Greetings, and welcome to the Know Labs 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 Jordyn Hujar, Know Labs’ Chief of Staff. You may begin..

Thank you, operator. Thank you, everyone, for joining us for today’s conference call to discuss Know Labs first quarter of fiscal year 2023 financial results and recent operating highlights. If you have not seen today’s financial results, press release and 10-Q filings, please visit the Investors page on the Company’s website.

Before turning the call over to Ron Erickson, Know Labs’ 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 limitations, the Company’s Form 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 and 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. Know Labs 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, Know Labs’ CEO.

Ron?.

one, continued development of our hardware solution or 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 are pleased today to report progress on all of these work streams. First, our Bio-RFID 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 KnowU 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 Kassayan, 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 Know Labs Bio-RFID sensor.

In parallel with KnowU hardware optimization, Bould Design, a respected industrial design firm behind successful products from large consumer goods brands, is providing Know Labs 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 dataset 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 Bio-RFID’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 Dexcom 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 are standing in the competitive landscape, we believe further testing is required.

We have recently expanded our team in clinical development functions, which allows us to increase the amount of data utilized to train Bio-RFID’s algorithm.

We have also been working with NOVUS 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, [Patent App Research] and ipCapital Group, two leading patent analytic firms, ranked Know Labs #1 for patent leadership in non-invasive glucose monitoring. On January 4th, the U. S.

Patent and Trademark Office granted Know Labs a new foundational patent that equates the company’s Bio-RFID 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 “high-performance glucose sensor”, 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 are very focused on accelerating our progress on hardware product development.

We plan to finalize our first-generation or gen-one 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 Bio-RFID algorithm and to secure third-party validation from leading research centers. Lastly, 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 the path to delivering on our goal to be the first FDA-cleared, non-invasive glucose monitoring device in the market and our broader vision to transform medical diagnostics through non-invasive means. Now, I’d like to turn the call over to Pete Conley to review our financials.

Pete?.

Thank you, Ron. We detailed the financial results in today’s first quarter earnings release, which, as noted by Jordyn, you can find on our website. But I’ll share a few key line items with you now.

Know Labs reported a net loss of $3.82 million in the first quarter of 2023 compared to a net loss of $5.36 million in the year-ago period, which translates to earnings per share of a loss of $0.08, an improvement over the year-ago period of $0.15.

I would note the net loss for the first quarter of $3.82 million included non-cash expense of $1.05 million, comprised primarily of stock-based compensation, warrant expense and depreciation and amortization. Research and development expense for the first quarter was $1.74 million as compared to $886,000 in 2022.

The increase in R&D expense was related to staff increases in engineering, third-party technical services and expenditures related to the development of our Bio-RFID technology as we continue to execute our path to FDA clinical trials and commercialization.

Selling, general and administrative expense for the quarter was $1.91 million versus $1.22 million in 2022, which increased versus the prior year, primarily due to key additions to the executive team and increases in third-party services. Turning now to the balance sheet.

As of December 31, 2022, we had cash and cash equivalents of $9.68 million as compared to $12.5 million at the end of September 30, 2022. Net cash used in operations for the quarter was $2.92 million, compared to $1.91 million in the prior year. We believe our cash on hand will be sufficient to fund our operations through February 15, 2024.

That concludes my review of our financial highlights. And I’ll return the call back to Ron..

Thanks, Pete. We now like to dedicate the next few minutes to questions submitted through the webcast portal. And I believe we have some. So the first question, when will Know Labs apply for FDA approval? Our intent and this – there are several parts to this. And I’ve talked to many of you independently regarding how this process works.

When you go to the FDA, obviously, you have to go with a product that’s complete, that’s ready to go in the market place. It has to have the final form factor. It has to have the final operating algorithms. It has to have all of those elements come together.

So as we do this and as we work to get toward the FDA, please understand that there are a number of pieces to this that have to come together simultaneously in order for us to go to the FDA with credibility.

It is our expectation that those pieces will come together and we’ll be able during the course of the year to announce many of those elements that we will be able to go to the FDA for submission during the course of 2023. So that should be your expectation by the end of 2023 that all of those elements will coalesce to allow us to do that.

One of the things is sort of an admonition. As we do this, a lot of what we do is it involves third parties. And as we found over the last couple of years, sometimes third parties are not as responsive as you’d like to have them be.

So I’d like to throw that out and indicate that that we are dealing with third parties and we encourage them to work as rapidly and as – and it’s such a focused matter that we can meet our milestones and our goals. But it is part of our reality that we deal with third parties, but sometimes they’re not as responsive as we’d like to have them be.

Let’s see. Another question coming in. Could you provide investors with an IRB status update? The IRB, which we announced last February, was for the purpose of having a protocol, an approved protocol that allowed us to bring investors - not investors, individuals off the street for what amounted to a five-minute test.

And we have brought a number of people in for that.

What we determined in this process is that we’re getting more robust data from our own internal three-hour tests, which are, as you might imagine, significant in their duration and also something that that has to be very well organized and managed for the purpose of data collection and the development of our algorithms.

So what we’ve discovered is the scale of the data we’re getting from the three-hour test was superior than the kind of data we’re getting from the five-hour and the five-minute test from individuals who are coming in off the street or voluntary pursuant to the IRB.

So the real focus has been on data collection and on a three-hour test as opposed to the five-minute test that was central to the IRB.

The next question, what are the terms of Phil Bosua with separation agreement?.

Ron, I can take that. In both the 10-Q on our website, I would direct investors to Page 34 in the index of exhibits, on item 10.8 is the link to Phil’s separation agreement. So I invite all of you that want to delve into that to read the agreement.

But I can just summarize at a high level some of the key points under the terms of the separation and the lease agreement. Phil was paid one-year severance, and then we hired Phil as a consultant for a period of one-year at a rate of $10,000 a month.

The company transferred to Phil certain assets related to AI Mind, which is a subsidiary we have established to pursue certain AI activities. AI has really filled passion and we felt it was appropriate to let Phil continue to do his work in AI.

Additionally, the company will have an exclusive perpetual and royalty free right to any patents or other IP that Phil develops for anyone working with or under Phil relating to Bio-RFID for a period of five years, following his separation on January 26th.

And lastly, Phil executed a lock-up with our agreement as pertains to his 3 million shares of the common stock that he owns. Outside of that, he forfeited – Phil forfeited stock options totaling approximately 7.4 million shares and all of that, again, is reflected in the separation agreement, which you can find linked to the 10-Q..

There’s a follow-on question. With Phil in a different position with Know Labs, but your progress slowed down. And I would say the short answer is no. Phil will continue to be a consultant with the company. We’ve got a great team in place. Phil was the inventor of the foundational IP that underscores and supports Bio-RFID.

We’ve got very precise roadmap and path that we’re following to accelerate the progress of the company based upon Phil’s invention. And so, no, I think progress will not slow down and we’re also supported by Phil and his consulting capacity. So I think it’s full speed ahead. That’s how the team feels. That’s how I feel.

And so we’ve got a big head of steam and excited to see the year unfold. Another question that just came in, I think this relates to as we get ready to go to the FDA, only go to the market.

One of the questioners wanted to know if Racer – if we still have a relationship with Racer Technology, if they will still be our manufacturing partner? Yes, they will. We’re still working with them. In fact, we have a call with them later today. They’ve been to Seattle, we’ve been to Singapore.

They are very renowned in their capacity to build world-class medical devices. We continue to work with them and expect we will do so for the long haul. Another question that just came in, because we’re a platform technology, people often ask us about other things we can do with this technology in addition to glucose.

And the question is whether or not we’re going to seek some of those other opportunities as we go through the process to obtain FDA clearance for our technology for blood glucose monitoring. The short answer is the focus is on blood glucose.

We have, in the past, announced our capacity to identify blood alcohol levels, blood oxygen levels, and identify the presence of tylenol and aspirin after they’ve been ingested, which is really a proxy for the therapeutics. At this time, our focus is on glucose.

We do believe over time, as we’ve indicated, that there will be a number of other analytes that we’re going to be able to identify. Those all relate to human health, and we think there are really going to be significant opportunities to do things with our technology over the years to come. But for now, the focus is on glucose as it must be.

That concludes our Q&A. I want to thank everyone for joining us this afternoon. As I’d love to look forward in 2023 and we’re excited to report on our progress, I know I speak with many of you, so to speak, Conley. We’re happy to entertain those calls, so don’t be a stranger.

We appreciate your support and we want to acknowledge the incredible effort of our team, of our wonderful talented employees. With that, I want to thank you. Have a great day, and I have to end by saying because it is the 14th of February, Happy Valentine’s Day to everyone out there, and thank you for dialing in, for participating.

We appreciate it very, very much..

Thanks, Ron. The conference call replay will be available on our website in the coming days. Thank you, everyone, for your participation..

Q - :.

Thank you. That does conclude today’s teleconference and webcast. You may now disconnect..