Dr. Lishan Aklog
Thank you, Matthew, and good morning, everyone. Thank you for joining us today and for your continued engagement and support. Let us begin with some key highlights for the fourth quarter and in recent weeks. We will start with some key highlights from the commercial side. Our EsoGuard test volume in the fourth quarter was 3,664. That exceeds our target range that we have articulated regularly of approximately 2,500 to 3,000 tests per quarter, and that represents a 29% increase from 2025. Revenue came in at $1,500,000 for the fourth quarter, about a 24% increase from 2025. We continue on the commercial side to engage our team in transitioning to target both Medicare, which we have talked about before, but now also the VA, which we will discuss in more depth. We are continuing our event-based testing to maintain the volume as prescribed. We are entering 2026 with significant momentum as we await Medicare coverage. Let us talk about the VA. It was a really important milestone for us that we were awarded a U.S. Department of Veterans Affairs, the VA, contract for EsoGuard. This was issued under the VA Federal Supply Schedule, or FSS, which centralizes ordering and includes pricing aligned with our established Medicare rate of $938. That was a great accomplishment. The VA, as most of you know, operates 170 medical centers across the country and serves approximately 9,000,000 enrolled veterans annually. This is a very clinically relevant population. Veterans have a higher risk of GERD and esophageal disease and a higher risk of having the risk factors recommended for esophageal precancer testing. We believe a significant portion of those 9,000,000 patients will be recommended for testing. We believe that our ability to secure this and to secure it at the Medicare rate is a testament to the strength of our clinical evidence. The VA is, in many ways, similar to Medicare in terms of how they view the clinical evidence and in approving this. We will discuss the business implications of this and the rollout from a commercial point of view in a bit more detail in the models. We are also very excited that we announced positive data from the largest reported real-world experience of esophageal precancer testing. This manuscript, which is now in the process of being peer-reviewed for publication, evaluated EsoGuard and EsoCheck in nearly 12,000 HET BRICK patients, and the results were outstanding. The study confirmed excellent technical test performance, rapid cell collection times, and appropriate physician use across the board. More specifically, the technical success rate for EsoCheck cell collection was 95%, and 95% of procedures were completed in under two minutes. It is important that we compare that to the historical alternative to EsoCheck and to explain this in contrast. The sponge-based tassel devices, which are 30 years old and somewhat antiquated, take at least 10 minutes or greater to do so. Being able to do this in a minute or two really provides an opportunity for us to roll this out in a variety of clinical settings. It was also 100% safe, in contrast to previous sponge-based devices, which have been plagued by Class I recalls as a result of unattached sponges. This data across a large number of patients—12,000 in a real-world setting—really confirmed the scalability and the viability of EsoGuard on samples collected with EsoCheck. It sets a very high standard that any clinically viable, widespread precancer screening tool must meet. We are quite skeptical that other technologies in this space will be able to reach that high standard. So, EsoGuard and EsoCheck clearly work in real life, in real patients, and at real-world scale, and the study demonstrates our preparedness for broad access. It has been extremely useful for us even in the preprint form in our engagements and discussions with commercial payers and even in our side conversations with Medicare. Before turning it over to Dennis, I wanted to provide more in-depth updates on two key aspects related to reimbursement and provide some additional context on the VA. Let us start with reimbursement. We are all anxiously awaiting the publication of a draft LCD for Medicare, and we remain highly confident that this is close. We have had ongoing engagements, in person and otherwise, with the leadership of MolDx. We continue to feel strongly and to understand and believe that the MolDx group and others view the CAC meeting, the Contractor Advisory Committee meeting, that occurred in September, as being a home run—with 11 clinicians unequivocally, in somewhat unprecedented fashion, all aligning with the clinical validity and clinical utility evidence that we demonstrated. We believe the fact that we are still waiting for this is related to logistical delays. There have been other LCDs that have been held up. We have some positive signs in that several LCDs that were in the CAC meeting process in the late summer of last year have started to come across the finish line, and we believe that we are next. The next steps, to remind everybody, once we get the publication of this draft LCD that proposes coverage for EsoGuard, there will be a mandatory 45-day comment period. After that public comment period, which includes the public meeting, there will be a publication of a final LCD and an official notice and register of EsoGuard coverage. Once that final LCD and that official notice are complete, then Lucid Diagnostics Inc. will be eligible for payments going back on Medicare claims dating back one year. While we are awaiting Medicare coverage—as everybody else is—I want to make it clear that we are continuing to push forward on two other very important fronts on the reimbursement, on the commercial side. As we hinted at last time, and now it has become clearer, we have some very positive engagements with several of the large payers. The most notable one is with UnitedHealthcare. As we noted at our last meeting, UnitedHealthcare included in their coverage policy for endoscopy for EGD in this condition the fact that a positive EsoGuard test was an appropriate indicator for coverage of the EGD, and we viewed that—and our consultants and others viewed that—as a sign of de facto coverage. We are viewing it as that and proceeding accordingly. We have entered into the credentialing process with UnitedHealthcare, and that positions us to enter into contracting discussions once that is secured. There are some other examples where that is also the case, though a little bit more complicated, including Cigna and potentially Anthem. We believe that we have the opportunity to leverage policies related to endoscopy to secure in-network coverage of EsoGuard, and we are pursuing those aggressively. What that allows us to do is to have an alternative pathway that is not typically available for molecular diagnostics tests. Molecular diagnostic tests typically have to work through the laboratory benefit management groups, the LBMs, and secure coverage through those groups that work on behalf of other payers and issue coverage policies accordingly. That is not to say that we do not remain deeply engaged with the LBMs—we do. In the situations where we have a pathway to securing in-network payment and contracting through the EGD policies, we will continue to do that, but we will also continue to engage with the laboratory benefit managers. Those engagements have been very positive. There has been very positive feedback on our clinical evidence, on our clinical validity, on our clinical utility data, and all of that. The one additional challenge with the commercial payers in general is that, unlike Medicare, they do look at cost-effectiveness data. We believe we have solid data already existing on that, but we are continuing to supplement that with more sophisticated modeling on cost-effectiveness that will be available for us to supplement these discussions in the coming quarters. We believe we have secured our first LBM positive policy coverage. We cannot disclose that yet. That will be coming up in the next couple of months. We had a very good conversation with the largest LBM recently and feel like we have a pathway forward for coverage on that front. We also continue to have extensive engagement with the Blue Cross Blue Shield Association, which is the umbrella organization of multiple Blue Cross Blue Shield plans. Those conversations continue to be in-depth and engaged, and we think they will result in future positive coverage policies from regional Blue Cross plans. In addition to that, we also remain engaged with IDNs, with integrated delivery networks. There are several large networks across the country, and one of them—a large one on the West Coast—we have had very good engagements with. We have good clinical champions within those. Engagements tend to be somewhat different than the engagements with the traditional commercial payers because they involve a more integrated, multifaceted engagement with both clinicians as well as the administrators. Those look good, and we feel like we will have some positive news on that front in the near future. Again, to reiterate, as we are waiting for Medicare, we are continuing to work hard on the commercial side. We believe that there are some near-term wins there and that the pipeline with our upgraded team is now very robust, and we will continue to start seeing some wins over the coming quarters. Let us talk about the VA system. We could not be more excited about this. This was an important win for our team. Getting on the FSS was important. Getting on the FSS without discounting relative to Medicare, acknowledging and validating the Medicare price and our clinical evidence, was a big win. What that now allows us to do is allows our team to engage with individual VA medical centers. We have a very robust pipeline of such engagements with individual centers across the country. Those engagements have been positive. We have been able to leverage the fact that we have solid data in a VA population. That is the Dr. Greer study from the Louis Stokes VA Center in Cleveland that is published, part of our clinical evidence package. Being in the VA population is very powerful as we engage. We know that the dynamics within the VA are different than they are at other centers—that the VA can often be resource-limited with regard to procedures. EGD resources in particular are limited. The wait times and timelines to get an EGD, particularly a screening EGD, can be high. EsoGuard really fits in nicely within this clinical ecosystem as a test that will allow for broader screening and triaging only those who are positive on EsoGuard—only those who have the highest yield—to EGD. The process is fairly straightforward. Since we are on the FSS now, we can engage, find clinical champions at that center, engage contracting, and have a PO issued. We do need to coordinate cell collection at these sites, and we have a variety of pathways to do that. We have also figured out how to allocate our commercial resources accordingly. As we have talked about before, prior to the VA, when it became clear that Medicare coverage was imminent, we made some changes to our commercial team to shift them and their incentives towards enhancing our Medicare volume so that once we get Medicare, we can put our foot on the gas and drive that Medicare business. We are reallocating our existing resources in the same way. We are not increasing our resources—we are very cognizant of our cash burn and our OpEx right now—but we are reallocating resources to make sure we are taking advantage of the opportunity with the VA. We have appointed one of our senior leaders on the commercial team to be a National Director for the VA, and he is working in close collaboration with our VP of Market Access to drive these engagements with the VA, turn them into contracts, turn them into POs, test volume, and ultimately revenue. That happens both at the senior leadership level and in the field. Everybody in the field within their region is incentivized to not just engage with primary care physicians or gastroenterologists or their call points or even with fire departments, but they are also incentivized within their region—and every region has a VA—to develop relationships with physicians and identify clinician champions that they can hand over to the senior leadership team on the more strategic side. All of this activity on the commercial team, all of the adjustments we have made for the Medicare side and now are making on the VA side, we are looking forward to those bearing fruit in the coming weeks and quarters. To summarize from a commercial point of view, throughout 2025 we demonstrated there is a market for EsoGuard, that we can maintain a steady volume that allows us to remain engaged with commercial payers, and that engaging with the commercial payers is starting to pay off into progress towards securing in-network coverage. We have demonstrated that we know how to generate demand. We know how to get physician adoption. We are increasingly improving our ability to engage with health systems, and our ability to engage with health systems will be accelerated dramatically once we get Medicare, because the lack of Medicare is an obstacle to engaging with health systems. All of that groundwork has been laid nicely, culminating in the data that will be published soon and has been publicly released on the real-world experience. That foundation—2025 was a really important year for us in laying that foundation. As we move into 2026, our focus is on converting the lessons that we have learned, converting our ability to generate that demand, into revenue, and the focus is on the VA right now and then on Medicare once we secure that coverage. Progress with the VA, with our commercial payers, and with Medicare puts us in a great position to turn the corner with regard to our commercial experience and track record and to ultimately put our foot on the gas and drive test volume and revenue accordingly. Everything we have done to date, all the real-world experience that we have been able to document, and our full body of clinical evidence puts us in a great position to do so. One aspect that comes up regularly, and the timing for this is perfect because we believe we are at an inflection point, has to do with EHR integration. In order, in 2026, for a molecular diagnostic test to be implemented clinically, it is not sufficient just to get physician adoption. Having EHR integration—which facilitates not only the ordering of the test but delivery of the test results, and in our case, facilitating the identification of patients through identification of risk factors—is a major boost to commercial activity. In addition to the work on the commercial side, the VA side, and on Medicare, we have started to push some resources to work on EHR integration. At this stage, we are doing so using systems that are more cost-effective to us, but that still allow us, when we engage with a health system, to engage in such a way so that the EHR—the Epic instance or whatever other system that that health system happens to be using—we can actually offer ordering physicians the ability to order the test and the ability to receive the results. Once we are in a position where we have accelerated volume and we are further along, we are prepared to invest in the most aggressive way to pursue EHR integration, which is to actually engage with Epic directly on Epicor, and we are well positioned to do that at the appropriate time. Again, we are all waiting for Medicare. Hopefully, that is any day now, but hopefully you get a sense of the extensive work this team has put in over the last quarter to set us up for a lot of success this year—what we are doing now and once we get it. I will now turn the call over to Dennis for the financial results.