Release Date: March 31, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Celcuity Inc (CELC, Financial) completed enrollment of the PIK3CA wild-type cohort in their VIKTORIA-1 Phase III study, marking significant progress in their clinical development programs.
- The company has selected approximately 200 sites for the VIKTORIA-2 Phase III study, indicating strong interest and support for their research initiatives.
- Preliminary data from the Phase Ib study showed that gedatolisib was equally potent in cell lines with and without PIK3CA mutations, suggesting broad efficacy potential.
- Gedatolisib demonstrated a favorable safety profile with a low treatment-related discontinuation rate of 4% in the Phase Ib study, which is promising compared to other treatments.
- Celcuity Inc (CELC) ended the year with a strong cash position of approximately $235.1 million, providing financial stability to support ongoing and future research activities.
Negative Points
- Celcuity Inc (CELC) reported a significant increase in net loss for the fourth quarter and full year 2024, with a net loss of $36.7 million for Q4 and $111.8 million for the full year.
- Research and development expenses increased substantially, reaching $104.2 million for the full year 2024, which may impact financial sustainability if not offset by future revenues.
- The company faces competition in the evolving treatment landscape for HR+, HER2-negative advanced breast cancer, with several investigational therapies under development.
- There is uncertainty regarding the timing of achieving the required number of events for the VIKTORIA-1 study, which could delay data readouts and subsequent regulatory filings.
- Celcuity Inc (CELC) anticipates entering a quiet period ahead of top line data release, which may limit communication and updates to investors during this critical phase.
Q & A Highlights
Q: Can you provide an update on the current status of the event rate for VIKTORIA-1? Are you expecting to achieve the required number of events soon?
A: Brian Sullivan, CEO, stated that they are not commenting on specifics related to achieving the ability to report top-line data. They are only providing guidance on when they believe the top-line data will be available.
Q: What are your plans following the second quarter readout, and when do you expect to file the NDA?
A: Brian Sullivan mentioned they hope to initiate a real-time oncology review request soon after obtaining top-line data. If approved, they would begin submitting within months and complete the package within 1 to 1.5 quarters after receiving the data.
Q: What extent of data do you plan to share in the 2Q top line, and what are the timelines for a medical meeting presentation?
A: Brian Sullivan explained they expect to present median PFS data for each of the three arms in the wild-type cohort and corresponding hazard ratios for the two primary analyses. A fuller presentation of the data will follow at the next available major medical meeting.
Q: Have you received any feedback from investigators regarding the Dear Doctor letters sent by Roche about life-threatening ketoacidosis?
A: Brian Sullivan noted that PI3K alpha inhibitors are known to induce high levels of hypoglycemia, requiring intense glucose monitoring. He mentioned that their drug, gedatolisib, could have a significant advantage if it shows favorable data and safety, as it would not require such monitoring.
Q: Can you elaborate on the assumptions behind the $2 billion second-line opportunity estimate?
A: Brian Sullivan explained that the estimate is based on third-party data, pricing assumptions of $15,000 to $20,000, and a served market potential of about $5 billion. They aim for a 40% market penetration, translating to a $2 billion revenue opportunity.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
