Celcuity Inc.

Good afternoon, and welcome to CellQAT's second quarter 2022 financial results conference call. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Robert Ewell. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and welcome to Selcuity's second 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 second quarter ended June 30th, 2022. The press release can be found on the investors section of the company website. Joining me on the call today are Brian Sullivan, Selkuity'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 the Q&A. Before we begin, I would like to remind investors 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 results, 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, CEO of Cellcuity.

Thanks, Robert. Good afternoon, everyone, and thank you for joining us today. As always, we really appreciate your continued support of Cellcuity. I'm happy to report that over the past few months, our team has made significant progress on a variety of fronts to advance the development of Geta tolicib. On this call, we'll review the regulatory status of Geta tolicib's clinical development program, our pivotal phase three trial in breast cancer, and our recent financing activity. In July, the U.S. Food and Drug Administration, or FDA, granted breakthrough therapy designation to Salcuity's lead drug product candidate, Getatilisib, an investigational pan-PI3K mTOR inhibitor, for the treatment of HR-positive, HER2-negative, locally advanced, inoperable, or metastatic breast cancer that has progressed after treatment with a CDK4-6 inhibitor in combination with a non-steroidal aromatase inhibitor. Breakthrough therapy designation is intended to expedite the review of drugs that the agency believes have significant potential in treating serious diseases with unmet medical need and offers the potential to receive an accelerated review if relevant criteria are met. We look forward to collaborating closely with the agency as we seek to advance the therapy to the clinic as quickly as possible. Get a Thalissa previously received fast-track designation from the FDA in January 2022. In our submission-seeking breakthrough status, we provided detailed clinical, safety, and pharmacological data with a focus on our early phase study evaluating getatolizib in combination with tolicic lipinfluvestrin in patients with advanced breast cancer whose disease progressed on a CDK4-6 inhibitor. This study reported very promising efficacy with a high objective response rate and extended progression-free survival periods. and safety data that compared favorably to the currently available therapies for advanced breast cancer patients in the second-line setting. The initial potential target patient population for getotelicib is patients with HR-positive HER2-negative advanced breast cancer disease progressed during treatment with the CDK4-6 therapy. We estimate this represents over 100,000 breast cancer patients globally on an annual basis. Current standard of care for these patients includes endocrine therapies such as fulvestrin, and regimens that combine fulvestrin with either an mTOR-specific or a 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 PI3K-mTOR pathway is considered one of the most important pathways involved in cancer. Blockading PI3K-mTOR efficaciously and safely, though, has been challenging because of its structural complexity and its linkage to key cellular metabolic processes. Gatotilisib inhibits all four class I PSUK isoforms and the mTORC1 and mTORC2 subunits. This is the biologically optimal approach because it limits the potential for cross-activation of uninhibited isoforms or subunits and the resulting drug resistance that can occur with PSUK isoform or mTORC-specific inhibitors. Completely blockading the pathway also enhances the potential to induce synergistic inhibition with other targeted therapies, such as CDK4-6 inhibitors. Gadotilisib's differentiated chemical structure and intravenous formulation results in a very favorable pharmacokinetic profile. The drug is potent against the various PI3K isoforms in mTOR subunits at low or sub-nanomolar concentrations and is able to 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 Geta-Telicib'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. To advance the development of Geta-Telicib, we are conducting a pivotal Phase III clinical trial, known as Victoria I, to evaluate the safety and efficacy of Gettysiliceb in combination with Silvestrin, with or without Pylosiclib 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 PI3K status. The clinical trial protocol we described in May included five arms. with three arms evaluating patients lacking PIK3CA mutations and two arms evaluating patients with PIK3CA mutations. At that time, we had received feedback from the FDA on our study design, but we were still waiting to receive feedback from the European Medicines Agency, or EMA. In late May, we received EMA's feedback to our protocol, which included a recommendation that the study arms for PIK3CA mutated patients mirror the same study arms for PIK3CA non-mutated patients. In response to this feedback, we modified the protocol to include an additional study arm to evaluate geta-telicib plus fulvestrin in 50 patients who have PIK3CA mutations. PIK3CA-mutated patients will now be randomized on a one-to-one basis to receive either geta-telicib plus pabliciclib and fulvestrin, geta-telicib plus fulvestrin, or the control alpalisib and fulvestrin. Once 50 PIK3CA-mutated patients are enrolled to the geta-telicib plus fulvestrin arm, Subsequent patients will be then randomized on a one-to-one basis to receive either getatilicib plus palbociclib and fulvestrin or alpalipsib plus fulvestrin. Subjects without confirmed PIK3CA mutations will continue to be randomly assigned on a one-to-one-to-one basis to receive a regimen of either getatilicib, palbociclib, and fulvestrin for arm A, getatilicib, and fulvestrin, arm B, or fulvestrin, arm C. No changes were made to the primary endpoints, and we continue to expect data for the PIK3CA non-mutated patients to be available in the second half of 2024 and data for the PIK3CA mutated patients to be available in the first half of 2025. We're also excited to report that the updated clinical trial protocol that includes the additional arm was submitted to the FDA and received no comments, and central institutional review board, or IRB, approval was received. We thus remain on track to dose the first patient in the next few months. Dosing the first patient in any study is a significant milestone. For us, it will be doubly significant since it will trigger the closing of the $100 million private placement we announced earlier this year, provided that it occurs on or before December 31, 2022. Investors in the private placement included Venrock Healthcare Capital Partners, New Enterprise Associates, RA Capital Management, Commodore Capital, Soleus Capital, and myself. We also made additional progress strengthening our balance sheet this past week. Our debt financing agreement with Innovata's capital partners was amended to provide Salcuity with up to $75 million in term loans, a $50 million increase from the original debt financing agreement. Salcuity received $15 million at the closing of the original agreement in April 2021. Salcuity will now be able to draw an additional $20 million following the closing of the $100 million private placement. Salcuity will also then be able to draw on two additional tranches of $10 million each and one additional tranche of $20 million upon achievement of certain clinical trial and financing milestones. Salcuity is entitled to make interest-only payments through April 25 or, if certain conditions are met, through April 2026. The loans will mature in April 2027, the sixth anniversary of the initial funding date. Now I'd like to move on to the diagnostic sides of our business. CellQA'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. 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 late 2021 and early 2022. Now with a lower COVID case load, Enrollment activities have resumed for these trials, and we expect interim results from the FACT I and II trials mid-2023. With that, I'd like to turn the call over to Vicki Hahn to review our financial results.