Celcuity Inc. (NASDAQ:CELC) Q3 2024 Earnings Conference Call November 14, 2024 4:30 PM ET

Company Participants

Apoorva Chaloori - ICR Westwicke, Investor Relations
Brian Sullivan - Co-Founder & Chief Executive Officer
Vicky Hahne - Chief Financial Officer

Conference Call Participants

Maury Raycroft - Jefferies
Brad Canino - Stifel
Tara Bancroft - TD Cowen
Chase Knickerbocker - Craig Hallum

Operator

Good afternoon, ladies and gentlemen, and welcome to the Celcuity Third Quarter 2024 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded, November 14, 2024.

I would now like to turn the call over to Apoorva Chaloori. Please go ahead.

Apoorva Chaloori

Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity's third quarter 2024 financial results and business update. Earlier today, Celcuity Inc. released financial results for the third quarter ended September 30, 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; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A.

Before we 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, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results, may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected.

On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP financial measures in today's press release.

And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Brian Sullivan

Thank you, Apoorva, and good afternoon, everyone. We continue to make great progress advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1, our Phase III clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib in the second-line setting remains robust and on track. We are very excited to announce that the PIK3CA wild-type cohort is 100% enrolled, an important milestone. It reflects the excellent execution by our clinical development and operations teams, and great support from the investigators at our sites.