Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to Socuity's fourth quarter and year-end financial results conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for a question. If anyone has any difficulties hearing the conference, please press star zero for operator assistance at any time. 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 fourth quarter and full year 2023 financial results and business updates. Earlier today, Salcuity released financial results for the fourth quarter and full year ending December 31, 2023. The press release can be found on the investor section of the website. Joining me on the call today are Brian Sullivan, Cellcuity'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 Cellcuity. Please go ahead.

Thank you, Maria, and good afternoon, everyone. In 2023, we made significant progress advancing development of Geta to Lissib while strengthening our balance sheet and adding to our leadership team. Our Phase III Victoria I trial remains on track to report top-line data from the PIK3CA wild-type patient subgroup in the second half of this year and top-line data for the PIK3CA mutated patient subgroup in the first half of 2025. We were also excited to begin development of Geta to Lissib for patients with metastatic castration-resistant prostate cancer this past year. Enrollment has begun in our Phase 1b2 trial, evaluating getatolizumab in combination with arlutamide, and we look forward to sharing preliminary data from this trial in the first half of 2025. Our Victoria 1 Phase 3 clinical trial is designed to evaluate getatolizumab in combination with fulvestrin with and without palbociclib in patients with advanced hormone receptor-positive HER2-negative breast cancer, whose disease has progressed after treatment with a CDK4-6 inhibitor. We're seeking to improve outcomes for this patient population, which today receives only limited benefit from current second-line standard of care therapies. We estimate that this initial potential target population represents over 100,000 breast cancer patients globally on an annual basis. Current standard of care for these patients includes endocrine therapies such as fulvestrant, and regimens that combine fulvestrin with an mTOR-specific or PI3K-alpha-specific targeted therapy. These therapies only offer modest progression-free survival periods, and in the case of the approved PI3K-alpha inhibitor, a very challenging safety profile. Significant unmet need for these breast cancer patients has led to development and subsequent investigation of a significant number of new therapies, an oral SIRG for patients with an ESR1 mutation, An AKT inhibitor for patients with a PIK3CA or AKT mutation was recently approved. Median progression-free survival, or PFS, for these two new therapies ranged from 3.8 to 5.5 months, respectively. In the same patient population, our Phase III trial is enrolling. While the availability of new drug alternatives for patients is always good news, based on the results reported for these drugs, the unmet need for these patients will still remain. To further elucidate the different therapeutic effects of gadotelicib versus other PI3K, AKT, mTOR, or PAM inhibitors, we performed a series of non-clinical studies using breast cancer cell lines. We presented the results of these studies during a poster session at the 2023 San Antonio Breast Cancer Symposium. In a panel of 28 breast cancer cell lines, gadotelicib was found to be more cytotoxic and at least 300-fold more potent on average compared to the single-node PAM inhibitors. Mechanistically, get a solicit decreased cell survival, DNA replication, protein synthesis, glucose consumption, lactate production, and oxygen consumption more effectively than the other PAM inhibitors. In vivo studies confirmed that PAM-PI3K mTOR inhibition by get a solicit reduced tumor cell growth more effectively than single-node inhibitors in breast cancer patient-derived xenograft models with and without PAM pathway mutations. We believe gettalizib's highly differentiated mechanism of action as an equipotent pan-PI3K mTOR inhibitor is uniquely suited to most effectively address this unmet need, especially since gettalizib has demonstrated activity independent of the PIK3CA or ESR1 mutational status of a patient's tumor. The results from our Phase 1b study and patients receiving the Phase 3 dosing schedule for gettalizib in combination with polycyclobin filvestrin was very promising. Median PFS was 12.9 months, and the objective response rate was 63%, both of which compares very favorably to published data for current standard of care regimens. Another important goal for us in 2023 was to begin development of getotelicib in a new tumor type. In the fourth quarter, we initiated a phase 1b2 clinical trial to evaluate getotelicib in combination with darolutamide, which is a potent androgen receptor signaling inhibitor, in patients with metastatic castration-resistant prostate cancer. We enrolled our first patient in the study in February, and we expect to report preliminary data in the first half of 2025. Treatment options for these patients are limited, and there's an urgent need for new drugs to treat them. Numerous preclinical studies have demonstrated interaction between the androgen receptor and PAM pathways, suggesting that combining a PAM inhibitor with an androgen receptor inhibitor may induce a synergistic anti-tumor effect in patients with prostate cancer. There's also compelling clinical evidence with an earlier generation TAM inhibitor providing a proof of concept of our hypothesis that combining Geta-thalysib with an androgen receptor inhibitor may be efficacious. And finally, as we get closer to having data for the PIK3CA wild-type patients in our Phase III breast cancer study, we need to begin laying the commercial and marketing groundwork necessary to bring Geta-thalysib to the clinic. To head up our commercialization efforts, Eldon Mayer joined our management team as our chief commercial officer in February. Eldon has over 30 years of biopharma commercial experience in companies ranging from early-stage biotechs to full-scale pharmaceutical companies across many therapeutic areas, including oncology. Eldon's an exceptional leader with a proven track record of building commercial organizations from the ground up to support the launch of a biotech company's first drug. And with that, I'll turn the call over now to Vicki Hahn, our Chief Commercial Officer, to review our financial results.