Celcuity Inc.

And welcome to the Selcuity third quarter 2022 financial results conference call. At this time, all participants will be in a listen-only mode. Later, we will conduct a question and answer session. I will now turn the conference over to your host, Robert Uhl, with ICR Westwick. Mr. Uhl, you may begin.

Thank you, operator. Good afternoon, everyone, and welcome to Selcuity's third quarter 2022 financial results and business update webcast and conference call. Earlier today, Salcuity Incorporated released financial results for the third quarter, ending September 30, 2022. The press release can be found on the Investors section of the 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, CEO of Selcuity.

Thank you, Robert. Good afternoon, everyone, and thank you for joining us today. I'm pleased to report that we made significant progress in the third quarter advancing Victoria I. our phase three clinical trial. Victoria One is evaluating the safety and efficacy of our lead drug product candidate, Geta-Tolicid, an investigational pan PI3K mTOR inhibitor for the treatment of HR-positive HER2-negative advanced breast cancer that has progressed after treatment with a CDK4-6 inhibitor in combination with an aromatase inhibitor. One of our key objectives for the third quarter was completing the selection of the clinical trial sites that will participate in this registrational study. We achieved this objective and selected approximately 200 clinical trial sites located in North America, Europe, Asia, Australia, and Latin America. Throughout the site selection process, we were very encouraged by the significant interest we received from sites and principal investigators across the world in participating in this study. Many of the world's most respected breast cancer clinical researchers are participating. The next critical objective for our team is to activate the selected sites so that we can begin enrolling patients. So QUT is now working closely with our selected sites to assure completion of regulatory and operational activities at each site as planned. Our first site was activated in the third quarter and we're on track to achieve our site activation goals across all regions. We also remain on track with our prior guidance of administering the first patient dose by the end of the year. 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. As we have previously reported, during the third quarter, the U.S. FDA granted breakthrough therapy designation to get a thalysm for the treatment of HR-positive HER2-negative advanced breast cancer. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gettys-Elissa previously received fast-track designation from the FDA in January 2022. We estimate that this initial potential target patient population 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 an mTOR-specific or PS3K-alpha-specific targeted therapy. These therapies offer only modest progression-free survival periods, and in the case of the approved PS3K-alpha inhibitor, a very challenging safety profile. Also during the quarter, an abstract with updates to results from a Phase Ib advanced breast cancer study was accepted for a spotlight poster discussion presentation at the 2022 San Antonio Breast Cancer Symposium in December. Preliminary data from this study was presented last year at a spotlight post of discussion and included data from the cohort of second- and third-line patients who received the three weeks on, one week off dosing schedule that we're using in our Phase III study. For patients in this cohort, the objective response rate was 63%, and the median progression-free survival period was 12.9 months. These results compare very favorably to historical controls from current standard-of-care therapies. Compelling safety data was also reported for this cohort. Only one patient, or 4% of the total, discontinued treatment due to an adverse event. In addition, only 7% of patients reported grade 3 or grade 4 hyperglycemia, and no patients discontinued treatment due to hyperglycemia. Now I'd like to move on to the diagnostic side of our business. CellSignia, 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 combine to develop companion diagnostics that enable a pharmaceutical company to expand the number of patients eligible to receive their targeted therapy. We expect interim results from the Cell Signia Platform's FACT-1 and FACT-2 trials in early-stage HR-positive HER2-negative breast cancer patients in mid-23. And finally, I'd like to welcome Dr. Polly Murphy to our board of directors. Polly has over 20 years of business development and commercialization experience at leading global pharmaceutical companies, including 12 years with positions of increasing responsibility at Pfizer. We're looking forward to having the perspective for broad industry experience we bring to our board. Now, I'd like to turn the call over to Vicki Hahn, our CFO, to review our financial results.