Good afternoon, everyone. I'm Anthony Vendetti. I'm the director of research at Maxim Group, and we're pleased to welcome you to day one of the Maxim Healthcare Virtual Conference. It's a three-day event. It lasts through this Thursday, October 17th. We have over 85 companies presenting, mostly the CEOs of these companies and other senior management. And today with us, we have Maria Zannes. She is the CEO of bioAffinity Technologies. Symbol is BIAF. We have a buy rating and a 12-month price target of $6. And wanted to turn it over to Maria to give you a approximately five-minute overview. Then we'll open it up to questions from the audience, as well as prepared questions that I have here. So with that, let me turn it over to Maria. First, thank you very much, Anthony. Thanks for this opportunity, and it's a morning for me here in San Antonio, which is where bioAffinity is located. bioAffinity is a small biotech firm that has developed and commercialized a test for the early detection of lung cancer. What's most important about this test is, one, its performance has been very good, showing very balanced and high accuracy, high sensitivity, specificity, and overall negative predictive value. This is a very patient-friendly test, in which people collect their sample at home and overnight it to a laboratory, where the test is then processed, and it uses sputum, and a physician, within just two days, typically gets a report of whether there is cancer or malignancy in the lung or not. We use... It is our first of what we believe to be many tests. This is a platform technology. Ours is not a molecular test. Ours actually uses flow cytometry, which has been used very effectively with blood cancers, such as leukemias, and we have taken it and applied it to the lung cancer market. To give you an idea of the market or the scope of benefit we can bring to the market, lung cancer is the leading cancer killer. It actually has an incidence rate similar to prostate or breast cancer, but unfortunately, it kills more people than both of them combined, largely because lung cancer is caught very late stage, and that's really where our test comes in. It's an add-on to low-dose CT. In other words, it's used after an individual has a nodule, or a pulmonary, we used to call it spot on the lung, but a pulmonary nodule that needs further indication or further, diagnosis, and the patient and the physician doesn't want to go into a biopsy just yet. We have brought the test to market. We've seen accelerated growth. We've been very pleased and encouraged in this last year. The test has a CPT code. It is being reimbursed both by Medicare and Medicaid and by, private insurers, which has, really accelerated our growth. And then recently, only last week, we got notice that the test will be on what's called the Federal Supply Schedule, so it will be available for physicians in the VA and in the military, which also is a very exciting time for us. Anthony, do you want to ask some questions? Was that That was perfect. That was exactly five minutes- Oh! ... so, right on time, Maria. That was great. So, CyPath Lung- Yes ... which is your laboratory developed test, an LDT, right? That's correct. And so you do get reimbursed for that. But it's not yet FDA-approved, but can be used because it's a laboratory developed test. Can you talk about where you are with the FDA? Because I believe you're looking at initiating a trial- Mm-hmm ... to submit a De Novo classification to the FDA. And- Yes ... do you think that further accelerates the adoption, and if so, why? So, let's start with as to where we are. We're meeting with the FDA, and we have the protocol in place. I want to point out something that's important about how we're moving forward, and which is we have long focused on the military and really the VA and the government as an important market for this test. And they are not only an important market for the test, but they are also very much collaborators with this trial, and I think that will be very important, and that's going along very well. And by that, I mean, I think that we'll have numerous VA sites and certainly military sites, for example, the Brooke Army Medical Center here in San Antonio. San Antonio is indeed Military City, USA, they like to say. But Brooke Army Medical and also Walter Reed will be part of that trial. So that's what we're doing now is we have the protocol in place. We have initial approval of that protocol with an IRB. It will require additional, not analysis, excuse me, it will the initial additional approval for the military and for the VA. All of those things we're working on now, with the idea of opening the trial soon. We anticipate a 2,000-patient trial. We will be following patients for up to two years, although we're really looking at patients who have nodules between six and 20 or 30 millimeters, meaning small pulmonary nodules that this test can help to determine whether to move forward or not move forward with more invasive procedures. And we can talk a little bit more about that, of why that's such an important market, an important place for this, for this test. So getting FDA approval will help us, not only I think, in being able to, have other laboratories, use the test or to sell the test, with other laboratories, I think, but it also helps us in the European market and the foreign market. We have a very strong patent portfolio, particularly in the EU, and we see this as a test that can be used not only in the same type of CE marking and approach that we're doing with an LDT, the LDT, but we also see in Asia and in the EU that FDA clearance will help us not only in the U.S., but worldwide. Yes. No, absolutely. The FDA is considered the standard, so we definitely understand that. Maybe just talk about... Because I think it's an astoundingly low number, maybe just let investors know what% of at-risk patients are actually screened for lung cancer right now, and what is BioAffinity doing to try to increase the awareness of the need to get scanned and the need to get scanned early? And why your test, which is very easy to administer, it's just literally sputum, or, you know, I guess the layman term, phlegm. It's just that's all it is. That should increase what is, like I said, an incredibly low number of patients that are getting screened currently. So it's our test is used. We see the physicians using the test, not only for individuals who have been screened, and let's talk about what screening is. People who are 50 to 80 years of age and who have smoked 20 pack years, the equivalent of one pack of cigarette a day for 20 years, those individuals are recommended for, and indeed, and the insurance pays for screening. Screening is used, is done by low-dose computed tomography, low-dose CT. In 2015, there was a study, results of a study released for 53,000 individuals. Half were screened by X-ray, the other half by low-dose CT, and they found a 20% drop in the death rate for those who were screened by low-dose CT, meaning that they caught lung cancer early. The problem with lung cancer is that it is caught in late stage. Unfortunately, the disease most often does not present early, so such that you have a low. You have a 10-year survival rate for prostate cancer, for example, of greater than 90%. You have only a five-year survival rate for lung cancer of about 28%. So you can see the difference, and remember, the same number of people get or close to the same number of people get both cancers. So finding cancer early makes a huge difference, and screening can make a huge difference. Unfortunately, the uptake has been maybe 15% of the 18 million people who are estimated to be at risk, at high risk for lung cancer. So there's a market there that needs to increase. You have a tremendous effort by the American Cancer Society, by GO2, by LUNGevity, by the American Lung Association, and by others, and ourselves, to push for more screening, and that's a very important market. But I can tell you that we also are getting about 50% of the patients who are using CyPath Lung, have something called incidental pulmonary nodules. In other words, you go in 'cause you have a shoulder problem, or you have a cough, or you have something that they wanna look at the heart, and they see a pulmonary nodule. Now, there, the question is what to do next? And we see also physicians using the test when there is another cancer, and they someone has prostate, and there's CT or imaging done, and indeed, there's a nodule there, and the patient is given to a suggested to see a pulmonologist, and the pulmonologist uses to determine whether that nodule might be malignant. Our test determines whether there is a malignancy in the lung and not necessarily whether it is lung cancer or another cancer, but it's still primarily used in that screening and that pulmonary nodule area, so I think that it will take time, but I think that there's a growing awareness. I also think for the importance of screening, and I also think that there's been a tremendous benefit from new drugs coming onto the market, Keytruda and others. We're seeing very much that people are surviving lung cancer as they have not before, so that idea that Oh, if I have lung cancer, that's the end, is not the case at all. In fact, lung cancer can is curable if found, certainly if found at early stage. There are studies, there was a New England Journal of Medicine study that showed that if you catch lung cancer in stage one and you treat it, you have a 10-year survival rate of greater than 90%. So certainly equal to what we're seeing in breast and in prostate cancer and other cancers, where there's that important early screening and continued screening for individuals. We play a tremendous, I think, role. CyPath Lung can play a tremendous role, not only in finding those indeterminate or detecting lung cancer in people who have small nodules, where a physician most often would say, "Just wait and see. Come back in six months, come back in eight months. Let's see if it grows." Instead, they can get an answer now. But I think that we also help with anxiety for those individuals. At least half of us who go in for a low-dose CT will have some kind of pulmonary nodule at one time or the other. But the lung cancer screening trial found that for every 100 people who have a positive screening, only three, four, or five of them actually have lung cancer. And so because of that, there's a hesitation at times to go in, because a physician, even physicians will say, "I'm not quite sure if you should do screening," 'cause we have a lower predictive value, positive predictive value. And that's, CyPath can really help there as well. That's a great segue. So, someone comes in, they have a nodule, right? It does not mean obviously it's cancer. That's correct. But if they get this, if they get your test, maybe talk about the specificity and sensitivity of your test once they have that nodule, to determine whether or not it is indeed lung cancer. Sensitivity is the measure of how well the test calls a true positive, a true positive. Specificity is the measure of how well a test calls a true negative, a true negative. Often with tests, you'll see and they're interconnected, so often you'll see high sensitivity, low specificity, or vice versa. What we were very pleased to see is that the test itself performed with high sensitivity and specificity, particularly with smaller nodules, less than 20 millimeters, less than two centimeters. For physicians, there's what's called an indeterminate nodule, sort of area, and that is between six and eight, and maybe 15-20 millimeters. CyPath Lung performed with 92% sensitivity and 87% specificity, with a 99% negative predictive value for individuals who are at high risk. These are people who have smoked, and they have nodules less than 20 millimeters. So we're very, very pleased with its performance and its ability to give really actionable results for physicians and their patients as they move forward. At one point, we should talk about how we brought this to market, because I think that's a very- Sure ... interesting. Yeah, sure, sure, sure. That's a good segue to do that, and then we can talk about, maybe, you know, what other indications. I know COPD might be on the horizon for you, but this test can be. It's like you said, it's platform technology. But sure, let's start from beginning, how it came to be, and then what the opportunity is. Sure. Sure, well, the initial, if you wanna go back far enough, we can go back to Los Alamos National Lab that had done some work on a specific label for cells, called a porphyrin. They had a specific porphyrin that labeled cancer cells, and it fluoresces. And you remember I talked about the fact that this is not a molecular test, this is a flow cytometry test. And what flow cytometry does is it looks at cell populations and is able to determine the microenvironment of the lung. It looks at how the lung changes because of the presence of a malignancy. What we found when we do our test with sputum is that indeed we have a certain populations that... One being the uptake of that porphyrin with cancer cells, but other things that indicate that there's cancer present. Another population, for example, is an apoptotic, in other words, a dying cell population that is upregulated, and as well as an immune cell population that is present and at greater numbers than whether you have cancer or whether you do not. We have taken that. I think groundbreaking with the test is that we have applied AI. We have applied an algorithm built by machine learning that then gives us standardized results as we run the phlegm, as you call it, that has been dissociated and labeled through the flow cytometer to determine cell populations. We acquired in last year in September a laboratory, Precision Pathology Laboratory Services. A very well-established laboratory with very good contracts with both private pay and other hospital systems for reimbursement. So that's one of the reasons I think we've been successful with getting reimbursement so quickly and getting paid so well. But nonetheless, we've worked with them and with Precision Pathology, who is now part of us, wholly owned subsidiary, to sell the test, and we decided to start in our own backyard. Now, we're in Texas, so it's a big backyard, so we're very pleased about that. We've moved in this last year through a more targeted Houston and San Antonio, to move to Dallas, to move now statewide. And that's where we're seeing growth. We've also seen growth by word of mouth in about a dozen other states where physicians have used our test and largely targeting pulmonologists right now, although we see a broadening to internists and family practices and others. But right now with pulmonologists, moving out and expanding our reach from a market standpoint because of word of mouth. And I think next year we'll look more strategically at moving, especially given that the entire VA system, the nationwide system, can now order our test, and that's really how we'll move out. The beta launch, I like to call it, the market launch in Texas, taught us how to do things better, faster, and cheaper, quite frankly. So we've been able to improve the test from a margin standpoint. We've been able to improve the test, and the operations of it. We've been able to improve the patient's journey and also the physician's journey as we bring this test to market. Okay, great. So we have about three minutes left- Uh ... and I want to focus on a couple things, Sure ... in these three minutes. So one is, you know, you started the rollout in Texas. Like you said, it's a big backyard. Maybe over the next kind of 12 months, maybe let investors know what the commercial rollout plan is as you move outside of Texas. And then also touch on the platform technology, how this could- this test could be used for things like COPD, which is obviously a very large TAM, total addressable market. So those are two things that I'd like to touch on before we conclude- Sure ... our call. Let me quickly address your second question, which is we do have very active research and development in COPD and also in a companion test to bronchoscopy. We see the bronchoscopy market just skyrocketing. There's a lot more. There's a lot of people in that market. But like LDCT, there's also it doesn't give you a concrete answer all the time. It doesn't give you a yes/no answer all the time. And so actually, when we talk to physicians, they're asking us, "Can we do this on bronchial lavage?" And that's what we're looking at. So those two markets, I think are. They're in lung, we know phlegm, we know BAL, we know how to do that. We can use and address that, and move something to market, I think quicker. In addition to which, it is a platform using the porphyrin, where we could look at other cancer indications, such as bladder or prostate. That's a different sample, it's a longer lead time, but indeed, it's something from a standpoint. We really have, I think, an excellent platform for using flow cytometry in AI, so that's very important. And from a strategic standpoint, that's just what we'll do. So I think we'll move in a strategically in the U.S. There are certain markets where we see larger practices that are interested in making this a standard of care. And so that's where we'll move into. There are larger hospital systems that are interested, and of course, the VA has eight million veterans, plus their families, all of whom now can order or very soon will be able to order CyPath Lung. That's great. That's great. So in the last minute or so, maybe just talk about, over the next 12 months, the rollout beyond Texas and what the plan is to, you know, go more nationwide with this, maybe state- Well ... by state or- Sure. So I think that there are certain areas where we see, just based on the number of screens, the number of pulmonologists, the interest that we've had. And what comes to mind, Florida, New Jersey, the Northeast, certainly California, the Northwest, will be very important, the South. And we'll strategically select or we'll strategically go into, I should say, not necessarily select. But I also want to. There are also very large VAs in Texas and throughout the country, and those will be very, very important as we move forward. But I think you'll see much more awareness as we get out of Texas for CyPath Lung, and much more marketing spend and, and benefit for what we're doing. We have a very good group of key opinion leaders who are working with us now and want to expand. We've been very pleased with the number of physicians who have used our test and said, "I wanna help. I wanna get out. I wanna speak. I wanna talk to my colleagues about this." So, that's a powerful way of marketing this test. Absolutely. Thank you, Maria. This was very helpful. Thank you ... informative for, I think, for all the investors to learn about this opportunity. I, you know, from a research standpoint, think diagnostics, early stage detection for lots of different cancers are critical in saving lives, and saving money for the healthcare system. So thank you for presenting bioAffinity's opportunities and technology. We look forward to tracking your continued progress. Thank you so much everyone for joining, and- Thank you very much. We look forward to speaking with you soon. Thank you.