Lucid Diagnostics | Lishan Aklog, Chairman

Lishan Aklog  0:00  
Good afternoon. glad everyone's here. I just like to start to thank start by thanking Scott on the LSI team for another great meeting. This is our third year here and it's just incredible how every year it seems to get more remarkable. So my name is Lishan Aklog. I'm chairman and CEO of Lucid diagnostics. And we'll tell you a little bit about Lucid. We're a commercial stage cancer prevention medical diagnostics company. And we're focused on early pre cancer detection in the millions of people with gastroesophageal reflux disease or GERD, also known as chronic heartburn, who are at risk of developing esophageal adenocarcinoma, which is a highly lethal form of esophageal cancer. And our mission is really simple as to prevent deaths from this cancer in these at risk patients with chronic heartburn. We have two lead products. The ESOGuard esophageal DNA assay, it's a molecular assay, which I'll talk about a bit and a very novel cell collection device called ESOCheck. Both of these are CMR cleared, ESOGuard as an LDT and EsoCheck is 510 K cleared and together they form the first and only commercially available test that's capable of serving as a widespread screening tool to prevent these deaths through the early detection of esophageal precancer. This came out of a research out of Case Western Reserve University that was published in a landmark paper in Science Translational Medicine in 2018. They presented two novel technologies a DNA methylation assay, which became EsoGuard and a swallowable balloon capsule catheter that became EsoCheck and they showed a greater than 90% sensitivity and specificity in detecting esophageal pre cancer and cancer. Some highlights of our company right now we have commercialized EsoGuard as a laboratory developed tests that are dedicated CLIA CAP laboratory we have lucid test centres where patients can go to get the procedure performed. We have CMS effective payment of $1,930. We're awaiting local coverage determination. We have breakthrough device designation and we have a large target population of 13 million patients who are at risk who are already recommended for screening. Some near term milestones which I'll talk about at a multibillion dollar tam. Important to note that lucid is a public company that's also a major subsidiary of Pavmed, which is another which is a NASDAQ listed diversified commercial stage medical technology company so Pavmed owns a majority interest in lucid Pavmed initially financed the development of this technology and its commercial launch, and Lucid completed a $70 million IPO in 2020. In the fall, but still managed by Pavmed. We have some renowned experts. We have the former chairman and CEO of Exact Sciences as their vice chairman Stan Lapidus, former head of the IBD branch at FDA as their primary regulatory adviser and a leading figure in the esophageal to space space and Nick Shaheen, who is the lead author on the guidelines as it relates to Barrett's so the opportunity, as I mentioned, is to prevent deaths from esophageal cancer. This is a bad actor highly lethal, 16,000 deaths a year second most lethal cancer 80% mortality. But the most important numbers here is in red, that even stage one disease carries a 40% mortality. And what that means is that it's not enough as in other cancers, breast, colon, cervical and others that you pick up stage one disease, you have to pick this up in the pre cancer stage, if you're going to have any hope of having an impact on on deaths. The other thing that's quite unique about this is that its incidence has increased dramatically 20,000 cases last year, a 500% increase over the last few decades. In contrast to all the cancers you can see their breast, colon, prostate and so forth, which have generally remained flat during that period of time likely related to the obesity epidemic epidemic. Its predisposing condition GERD is also ubiquitous. One in four adults have it 13 billion in sales of proton pump inhibitor medications a year and 50 million people who have weekly symptoms. So the key factor to know about the biology here is that GERD can lead to esophageal pre cancer and cancer and there's a steady progression. There's no controversy about this, you know, the predisposing condition. Early Stage pre cancer was called non dysplastic Barrett's late stage pre cancer dysplastic Barrett's and ultimately malignant cancer.

Unknown Speaker  4:16  
The good news is that the pre cancer can be monitored and cured before the cancer develops. So if you have non dysplastic, you can get an endoscopic surveillance and pick up when it reaches the dysplastic stage before it's fully malignant, and that can be treated with a highly effective endoscopic ablation procedure, which will I believe, prevents progression to cancer and reverses the process. The societies recommend screening so we know what the risk factors are. I want to numerate them there but they're very common risk factors three out of six, plus a history of GERD, strong recommendation to get screened by all the major societies with an endoscopy. The 13 million people are the highest target group in this population. The bad news is that it just doesn't get done. Unlike colonoscopy where 60-70% of people gets screened less than 10% of people who are already recommended for screening what will now be the third round of guidelines that are about to be published get screened. And that's just a tragedy. People are dying endlessly, every single day of esophageal cancer who had GERD had chronic heartburn who could have been screened, who didn't. And we know that screening works. We know breast colon 40 50%, declines in mortality over the last 20 years. And all we need is a viable screening program. We've had all the other elements here, I want to numerate them, you can read them there. But the one thing that's been missing until now was a widespread screening tool. And now we have that commercial opportunity is massive. 13 million patients, I already told you that Medicare's kind of set the bar at this $1900, just under $2,000 payment. 90% margins, huge, huge market opportunity, overall. The assay is a available now as a laboratory developed test, we launched our own laboratory we had this contracted out until last month. Now we have our own laboratory just up not too far from here in Lake Forest. And the sample gets sent to the central laboratory, the Esoguard assay, which as I mentioned is an NGS assay is performed, patient report positive or negative return which tells you either you have anything along the spectrum from pre cancer all the way to cancer. The procedure also very straightforward. Here's the device, it's a catheter with a capsule, you can see it in its Virtus state on the right about the size of a multivitamin. A balloon emerges from this as it's inflated as these ridges, and it allows you in less than five minutes non invasively in an office, no anesthesia and really two minutes to anatomically sample cells in the lower five centimeters, the esophagus where this condition occurs, and it protects that sample from dilution and contamination as you move up. A commercial strategy is straightforward. As I mentioned, we have made a lot of progress on reimbursement, we have payment, we're awaiting local coverage determination, hopefully sometime quite soon. And we're in the process of working with private payers as well.

Lishan Aklog  6:58  
We're targeting three different constituents here from gi physicians and for good surgeons who are really focused on the esophagus to primary care physicians where most of these patients that are no one has actually very few patients see a gastroenterologist to patients themselves who understand heartburn. They understand cancer, they just don't, they just need to be educated on the relationship between the two. We've determined that the most efficient and effective way to get out there and get people to get this test is actually have our own test centers. So we've opened test centers in Phoenix, Salt Lake City, Denver, and Vegas. And this soon, we'll have three more centers in the northwest and eventually through this year, we'll be expanding nationwide. And this is what our test centers look like we have a nice office patient comes in a nurse practitioner that may meet them, they do this procedure, they can do about 20 of these a day. That's our that's our salt lake city center. This is our Scottsdale center, open houses, other opportunities to educate patients and physicians. And the economics of this are really attractive, doesn't take much to lease an office doesn't take and as a certain amount of costs associated with an NP and a Medical Assistant, we only need to do two tests a day to break even so this is a variable cost opportunity. So in Phoenix, we've actually expanded that beyond the test centers to actually do direct to direct to consumer telemedicine. So there's a platform right now, Esoguardconsultation.com or through Esoguard.com. where anybody can go and make a visit with a telemedicine physician to determine whether they're a candidate for this, they'll get sent to our test center, we have some advertising and we're sort of learning what what the yield on direct to consumer would be. We have a variety of clinical trials going on. I won't I won't go through all of them. But we have a PMH study going on to transition from an LDT to a PMA and a variety of other registries and, and tests and studies across the board both institutional and and sponsored by us. And we raised this capital in October to really drive our growth strategy around commercial expanding, we're expanding to a full time sales team. We have we're working towards having nationwide test centers and nationwide DTC program we've already acquired our own CLIA laboratory is using those proceeds and expanding the clinical evidence. We're moving forward to get support and guidelines, both specialty guidelines, internal medicine guidelines, and hopefully at some point, US PSDF. So with that, I'll stop and appreciate you guys taking the time to hear about our story. Thank you