Celcuity Inc.

Thank you. Thank you. Good afternoon, ladies and gentlemen, and welcome to the SELQET second 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. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded today, August 14th, 2024. I would now like to turn the conference over to Maria Jankowski with ICR Westwick. Please go ahead.

Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's second quarter 2024 financial results and business update. Earlier today, Salcuity released financial results for the second quarter ending June 30, 2024. The press release can be found on the Investors section of the website. Joining me on the call today are Brian Sullivan, Felcuity'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. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Selcuity. Please go ahead.

Thank you, Maria, and good afternoon, everyone. We appreciate your interest in Selcuity. We made significant strides advancing the clinical development of Get It to Listed this quarter. Overall enrollment in Victoria 1 Our Phase 3 study evaluating geta-telicib plus fulvestrin with and without palbociclib as second-line treatment for patients with HR-positive HER2-negative advanced breast cancer remains robust and on track. Our Phase 1b2 trial evaluating patients with metastatic castration-resistant prostate cancer is also enrolling on schedule. And we further expanded the patient population eligible for geta-telicib when we initiated efforts to launch Victoria 2, a Phase 3 study designed to evaluate geta-telicib as a first-line treatment option for patients with HR-positive, HER2-negative, advanced breast cancer. In our view, each of these three programs has the potential to generate blockbuster levels of revenue. If these three programs ultimately result in regulatory approvals, we estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with gadotelicib. We first announced our plans to conduct the FICTORIA-1 study over two years ago, in May 2022. At that time, we estimated that 65% of the patients enrolled would lack detectable PIK3CA mutations and would thus be assigned to the study's PIK3CA wild type cohort. And this assumption was used to estimate enrollment by cohort and, in turn, the timing of events for primary analysis. We estimated that the threshold number of events required to trigger the primary analysis for this PIK3CA wild type cohort of patients would be reached in the second half of 2024. And while the study's overall enrollment remains on track and robust relative to the estimate we made over two years ago, the total proportion of patients enrolled who have PIK3CA wild-type tumors has recently shifted lower. We now project that 60% of the patients enrolled in the study will be enrolled in the PIK3CA wild-type cohort rather than the 65% originally estimated. And this proportion, while lower than our original estimate, is within the range reported in other studies. and thus we don't believe this shift is study-related, but simply a result of normal sample variation within a population. Despite the lower proportion of PIK3CA wild-type patients completed, enrollment for the PIK3CA wild-type cohort is over 80% complete. We expect to reach the enrollment target for the PIK3CA wild-type cohort during the fourth quarter rather than the end of the third quarter, as we originally forecast. We now expect the primary analysis event threshold trigger for the PIK3CA wild-type cohort will be reached sometime between late Q4-24 and the end of Q1-2025. Our guidance regarding the PIK3CA mutant patient subgroup remains unchanged, and we expect primary analysis for this cohort to be triggered during the first half of 2025. Turning now to our Victoria 2 study, we announced our plans to initiate this Phase 3 clinical trial this past May. The study will evaluate gadotelicib plus a CDK4-6 inhibitor and fulvestrin, as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer whose disease recurs while receiving or within 12 months of completing adjuvant endocrine therapy. Now, these patients are considered to have endocrine therapy-resistant disease. They have a significantly poorer prognosis than endocrine therapy-sensitive patients whose disease recurs more than 12 months after completing their adjuvant endocrine therapy. Current standard of care first-line treatment for endocrine therapy-resistant patients includes any of the three approved CDK4-6 inhibitors combined with fulvestrin. The limited efficacy these regimens offer endocrine therapy-resistant patients, though, was not well understood until the Innovo 120 study, Phase III clinical trial for the PI3K-alpha inhibitor in Innovolizid, reported results last December. As part of this trial, the efficacy of standard of care palvocyclib and fulvestrin was evaluated. as first-line treatment in patients who were resistant to endocrine therapy. And for these patients, median PFS was only 7.3 months. And for those patients whose disease relapsed within the first two years of their adjuvant endocrine therapy, the median PFS was only 3.7 months. And these results compare poorly to the median PFS of 27 months reported for patients who were sensitive to endocrine therapy and who received the same regimen highlighting a significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy. We reported last year the preliminary clinical data from our Phase Ib trial for getatolizumab as first-line treatment in patients with advanced breast cancer. As you may recall, the median progression for survival in endocrine-sensitive patients who were treatment-naive and were treated with getatolizumab in combination with polycyclobin letrozole was 48.6 months. And the objective response rate was 79%. And these results compare very favorably to the results reported for palvocyclib plus letrozole in this population. Additionally, the NFO-120 study that evaluated in a volicib combined with palvocyclib and filvestrin in the endocrine-resistant patients reported positive data. Now, these patients had tumors with PIK3CA mutations, and the patients were not pre-diabetic or diabetic. So this subgroup only represents about 20% of the total endocrine-resistant patient population. However, the results reported were positive relative to the control, providing further evidence of the critical role the PIK3CA pathway plays as a driver of disease in treatment-naive patients.