Celcuity Inc.

Good afternoon and welcome to the Cellquity first quarter 2022 financial results and corporate update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Robert Aul with ICR Westwick. Please go ahead.

Thank you, operator. Good afternoon, everyone, and welcome to Selcuity's first quarter 2022 financial results and business update webcast and conference call. Thank you for joining us. Earlier today, Selcuity Incorporated released financial results for the first quarter ended March 31, 2022. The press release can be found on the investor section of our 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'd like to turn the call over to Brian Sullivan, Cellcuity's CEO.

Thank you, Robert, and 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 financial results and key activities over the next few months. In particular, we'll review the financing transaction we announced this morning and the status of the clinical development program and pivotal phase three trial design for Get It to Listen. Today, we announced that we entered into a definitive securities purchase agreement with a premier group of biopharmaceutical investors and a private placement that is expected to result in the aggregate proceeds of $100 million. Venrock Healthcare Capital Partners is the lead investor. Commodore Capital, New Enterprise Associates, RA Capital Management, Soleus Capital, and I are also participating. Investors will purchase shares of common stock and preferred stock at a price per share of $5.75, which is on an as-converted-to-common-stock basis. For each share of common stock and each one-tenth of a share of preferred stock purchased, investors will receive a warrant initially exercisable for preferred stock equivalent to 0.4 shares of common stock on an as-converted basis. The exercise price of the warrants will be at a 40% premium to the price paid by investors for the initial shares of common stock purchased in the private placement. The preferred stock will be convertible into common stock at the holder's election, subject to certain limitations such as beneficial ownership and the approval by the company stockholders to increase the number of authorized shares of common stock sufficient to cover the shares of common stock issuable. The warrants are initially exercisable for preferred stock and will convert into warrants to purchase common stock if the proposed increase in the company's authorized common stock is approved by stockholders. The closing of the private placement is expected to occur shortly after the first patient enrolled in our forthcoming Phase 3 study, Victoria 1, receives their first dose of treatment at a clinical site located in the United States, provided that this occurs before December 31, 2022. you'll be able to find additional details regarding the private placement in a form 8K that we will soon file with the SEC. We're very pleased to have attracted such a well-regarded group of investors in this very difficult equity capital market. The erosion in the value of clinical stage biopharmaceutical companies over the past six months and the corresponding drop in financing activity create significant uncertainty for companies like Cellcuity. This uncertainty in turn can significantly undermine a company's ability to implement its clinical development programs. In light of the uncertainty this challenging capital market creates, we concluded that strengthening our balance sheet was paramount. With the capital we expect to raise from this transaction, we believe we significantly enhance our ability to develop Geta-Telicib as a new therapeutic option for cancer patients and to create value for our shareholders. Geta-Telicib targets PI3K mTOR, which is considered one of the most important and complex pathways involved in cancer. Blockading PI3K mTOR efficaciously and safely, though, has been challenging because of its structural complexity and its linkage to C-key cellular metabolic processes. Gatotilicib inhibits all four Class I PI3K isoforms and mTORC1 and mTORC2. And this is the optimal approach biologically because it avoids the cross-activation of uninhibited subunits and resulting drug resistance that can occur with PI3K isoform or mTOR-specific inhibitors. Completely blockading the pathway also enhances the potential to induce synergistic inhibition with other targeted therapies, such as CDK4-6 inhibitors. Getis-Helicib's differentiated chemical structure and intravenous formulation result in a very favorable pharmacokinetic profile. The drug is potent at low or sub-nanomolar concentrations and can maintain pathway inhibition with a tiny fraction of drug compared to approved oral PI3K inhibitors. This results in a safety profile that compares very favorably against approved isoform-specific PI3K inhibitors. Thus, we believe gadotilicib's unique properties position it to realize the significant potential first envisioned for PI3K therapies when the pathway's critical role in cancer was discovered. The initial potential target population for gadotilicib is patients with HR-positive, HER2-negative advanced breast cancer whose disease progressed during treatment with the CDK4-6 therapy. We estimate this represents over 100,000 breast cancer patients globally on an annual basis. To advance the development of gettalizib in March, we announced the trial design for Victoria 1, a pivotal phase 3 clinical trial, to evaluate the safety and efficacy of gettalizib in combination with fulvestrin, with or without palbociclib, in adults with HR-positive, HER2-negative, advanced breast cancer, whose disease progressed while receiving prior CDK4-6 therapy. This open-label randomized clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PIK3CA mutations will be randomly assigned on a one-to-one-to-one basis to receive a regimen of either getotelicib, pabliciclib, and fulvestrin in arm A, getotelicib and fulvestrin in arm B, or fulvestrin in arm C. Subjects who meet eligibility criteria and have confirmed PIK3CA mutations will be randomly assigned on a one-to-one basis to receive a regimen of either getotelicib, palbociclib, and fulvestrin in arm D or opalipsib and fulvestrin in arm E. We are receiving the supply of palbociclib for this trial from Pfizer at no cost to cell acuity. The primary endpoints of the study are progression-free survival per RESIST 1.1 criteria as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who lack PIK3CA mutations and in those who have PIK3CA mutations. This multicenter international trial is expected to enroll patients at clinical sites across the U.S., Europe, and Asia. We expect to activate the VICTORIO1 study in mid-2022 and that the first patient receiving their first dose is expected to occur 6 to 10 months later. There are roughly twice as many patients who lack PIK3CA mutations as those that have them. Therefore, PFS for the subject lacking PIK3CA mutations will be available earlier than the data from those who have PIK3CA mutations. As a result, we expect that the primary analysis for PIK3CA non-mutated patients in arms A, B, and C will be available in the second half of 2024, and we expect data for the PIK3CA mutated patients from arms D and E to be available in the first half of 2025. There are limited options with limited efficacy for patients whose disease progresses on a CDK4-6 inhibitor. Current standard of care treatment includes either a selective estrogen receptor degrader, or SIRD, such as fulvestrin, or a regimen that combines an mTOR or PIK3-alpha targeted therapy with an endocrine therapy. Finding more effective treatment for these patients is a significant unmet need. To support our development efforts, we received fast-track designation for get a solicit for the treatment of patients with HR-positive HER2-negative advanced breast cancer in January. Fast-track designations granted by the FDA for products which demonstrate the potential to address a serious unmet medical need. This designation will enhance our ability to interact frequently with the FDA to discuss our development plan. And now I'd just like to take a few moments to discuss the diagnostic sides of our business. You know, Celsignia, our 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. Our strategy is to develop companion diagnostics that enable a pharmaceutical company to expand the number of patients eligible to receive their targeted therapy. Our ongoing fact trials were negatively impacted by COVID-19-related delays during early 2022. Now, with the lower COVID caseload, enrollment activities are resuming for these trials, and we expect to receive interim results from the FACT I and FACT II trials in the first half of 2023. I'd like now to turn the call over to Vicki Hahn, our CFO, to review our financial results.