NYSEAMERICAN:KNW Know Labs Q3 2023 Earnings Report $0.46 -0.02 (-3.63%) Closing price 04:10 PM EasternExtended Trading$0.46 0.00 (-0.02%) As of 04:28 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Know Labs EPS ResultsActual EPS-$3.20Consensus EPS -$0.80Beat/MissMissed by -$2.40One Year Ago EPSN/AKnow Labs Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AKnow Labs Announcement DetailsQuarterQ3 2023Date8/14/2023TimeN/AConference Call DateMonday, August 14, 2023Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptQuarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Know Labs Q3 2023 Earnings Call TranscriptProvided by QuartrAugust 14, 2023 ShareLink copied to clipboard.There are 4 speakers on the call. Operator00:00:00Welcome to the NOLabs Fiscal Year 2023 Third Quarter Earnings Conference Call. Please note this conference call is being recorded. I will now turn the conference over to Jordan Hujar, Knowlabs' Chief of Staff. You may begin. Speaker 100:00:15Thank you, operator. Thank you, everyone, for joining us for If you have not seen today's financial results, press release and 10 Q filing, please visit the Investors page on the company's website at www.nolabs. 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 We encourage you to review the company's SEC filings, including without limitations the company's Forms 10 ks 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 3rd 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. Speaker 100:01:51Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward looking statements. NOLabs 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 supported by a slide presentation, which will be shared through the webcast portal and can be downloaded from the Investors page on the company's website. This call will be followed by a Q and A session. Your questions can be submitted through the webcast portal, which can be accessed through our website. Speaker 100:02:26With that, I'll turn the call over to Ron Erickson, KnowLab's CEO. Ron? Speaker 200:02:31Thanks, Jordan. Welcome everyone to our conference call to review the fiscal results and operating highlights of our Q3 fiscal year 2023. Joining me today is Pete Conley, our Chief Financial Officer and Senior Vice President of Intellectual Property, who will discuss our financial results. I'm going to walk you through our progress today against the work streams we've articulated in our previous earnings call. I'll provide an overview of our progress to date and I'll preview our goals for the balance of fiscal year 2023. Speaker 200:03:01Being transparent is critical for us and I'm proud of the communication channels we've established with our investors and followers. In addition to following our press releases, which are distributed every time a material event occurs, I encourage you to reach out to us through our email asknolabs.co and subscribe to our newsletter on our website. You should also visit our website, www.nolabs.co, as we are constantly updating our research and validation webpage. This section of our website provides access to our progress and data from our clinical trials. We have significantly raised the bar in terms of data transparency. Speaker 200:03:42I'd like to start today's discussion by revisiting some of our major events in calendar 2023. A lot has happened this year, Starting with significant leadership changes and an acceleration of our development, progress and operational execution. On January 26, I was named Chief Executive Officer by the company's supportive directors, while continuing as Chairman of the Board. We added new members to the executive team and redistributed core responsibilities. We disclosed new and existing strategic partners in data science, These changes have proven to be very effective as we achieved a long list of meaningful milestones in the past 6 months. Speaker 200:04:28In June, we revealed our Generation 1 device. The GEN-one device is an important stage in the development of our proprietary bio RFID technology. It's a portable research lab designed to be a powerful data collection device. This device allows our team to scale data collection tenfold, including testing across more diverse This is Generation 1. We will refine the next generation device based on what we learned from Generation 1. Speaker 200:05:07We cannot speculate today regarding what generation will be the version that we'll take to the FDA for clearance. In terms of clinical testing and data collection, our research and development team has collected more than 303 hour glucose datasets in the last 6 months, which resulted in the collection of almost 2,000,000,000 data points. Multiple protocols which have received IRB approval are being run-in parallel to test and improve our bio RFID Testing with a broad population to obtain results that are generalizable. That is what we work on every day. Scientific validation is critical for the development of our technology. Speaker 200:05:52In the last 6 months, we have published 5 manuscripts and Liquid Solutions' implications for non invasive physiologic monitoring was conducted in Collaboration with Mayo Clinic and was presented at the 2023 American Physiological Society Summit. This study demonstrated the accuracy of Nolab's proprietary BioRFID sensor in quantifying different analytes in vitro, blood glucose monitoring compared to DexCom G6 was presented at the American Association of Clinical Endocrinology See stability and repeatability. Going from a MARD, MARD, we call it a 20.6% to a margin of 11.3%, which positions us in an accuracy range similar to other FDA cleared devices and much closer to our goal of delivering a device with a marred under 10%. On the intellectual property We grew our portfolio by more than 70% in just 6 months. As of today, we have more than 169 patents issued and Pending, which is a significant increase over the last year. Speaker 200:07:34We had 98 patents issued and pending by the end of December 2022. We can continue to expand our portfolio and focus on maintaining the number one position for patent leadership in non invasive glucose monitoring. This position has been documented by 2 organizations We retained PatSnap Research and IP Capital Group, leading patent analytic firms. Our trade secret algorithms are another aspect of our intellectual We've also established a scientific and technical advisory board comprised of distinguished researchers, innovators and experts in medical technology and human health. These individuals have been advising the company and its Strategic partners on advancing the company's progress across all work streams, including algorithm refinement, was established in 2020. Speaker 200:08:40Bringing industry experts on board has been invaluable as they help us to validate and accelerate our work. Lastly, 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 reduced our burn rate from $1,200,000 per month to roughly 800,000 per month. Now, I'd like to share with you some of the lessons we learned in the last 6 months. But before jumping into those, I want to point out this graph. Speaker 200:09:15This is self explanatory as it shows the marked progress from other FDA cleared devices throughout time. We're proud of the impressive improvement we've been able to achieve with Bio RFID in such a short period of time, especially when We compare it to how long it took others to achieve a similar level of improvement. Our goal is to deliver a device with marred under 10% Compared to a blood reference device and I believe we're on track to do just that. Moving to our next slide, we worked hard, we achieved a lot and we learned a lot. We're inventing something new that has never been done before. Speaker 200:09:56Part of inventing is discovering new things. As we intensified our clinical development and experiments, As we brought new expertise in house through partnerships and experienced hires and as we amplified discussions with other relevant stakeholders in the space such as research institutes and key players we've listened and learned. We learned in more detail what needs to be accomplished before presenting our technology and devices to the FDA And before launching Imvenical Device in the global marketplace, we learned there is more work to do to conform with all regulatory requirements, especially in topics Like the following data accuracy across all glycemic ranges. More than 80% of our current data is Still concentrated in the normal glucose range, which is 80 to 150 megoliters per deciliter. We need to expand data collection to a wider range, including hypo and hyperglycemic scenarios to be successful in front of the FDA. Speaker 200:10:57These will also help us determine the intended use of our glucose monitoring devices in people with Type 1 and Type 2 diabetes or other sub segments. Patient physiological characteristics, we need to expand our data collection efforts So they include a more diverse set of patients with different skin pigmentation, skin thickness and the presence of other Elements that could cause interference such as hair, sweat and intense movement and environment and human factors. Our tests are currently conducted in a controlled laboratory environment. Ultimate regulatory approval requires us to have a deep understanding Real world environmental conditions such as air pressure, temperature, humidity, other substances, noise and human interaction with the technology All may interfere with its signal and ultimately impact its accuracy. These are all natural steps involved in the development of a medical device, Type 1 diabetes, Type 2 diabetes and pre diabetes. Speaker 200:12:04Data science and algorithm refinement. As we increase the amount of data used Train our algorithm, it just gets better. More data equals better accuracy. In sensor characterization, we have demonstrated The sensor performance, stability and repeatability in a controlled environment. Now we need to demonstrate the same in real world applications outside of our laboratory And scientific validation. Speaker 200:12:29We must continue with external research institutes to further validate our technology. These additional publications are critical when presenting our application to the regulatory agency. These work streams should increase generalizability of our BioRFID This is a concept we haven't addressed much in the past, but is extremely critical for our success. Medical devices that support patients and physicians to manage health conditions must be safe and accurate and maintain that level of accuracy under any condition and regardless of the patient as determined by its intended use. Moving forward, NOLAB's mission has been and continues to be making a difference in the lives of millions of people around the world by Convenient, accessible and affordable non invasive medical diagnostic solutions with a first focus On blood glucose monitoring, I'd like to emphasize the importance of increased accessibility and affordability. Speaker 200:13:35According to the International Diabetes Federation, there are 537,000,000 adults living with diabetes in the world in 2021. 3 in 4 people with diabetes live in low and middle income countries. These countries are experiencing accelerated diabetes growth With Africa facing a 129% projected increase from 20 21 to 2,045. Middle East and North Africa, an 87% increase and 50% increase in South and Central America. These are significantly higher rates than projected for the developed areas like North America and Europe with a 24% and 13% projected increase respectively. Speaker 200:14:15A non invasive device has the potential of addressing accessibility issues by providing a convenient, user friendly, Consumable free and therefore more affordable solution. Most of you are familiar with our technology, but it's important to remind everyone that the key features of The Bio RFID sensor is a novel sensor that can potentially measure anything. Its core components are IP protected such as the antennas array and the spectrum that emits and captures radio wave signals, which we like to refer to as the energy field. The RF generator that enables frequency sweeps in the microwave spectrum from 1500 Mega Hertz to 4000 Megahertz at 0.1 intervals is also IP protected and the combination Of these elements allows us to collect approximately 1,500,000 data points per hour, which makes it a powerful research sensor. Right now, it's being used to identify, measure and monitor blood glucose, but it has the potential to expand into other biomarkers Now to the Bio RFID platform. Speaker 200:15:34Our technology is a platform, not just a sensor. We're building a proprietary non invasive technology platform that can measure multiple analytes and combines uniquely designed hardware with powerful data processing algorithm. It leverages electromagnetic energy to accurately identify and measure a wide range of organic and inorganic materials, molecules and compositions of matter. From others leveraging spectroscopy as we target a specific bandwidth in the electromagnetic spectrum from microwave to radio waves. Bio RFID is form factor agnostic. Speaker 200:16:18It can be integrated into a variety of wearable, mobile or bench top form factors. It is pain free because it doesn't require needles or invasive transmitters poking into the skin or through the skin. It doesn't have any consumables, which combined with a low bill of materials translates into high potential to The 3 to 5 times less expensive than current FDA cleared options. Cutting edge trade secret machine learning and artificial intelligent models Power is highly accurate real time algorithms and it's shown the potential to target more than 100 analytes beyond blood glucose monitoring, which could make it an important enabler of predictive health and a powerful diagnostic tool. I get a lot of questions on how and why Bio RFID is different. Speaker 200:17:09This slide is a simple representation of why we believe Bio RFID is different and has the potential to transform non invasive medical diagnostics. BioRFID safely collects Data from the body, enabling a comprehensive picture of glucose that optical sensors are unable to achieve. To our knowledge, Bio RFID 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. U. Speaker 200:17:47S. Patent number 11529077 titled High Performance Glucose Sensor It's proof of RFID's novel approach. As stated by the patent, Bio RFID Technology approaches blood glucose reading very differently than FDA cleared devices currently available on the market. Radio frequency spectroscopy Enhanced by time frequency synchronization, decoupled antenna designs allows the BioRFID technology to collect a massive amount of data signals across real time glucose concentrations in the interstitial fluid, capillary and venous blood and cellular tissue. Nolab's energy field penetrates more than 1 inch into the body. Speaker 200:18:36In contrast, current microfilaments used by minimally invasive devices Such as the DexCom G6, G7 and Avilab Street Style Libre systems are limited to readings of only the interstitial fluid typically You've seen this slide before and I assume you have a good understanding of our product portfolio strategy. We've previously announced 2 devices focused on glucose monitoring. The U band is a wearable continuous glucose monitoring device. It provides real time blood glucose monitoring to the user, For a wearable continuous glucose monitoring device to manage their diabetes. Some simply want to replace the painful, inconvenient and expensive finger The Know You is a convenient non wearable on the go alternative to finger sticks. Speaker 200:19:37The know you can provide convenience as the patient can easily run spot checks of his or her blood glucose levels. We still don't have a full bill of materials for these products, but manufacturing of the GEN-1 device, which is powered and engineered for research and development, Indicates we should be capable of developing and delivering a final product at a much lower price point than the FDA cleared options currently available in the market. Some of you asked me why we keep testing, why do we need to keep testing. This graph makes it very simple to address that question. As our data set increases, we've experienced a clear improvement in the algorithm's accuracy. Speaker 200:20:20This allowed us to go from an above 20% mark to a mark of 11.3%, which was published a few weeks ago. A slide covering the details of this study has been included in the appendix of this presentation, which I direct you to read on our website. As we prepare to undertake clinical testing with the new GEN-one devices, we estimate we'll have tens of billions of observations to process. We're confident that we can get more reference labels combined with more raw data collected with our sensor, our algorithm performance will improve. This is standard procedure and machine learning will hopefully lead to a higher accuracy level or lower MARC figures. Speaker 200:21:02As we increase sample size, it is expected there are changes in accuracy resulting from variability in testing conditions, biological diversity and other factors. This is the core goal of expanded data collection. This massive amount of data requires a robust approach to data engineering, artificial intelligence and Ed Jimpulse, the creator of the industry leading development toolkit for machine learning has been collaborating with our team to accelerate BioRFID's NUP30 is our next target. We've already started planning for this new study and plan to get underway soon, which follows a protocol slightly different from the previous protocols. In addition to using CGMs to collect reference data points, we'll be using venous blood as the gold standard. Speaker 200:21:51We'll also be increasing the diversity of our population by including people with diabetes and pre diabetes. As soon as these results are ready, we'll publish them As we have with previous results, this is a great reason to visit our research and validation page on our website, Do that frequently and sign up for our newsletter. Our core goals for the balance of 2023 are very straightforward. We'll continue to focus on expanded data collection, which means more participants, extended glycemic range and exhausting environmental and biodiversity parameters. Algorithm refinement with the goal to deliver an under 10% MARG Generation 2 design, which we aim to be at least 50% smaller in design for manufacturing regulatory strategy and technology We'll continue growing the organization areas that support our core goals, Data collection, data science, hardware design and regulatory affairs and support business needs with additional capital as required. Speaker 200:23:07We have an aggressive and results oriented plan in place. We've made significant progress in the last 6 months and we'll continue to focus on our core work streams, data collection, data science and algorithm refinement, sensor and hardware characterization, Scientific validation. In addition, we will continue the strategic development of our intellectual property We will go to the FDA to commence clinical trials and ultimately obtain FDA clearance for our non invasive blood glucose monitoring device. It's difficult to set forth exact dates. We're inventing and developing new technology that's never been done before. Speaker 200:24:03As we expand data collection and testing conditions, we will continue to learn more about what needs to be addressed. We must achieve a repeatable accurate standard of excellence With a market ready product before undertaking clinical trials for the FDA clearance application. This takes time, but rest assured that as soon as we have high FDA clearance related timelines, we'll share them with you. We are executing the plan to deliver First FDA cleared truly non invasive glucose monitoring device in the market and our broader vision to transform medical diagnostics through non invasive means. 2023 has thus far been a year of change and significant advancement for Knowlabs. Speaker 200:24:45Now, I'd like to turn the call to Pete Conley, We will review our financials. Speaker 300:24:51Thank you, Ron. We detailed the financial results in today's 3rd quarter Earnings release, which as noted by Jordan, you can find on our website, and I will share a few key line items. NOLAS reported a net loss of $3,590,000 in the Q3 of 2023 Compared to a net loss of $3,030,000 in the year ago period, which translates to earnings per share The loss of $0.07 unchanged from the year ago period and the loss of $0.07 and this is before preferred stock dividends. In the Q3, we also recorded a non cash charge to earnings of $4,960,000 Related to the fair market value of dividends on our Series C and D preferred stock that were either paid or accrued in shares Research and development expense for the Q3 was $1,870,000 As compared to $1,270,000 in 2022, an increase of 48% year over year. The increase in R and D expense was related to increases in engineering, third party technical services and expenditures related to the development Our Generation 1 device, which we completed and announced on June 7, as we continue to execute our path To FDA clinical trials and commercialization. Speaker 300:26:21Selling, general and administrative expenses for the 3rd quarter Was $1,350,000 which was sequentially lower by $890,000 in the $2,240,000 in the 2nd quarter as well as lower than the year ago period of $1,580,000 as we continue our initiatives to reduce our cash burn. Turning now to the balance sheet. As of June 30, 2023, we had cash and cash equivalents of $3,930,000 as compared to $12,590,000 at the end of September 30, 2022. Net cash used in operations for the 9 month period ending June 30, 2023 was 8,970,000 dollars compared to $3,690,000 in the prior year. During the quarter that ended June 30, The company made adjustments to its fixed expenses and the impact of those adjustments has significantly reduced our monthly burn rate. Speaker 300:27:25Given the significant reduction in fixed expenses, the company believes that it has enough available cash and flexibility with operating expenses to operate until at least December 2023. As we have stated in our Q3 10 Q, During 2023, we expect to raise additional funds through the issuance of preferred stock, convertible debentures and equity. That concludes my review of our financial highlights, and I'll return the call to Ron for closing remarks. Speaker 200:27:57Thanks, Pete. We'll now dedicate The first question is what MARD level would be needed to seek FDA approval. How long would the sample take to move forward? As we indicated, We are working on IMARD that is under 10% and we think when we get into that range, that's a range Sufficient to allow us to go forward and seek FDA approval. How long will the sample take to move? Speaker 200:28:44I'm not sure exactly What that question means, Pete? Speaker 300:28:49Yes, I think it's important to note It's important to look at the size of the sample as much as it is what the absolute MAR number is and To really reach the degree of clinical accuracy required by the FDA, it requires both a MARG under 10% Combined with a very broad population that's being tested broad in terms of age, gender, Geographic diversity, biological diversity and so forth, and it's the combination that will position us for the FDA. Now the Speaker 200:29:27next question really sort of follow-up on that Pete and cover some of the same territory. The question is what's the timeline For additional measures, we pointed out I. E. Diverse populations, environmental factors, skin thickness, hair, sweat and amyloid and pigmentation. There, these additional measures, these additional, I'm going to say, features of the population are Being factored in the end of 30 study that I referenced in my remarks, the one using venous blood is a gold standard as a And this is going to include people with diabetes, pre diabetes and we're looking at all those other Speaker 300:30:30Yes. We have a question here. Any concerns with being removed from the NYSE due to the sub-one dollar share price? The NYSE American Continued Listening criteria does not specify a minimum share price. What it does specify is a minimum market cap. Speaker 300:30:50And based on the shares outstanding as of our June 30, 2023 10 Q, which is 52,300,000 shares. We meet the $50,000,000 minimum market cap At a share price of $0.95 and it's not a single day criteria. The NYSE looks at the range of our share price over a period of time. So this is something obviously we pay close attention to And we are committed to ensuring compliance with the continued listing requirement. Market cap is not something we can directly control, but we are very aware. Speaker 200:31:39Here's a question. With the stock at 4 year lows, despite all the latest advancements with technology, what's the company doing It's interesting. I think we're impacted by broader market forces. I think one of the things those of you who are shareholders and we're shareholders here in the room in Seattle, I think we We all have seen what's happened in the broader market, especially in the, I'd say, the microcap space, technology related microcap That being said, our focus is to just stay the course, keep doing what we're Staying focused on what we're doing. We have a very clear roadmap as we address today. Speaker 200:32:38We're making significant progress than we have over the last 6 months. We're going to continue to do our clinical research under these various IRB protocols. We're going to continue to report the results as we have them with complete transparency. We're building the IP portfolio. We've got Gen 1. Speaker 200:32:55We're working on Gen 2. We continue to build and further cement our position as a leader in the area of non invasive blood glucose monocrene. And at the same time, we do everything we can In terms of Investor Relations, getting the word out, I think one of the things that's noteworthy since we up listed on the New York Stock Exchange We've had somewhere in the neighborhood of 25 institutions begin to accumulate our stock. We had 0 institutions before we did the uplift. So What we want to do is with results be results oriented and continue to do what we're doing and We believe the stock price will take care of itself. Speaker 200:33:35We don't like it where it is today, no doubt. Pete, do you want to amplify that? Ron, if Speaker 300:33:40I could add to your comments to the specific question, what is the company doing to build confidence? And I think if you go visit our website and look at the research and validation section of the website, You will see something that I don't think any of the other companies in our sector do. We publish Our clinical studies, we publish our posters, we publish our manuscripts. When you review these documents, we very clearly Educate the market as to what we're doing and through that education, one can see that what we're doing is quite different from anybody else. And so as Ron indicated earlier, we are committed to education. Speaker 300:34:29We are committed to transparency. And these papers, I think, inform investors. And I think an informed investor can become a confident investor Next question, how did the company utilize the GEN-one device? Well, the Gen 1 device now was announced about 2 months ago. We are using the device actively in our Testing, we are actively conducting testing with the GEN-one in parallel with ongoing clinical Research using our stationary lab system and the parallel path is best is the best practice when introducing new environmental Human factors in the testing protocol. Speaker 300:35:32And there's a follow on question. How many Gen 1 devices have been Constructed and sent out for use in the real world. As we sit here and speak now, about a dozen Units have been built. We have component inventory to build 100. We anticipate reaching that number somewhere towards the end of the year, early 2024. Speaker 300:36:00Once we Get to what we would consider a characterized sensor with the Appropriate algorithms, we will begin to have external testing. We would expect the 1st external testers Speaker 200:36:17At the Speaker 300:36:17end of the year, beginning of 2024. Speaker 200:36:21I think I want to just add something about the Gen 1 devices by the way, And you saw our video, you saw the video in June. Those are all hand built, right? Everyone's hand built. We're now Doing work as I indicated earlier on Gen 2. Gen 2 will be designed for manufacturing and that will be done in concert with our manufacturing partner, Racer Technologies that we've spoken of in the past. Speaker 200:36:50So that's a very different circumstance. When you're designing something for manufacturing where you have the opportunity to do significant unit volume And that's the product Gen 2 that is likely to be the product that would then find its way ultimately the FDA trials into These are hand built and these are really the Gen 1, it's about the size of a mouse. You've all seen Pictures of it and you've seen kind of how it relates to the size of a human hand, if you will. That's really A sort of a research lab in your pocket. That real focus is for gathering data. Speaker 200:37:31And so they're robust and they're hand built. Speaker 300:37:38Here we have another question. On the last call, it suggests You had enough cash through next February 2024. Now it's December of this year. So that's a 2 month delta between the 2 and 800,000 burn, that's 1,600,000. If you I'll go through our financials in the 10 Q that was released today. Speaker 300:38:05You'll see in the quarter just reported The R and D expense increased 48% year over year. In dollar terms, it was $606,000 Increase year over year and what that reflects is the accelerated rate of development from GEN-1 as Ron We're already working on Gen 2. And so we believe that accelerating The development of our products accelerating the filing of our patents, again as Ron noted, In the 1st 6 months this year, we have increased our patent portfolio 70%. And so We believe that that's the best use of the capital that we have. There's another related question here. Speaker 300:38:58How will NOLABS fund the operations of the company? In the 10 Q, in the liquidity section, we talk about the fact that right now we are Underway on the capital financing plan for the balance of 2023, And we believe that we'll have the funds to execute our plan. We have not commented on this Speaker 200:40:22How many employees have been hired or lost since Gen 1 came out in June? We haven't lost any employees. We have 11 Speaker 300:40:47Does AI help NOLabs get the MARR lower? When is the MARR to So, Tim projected to be accomplished. We utilize AI and we utilize machine learning in developing Our algorithms, which will impact MARS, but the biggest determinant of MARS is the size of the We are increasing our cohorts now as Ron indicated. We are underway of ANA-thirty. We anticipate going to ANNO50 than ANNO100. Speaker 300:41:26If one wants to Get a sense of what kind of data is required to have a FDA cleared product. You can Download DexCom's G7 summary of decision from the FDA and DexCom achieved their MARG readings Speaker 200:41:56We appreciate very much everyone's questions and active engagement. As we indicated earlier, So don't hesitate to stay in touch. We try to be responsive. This will conclude our Q and A. Thank you to everyone for joining us today. Speaker 200:42:19There's a lot to look forward to here in the balance of 2023 and we're excited to report on our progress. We appreciate your support And I also want to acknowledge the incredible effort of our team of really talented employees and not just our employees. We have 11 employees as we indicated, but we have people working with us engineering, machine learning, product design and development that are They're external to the company, but they're every bit as committed and excited to be part of this journey we're on. I want to thank them as well. Thank all of you who are shareholders and supporters. Speaker 200:42:56We appreciate it very much. Thank you all and have a great day. Speaker 100:43:01The conference call replay will be available on our website in the coming days. Thank you for your participation. Operator00:43:09This does conclude today's teleconference. You may disconnect your lines at this time. Enjoy the rest of yourRead morePowered by Key Takeaways Since January the company has restructured leadership, expanded its executive team, revealed its Generation 1 device for scalable data collection, and grown its patent portfolio by 70% to 169 issued and pending patents. R&D efforts have collected over 303 hour glucose datasets (nearly 2 billion data points), driving MARD down from 20.6% to 11.3% and moving toward the goal of under 10% MARD accuracy. Clinical plans include an upcoming ANNO30 study using venous blood and IRB-approved protocols to broaden glycemic ranges, patient diversity, and real-world environmental testing to support FDA clearance. Cost management reduced the monthly cash burn from $1.2 million to $0.8 million, with Q3 net loss of $3.6 million and sufficient liquidity to fund operations through at least December 2023. The proprietary BioRFID platform leverages microwave and radio wave spectroscopy to penetrate over one inch into tissue, enabling multi-analyte, consumable-free monitoring with over 1.5 million data points per hour. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallKnow Labs Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsQuarterly report(10-Q) Know Labs Earnings HeadlinesKnow Labs Sensor Non-Invasively Identifies pH Levels in Real TimeMarch 19, 2025 | finance.yahoo.comKnow Labs to Attend the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)March 18, 2025 | finance.yahoo.comNow I look stupid. Real stupid... I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. May 23, 2025 | Porter & Company (Ad)Know Labs Announces NYSE Removal of Trading SuspensionFebruary 28, 2025 | finance.yahoo.comKnow Labs Announces Cancellation of Special Meeting of StockholdersFebruary 21, 2025 | businesswire.comKnow Labs, Inc. to Report First Quarter FY 2025 ResultsFebruary 14, 2025 | businesswire.comSee More Know Labs Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Know Labs? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Know Labs and other key companies, straight to your email. Email Address About Know LabsKnow Labs (NYSEAMERICAN:KNW), together with its subsidiaries, focuses on the development and commercialization of proprietary sensor technology by radio and microwave spectroscopy in the United States. The company's proprietary platform technologies include ChromaID and Bio-RFID technologies that utilizes electromagnetic energy to detect, record, identify, and measure the signature of said materials or analytes. The company was formerly known as Visualant, Incorporated and changed its name to Know Labs, Inc. in May 2018. 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There are 4 speakers on the call. Operator00:00:00Welcome to the NOLabs Fiscal Year 2023 Third Quarter Earnings Conference Call. Please note this conference call is being recorded. I will now turn the conference over to Jordan Hujar, Knowlabs' Chief of Staff. You may begin. Speaker 100:00:15Thank you, operator. Thank you, everyone, for joining us for If you have not seen today's financial results, press release and 10 Q filing, please visit the Investors page on the company's website at www.nolabs. 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 We encourage you to review the company's SEC filings, including without limitations the company's Forms 10 ks 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 3rd 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. Speaker 100:01:51Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward looking statements. NOLabs 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 supported by a slide presentation, which will be shared through the webcast portal and can be downloaded from the Investors page on the company's website. This call will be followed by a Q and A session. Your questions can be submitted through the webcast portal, which can be accessed through our website. Speaker 100:02:26With that, I'll turn the call over to Ron Erickson, KnowLab's CEO. Ron? Speaker 200:02:31Thanks, Jordan. Welcome everyone to our conference call to review the fiscal results and operating highlights of our Q3 fiscal year 2023. Joining me today is Pete Conley, our Chief Financial Officer and Senior Vice President of Intellectual Property, who will discuss our financial results. I'm going to walk you through our progress today against the work streams we've articulated in our previous earnings call. I'll provide an overview of our progress to date and I'll preview our goals for the balance of fiscal year 2023. Speaker 200:03:01Being transparent is critical for us and I'm proud of the communication channels we've established with our investors and followers. In addition to following our press releases, which are distributed every time a material event occurs, I encourage you to reach out to us through our email asknolabs.co and subscribe to our newsletter on our website. You should also visit our website, www.nolabs.co, as we are constantly updating our research and validation webpage. This section of our website provides access to our progress and data from our clinical trials. We have significantly raised the bar in terms of data transparency. Speaker 200:03:42I'd like to start today's discussion by revisiting some of our major events in calendar 2023. A lot has happened this year, Starting with significant leadership changes and an acceleration of our development, progress and operational execution. On January 26, I was named Chief Executive Officer by the company's supportive directors, while continuing as Chairman of the Board. We added new members to the executive team and redistributed core responsibilities. We disclosed new and existing strategic partners in data science, These changes have proven to be very effective as we achieved a long list of meaningful milestones in the past 6 months. Speaker 200:04:28In June, we revealed our Generation 1 device. The GEN-one device is an important stage in the development of our proprietary bio RFID technology. It's a portable research lab designed to be a powerful data collection device. This device allows our team to scale data collection tenfold, including testing across more diverse This is Generation 1. We will refine the next generation device based on what we learned from Generation 1. Speaker 200:05:07We cannot speculate today regarding what generation will be the version that we'll take to the FDA for clearance. In terms of clinical testing and data collection, our research and development team has collected more than 303 hour glucose datasets in the last 6 months, which resulted in the collection of almost 2,000,000,000 data points. Multiple protocols which have received IRB approval are being run-in parallel to test and improve our bio RFID Testing with a broad population to obtain results that are generalizable. That is what we work on every day. Scientific validation is critical for the development of our technology. Speaker 200:05:52In the last 6 months, we have published 5 manuscripts and Liquid Solutions' implications for non invasive physiologic monitoring was conducted in Collaboration with Mayo Clinic and was presented at the 2023 American Physiological Society Summit. This study demonstrated the accuracy of Nolab's proprietary BioRFID sensor in quantifying different analytes in vitro, blood glucose monitoring compared to DexCom G6 was presented at the American Association of Clinical Endocrinology See stability and repeatability. Going from a MARD, MARD, we call it a 20.6% to a margin of 11.3%, which positions us in an accuracy range similar to other FDA cleared devices and much closer to our goal of delivering a device with a marred under 10%. On the intellectual property We grew our portfolio by more than 70% in just 6 months. As of today, we have more than 169 patents issued and Pending, which is a significant increase over the last year. Speaker 200:07:34We had 98 patents issued and pending by the end of December 2022. We can continue to expand our portfolio and focus on maintaining the number one position for patent leadership in non invasive glucose monitoring. This position has been documented by 2 organizations We retained PatSnap Research and IP Capital Group, leading patent analytic firms. Our trade secret algorithms are another aspect of our intellectual We've also established a scientific and technical advisory board comprised of distinguished researchers, innovators and experts in medical technology and human health. These individuals have been advising the company and its Strategic partners on advancing the company's progress across all work streams, including algorithm refinement, was established in 2020. Speaker 200:08:40Bringing industry experts on board has been invaluable as they help us to validate and accelerate our work. Lastly, 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 reduced our burn rate from $1,200,000 per month to roughly 800,000 per month. Now, I'd like to share with you some of the lessons we learned in the last 6 months. But before jumping into those, I want to point out this graph. Speaker 200:09:15This is self explanatory as it shows the marked progress from other FDA cleared devices throughout time. We're proud of the impressive improvement we've been able to achieve with Bio RFID in such a short period of time, especially when We compare it to how long it took others to achieve a similar level of improvement. Our goal is to deliver a device with marred under 10% Compared to a blood reference device and I believe we're on track to do just that. Moving to our next slide, we worked hard, we achieved a lot and we learned a lot. We're inventing something new that has never been done before. Speaker 200:09:56Part of inventing is discovering new things. As we intensified our clinical development and experiments, As we brought new expertise in house through partnerships and experienced hires and as we amplified discussions with other relevant stakeholders in the space such as research institutes and key players we've listened and learned. We learned in more detail what needs to be accomplished before presenting our technology and devices to the FDA And before launching Imvenical Device in the global marketplace, we learned there is more work to do to conform with all regulatory requirements, especially in topics Like the following data accuracy across all glycemic ranges. More than 80% of our current data is Still concentrated in the normal glucose range, which is 80 to 150 megoliters per deciliter. We need to expand data collection to a wider range, including hypo and hyperglycemic scenarios to be successful in front of the FDA. Speaker 200:10:57These will also help us determine the intended use of our glucose monitoring devices in people with Type 1 and Type 2 diabetes or other sub segments. Patient physiological characteristics, we need to expand our data collection efforts So they include a more diverse set of patients with different skin pigmentation, skin thickness and the presence of other Elements that could cause interference such as hair, sweat and intense movement and environment and human factors. Our tests are currently conducted in a controlled laboratory environment. Ultimate regulatory approval requires us to have a deep understanding Real world environmental conditions such as air pressure, temperature, humidity, other substances, noise and human interaction with the technology All may interfere with its signal and ultimately impact its accuracy. These are all natural steps involved in the development of a medical device, Type 1 diabetes, Type 2 diabetes and pre diabetes. Speaker 200:12:04Data science and algorithm refinement. As we increase the amount of data used Train our algorithm, it just gets better. More data equals better accuracy. In sensor characterization, we have demonstrated The sensor performance, stability and repeatability in a controlled environment. Now we need to demonstrate the same in real world applications outside of our laboratory And scientific validation. Speaker 200:12:29We must continue with external research institutes to further validate our technology. These additional publications are critical when presenting our application to the regulatory agency. These work streams should increase generalizability of our BioRFID This is a concept we haven't addressed much in the past, but is extremely critical for our success. Medical devices that support patients and physicians to manage health conditions must be safe and accurate and maintain that level of accuracy under any condition and regardless of the patient as determined by its intended use. Moving forward, NOLAB's mission has been and continues to be making a difference in the lives of millions of people around the world by Convenient, accessible and affordable non invasive medical diagnostic solutions with a first focus On blood glucose monitoring, I'd like to emphasize the importance of increased accessibility and affordability. Speaker 200:13:35According to the International Diabetes Federation, there are 537,000,000 adults living with diabetes in the world in 2021. 3 in 4 people with diabetes live in low and middle income countries. These countries are experiencing accelerated diabetes growth With Africa facing a 129% projected increase from 20 21 to 2,045. Middle East and North Africa, an 87% increase and 50% increase in South and Central America. These are significantly higher rates than projected for the developed areas like North America and Europe with a 24% and 13% projected increase respectively. Speaker 200:14:15A non invasive device has the potential of addressing accessibility issues by providing a convenient, user friendly, Consumable free and therefore more affordable solution. Most of you are familiar with our technology, but it's important to remind everyone that the key features of The Bio RFID sensor is a novel sensor that can potentially measure anything. Its core components are IP protected such as the antennas array and the spectrum that emits and captures radio wave signals, which we like to refer to as the energy field. The RF generator that enables frequency sweeps in the microwave spectrum from 1500 Mega Hertz to 4000 Megahertz at 0.1 intervals is also IP protected and the combination Of these elements allows us to collect approximately 1,500,000 data points per hour, which makes it a powerful research sensor. Right now, it's being used to identify, measure and monitor blood glucose, but it has the potential to expand into other biomarkers Now to the Bio RFID platform. Speaker 200:15:34Our technology is a platform, not just a sensor. We're building a proprietary non invasive technology platform that can measure multiple analytes and combines uniquely designed hardware with powerful data processing algorithm. It leverages electromagnetic energy to accurately identify and measure a wide range of organic and inorganic materials, molecules and compositions of matter. From others leveraging spectroscopy as we target a specific bandwidth in the electromagnetic spectrum from microwave to radio waves. Bio RFID is form factor agnostic. Speaker 200:16:18It can be integrated into a variety of wearable, mobile or bench top form factors. It is pain free because it doesn't require needles or invasive transmitters poking into the skin or through the skin. It doesn't have any consumables, which combined with a low bill of materials translates into high potential to The 3 to 5 times less expensive than current FDA cleared options. Cutting edge trade secret machine learning and artificial intelligent models Power is highly accurate real time algorithms and it's shown the potential to target more than 100 analytes beyond blood glucose monitoring, which could make it an important enabler of predictive health and a powerful diagnostic tool. I get a lot of questions on how and why Bio RFID is different. Speaker 200:17:09This slide is a simple representation of why we believe Bio RFID is different and has the potential to transform non invasive medical diagnostics. BioRFID safely collects Data from the body, enabling a comprehensive picture of glucose that optical sensors are unable to achieve. To our knowledge, Bio RFID 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. U. Speaker 200:17:47S. Patent number 11529077 titled High Performance Glucose Sensor It's proof of RFID's novel approach. As stated by the patent, Bio RFID Technology approaches blood glucose reading very differently than FDA cleared devices currently available on the market. Radio frequency spectroscopy Enhanced by time frequency synchronization, decoupled antenna designs allows the BioRFID technology to collect a massive amount of data signals across real time glucose concentrations in the interstitial fluid, capillary and venous blood and cellular tissue. Nolab's energy field penetrates more than 1 inch into the body. Speaker 200:18:36In contrast, current microfilaments used by minimally invasive devices Such as the DexCom G6, G7 and Avilab Street Style Libre systems are limited to readings of only the interstitial fluid typically You've seen this slide before and I assume you have a good understanding of our product portfolio strategy. We've previously announced 2 devices focused on glucose monitoring. The U band is a wearable continuous glucose monitoring device. It provides real time blood glucose monitoring to the user, For a wearable continuous glucose monitoring device to manage their diabetes. Some simply want to replace the painful, inconvenient and expensive finger The Know You is a convenient non wearable on the go alternative to finger sticks. Speaker 200:19:37The know you can provide convenience as the patient can easily run spot checks of his or her blood glucose levels. We still don't have a full bill of materials for these products, but manufacturing of the GEN-1 device, which is powered and engineered for research and development, Indicates we should be capable of developing and delivering a final product at a much lower price point than the FDA cleared options currently available in the market. Some of you asked me why we keep testing, why do we need to keep testing. This graph makes it very simple to address that question. As our data set increases, we've experienced a clear improvement in the algorithm's accuracy. Speaker 200:20:20This allowed us to go from an above 20% mark to a mark of 11.3%, which was published a few weeks ago. A slide covering the details of this study has been included in the appendix of this presentation, which I direct you to read on our website. As we prepare to undertake clinical testing with the new GEN-one devices, we estimate we'll have tens of billions of observations to process. We're confident that we can get more reference labels combined with more raw data collected with our sensor, our algorithm performance will improve. This is standard procedure and machine learning will hopefully lead to a higher accuracy level or lower MARC figures. Speaker 200:21:02As we increase sample size, it is expected there are changes in accuracy resulting from variability in testing conditions, biological diversity and other factors. This is the core goal of expanded data collection. This massive amount of data requires a robust approach to data engineering, artificial intelligence and Ed Jimpulse, the creator of the industry leading development toolkit for machine learning has been collaborating with our team to accelerate BioRFID's NUP30 is our next target. We've already started planning for this new study and plan to get underway soon, which follows a protocol slightly different from the previous protocols. In addition to using CGMs to collect reference data points, we'll be using venous blood as the gold standard. Speaker 200:21:51We'll also be increasing the diversity of our population by including people with diabetes and pre diabetes. As soon as these results are ready, we'll publish them As we have with previous results, this is a great reason to visit our research and validation page on our website, Do that frequently and sign up for our newsletter. Our core goals for the balance of 2023 are very straightforward. We'll continue to focus on expanded data collection, which means more participants, extended glycemic range and exhausting environmental and biodiversity parameters. Algorithm refinement with the goal to deliver an under 10% MARG Generation 2 design, which we aim to be at least 50% smaller in design for manufacturing regulatory strategy and technology We'll continue growing the organization areas that support our core goals, Data collection, data science, hardware design and regulatory affairs and support business needs with additional capital as required. Speaker 200:23:07We have an aggressive and results oriented plan in place. We've made significant progress in the last 6 months and we'll continue to focus on our core work streams, data collection, data science and algorithm refinement, sensor and hardware characterization, Scientific validation. In addition, we will continue the strategic development of our intellectual property We will go to the FDA to commence clinical trials and ultimately obtain FDA clearance for our non invasive blood glucose monitoring device. It's difficult to set forth exact dates. We're inventing and developing new technology that's never been done before. Speaker 200:24:03As we expand data collection and testing conditions, we will continue to learn more about what needs to be addressed. We must achieve a repeatable accurate standard of excellence With a market ready product before undertaking clinical trials for the FDA clearance application. This takes time, but rest assured that as soon as we have high FDA clearance related timelines, we'll share them with you. We are executing the plan to deliver First FDA cleared truly non invasive glucose monitoring device in the market and our broader vision to transform medical diagnostics through non invasive means. 2023 has thus far been a year of change and significant advancement for Knowlabs. Speaker 200:24:45Now, I'd like to turn the call to Pete Conley, We will review our financials. Speaker 300:24:51Thank you, Ron. We detailed the financial results in today's 3rd quarter Earnings release, which as noted by Jordan, you can find on our website, and I will share a few key line items. NOLAS reported a net loss of $3,590,000 in the Q3 of 2023 Compared to a net loss of $3,030,000 in the year ago period, which translates to earnings per share The loss of $0.07 unchanged from the year ago period and the loss of $0.07 and this is before preferred stock dividends. In the Q3, we also recorded a non cash charge to earnings of $4,960,000 Related to the fair market value of dividends on our Series C and D preferred stock that were either paid or accrued in shares Research and development expense for the Q3 was $1,870,000 As compared to $1,270,000 in 2022, an increase of 48% year over year. The increase in R and D expense was related to increases in engineering, third party technical services and expenditures related to the development Our Generation 1 device, which we completed and announced on June 7, as we continue to execute our path To FDA clinical trials and commercialization. Speaker 300:26:21Selling, general and administrative expenses for the 3rd quarter Was $1,350,000 which was sequentially lower by $890,000 in the $2,240,000 in the 2nd quarter as well as lower than the year ago period of $1,580,000 as we continue our initiatives to reduce our cash burn. Turning now to the balance sheet. As of June 30, 2023, we had cash and cash equivalents of $3,930,000 as compared to $12,590,000 at the end of September 30, 2022. Net cash used in operations for the 9 month period ending June 30, 2023 was 8,970,000 dollars compared to $3,690,000 in the prior year. During the quarter that ended June 30, The company made adjustments to its fixed expenses and the impact of those adjustments has significantly reduced our monthly burn rate. Speaker 300:27:25Given the significant reduction in fixed expenses, the company believes that it has enough available cash and flexibility with operating expenses to operate until at least December 2023. As we have stated in our Q3 10 Q, During 2023, we expect to raise additional funds through the issuance of preferred stock, convertible debentures and equity. That concludes my review of our financial highlights, and I'll return the call to Ron for closing remarks. Speaker 200:27:57Thanks, Pete. We'll now dedicate The first question is what MARD level would be needed to seek FDA approval. How long would the sample take to move forward? As we indicated, We are working on IMARD that is under 10% and we think when we get into that range, that's a range Sufficient to allow us to go forward and seek FDA approval. How long will the sample take to move? Speaker 200:28:44I'm not sure exactly What that question means, Pete? Speaker 300:28:49Yes, I think it's important to note It's important to look at the size of the sample as much as it is what the absolute MAR number is and To really reach the degree of clinical accuracy required by the FDA, it requires both a MARG under 10% Combined with a very broad population that's being tested broad in terms of age, gender, Geographic diversity, biological diversity and so forth, and it's the combination that will position us for the FDA. Now the Speaker 200:29:27next question really sort of follow-up on that Pete and cover some of the same territory. The question is what's the timeline For additional measures, we pointed out I. E. Diverse populations, environmental factors, skin thickness, hair, sweat and amyloid and pigmentation. There, these additional measures, these additional, I'm going to say, features of the population are Being factored in the end of 30 study that I referenced in my remarks, the one using venous blood is a gold standard as a And this is going to include people with diabetes, pre diabetes and we're looking at all those other Speaker 300:30:30Yes. We have a question here. Any concerns with being removed from the NYSE due to the sub-one dollar share price? The NYSE American Continued Listening criteria does not specify a minimum share price. What it does specify is a minimum market cap. Speaker 300:30:50And based on the shares outstanding as of our June 30, 2023 10 Q, which is 52,300,000 shares. We meet the $50,000,000 minimum market cap At a share price of $0.95 and it's not a single day criteria. The NYSE looks at the range of our share price over a period of time. So this is something obviously we pay close attention to And we are committed to ensuring compliance with the continued listing requirement. Market cap is not something we can directly control, but we are very aware. Speaker 200:31:39Here's a question. With the stock at 4 year lows, despite all the latest advancements with technology, what's the company doing It's interesting. I think we're impacted by broader market forces. I think one of the things those of you who are shareholders and we're shareholders here in the room in Seattle, I think we We all have seen what's happened in the broader market, especially in the, I'd say, the microcap space, technology related microcap That being said, our focus is to just stay the course, keep doing what we're Staying focused on what we're doing. We have a very clear roadmap as we address today. Speaker 200:32:38We're making significant progress than we have over the last 6 months. We're going to continue to do our clinical research under these various IRB protocols. We're going to continue to report the results as we have them with complete transparency. We're building the IP portfolio. We've got Gen 1. Speaker 200:32:55We're working on Gen 2. We continue to build and further cement our position as a leader in the area of non invasive blood glucose monocrene. And at the same time, we do everything we can In terms of Investor Relations, getting the word out, I think one of the things that's noteworthy since we up listed on the New York Stock Exchange We've had somewhere in the neighborhood of 25 institutions begin to accumulate our stock. We had 0 institutions before we did the uplift. So What we want to do is with results be results oriented and continue to do what we're doing and We believe the stock price will take care of itself. Speaker 200:33:35We don't like it where it is today, no doubt. Pete, do you want to amplify that? Ron, if Speaker 300:33:40I could add to your comments to the specific question, what is the company doing to build confidence? And I think if you go visit our website and look at the research and validation section of the website, You will see something that I don't think any of the other companies in our sector do. We publish Our clinical studies, we publish our posters, we publish our manuscripts. When you review these documents, we very clearly Educate the market as to what we're doing and through that education, one can see that what we're doing is quite different from anybody else. And so as Ron indicated earlier, we are committed to education. Speaker 300:34:29We are committed to transparency. And these papers, I think, inform investors. And I think an informed investor can become a confident investor Next question, how did the company utilize the GEN-one device? Well, the Gen 1 device now was announced about 2 months ago. We are using the device actively in our Testing, we are actively conducting testing with the GEN-one in parallel with ongoing clinical Research using our stationary lab system and the parallel path is best is the best practice when introducing new environmental Human factors in the testing protocol. Speaker 300:35:32And there's a follow on question. How many Gen 1 devices have been Constructed and sent out for use in the real world. As we sit here and speak now, about a dozen Units have been built. We have component inventory to build 100. We anticipate reaching that number somewhere towards the end of the year, early 2024. Speaker 300:36:00Once we Get to what we would consider a characterized sensor with the Appropriate algorithms, we will begin to have external testing. We would expect the 1st external testers Speaker 200:36:17At the Speaker 300:36:17end of the year, beginning of 2024. Speaker 200:36:21I think I want to just add something about the Gen 1 devices by the way, And you saw our video, you saw the video in June. Those are all hand built, right? Everyone's hand built. We're now Doing work as I indicated earlier on Gen 2. Gen 2 will be designed for manufacturing and that will be done in concert with our manufacturing partner, Racer Technologies that we've spoken of in the past. Speaker 200:36:50So that's a very different circumstance. When you're designing something for manufacturing where you have the opportunity to do significant unit volume And that's the product Gen 2 that is likely to be the product that would then find its way ultimately the FDA trials into These are hand built and these are really the Gen 1, it's about the size of a mouse. You've all seen Pictures of it and you've seen kind of how it relates to the size of a human hand, if you will. That's really A sort of a research lab in your pocket. That real focus is for gathering data. Speaker 200:37:31And so they're robust and they're hand built. Speaker 300:37:38Here we have another question. On the last call, it suggests You had enough cash through next February 2024. Now it's December of this year. So that's a 2 month delta between the 2 and 800,000 burn, that's 1,600,000. If you I'll go through our financials in the 10 Q that was released today. Speaker 300:38:05You'll see in the quarter just reported The R and D expense increased 48% year over year. In dollar terms, it was $606,000 Increase year over year and what that reflects is the accelerated rate of development from GEN-1 as Ron We're already working on Gen 2. And so we believe that accelerating The development of our products accelerating the filing of our patents, again as Ron noted, In the 1st 6 months this year, we have increased our patent portfolio 70%. And so We believe that that's the best use of the capital that we have. There's another related question here. Speaker 300:38:58How will NOLABS fund the operations of the company? In the 10 Q, in the liquidity section, we talk about the fact that right now we are Underway on the capital financing plan for the balance of 2023, And we believe that we'll have the funds to execute our plan. We have not commented on this Speaker 200:40:22How many employees have been hired or lost since Gen 1 came out in June? We haven't lost any employees. We have 11 Speaker 300:40:47Does AI help NOLabs get the MARR lower? When is the MARR to So, Tim projected to be accomplished. We utilize AI and we utilize machine learning in developing Our algorithms, which will impact MARS, but the biggest determinant of MARS is the size of the We are increasing our cohorts now as Ron indicated. We are underway of ANA-thirty. We anticipate going to ANNO50 than ANNO100. Speaker 300:41:26If one wants to Get a sense of what kind of data is required to have a FDA cleared product. You can Download DexCom's G7 summary of decision from the FDA and DexCom achieved their MARG readings Speaker 200:41:56We appreciate very much everyone's questions and active engagement. As we indicated earlier, So don't hesitate to stay in touch. We try to be responsive. This will conclude our Q and A. Thank you to everyone for joining us today. Speaker 200:42:19There's a lot to look forward to here in the balance of 2023 and we're excited to report on our progress. We appreciate your support And I also want to acknowledge the incredible effort of our team of really talented employees and not just our employees. We have 11 employees as we indicated, but we have people working with us engineering, machine learning, product design and development that are They're external to the company, but they're every bit as committed and excited to be part of this journey we're on. I want to thank them as well. Thank all of you who are shareholders and supporters. Speaker 200:42:56We appreciate it very much. Thank you all and have a great day. Speaker 100:43:01The conference call replay will be available on our website in the coming days. Thank you for your participation. Operator00:43:09This does conclude today's teleconference. You may disconnect your lines at this time. Enjoy the rest of yourRead morePowered by