Celcuity Inc. (NASDAQ:CELC) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET

Company Participants

Robert Uhl – ICR Westwicke

Brian Sullivan – Chief Executive Officer and Co-Founder

Vicky Hahne – Chief Financial Officer

Conference Call Participants

Maury Raycroft – Jefferies

Boris Peaker – Cowen

Gil Blum – Needham and Company

Operator

Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2023 Earnings Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we’ll conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Thursday August 10, 2023.

I would now like to turn the conference over to, Robert Uhl, ICR Westwicke. Please go ahead.

Robert Uhl

Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity’s second quarter 2023 financial results and business update. Earlier today, Celcuity released financial results for the second quarter ending June 30, 2023. The press release can be found on the Investors section of the company 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 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, Robert, and good afternoon to everyone joining us on today’s call. Our top priority this quarter was continuing to execute enrollment activities at trial sites globally for our VIKTORIA-1 Phase 3 clinical trial. As we’ve discussed previously, VIKTORIA-1 is evaluating our lead compound gedatolisib combined with fulvestrant, with or without palbociclib in patients with HR+/HER2- advanced breast cancer whose disease progressed while receiving a CDK4/6 inhibitor.