Celcuity (CELC) Corporate presentation summary

Market opportunity and positioning

• REVTORPYK (gedatolisib) is FDA-approved for HR+/HER2- advanced breast cancer without PIK3CA mutation after progression on endocrine therapy, representing a $10B+ U.S. market potential across 1L and 2L settings.

• Addresses significant unmet need in both PIK3CA wild-type and mutant populations, with a single agnostic treatment simplifying therapy.

• Over 500,000 addressable patients in the US, EU5, and Japan, with additional blockbuster potential in prostate and other solid tumors.

Clinical efficacy and safety

• Phase 3 trials show gedatolisib regimens deliver the highest mPFS ever reported in 2L HR+/HER2- ABC, with 4.5x improvement in wild-type and 2x in mutant cohorts versus comparators.

• Objective response rates up to 49% and median duration of response up to 24.2 months, with favorable overall survival trends.

• Well-tolerated safety profile with low discontinuation rates and lower rates of hyperglycemia and diarrhea compared to alpelisib.

Differentiated mechanism and development

• Gedatolisib is a first-in-class, best-in-class PAM inhibitor, potently inhibiting all Class I PI3K isoforms and mTORC1/2, with >300x higher potency than other PAM inhibitors.

• Demonstrates similar efficacy in both PIK3CA mutant and wild-type tumors, overcoming limitations of earlier generation inhibitors.

• Ongoing Phase 3 studies in 1L advanced breast cancer and Phase 1b/2 in prostate cancer, with promising early results in other solid tumors.