Celcuity(US:CELC)2026-02-11 15:32Summary of Celcuity Conference Call Company Overview - Company: Celcuity - Product: Gedatolisib - Industry: Healthcare, specifically oncology Key Points Product Development and Approval Timeline - Celcuity has received positive phase 3 data for gedatolisib in breast cancer and has an NDA accepted with a PDUFA date set for July 17, 2024, indicating a potential launch soon after approval [3][4] - Data for the mutant cohort of the VIKTORIA-1 study is expected to be available later this quarter or in Q2 2024 [4] Commercial Infrastructure - The Chief Commercial Officer was appointed in Q1 2024, with plans to prepare for a mid-2026 launch [7] - The commercial organization is being built out, with hiring in marketing, commercial operations, and medical affairs largely completed, leaving only field sales representatives to be hired [7][8] Clinical Data and Efficacy - Gedatolisib has shown a hazard ratio of 0.24, translating to a 76% reduction in the risk of progression or death compared to endocrine therapy, which is unprecedented [12] - The drug's efficacy is expected to be superior to existing options, with a nearly 5-fold improvement in progression-free survival (PFS) [12] Patient Experience and Side Effects - Stomatitis is a common side effect but tends to resolve within two weeks, with patients reporting a good sense of well-being while on the drug [16][17] - Gedatolisib's pharmacokinetics allow for dosing three times a month, maintaining effective drug levels while minimizing adverse effects [18][19] Market Opportunity - The overall market for gedatolisib is estimated to exceed $6 billion, with a potential of over $2 billion in the second-line indication alone at a 30% market penetration [35][36] - The drug could become a multi-billion dollar product, especially if successful in first-line settings [37] Ongoing Trials and Future Prospects - The ongoing trial for the treatment-naive population is focused on women who are endocrine resistant, with a safety run-in phase expected to conclude soon [40][41] - The company is optimistic about the results from the VIKTORIA-1 study, which showed significant benefits even in patients with prior CDK treatment [43][44] Financial Position - Celcuity reported $450 million in cash at the end of Q3 and has access to an additional $500 million through a term loan facility, providing flexibility for future operations [48] Additional Insights - The company is confident in its ability to execute the commercial launch of gedatolisib and is focused on building the necessary infrastructure [23][24] - The competitive landscape includes drugs like Truqap, which has a median PFS of 5.5 months, suggesting that gedatolisib could offer significant advantages in terms of efficacy [32][35]