing and planned Phase 2 trials in breast cancer, DCIS, and breast density reduction, with anticipated key milestones in 2026.

• Collaborative trials with leading institutions, including I-SPY2 and RECAST, focus on high-risk and hormone receptor-positive breast cancer.

• Combination therapy studies with CDK4/6 inhibitors and ovarian function suppression agents are underway.

• Non-oncology indications include Duchenne Muscular Dystrophy, McCune-Albright Syndrome, and gynecological cancers, with pre-IND meetings targeted for 2026.