Nelson Patterson, Anavasi Diagnostics - Molecular Diagnostic Company | LSI USA '24

Nelson Patterson  0:03  
The Story In short, we were founded in 2020 as part of the whole COVID era with technology out of the University of Washington, we use reverse transcriptase loop mediated isothermal amplification, also known as RT lamp. To diagnose the presence of RNA, whatever our target is, we focus on sexual health and respiratory. We are generating revenue today last year 375,000. This year, we target 1.6 million. We have two assays prepared for clinical trial this fall a multiplex flu COVID and separately a strep a molecular we also have early indications from the FDA that a assay in development for sexually transmitted disease is likely to achieve a breakthrough status when it comes out. We've raised $35 million to date primarily in seed funding 15 million of that from the NIH, and we're seeking to raise 20 million more. The problem, as we all know, has been that point of care diagnostics has been the tip of the spear, it's where people want accurate information. And if anything, that pandemic showed us that that is lacking, that creates a real delay in treatment, and increases the cost of diagnosis. And it helps perpetuate we think health care inequity. As a result, we bring a point of care device, I can hold it in my hand weighs about five ounces. And it has all the capabilities of a PCR device that you would spend hundreds of 1000s of dollars for a high complexity lab. This detector can do real time led fluorescence against our targets. The form factor, as I said is low. The nice thing is it's inexpensive, and it can be used up to 5000 times it is not a disposable. It adds to the fact that we have a very strong chemistry background. People think about our tea lamp, that historical concern has been you can't multiplex we just proved that with our very first assay, and which we multiplexed source code to do, you can see that illustration as of the end gene or nucleocapsid. Gene for SARS, we had three targets on it, which meant something really critical. We were multiplex from day one. Importantly, as you can see up here, we also had target redundancy, so that as it developed, mutated and evolved, we were able to actually detect every variant that we encountered. We have superior sample artifact minimization, which means that we don't get a lot of interference from other substances that you're going to find in your samples. Importantly, the chemistry also builds on a proprietary polymerase. Why is that critical? It enables us to develop predictably rapidly and with a high degree of confidence that we will turn out the product that we want this multiplex approach, actually with Rosalind, which is used by NIH to gauge different assays, we show that we were 99.97% effective in detecting every known variant of SARS Cove to in their database, Rosalind has over 3800 different genetic sequences. And our RT lamp approach has actually proven itself to be as accurate up to a CT equivalent against a highly complex $250,000 piece of equipment, running $125 assay. We were up to 36.7 95% agreement, we ended up with a PPA of 89.2. So what makes us different, what is the real value that we bring? I've already mentioned that our speed is there. In our clinical trial, we got positives and approximately 17 minutes negatives a little bit longer because our internal control is against our negative fluorescence our size, I can hold this in the palm of my hand, it's five ounces, it contains 61 parts that can be assembled very inexpensively. The cost for this is low compared to others where we compete at the point of care. The lowest cost device that we know of is about $8,500 and comes with a contract that requires that you buy a minimum number of tests every month. We have low waist, high accuracy, and dependability we think is critical, less than a 1.5% malfunction rate or inconclusive rate in our clinical trial. Compared to products that are in the market today that would go between five and 20% equivalent. So where are we going? We think that's what's critical. We have two key focus areas as I mentioned in respiratory and sexual health We have a multiplex fluke COVID assay and a strep assay that will go into clinical trial this fall. We can also extend that into other areas as you can see, including tuberculosis, and sexual health, we see the best opportunity for future growth because of the booming size of that market. We're focusing right now, thanks to two leading academics that came to us asking to prepare an assay on this platform with a syphilis HSV. One HSV two test that we think will provide primary diagnosis of an active infection. That is a huge savings compared to the two step diagnosis that is required today for syphilis. Gonorrhea trick mon trick, as well as chlamydia will be a future one. On top of that, we also have developed a test for monkey pox that is already in the bag ready to go when it is needed. We have great IP, we already have five patents already filed. We have two more that are in process based upon the new design for our device. And we also know that with each assay, we have the opportunity to file two more to provide more of an IP moat around our core technology. The NIH Baptists to the radix program with about 15 point 3 million and non dilutive funding. And currently we have submissions in front of BARDA, CDC and the NIH for up to $80 million more in funding. As I said, we're commercial Henry Schein and Medline our two largest national distributors. Because of our focus on the point of care, we also use regional and vertically focused distributors, regional Atlantic medical systems, and vertically focused folks that are focusing on pharmacy like RX rise and CLIA waived. Our market penetration strategy is fairly straightforward. We go after the point of care. The majority of testing is being done at urgent cares in emergency rooms, as well as in primary care, large primary care physician offices. Workplace screening has been important for us as you can see, on the right side premise health is one of our largest customers. That puts us into the medical centers at every Goldman Sachs office, as well as the newest customer that just picked us up MasterCard. We have other healthcare focused customers like signature health, and icon, which is a well known CRO uses us to screen all their incoming patients or subjects that are going to participate in clinical trials. We think this is a significant opportunity. If you look at the global market today, just for flu, COVID, strep a syphilis and CTN G. That's $100 billion market. The serviceable market that we see here just in the US and we focus that just in the US because there are a variety of different tests, we think is about an $18 billion market. And for us, we think $220 million opportunity. As I said, we completed about 1.6 million we think this coming year with our source code to product fiscal year 2025. We anticipate launch of two new products, which will accelerate our revenue and we expect to be EBIT a positive and 2026. Behind that. We also have three clinical trials that we will be running in 2026. Our management team is deep and experienced and brings a lot of complementary skills. I'm here you can see our co founders across the top and then we have a wide bench. We have very nice outside board as well, including the sector leader for medical device at Korn Ferry, one of the leading hardware developers at Illumina. So again, we're seeking $20 million in series a funding primarily to fund our clinical trials and our r&d development. Thank you