Lishan Aklog, Lucid Diagnostics - Cell Collection Device for the Esophagus | LSI USA '24

Lishan Aklog  0:04  
It's great to be here. Thank you all for joining us this morning. This is really like to thank the LSI team. This is, I believe, my fifth, fourth or fifth meeting. And it's great to be back. Lishan Aklog, I'm the Chairman CEO of Lucid Diagnostics, and I'm going to talk today about esophageal pre cancer testing, a breakthrough in cancer prevention. Before the session is over 40 individuals in this country will be issued near death sentences at the time of an endoscopy. 10 of them will be dead in one year, and only eight of them will still be alive after five years. So what is this ruthless killer? It's esophageal cancer. It's not one that we don't speak enough about 21,000 patients were diagnosed with this last year, the incidence has increased 500% Over the last four decades, four and a half decades or so by far outstripping every other cancer. So what if cancer could be prevented? We talk a lot about early detection. We've had great success with breast and lung and prostate, but that's all early cancer detection. That's not prevention. The really only two modalities that that actually prevent cancer. One is pap testing and when it's colonoscopy, those have worked. So mortality rates have declined substantially in those areas. But we have several many other cancers, including esophageal cancer, which I include in the deadly three, the three most deadly cancers that we don't talk about enough. And that's despite the fact that more people last year died of these three cancers than colorectal and breast cancer combined. I was actually I'm a physician, I was actually shocked by that number. And the important thing about these is that they have a high early stage mortality stage one, detecting it early is not a win because they have a high mortality, you need to do pre cancer detection in order to prevent cancer in these cancers, including esophageal cancer. The good news is we don't have much going on and pancreas we don't have much going on in the liver right now. But we do have now a solution for esophageal cancer. So esophageal cancer can be prevented because we can detect esophageal pre cancer now. So what's our company Lucid Diagnostics, is a NASDAQ listed public company. We're commercial stage. We're in the cancer prevention space focused on early pre cancer detection. And our mission is simple. It's to prevent those 16,000 esophageal cancer deaths in at risk patients using our technologies. Few highlights we have a high margin acid, we have a massive market opportunity. We have a well honed and well established multi prong commercial strategy. We have operational excellence in our field team and our laboratory team. And we have world class leaders. And we're a board of directors. I'll highlight two at the bottom there Stan Lapidus, the founder of Cytec and the inventor of the original Pap test, any of you are in the diagnostic space No, Stan, he also was the founder of exact sciences. Nick Shaheen is the leading esophageal gastric customer and neurologists in this country. He is the lead author of the guidelines in the space and the head of our medical advisory board. So what is Isa guard isa guard is it as a DNA test is the first and only commercially available test that can serve as a widespread screening tool to prevent these deaths through the early detection of esophageal pre cancer. The key adjunct to it is a cell collection very clever, but simple cell collection device that as an alternative to endoscopy out allows the collection of cells from the lower part of the esophagus where this pathology occurs in less than two minutes in an office, no anesthesia, no sedation, it's got to click the clever technology can see there's a capsule attached to a balloon that can inflate and deflate and basically allows you to swab the lower esophagus. But to do so in an anatomically targeted way and also in a protected way. So it's not contaminated by cells in the upper esophagus and the mouth. So the cycle is I start on the left the clinic, the clinician collects this sample in an office setting specimen is sent to our central Laboratory, which is just 10 minutes up the street here in Lake Forest, and it positive or negative result is returned. I don't have a lot of time to go over all of our data. So I summarized it here to sort of talk about our performance relative to something we know a little bit more about, which is colorectal screening. And there's more attention to that. So if you think of wildly successful tool, install DNA testing and Color Guard, a lot of interest and excitement right now for blood tests for liquid biopsy tests from garland. And the as you can see there on the left with cancer we do really well we have a 96% sensitivity for esophageal cancer comparable to those as you get to the liquid biopsy side you start to lose especially early stage. The key the key differentiation starts to happen as we get to pre cancer, the pre cancer cases still high sensitivities and the high 80s negative predictive values of 99% approximately and the the other tests start to fall off. And most notably for early pre cancer there is no other molecular diagnostic test that can detect that early pre cancer with any sensitivity Color Guard zero garden zero and in those situations, and we have a solid positive predictive value as well. Who should be tested? No contrary Diversity here it's well established and guidelines who should be tested. You can see here there are seven risk factors. Most many of you in the room would probably qualify for this. It includes heartburn, and three out of the three out of those remaining six risk factors, all three major gi societies have endorses and they've added non endoscopic biomarker testing to it. So how big is the market there are 30 million patients who who satisfy the most conservative of those, we have Medicare payments established at $1,930. So this is a massive market opportunity. It's over $60 billion. And we've already established a 90% gross margin at our current volumes. We've been working for several years on a multi prong commercial strategy. We have our own physical locations where we do testing our own clinicians do it we send clinicians into physician's offices, sort of like phlebotomist go to, and park themselves in a physician office to do to do testing. We have physician practices that do it themselves. We have mobile testing units in Florida. And we have one of the more exciting parts. We have these health fairs like at fire departments where there's a high incidence of cancer where we can go in and test 100 firefighters over several shifts in the day. We've been steadily growing test volume over the last couple of years. And we're now at a level where we have a critical mass of test volume that can generate claims history and sort of advances along the path towards predictable reimbursement. So what have we accomplished and what our near term goals? We've come shallot, you really checked a lot of the boxes here are more sales and marketing processes, you know, produce high adoption physician yield, as I mentioned, our acquisition strategies, multipronged works well, we are able to train people to do the stock collection test with 99% technical success. Our laboratory operates really well we have an NGS facility with high efficiency of the assay. And as I said, we've gotten our cost down our cogs down. So we now run at a 90% gross margin. We've been publishing clinical evidence, substantial clinical evidence over the last year for clinical validity studies, three clinical utility studies that are either in print published, peer reviewed or in on a preprint server. And we have we're working our way through the last the last hurrah here, which is reimbursements that we have excellent revenue cycle management with codecs, that price is holding the Medicare prices holding for us even in our network payments. We're building a market access team, we've hired some new folks, and we're plowing ahead on on medical policy coverage with both commercial payers and with with CMS. There's a moldy X foundational LCD that covers this category of tests. And we're working our way to submit a technical assessment for that. We're really excited about a major initiative we've launched we've just started to dabble in and we have we've signed one contract to prove this as a concept of offering an electric diagnostic test as a covered health benefit within your health and wellness program. And it's something that other diagnostic companies have done and we're really excited about the prospects of that. So we've been around for a while but we are actually still raising money. We did close the pipe last week. And so we are there's still opportunities to to come in at the early stages. Here are some of the highlights there in our investment thesis and I will close there. So thank you for your attention.