Know Labs, Inc. (NYSE:KNW) Q4 2023 Earnings Call Transcript

As of today, we have more than 250 patents issued pending and in process, which is a significant increase over the last year. Our portfolio growth rate is at least four times higher than the average patent market growth rate for noninvasive blood glucose monitoring. We continue to expand our patent portfolio and focus on maintaining our number one global position for patent leadership in noninvasive glucose monitoring. Our top rank has been documented by PatSnap research and IP Capital Group, two leading patent analytic firms. We completed a new public offering in September of 28 million shares of Know Labs’s common stock that was priced at $0.25 a share, achieving gross proceeds of $7 million. These were not the terms we were expecting to achieve, but the capital markets have been challenging, and the additional funding was critical to continue our R&D work.

Our efforts to better align our resources to critical functions such as clinical and product development and to streamline the organization’s expenses have also paid off. In addition to accelerating progress, we’ve reduced our burn rate from $1.2 million per month to roughly $700,000 per month. Lastly, we have undertaken conversations with several global brand-name companies, which may lead to strategic collaborations. Joint development agreements or JDA discussions are underway with potential biopharma, medical device manufacturers, and consumer electronics partners. These could play an important role in the acceleration of product development, the provision of additional funding, and achieving commercialization. For obvious confidentiality reasons, we cannot disclose the names of these companies nor the scope of these discussions.

We revealed our Generation 1 device in June of 2023. The Gen 1 device is a portable research laboratory designed to be a powerful data collection device. As you can see on the slide, the Gen 1 is roughly the size of a computer mouse. Users rest their palm, wrist, or arm on the portable device to obtain blood glucose-level data. This device has allowed our team to scale data collection outside of our laboratory. This was the first true working prototype we could take with us outside our facilities. Generation 1 was built for remote data collection and research purposes. We do not plan on taking this device to the FDA for market clearance. It is robust in design and even includes a computer with the power of a laptop. Our priority is to build a wearable, continuous, non-invasive blood glucose monitoring device that is convenient for users to rely on anywhere they are.

That will be our Generation 2 device prototype, a wearable, continuous glucose monitoring device. We expect Generation 2 to be the form factor we’ll present to the FDA for clearance. This device will be wearable and more than 50% smaller than Generation 1, adding convenience to the user experience. We expect to reveal Generation 2 in the next few months, potentially at the ATTD conference in Florence, Italy in March of 2024. I get a lot of questions on how and why our technology is different. This slide is a simple representation of why we believe our sensor is different and has the potential to transform non-invasive medical diagnostics. Our technology is based on radio frequency spectroscopy. The RF dielectric spectroscopy sweeps the entire tissue stack, capillary and venous blood, interstitial fluid, and cellular material to collect high resolution voltage data at a high speed that fixed wavelength optical sensors are incapable of achieving.

In other words, our technology safely collects data from the body, enabling a comprehensive picture of glucose that optical sensors and others claiming to be noninvasive are unable to achieve. We believe our sensor is the only technology currently targeting both the microwave and radio wave bandwidths in the electromagnetic spectrum. This allows it to achieve a higher signal transmission depth than the other technologies being explored by other companies. US patent number 11-529-077, titled “high performance glucose sensor” sets forth evidence of our novel approach. As stated in the patent, Know Labs technology approaches blood glucose reading very differently than FDA-cleared devices currently available on the market. Radio frequency spectroscopy, enhanced by time frequency synchronization and decoupled antenna designs, allows our technology to collect a massive amount of data signals across real-time glucose concentrations in the interstitial fluid, capillary, venous blood and cellular tissue.

Know Labs’ energy field penetrates more than 1 inch into the body. In contrast, current microfilaments used by minimally invasive devices such as the Dexcom G6 and G7 and Abbott Lab’s FreeStyle Libre systems are limited to readings of only interstitial fluid, typically within 2/10 of an inch of the skin surface. Everything I’m describing is clearly demonstrated in this slide. It may look a little bit complex, but I will explain what this slide means. I also encourage you to download this presentation from our website and revisit this slide in detail. It explains the power of our technology and why it is different. There are two graphs on this slide. The graph on the left refers to in-vitro testing, meaning performed or taking place in a test tube or elsewhere outside of a living organism.

And the graph on the right refers to in-vivo or clinical testing, meaning testing performed or taking place in a living organism. So let’s start with the curve on the left. Plotted data are frequency sweeps using our sensing technology. As you can see on the graph, during this experiment, our sensor was set to emit and receive signals from 1,500 megahertz to 2,550 megahertz. Each line represents a different glucose concentration level in distilled water. And the values on the y-axis are the amount of energy captured by the receiving antennas. The curves for each concentration level are very different from each other. Many technologies can identify glucose, but they can’t distinguish the different concentration levels like our technology does.