Release Date: November 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Celcuity Inc (NASDAQ:CELC) achieved 100% enrollment in the P3CA wild type cohort for their Victoria 1 phase three clinical trial, marking a significant milestone.
• The company is on track to enroll its first patient in the Victoria 2 phase three clinical trial by the second quarter of 2025.
• Celcuity Inc (NASDAQ:CELC) reported promising safety profiles for their treatment, with a low treatment-related discontinuation rate of 4% in the phase one B arm.
• The company has a strong cash position, ending the quarter with approximately $264.1 million in cash, cash equivalents, and short-term investments.
• Celcuity Inc (NASDAQ:CELC) has received encouraging feedback from oncologists and market access stakeholders regarding the potential of their treatment, Geta Tlic.

Negative Points

• Celcuity Inc (NASDAQ:CELC) reported a net loss of $29.8 million for the third quarter of 2024, an increase from the $18.4 million net loss in the same quarter of 2023.
• Research and development expenses increased significantly by $10.1 million compared to the previous year, impacting overall financial performance.
• The company faces uncertainties related to event rates in their clinical trials, which could affect timelines and outcomes.
• General and administrative expenses rose to $2.5 million, up from $1.4 million in the third quarter of 2023, indicating increased operational costs.
• Celcuity Inc (NASDAQ:CELC) operates in a competitive landscape with evolving treatment options, which could impact the market potential of their therapies.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Sign with CELC.

Q: Can you provide more insights into the event rate and whether there is a relationship with patient baseline characteristics? Also, was any timeline shift related to slower enrollment? A: Brian Sullivan, CEO: The timeline update is primarily due to the rate of events occurring, not enrollment changes. We are slightly ahead of our August projections. Factors affecting event rates are beyond our control and relate to patient responses to therapies. We track events in aggregate and forecast based on when we expect to reach primary endpoint thresholds.

Q: With Roche's approval of a new combination therapy, how might this affect the use of your treatment in the second line if approved for the mutation population? A: Brian Sullivan, CEO: The Roche study supports our hypothesis that inhibiting all three pathways is beneficial. Our current indication targets patients who are endocrine treatment sensitive, and we don't expect the Roche approval to impact our targeted population. Our Victoria two study will address a similar population but will enroll 100% of eligible endocrine treatment-resistant patients.

Q: What are your expectations for the absolute median PFS in the wild type triplet and doublet to ensure confidence in the mutant population? A: Brian Sullivan, CEO: We aim for results consistent with our phase one B study, which showed a median PFS of 12.9 months. We hope to replicate this in the phase three study, which involves a population with potentially more favorable prognoses. A three-month median PFS delta relative to control is considered meaningful by KOLs and community physicians.

Q: Can you discuss your enrollment expectations for the Victoria two study, given your experience with Victoria one? A: Brian Sullivan, CEO: We are optimistic about Victoria two enrollment, as many sites from Victoria one are participating again. First-line patient studies generally enroll more easily, and we expect the enrollment rate for Victoria two to be at least as good, if not better, than Victoria one. We are on track to enroll our first patient by the second quarter of 2025.

Q: What will be your focus at the San Antonio Conference, and how do you view potential new combination therapies that could compete with your treatment? A: Brian Sullivan, CEO: At the conference, we aim to present updated analyses and data on our treatment's mechanism of action. We will also monitor data from other studies, particularly those involving oral cert and CDK doublets. We will assess these studies' relevance to our target population, focusing on subgroups that align with our second-line treatment focus.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.