bioAffinity Technologies, Inc.

Good morning and welcome to the BioAffinity Technologies fourth quarter 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal 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 on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded I'd like to turn the conference over to Julianne Overton, Director of Corporate Communications. Please go ahead.

Thank you, Operator. Good morning, everyone, and welcome to today's conference call to discuss BioAffinity Technologies' fourth quarter and full year 2022 financial results and our recent business progress. Please note that certain information discussed during today's call is covered under the Safe Harbor provisions. of the Private Securities Litigation Reform Act. We caution listeners that BioAuthenticity Technologies Management will be making forward-looking statements and that actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These risks and uncertainties are detailed in and are qualified by the cautionary statements contained in BioAuthenticity Technologies press releases, and SEC filing. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast today, April 3rd, 2023. BioAffinity Technologies undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. I would like to now turn the call over to Maria Zanes, President and Chief Executive Officer of BioAffinity Technologies. Maria?

Thank you, Julianne, and thank you to our listeners for joining us today. In terms of structure for today's call, first, I will provide an overview of the market opportunity we are targeting with SciPath Lungs. and the urgency of addressing the unmet medical need for the detection of lung cancer at early stage. Second, I will map out our commercial growth strategy, which begins with the limited launch of SciPath Lung in Texas that is designed to build and evaluate our marketing program and help us ensure each step in the care pathway is efficient and effective before expanding our footprint beyond Texas and potentially beyond lung cancer. We also will be seeking FDA clearance for SciPath Lung as a Class II IVD medical device. And as innovation has led to invention, we will be strengthening our patent portfolio. And third, Michael Edwards, our Chief Financial Officer, will provide an update on the company's financial position and capital strategy. We will then conclude with Michael, Julianne, and me available to answer your questions. But first, let me address the need for early lung cancer diagnosis. Our mission at BioAffinity Technologies is to detect cancer at an early stage because, simply put, Earlier diagnosis leads to better clinical outcomes and increases a patient's long-term survival. The need for early lung cancer detection is crucial. Lung cancer is the leading cause of cancer-related deaths worldwide. And this is largely due to the fact that people often show no symptoms of lung cancer until the disease has progressed to advanced stages, such as stage four, at which point, Five-year survival is only around 5%. However, when lung cancer is detected early, the prospects for successful treatment and even cure are significantly higher. Finding lung cancer at stage one, for example, and treating it can result in a 10-year survival rate of greater than 90%. This differential is where Cypeth Lung takes aim and intends to make an impact. Moreover, early lung cancer detection also reduces the cost of treatment and the need for additional tests. Treating lung cancer in advanced stages requires more aggressive treatments and hospitalization, both of which can significantly increase the cost of patient care. Our first diagnostic test is called CYPATH Lung. The test is sold as a laboratory-developed test by our partner, Precision Pathology Services, a well-established CAPCLIA clinical laboratory. SkyCath Lung is cost-effective, non-invasive, patient-friendly, with at-home sample collection that enables physicians to more confidently distinguish between patients who will likely benefit from timely intervention from those who should continue continue annual screening by low dose CT. Low dose CT is the standard of care for screening patients at high risk for lung cancer. Screening can significantly increase survival by finding early stage cancer. So screening is essential to lower the death rate of lung cancer. But the process can be improved. Screening has a low positive predictive rate of 3.8%, and that means that only four out of 100 people who get a positive result from screening actually have lung cancer. By using CYPATH Lung in conjunction with screening, we improve that positive predictive value, resulting in fewer unnecessary diagnostic procedures, earlier cancer detection, and a reduction in healthcare costs. We bring confidence and certainty to the diagnostic process. After a positive screening result, ThyPath Lung efficiently stratifies patients into one of two risk groups. Patients deemed likely to have lung cancer can proceed to more invasive and costly follow-up, while those deemed unlikely would continue imaging surveillance in accordance with the standard of care. The physician receives actionable results, informing him or her that SciPath Lung has detected the presence of lung cancer or has not. Results also include a numerical score, so physicians have more information in addition to the binary yes or no answer. We are beginning to test market SciPath Lung in Texas, and we are creating our brand. BioAffinity Technologies is based in San Antonio, and so we started our commercial rollout close to home, making sure we have everything right before expanding our footprint. The limited launch in Texas is designed to build and evaluate our marketing program and help us ensure each step in the care pathway is efficient and effective. From the initial order by physicians, to patient sputum collection and processing, to generating and delivering the patient report. We will build upon feedback from this test market, find future positioning, and develop our strategic insight for our SciPath lung test. We are very pleased to be working with Havas Health and You and Trinity Life Sciences, two global leaders in healthcare marketing. They are developing our brand, our messaging, and our strategic marketing plan to optimize commercial success. In addition to building our path to a staged nationwide U.S. expansion, we have begun work towards commercializing CYPATH lungs in the European Union, where there are an estimated 34 million smokers at high risk. One of the most impactful accelerants for driving sales can be FDA clearance of CYPATH lung as an in vitro diagnostic. We are finalizing the design and preparing a pre-submission package to FDA. Agency approval, if and when received, would enable us to directly market to physicians and their patients. And we are finalizing the design of a planned 1800 patient pivotal trial so that we can submit a pre-submission package and launch the trial this year. Among other measures of accuracy, this longitudinal clinical diagnostic study will establish the sensitivity, specificity, positive predictive value, and negative predictive value of CYPATH-1, and will likely require three years. As ambitious as it sounds, our mission is even more than becoming a leader in the early stage lung cancer diagnostic market. We have begun research to expand beyond that and see significant potential in the development of automated analysis to be used with flow cytometry technology. We are working to design non-invasive diagnostic tests for detecting and monitoring additional lung diseases. the first of which is Chronic Obstructive Pulmonary Disease, or COPD. COPD is the fourth leading cause of death, representing another multi-billion dollar market opportunity for our growing platform. Innovation is a hallmark of bioaffinity technologies. Our R&D efforts brought SciPath Lung to market, and our ongoing research continues to reduce costs and improve accuracy. In the past year, our discoveries have led to significant publications in scientific journals. Last week, we announced publication in the peer-reviewed Journal of Visualized Experiments of an article describing compensation beads we engineered that improve precision, lower the cost, and accelerate sample processing in our AI-developed flow cytometry platform. In January, we published results of our clinical trial for PSYCATH Lung, reporting that our test achieved 92% sensitivity and 87% specificity in detecting lung cancer in people at high risk who had small lung nodules less than 20 millimeters. Building awareness of our company and our technologies within the scientific and medical communities helps us to set the stage for our future plans and diagnostics, as well as our longer-term plans for developing therapeutics. We are still in the early innings of establishing the value of BioAffinity Technologies and SciPath Lung for the early detection of lung cancer, and in establishing our company as a leader in flow cytometry-based diagnostics. I am proud of our companies many accomplishments, including during these first few months as a public company. And there's so much potential for our team to address in the massive unmet medical need of early diagnosis for an estimated 18 million Americans at high risk for lung cancer. I look forward to continuing to share further updates with you. But for now, I'll turn the presentation over to Michael Edwards, our Chief Financial Officer, to review our financial results for the quarter and the year. Michael?