Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to the Socuity First Quarter 2025 Financial Results Webcast 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. I would now like to turn the conference over to Apurva Chaluri with ICR Healthcare. Please go ahead.

Thank you, Operator, and good afternoon to everyone. Thank you for joining us to review Salcuity's first quarter 2025 financial results and business update. Earlier today, Salcuity Inc. released financial results for the first quarter ended March 31st, 2025. The press release can be found on the investor section of Salcuity's 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. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Selcuity. Please go ahead.

Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our first quarter financial results conference call. We have an exciting year ahead of us with multiple upcoming clinical data readouts. We expect to report top-line data from the PIC3CA wild-type patient cohort of our Phase 3 Victoria 1 trial in Q3 2025. and from the PIK3CA mutated patient cohort in Q4 2025. We also anticipate reporting preliminary top line data for the Phase 1B portion of our Phase 1B2 trial in prostate cancer in late second quarter. And finally, we made great progress activating trial sites for our Phase 3 first line Victoria 2 trial over the past few months. In our view, each of our three programs has the potential to generate significant levels of revenue. If these programs ultimately result in regulatory approvals, we estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with getotelicib. Let's turn now to our Victoria 1 trial. Our Phase 3 Victoria 1 trial is designed to evaluate getotelicib in combination with fulvestrin with and without palbociclib in patients with hormone receptor-positive HER2-negative advanced breast cancer whose disease has progressed on or after treatment with a CDK4-6 inhibitor. The VICTORIA-1 trial includes two patient cohorts with independent statistical analysis plans and primary endpoints. The primary endpoints for VICTORIA-1 are progression-free survival, or PFS, as assessed by blinded independent central review. The study is designed to independently evaluate a PIK3CA wild-type cohort and a PIK3CA mutant 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. The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression events. And based on the current blinded event rates, we anticipate the primary completion of the PIK3CA wild-type patient cohort will occur in June, which would allow us to announce in a press release top-line data in the third quarter and to present full results from this patient cohort at a medical conference later in 2025. If positive, we expect the data will support our first new drug application, and if approved, our transition to a commercial stage company. If proven effective, gadotelicib in combination with fulvestrin and palbociclib could offer a new standard of care for patients with HR-positive HER2-negative advanced breast cancer whose disease progressed on or after treatment with a CDK4-6 inhibitor. For the PIK3CA mutant patient cohort, we anticipate reporting top-line data in the fourth quarter of 2025. The current second-line treatment paradigm for HR-positive HER2-negative patients with selective estrogen receptor degraders, or SIRDs, like fulvestrin or elacetrin, as single agents, or one of three approved PAM inhibitors combined with endocrine therapy. However, each of the PAM inhibitors only targets a single PAM node, such as PI3K-alpha, AKT, or mTORC1, which is suboptimal because the uninhibited PAM nodes can induce compensatory resistance. In patients who've received prior treatment with a CDK4-6 inhibitor, None of these single-node PAM inhibitors have demonstrated efficacy in patients who have PIK3CA wild-type tumors, while only the PIK3CA-alpha and AKT inhibitor have reported benefit in patients with PIK3CA mutations. And these results are consistent with the non-clinical data that shows these single-node inhibitors are three to four times less potent in breast cancer cells without PIK3CA mutations than in those with them. Of course, we recognize the foundation of Geta Thalyssib's role in this treatment landscape will require that get it to be well-tolerated and report a clinically meaningful result measured in terms of the incremental improvement in both PFS and the hazard ratio relative to standard of care. Breast cancer care wells and regulators generally consider an incremental improvement in PFS of three months relative to its control to be clinically meaningful. Current NPFS, or Median Progression-Free Survival, benchmarks for patients pretreated with a CDK4-6 inhibitor, patient population we're evaluating, are modest. only two non-chemo-related therapies have been evaluated in this patient population and received approval. One reported a 1.9-month incremental median PFS improvement relative to its comparator in patients with ESR1 mutations. The other did not report median progression-free survival improvement relative to current standard of care, but it did report a more favorable safety profile in patients with PIK3CA mutations. Despite the modest or no efficacy improvements on this benchmark, Both of these recently approved drugs has experienced rapid market adoption and penetration. Each drug reached revenue run rates within the first 12 months of launch estimated to be nearly half a billion dollars despite approvals that only addressed 30 to 40% of the eligible second line patient population. We believe this demonstrates the significant interest amongst oncologists for new treatment options for these patients and the relatively low bar required to obtain adoption and market penetration. Potentially more important data point than incremental PFS benefit to consider in advanced breast cancer when assessing the clinical benefit of one therapeutic regimen relative to another is the hazard ratio. And this is because recent randomized studies evaluating therapies for patients with HR-positive HER2-negative advanced breast cancer have enrolled widely heterogeneous patient populations. Since physicians make different treatment decisions for patients depending on on, among other factors, how many lines of therapy, how well they responded to prior therapy, and which type of therapy they may have received, results from these studies can be hard to interpret using absolute median PFS or incremental PFS benefit alone. As a result, top-line MPFS results from these studies don't provide sufficient clarity about the actual benefit a particular patient population may receive. The hazard ratio essentially factors out the differences in study populations, and thus provides physicians with a more objective benchmark. We thus not only hope to report a hazard ratio that is statistically significant, but one that compares favorably to the hazard ratio reported for other therapies available for second-line patients whose disease progressed while receiving a CDK4-6 inhibitor. If gadotilisib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for this second-line indication could exceed $2 billion with just 40% market penetration. I'd like now to turn to our first-line breast cancer program in our Victoria 2 trial. The Victoria 2 study is a global phase 3 open-label randomized clinical trial evaluating the efficacy and safety of gadotelicib in combination with fulvestrin, plus investigators' choice of either ribociclib or palociclib as a first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer, and these patients are endocrine therapy-resistant. Approximately 638 subjects will be assigned to a cohort based on their PIK3CA mutation status. The primary PFS endpoint for each of the cohorts will be evaluated independently. Prior to 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 getatilicib in combination with ribosiclib and fulvestrin. And during the first quarter, we completed our site qualification activities and we're now focused on activating the nearly 200 sites we've qualified across North America, Europe, Latin America, and Asian Pacific. We've also begun screening patients and expect to dose our first patient during the second quarter. Current standard of care first-line treatment for most endocrine therapy-resistant patients includes any of the three approved CDK4-6 inhibitors combined with fulvestrin. Results from a recent trial suggest that the median PFS period for patients receiving one of these three regimens is only seven to eight months. And these results compare poorly to the median PFS of 25 to 27 months reported for patients who are sensitive to endocrine therapy and who receive a similar regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy. Now I'd like to turn to our Phase 1b2 trial, That's evaluating the safety and efficacy of getotelicib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer whose disease progressed while receiving a next-generation androgen receptor inhibitor. The Phase 1b2 study evaluates getotelicib in combination with darolutamide, which is an androgen receptor signaling inhibitor, in patients with metastatic castration-resistant prostate cancer. We've completed enrollment of the phase 1B dose escalation portion of the study and anticipate reporting top line data by the end of the second quarter this year. Since we're at an earlier phase in this program, our focus is optimizing the dose and schedule for this tumor type and drug combination. This data set will include approximately 36 patients, half of whom will have received a 120 milligram dose of gadotilicib, the other half a 180 milligram dose. Each are administered on a three week on, one week off schedule. And we're comparing both the landmark PFS at six months and safety profile of these two arms to each other and to historical control data for second-line metastatic castration-resistant prostate cancer patients who were retreated with an androgen receptor inhibitor. And finally, we're excited about the opportunity we announced today to collaborate with the Dana-Farber Cancer Institute and Massachusetts General Hospital to evaluate getotelicib in combination with bemaciclib and letrozole in patients with endometrial cancer. The rationale to initiate this study is based on compelling historical clinical data that indicates women with ER-positive, or type 1, endometrial cancer may benefit from treatment with a PI3K-AKT mTOR inhibitor, like getathalysib, in combination with endocrine therapy. Additionally, results from a prior phase 2 clinical study evaluated getathalysib as a monotherapy in patients with either type 1 or type 2 endometrial cancer, and these results were encouraging. So I'd like now to turn the call over to Vicki to review our finances.