Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to the Selcuity 3rd 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 the call you require immediate assistance, please press star zero for the operator. This call is being recorded November 14th, 2024. I would now like to turn the call over to Apoorva Chalori. Please go ahead.

Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's third quarter 2024 financial results and business update. Earlier today, Salcuity, Inc. released financial results for the third quarter ended September 30th, 2024. The press release can be found on the investor section of the website. Joining me on the call today are Brian Sullivan, Salcuity's chief executive officer and co-founder, Vicky Han, 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 financial measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Zilkiuti. Please go ahead.

Thank you, Apoorva, and good afternoon, everyone. We continue to make great progress advancing the clinical development of gadotilisib this quarter. Overall enrollment in Victoria 1 Our Phase III clinical trial, evaluating getatilicib plus fulvestrin with and without palvocyclib in the second-line setting, remains robust and on track. We're 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. And enrollment in the PIK3CA mutant cohort is on plan. Our Victoria 2 Phase 3 clinical trial that will be evaluating getatilicid plus fulvestrin and a CDK4-6 inhibitor in the first-line setting remains on track to enroll its first patient in the second quarter of 2025. And our Phase 1b2 trial evaluating patients with metastatic castration-resistant prostate cancer is ongoing and remains on track to report preliminary data in the second quarter of 2025. The primary endpoints for the Victoria 1 clinical trial are progression-free survival, or PFS, per Rhesus 1.1 criteria, as assessed by blinded independent central review. The study is designed to independently evaluate a PIK3CA wild-type patient cohort and a PIK3CA mutant patient cohort. For the PIK3CA wild-type cohort, there are two primary endpoints that will be tested hierarchically, whereas the PIK3CA mutant patient cohort has a single primary endpoint. Primary analysis for each patient cohort is triggered upon reaching a predefined number of progression events. With a PIC3CA wild-type patient cohort, the threshold number of events for both primary endpoints must be achieved before the primary analysis is triggered. Based on our current forecast of reaching the event thresholds that will trigger primary analysis, we expect to report top-line data for the PIC3CA wild-type cohort sometime in late Q1 2025 or Q2 2025. and to report top-line data for the PIK3CA mutant cohort in the second half of 2025. If the results from the PIK3CA wild-type patient cohort are positive, we would expect to file a new drug application, or NDA, with this data and follow up with a supplemental NDA or SNDA if the results from the PIK3CA mutant cohort are also positive. Obviously, the foundation of Geta-Telicib's potential future positioning will require that Geta-Telicib report a clinically meaningful median PFS benefit. Current median PFS benchmarks for patients pretreated with a CDK4-6 inhibitor are modest. Published reports of median progression-free survival for the SIRDs range from 2 to 3.8 months, and in patients with PIK3CA mutations, ranges between 5.5 and 7.3 months for the AKT and PI3K-alpha inhibitors. The two most recently approved therapies for this patient population reported between 2 and 3.5 months of incremental PFS benefit. The threshold KOL is generally considered to be clinically meaningful. In addition, we've consistently heard from oncologists that they greatly prefer to delay use of chemotherapy or ADCs until the benefit from endocrine backbone regimens is exhausted. We also think the get-up-to-lispsib safety profile may also favor its potential positioning in a future treatment landscape. Gadotilisib's treatment-related discontinuation rate was only 4% in the Phase 1b arm with the Phase 3 intermittent dose schedule, which is comparable to the 6% to 8% discontinuation rates for the CDK4-6 plus fulvestrant regimens. These results compare favorably to the treatment-related discontinuation rates reported in the Phase 3 studies for alpalisib plus fulvestrant, where 26% of patients discontinued, and everolimus plus eczemistane, where 24% of patients discontinued. The results for getatelicib are especially encouraging given that patients in the Phase 1b study did not receive prophylactic treatment for stomatitis. Since we are prescribing stomatitis prophylaxis in our Phase 3 trial, we would expect fewer stomatitis-related adverse events, which would further enhance getatelicib's already promising safety profile. We recognize that the treatment landscape is evolving with new potential therapies under development. is that the underlying biological drivers of HR-positive, HER2-negative, advanced breast cancer will ultimately determine which regimens become standard of care. Three interconnected signaling pathways, estrogen, cyclin D1, CDK4-6, and PI3K-AKT mTOR, promote this disease. And we believe that simultaneous blockade of all three of these pathways is required to optimize anti-tumor control. And this suggests that a triplet regimen that addresses these disease drivers whether in the first- or second-line setting, may have a long-term advantage versus a doublet regimen or monotherapy that addresses just one or two of these signaling pathways. Additionally, a triplet regimen that could treat all patients, regardless of PIK3CA or ESR1 status, would have an even greater advantage. We believe that a triplet regimen that includes getotelicib is well-positioned to establish this new standard of care, And we're optimistic that the VICTORIO-1 data from our PIK3CA wild-type and mutant cohorts can live up to this potential. Feedback we're receiving from oncologists and market access stakeholders, in conjunction with our preliminary commercial launch-related activities, further reinforces our optimism about the potential for get a TELICIB. Of particular note is the encouraging feedback received regarding get a TELICIB's IV route of administration. This preliminary research suggests that IV administration will not be a barrier to utilization of gadathalysib and, in fact, likely offers important advantages, particularly from a market access and adherence to therapy perspective. If gadathalysib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for the second-line and delay indication alone could exceed $2 billion. Returning to our Victoria 2 study, Our site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track. We're very pleased with the interest we're receiving from our current Victoria 1 sites as well as new sites that have expressed interest in participating in this study. We expect these activities will allow us to enroll our first patient in the second quarter of 2025. The Victoria 2 study is a global phase 3 open-label randomized clinical trial evaluating the efficacy and safety of getatolizib in combination with fulvestrin plus a CDK4-6 inhibitor as a first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer who are endocrine therapy resistant. Prior to the initiation of the Phase III portion of the trial, a safety run-in study will be conducted in 12 to 36 participants to assess the safety profile of getatolizib in combination with rivociclib and fulvestrin. Earlier this year, we dosed our first patient in our Phase 1b2 trial that is evaluating getotelicib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer. This study is ongoing, and we are on track to report preliminary data from this study in the second quarter of 2025. Just recently in October, the journal Cancers published results of our non-clinical studies in gynecological cancer cell line models, highlighting the differences between single-node inhibitors of the PI3K-AKT mTOR pathway and gadotilisib. The published manuscript is available online and on the publication sections of CellQD's website. The results from these studies are consistent with the non-clinical studies we published earlier this year that evaluated breast and prostate cancer cell line models. In all three tumor types, gadotilisib demonstrated superior potency and cytotoxicity compared to single-node PI3K-AKT mTOR inhibitors. And this December, We're looking forward to presenting one clinical poster and two non-clinical posters at the San Antonio Breast Cancer Symposium. Our clinical poster will present overall survival data from our Phase Ib clinical trial that evaluated getotelicib in combination with palbociclib and endocrine therapy. The two non-clinical posters will present data that further characterizes the mechanism of action of getotelicib and its effect on key breast cancer cell metabolic functions. Overall, we're very pleased with the progress we made this quarter advancing the clinical development of getotelicib. I'd like now to turn the call over to Vicki, who will review our financial results.