Celcuity (NASDAQ:CELC) CEO Brian Sullivan said the company’s recently presented breast cancer data support gedatolisib as a potential new standard of care in second-line advanced breast cancer, while outlining preparations for a possible commercial launch and longer-term development plans during a fireside chat with Jefferies biotech analyst Maury Raycroft.
Sullivan said Celcuity began about 12 years ago with a focus on cellular analysis technology before shifting toward drug development targeting the PI3K/AKT/mTOR, or PAM, pathway. The company later licensed gedatolisib from Pfizer after identifying the drug as a fit for its view of how the pathway should be addressed.
ASCO Data Highlight Second-Line Breast Cancer Results
Discussing data presented at ASCO, Sullivan described a three-arm trial evaluating gedatolisib in combination with palbociclib and fulvestrant against alpelisib plus fulvestrant, as well as gedatolisib plus fulvestrant without palbociclib. He said the trial provided the first head-to-head comparison of two drugs targeting the PI3K/AKT/mTOR pathway.
According to Sullivan, both the gedatolisib triplet and doublet showed median progression-free survival of more than 11 months and “a doubling of the likelihood of survival without disease progression or death.” He said the hazard ratios were approximately 0.5, exceeding internal expectations. The control arm, alpelisib, showed median progression-free survival of 5.6 months, while the triplet showed 11.1 months in the primary analysis, he said.
Raycroft asked why the triplet and doublet had similar progression-free survival in the PIK3CA-mutant cohort. Sullivan said Celcuity believes the PAM pathway is a primary driver in the mutant setting, making CDK4/6 inhibition less important for median PFS. However, he said the triplet showed a higher objective response rate, nearly 50% compared with 36% for the doublet, and a duration of response of nearly 16 months.
Sullivan also said differences between the phase 3 results and an earlier phase 1 study may reflect baseline differences, including prior CDK exposure, tumor burden and the inclusion of endocrine-resistant patients. He noted that about 80% of patients had liver or lung metastases, and 15% were endocrine resistant.
Regulatory Review and Launch Preparation
Celcuity is approaching a July 17 PDUFA date for gedatolisib in the wild-type second-line setting, Sullivan said. He described the application as under priority review and said the company remains “very optimistic,” citing breakthrough therapy designation and prior interactions with the FDA during the submission process.
Sullivan did not provide specifics on labeling discussions, but said the company expects an “informative” and “appropriate” label that helps physicians understand how to manage patients on treatment.
On commercialization, Sullivan said Celcuity began launch preparation several years ago, including hiring a chief commercial officer and building teams in marketing, commercial operations, market access, sales and medical affairs. He said the sales force has been hired, trained and is now profiling physicians, though it cannot market or sell the drug before approval.
In the first 90 days after launch, Sullivan said Celcuity would focus on submitting dossiers to national payer accounts, moving quickly with NCCN submission and ensuring sales representatives have contacted physicians in their territories. He said each representative is responsible for roughly 80 doctors.
Market Positioning and Use in Practice
Sullivan said market research indicated physician preference in the wild-type setting leaned toward the triplet regimen over the doublet by roughly an 85/15 split. He said having both regimens could allow physicians to tailor treatment based on patient characteristics, such as more aggressive disease or concerns about tolerability.
In the mutant setting, Sullivan said Celcuity expects meaningful uptake versus standard of care, citing both efficacy and tolerability. He said some key opinion leaders who reviewed the data privately reacted positively and viewed the data as strong enough to support standard-of-care positioning.
Asked about community versus academic adoption, Sullivan said company research does not indicate a wide separation in expected use. He noted that community practices account for roughly 80% or more of treated patients and said infusion capacity has not emerged as a concern in Celcuity’s discussions, given oncology practices’ existing experience with infused breast cancer therapies.
Frontline Studies and Subcutaneous Formulation
Sullivan also discussed VIKTORIA-2, Celcuity’s frontline advanced breast cancer program. He described it as effectively two studies in one, enrolling endocrine-resistant and endocrine-sensitive patients simultaneously. He said endocrine-sensitive patients represent about two-thirds of the population, while endocrine-resistant patients represent about one-third.
Celcuity currently estimates data from the endocrine-resistant frontline study around the end of 2028 and data from the endocrine-sensitive population in the 2030 timeframe, Sullivan said. He added that current standard-of-care duration of treatment is much longer in endocrine-sensitive disease, at about 24 months.
The company is also developing a subcutaneous formulation of gedatolisib. Sullivan said Celcuity does not expect intravenous administration to materially limit penetration in the near term, but believes a subcutaneous option could be important for the endocrine-sensitive population if patients remain on therapy for two and a half to three years. He said the company is targeting availability of the subcutaneous formulation in the 2031 timeframe.
Cash Runway
Sullivan said Celcuity recently closed a $500 million convertible note offering, with an additional $75 million greenshoe option. After paying down about $130 million of debt, he said the company would net around $420 million if the greenshoe is exercised. Combined with $380 million in cash at the end of the first quarter, Sullivan said Celcuity would have about $900 million on a pro forma basis and expects that to fund the company “through 2029.”
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.
