Celcuity (CELC) Wells Fargo 21st Annual Healthcare Conference summary

Recent achievements and product approvals

• Lead drug REVTORPYK, a pan-PI3K/mTORC1/2 inhibitor, received approval for second-line treatment in metastatic breast cancer patients without PIK3CA mutation.

• Two regimens approved: REVTORPYK with palbociclib and fulvestrant, or with fulvestrant alone.

• Commercial launch is planned by the end of the current quarter, pending FDA feedback on a second manufacturer to ensure adequate supply.

• Expanded access protocol (EAP) is active in the U.S., with positive response and transition plans for patients as commercial drug becomes available.

• Supplemental NDA for PIK3CA mutant patients submitted, with potential approval expected in Q2 next year.

Clinical development and pipeline updates

• Two phase III studies are enrolling for first-line advanced breast cancer: one for endocrine-sensitive and one for endocrine-resistant populations.

• Data from the endocrine-resistant group expected late 2028/early 2029, and from the sensitive group late 2029/2030.

• Phase I/II study in prostate cancer ongoing, with favorable initial data and an update planned for later this year.

• Subcutaneous formulation development underway, targeting approval to coincide with first-line regimen in 2030.

Market opportunity and commercial strategy

• Approximately 90,000 patients annually could be eligible for REVTORPYK in the U.S.

• Pricing set at $30,000 per cycle or $32,500 per month, with an average treatment duration of 10 months and gross-to-net estimated at 80%.

• 90 oncology sales representatives and a strategic accounts team are in place to drive adoption and pathway inclusion.

• Buy-and-bill model with temporary J-code may cause initial reimbursement friction, mitigated by extended payment terms.

• Revenue will be the primary launch metric, with additional activity metrics provided to investors.