Fifth annual virtual conference. It's a three-day conference with over 85 companies. Today's day one, wrapping up on this Thursday, October 17th. I'm Anthony Vendetti. I'm the director of research at Maxim, and with me today, I have Dennis McGrath, the CFO of Lucid Diagnostics. Symbol is LUCD. We have a buy rating and $4 price target on Lucid, and we have a lot to cover in the 25 minutes. So I'm gonna turn it over to Dennis to give a quick overview, and then we'll open it up to questions that I have here prepared, as well as any questions from the audience. So with that, let me turn it over to Dennis. Thanks, Anthony. Lucid Diagnostics has two primary technologies, EsoGuard and EsoCheck, and together they represent a comprehensive pre-cancer screening solution to prevent deaths from esophageal cancer. Esophageal cancer is one of the most deadliest cancers, with a mortality rate of up to 80%. Most patients are diagnosed in stage three, but even with a stage one diagnosis, survival is only a bit more than a 50-50 proposition for the patient. So, our technologies, which are commercial stage at this point, its mission is to save lives from esophageal cancer. Yeah, no, that's a great overview, and, you know, before I kick it off with questions, you know, diagnostics, early stage diagnostics, we believe, speaking from a research standpoint, is key to saving not just lives, but saving the healthcare system money. You know, there's companies out there that are doing that. You know, I look at Lucid on the esophageal side, you know, there's companies that you're probably familiar with, Exact Sciences with their Cologuard product for colon cancer. There's other companies that we follow on the diagnostics side as well, and these are diagnostics that we believe are just starting really to hit sort of the forefront of healthcare. 'Cause you know, healthcare, I think, has been more reactive. You know, you start having symptoms, you go to the doctor, and sometimes by the time you're diagnosed, it is too late most of the time. So the key is not only to catch it early stage, but in the case of Lucid, to really kind of catch it pre-cancer at the pre-cancer stage, which sometimes is Barrett's esophagus, where these cells just start to change before they actually become cancerous, and that's what Lucid can do. They can catch it prior to it even being early stage cancer, which is critical in preventing esophageal cancer from being lethal. And Lucid is already there, so maybe talk about... You know, maybe start from the basic stage one here. Not stage one cancer, but is it an FDA-approved product? Are you getting reimbursed for it? What is that total addressable market for Lucid? And then we'll jump into more specific questions. Go ahead, Dennis. First, you know, new healthcare technologies, you frequently hear executives like myself preach about an unmet clinical need. Kind of to make our case, I'll borrow an illustration from one of our KOLs. Anthony, just down the street is Madison Square Garden. If you fill up that stadium with a Knicks or a Rangers sporting event, that's the amount of people that'll die this year from, in the U.S., from esophageal cancer, and again, next year, and the following year, and again, in perpetuity. The prevalence is growing, as it's been over the last several decades. All of these deaths, if not all, could have been prevented, and that's the tragic missed opportunity and why EsoGuard and EsoCheck are needed to change the trajectory of esophageal cancer. Particularly in this cancer, a diagnosis of even a stage one cancer, esophageal cancer, is a patient failure because once there's a malignancy, there's very little that can be done with the patient. If a patient is found to have these pre-cancers, they can be monitored, surveilled, and an intervention can occur to set the clock back to zero, and that's why it's a tragic missed opportunity. With this office-based cell collection and molecular diagnostic test, these patients can be found with early pre-cancer, and you can save their lives. There is a gold standard out there, at least a theoretical gold standard, and that's an upper endoscopy that's been established for a long period of time, and yet less than 5% of the patients out there avail themselves to this test, even in the face of well-established guidelines that indicate who the at-risk patients are and should be screened, and yet less than 5% avail themselves to an endoscopy. And many are self-medicating, going to the pharmacy, buying over-the-counter Prilosec or Nexium to bring comfort to their acid reflux, which is one of the early signals that there could be an issue here. And they're unaware that this progression to this deadly disease can occur within them. So screening is important. Expanding the screening is extremely important to save lives from esophageal cancer. This is not one that is survivable even in an early stage cancer detection, unlike a lot of other cancers, that the stage one diagnosis is survivable. This is not. ... It's a great point. I think you're right. I think there's, you know, 5% is a very obviously low number of people that are aware. I think, you know, awareness has to increase, right? Because I think patients with GERD, like you said, they think, "Oh, I'll just treat my acid reflux," without realizing that GERD is one of the symptoms that could lead to esophageal cancer. But there's other factors, right? And if you have GERD, that's one, but if you're a white male, obese, or over the age of 50, if you have those issues, even without GERD, you should probably be screened, right? Is that- Right. That's what I've heard from otolaryngologists and ENTs. Yes, there are seven risk factors, and the two GI societies have published their updates to those guidelines about 18 months ago. So in the most conservative view, if you have a chronic GERD condition or acid reflux condition, and you have three of the remaining six risk factors, and you've identified some of them: age over 50, race, white, gender, male, obesity, family history, smoking. Three of those six, in addition to your GERD, you should be screened, and that's the at-risk patient population, and yet, very few people are being screened. And our mission is to increase this awareness through access and education to this, office-based test. And you have a number of ways to do that. You have, you know, CheckYourFoodTube.com, right? You have a couple of different things you're doing, more than a couple, I guess, maybe. So maybe go into those events that you hold, the marketing, the centers that you have, you know, to get this awareness out there. I think you're doing a lot to get the awareness out there, but there's still, you know, more that probably needs to be done. But, maybe just touch on a couple of the things you're doing to get the awareness up. Sure. We meet patients in a variety of ways. Early on in our commercial launch, it was important to us to call on the GIs largely to understand the alliance the alignment with them in terms of increasing you know patient screening. They realized they weren't seeing all of the patients out there that needed to be screened, and you know we were equipped with all of the objection handlings, and it quickly became clear to us that we were fully aligned. They saw us as finding them patients that they do not see. And so our sales team then started to go to that referral base. So, the primary care physicians, where a good portion of these patients, thirty million of them in the United States, as defined by the guidelines, are seeking, you know, prescriptions, their Prilosec or Nexium, for their acid reflux, and it is that area where we're educating in terms of the EsoGuard test that they should avail their patients. However, out of that thirty million patients, a good portion of them, maybe up to half, are self-medicating and just buying over the counter Prilosec and Nexium and these proton pump inhibitors, and it is that area that is a growing opportunity. However, where our commercial activities are at this point in time, limited by traditional reimbursement and the evolution, and we'll. I'm sure we'll talk more about where we stand in that process. We are kind of running at mid-throttle level from a commercial activity. We're generating 2,500 tests-3,000 tests per quarter. It's the equivalent of $6 million-$7 million in claim submissions to insurance companies, and this is at a sufficient level to kinda drive medical policy, claims history, appeals processes, all of the key components to change medical policy, and with medical policy becomes a number of tools that we can implement to increase that awareness, including at the next phases over the next several quarters, including patient awareness through advertising and a variety of things, but we need to get reimbursement in place before we can afford to do those other things, so that's one aspect of awareness. The other is, there are growing areas of revenue opportunity for us, including direct contracting, where you have self-insured employers who kinda dictate to their insurance company what gets covered, and that are very sensitive to cancer screening on a variety of fronts for their employee base. We have cash pay opportunities with concierge medicine groups. We have these large CheckYour FoodTube events that started a little bit accidentally about a year and a half ago with one of our lead salespeople calling on a physician in San Antonio, happened to be the lead physician for the San Antonio Fire Department, only to learn through our additional research that firefighters and first responders have an elevated risk for esophageal cancer, and that's just taken on momentum by itself. And that area is moving into more of these contracted payment, guaranteed events. As I mentioned, we meet patients in a variety of ways. We've tried to be as creative as possible, primary care, GIs, the foregut surgeons, these Check Your Food Tube events, direct employer call points. We even have innovated in areas where we're limited by regulations in terms of our personnel having access inside a physician's office and implemented a mobile Lucid test center, where a van can pull up to the parking lot of a physician's office, and patients can be tested, samples can be collected and sent to our lab for processing. Very innovative in terms of meeting patients where they're at, creating access, creating the education necessary for patients to understand why they should have a sensitivity to being screened. Yeah. So I think for investors that are just learning the story, right? There's endoscopy, which, you know, is typically done by ENT or otolaryngologist, you know, it's invasive. This is very minimally, right? It's an easier test, it's less expensive. You go in, it's just a small little tube, goes down, with a ball, pulls some cells out quickly, right? It doesn't require sedation, so it's less expensive for the healthcare system. So it's a simpler test. It's easier. There's no sedation required. So talk about that, as well as, you know, getting reimbursed. What's the current status with Medicare and also private insurers? Great. Touch upon a couple of the first points you made. So endoscopy is under sedation, right? Two, people need to take off work. You need a travel companion because they're not gonna let you travel to or from with anesthesia. And they're basically sticking a tube down your throat to do a visual inspection of changes in color at the most targeted anatomy, and that's the area where the stomach and the esophagus meet. And if you think about kind of the cause of acid reflux, it's the acidic fluids in your stomach to start to percolate up into that lower esophagus because that sphincter is maybe not functioning as properly as it should, and that acidic fluid starts to change the lining. So the target anatomy is the lower esophagus, and again, visual inspection, if they see a salmon-colored mucosa, they'll take biopsies of different quadrants around there. Our test is office-based. It's a swallowable pill size capsule, tethered to a silicone catheter. It's swallowed. Once the operator realizes it's in the stomach, and they can tug it against the sphincter that exists there, the GE junction, and know that it's in the right spot, they'll inflate an encapsulated balloon. That balloon will sample the 360-degree circumference of that lower 5 cm of the esophagus. Importantly, to the performance of the test, the design of the capsule is such that they can add... An operator, the device administrator, can add a vacuum to it and pull that balloon back into the capsule to protect from contamination as it finishes its journey up through the upper esophagus and the mouth. That is clear that is extremely important. EsoCheck and its design enhances the performance of the test, and that sample will then be sent off to the lab, so office-based, very simple. It's well-tolerated, 98% tolerable tests from all of our studies. About 2% of the patient population who might have problems swallowing vitamin pills will probably have a challenge here, but it's well-tolerated. The results are unprecedented in terms of the clinical results, particularly across all of the spectrum of the disease state, from this early pre-cancer, as you mentioned, Barrett's esophagus, to the smallest and earliest segments of cancer origin. Key point to make here is 70% of all esophageal cancers begin in what's considered short segment Barrett's esophagus, less than one or two centimeters in origin. Because our test, with its high sensitivity and the sampling of that circumference of the lower esophagus, can identify these with a very high degree of sensitivity. The data that's been collected over the last year and a half, largely starting with an extreme focus after Medicare published what's considered a Local Coverage Determination, an LCD, about 18 months ago. And in the review of that foundational policy, our assessment was that we needed to bulk up on clinical utility data and along the way, adding clinical validity. And so we have now four published or four completed clinical utility studies, three of which have been published in peer-reviewed journals and one pending. We have four completed clinical validity studies, three of which have been published, and one of which is pending. That across all of the stages, cancer detection, very strong. Again, emphasizing the point that just cancer detection is still a patient failure because the likelihood is they will not be able to survive that. The early pre-cancer and earliest pre-cancers, our sensitivity stays very consistent across the board. Our negative predictive value is nearly perfect. 99% negative predictive value, that is your false negative quotient, so extremely good. So all of this leads to where we stand in reimbursement, and I'm gonna kinda broaden that conversation into just increased payment. And as I mentioned, we're generating $6 million-$7 million in submitted claims for each quarter. Our realization or the amount we collect, that's our internal characterization of that gap, the realization is about 20% of that amount, and our mission is to change that gap, and there are multiple ways to do so. The market access team, they're focused on closing the gap between billed amounts and realization amounts by changing medical policy for both government insurance and traditional private pay insurance, the Blue Cross, the United, Cigna, Aetnas of the world. Additionally, our sales team is focused on contracted guaranteed revenue and cash pay opportunities. Examples would be self-insured employers, EsoGuard as a covered benefit through benefit packages promoted by health insurance brokers, cash pay through concierge medicine groups. All of these efforts will close that gap. In the interest of our time here today, I'm gonna focus on Medicare and traditional insurance. But suffice it to say that I would not be surprised in the next couple quarters, cash pay and contracted revenue represent a significant portion of our growing revenue base. We've had some initial wins in this area. Our pipeline is growing significantly, but I wanna address Medicare. I'm sure that's where most of our audience is most interested where we're at. So with regard to Medicare, there are two parts: there's payment and coverage. Payment has already been approved and determined, and that rate is $1,938, just less than $2,000, and it results in a 90% margin for us for the next patient in the door. So payment is behind us. Coverage, namely, who of the Medicare beneficiaries can avail themselves to our test, is what we're actively working on. About 20% of our test volume is Medicare related. In the large patient pool, that 30 million at-risk patient pool, it's probably 40%-45%. Hence, Medicare is important to us. We've announced that we had an extensive Medicare meeting in July, where we had a very unique opportunity to present our clinical data, the clinical validity, the clinical utility, the analytical validity, both published and pending to be published during that session. Our internal conclusion coming out of that meeting was that we still needed the last clinical validity study, our BE-1 study, to be accepted for peer review publication. It's kind of a gating factor to enable us to submit our data to Medicare for coverage consideration. The acceptance of that publication in the American Journal of Gastroenterology has been pending for some time. Look, this journal is one of the most prestigious industry journals and will serve us well both now and later. So naturally, they have multiple critical thinker types to pore over the manuscript. Fairly quickly, we turned around our responses to their initial questions and comments from all of the various reviewers of that manuscript. Just last week, we received an update with one remaining reviewer's comment, meaning the other reviewers certainly appear to have been signed off. We'll add some of the minor edits- One left. One left. Yeah. We'll add some minor edits in response to the reviewer's comment related to really a non-EsoGuard data reference, and resubmit that data. Hence, we're highly confident that this will not only be accepted, but soon, and that publication or acceptance for publication will clear the pathway to file our clinical data with Medicare for the last component of this process, namely, coverage for the at-risk Medicare beneficiaries. With regard to the private payers, we submitted claims to hundreds of insurers. We're getting paid by several of them, but at out-of-network timelines and wide-ranging payment rates. We believe we're generating sufficient claims history to make us relevant, to gain attention, and advance the ball with major insurance payers and advanced medical policy efforts. The Medicare approval certainly will be helpful in gaining national coverage policies with private payers. In the meantime, there are ongoing discussions on medical policy as well as filing applications for coverage and pilot programs like Coverage with Evidence Development. All of these things are advancing the reimbursement landscape for us, so we're optimistic about where Medicare is heading. You know, it's been longer than any of us thought it would, given this publication of the last clinical validity study. But we think that with payment, with Medicare approval, with the improvements we are making on the private side, along with closing the gap in that payment realization through other means, direct contracting and concierge medicine, we think the next couple quarters in front of us good reason to be optimistic. Yep, and we only have one minute left, so I think that's a pretty good summary, unless you wanna spend, Dennis, just a minute talking about, right? That because I think, you know, we're in New York, and concierge medicine is probably, you know, something that's more relevant to us here or, and, you know, other zip codes maybe on the coast. But, direct contracting, you know, seems like a great opportunity for Lucid. If you wanna spend 30 to 60 seconds on that? But it seems like you're making a lot of progress on all the other initiatives you just laid out for us. Well, I think it ties into you know where we're heading with increasing our sales teams, right? Our sales teams will be increased in parallel with traditional reimbursement at Medicare. However, on the direct contracting and employer base, we are hiring in that area with concierge medicine direct contracting. As you think about larger employers, a thousand employees and more, they typically are self-insured. They have an umbrella major medical policy, but they have wide ability to dictate what goes in their plan. So selling at the employer level, where they still have an insurance overseer or a administrative service provider, they will still file claims with that provider, but the decision is made at the employer level. So demonstrating to them that this test is meaningful to their employee base, they have at-risk patients for this particular type of cancer. Some of our focus will be occupational related, 'cause it's just not first responders. You can think of a whole bunch of employers that have these issues, right? Carcinogens they work in and around that are at risk, and therefore, become a target for us to expand our base. And because payment's guaranteed as part of the contract, we don't have to worry about the irregularities of traditional insurance and wonder if we're gonna get paid. That's determined in advance. Okay, great. Dennis, I think that was a great overview. Really appreciate the time. You know, Dennis always makes himself available, so if you have any other questions, I'm sure you can reach out to Dennis, you can reach out to me. We've been following the company for some time right now, and be glad to answer any of your questions. So look forward to continuing to track your progress and updates as we go forward. Thanks, everyone, for joining, and look forward to speaking with you soon. Anthony, thanks for the invite to you and your team. Thank you very much. Absolutely. Have a great day. Bye now.