Good morning, and welcome to the Lucid Diagnostics Third Quarter 2024 Business Update Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference over to Matt Riley, Lucid Diagnostics' Director of Investor Relations. Please go ahead.

Thank you, operator and good morning everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of Lucid Diagnostics, along with Dennis McGrath, Chief Financial Officer of Lucid. The press release announcing our business update and financial results is available on Lucid's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update press release and the conference call all include forward-looking statements and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors in Lucid's most recent annual report on Form 10-K filed with the SEC and any subsequent updates filed in the quarterly reports on Form 10-Q and subsequent forms 8-K. Except as required by law, Lucid disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics. Take it away, Lishan.

Thank you, Matt and good morning everyone. Thank you for joining our quarterly update call today. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. Our team has always remained singularly focused on driving Lucid enterprise towards its substantial commercial potential and to enhance our long-term shareholder value. This has really been a great quarter for Lucid, especially after key milestones that we announced last week. We're here. We've been working on this for four years and we're now fully armed with a complete body of outstanding clinical data to go along with a renewed commercial focus. And we're really poised now to make our final push towards broad coverage and reimbursement to drive EsoGuard revenue and revenue growth. So let's start with some key highlights related to our commercial execution. In the third quarter, revenue was $1.2 million, about 20% increase quarter-on-quarter and our -- and that's a record quarterly revenue for us. The third quarter test volume was 2,787. While third quarter volume is in range with recent quarters, following a record second quarter, the fourth quarter is off to a good start with a record test volume in October. Our commercial ramp remains at mid-throttle. We have a critical mass in terms of testing volume to drive our revenue cycle management and medical policy efforts. As we mentioned, we've expanded our direct contracting initiative with multiple programs that are focused on driving near-term revenue building on the first large Check Your Food Tube event with an upfront contracted payment that we announced earlier. I will dive deeper into this -- into these exciting developments later in the presentation. We continue to be pushing hard with our efforts with firefighters with Check Your Food Tube events and have now tested over 7,000…

Thanks, Lishan, and good morning, everyone. The summary financial results for the third quarter were reported in our press release that has been distributed. On the next three slides, I'll emphasize a few key financial highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q. With regard to the balance sheet, cash at quarter end September 30 was $14.5 million. Last Friday, we gave notice to the convertible debt holder that the company is exercising its right to redeem the remainder of the outstanding note. To finance this payoff, Lucid has entered into convertible note purchase agreements with certain accredited investors that exceed the redemption price. The majority of the new investment is from existing preferred shareholders, which all have a long-term view of the company. We expect to make the payment to the existing convertible debt holder no later than November 22, which is immediately after the expiration of the minimum 10 trading day notice period. During this window, we expect to close on the purchase agreements. The net proceeds to the company, less the payoff amount, is subject to change depending in part on whether the existing debt holder converts any additional amounts of the debt between now and the payoff. However, with the current indications of interest minus the current payoff amount, we expect to increase our cash runway by more than an additional quarter, which puts us much closer to a Medicare approval. The terms of the replacement convertible debt are detailed in our related 8-K on the topic, but generally reflect a five-year maturity, interest only at an annual interest rate of 12%, a voluntary conversion price of $1 with no conversions permissible for six months. The company…

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Our first question comes from the line of Kyle Mikson from Canaccord. Your line is open.

Hi, Kyle. Q – Kyle Mikson: Hi, guys. Thanks for the question. Good to see the increase in ASP this quarter. But on that note though like, the sequential decline in test volume was interesting. Maybe there was something that was inflating the results last quarter that caused it to look like a decline. But do you want to just walk through, what happened in the third quarter like the summer month of September that caused that kind of a decline because it was pretty material, 11% quarter-over-quarter. So I just wanted to start there. Thanks.

So interesting, Kyle, that July was about 700 tests and October was double that amount. So if you look at August and September and October, it's a record total. And so in July, you have fewer large events because of the summer period, but picked up pretty dramatically through August and September. And November is off to a very good start as well.

Yes. So, really nothing material Kyle. This is -- we've -- I think as we said before we've kept our sales team headcount flat to down. And this is sort of where we would expect our numbers to be. Last quarter it was up. This was a bit down. Next quarter this month looks great. It's all sort of within the range that we expect as we now start pushing hard on the direct contracting side.

Okay. So, I mean -- that was great. If October had like 1,400 claims or so, that would be roughly half of what you did in the second quarter of this year. So, is it safe to say that the fourth quarter is going to be like a record volume quarter for Lucid?

I think you have to temper that by the fact that the tail end of the quarter starts to have some holiday periods. We saw last year some of the large events tailed off because of the holidays. So, you have a baseline of 2,500 to 3,000 tests on a quarter-by-quarter basis and that can be additive by some of these large events which give a little bit more choppiness to the predictability of it. But the bottom-line is the adoption is continuing to be validated and expanded by some of the additional channel -- sales channels that Lishan outlined.

And the pipeline is robust. The CYFT pipeline is pretty robust. And so yes I think again I'd sort of just reiterate this is -- yes, I would consider this sort of a stable to overall modest little increases, which is exactly how we've been positioning ourselves to maintain our operating expense where it is as we move towards recognizing broader reimbursement and recognizing a greater percentage of this test volume being paid through direct contracting.

Yes. So, bottom-line is the first six, seven weeks of the fourth quarter are very encouraging in terms of the results so far.

All right, great. That sounds promising. And then separately on the recent kind of announcement to further push or penetrate into the concierge medicine market with some new folks from GRAIL and so forth. So, that's super interesting kind of non-traditional non-conventional way to do this type of like almost like wellness screening because I think you typically take this BCP kind of effort I guess or kind of call point. But this is a good market obviously right? So, can you just talk about the historical sort of penetration and success that you've had in the concierge medicine market? And then maybe like why now there could be like an inflection in that market for you? And why that why it really like meshes well with your type of screening?

Yes. So, it's a great question. So, as I mentioned the concierge medicine side of this is new. We have done some -- we've had some activity on the employer market side with self-funded entities as well as working and establishing our network of brokers that work to add EsoGuard as a covered benefit within brokerage plans. So that's moving forward. We're actually getting -- we've been -- prior to this initiative, we've been getting -- we've established some success at getting amendments to health and wellness plans that include EsoGuard as a benefit. The concierge medicine pathway is actually quite new -- is new for us entirely new for us. And it's really just been a result of us sort of seeing the success of other companies at putting forward new groundbreaking technologies where there's a real appetite for that in the concierge's medicine sector. That's a rapidly expanding sector. The timing of all of this is related to the fact that it's really related to our data. So, we've been pushing on the employer market side but this sort of acceleration of these efforts and bringing in people with direct experience and success from other companies who've done this is really linked to the fact that now we have a strong package of data. When you call on concierge medicine the initial engagement is fundamentally not that different than when we call on traditional primary care physicians. We have to make our case. We have to show our data and show the value of our test. The way this sector works is that they -- the physician the concierge medicine physicians are looking for these kinds of technologies to offer to their higher-end client patients who pay out of pocket for these kinds of tests and they've had a proven track record of getting patients to do so. So, we really look forward to starting to see some traction in this space.

Okay. One last one on that point. So, is it fair to say that your past work with employers health systems the test centers all that that actually helps you succeed I guess in the concierge market?

Absolutely. Yes. The -- as I mentioned the initial engagement is no different. So the folks that right now are focusing on concierge medicine their training and the way we go about talking to physicians -- physicians are physicians at the end of the day, is identical. And the groundwork we laid for that is definitely going to help us. There are just some nuances about how you actually structure those engagements that are unique to the concierge medicine side. The other part which of course is critical in all this is the infrastructure that we've established on the cell collection side of things, right? So we have a completely well-oiled machine right now in getting patients tested getting the cell collection performed and doing so either through our physical test centers but as we've talked about before increasingly through having our clinicians actually come to the physicians' offices on a regular basis and do the testing. So we were able to offer that to these concierge medicine practices as well as to larger networks. These concierge medicine practices are growing. There have been roll-ups that have large, large numbers hundreds of physicians within this -- within their infrastructure. So the infrastructure that we've put together on cell collection is obviously critical for that.

Okay. And then does the pricing in that market work more like the commercial market like you have a negotiated rate? Or is there like a bundle? Is it volume based? How does payment and pricing work in that market?

You establish a rate with the practice or the network practice and that's the rate -- and that's the rate that the patients pay.

Perfect. That sounds great. Thanks a lot. Appreciate it.

Yes, thanks, Kyle.

Our next question comes from the line of Mark Massaro from BTIG. Your line is open.

Hi, Mark.

Hi, guys. Thank you for taking the questions. Great updates. I appreciate the color on October and November volumes. Things are obviously moving in the right direction. I wanted to just clarify the -- maybe Lishan your commentary about the EsoGuard BE-1 study accepted for peer-reviewed publication in the American Journal of Gastroenterology. Is it fair to say that that publication is on track to hit maybe by the end of this calendar year? And I would assume that you would be submitting this to MolDX immediately after that. Can you just give us a sense for timing?

Yes. No -- so it's this is from this point it's a formality. It's been accepted for publication. I believe the PDF of the sort of the unformatted will be available on their site soon. We're going through the usual formalities of getting the formatting before it will be posted on their website as being published very, very soon. And so we are poised now having met with MolDX having this particular paper now done and accepted to file our data and our request for reconsideration of the LCD in the coming days.

Okay. Great. Can you give us a sense for what your funnel looks like in the CYFT pipeline? You characterized it as robust. However, I recognize that December gets pretty cold. And so I'm just thinking about weather and seasonality and also fewer days due to holidays. Just give us a sense for maybe how many events you are planning to host in Q4 and what your runway might look like into 2025?

I think Mark we're going to limit it to say that usually these Check Your Food Tube events are scheduled out three months and four months ahead. And except for the holidays in December our teams have their hands full over that period of time. So we'll update that as we go forward. But let's leave it at that. It's fairly robust. And rather than giving that prospective information we'll update it the next time we talk to the Street.

Okay. That's helpful. And then maybe last one for me. Yes, the concierge medicine is certainly interesting. Maybe just to clarify because I know that you've done a nice job of holding your ASPs, your $1,938 Medicare price. You've done a nice job of holding with commercial health plans. Can we look at that Medicare price as a potential proxy when you're going to sell into concierge? Or do you think because it's full self-pay there might be a discount to that?

We don't know yet. We come in with a – our list price is $2500. So that's our starting point. And this will be charged to patients. So I think it's a little bit too early to say but we are – we think the pricing is going to remain robust. Our margins are going to remain robust. And obviously, the opportunity to have guaranteed payment within the sector is very attractive to us. So just – I think I'll just leave it at that. Our pricing is – we think the pricing is going to hold up.

Okay. Great. Thanks for the reminder on the list price. That’s it for me. Thanks, guys.

Hey, thanks, Mark.

Our next question comes from the line of Anthony Vendetti from Maxim Group. Your line is open.

Thank you. Hey, Dennis. Hey, Lishan. How are you?

Good morning.

Great.

So I just wanted to dig in a little bit more on – it sounds like you're just about ready to submit the data package for Medicare coverage. What is that time line for that? Then once you submit it, what is the expected time line for a decision and then your plan to prepare for the eventual coverage decision, sales force all that?

Yes. So obviously, as with anything like this, whether it's FDA or CMS, there's no assurances as to how – we can't give sort of hard projections with regard to the time. But as I've said before, we've been deeply engaged with MolDX. We have a high level of confidence in our data. We understand that this reconsideration of the LCD is fairly straightforward because the work that had been done in the original LCD is very comprehensive. And we have no qualms with regard to how that's written. We're just looking for coverage for our own test. So I will just kind of leave it at we're very optimistic. We think it's likely to be a first half event for next year. And we'll know then. We're just really happy to have reached this point to have the data to be able to get this thing filed. And we're entering into this with a lot of optimism and confidence in both the data and in both our efforts to figure out how to precisely navigate this process with MolDx.

Okay. And the concierge option I guess concurrent with this submission is there – has there been decisions on pricing that? Would that be different than the current pricing for coverage decisions? Can you delve into that a little bit? Or is it...

Yes, yes. I touched on this a little bit with Mark but we're not – this doesn't really have anything to do with the coverage side of things, right? These are you walk in, you engage with a practice. You first make the case with regard to their understanding of the value of the test and their excitement about offering this test to their cash-paying patients and you negotiate a price. And as I said to Mark, our benchmark, our list price is $2500. And it's a negotiation to determine at what price they feel their patients will pay. This is a very select group. The concierge medicine practice is one where people are very used to not simply paying sometimes a substantial amount on a regular, monthly or annual basis just to be part of the practice but for added services, whether it be tests like this or the GRAIL test or other comprehensive cardiac evaluations and things like that. So that's how this ecosystem works. And we'll start at $2500 and we'll make a – we'll end up with sort of contractually arranged pricing that the practices will pass on to their patient. And it doesn't – this doesn't require – remember, this is direct pay. So this doesn't require us to submit claims and to work through the revenue cycle management process or all of the other hoops you have to jump through traditional reimbursement. This is effectively cash pay by the patients.

Great. Excellent. Thanks for the update. Appreciate it, Lishan.

Thanks, Anthony.

Our next question comes from the line of Mike Matson from Needham. Your line is open.

Yes. Hey, guys. So I guess first just when and if you get Medicare coverage probably not at this point, how does your marketing strategy kind of go-to-market approach change? I mean, I know you're deliberately targeting places that you're likely to get paid now but -- and doing the CYFT events and stuff. But are you going to do something differently when you get Medicare coverage?

Yes. So, about 25% of our volume right now is Medicare population, and you sort of hinted that we have the ability with our CYFT events to target folks, but really not so much based on payer right now. The epidemiology would suggest that up to 40% or more of the target population here are Medicare population. So, we certainly will have the ability upon Medicare approval to direct our resources towards that. But obviously -- and drive -- perhaps drive that percentage higher and certainly drive the proportion of our revenues that come from Medicare to be higher targeting retirement villages or population centers that have higher than average ages and so forth right? So -- but as a key reminder, this is not just about Medicare, right? Having Medicare coverage is the ticket or the entry or the gateway to finalizing ongoing conversations with commercial payers through their laboratory management groups like Evercore and others that do technical assessments on behalf of the larger plans. So, it's really a stepping stone towards getting broader commercial coverage. And we certainly would expect that to accelerate immediately after -- those efforts to accelerate and for us to start getting some runs across the plate after we secure Medicare coverage. So it's a combination of the two.

Okay. Yes, got it. And that kind of leads into my second question, which maybe you already partially answered. But just the dossier or data package, you're putting together for MolDx, do you think that that's sufficient for private insurers? And then to what degree do you think those private insurers sort of factor Medicare coverage assuming you get it into their own coverage decisions?

Yes. I mean, we obviously -- we have a lot of confidence in our data. We do believe it's sufficient for both Medicare as well as the commercial payers. And as I sort of already mentioned that it's not like we're not having active engagements or discussions on policy and so forth with the commercial payers right now. But having Medicare coverage in your pocket certainly has a big impact on those conversations.

Okay. Great. Thanks.

Okay. Thanks, Mike.

Our next question comes from the line of Ed Woo from Ascendiant Capital. Your line is open.

Hi. Ed.

Yes. Thank you for taking my question. My question is on the geographic dispersion of the test. Have this been pretty uniform? And is there certain areas of the country where you guys are more stronger?

Yes. There are certainly areas where -- just as with any commercial ramp you get areas where you develop traction as it relates to your personnel and so forth. And our team -- we've kept our team flat, but the team has been pretty dynamic in allocating resources in various locations. So, we're strong in California in Texas and Florida, but also in other parts of the country. We have -- we've talked about this before, I didn't mention it today that there are states that have biomarker legislation that have state legislation that mandates coverage for biomarker tests. And we've certainly taken that into consideration as well as we've looked to our geographic distribution.

Great. Well, thank you for answering my questions and wish you guys good luck.

Thanks, Ed.

Thanks, Ed. Appreciate it.

There are no further questions at this time. I would now like to turn the call over to Dr. Lishan Aklog for closing remarks.

Hi, so with that thank you all for your time and attention this morning. I think it should be clear that this is a moment in time for our company and we have a lot of exciting things to look forward to in the coming weeks and months. So, make sure you keep abreast of our progress via news releases and periodic calls such as this. And the best way to do so is to sign up for our e-mail alerts on the Lucid Investor Relations website and to follow us on Twitter, LinkedIn and our website. So, thank you everyone. We really appreciate it. And have a great day.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.