Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Celcuity Inc (CELC, Financial) reported that the Phase three trial, Victoria one, remains on track to report top-line data in the second half of 2024, with enrollment proceeding well.
- The company successfully achieved a significant enrollment threshold, allowing them to draw down an additional $10 million tranche from their current debt facility.
- Celcuity Inc (CELC) highlighted the potential of gedatolisib, noting its potency and efficacy in breast cancer cell lines with and without PiC3CA mutations, suggesting a broad application in treatment.
- The company's financial position remains strong with approximately $177.7 million in cash, cash equivalents, and short-term investments, providing a solid foundation for ongoing and future trials.
- Celcuity Inc (CELC) is actively preparing for the commercialization of gedatolisib, with strategic hires and planning initiatives aimed at a successful launch.
Negative Points
- Celcuity Inc (CELC) reported a net loss of $21.6 million for the first quarter of 2024, which is an increase from the $11.9 million net loss in the first quarter of 2023.
- Research and development expenses significantly increased to $20.7 million from $11.3 million in the previous year, reflecting higher costs associated with advancing clinical trials.
- The company faces intense competition in the HR-positive HER2-negative advanced breast cancer treatment landscape, with several other treatments targeting similar pathways.
- There are inherent risks associated with the reliance on the success of one major trial (Victoria one), which if unsuccessful, could significantly impact the company's future.
- Despite a strong cash position, the increased burn rate and the need for additional funding could pose financial risks if the trials do not meet their endpoints or face delays.
Q & A Highlights
Q: For the Phase three study, can you remind us how the primary analysis is going to be triggered in terms of events and maturity and what are the PFS assumptions for treatment and control that went into the guidance? Second half 24 top-line data?
A: The study's primary analysis will be triggered by hitting a threshold number of events, independent of follow-up. The assumptions about the follow-up period help estimate the timing for these events, which informs sample size assumptions. The PFS assumptions for treatment and control have not been published, but data suggests that 2 to 3.5 months, centering around 2.7 for fulvestrant, is most likely.
Q: Can you explain the reasoning behind stratifying patients by six months on prior therapy versus 12?
A: The stratification factor for prior treatment duration is based on current guidelines, which define androgen resistance in the advanced setting as patients receiving less than six months of PFS on an endocrine therapy. This is a validated way of defining a patient population with a clear demarcation of responsiveness to subsequent rounds of chemotherapy.
Q: How important is it for your strategy to be able to report the full data for the wild-type cohort at the San Antonio Breast Cancer Meeting in December?
A: Reporting the full data at the meeting would be nice, but it is not essential. The most important aspect is the data itself, regardless of the timing of the presentation.
Q: Could you point us to any data that might help quantify the degree of impact that prior chemo and bone only patient factors can have on durability and PFS?
A: Data across many tumor types shows that patients who receive chemo and then are treated with targeted therapy generally have worse outcomes than those who hadn't had prior chemo. In the breast cancer space, chemo-naive patients tend to have a more favorable prognosis.
Q: What initiatives have you implemented or plan on implementing to prepare for the launch in Europe?
A: The preparation for launch involves building the initial team, including leaders for marketing, business operations, and managed market efforts. The focus is currently on developing a preliminary plan, identifying organizational structure, budget, and cross-departmental dependencies required to support the launch.
Q: Given you're enrolling patients with better expected outcomes, shouldn't this overall extend timelines for study readout?
A: While enrolling patients with better expected outcomes might extend timelines, there's a cap on the potential for fulvestrant. The focus is on treating the untreated disease mechanism with gedatolisib, which is expected to provide more significant benefits than just selecting a more favorable patient population.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
