2/14/2024

speaker
Operator
Conference Operator

Greetings and welcome to the NOLAB's first quarter 2024 earnings conference call. Please note this conference call is being recorded. You may submit questions through the Q&A box on the webcast at any time. I will now turn the conference over to Jordan Hujar, NOLAB's Chief of Staff. Thank you, Jordan. You may begin.

speaker
Jordan Hujar
Chief of Staff

Thank you, Operator. Thank you, everyone, for joining us for today's conference call to review NOLAB's first quarter 2024 financial results and operating highlights. If you have not seen today's financial results, press release, and 10-Q filing, please visit the investor page on the company's website at www.nolabs.co. 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-Qs, 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. 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. A Q&A session will follow this call. Your questions can be submitted through the webcast portal, which can be accessed through our website. We will not be taking questions over the phone during today's call. With that, I'll turn the call over to Ron Erickson, NOLAB's CEO. Ron?

speaker
Ron Erickson
Chairman and Chief Executive Officer

Thanks, Jordan. Welcome, everyone, to our conference call to review the financial results and operating highlights of our first quarter for fiscal year 2024. And as you all know, our calendar year, our fiscal year ends September 30, so this is that last quarter of 2023. Joining me today is Pete Conley, our Chief Financial Officer and Senior Vice President of Intellectual Property, who will discuss our financial results. Over the past eight months, since the announcement of our Generation 1 prototype, the NOLAB team has undertaken an accelerated work program. The results of this work will soon become public. As we recently announced, we will be participating in the 17th International Conference on Advanced Technologies and Treatment for Diabetes, it's called ATTD, in Florence, Italy from March 6 to 9. As we expect a number of material events to occur throughout this next month as we lead up to the ATTD conference, this call today will be relatively short. I will focus today on providing a brief update on our progress against the four core work streams we've articulated in our previous earnings calls. Work stream one, hardware. A critical work stream in an area with a lot of progress has been hardware development. In June 2023, we announced the completion of our portable Gen 1 prototype device for noninvasive glucose monitoring. We spent the next several months with this device undergoing sensor characterization to better understand how our sensor performs in a completely wireless unit and answer questions surrounding battery life, signal quality, and temperature. These tests included both testing in our lab and outside our lab with humans. Data collected throughout these tests were compared to a continuous glucose monitor, allowing us to better understand how our sensor performs in a real-life setting. Pulling from these findings, our product team alongside our hardware firmware, electrical engineering, and industrial design partners continue to further miniaturize the Generation 1 prototype, which will find form in the next iteration of our device. We look forward to sharing those details with you very soon. Workstream 2, clinical trials and data collection. Clinical testing continues to be an important area of development for the company. During the first quarter of 2024, we continued our internal trial with up to 100 participants focused on a population with diabetes and prediabetes. This trial has been critical in enabling the R&D team to collect more data in the hyper and hypoglycemic ranges. This trial is still ongoing. A core focus of our next series of trials will be enrolling a more diversified population, including people with type 1 and type 2 diabetes. This is necessary to collect more data in the hypoglycemic range of 50 to 100 mg per deciliter and the hyperglycemic range above 350 milliliters per deciliter, ranges that the FDA is focused on. This increase in data will be used to further refine and inform our algorithm development, another core work stream. Work stream three. algorithm development. We leverage all of the data that is collected during our sensor characterization work in vitro tests and clinical trials for algorithm development. As we continue refining the algorithm, we learn exactly what data is needed to increase accuracy. This includes a wider range of glycemic levels along with data from a more diverse population and data that takes into account temperature, location on the body, and other interferences. Our goal is to achieve an algorithm with a mean absolute relative difference or MARD of 10% or less. We'll also need to meet FDA's requirements for accuracy in varying glycemic ranges, all of which we're considering during our algorithm development. The goal of our data science and algorithm development efforts in 2024 are to further refine our algorithm to become more generalizable. We're still in the early stages of generalizable algorithm development capable of delivering highly accurate readings to any individual in the world. The current version of our algorithm performs well within a known population and trial. We are first focused on improving accuracy for a known population set in a different setting or trial so we can then move into generalizability. As we move forward, new approaches such as device calibration will be tested to enable our development of a generalizable algorithm work stream for intellectual property with respect to intellectual property we continue to grow our portfolio. As of December 31 2023 we have 264 patents issued pending and in process, reflecting our continuing high rate of innovation. This issued and pending patents, these issued and pending patents cover fundamental aspects of our radio frequency spectroscopy technology and a number of unique applications. Intellectual property will continue to be a focus for the company in 2024. And as we continue to build and reinforce what we call a defensible intellectual property moat around our technology. As we indicated during our last earnings call, we added three new members to the board of directors and three new members to our medical and scientific advisory board in the last quarter. Their insights will help us build upon the existing knowledge and skills of our team in each of our four core work streams. Finally, as I already mentioned, we will be presenting at the 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy in early March. We'll share updates on the latest developments of our noninvasive glucose monitor there and present results from our ongoing clinical research with two abstracts accepted for e-poster presentation in the scientific program. As we indicated in an earlier press release, January 23rd, which I'm sure many of you saw, that presentation will be done by Dr. Varen Summers of the Mayo Clinic. who has served as both an author and a co-investigator in our current clinical research protocol. So we're very excited about that and about his presentation. Attending and presenting at ATTD is a really important step for us in building awareness and growing our network in the medical and technical communities and those people globally who suffer from the pandemic of diabetes. I'm really proud of what we've been doing, proud of what we've achieved during the last quarter. You'll start to see some results as things come to fruition over the next several weeks. You'll see the results of our team's intense work and dedication as we disclose some of these achievements. Now I'd like to turn the call over to Pete Conley so he can review our financials.

Disclaimer

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