Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Celcuity Inc (CELC, Financial) made significant progress in advancing the clinical development of gedatolisib, with robust enrollment in their Phase 3 study, Victoria one.
- The company initiated efforts to launch Victoria two, a Phase 3 study for gedatolisib as a first-line treatment, potentially expanding the eligible patient population.
- Celcuity Inc (CELC) raised $129 million in gross proceeds from equity and debt offerings, strengthening their balance sheet and accelerating trial initiation.
- Preliminary clinical data from a Phase 1b trial showed promising results for gedatolisib in combination therapies, with a median progression-free survival of 48.6 months.
- Non-clinical research published in leading journals demonstrated gedatolisib's potent antitumor activity compared to single node inhibitors, supporting its therapeutic potential.
Negative Points
- Celcuity Inc (CELC) reported a net loss of $23.7 million for the second quarter of 2024, an increase from the previous year's loss.
- Research and development expenses rose significantly, primarily due to activities supporting ongoing trials and increased employee and consulting expenses.
- The proportion of patients with wild-type tumors in the Victoria one study shifted lower than initially estimated, affecting enrollment timelines.
- The company anticipates a delay in reaching the primary analysis event threshold for the wild-type cohort, now expected between late Q4 2024 and Q1 2025.
- General and administrative expenses increased, driven by higher employee and consulting-related costs, as well as professional fees.
Q & A Highlights
Q: Is it possible that wild-type and mutant readouts could happen at the same time, or are you confident they will be staggered? Will there be another update on enrollment in the fourth quarter?
A: Brian Sullivan, CEO: We expect the results for the mutated cohort to be available in the first half of 2025. Enrollment for the mutated cohort will take longer due to the higher proportion of mutated patients. We will continue to update guidance on when we expect to report top-line results.
Q: Can you talk more about the safety run-in for Victoria two in the frontline setting? Why is there a range of patients that you could enroll?
A: Brian Sullivan, CEO: The study is designed to evaluate various dose levels of gedatolisib to define the Phase 3 dose. If we don't need to reduce the dose in the first cohort, we can proceed with data from that group of 12 patients. Igor Gorbatchevsky, CMO: It's a straightforward safety run-in with three dose levels tested, 12 subjects per dose level, and DLT assessed after one cycle.
Q: What is the current percentage split of wild-type versus mutant populations compared to previous expectations? Does target enrollment mean completion?
A: Brian Sullivan, CEO: We were at 65% wild-type at the end of 2023, but now it's 60%. Completed enrollment means reaching the target number, but additional patients may be enrolled if they are already in screening.
Q: Does the potential approval of Roche's drug affect your clinical and regulatory strategy for the frontline setting? How important is the label outcome around metabolic parameter eligibility?
A: Brian Sullivan, CEO: We don't think Roche's drug will affect us as it targets a narrower population. Our design has been reviewed with the FDA, and we are confident in it. The label will likely address hyperglycemia risks, similar to alpelisib.
Q: Are you planning to present data at the San Antonio conference?
A: Brian Sullivan, CEO: We will announce data availability and provide guidance on presentation venues once the data is ready. The timing will depend on the most relevant upcoming meeting.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
