Celcuity Inc.

Greetings and welcome to the CellQ&E third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentations. 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. I would now like to turn the call over to Robert Uhl with ICR Westwick. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and welcome to Selcuity's third quarter 2021 financial results and business update webcast and conference call. Thank you for joining us. Earlier today, Selcuity Incorporated released financial results for the third quarter ended September 30th, 2021. The press release can be found on the investor section of our website. Joining me on the call today are Brian Sullivan, Selcuity'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 elevate the company's current 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'd like to turn the call over to Brian Sullivan, Cellcuity'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 third quarter financial results, the status of our Gadalilisib clinical development program, and an update on our Celsignia companion diagnostic activities. Vicki will follow my comments with a discussion of our financial results, and then we'll open up the line for questions. As most of you may know, Salcuity took a transformational step in April this year when we licensed the Pan PI3K mTOR inhibitor, Gadalilisib, from Pfizer. We took this step because of the significant potential that a well-tolerated hand PI3K mTOR inhibitor offers to improve outcomes for patients with many different tumor types. This potential reflects the central role hyperactive PI3K mTOR signaling plays in the development and proliferation of many tumor types. Blockading PI3K mTOR efficaciously and safely, though, is challenging because of its structural complexity and its linkage to key cell metabolic processes. While the optimal approach to inhibiting PI3K mTOR requires targeting five different subunits, doing so has, until Gital Elisib's development, resulted in drugs that patients could not tolerate. We believe Gital Elisib is the first PI3K mTOR inhibitor that combines high potency against all five subunits with a safety profile that compares very favorably against approved isoform-specific PI3K inhibitors. Thus, we believe Gital Elisib is uniquely positioned to realize the significant potential first envisioned for PI3K therapies when the pathway's critical role in cancer was discovered. We are currently developing Gadalilisib to treat patients with ER-positive HER2-negative advanced or metastatic breast cancer. We estimate that over 100,000 breast cancer patients globally would potentially be eligible to receive Gadalilisib if approved. Given the broad role PI3K mTOR signaling has been demonstrated to play in a broad range of tumor types, We also believe we have a substantial opportunity to develop additional indications outside of breast cancer. During the quarter, we completed the transfer of regulatory clinical trial and safety reporting responsibilities for Gitalalisib from Pfizer to CellQID ahead of schedule. For our ongoing Phase 1B breast cancer clinical trial, we're now working with the participating sites to transition the 14 patients who are continuing to receive Gitalalisib treatment to an updated clinical trial protocol. This ongoing clinical trial is evaluating Katalalizab in a combination with the CDK4-6 inhibitor Ibrance and two different endocrine therapies. We're very pleased that updated data from our ongoing Phase 1B clinical trial for patients will be presented at the San Antonio Breast Cancer Symposium during a spotlight poster discussion session on December 10th. Dr. Rachel Lehman, an oncologist at the University of Texas MD Anderson Cancer Center, who was a principal investigator for the clinical trial, will be the presenter. Our preparations to initiate a Phase III clinical trial, evaluating Gatotilisib in combination with Palbociclib and Filvestrin, which is an endocrine therapy in patients with advanced breast cancer, are well underway. We have engaged the CRO and other critical vendors, started the process of site identification and qualification, and received commitments from a number of globally recognized breast cancer KOLs to serve as members of our trials steering committee. Our meeting with the FDA is scheduled, and subject to their feedback, we continue to expect to activate this clinical trial in the first half of 2022. We also began evaluating and prioritizing new potential indications for Guttal Alyssa. This evaluation includes assessment of previous trials for other PI3K and mTOR inhibitors, review of tumor microenvironment factors related to PI3K mTOR activity, and identification of non-clinical and clinical evidence of pathways that may cooperate with PI3K mTOR. Our goal is to develop a lifecycle development plan in the first half of 2022 that will guide our long-term plans for Gatalla-Elizib. As we've previously discussed, our assessment of different PI3K and mTOR inhibitors using our CellSignia platform led us initially to approach Pfizer about our interest in pursuing a collaboration to evaluate Gatalla-Elizib. Subsequent to that initial internal study, and as part of our due diligence on Gatalla-Elizib's mechanism of action, We conducted additional studies to evaluate Gitalalisib and a PI3K inhibitor in breast and ovarian patient tumors using our CellSignia platform. We presented the results of these studies at the AACR Annual Meeting this past April. These studies demonstrated the value of leveraging our CellSignia platform to gain valuable insights about drug development opportunities. Thus, as part of our lifecycle development planning efforts, we are conducting additional investigations using our CellSignia platform to support our assessment of different indications for Gdolalicin. Now I'd like to move on to the diagnostics side of our business. Celsignia, Cellcuity's third-generation diagnostic platform, identifies the underlying cellular activity, dysregulated pathway signaling, that may be driving a patient's tumor so that a matching targeted therapy can be identified. Since dysregulated signaling is too complex for molecular tests to characterize in most cases, our platform can identify new treatment options for patients who lack actionable molecular biomarkers. Our strategy is to develop companion diagnostics that enable a pharmaceutical company to expand the number of patients eligible to receive their targeted therapy. To achieve this, we're collaborating with pharmaceutical companies to evaluate the efficacy of their targeted therapies in patient populations selected by a cell-signia pathway activity test. If the clinical trial results are favorable, These collaborations may lead to advancement of a new indication that expands the market for targeted therapy. In October, Cellcuity entered into a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology. This open-label Phase II trial will evaluate the efficacy and safety of Puma's pan-her inhibitor, NeurLynx, or Neratinib, and the chemotherapy, Capacetabine, in previously treated patients selected with Cellcuity's CellSigMia HER2 activity test who have metastatic HER2-negative breast cancer with brain metastases. This will be our first collaboration to study metastatic breast cancer patients with brain metastases, a patient population with an unmet and challenging medical need. While we're hopeful, salicylamine may allow us to identify much needed new treatment options for them. Based on estimates of patient enrollment rates, Salcuity expects to obtain interim results 12 to 15 months after initiation of the trial, followed by the final results 12 to 15 months later. Enrollment is planned to begin by mid-2022. We now have six clinical trial collaborations in place. The ongoing FACT1 and FACT2 trials that Salcuity is conducting are evaluating anti-HER2 therapies in early-stage HER2-negative breast cancer patients. The goal of each of these trials is to demonstrate that breast cancer patients identified by our Celsignia HER2 pathway activity test obtain a higher rate of pathological complete response to neoadjuvant anti-HER2 drug treatment than from current standard-of-care chemotherapies. Patients who receive a pathological complete response to neoadjuvant drug treatment are less likely to have their cancer recur, so we believe our Celsignia test can play a significant role in extending the lives of many breast cancer patients. Enrollment in both the FACT-1 and FACT-2 trials, though, were negatively impacted by COVID-19-related delays during the third quarter. Hospitalizations of patients with COVID-19 increased dramatically during this period, which led hospitals to reduce clinical trial-related activities, especially those that require a screening step, such as Celsignia. We now expect interim results from our FACT I and FACT II trials in the second half of 2022. This is later than our previous expectation of interim results in the first quarter of 2022. Nevertheless, 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 months. Now, I'd like to turn our call over to Vicki Hahn to review our financial results.