Celcuity Inc. (NASDAQ:CELC) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET

Company Participants

Robert Uhl - ICR Westwicke

Brian Sullivan - CEO and Co-Founder

Vicky Hahne - CFO

Igor Gorbatchevsky - Chief Medical Officer

Conference Call Participants

Maury Raycroft - Jefferies

Boris Peaker - Cowen

Connor Stevenson - Craig-Hallum

Operator

Good day and welcome to the Celcuity Third Quarter 2022 Financial Results Conference Call. [Operator Instructions]

I will now turn the conference over to your host, Robert Uhl with ICR Westwicke. Mr. Uhl, you may begin.

Robert Uhl

Thank you, operator. Good afternoon, everyone, and welcome to Celcuity's third quarter 2022 financial results and business update webcast and conference call. Earlier today, Celcuity Inc. released financial results for the third quarter ending September 30th, 2022. 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 measures in today's press release.

And with that, I'd like to turn the call over to Brian Sullivan, CEO of Celcuity.

Brian Sullivan

Thank you, Robert. Good afternoon, everyone, and thank you for joining us today. I'm pleased to report that we made significant progress in the third quarter, advancing VIKTORIA-1, our Phase 3 clinical trial. VIKTORIA-1 is evaluating the safety and efficacy of our lead drug product candidate, gedatolisib, an investigational pan-PI3K/mTOR inhibitor for the treatment of HR-positive/HER2-negative advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.