Celcuity (CELC) used its presentation at the Wells Fargo 21st Annual Healthcare Conference on September 8 to detail the commercial launch of REVTORPYK (gedatolisib) and update investors on its clinical pipeline.
Chief Executive Officer Brian Sullivan stated that the drug’s commercial launch is targeted for the end of the third quarter of 2024, pending approval of a second manufacturing facility. The company also reported that a supplemental new‑drug application for the PIK3CA‑mutant population was submitted in August, with a regulatory decision expected in the second quarter of 2025.
Sullivan highlighted data from the VIKTORIA‑1 study, in which a triplet regimen of gedatolisib, palbociclib, and fulvestrant produced a median progression‑free survival of 9.4 months versus 2 months for fulvestrant alone—a hazard ratio of 0.24. A doublet regimen (gedatolisib plus fulvestrant) yielded a hazard ratio of 0.33. The estimated physician usage split favors the triplet at approximately 85‑15 in the wild‑type setting.
The drug carries a wholesale acquisition cost of $30,000 per 20‑day cycle (13 cycles annually) or $10,000 per vial. Gross‑to‑net margins are estimated at about 80%, reflecting a 20% discount. Average treatment duration is roughly 10 months for wild‑type patients and 11‑12 months for PIK3CA‑mutant patients. The addressable second‑line population is approximately 90,000 eligible patients annually, with wild‑type and mutant cohorts representing 60% and 40% of that population, respectively.
Celcuity reported a negative EBITDA of $208 million over the last twelve months but maintained a current ratio of 8.93, indicating liquid assets exceed short‑term obligations. The commercial team will consist of 90 oncology sales representatives across ten regions, supported by medical science liaisons and a strategic accounts group. The company noted that UPMC’s ClinPath document influences treatment guidance for systems covering roughly 15% of patients.
Reimbursement timelines are expected to take about 60 days under normal processes, but could stretch to 120 days while a temporary J‑code is in place; Celcuity plans to offer extended payment terms to ease cash‑flow friction for accounts.
On the pipeline front, updated data from a Phase I/II prostate‑cancer study is expected in the fourth quarter of 2024. Phase III trials in first‑line advanced breast cancer are underway, with endocrine‑resistant population data anticipated in late 2028 or early 2029, and endocrine‑sensitive population data expected in late 2029 or 2030. A subcutaneous formulation is targeted for approval around the same time as the endocrine‑sensitive indication, near 2030.
Non‑clinical work indicated that gedatolisib is approximately 300 times more potent than single‑target inhibitors in breast cancer cell lines, requiring 12 nanomolar versus 6,000 nanomolar for a half‑maximal effect. The discontinuation rate for gedatolisib in the mutation study was 4‑5%, and a survey found only 5‑8% of physicians viewed intravenous delivery as a negative factor.
