Celcuity (NASDAQ:CELC) CEO Brian Sullivan outlined the company’s expected regulatory timeline and commercial preparations for gedatolisib during an appearance at the Guggenheim Healthcare Conference, while also previewing upcoming clinical catalysts and how the company views the therapy’s positioning in breast cancer.
Regulatory timeline and upcoming data
Sullivan said the FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 17 for the company’s NDA, and that Celcuity would expect to launch gedatolisib “soon after” approval if the decision is positive.
Asked whether FDA’s Real-Time Oncology Review (RTOR) could lead to an earlier decision than the July date, Sullivan said Celcuity’s review of comparable RTOR cases suggested that first-time NDAs with priority review are generally approved around the PDUFA date. He said earlier-than-PDUFA outcomes appeared more common in supplemental NDAs, where the agency has already reviewed the product and the data package is narrower.
Commercial build-out and launch readiness
Sullivan described a commercial build that began with the hiring of a chief commercial officer in the first quarter of 2024, initially planning toward a mid-2026 launch timeline. He said Celcuity built out senior commercial leadership in 2024, then expanded hiring through 2025 across:
- Marketing
- Customer commercial operations
- Market access
- Medical affairs
He said the main remaining hiring need is for field sales representatives, noting that sales leadership and sales management are already in place. Sullivan also emphasized that transitioning to a commercial-stage company required broader systems and staffing upgrades, including in IT, safety, HR, and other administrative functions.
How Celcuity explains gedatolisib’s approach to PAM pathway inhibition
In discussing feedback from medical meetings and physician outreach, Sullivan contrasted gedatolisib with earlier and current approaches to inhibiting the PI3K/AKT/mTOR (“PAM”) pathway. He said drug development initially focused on pan-PI3K/mTOR inhibitors to comprehensively block a pathway with redundancy mechanisms, but those programs were often limited by toxicity. He said the field then shifted toward agents that hit single pathway components, which he argued does not sufficiently address pathway activity in patients without PIK3CA mutations.
To explain the rationale for broader inhibition, Sullivan pointed to the pathway’s role in tumor metabolism and glucose uptake, referencing the Warburg effect and describing the PAM pathway as regulating a key energy source for tumor cells.
Physician reaction, infusion logistics, and stomatitis management
Sullivan said clinicians have described the efficacy results as “unprecedented,” citing Celcuity’s reported hazard ratio of 0.24 (a 76% reduction in the risk of progression or death) and an approximately five-fold improvement in progression-free survival (PFS) versus endocrine therapy. He said feedback has been favorable, while noting some physicians prefer to gain experience using the drug in their own practice.
On adoption of a triplet regimen that requires multiple IV visits per month, Sullivan said oncology practices are already structured around infused drugs, including several multi-billion-dollar therapies in breast cancer. He added that infusion-based treatment can also address adherence concerns because providers can confirm patients are receiving therapy.
Addressing stomatitis, Sullivan said it occurs in a high proportion of patients but typically appears early—within the first couple of weeks and first two infusions—and then declines substantially. He said stomatitis often resolves within about two weeks to a lower grade, with few patients experiencing grade 3 stomatitis by the end of the second cycle. Sullivan also highlighted quality-of-life findings, saying the company observed no degradation in patients’ reported “sense of well-being” from baseline through the eighth cycle.
He attributed tolerability in part to gedatolisib’s potency and pharmacokinetic profile, describing an approach where dosing three times per month could maintain therapeutic exposure while limiting peak concentrations that can drive adverse events. Sullivan said physicians have anecdotally commented that some patients “didn’t feel like they were on a cancer drug.”
Mutant cohort readout, benchmarks, and market sizing
Turning to the upcoming mutant cohort readout, Sullivan said enrollment timing was consistent with targets, but event rates slowed in the third quarter, pushing out the projected date for reaching the event threshold needed for top-line results. He noted the study uses alpelisib plus fulvestrant as a control arm and referenced the EPIK-B5 Phase 3 results presented at the San Antonio Breast Cancer Symposium showing a median PFS of about 7.3–7.4 months for that regimen, which he said aligned with assumptions used in Celcuity’s study design and with prior BYLieve results.
On what would constitute success, Sullivan said statistical significance would require outperforming alpelisib and suggested that roughly a three-month median PFS improvement (around 10 months median PFS for the study arm) could meet that bar. He added that even that level could be clinically meaningful in his view because he said the current “go-to” standard of care has shifted to capivasertib (Truqap), which he said reported about 5.5 months median PFS in a similar population.
Sullivan also discussed the commercial opportunity. Using Truqap as a benchmark, he said that normalizing for a broader patient population implied a larger overall market. He said Celcuity estimates a second-line opportunity that could exceed $6 billion, based on assumptions including approximately 37,000 eligible women, an average treatment duration of about 10 months, and pricing comparable to current therapies. He said that even a 30% penetration could translate to more than $2 billion in the second-line indication, and argued that success in first-line settings could expand the opportunity further.
Finally, Sullivan addressed liquidity, saying Celcuity had $450 million in cash at the end of the third quarter and expanded its term loan facility to access up to $500 million, with $125 million drawn to date. He said the facility provides flexibility and that the company could have options to further augment its balance sheet.
About Celcuity (NASDAQ:CELC)
Celcuity, Inc is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.
Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways.
