Celcuity Inc.

Greetings and welcome to the CellQED third quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Maria Jankowski with ICR. Thank you, ma'am. You may begin.

Thank you, Operator, and good morning to everyone on the call. Thank you for joining us to review Salcuity's third quarter 2023 financial results and business updates. Earlier this morning, Salcuity released financial results for the third quarter ending September 30th, 2023. The press release can be found on the Investors section of the website. Joining me on the call today are Brian Sullivan, Solcuity's Chief Executive Officer and Co-Founder, and Vicki Hahn, Chief Financial Officer. 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 NIR 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 morning to everyone joining us on today's call. Our current focus at Cellcuity is to develop treatments for patients who have cancers involving the PI3K mTOR, or PAM, signaling pathway. The PAM pathway is one of the most important oncogenic pathways. It regulates key metabolic functions, cross-regulates other oncogenic pathways, and affects the tumor microenvironment. which can directly affect how a patient's immune system responds to a tumor. It is also the most highly mutated by a significant margin of all signaling pathways. 38% of solid tumors have a PAM-related mutation or alteration. Mutations obviously serve as potential targets, but the overall proportion of pathway alterations in a tumor highly correlates to its overall role as a cancer driver. Despite its importance as a cancer driver, The number of patients treated today with a PAM inhibitor is trivial compared to the number who could potentially benefit from them. And this is why we think the PAM pathway represents the largest drug development opportunity in solid tumors. The primary reason why PAM inhibitors have not become standard of care drugs, despite the importance of the PAM pathway, is because it is very difficult to safely and efficaciously inhibit this pathway. Unlike most pathways, where inhibition of a single kinase may induce the desired activity. The PAM pathway involves multiple nodes. Each of them must be targeted because of the complex interaction that takes place between them. Otherwise, uninhibited nodes may be activated and compensatory resistance may be induced, which in turn compromises efficacy. The available therapies that target this pathway only target a single node, such as mTORC1 or PI3K-alpha. and have only reported limited improvements in patient outcomes. That is why we believe development of an optimized PAM inhibitor, like getatilicin, that targets all class 1 PI3K isoforms and mTORC1 and mTORC2 represents one of the most important opportunities to improve the standard of care in these cancers. With our phase 3 program in HR-positive HER2-negative advanced breast cancer and our newly initiated phase 1B2 program in metastatic castration-resistant prostate cancer, We hope to eventually impact over 500,000 patients globally who have one of these tumor types. Our Phase III Victoria I clinical trial is evaluating getatilizumab in combination with fulvastrin with and without palvocyclib in adults with HR-positive, HER2-negative, advanced breast cancer who have progressed on prior treatment with a CDK4-6 inhibitor. We are now recruiting patients at nearly 220 sites in 23 countries in North and South America, Europe, and Asia. The trial remains on track to provide initial data and analysis of the PIK3CA wild-type patient subgroup in the second half of 2024 and the data for the PIK3CA mutated patient subgroup in the first half of 2025. In August, we announced our plans to initiate the clinical development of getotelicid in patients with metastatic castration-resistant prostate cancer whose disease progressed while receiving treatment with an androgen receptor inhibitor. Treatment options for these patients are limited, and there's an urgent need for new drugs to treat this patient population. Numerous preclinical studies have demonstrated interaction between the antigen receptor and PAM pathways suggests that combining a PAM inhibitor with an antigen receptor inhibitor may induce a synergistic antitumor effect in patients with prostate cancer. There's also compelling clinical evidence with an earlier generation PAM inhibitor providing a proof of concept of our hypothesis that combining getatilicid with an androgen receptor inhibitor may be efficacious. The FDA cleared our IND and gave us allowance to proceed with our Phase 1b2 trial to evaluate getatilicid in combination with darolutamide, which is a potent androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer. We expect to activate this trial in the first quarter of 2024 and report initial data in the first half of 2025. In the phase 1B portion of the study, the acuity expects that up to 42 participants will be randomly assigned to receive 600 milligrams of darolutamide combined with either 120 milligrams of getothalicin in arm 1 or 180 milligrams of getothalicin in arm 2. An additional 12 participants will then be enrolled in the phase 2 portion of the study at the recommended phase 2 dose level to enable evaluation of a total of 30 participants treated with a phase 2 dose of getothalicin. The primary objectives of the Phase 1B portion of the trial include assessment of the safety and tolerability of getatolizumab in combination with darolutamide and determination of the recommended Phase 2 dose of getatolizumab. The primary objective of the Phase 2 portion of the trial is to assess the six-month radiographic progression-free survival rate of patients who received the Phase 2 dose. We're excited that Bayer agreed to enter into a clinical trial collaboration and supply agreement to provide darolutamide, their approved androgen receptor inhibitor, For this trial, at no cost, darolutamide is structurally unique to other androgen receptor inhibitors, with an excellent efficacy and differentiated tolerability profile, coupled with minimal drug-drug interactions, making it an ideal combination partner for gettalicin. And finally, in September, we hosted a virtual science day, where we provided an in-depth overview of the scientific and strategic rationale supporting our clinical development strategies. We reviewed how gettalizib's differentiated mechanism of action, safety profile, and potency solves the riddle of comprehensively inhibiting the PAM pathway without inducing unacceptable levels of toxicity. We then characterized the significant unmet needs in breast and prostate cancer and why gettalizib is uniquely positioned to potentially improve the outcomes for the hundreds of thousands of patients with these tumors. For nearly 20 years, the PAM pathway has confounded drug developers. This has led many drug developers and investors to question the relevance of the pathway as a cancer target. We think that sentiment is misguided. We blame the drugs, not the pathway. We're excited about the opportunity to potentially offer breast and prostate cancer patients effective treatment for their PAM pathway-involved tumors, and we look forward to updating you on our progress over the coming quarters. With that, I'll turn now the call over to Vicki Hahn, our CFO, to review our financial results.