Celcuity Inc.

Your program is about to begin. If you need audio assistance during today's program, please press star zero. Good day, everyone, and welcome to today's sub-Q&E release of third quarter 2020 financial results. At this time, all participants are in a listen-only mode. Later, you will have an 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 touchtone phone. Please note this call may be recorded. It is now my pleasure to turn today's program over to Vicky Hahne. Please go ahead.

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

Thank you, Vicky. Good afternoon, everyone. Thank you for joining us today. I'm glad that we're able to update you on our progress this past quarter. I'd like to comment on our third quarter results. I will focus in particular on the status of our collaboration discussions. our product development projects, and as well as fact one and fact two clinical trials. Vicky will follow my comments with a discussion of our financial results, and then we'll open the line for questions. So Acuity's third generation diagnostic platform, Cell Signia, 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 their patients our cell signia tests identify. Since dysregulated signaling is too complex for molecular tests to characterize in most cases, we can leverage the capability of our cell signia platform to create a proprietary business strategy. To execute our strategy, we continue to make progress advancing collaboration agreements with pharmaceutical companies and our clinical sponsors. Over the past several months, our clinical collaborators have received approvals from several major pharmaceutical companies to contract and finalize protocols for clinical trials that evaluate their approved targeted therapies in patients our sub-signia tests select. These are the same collaboration discussions we have referenced previously when they were at an earlier stage. Once our clinical sponsor collaborators receive an approval from a pharmaceutical company, A number of actions are required to translate the pharmaceutical company's intent to collaborate with us into a final agreement between Cellcuity, our clinical sponsors, and the pharmaceutical company. This process is, as I have described previously, an extensive and time-consuming one because of the number of parties and documents involved. For example, the first clinical, the final clinical trial protocol must get approved separately by several groups at the clinical sponsors institutions and then by and other separate groups within the pharmaceutical company before collaboration agreements can get finalized. Each of these review steps can take months. Fortunately, we are close to completing these steps for several collaborations, which is why we expect to close several pharmaceutical company collaborations over the next few months, including one or two before year-end. The collaborations we expect to close soon will evaluate different drug combinations with HER2-negative metastatic breast cancer patients selected with our CellSignia multi-pathway activity test. These will be our first collaborations to study late-stage metastatic patients. Our collaborations with Genentech and Pruma are evaluating early-stage breast cancer patients. There is a significant unmet need for new therapeutic options for HER2-negative metastatic breast cancer patients. Our research suggests that many of these patients have an undiagnosed and thus untreated disease mechanism. We believe our cell stigmia test can identify the disease mechanism for roughly 25% to 35% of these late-stage patients. and the targeted therapies most likely to benefit them. The collaborations we expect to close soon will evaluate patients with either hyperactive HER2 signaling tumors or those with hyperactive CMET and HER2 signaling tumors. Our discussions with pharmaceutical companies to evaluate PI3K inhibitors in breast and ovarian cancer patients with hyperactive PI3K signaling are also progressing. These discussions are at an earlier stage than those involving patients with hyperactive HER2 or CMET signaling. So we don't expect those collaborations to close until sometime at mid-2021 or beyond. For pharmaceutical companies, a collaboration with CellCuity offers a unique opportunity to evaluate the efficacy of their targeted therapies in patient populations the company would not otherwise be able to evaluate. If successful, these collaborations would represent a critical step towards obtaining a new indication that expands the market for the evaluated targeted therapies. We're also very excited about the clinical investigators we expect to partner with to field these trials. They are amongst the most respected oncology thought leaders and researchers in the country, and we believe their interest in collaborating with us reflects their respect for the unique potential our Celsignia test offers to identify undiagnosed disease drivers for their patients. During the third quarter, we also continue to advance development of additional Celsignia pathway activity tests. Our goal is to develop new cell signal tests that identify RAS pathway-driven cancers undetectable with molecular tests in breast and ovarian cancer. This regulated signaling involving RAS network nodes is responsible for a significant percentage of all cancers, which has led many pharmaceutical companies to sponsor research in this area. We expect to report data for these new tests at a cancer conference in the first half of 2021. Our self-signia platform also provides unique insights into the interdependence of the various RAS pathways. For many patients, a targeted therapy that inhibits one RAS pathway in turn may activate another RAS pathway. And this is typically referred to as a resistance mechanism, which at present can reduce the efficacy of the targeted therapy. For instance, it is generally understood that the inhibition of PI3K can detrimentally activate mTOR or MEK signaling and vice versa in some patients. With cell signia, we can analyze these interactions between the different pathways in this interconnected network using a patient's tumor cells. This allows us to identify drug combinations that can blockade these interactions and prevent the resistance mechanisms from occurring. The benefit to the patient would be better tumor control and ultimately longer overall survival. In addition, We can also assess the relative potency and efficacy of the different therapies targeting RAS nodes. This enables us to characterize the relative superiority of the different approved and investigational targeted therapies for RAS pathways, which will help guide our collaboration activities. Finally, we continue to expect interim results from our FACT I and FACT II trials in the second half of 2021. Although some sites continue to experience COVID-19 delays, it should not further delay reporting of results. However, as you are all aware, we do not yet know whether the recent increase in COVID-19-related hospitalizations in a number of states will impact enrollment activities for these trials over the next few months. 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 self-signia HER2 pathway activity test obtain a higher rate of pathological complete response to neoadjuvant anti-HER2 drug treatment than the current therapies. Since patients who receive a pathological complete response to neoadjuvant drug treatment are less likely to have their cancer recur, we're hopeful our self-signia test can play a significant role in extending the lives of many breast cancer patients. That concludes my initial remarks, but I'd like to now turn it over to Vicky to review our financial results.