Celcuity Inc.

Greetings and welcome to CEL QED First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Robert Ewell, with ICR last week. Please go ahead.

Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's first quarter 2023 financial results and business update. Earlier today, Salcuity released financial results for the first quarter ending March 31, 2023. The press release can be found on the Investors section of the website. Joining me on the call today are Brian Sullivan, Salcuity's Chief Executive Officer and Co-Founder, Vicki Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, 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. With that, I would now like to turn the call over to Brian Sullivan, CEO of CellCuity. Please go ahead, sir.

Thank you, Robert, and good afternoon, everyone. Since we provided a corporate update just seven weeks ago during our full year of 2022 financial call, I'll only make brief prepared remarks today. I'm very pleased with the execution to date of our Victoria I Phase III clinical trial enrollment activities at our trial sites. As we've reported previously, Victoria I is evaluating Geta-Tolicit in combination with Fulvestrin with and without polycycline in adults with HR-positive or 2-negative advanced breast cancer whose disease progressed while receiving a CDK4-6 inhibitor. Our team is relentlessly focused in keeping us on track to report the primary analysis for the PIK3CA non-mutated patient subgroup in the second half of 2024 and the primary analysis for the PIK3CA mutated patient subgroup in the first half of 2025. This is consistent with our prior guidance. At the Asthma and Breast Cancer Congress last week, We presented updated median progression-free survival data for treatment-naive HR-positive for two negative advanced breast cancer patients. We think the data is very encouraging. In our poster presentation, we provided updated efficacy and safety data in treatment-naive patients who are enrolled in Escalation Arm A and Expansion Arm A of our Phase 1b study. We had previously reported data for this group of patients at the San Antonio Breast Cancer Symposium last December. a cutoff date of June 29, 2022, but the median PFS and expansion RMA had not yet been reached. As of a March 16, 2023 data cutoff date, with the benefit of the additional follow-up period, we were able to report final median progression-free survival and median duration of response data for these patients. For treatment-naive patients in escalation RMA, median progression-free survival was 45.8 months, and for patients in expansion RMA, It was 48.6 months. When the results for treatment-naive patients from each of these arms are analyzed together, median progression-free survival was 48.6 months, and median duration of response was 46.9 months. These results compare very favorably to the median PSS of 24.5 months reported in the PILOMA3 study for polycyclic plus letrozole. We think these results demonstrate the intrinsic role the PI3K mTOR pathway plays as a disease driver in advanced HR-positive HER2-negative breast cancer. The data also highlight the potential opportunity to develop getathelizib as a first-line treatment option. We continue to characterize getathelizib's activity in various tumor types and compare its activity to other drugs in the class. As we've previously reported, the non-clinical studies we presented at ASCO-GU in February for prostate cancer and at AACR in April for gynecological cancers highlighted get it elicit differentiation from other drugs in this class. In each of the studies we performed, in all of the tumor types assessed, get it elicit demonstrated superior therapeutic effect relative to the other PI3K, AKT, and mTOR inhibitors evaluated. Based on the results from these internal nonclinical studies, as well as published reports of prior clinical results with drugs in this class, We think there is a significant opportunity for us to develop Geta-Felicib in these tumor types. We'll provide an update on our clinical development priorities later this year. And finally, the FACT-1 and FACT-2 trials are continuing to enroll patients with early-stage HR-positive HER2-negative breast cancer whose HER2 pathway is hyperactive, as detected with our CYGNIA test. We now expect to announce interim results from these studies in the first half of 2024. And with that, I'll now turn the call over to Vicki Hahn, to review our financial results.