Anavasi Diagnostics | Nelson Patterson, CEO

(Transcription)

Nelson Patterson  0:03  

Good afternoon. I'm Nelson Patterson. I'm the president and CEO of Anavasi Diagnostics. We are a molecular diagnostic technology firm. We just submitted our EUA for our device this past Monday. And we are also selected and part of the NIH is rad X program. Simply put, we are a molecular diagnostics initially for the test and detection of RNA from the SARS cov. Two virus, we use a proprietary reverse transcriptase methodology in order to look for three different locations on the end gene. So we are in essence, a multiplex test, we've developed this platform, and we believe it can is can be extended well beyond SARS, or COVID. To respiratory, urinary tract, sexually transmitted disease, as well as RSV and other household diseases. We are differentiated on a few key vectors, accuracy, speed reporting, and most importantly, availability in today's market. We have a strong IP portfolio. And as you will see a team of experts that has enabled us to move from an idea and a lab at the University of Washington in February of 2020, to having raised over $23 million in funds to date, and already submitted in EUA, with a clinical trial complete in two years. So COVID testing is here to stay. Like it or not, we have a pandemic that we think that we have gotten through. But if you read the headlines with China's shutting down an additional seven cities this week, with cases rising in Germany, in the UK, as we are seeing the Biden administration's already spent over $12 billion in testing, everyone agrees testing will be around and other variants will be appearing. And as you've probably experienced, you know, there are two types of tests you can get an antigen test, or a PCR test. PCR is just another type of a reverse transcriptase or nucleic acid test for the detection of a particular virus via its RNA antigen tests, probably 50% of the time, they're accurate, maybe a little bit better. With a molecular test, the challenge has always been expense and delay in getting a result. The demand for testing is going to continue to be quite strong point of care testing around the world is almost a $42 billion business. And if you look just at the COVID alone, that's about a $20 billion business, we feel that we can address in the United States a $1 billion opportunity for point of care, highly accurate molecular diagnostic testing. That's our product speed, under 30 minutes in our clinical trial where we collected 218 samples, clinical samples, our average time to a positive was 22 minutes, average time to negative was slightly longer because our internal control takes a little bit longer to rise so that we're sure that we absolutely positively do not have a positive case, it reduces false positives and reduces false negatives. simplicity of our product is another distinguishing feature. This is the entire product in my hand, you have a kit. This device right here is as sophisticated as a full PCR lab used in a highly complex laboratory setting, and precision. Our laboratory results, our clinical results, our analytical results are all very strong and very compelling. We obviously are members of the radix program, and went through an extremely deep dive with them before we are admitted to the program and given funding. We believe one of the distinguishing features is that we are easy to use, or a lower nasal swab. We target right now, as I said three different locations on the end gene. And we have a real time internal control, which again is a distinguishing feature for us. Another part of our program that we think is distinguishing and something we have IP on is a very specific algorithm that is able to look at signal to noise ratios and make a better call or as we like to say, can discern between a ball and a strike much easier. So you get a much clearer idea of a positive and a negative. Typically we like to say we do that in less than 30 minutes. Our clinical trials show that we get positives and 22 and negatives and about 33 It's small, it's reused. The bowl, we believe it's good right now our testing prolonged testing, we're close to 4000 uses on it, we'll probably make an initial claim of 3000 uses on the device. Importantly, we don't require Bluetooth, or Near Field Communication in order to work, which means you're not tying up a phone, or some other device we plug in. And we provide results at the end via a QR code that transmits anonymized data to local state and federal health authorities for reporting purposes to ensure that there is tracking of the result. Or our technology, as I mentioned, is strong. We currently have four filed pieces of IP, when we made the slide it was five, because we added an additional one. This week, we've added a sixth one. Every time we create a test, we will add two additional pieces of IP. We believe in a strong IP mode strategy in order for us to maintain our unique position. As I said, the NIH recognized this as part of the radix program. And according to them, we are the first program to have gone from their redirect, which was the starting point that we had all the way through to EUA. With fully with their funding in the time of approximately 18 months of being involved with them. Our team is what makes it most impressive and the reason we're able to move ahead so fast. We have over 125 years medical device experience cumulatively among the faces that you see on the screen here. We have 11 successful exits. We have a software engineer who was an early Microsoft employee. Our founder is one of our founders, three co founders is started a contract device medical device manufacturing and design firm that now has four offices up and down the West Coast. We have two PhDs, two ABDS one MD, we have over 350 combined publications on the team and more than 75 patents. This is not a team that is sitting around waiting for paint to dry. This is a team that works incredibly effectively together, and has proven that by moving this project forward with the speed that it has in less than two years. We're geared for significant growth. And yes, these numbers look a little bit eye popping, you'll say how is it possible that you're going to hit a number like $50 million in your first year? Well, it's because you have a razor and a razor blade. The device is our obviously our razor. And the razorblade obviously is our kit, the kit will sell for about $32. Based upon our current commercial commitments that we've had from entities that are looking to supply current existing market needs, we can account for almost 1.2 million of our 1.6 million initial interest for 2022. We have very, very strong gross margins, as you can see, and importantly, our EBITA we believe is positive in year one. So who are we? We're on Anavaci Diagnostics, we're going to be starting a series a looking to raise $20 million, allocating that towards r&d, manufacturing personnel, and obviously commercial expansion. We believe we can help reimagine the world of diagnostic imaging and particularly molecular diagnostic imaging, our use of funds for this as I shared a scene there in the lower right. But we believe that the future is going to be in using very precise small point of care and eventually at home molecular diagnostic testing to help address the needs of the growing pandemics that we expect in the future. Thank you very much.