Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to the Selcuity second quarter 2023 earnings conference call. At this time, all lines are in a 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 on Thursday, the 10th of August, 2023. I would now like to turn the conference over to Robert Uhl, 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 2023 financial results and business update. Earlier today, Salcuity released financial results for the second quarter ending June 30, 2023. The press release can be found on the Investors section of the company 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, Robert, and good afternoon to everyone joining us on today's call. Our top priority this quarter was continuing to execute enrollment activities at trial sites globally for our Victoria I Phase III clinical trial. As we've discussed previously, Victoria I is evaluating our lead compound, get a tolicib, combined with fulvestrin with or without palbociclib in patients with HR-positive HER2-negative advanced breast cancer whose disease progressed while receiving a CDK4-6 inhibitor. We are pleased to report that we now have nearly 200 trial sites recruiting patients in 20 countries. Throughout the first half of this year, our team has done a fantastic job of coordinating with regulatory authorities and individual sites to ensure our sites can begin recruiting patients as quickly as possible. They're relentlessly focused in keeping us on track to report the primary analysis for the PI3K non-mutated patient subgroup in the second half of 24 and the primary analysis for the PIK3CA mutated patient subgroup in the first half of 2025. This is consistent with our previously discussed expectations. We are seeking to improve outcomes for a patient population that receives 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 fulvestrant with an mTOR-specific or PI3K-alpha-specific targeted therapy. These therapies offer only modest progression-free survival periods, and in the case of the approved PI3K alpha inhibitor, a very challenging safety profile. The significant unmet need for these breast cancer patients has led to development and subsequent investigation of a significant number of new therapies aimed at these patients. An oral SIRD for patients with an ESR1 mutation was recently approved, and an AKT inhibitor reported positive results from its Phase III study late last year. Median PFS for these two new therapies ranged from 3.8 to 5.5 months in our patient population. 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. As we've discussed previously, there's a general consensus amongst leading breast cancer researchers that HR-positive HER2-negative breast cancer involves the estrogen CDK4-6 and PI3K mTOR pathways. each of which can cross-activate the other. To most effectively treat this disease, we believe data from our Phase 1b study strongly suggests that simultaneous inhibition of these three pathways is required to optimize outcomes for these patients. And to date, randomized studies have consistently shown that partial inhibition of the PI3K mTOR pathway with drugs that only target a single component of this pathway, such as ones that target PI3K alpha, AKT, or mTORC1, can provide only modest anti-tumor effects when patients have progressed on prior CDK4-6 treatment. Thus, we believe getathalysib'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 getathalysib has demonstrated activity independent of the presence of PIK3CA or ESR1 mutations in a patient's tumor. Our confidence that GEDF-elicit can play an important role in improving outcomes for women with HR-positive HER2-negative advanced breast cancer was reinforced with the updated PFS data we reported at the ESMO Breast Cancer Commerce in May for first-line patients from our Phase I D-study. Treatment-naive patients with HR-positive HER2-negative advanced breast cancer treated with GEDF-elicit, palvocyclib, and letrozole obtained a median progression-free survival period of 48.6 months, and 79% reported an objective response. Outcomes were comparable for patients with and without PIK3CA mutations, highlighting the rationale for comprehensive as opposed to selective inhibition of the PI3K mTOR pathway. These results compare very favorably to the median PFS of 24.5 months and the 55% objective response rate reported in the PILOMA3 study for polycyclic pusletrozole. We believe the data suggests getotelicid has the potential to eventually become a first-line treatment option. Last year, we began evaluating and prioritizing new potential indications for getatolizib. We assessed previous trials for other PI3K and mTOR inhibitors and characterized the activity of getatolizib and other PI3K, AKT, mTOR inhibitors in different hormonally-driven tumor types. Our initial results from non-clinical studies in prostate cancer were presented at ASCO-GU in February and in gynecological cancers at AECR in April. In each of these studies, Geta Thalyssib exhibited superior activity relative to all of the other PI3K, AKT, mTOR inhibitors evaluated. Thus, based on the review of prior clinical studies with PI3K, AKT, and mTOR inhibitors and our assessment of the relative advantage Geta Thalyssib's mechanism of action provides, we believe there is a significant opportunity for us to develop Geta Thalyssib in these additional tumor types over time. We expect to provide you with an update on our pipeline development strategy by the end of the third quarter. Now, I'd like to shift our discussion to the diagnostic side of our business that centers on Celsignia, our third-generation diagnostics platform. Our FACT-1 and FACT-2 trials are ongoing and enrolling patients with early-stage HR-positive HER2-negative breast cancer whose HER2 pathway is hyperactive, as detected with our Celsignia test. We continue to expect to announce interim results from these studies in the first half of 2024. With that, I'll turn the call now over to Vicki Hahn to review our financial results.