Lucid Diagnostics Inc.

Good morning and welcome to the Lucid Diagnostics First Quarter 2025 Business Update Conference Call. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Matt Riley, Lucid Diagnostics Senior Director of Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone.

Thank you for participating in today's business update call. Joining me today on the call are Dr. Leshawn Ackog, Chairman and Chief Executive Officer of Lucid Diagnostics, along with Dennis McGrath, Chief Financial Officer. 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 SEC. For a list and a description of these and other important risks and uncertainties that may affect our future operations, see Part 1, Item 1A, entitled Risk Factors in Lucid's Most Recent Annual Report on Forms 10-K, filed with the SEC, and any subsequent updates filed in quarterly reports on Forms 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. Leshawn Acklog, Chairman and CEO of Lucid.

Leshawn? Thank you, Matt, and good morning, everyone.

Thank you all 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 here at Lucid remains singularly focused on driving this enterprise towards its substantial commercial potential, and to enhance our long-term shareholder value. I really believe we're now better positioned than ever to capitalize on ESAGAR's really huge clinical and market opportunity. We continue to make steady progress since the last update, which was just six weeks ago. Perhaps most importantly, we've secured capital to extend our runway past some reimbursement milestones. And we are continuing to drive our cash pay and contracted programs that we launched earlier this year, targeting concierge medicine practices and employers. We continue to have momentum in our engagements with regional commercial insurers on securing ESA card coverage. We're waiting to hear back from the Moldy Exit Program on ESA card Medicare coverage, which we continue to believe is imminent. Thanks to our recent financings, we have plenty of runway, and we're well positioned to accelerate our commercialization once we secure Medicare coverage. So let's start with some key highlights related to our commercial execution. So we performed 3,034 e-cigarette tests in the first quarter. That's the upper end of our range of 2,500 to 3,000 tests per quarter. And as we mentioned before, we're kind of happy to maintain that volume, that we've been able to maintain that volume. while transitioning our commercial team to these new sales channels to drive revenue, such as concierge and employers. Our revenue of $800,000 fell a bit short due to external headwinds and greater concentration of testing through our health fair events, and Dennis will provide some more details and color on that a bit later. We also launched our Embrace the Future campaign, showcasing ESUCHEC's groundbreaking Collect and Protect Cell Collection technology relative to antiquated sponge-on-string devices, and we'll provide some more details on that a bit later. We have had a successful partnership with a major health system to launch a comprehensive ESAGARD esophageal precancer testing program, and this will expand access to at-risk patients across the full spectrum of their digestive health teams, their gastroenterology team, primary care, and for the first time, a concierge medicine program that is housed within a major health system. We'll have a more formal announcement coming in the very near term on this. And we have continued momentum executing our concierge medicine program to expand e-cigarette access on a cash-pay basis. We doubled our total number of contracts in the past six weeks, and our team is starting to build critical procedures and materials, marketing materials and other patient materials to drive patient volume once contracts are in place. We continue to expect an impact on revenue from this effort in the second half of this year. And we're also making meaningful progress executing employer market contracts, and we have a strong pipeline of opportunities, both with employers as well as with fire departments. We doubled the number of employer contracts in the first quarter. And, of course, these two efforts, the cash pay concierge medicine practice, as well as our direct contracting with employers and fire departments, really serves to complement our ongoing efforts at traditional reimbursement through coverage and positive medical policy from private payers and with Medicare. Now let's discuss some of our recent strategic accomplishments. As I noted earlier, we're extremely happy that we strengthened our balance sheet with an underwritten public offering of common stock that netted approximately $16.1 million in proceeds. This really significantly bolsters our balance sheet with over $40 million in pro forma cash at the end of the first quarter. And this importantly extends our runway well into 2026 and past key milestones. And this really mitigates our risk from the perspective of external factors. And it also provides us the resources to immediately ramp up our commercial efforts after we receive Medicare approval. We're also happy to report that the new piece of clinical data that the NCI-sponsored study showed that Isagard was effective at detecting the self-suggested pre-cancer in at-risk patients without heartburn and GERD symptoms, and that this will ultimately support an expanded indication and market opportunity. This was the initial study that led to the larger ongoing study, five-year NIH study for which a large NIH grant was secured. And it showed 100% negative predictive values, so no false negatives. And a prevalence in this population of patients without GERD symptoms or who are otherwise have risk factors consistent with the American Gastroenterological Association, the prevalence was about 8%, which is really not that much lower than in the heartburn population. So it really demonstrates that this is a target population that could emerge in the future. If the NIH study replicates this and, in fact, the target population expands to patients without symptoms of heartburn, then our already large $60 billion total addressable market could increase by as much as 70%. So before turning the call over to Dennis, I just want to provide a bit more detail on a couple of select topics. I'd like to review in a bit more detail our ongoing reimbursement efforts and talk a bit about our Embrace the Future campaign related to EtherCheck and our experience with that at the big DDW conference earlier this month. Let's start with commercial payers. As we announced in March, we secured our first positive policy coverage from Highmark Blue Cross and Shield of New York, and that policy will be active just in a couple weeks later this month. our expectations with regard to that have played out. So this clearly is helping us in our conversations with other regional plans, including other regional Blue Cross Blue Shield plans. It serves as a precedent to drive additional positive policy coverage decisions, and that's played out in the field as we continue to engage, and we remain deeply engaged with a robust pipeline of regional plans. As we've clearly expressed in the past, and just to reiterate, that we believe there's plenty of opportunity to hunt in the regional plan territory, but that the larger plans, the nationwide, United, Anthems, and others, will likely wait for us to secure Medicare coverage. Another big area, again, just in the last six weeks that we've noticed is that, as we announced in March, the NCCN, National Comprehensive Cancer Care Network, updated its clinical practice guidelines to include, for the first time, a section on esophageal precancer screening that mimics the GI guidelines. And we knew this was highly influential. It's something that payers pay a lot of attention to. But what we've already learned just, again, in the field is that this has been very helpful already in our conversations with payers. We've already had multiple meetings where medical directors at regional plans have acknowledged the importance of these NCCN guidelines and have acknowledged that us having it would be helpful. So we really do believe, just even on the early experience from just a few weeks into this, that the NCCN clinical practice guidelines will really be a valuable tool in helping us drive positive commercial insurance policy coverage decisions in the coming months. And on to Medicare. So just to remind people a little bit of history here, we previously, at the end of last year, submitted our complete EFA Guard clinical evidence package in support of a request for reconsideration. of an existing Medicare LCD that seeks to cover eSAGARD and tests in this category based on existing coverage criteria that align with the American College of Gastroenterology guidelines. And we really believe that this package is outstanding, it's complete, and provides unprecedented data. And as I mentioned, it really aligns with the criteria for coverage that are already in the existing LCD. And so we really remain optimistic about the outcome. The next step will be the issuance of a draft LCD proposing Medicare coverage. And we really, again, believe this is imminent. And we're in good shape with plenty of runway to navigate this process before ultimately accelerating commercialization once we secure Medicare coverage, which, again, we believe is imminent. Moving on to our Embrace the Future campaign, thought we'd give you a little bit of a highlight of what we're doing in this space. Historically, our marketing efforts to the physician community is focused on E-Cigar, and that's appropriate because that's the actual test that's delivering the results and giving the positive and negative results that drive patient care. But there's really an opportunity that we've decided to really highlight the outstanding performance of not just E-Cigar, but our cell collection in over now 30,000 patients to date. and to really contrast them to these legacy sponge-on-a-string devices, which are decades old and sort of the equivalent of a Brillo pad versus our soft balloon, modern soft balloon device. There have been publications out there for other tests. There have been some presentations, electric tests that seek to enter the space using these sponge-on-a-string devices, so we thought that this was the opportunity to highlight to the GI community what the future of esophageal cell collection is. And so we've been put forth, as you can see on the slide here, a variety of marketing materials that demonstrates a pristine safety record, really high patient satisfaction, very high success rates of over 95, 96%. The fact that ESO check can be performed in less than three minutes or early down to less than two in our hands. and contrast that to the safety profile to the FDA recalls that have occurred with multiple sponge-on-string devices. And so this has been successful. We had a really positive experience at DDW highlighting this in a pretty assertive, let's just say, ad campaign that highlights this contrast. And we'll continue to do that, really, to just remind the gastroenterology community in particular of the unique features of ESOCHEC that we think ultimately play a critical role in the performance of ESOGARD and the clinical validity data we've been able to generate. So with that, before handing it over to Dennis, I'd like to summarize by saying we really believe we're set up very well from a commercial point of view and based on our financial resources and balance sheet to really advance the ISA Guard through our efforts to gain Medicare and commercial coverage as well as through our new sales channels where we seek to drive revenue. So we really do look forward to continuing to maintain our test volume and grow revenue over the coming quarters.

So with that, let's pass the call on to Dennis. Thanks, Leshauna.

Good morning, everyone. Summary financial results for the first quarter were reported in our press release, but it's been distributed. On the next three slides, I'll emphasize a few key financial highlights from the first quarter, but I encourage you to consider those remarks in the context of full disclosures covered in our annual report. and on Form 10-Q. With regard to the balance sheet, cash at the end of the quarter on March 31st was $25.2 million. Obviously, this does not include the net proceeds from the recent $16 million confidentiality market public offering completed on April 11th, which when added to the above would give us the pro forma cash of about $41 million as we entered the second quarter. You'll recall that during the fourth quarter, we refinanced our convertible debt, which is a five-year note, interest only at 12%, with a dollar conversion price, and it's held by long-term shareholders. The fair value of the convertible notes at 32.8 million at quarter end is really the only other substantive change from the previous reported balances at the end of December. The fair value increase reflects a mark-to-market uh quarterly adjustment in parallel with the common stock price increase of 82 percent from december 31st to march 31st the quarterly burn rate was 11.3 million which is slightly higher than the average burn rates with the four preceding quarters of 11.1 part of which is due to a full quarter's interest charge on the convertible debt mostly paid in cash the burn in the first quarter included 8.2 million from ongoing operations and $3.1 million from the quarterly management services agreement. Shares outstanding, including unvested RSAs as of last week, are approximately $108 million. The GAAP outstanding shares as of March 31st of $84.4 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested restricted service awards. At present, PadMed continues to be the single largest shareholder of Lucid Diagnostics with ownership of approximately 29% of the common shares outstanding. Although PadMed no longer has voting control of Lucid, PadMed together with the board and management still have significant influence over Lucid with more than 27% of the voting interest. As you're aware, Lucid's financing last year included the issuance of a series of voting convertible preferred securities, whereby the preferred shareholders are significantly incentivized to delay conversion of the preferred shares into common shares until 2026, namely the second anniversary from closing. If all of the preferred shares outstanding were converted to common shares as of today, there would be an additional 49.6 million shares outstanding. With regard to the P&L, This slide compares this year's first quarter to last year's first quarter on certain key items. I trust you'll review the information in my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information. With over 3,000 tests for the first quarter, we invoiced more than $7.5 million and recognized revenue of approximately $800,000, largely based on the amounts collected during the quarter. Collections were lower sequentially and year over year, mostly related to delayed cash collections from UnitedHealthcare, which generally pays us at the Medicare rate and within a reasonable timeframe, but had a national issue with rolling out its new system deck Z code for molecular pathology claims that delayed processing these claims. They're still working through the backlog with a 60 to 90 day time delay from the initial Z code assignment to final CPT code pairing and claim readiness. Additionally, the quarterly test mix included some larger testing events that involved Kaiser, and we're still working through claim denials with that insurer. With new investors once again joining us for this call, it's worth repeating what we've communicated in past quarters about revenue recognition. Key determinant in how revenue is recognized at this point in our reimbursement journey is the probability of collection. Therefore, due to the fact that we are in the early stages of the reimbursement process, means revenue recognition claims submitted to traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is delivered, invoiced, and submitted for reimbursement. You'll see in our 10-Q, this is called Variable Consideration, a jargon of GAAP's ASC 606 Revenue Recognition Guidelines where presently there is insufficient predicted data to reflect revenue when the test report is delivered to the referring physician. for billable amounts contracted directly with employers or through concierge medicine and that are fixed and determinable will be recognized as revenue when our contracted service is delivered. Generally, that means when the report is delivered to the referring physician. Our non-GAAP loss for the first quarter of $11.2 million is slightly higher than the trailing four-quarter average of $10.8 million. However, if adjusted for the $800,000 financing cost incurred in the quarter would have been modestly lower than the four-quarter average. The non-GAAP net loss per share of 16 cents is lower sequentially as well as in each of the last four quarters with a trailing four-quarter average of 20 cents per share. On a GAAP EPS basis, the first quarter non-cash charges accounting for approximately 36 cents per share include 13 cents per share related to the Series B preferred dividend issued on March 13th. With regard to our operating expenses, this slide is a graphic illustration of our operating expenses after eliminating non-cash expenses for the periods reflected. Non-GAAP operating expenses were flat sequentially and after normalizing for deal expenses and interest expense for both fourth quarter and first quarter are in line with the last six quarters. Let me close with a few reimbursement highlights for the first quarter. In the first quarter, we billed 3,034 tests, reflecting just over $7.5 million in pro forma revenue. During the first quarter, we collected $800,000 from traditional reimbursement claims. Of that amount collected, about 20% was for claims submitted in the first quarter, about 60% from claims submitted in the previous quarter, and the balance from claims submitted more than six months ago was the longest-dated item roughly 21 months ago. Of the claims submitted in the first quarter, about 60% have been adjudicated, 40% are pending. Out of the 60% that have been adjudicated, about 30% resulted in an allowable amount by the insurance company with an average of about $1,362 per test. Important to note that the median was right at the Medicare rate. $19.38 and one cent. Of those denied, about 50% are either A, deemed not medically necessary, B, require prior authorization, or C, required additional medical records. Additionally, about 30% were deemed to be non-covered. So with that, operator, let's open it up for questions.

Thank you, ladies and gentlemen. We'll now begin the question and answer session. Should you have a question, please press the star, followed by the one on your touch-tone phone. You'll then hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star, followed by the two. If you are using a speakerphone, please lift the hands up before pressing the two. One moment, please, for your first question. And your first question comes from Mark Mazower from BTIG. Please go ahead.

Hey, good morning, guys. Thank you. Thanks for taking the questions.

Hey. So yeah, I just figured I would start with the Q1 volumes. Obviously, you did come in above the high end of that 2,500 to 3,000 threshold that you've talked about to get a large enough number of claims for payers, so that's good. Can you just give us a sense if weather was an impact in the quarter? And then as we think about Q2, Would it be reasonable to think that that number might increase, or is it still a little too early based on the timing of events?

Yeah, thanks, Mark. So you characterized it correctly. As we said before, during this period while we're waiting for broader coverage, our goal is to sort of maintain, to protect our cash burn and operating expenses to maintain a volume in this range that gives us sufficient volume to remain engaged with the regional health payers and other payers, and that's held up. The one thing that Dennis hinted at that was different, the direct answer to your question is no, we don't believe weather. We have no evidence. Let's just say that weather was a factor. The one thing that Dennis hinted at, which may be worth emphasizing, is that as we've made this transition with our sales team to have a subset of them focus on new sales channels, such as concierge medicine and increasing emphasis on contracted and revenue-generating targets that the proportion of the volume that is represented by these larger Check Your Food Tube events has increased. And that's just sort of the natural effect of that. As those events are much more efficient, they allow us to kind of reach these numbers and draw out the number of claims submissions to the traditional plans. One thing that comes of that is they tend to be lumpier, right? So if you have 1,000 tests that are being ordered by a whole variety of physicians versus a handful of fire departments where there's a single payer typically for that, it tends to be lumpier, and so that can make the revenue number lumpier. But overall, no, things are pretty steady. Beyond that, somewhat shift more towards the check for these CYFT events, the health fair events. And I would still recommend that we sort of assume that we'll be in this range until either we get Medicare and are able to drive a volume towards elderly populations or as the commercial coverage, as we start to get broadening commercial coverage, at which point we'll look to drive volume beyond these levels.

Okay, great. I think, Leishon, you indicated that you think the Palmetto GBA decision for Medicare coverage could be imminent. I was just curious if you could provide any color with respect to whether or not there is active dialogue, or is this more of like you had a conversation or meeting months ago, and you're just waiting to hear something?

Yeah. That's a good question. Yeah, no, we haven't gone back and engaged with the Moldy X group. It wasn't a meeting. We had multiple meetings and multiple engagements heading up to the submission. And our expectations with regard to how long it would take them to process this request for reconsideration is based on the details of those conversations. As a reminder, sort of the substance of that is that what we submitted was a request to reconsider the previous LCD which was written as a coverage LCD but was non-covered because there were no tests that had sufficient data at the time that was published not two years ago and so the work that was that's required for them is very different and substantially less than a typical new LCD or even a typical reconsideration which was which seeks to change the coverage criteria or change other meaningful aspects of the LCD. We did not do that. We just said, here's our data, here's a summary of our data. We provided a detailed summary that, and frankly, a red line of the existing LCD that simply incorporates our data and asks that the test not be covered based on that. So because of that, because the group had already done all of the hard work that typically takes the periods of time assessing the space and understanding the underlying clinical and scientific basis for all of this. That's where our estimates as to how long it would take them to complete that process of reviewing our data and acknowledging that it aligns with the coverage criteria. And that's why we still think it's coming soon.

Okay, great. And then I'll ask one more and then hop back in the queue. It was great to see the NCI-sponsored study, which showed the value of ESAGARD in patients without symptomatic GERD. I'd be curious to understand what is next. You know, I imagine that additional studies or data would have to be presented in order to, longer term, potentially gain Medicare coverage. And I think there was an NIH grant that was associated with that. So how are you thinking about investing in additional data and what are your thoughts about timelines?

Yeah, exactly. So let's make sure we put this, you got that right. Let's just make sure we put this in the right perspective, right? Right now, our goal is to target the 30 million plus patients who fulfill the more conservative American College of Gastroenterology guidelines, which require that the patient have longstanding heartburn plus three out of six risk factors. There's plenty of room for us to hunt in that space. And our conversations with payers, frankly, including Medicare, are limited to that, right? So the Medicare LCD criteria match are identical to that more conservative criterion. However, there's a growing understanding within the GI community that GERD heartburn is not as powerful a risk factor and also very hard to document accurately. And the reason for that is a variety of things, but one of them being that patients are taking PPI medications that are effective at suppressing symptoms. And also the development of these precancerous conditions can blunt the symptoms. So there's an increasing realization of that that was first manifested in the fact that the other big GI society, the American Gastroenterological Association, removed a requirement for GERD and just made it to be a risk factor. So that's, it's that momentum within the GI community and sort of the understanding of the clinical situation here that in order for us to really have, you know, maximal effect at preventing cancer, that we have to look at these asymptomatic patients. This NCI-sponsored study was the first step towards that, and it showed, as I said, two really critical things. One, that Isagard works in patients who don't have heartburn. We're not surprised by that, but it showed 100% negative predictive value for e-cigarettes. But perhaps the more important, or at least as important, data point was that 8% prevalence. You might wonder if you remove heartburn that, okay, well, maybe that's a lower-risk population. Maybe they're at 3% or 4%, and the long-term opportunity to justify testing in a group of patients that have less pre-cancer might be lower. So that 8% number is really right up there in a similar range to those who have GERD. So that first box has been checked. You're right, that's not going to be sufficient for there to be expanded. The universal guidelines, for all the guidelines to say that, and frankly for the payers to buy into that, that's going to require more data. And that's where the NIH study comes in. So the group led by Case Western, but that includes multiple major academic centers, received an NIH, $8 billion NIH grant to replicate the data from this pilot study on a larger basis. I believe the number is 800 patients over the coming years. And that data will be the sort of definitive data that will drive the expansion of the clinical indications and therefore the expansion of the market opportunity. I don't think we'll need any more data beyond that.

Oh, wow. Okay. Thanks very much, guys.

Thank you. And your next question comes from Kyle Mixon from Canaccord Genuity. Please go ahead.

Good morning, Kyle. Hey, guys. Good morning. Thanks for the questions. I wanted to talk about a volume that's helpful. On ASP, though, I know you're just collecting cash, and it's not a perfect system right now given the lack of reimbursement. But I feel like you're working with more concierge medicine, more contracting companies. and the payment rate should be a little more, at least should be elevated, I thought, and now it looks like it declined quarter over quarter, the effect of ASP. So could you just talk about mixing the quarter? I know you got the events and everything, but just mix and then how that flows into pricing and everything, and again, maybe how we should think about it for the rest of the year.

Yeah, let me have Dennis talk about that, but just to start off, just a reminder that The institution, particularly the concierge practice and the expanded targeting of the contracts and the FOIA stuff happened pretty recently, right? The shift in the sales team happened at the beginning of the year. We just started pulling in contracts in the past couple of months, and we've expanded the number of contracts. We've demonstrated that we can get concierge practices on board, but translating that into patients who are actually getting tested, even with the lower bar to recognize revenue in those patients, we're still somewhat early in that process. So I think Dennis can probably comment on sort of that contribution to the current revenue numbers and the ASP is minimal for this quarter, for the first quarter. Next.

Dennis? Yeah, that is absolutely true. Kyle, I don't want to put too much undue weight on this topic because if we were in-network, this wouldn't even be a discussion point as it would not even affect our revenues. or even our analysis of the business performance, maybe an uptick in our receivables, but not affecting our revenue just because of the accounting methodology. So the only issue is that we are still working through reimbursement, and the central actor here still in the storyline is Medicare approval. But with that, let me give you a couple stats. The two that I mentioned, and you can use any AI-generated data source, you'll see that the Z code issue has been a chronic issue with United. But in any case, both United and Kaiser in the last two quarters generated each 1.3 million in billable amounts. And specifically with United, the collection rate for United in the third quarter last year was 30 plus percent, 32% I think it was. In the first quarter was only 10%. And that Z code issue related to a number of denials and resubmission and working through it. Kaiser on the other hand came about and that was about 10% of our volume in the first quarter. and a little bit less than that in the fourth quarter. That 1.3, we have collected zero on, and our teams are working through that. Kaiser and other IDNs like it. We will be important long-term, so it's important we start filing claims, we engage with them, we start that process to get into their network. But that resulted in zero of our collections. So there's some of the stats related to the mix. But like I said, I don't want to put a whole lot of weight on this topic simply because it's not an indication of the performance of the business. It's an indication of where we stand with the reimbursement journey.

Maybe I could just emphasize one other thing, Kyle, if you don't mind. I know your focus was around concierge and employers, and that is, again, there was not any meaningful concierge activity in the first quarter, but The IDN question is really an interesting one because they're not traditional, just sort of commercial payers, but they have health plans as well. And we have had a handful of them, the notable one obviously being Kaiser and a handful of others. And our ability to engage with them as a result of the increased volume of activity within them has been positive. So we've had some positive engagements with them. the larger IDNs, and we look forward to securing contracted coverage with them while we're sort of in the same vein as we're doing with the regional plans.

Okay, perfect. That was great. And can you actually just talk about the Medicare mix and how that's trended recently and how you expect it to go going forward?

Yeah, we should always... Go ahead, Dennis, sorry. Yeah, so... interesting question i'm going to expand upon that so we have about 19 million dollars total in our backlog that our reimbursement teams are working on collecting about 15 million of that is in the last 12 months and the medicare percentage changes every quarter we focus on this because of when we get final approval you've got the 12 months a backlog that you can submit claims And that varies quarter by quarter. And given that we are now awaiting the approval and our teams have been focused on concierge medicine, the percentage of Medicare is lower. It's probably right now 10, 12 to 15% of our volume. But obviously the goal there is 40%. When you think about the 30 million patients that are symptomatic that are part of the ACG guidelines and what we're seeking for Medicare, 40% of that $30 million is our targeted audience. It could be even higher than that, but that's generally the way we think about it. And with Medicare approval, we already have plans in place and tactics that are ready to go to start hunting for that particular patient that is in the Medicare group. And our goal will be as quickly as possible to take that initiative 12 to 15% up to 40% of our test volume and our growing test volume.

Perfect.

And finally, um, yeah, I guess you're like alluding to partnering with the major health system to do like a comprehensive, um, you know, e-cigar testing program. Do you have like a lot of those, um, health systems in the pipeline or is this more of like a pilot and you'll try it out and you'll see if others make sense to partner with?

No, no, we have a, but we have a good pipeline of those, but these are long lead time. I think this particular one we've been working on for about a year. We've had positive engagements with the gastroenterologist. And what's a bit interesting, and also, by the way, we haven't sort of announced every time we have a major health system. We've been careful to just sort of wait and see how they develop in terms of traction. But what's interesting about this one, as I said, we'll provide a more detailed announcement once it's once we have signed off to do so from the institution, from the health system, is that they have a very large concierge medicine practice. So this was the first time where we've gone into a health system and said we'd like, you know, not only to implement broad-based esophageal pre-cancer testing that includes ESOCHEC and the ESOGARD and work out exactly who's going to do the cell collection and how we're going to go target patients and how are we going to communicate with the primary care physicians and all of the things that go into building that kind of a program. This particular health system, and many, they're not unique in this, has a large concierge medicine practice. So the work we've done in learning how to engage with concierge medicine practices over the last couple of months really paid off. And so this is an engagement that covers all of the above, and it requires some slight tweaks to how it's done within the concierge group versus the broader group. And so it does serve as a template for the future, but we do have a significant pipeline of others that we're working on, but they're longer lead times. So we have to do this as well as the other paths to engaging employers, fire departments, and as well as individual and smaller practices.

Okay, that's interesting. Thanks, LeSean. Thanks, Dennis. Yeah, thanks, Kyle.

Thank you. And your next question comes from Mike Mattson from Needham Company.

Please go ahead. Yeah, thanks. Glad to hear that you're feeling positive about the Moldy X. I guess not to sound negative here, but just, you know, do you have any contingency plans or, you know, I guess what would you do if for some reason you don't get it when you expect it?

Well, I mean, I think the key thing is that we've already sort of started, I wouldn't say contingency plans, really, but because we do expect to get it, but we are also, you know, we are building this parallel pipeline of concierge and employer contracted revenue to drive revenue. And, you know, Dennis talked last time about our expectations with how that will register in the second half and cut our burn. The most important mitigating factor is that we've raised capital to get us through these milestones. And so we're well positioned to handle any delays, but we really are expecting it. The time has come, given the amount of work that we expect they needed to do in order to do the analysis and proceed with the draft coverage.

Okay, got it. And then, you know, leads into my next question, just on the concierge program. So I guess, you know, I'm not real familiar with how those things work, but you know, how do the patients that are, you know, enrolled in those kind of hear about Esoguard and, you know, decide whether or not that's something they want to opt in for? And is there anything you can do to kind of market the tests, you know, or provide kind of information to those people in those plans? Yeah.

So that's exactly what you described is exactly what we're doing. And we're not inventing this from scratch. There are other companies that have done this, most notably Grail, that has been engaged with concierge practices for a while and has sort of figured out the secret sauce to go from having a concierge practice that you've won over and you've convinced this is something that they should be offering to their patients on a cash pay basis along with other other testing that is attractive to this particular patient population, and it's exactly what you described, and that's exactly what I was mentioning earlier that we are in the process of doing. So we now know that our team can go out and secure contracts. That's clear. Our talk track, the data that we've built up has worked very well in our ability to engage the physicians to say, oh, yeah, this is something I'd like to offer my patients. by concierge patients. And now we are in the process of optimizing and kind of fine-tuning our patient-facing materials to target this particular patient population and also our processes by which we work hand-in-hand with the practice to go out and let their patients know that this is available and why it might be valuable and who's at risk and who's at Who would be the appropriate patients to do that? So that's a very active process that we're engaged with, and we're making, you know, as you might imagine, we have a pretty robust methodology for doing that from our traditional approach, targeting primary care physicians. That includes even helping them figure out how to go to their EHRs and identify at-risk patients and contacting them directly and proactively to suggest this. So we have experience doing this. We're just in the process of tailoring those processes and materials to the unique aspects of a concierge medicine practice patient.

Okay, got it. Thank you. Great. Thanks, Mike.

Thank you. And your next question comes from Jeremy Perlman from Maxim Group. Please go ahead.

Hi, Jeremy. How are you? Good. How are you? I'm doing well. So this shift in commercial strategy more towards the cash pay and concierge medicine, is that more short-term to just bridge the gap to the potential Medicare coverage, or is that market in the cash pay concierge large enough? Have you seen that it's worthwhile to continue that commercial push even after a potential approval for Medicare? At that point, you would supplement sales reps and target additional insurers.

So, yeah, let's be careful about words here because I don't want to characterize this as a shift, really. It's really just supplemental alongside. It's all of the above, right? We're going, we're targeting coverage and payment and revenue everywhere we can. So we're on the traditional side. We are engaging with regional plans that we believe we can secure even before Medicare, right? So we have Highmark at the Highmark. coverage policy is helping us engage with others, and we think that will continue to remain fruitful. The larger plans will wait for Medicare. Medicare obviously will wait for Medicare. But then on top of that, supplementing that, we've allocated resources towards areas where there are patients that can pay out of pocket and so that or institutions like entities like employers and fire departments that can pay on a contracted basis. So we guarantee revenue. So that's what we're doing now. We're not shifting yet. We've shifted some resources, but we're not shifting our strategy. Overall, it remains on all of the above efforts while we're pushing on the coverage side. Once we get broad, once we get broad, once we get Medicare coverage and that leads to broader commercial coverage, look, the vast majority of the opportunity here, the vast majority of those 30 million patients are going to be within traditional plans, and that's where we will put our resources. But I wouldn't underestimate there is a significant, on the employer side, about half, 50% of the population are in self-insured plans through their employer, so there's still a lot of opportunity to to grow there. And the concierge medicine sector is exploding. And given the attractiveness of the economics of targeting those, I suspect we'll continue to do so. But once we have broad coverage, the more traditional pathways will become dominant.

Understood. And then just one last question from us. There's some legislative efforts underway in some states. I think it's even been enacted in some states to cover, you know, biomarker testing, and particularly in cancer patients. Does that have any effect on your business? And are you helping with that? Is that, how would that, you know? Yeah, we're actively engaged in that.

We're helping with that. We are active in AdvaMed and other groups that are seeking to push those. New Jersey just passed one just across the river from us. And there are examples where that can be helpful, but there's always generally a fair amount of hair on those. You start with a state legislation that mandates this, but translating that into actually forcing payers to pay for your test takes time. There are larger advocacy groups that are sort of helping to narrow that, to make that more straightforward. So we're actively involved in that, but we're not... assuming that that's going to be the panacea by any stretch. It'll be helpful, but it won't be the panacea.

Understood. All right. Thank you for taking my questions. Thanks, Jeremy.

Thank you. And your next question comes from Ross Osborne from Kent or Fitzgerald. Please go ahead. Hey, guys.

Thanks for taking our questions. Good morning. So looking at your growing body of clinical utility data, would be curious to hear feedback from physicians and what they're excited about from recent publications and how you're now feeling about general awareness of ESA from the clinical community.

That's a great question. It's not something we talk about enough, probably, because, you know, the clinical validity data is sort of a sexier part of your clinical evidence package. But what's exciting is that we have the sort of full chain of evidence right now. We have and all of these are published, that physicians use the e-cigar test appropriately to triage patients who are positive to endoscopy and negative to not getting any further testing. The concordance of that is nearly 100%. We have published data that shows that when patients are diagnosed When patients have a positive isogard test, there's 85% compliance with them getting the endoscopy, which is really a high number relative to other tests where you triage patients to a more invasive test. And notably, we haven't highlighted this a whole lot, but it's double what the compliance rate is with an endoscopy without isogard. So if somebody... physician just says, hey, I'd like you to get an endoscopy, only about 40% of the patients will do that. If they have a positive e-cigar test, the likelihood of them completing that is double. And then the data that shows that when the patients do get in their endoscopy, the yield from that endoscopy in terms of the number of positive precancers that are detected is two and a half to threefold. So all three of those are really important. They're particularly important for different physician groups. So the primary referring docs want to know that they understand how to use the test appropriately. And then at the very end, the gastroenterologists are excited about the fact that their endoscopies are going to have a higher yield. They're going to find more positive patients that they will put through surveillance and then interventional ablation if needed. The awareness. excuse me, has been increasing and good. It's something that, you know, as a small company, you always have to work hard at to get attention. I think the, this was our, the DDW meeting is the biggest gastroenterology meeting in the world. It's a massive meeting. This year it was in Seattle. And we had a very strong presence there this year. We had a very active booth. We had a second area that I showed in the slides where we were able to talk about the advantages of, you know, how great ESOCHEC works. And, you know, you could tell just from the general traffic and the general engagement that there is much better awareness and understanding of the availability of this testing. So that's all been positive. We look forward to very soon having, being able to release data that corroborates this and will make our efforts, will strengthen our efforts in this area, which is we're in the final stages of collecting a very large 12,000 patient experience with ESOGARD and ESOCHEC testing in the real world, so a real-world experience that provides really outstanding data on how ESOCHEC is performed as well as on the types of patients that are being tested and how that's playing out in the real world. And that kind of real-world evidence is also often very useful, particularly when you have such a large sample size. So that will be coming soon as well, and that will help with those efforts.

But those efforts are going well.

Great. Glad to hear it. Thanks for taking our questions. Great. Thanks, Russ. Great question.

Thank you. And your last question comes from Ed Wu from Capital. Please go ahead.

Yeah. Thanks for taking my question. My question is, what's your visibility for large testing events for the rest of the year? And is there any seasonality to them?

The pipeline for the large testing events is great. We have a deep pipeline. We're scheduling months in advance. Our goal, of course, I think we've said this before, our goal is to transition those larger testing events, which still are dominated by fire departments, but we'll be increasingly including self-insured employers, to have those be contracted in advance. And so our team, we have now a dedicated team that's working with the fire departments on grants and other ways to make sure that when we do these larger events, that we get paid without having to go through the traditional claims process. And the visibility has also been great. We have just about every week there's local media coverage, particularly with the fire departments. We get really strong local media coverage on testing of fire departments and firefighters. And so there's increasing visibility. But the key aspect there is really transitioning those high-volume events to ones where we have contractually guaranteed payment in advance.

Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.

Yeah. Thanks, Ed.

Thank you. And there are no further questions at this time. I will now like to turn the call back over to Dr. Lishan Eklog. Please continue.

Great. So, hey, thank you all for your time and attention this morning. Thanks for all the great questions. Hope you got a sense that we feel really confident and like we are really well positioned to capitalize on this opportunity that we have in front of us with these regards that there's a variety of things that are imminent. We believe Medicare coverage is imminent. We believe we're going to continue to get momentum with the regional commercial insurers and that the larger insurers will follow with Medicare when we have you know, really good early signs with the cash pay and contracted sales channels. Those efforts then began in the first quarter. We believe we'll still, we'll actually start reflecting in our revenue numbers over time. And I'm happy that we have a stronger balance sheet to be able to navigate this process over the coming quarters. So with that, again, appreciate your time. We encourage you to keep abreast of our progress via our news releases and these calls, as well as on our website and through social media on Twitter and LinkedIn.

So thanks again, everybody, and have a great day.

Ladies and gentlemen, this concludes your conference call for today. We thank you very much for your participation and ask that you please do disconnect. Have a great day.