Celcuity Inc.

Good day, everyone, and welcome to today's CellCuity release of the second quarter 2020 financial results. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad. Please note, today's call may be recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn today's conference over to Brian Sullivan and Vicky Hahne. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today for a discussion of Cellcuity's second quarter 2020 financial results and business highlights. We issued a press release announcing our financial results for the second quarter ended June 30, 2020, a few minutes ago. Today's press release can be found on the Investors section of our website, www.cellcuity.com. 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 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 a table reconciling the non-GAAP financial measures to GAAP financial measures in today's press release. And with that, I'd like to introduce Brian Sullivan, our CEO.

Thank you, Vicky, and good afternoon, everyone. I'm very pleased that you joined us today for an update on our progress this past quarter. I'll first comment on our second quarter results, focusing in particular on the status of our product development projects, our collaboration discussions, and our FACT I and FACT II clinical trials. Vicky will follow me to discuss our financial results and then we will open the line for questions. So QITI's third generation diagnostic platform, Celsignia, identifies the underlying cellular activity, dysregulated pathway signaling, that drives many cancers. And this allows us to diagnose dysregulated signaling pathways in a patient's tumor that have a disease mechanism treatable with a matching targeted therapy. Our strategy is to help pharmaceutical companies obtain new indications for their targeted therapies to treat the patients our cell signia tests identify. Since dysregulated signaling is too complex for molecular tests to characterize, we can leverage the capability of our cell signia platform to create a proprietary business model. To execute our strategy, we continue to advance development of additional cell signia pathway activity tests during the second quarter. In June, we presented results from studies of our first cell-signia pathway activity test for ovarian cancer at the American Association for Cancer Research, or AACR, annual meeting. Our cell-signia test for ovarian cancer identifies a subset of ovarian cancer patients whose tumors have abnormal CMET signaling that's coincident with abnormal HER2 signaling. Nearly 15,000 women a year die from ovarian cancer, which is a disease that has less than a 50% five-year survival rate. Only a small proportion of ovarian cancer patients benefit today from the advancements made over the past 20 years in molecular-based medicine, since most patients lack an actionable biomarker, which is typically a molecular mutation. These patients have an undiagnosed cancer driver and are thus precluded from receiving, in many cases, the optimal drug to treat their cancer. There's also a significant unmet need for a new diagnostic approach that can identify treatment options for ovarian cancer patients who lack actionable molecular mutations. Cell Signia Test is intended to address this unmet need by helping pharmaceutical companies obtain new indications to treat ovarian cancer patients whose cancer driver is identified by our Cell Signia Test. Regarding our collaborations, our discussions with pharmaceutical companies progressed during the quarter. Despite the headwinds COVID-19 presents, We remain very confident we'll finalize one to two collaborations before year-end and then additional ones in the first half of 2021. Our potential collaboration partners include many of the country's leading cancer research centers as well as several global pharmaceutical companies. And these collaborations are intended to evaluate the efficacy of targeted therapies in patient populations our cell-signia test identifies. The pharmaceutical company would not otherwise be able to evaluate their drugs in these patient populations. These potential collaborations would, if finalized, enable us to study a range of drugs, either as single or combination agents. If successful, these collaborations would represent a critical step towards obtaining a new indication for the evaluated targeted therapies. Finally, although our Fact 2 and Fact 1 trials remain somewhat impacted by COVID-19-related delays, we've seen many sites restart their clinical trial activities. We continue to expect interim results, as we reported last call, from these trials in the second half of 2021. Both the FACT-1 and FACT-2 trials are evaluating anti-HER2 therapies in early-stage HER2-negative breast cancer patients. The goal of each trial 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 the current therapies. Since cancer patients who receive a pathological complete response to neoadjuvant drug treatment are less likely to have their cancer recur, We are hopeful our Cell Signia test can play a significant role in extending the lives of many breast cancer patients. So I'd like to now turn back to Vicky who will review our financial results.