Celcuity (CELC) Goldman Sachs 47th Annual Global Healthcare Conference 2026 summary

Strategic focus and lead candidate

• Focused on diseases involving the PI3K/AKT/mTOR (PAM) pathway, with a lead multi-target inhibitor, gedatolisib, showing superior efficacy and tolerability compared to existing drugs in this class.

• Gedatolisib demonstrated unprecedented results in HR+/HER2- advanced breast cancer, especially in the wild-type population.

• Commercial organization and sales force have been fully built out in anticipation of approval, with comprehensive launch preparations including market access, reimbursement, and supply chain partnerships.

• Over 90% of payor and provider pathway entities have been engaged, and key account relationships are established.

• Medical Science Liaison and regional marketing teams are active, with extensive KOL engagement and foundational sales training completed.

Regulatory and commercial milestones

• FDA granted priority review with a PDUFA date in July for the wild-type breast cancer population, with a decision expected July 17, 2026.

• Supplemental NDA for the mutant population planned for submission in Q3.

• Recent fundraising of $575 million extends financial runway through at least 2029, supporting commercial launch and two additional phase III studies.

• Patent exclusivity for gedatolisib is expected through 2042, with potential for further extension via new formulations and pending applications.

• Upcoming milestones include data updates from ongoing studies in Q4 2026 and regulatory submissions in the US and Europe.

Clinical trial results and analysis

• VIKTORIA-1 phase III study showed median PFS of ~17 months in regions with high CDK4/6 inhibitor use; less favorable results in regions with less experience, but these represent a small commercial segment.

• In HR+/HER2-, PIK3CA-mutant advanced breast cancer, gedatolisib-based regimens (triplet and doublet) achieved median PFS of 11.1 and 11.3 months, respectively, versus 5.6 months for the control arm.

• Both gedatolisib regimens doubled the likelihood of survival without disease progression and achieved the highest reported objective response rates for any phase 3 regimen in this setting.

• Safety profiles for gedatolisib regimens were favorable, with most adverse events being grade 1 or 2; rates of hyperglycemia and diarrhea were notably lower than with alpelisib.

• Subgroup analyses confirmed consistent PFS benefit across age, menopause status, geographic region, visceral metastasis, and prior therapies.