Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to Saltuity First Quarter 2024 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. You can go ahead.

Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Salcuity's first quarter 2024 financial results and business updates. Earlier today, Salcuity released financial results for the first quarter ending March 31, 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, Vicki Hahn, chief financial officer, as well as Igor Gorbachevsky, chief medical officer, who will be available during Q&A. Before I 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 Salcuity. Please go ahead.

Thank you, Maria, and good afternoon, everyone. We appreciate your interest in Salcuity. Our Phase 3 trial, Victoria 1, remains on track to report top-line data for the PIC3CA wild-type subgroup in the second half of 2024. Enrollment continues to proceed well. During the first quarter, in conjunction with an update related to our debt facility, we reported that the wild-type subgroup was more than 50% enrolled. Achieving this enrollment threshold during the first quarter gave us the right to draw down an additional $10 million tranche from our current debt facility. The patients we're evaluating in this study have HR-positive HER2-negative advanced breast cancer, whose disease progressed while receiving treatment with a CDK4-6 inhibitor and an aromatase inhibitor. And patients are eligible for enrollment if they've received up to two prior lines of endocrine treatment. But we anticipate that most of those enrolled will be receiving second-line treatment. And these patients typically remain on their first-line CDK4-6 inhibitor plus letrozole regimen for a median of 18 to 22 months, depending on the CDK4-6 inhibitor. And this compares to the 13 months medium duration of prior treatment reported for patients enrolled in the comparable arm of our Phase I B breast cancer study that evaluated gadotilisa combined with palbociclib and fulvestrin. Patients who received prior chemo in the advanced setting are not eligible for our Phase III study, unlike the comparable arm of our Phase Ib study. And this is relevant since the prognosis tends to be worse for individuals who have previously undergone chemotherapy for advanced breast cancer compared to those who are chemo-naive. Another difference in the Phase III eligibility criteria relative to our Phase Ib study is the allowance of patients with bone-only disease. Based on data from other Phase III trials, We expect that roughly 20% of the patients enrolled in our Phase 3 study will have bone-only disease. Our Phase 1b study did not allow bone-only patients. Only those with visceral disease were enrolled. And this is relevant since patients with non-bone-only disease generally have worse prognosis than those with bone-only disease. By not allowing patients who have received prior chemotherapy in the advanced setting, and by including those with bone-only disease, we're eliminating two factors in our phase three study that correlate with worst outcomes. As we begin preparing to get up to Elissa's potential position in a future treatment landscape, we'll take into account the criteria oncologists use to select a cancer therapy. We think these criteria, in order of importance, are efficacy, then safety, then mode of administration. And this is consistent with guideline recommendations, which are based on efficacy and safety considerations not mode of administration preference, especially in advanced breast cancer. The current second-line treatment paradigm for ER-positive HER2-negative patients with advanced breast cancer are selective estrogen receptor degraders, or SIRDs, like fulvestrin or elacitrin, as single agents, or one of three approved PAM inhibitors combined with fulvestrin. 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 have received prior treatment with a CDK and 4,6 inhibitor, none of these drugs have demonstrated efficacy in patients who have PIK3CA wild-type tumors, while only the PI3K-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. This is in sharp contrast to the non-clinical and preliminary efficacy data we've reported for gadotilicib. In studies evaluating breast cancer and prostate cancer cell lines, gadotilicib was found to be equally potent and efficacious in cell lines with and without PIK3CA mutations, and at least 300 times more potent, on average, in breast cancer cells than the improved single-node PAM inhibitors. Consistent with these non-clinical results, the preliminary efficacy we reported in our Phase 1b breast cancer study that evaluated getup to elastib combined with palacyclib and either letrozole or fulvestrin was comparable in both treatment-naive and second- and third-line patients with and without PIK3CA mutations. And we think these results demonstrate that along with the estrogen receptor and CDK4-6 pathways, the PAM pathway plays an intrinsic role as a disease driver in HR-positive HER2-negative advanced breast cancer. That's independent of the presence of an activating mutation like PIK3CA. And that's why we believe development of an optimized PAM inhibitor like Getatilicib that targets all class 1 PI3K isoforms and mTORC1 and 2 represents one of the most important opportunities to improve the standard of care in HR-positive HER2-negative advanced breast cancer. Now, obviously, the foundation of getafilicib's potential future positioning will require that getafilicib report a clinically meaningful MPFS benefit. The current median PFS benchmarks for patients pretreated with a CDK4-6 inhibitor are modest. Published reports of median PFS for the surge range from 2 to 3.8 months, and in patients with PIK3CA mutations, 5.5 to 7.3 months for the AKT and PI3K alpha inhibitors, respectively. The two most recently approved therapies for this patient population reported 2 to 3.5 months of incremental PFS benefit, the threshold KOLs generally consider to be clinically meaningful. In addition, we've consistently heard from oncologists that they lately prefer to delay use of chemotherapy or ADCs until the benefit from endocrine backbone regimens is exhausted. And this perspective was actually recently echoed by senior management from an ADC sponsor that characterized ADCs as creating a third pillar in the treatment landscape for HR-positive HER2-negative breast cancer that sits between endocrine therapy-based regimens and classical chemotherapy. And these comments are consistent with the sponsor's drug development strategy in breast cancer, which includes development of an oral SIRD and AKT inhibitor. We also think get a telicid safety profile may favor its potential positioning in a future treatment landscape. Gadantilisib'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 CDK4-6 plus fulvestrant regimens. And these results compare favorably to the treatment-related discontinuation rates reported in the Phase 3 studies for apalipsib plus fulvestrant, where 26% of patients discontinued, and everolimus plus eczemistine, where 24% of patients discontinued. The results for getathelizib are especially encouraging, given that patients in the Phase 1b study did not receive prophylactic treatment for stomatitis. Since we're prescribing stomatitis prophylaxis in our Phase 3 trial, we would expect fewer stomatitis-related adverse events, which would further enhance getathelizib's already promising safety profile. And finally, in-office administered therapies, such as an infused therapy like getathelizib, have several key advantages relative to orally or self-administered drugs. In a real-world setting, convenience is only a meaningful consideration when the efficacy and safety profile of the alternative drugs are comparable or when a patient lives a significant distance from the treatment site. Otherwise, a well-tolerated therapy that offers a clinically meaningful PFS benefit will be overwhelmingly preferred by oncologists relative to one that offers less efficacy but is more convenient. And office-administered therapies, such as Get It to Listen, fall into the medical benefit category, which has a far more streamlined reimbursement process than orally-administered drugs, which fall into the pharmacy benefit category. And this has several implications. First, oncologists can recover additional costs associated with treating their patients. Second, oncologists have more autonomy to select therapies, and the care management process is much less burdensome. And third, Pair contracting is less frequent, which results in fewer price discounts for this pharmaceutical company. And fourth, patients typically incur lower out-of-pocket costs with an infused therapy, which is an important consideration for most patients. Beyond our breast cancer program, we're excited about the opportunity to develop get a solicit for patients with metastatic castration-resistant prostate cancer, or CRPC. This past February, We dosed our first patient in a phase 1b2 trial evaluating getotelicid in combination with darolutamide, an androgen receptor inhibitor, in CRPC patients previously treated with an AR inhibitor. Like HR-positive breast cancer, prostate cancer involves both a hormonal pathway and the PAM pathway. The role the PAM pathway plays in prostate cancer has been well characterized non-clinically and in two since-continued PAM inhibitors. which showed compelling proof-of-concept clinical trial data and two randomized studies. In each of the clinical trials for these other PAM inhibitors, the clinically meaningful treatment benefit was reported relative to the androgen receptor inhibitor control arm in patients with CRPC. This is especially encouraging since gadotilicib is significantly more potent and efficacious than these PAM inhibitors in vitro. Primary objectives of the Phase Ib portion of the trial include assessment of the safety and tolerability of gettalicib in combination with darolutamide, and determination of the recommended phase two dose of gettalicib. We anticipate reporting initial preliminary data in the first half of 2025. And with that, I'll turn the call over now to Vicki Hahn, our chief financial officer, to review our financial results.