Celcuity (CELC) TD Cowen 46th Annual Health Care Conference summary

Clinical development and trial updates

• Three ongoing trials target the PAM pathway, including a Phase 3 trial for Gedatolisib in combination therapies for breast and prostate cancer, with new data expected in the coming months.

• Mutant cohort data is anticipated by late Q1 or early Q2, with confidence in meeting this timeline.

• Phase 1B and III data show promising median PFS, especially in mutant populations, supporting high probability of success.

• Frontline and second-line studies address both endocrine-sensitive and resistant metastatic breast cancer, with early data showing strong efficacy.

Regulatory and launch preparation

• NDA accepted with a PDUFA date in July; Real-Time Oncology Review (RTOR) and Breakthrough designation facilitate rolling data submissions and priority review.

• Approval decision is expected at the PDUFA date, with potential for faster review on supplemental NDAs if mutant data is positive.

• Launch preparations began two years ago, with commercial team hiring nearly complete and sales force onboarding planned for Q2.

• Company-wide launch plan includes IT, safety, HR, and finance infrastructure upgrades.

Market segmentation and commercial strategy

• Market divided into PIK3CA wild type (60%), mutant, and other biomarker segments, with initial focus on wild type patients.

• 80% of the market is seen as highly favorable for Gedatolisib, with strong differentiation in patients lacking alternative targeted therapies.

• Sales strategy prioritizes targeted outreach based on physician profiles and tailored messaging to position Gedatolisib against existing alternatives.

• Peak revenue potential estimated at $10 billion+ in breast cancer alone, with 37,000 eligible second-line patients and expansion expected into first-line settings.