Q1 2024 Celcuity Inc Earnings Call Transcript
Key Points
- Celcuity Inc (CELC) 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.
- 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.
Good afternoon, ladies and gentlemen, and welcome to Celcuity first-quarter 2024 financial results conference call. (Operator Instructions)
I would now like to turn the conference over to Maria Yonkoski with ICR Westwicke. Please go ahead.
Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Celquity's first quarter-2024 financial results and business update.
Earlier today, Celcuity released financial results for the first quarter ending March 31, 2024. The press release can be found on the Investors section of the website.
Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicki Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A.
Before I begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties
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