12/20/2022

speaker
Operator
Operator

Greetings. Welcome to the NOLAB's fourth quarter and fiscal year 2022 earnings conference call. Please note this conference is being recorded. I will now turn the conference over to Jordan Hujar, NOLAB's Chief of Staff. You may begin.

speaker
Jordan Hujar
Chief of Staff

Thank you, Operator. Thank you, everyone, for joining us for today's conference call to discuss NOLAB's fourth quarter and year-end 2022 financial results and recent operating highlights. you have not seen today's financial results press release and 10k filing please visit the investors page on the company's website before turning the call over to ron erickson no labs executive chairman and founder i would like to remind you that during this conference call the company will make projections and forward-looking statements regarding future events any statements that are not historical facts are forward-looking statements we encourage you to review the company's sec filing including, without limitation, the company's forms 10-K and 10-Q, which identify specific risk factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and or commercialization of potential diagnostic products, uncertainty in the results of clinical trials or regulatory approvals, the need to obtain third-party reimbursement for patients' use of any diagnostic products the company commercializes, our need and ability to obtain future capital and maintenance of IP rights, risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory, or political changes in the applicable jurisdictions, accounting and quality controls, greater than estimated allocations of resources to develop and commercialize technologies or failure to maintain any laboratory accreditation or FDA certification and uncertainties associated with the COVID-19 pandemic and its possible effects on our operations. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. No lab expressly disclaims any intent or obligation to update these forward-looking statements except as otherwise may be required under applicable law. With that, I'll turn the call over to Ron Erickson. Ron?

speaker
Ron Erickson
Executive Chairman and Founder

Thank you, Jordan. Welcome, everyone. Thank you for joining us today on this conference call to discuss our fourth quarter 2022 and year-end financial results and operating highlights. Joining me today is Pete Conley, our Chief Financial Officer, who will discuss our financial results. I'm going to walk through our progress against our strategic milestones, as well as provide an overview of our achievements for fiscal year ending September 30, 2022, and a preview of our goals for fiscal year 2023. As we discussed in our outlook for the year provided in March 2022, we set forth our plan to bring the first FDA-cleared noninvasive glucose monitoring device to the market. Our plan is comprised of four coordinated workstreams. Specifically, one, continued development of our hardware solution, namely our patented BioRFID sensor. Two, the continued development of our software solution, namely our proprietary algorithm and machine learning platform. Three, continued in vivo testing both internally and under current and future IRB approved protocols to drive our clinical data collection and analysis. And four, continued strategic development of our intellectual property portfolio namely our patents issued pending and in development, as well as codifying our trade secrets. We are pleased to report progress on all four work streams during the course of the fiscal year 2022. First, our BioRFID prototype sensor has achieved its intended performance goals, and while it will be continually improved, has enabled us to collect data and conduct testing on a prototype sensor to accurately measure and monitor in vivo glucose readings in real time. Second, as a result of our internal testing, we've generated tens of millions of clinical observations to comprise our data set, from which to refine our algorithms and train our machine learning platform to accurately measure glucose levels in vivo in real time. Third, our internal studies have yielded results with greater than 90% correlation to our gold standard Dexcom G6, with less than 10% mean absolute error. To this end, last fall we announced internal results which resulted in a mean MARD reading of 5.8% when benchmarked to FDA cleared Roche's AccuCheck, Abbott's Freestyle Libra, and Dexcom's G6 across 180 paired observations within a plus or minus 15%. While we believe these internal results speak strongly to the specificity and sensitivity necessary to achieve our goal of FDA clearance and our competitive standing, we're working tirelessly in anticipation of upcoming third-party validation of our clinical protocols in 2023. And fourth, our unrelenting effort to build the world's most robust patent portfolio has been independently validated by PatSnap Research and IP Capital Group. two leading patent analytic firms who each ranked NOLAB's number one for patent leadership in non-invasive glucose monitoring. To that end, we're pleased to announce today the U.S. Patent and Trademark Office granted our U.S. patent $11,529,077 entitled, quote, High-Performance Glucose Sensor, close quote. While we'll have more to say about the 077 patent in the coming days, we believe this patent, as the title states, is a significant event for the noninvasive CGM industry, as we believe that this will be the first and only patent granted where its claims explicitly state a MARD range, an FDA-accepted benchmark of clinical accuracy of 5% to 9.9%, which is equal to or superior to the MARD reading of FDA-cleared products. In reviewing our progress for fiscal 2022, we're very pleased to say that we also achieved our longstanding goal of an uplist to a major exchange from the OTC market. On September 15, 2022, we successfully completed an $8.3 million underwritten IPO in the New York Stock Exchange American with the new stock symbol, quote, KNW, close quote. We're now beginning to realize our goal of increased market liquidity and institutional ownership. On November 18, 2022, we were invited to and presented at the Bernstein's second annual CGM Disruptors Conference, where we shared our story to Bernstein's institutional audience for the first time. Looking ahead to 2023, we're very focused on continuing progress across our four workstations. On hardware product development, we plan to finalize our Gen 1 product, which we plan to take to the FDA. On software development, we plan to complete our algorithm development and machine learning platform to enable us to proceed on our path to the FDA. On clinical studies, our goal is to secure third-party validation from leading research centers. And fourth, we will continue our efforts to build a world-class patent portfolio that will serve as a foundation for our company to derive strategic value in the marketplace. In summary, we believe we are executing on delivering on our goal to be the first FDA cleared noninvasive glucose monitoring device to market and our broader vision to transform medical diagnostics through a noninvasive means. Now I'd like to turn the call over to Pete Connolly to review our financials. Pete.

Disclaimer

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