Celcuity Inc.

Greetings, ladies and gentlemen, and welcome to the security release of first quarter 2021 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Should anyone require operator assistance, please press star zero on your telephone keypad. It is now my pleasure to introduce your host, Mr. Robert Uhl with Westwick Investor Relations. Thank you, sir. You may begin.

Thank you, Operator. Good afternoon, everyone, and welcome to Cellcuity's first quarter 2021 financial results webcast and conference call. Thank you for joining us. Earlier today, Cellcuity released financial results for the first quarter ended March 31, 2021. The press release can be found on the Investors section of our website. Joining me on the call today are Brian Sullivan, Cellcuity'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 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. With that, I'd like to turn the call over to Brian Sullivan, Salcuity's CEO.

Thank you, Robert. Good afternoon, everyone, and thank you for joining us today. As always, we appreciate your continued support of Cellcuity. On this call, we'll update you on our first quarter results and other business activities, focusing in particular on our strategic licensing agreement with Pfizer to develop and commercialize gadadalicid, recently reported encouraging clinical trial data for gadadalicid, and an update on our clinical trial collaborations. Vicky will follow up my comments with a discussion of our financial results, and then we'll open up the line for questions. We have had a few busy months recently. We entered into a worldwide exclusive license agreement with Pfizer to develop and commercialize gadadalicid, the first-in-class PI3K mTOR inhibitor. We raised approximately $43 million in equity and debt. We signed clinical trial collaborations with Novartis, Pfizer, and PUMA. And we presented compelling clinical and non-clinical data for gadadalicid. Obtaining the exclusive license for gadadalicid from Pfizer as a transformational strategic step for cell acuity. Taking on the responsibility for the clinical development of a targeted therapy builds off the research we've conducted over the past few years using our Cell Signia platform. Our unique ability to assess the dynamic activity of signaling pathways in live patient tumor cells gives us proprietary insights into cancer drivers not available for molecular assessments. Our research to identify various breast cancer disease mechanisms led us to focus on one of the most complex pathways linked to breast cancer, PI3K mTOR. Our findings revealed that many breast cancer tumors have dysregulated PI3K pathways despite lacking PI3K alpha mutations. Our research also found evidence of the importance of inhibiting all class one PI3K isoforms in patients with PI3K alpha mutations. We subsequently evaluated various PI3K inhibitors using our CellSignia platform in live patient tumor cells and found that gadadalus's unique mechanism of action was potentially ideally suited to inhibit PI3K mTOR-involved signaling. Ultimately, our internal research findings and the clinical data Pfizer generated in a trial evaluating patients with ER-positive HER2-negative metastatic breast cancer motivated us to enlicense gadadalicib. Under the terms of the licensing agreement, Pfizer granted Selcuity an exclusive worldwide license to develop and commercialize gadadalicib. Salcuity paid a license fee of $5 million cash and $5 million of Salcuity's common stock as upfront payments. Pfizer is also eligible to receive up to $330 million of back-end loaded development and sales-based milestone payments and to receive additional tiered royalties on potential sales. In early April, Salcuity also announced preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase Ib clinical trial evaluating gadadalizib in combination with the CDK4-6 inhibitor Ibrans and an endocrine therapy. Preliminary analysis of the efficacy and safety data as of a January 11, 2021 cutoff date found that 53 of the 88 evaluable patients, or 60%, had an objective response and that 66 of the 88 evaluable patients, or 75%, had a clinical benefit. The safety analysis found that gadadalizib was also generally well tolerated with the majority of treatment-related adverse events, or TRAEs, being grade 1 or grade 2. The most common grade 3 or grade 4 TRAEs related to gedadolizib were stomatitis and rash. Gedadolizib was also found in this study to induce a far lower rate of grade 3 or 4 hyperglycemia than other PI3K inhibitors that target the PI3K alpha isoform. Amongst all patients enrolled in the Phase 1B trial, Only 7% had grade 3 or 4 hyperglycemia. This is in sharp contrast to opalypsib, PI3K-alpha targeted therapy approved for breast cancer, where 39% of patients in a phase 3 trial recorded grade 3 or grade 4 hyperglycemia. Our next step is to meet with the FDA to discuss our clinical development study plans for gadadilisib. Subject to the FDA's feedback, we would then initiate a phase 2-3 clinical trial evaluating gadatalysib in combination with public cyclob and an endocrine therapy in patients with ER-positive, HER2-negative metastatic breast cancer in the first half of 2022. Additionally, in April, we presented results of studies evaluating gadatalysib, inovilisib, the PI3K-ALF inhibitor, and the viticlax, a BCL inhibitor, in breast and ovarian patient tumors at the annual meeting of the American Association for Cancer Research. The results showed that inhibition of hyperactive PI3K mTOR-involved signaling is nine times more effective with gadadilisib than with the PI3K alpha inhibitor alone, such as inovilisib. Our data also showed the synergistic cooperation between PI3K mTOR and BCL signaling was detectable, suggesting potential patient benefit of combining gadadilisib with a BCL inhibitor. These results supported our internal evaluation of gadadilisib and further revealed the potential advantage of inhibiting all PI3K isoforms and mTOR, not just PI3K alpha signaling, when treating PI3K-involved signaling tumors. We also made significant progress advancing development of our CellSignia companion diagnostics. CellSignia is a third-generation diagnostic platform that identifies the underlying cellular activity, dysregulated pathway signaling, in a patient's tumor so that a matching targeted therapy can be prescribed. Disradiated signaling is too complex for molecular tests to characterize in most cases. This gives us the unique opportunity to help pharmaceutical companies obtain new indications for their targeted therapies to treat the patients our Cell Signia tests are uniquely able to identify. To take the first step towards realizing this goal, we collaborate with pharmaceutical companies to evaluate the efficacy of their targeted therapies in patient populations selected by a Cell Signia pathway activity test. If successful, These collaborations would represent a critical step towards obtaining a new indication that expands the market for the evaluated targeted therapies. We continue to believe there is a significant unmet need for new therapeutic options for HER2-negative breast cancer patients. Our research suggests that many of these patients have an undiagnosed and untreated disease mechanism. We believe that Celsignia can identify the disease mechanism for roughly 25% to 35% of these patients and the targeted therapy most likely to benefit them. Our efforts in this area are gaining momentum And in the first quarter, we entered two new clinical trial collaborations. In January, as we previously announced, we entered into a collaboration with the Sarah Cannon Research Institute and Pfizer for a Phase II trial. The trial will evaluate the efficacy and safety of two Pfizer-targeted therapies, Vizimpro, which is a pan-HER inhibitor, and Zalcori, a CMED inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with our cell-signia test. Patient enrollment is expected to begin in the third quarter of 2021 with interim results in the second half of 2022. In March, we entered into a clinical trial collaboration with MD Anderson, Novartis, and Puma Biotech to study a new drug regimen. The collaboration will evaluate the efficacy and safety of Novartis' targeted therapy to Brekta and Puma's Neuralynx in patients with metastatic HER2-negative breast cancer selected by the CellSignia platform. This is our second clinical trial to treat patients diagnosed with hyperactive HER2 and CMET signaling breast cancers with matching targeted therapies. We now have five clinical trial collaborations in place and we are proud to have advanced and finalized these agreements despite the headwinds from COVID-19. Our ongoing FACT I and FACT II trials are evaluating anti-HER2 therapies in early stage HER2 negative breast cancer patients. The goal of these trials is to demonstrate that breast cancer patients identified by our cell signia HER2 path reactivity test, obtain a higher rate of pathological complete response to new neoadjuvant anti-HER2 drug treatment than from current standard-of-care chemotherapies. Since patients who receive a pathological complete response to neoadjuvant drug treatment are less likely to have their cancer recur, we believe our self-significant test can play a significant role in extending the lives of many breast cancer patients. We continue to expect interim results from our FACT I and FACT II trials in late 2021 or early 2022, barring any unforeseen additional COVID-19-related disruptions. We're excited about these collaborations and the opportunity to work with some of the world's most prominent cancer research centers. We have additional collaboration discussions in progress, and our goal is to announce new agreements in the coming quarters. We're also looking forward to having the opportunity to collaborate with the clinical investigators that will be conducting these new trials through our collaboration agreements. They're highly respected oncology thought leaders and researchers, and we believe their interest in collaborating with us reflects their respect for the unique potential our cell-signia test offers to identify undiagnosed disease drivers in their patients. And finally, we recently closed two financings that resulted in gross proceeds of approximately $43 million. These financing strengthened our cash position and will allow us to fund key clinical development initiatives. Vicki will describe the financings in more detail in her remarks. So, Vicki, I'd like to turn now to you to review our financial results.