Know Labs, Inc.

Greetings, and welcome to the NOLAB's Fiscal Year 2023 First Quarter Earnings Conference Call and Webcast. Please note, this conference call is being recorded. I will now turn the conference call over to Jordan Hujar, NOLAB's Chief of Staff. You may begin.

Thank you, Operator. Thank you, everyone, for joining us for today's conference call to discuss NOLAB's first quarter of Fiscal Year 2023 financial results and recent operating highlights. If you have not seen today's financial results, press release, and 10Q filing, please visit the investors page on the company's website. Before turning the call over to Ron Erickson, NOLAB's chairman and chief executive officer, 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 filings, 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. Today's call will be followed by a Q&A session. Your questions can be submitted through the webcast portal, which can be accessed through our website. Due to the large number of participants on today's call, we will not be taking questions over the phone. With that, I'll turn the call over to Ron Erickson, NOLAB CEO. Ron?

Thanks, Jordan, and welcome everyone to our conference call to discuss our first quarter 2023 financial results and operating highlights. Joining me today is Pete Conley, our Chief Financial Officer, who will discuss our financial results. Today, I'm going to walk through our progress against our strategic milestones, provide an overview of our achievements for the fiscal quarter ending on December 31, 2022, and preview our goals for the balance of fiscal year 2023. Our team continues to work to bring the first FDA-cleared noninvasive glucose monitoring device to the market. We've made significant changes to our leadership team to accelerate our execution. As disclosed on January 26th, Phil Bosch will step down as an executive officer of the company and board member, and I was named chief executive officer by the company's board of directors while continuing as chairman of the board. Phil remains engaged with Nolabs in a consulting capacity, which will allow him to pursue his passion for new discoveries in science, software, and artificial intelligence while providing as-needed technical guidance to our product development team. We've welcomed new members to the executive team and redistributed core responsibilities. These leadership changes were detailed in a press release issued on January 27th. This new structure should accelerate product development and testing while work toward the FDA clearance process for medical devices is being executed in parallel. I believe we put an aggressive and results-oriented plan in place, which I'll review with you this afternoon. We also recently disclosed on February 2nd, strategic partners in data science, sensor technology, product design, and regulatory affairs who we've been engaging with over the past few years and are continuing in their support of the Nolabs team. We're fortunate to have world-class respected experts working alongside our own talented team. These press announcements can all be found on our website. Our most important goal for 2023 is external validation of our BioRFID technology platform. We will achieve this through a heavy focus on feature engineering, through data science and algorithm refinement, clinical development and trials, and partnerships with leading research institutions for additional data collection and accuracy validation. Taking this objective into consideration, our plan is comprised of four coordinated work streams. continued development of our hardware solution, our patented sensor. Two, the continued development of our software solution, working in conjunction with key third parties on our proprietary trade secret algorithm and machine learning platform. Three, continued testing both internally and under current and future IRB approved protocols to increase our clinical data collection and analysis. And four, continued strategic development of our intellectual property portfolio our patents issued pending and in development, as well as codifying our trade secrets. We're pleased today to report progress on all of these work streams. First, our BioRFID prototype sensor has achieved its intended initial performance goals, and while it will be continually improved, it has enabled us to collect data and conduct testing on a prototype sensor to accurately measure and monitor in humans glucose readings in real time. Our team has been working on the development of a functional know-you prototype, which we expect to share with you when completed. IGOR Institute, a product development firm specializing in mechanical, electrical, and firmware engineering, and Dr. Reza Kassian, an MD, is a lead designer and system architect for numerous commercially successful large-scale projects. These are two critical partners for this endeavor. Both assist our team with the miniaturization and refinement of Nolab's BioRFID sensor. In parallel with Milieu hardware optimization, Bold Design, a respected industrial design firm behind successful products from large consumer goods brands, is providing Nolab with design support for this updated prototype. Second, as a result of our internal testing, we've generated tens of millions of clinical observations to comprise our data sets. from which to refine our algorithms and train our machine learning platform to accurately measure glucose levels in humans in real time. Edge Impulse, creator of the industry-leading development toolkit for machine learning, is collaborating with our team to accelerate BioRFID's algorithm refinement. This is an essential step before launching large-scale clinical trials. Third, our internal studies have yielded results with greater than 90% correlation to the gold standard DESCOM G6 with less than 10% mean absolute error. While we believe these internal results speak strongly to the specificity and sensitivity necessary to achieve our goal of FDA clearance and our standing in the competitive landscape, we believe further testing is required. We've recently expanded our team in clinical development functions, which allows us to increase the amount of data utilized to train BioRFID's algorithm. We've also been working with Milvus Management, a medical device consulting firm, on the implementation and execution of regulatory systems and strategy in anticipation of upcoming third-party validations of our clinical protocols and preparation for the FDA clearance process. And fourth, we continue to expand our robust patent portfolio. As previously disclosed, PatNAP research and IP Capital Group, two leading patent analytic firms, ranked Nolab's number one for patent leadership in non-invasive glucose monitoring. On January 4th, the U.S. Patent and Trademark Office granted Nolab's a new foundational patent that equates the company's BioRFID diagnostic technology to a current reference standard for glucose monitoring, widely used by diabetes researchers, hospital labs, and glucose meter manufacturers, and establishes a specific superior benchmark range of clinical accuracy known as the MARD or mean absolute relative difference. The patent issued was entitled, quote, high performance glucose sensor, close quote, extending our IP portfolio to over 100 patents issued and pending, reinforcing our position as the top worldwide IP holder in non-invasive blood glucose monitoring. As we continue to accelerate our activities, we plan to bring on new technical and scientific board members with relevant sector expertise. We believe our advisory board members will be critical in guiding us as we get closer to our end goal. Looking ahead in 2023, we're very focused on accelerating our progress on hardware product development. We plan to finalize our first generation or Gen 1 product, which will be a functioning freestanding prototype that we'll use to continue our data collection efforts. On software development, we plan to further our algorithm development accuracy across an increasing number of individuals to enable us to continue on our path to the FDA. In clinical studies, our goal is to collect large amounts of data to continue training the BioRFID algorithm and to secure third-party validation from leading research centers. Lastly, we'll 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're executing on the path to delivering on our goal to be the first FDA-cleared noninvasive glucose monitoring device in the market and our broader vision to transform medical diagnostics through noninvasive means. Now I'd like to turn the call over to Pete Conley to review our financials. Pete?