Q2 2024 Know Labs Inc Earnings Call
Operator: Greetings. Welcome to NOLAB's second quarter 2024 earnings conference call. Please note this conference call is being recorded. I will now turn the conference over to Jordan Hujar, NOLAB's Chief of Staff. You may begin.
Greetings and welcome to <unk> second quarter 2024 earnings Conference call. Please note. This conference call is being recorded I will now turn the conference over to Jordan, who jar lid lapses.
Jordan: The chief of staff you may begin.
Jordan Hujar: Thank you, Operator. Thank you, everyone, for joining us for today's conference call to review NoLabs' second quarter 2024 financial results and operating highlights. If you have not seen today's financial results, press release, or 10-Q filing, please visit the investors page on the company's website at www.nolabs.co. Before turning the call over to Ron Erickson, NOLABS 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.
Jordan: Thank you operator.
Jordan: Thank you everyone for joining us for today's conference call to review <unk> second quarter, 'twenty 'twenty four financial results and operating highlights.
Jordan: We have not seen today's financial results press release or 10-Q filing. Please visit the investors page on the company's website at Www Dot No labs Dot C O.
Jordan: Before turning the call over to Ron Ericsson, No 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.
Jordan Hujar: Any statements that are not historical facts are forward-looking statements. We encourage you to review the company's SEC filings, including, without limitation, the company's Forms 10-K and 10-Qs, which identify specific risk factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and or commercialization of potential diagnostic products; uncertainty in the results of clinical trials or regulatory approvals, the need to obtain third-party reimbursement for patients' use of any diagnostic products the company commercializes, our need and ability to obtain future capital and maintenance of IP rights, risks inherent in strategic transactions, such as failure to realize anticipated benefits, legal, regulatory, or political changes in the applicable jurisdictions, Accounting, and Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements.
Jordan: Any statements that are not historical facts are forward looking statements.
Jordan: We encourage you to review the company's SEC filings, including without limitation the <unk>.
Jordan: Company's forms 10-K, and thank you, which identifies specific risk factors that may cause actual results.
Jordan: Or events to differ materially from those described in these forward looking statements.
Jordan: These factors may include without limitation risks inherent in the development and commercialization of potential diagnostic products.
Jordan: Uncertainty in the results of clinical trials or regulatory approvals the.
Jordan: The need to obtain third party reimbursement for patients use of any diagnostic products the company commercialize this.
Jordan: Our need and ability to obtain future capital and maintenance of IP rights.
Jordan: Risks inherent in strategic transactions, such as failure to realize the anticipated benefits legal regulatory or political changes and the applicable jurisdictions are counting and quality controls.
Jordan: Then estimated allocations of resources to develop and commercialize technologies.
Jordan: Or failure to maintain any laboratory accreditation or FDA certification.
Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward looking statements.
Jordan Hujar: No Labs expressly disclaims any intent or obligation to update these forward-looking statements, except as otherwise may be required under applicable law. A Q&A session will follow this call. Your questions can be submitted through the webcast portal, which can be accessed through our website. We will not be taking questions over the phone during today's call. With that said, I'll turn the call over to Ron Erickson, NoLabs CEO.
No labs expressly disclaims any intent or obligation to update these forward looking statements, except as otherwise may be required under applicable law.
Jordan: A Q&A session will follow this call for your questions can be submitted through the webcast portal, which can be accessed through our website.
Jordan: We will not be taking questions over the phone during today's call.
Speaker Change: With that I'll turn the call over to Ron Ericsson No lab C E O.
Ron Erickson: Thank you, Jordan. I welcome everyone to our conference call to review the financial results and operating highlights of our second quarter for fiscal year 2024. Joining me today is Pete Conley, our Chief Financial Officer and Senior Vice President of Intellectual Property, who will discuss our financial results. Since our last earnings call on February 14th, many milestones have been achieved. These milestones resulted from an accelerated work program we implemented at the beginning of 2023.
Ron Ericsson: Thank you Jordan and welcome everyone to our conference call to review the financial results and operating highlights of our second quarter for fiscal year 2020 for joining me today is Pete Connolly, our Chief Financial Officer, and senior Vice President of intellectual property, who will discuss our financial results since our last earnings call in February.
Ron Ericsson: 14th many milestones have been achieved these milestones resulted from an accelerated work program. We implemented at the beginning of 2023 now I'll provide a brief update on these milestones and the progress we've made against the four core work streams, we previously articulated.
Ron Erickson: Now, I'll provide a brief update on these milestones and the progress we've made against the four core workstreams we previously articulated. Workstream number one, hardware. A critical workstream in an area with a lot of progress has been hardware development. In June 2023, we announced the completion of our portable Generation 1 prototype device for non-invasive glucose monitoring. We spent the next several months with this device undergoing sensor characterization to better understand how our sensor performs in a completely wireless unit and answer questions surrounding battery life, signal quality, and temperature.
Ron Ericsson: Work stream number one hardware.
Ron Ericsson: Critical work stream in an area with a lot of progress has been hardware development in June 2023, we announced the completion of our portable generation one prototype device for noninvasive glucose monitoring we spent the next several months with this device undergoing sensor characterization to better understand how our sensor performs.
Ron Ericsson: Clearly wireless unit and answer questions surrounding battery life signal quality and temperature. These tests included testing in and outside of our lab, both in vitro and with humans data collected through these tests was compared to data collected with FDA cleared glucose monitors, helping us to understand how our.
Ron Erickson: These tests included testing in and outside of our lab, both in vitro and with humans. Data collected through these tests was compared to data collected with FDA-cleared glucose monitors, helping us to understand how our sensor performs in real-life settings. Pulling from these findings, our product team, alongside our hardware, firmware, electrical engineering, and industrial design partners, continued to miniaturize the Generation One prototype further.
Ron Ericsson: Sensor performs in real life settings.
Ron Ericsson: Pulling from these findings our product team long side or hardware for more electrical engineering and industrial design partners continued to miniaturize miniaturize the generation one prototype further.
Ron Erickson: These efforts resulted in the announcement of the KnowU, our Gen 2 device, on February 27th. The KnowU is a wearable, non-invasive, continuous glucose monitoring device, or CGM. It incorporates our proprietary technology and sensor, which we plan to submit to the FDA for clearance. This center has now been tested and proven stable and accurate. By including it in a wearable format, we can amplify the technology's testing and validation outside the lab. The NOE can be worn with an adhesive, allowing the user to clip the sensor on and off, or on the arm or forearm with a strap.
Ron Ericsson: These efforts resulted in the announcement of the no you are gen. Two device on February 27th to know you as a wearable noninvasive continuous glucose monitoring device or C. G O.
Ron Ericsson: It incorporates our proprietary technology and sensor, which we plan to submit to the FDA for clearance.
Ron Ericsson: This sensor has now been tested and proven stable and accurate by including it in a wearable format. We can amplify the technology's testing and validation outside the lab.
Ron Ericsson: No you can be worn within adhesives, allowing the user to clip the sensor on and off or on the arm or for them with a strap the device significantly smaller and lighter than the generation. One prototype includes onboard computing power and built in machine learning capabilities. They know you is designed to optimize the customer.
Ron Erickson: The device, significantly smaller and lighter than the Generation 1 prototype, includes onboard computing power and built-in machine learning capabilities. The KnowU is designed to optimize the customer experience, which is expected to last for years, ultimately getting rid of costly disposables and connecting with an easy-to-use companion mobile app. More work will need to be done to prepare the NOU for commercialization, including further miniaturization and adjustments based on inputs from clinical trials and human factors testing, and most important, what works best for the patient user.
Ron Ericsson: Experience, which is expected to last three years all of them all of them.
Ultimately.
Ron Ericsson: Getting rid of eliminating costly disposables.
Ron Ericsson: And connecting with an easy to use companion mobile app.
Ron Ericsson: More work will need to be done to prepare the no you for commercialization, including further miniaturization and adjustments based on inputs from clinical trials and human factors testing and most important what works best for the patient user.
Ron Erickson: Through 2024, the KnowU device will support accelerated data collection, including determining the technology's performance through continuous wear in different locations on the body and within more expansive glycemic ranges and diverse populations. If you haven't seen it, I encourage you to watch the video we published on our website with specific details on the MOU feature.
Ron Ericsson: Through 2020 for the new <unk> device will support accelerated data collection, including determining the technology's performance through continuous we're in different locations on the body and within more expansive glycemic ranges and diverse populations. If you haven't seen it I encourage you to watch the video we published on our website.
Ron Ericsson: With specific details on that though you features.
Ron Erickson: Workstream number two involves clinical trials and data collection. Clinical testing continues to be an important area of development for the company. During the first half of our fiscal year 2024, we completed an IRB-approved internal trial with more than 30 participants with prediabetes or type 2 diabetes. Eighty percent of the data collected from our sensor was randomly selected to train our algorithm. The remaining 20 percent of the data was then applied to the trained algorithm and compared to a paired venous blood glucose reference value, resulting in a mean absolute relative difference, or MARD, of 11.1 percent. This was the first time we implemented a clinical research protocol involving people with diabetes using venous blood as a comparative reference, the gold standard expected by the FDA. That's very important.
Clint: Work stream number two involves clinical trials and data collection Clint.
Clint: Clinical testing continues to be an important area of development for the company during the first half of our fiscal year 'twenty 'twenty four we completed an IRB approved internal trial with more than 30 participants with pre diabetes or type two diabetes.
Clint: 80% of the data collected from our sensor was randomly selected to train our algorithms. The remaining 20% of the data was then applied to the trained algorithm and compared to a pared venous blood glucose reference value, resulting in a mean absolute relative difference or mark of 11, 1%.
Clint: This was the first time, we implemented a clinical research protocol involving people with diabetes using venous blood as a comparative reference the gold standard expected by the F. D. A that's very important.
Ron Erickson: Dr. Summers, Varen Summers from the Mayo Clinic, was an author and a co-investigator on that research protocol. Dr. Summers presented, and we announced on March 6, the interim results of this study titled, quote, Noninvasive Blood Glucose Monitoring in People with Diabetes Using an RF Sensor and Venous Blood Comparator. This he did at the 17th International Conference on Advanced Technologies and Treatments for Diabetes, or ATTD, in Florence, Italy. This trial has been completed and enabled the R&D team to collect more data in the hyper and hypoglycemic ranges. In previously published studies, most of the data collected was within the normal glycemic range, 70 to 100 milligrams per deciliter, and glucose values from a popular CGM were used as a comparative reference.
Clint: Doctor Summers Varun summers from the Mayo clinic was an author and a co investigator on that research protocol.
Ron Erickson: By including participants with type 2 diabetes, this study increased the number of data points outside the normal glycemic range. Demonstrating similar accuracy across all ranges is an essential milestone in our technology development roadmap. While many devices typically underperform outside the normal glycemic range, our sensor delivered consistent accuracy across the hyperglycemic, normal, and hypoglycemic ranges in this study. The MARD for these ranges were 11.5%, 11%, and 9.5%, respectively.
Clint: Doctor Summers.
Clint: Presented and we announced on March six the interim results of this study titled quote Noninvasive blood glucose monitoring and people with diabetes, using an RF sensor and venous blood comparator.
Ron Erickson: These results suggest that our sensor, paired with our trade secret machine learning AI algorithms, holds considerable promise for non-invasive blood glucose monitoring. A core focus of our next series of trials will be enrolling a more diverse population, including people with type 1 diabetes. This is necessary to collect more data in the very low hypoglycemic range of 40 to 70 milligrams per deciliter and the very high hyperglycemic range of 350 to 400 milligrams per deciliter.
Ron Erickson: The FDA is focused on these ranges, and accuracy is critical for those managing diabetes. The wearable nature of the KnowU will also enable continuous data collection and yield a large volume of data that machine learning algorithms require to improve accuracy across all intended use cases. This increase in data will be used to further refine and inform our algorithm development. Work stream three is algorithm development. We leverage all the data that's collected during our sensor characterization work, in vitro tests, and clinical trials for algorithm development.
Ron Erickson: As we continue refining the algorithm, we learn exactly what data is needed to increase accuracy. This includes a wider range of glycemic ranges, along with data from a more diverse population, and data that takes into account temperature, location on the body, and other interferences. Our goal is to achieve an algorithm with a mean absolute relative difference or MARD of 10% or less.
Clint: This he did at the 17th International Conference on advanced technologies, and treatments for diabetes or E. T T D in Florence, Italy.
Clint: This trial has been completed and enable the R&D team to collect more data in the hyper and hypoglycemia ranges.
Clint: And previously published studies most of the data collected was within the normal Glycemia cranes 7200 milligrams per deciliter and glucose values from Epocrates C. G. M were used as a comparative reference Brian.
Clint: By including participants with type two diabetes. This study increase the number of data points outside the normal glycemic range, demonstrating similar accuracy across all ranges as in a central milestone in our technology development roadmap.
Clint: While many devices typically underperform outside the normal glycemic range, our sensor delivered consistent accuracy across the hyper normal and hypoglycemic ranges in this study the Mart for these ranges were 11, 5%, 11% and nine 5% respectively. These re.
Clint: Results suggest that our sensor paired with our trade secret machine learning AI algorithms holds considerable promise for noninvasive blood glucose measurement.
Clint: A core focus of our next series of trials will be enrolling a more diverse population, including people with type one diabetes. This is necessary to collect more data in the very low hypoglycemic range of 40 to 70 milligrams per deciliter and the very high hyperglycemia range of 350 to 400 milligrams per deciliter.
The F. D. A is focused on these ranges and accuracy is critical for those managing diabetes.
Clint: The wearable nature of the no you will also enable continuous data collection and yield a large volume of data that machine learning algorithms required to improve accuracy across all intended use cases. This increase in data will be used to further refine and inform our AGA rhythm development.
Clint: Our work stream three is the algorithm development, we leverage all the data that's collected during our sensor characterization work in vitro tests in clinical trials for algorithm development.
Clint: As we continue refining the algorithm we learn exactly what data is needed to increase accuracy. This includes a wider range of glycemic ranges along with data from a more diverse population and data that takes into account temperature location on the body and other interference.
Clint: Our goal is to achieve an algorithm with a mean absolute relative difference or mart at 10% or less more importantly, we also need to meet the fda's requirements for accuracy and Varian glycemic ranges and over different periods of time, all of which were considering during our algorithm development the.
Ron Erickson: More importantly, we also need to meet the FDA's requirements for accuracy in varying glycemic ranges and over different periods of time, all of which we're considering during our algorithm development. The goal of our data science and algorithm development efforts during fiscal 2024 includes building personalized models for each user following a calibration period. The outcome will be an algorithm that can develop an accurate glucose value estimate for those individuals whenever they are wearing the KnowU device.
Clint: The goal of our data science and algorithm development efforts during fiscal 'twenty 'twenty. Four include building personalized models for each user following calibration period. The outcome will be an algorithm that can develop an accurate glucose value estimate for those individuals' whenever they're wearing the <unk> device.
Ron Erickson: Building personalized models is an early step toward a generalized algorithm, but the ability to create these models may themselves prove to be viable in an FDA-cleared commercial device. The current version of our algorithm performs well within a known population from data collected in our lab in Seattle.
Clint: Building personalized models as an early step toward a generalized algorithm, but the ability to create these models made themselves crews proved to be viable in an FDA cleared commercial device. The current version of our algorithm performs well within a known population from data collected on our lab in Seattle.
Ron Erickson: We're first focused on understanding performance in different settings outside of the lab and expanding our population of study to those with type 1 diabetes. As we move forward, new approaches, such as device calibration, will be tested. Our fourth workstream involves intellectual property. With respect to intellectual property, we continue to grow our portfolio. At the end of this quarter, we had over 300 patents issued, pending, and in process, reflecting our very high rate of innovation.
Clint: We're first focused on understanding performance in different settings outside of the lab and expanding our population of study to those with type one diabetes as we move forward new approaches such as device calibration will be tested our fourth work stream involves intellectual property.
Ron Erickson: The issued and pending patents cover fundamental aspects of our radio frequency spectroscopy technology and several unique applications. Intellectual property that includes patents and trade secrets will continue to be a focus for the company, and we will work to reinforce a defensible intellectual property moat around our technology. We remain focused on maintaining our position as the leading worldwide IP holder in non-invasive blood glucose monitoring. Finally, a corporate update. As I already mentioned, our team was in Florence, Italy, in early March to attend the 17th International Conference on Advanced Technologies and Treatments for Diabetes. The industry calls it ATTD, and it's the number one worldwide show each year on the subject.
Clint: With respect to intellectual property, we continue to grow our portfolio at the end of this quarter, we had over 300 patents issued or pending and in process.
Clint: Reflecting our very high continuing rate of innovation, the issued and pending patents cover fundamental aspects of our radio frequency spectroscopy technology and several unique applications [noise] intellectual property that includes patents and trade secrets will continue to be a focus for the company and we will work to re.
Clint: And force a defensible intellectual property moat around our technology, we remain focused on maintaining our position as the leading worldwide.
P holder and noninvasive blood glucose monitoring.
Clint: Finally, our corporate update.
Clint: I already mentioned our team was in Florence, Italy in early March to attend to the 17th International Conference on advanced technologies and treatments for diabetes.
Clint: Industry calls it E T T D and it's the number one worldwide show each year on the subject we displayed the new U two attendees.
Ron Erickson: We displayed the KnowU to attendees and presented the results of our recent clinical study. We also had meetings with companies in our space and physicians leading critical diabetes research around the world. We co-hosted a luncheon event with Children with Diabetes, a well-known nonprofit organization dedicated to providing education and support to families living with type 1 diabetes. This luncheon was attended by more than 60 physicians who are prominent thought leaders in the diabetes management field.
Clint: And presented the results of a recent clinical study. We also had meetings with companies in our space and physicians, leading critical diabetes research around the world.
Clint: We co hosted a luncheon event with children with diabetes, a well known nonprofit organization dedicated to provide education and support the families living with type one diabetes dysfunction was attended by more than 60 physicians, who are prominent thought leaders in the diabetes management field.
Ron Erickson: This group had the opportunity to learn more about our company, our technology, and our technology roadmap. Many medical and technical questions were addressed, and new clinical collaboration opportunities were discussed, and we will continue to follow up on those. The ATTD organization also awarded us an emerging technology grant as an outstanding startup company presenting an innovative product. As a part of this grant, we participated in the International Fair of New Technologies with two scheduled presentations and an exhibition hall booth that allowed us to display our progress to the more than 5,000 attendees at the conference.
Clint: This group had the opportunity to learn more about our company, our technology and our technology roadmap.
Clint: Any medical and technical questions were dressed in new clinical collaboration opportunities were discussed and we continue to follow up on those.
Clint: The a T T D organization also awarded US an emerging technology grant as an outstanding startup company presenting an innovative product.
Clint: As a part of this grant we participated in the international Fair of New technologies with two scheduled presentations and an exhibit exhibition hall booth that allowed us to display our progress to the.
Clint: More than 5000 attendees at the conference we will continue to attend present and engage with the medical community at other conferences that are important for the diabetes space, including American Association for clinical Endocrinology, where are we.
Ron Erickson: We will continue to attend, present, and engage with the medical community at other conferences that are important for the diabetes space, including the American Association for Clinical Endocrinology, where we just presented May 9 to 11, in New Orleans; the American Diabetes Association Scientific Sessions, June 21 to 24, in Orlando; and the ATDC Conference on Practical Targets for Diabetes Care, July 10 to 13, in Keystone, Colorado; and there are many others. These conferences have proven to be valuable in our continued efforts to pursue collaboration agreements with other companies and to engage with preeminent clinicians from around the world. Lastly, we entered into a funding agreement for an investment of up to $12 million. This agreement was executed with LEND Global Fund 2LP, an investment entity managed by the LEND partners.
Clint: Just presented May nine to 11 in New Orleans, The American Diabetes Association scientific sessions June 21 to 24 in Orlando.
Clint: And the eight T D C conference on practical.
Clint: Targets for diabetes care from July 10, 2014 in Keystone, Colorado, and there are many others. These conferences have proven to be valuable and our continued efforts to pursue collaboration agreements with other companies and to engage with preeminent clinicians from around the world.
Clint: Lastly, we entered into a funding agreement for an investment of up to $12 million. This agreement was executed with Lynn Global Fund two L. P and investment entity managed by the Lind partners. This investment will enable us to accelerate development across our four core our four core work streams that are enumerated.
Ron Erickson: This investment will enable us to accelerate development across our four core workstreams that I've enumerated, including hardware development, expanded data collection, algorithm development, and our IP. It will also allow us to reinforce our team in areas that are critical for our development roadmap and our desire to start generating revenues from our robust IP portfolio. In this arena, we recently brought on board Chris Somogyi as President International. Chris has an academic and career background in biomedical engineering and over 40 years of experience in commercializing innovation across related industries.
Clint: Including hardware development expanded data collection, Auger rhythm development and our IP.
Clint: Allow us all through the reinforce our team in areas that are critical for development roadmap and our desire to start generating revenues from our robust IP portfolio. In this arena. We recently brought on board, Chris Emoji as President International Chris has an academic and career background in biomedical engineering and over.
Ron Erickson: Chris will play a pivotal role in identifying global opportunities to license our extensive intellectual property portfolio and will focus on securing strategic development partnerships as we look at opportunities in the rest of the world. You will see a more comprehensive overview of Chris and his areas of focus in a press release that we will issue tomorrow morning prior to the market opening.
Clint: 40 years of experience in commercializing innovation across related industries, Chris will play a pivotal role in identifying global opportunities to license our extensive intellectual property portfolio and will focus on securing strategic development partnerships as we look at opportunities in the rest of the world you will see a more comprehensive.
Speaker Change: Nancy will review on Chris and his areas of focus and a press release that will issue tomorrow morning prior to the market open.
Ron Erickson: It's important as we approach the market with what we call the next generation of the glucose monitor to do so in the context of the progress that's been made over the last 40 years. Glucose levels were historically determined by testing urine. In the early 1980s, the finger stick came into the market with its enzymatic determination of glucose levels from blood drawn from the finger. In the early 2000s, companies came to the market with the first continuous glucose monitors utilizing their own enzymatic determination of blood glucose from interstitial fluid. The NoLabs noninvasive glucose monitor is the next generation, whether used in a continuous form or in a spot check screening. I'm very proud of our team's achievements during the last quarter.
Speaker Change: It is important as we approached the market with what we call. The next generation of the glucose monitor to do so in the context of the progress that's been made over the last 40 years glucose levels, where historically determined by testing urine and the early 19 eighties came the introduction of the finger stick with it and the NAMIC it's ends.
Speaker Change: <unk> determination of glucose levels from blood drawn from the finger in the early two thousands companies came to the market with the first continuous glucose monitors utilizing their own enzymatic determination of blood glucose from interstitial fluid.
Speaker Change: <unk> labs noninvasive glucose monitor is the next generation, where they're using a continuous form or in a spot check screening manner.
Speaker Change: I'm very proud of our team's achievements during the last quarter, we remain committed to delivering an accessible affordable and accurate solution that improves the current standard of care and enhances the quality of life for those living with diabetes. The recent milestones such as the no new product brings us closer to a future where.
Ron Erickson: We remain committed to delivering an accessible, affordable, and accurate solution that improves the current standard of care and enhances the quality of life for those living with diabetes. Recent milestones, such as the KnowU product, bring us closer to a future where equitable care and diabetes management can become a reality. I encourage you to visit our investor relations website at ir.nolabs.co to stay updated on our progress. And now, I'd like to turn the call over to Pete Connolly, who can review our financial...
Equitable care in diabetes management can become a reality I encourage you to visit our Investor Relations website at IR Dot No lab stuff.
peak Connolly: Oh to stay updated with our progress and now I'd like to turn the call to peak Connolly, who can review our financials.
Speaker Change: Pete.
Pete Conley: Thank you, Ron. We detail the financial results in today's second quarter of FY 2024 earnings release, which, as noted by Jordan, you can find on our website, but I'll share a few key line items for Q2. In fiscal 2024, NO Labs reported an operating loss of $4.73 million compared to an operating loss of $4.81 million in Q2 fiscal 2023, a reduction in operating loss of 1.7 percent. This translates to earnings per share of a loss of $0.07, better than the prior year earnings per share loss of $0.10, an improvement of 30%, before preferred stock dividends.
Pete Connolly: Thank you Ron we detail the financial results in today's second quarter, FY 'twenty 'twenty four earnings release, which as noted by Jordan you can find on our website, but I'll share a few key line items for Q2.
Pete Connolly: Fiscal 'twenty 'twenty four no labs reported an operating loss of $4 seven $3 million compared to an operating loss of $4.81 million in Q2 fiscal 2023.
Pete Connolly: A reduction in operating loss was one 7%.
Pete Connolly: This translates to earnings per share of loss of seven cents better than the prior year earnings per share of loss of 10 cents an improvement of 30%.
Pete Connolly: Preferred stock dividends in.
Pete Conley: In Q2 fiscal 2024, we also recorded a non-cash charge to earnings of $976,000, principally related to stock-based compensation of $617,000 and issuance of common stock for services of $251,000. Research and development expense for Q2 fiscal 2024 was $2.18 million, as compared to $2.56 million in Q2 fiscal 2023, a decrease of 15.1% year-over-year. The decrease in R&D expenses was related to decreased personnel and the use of external consultants to reduce the cost of product development.
Pete Connolly: In Q2 fiscal 'twenty 'twenty four we also recorded a noncash charge to earnings of $976000 principally related to stock based compensation of $617000 and issuance of common stock for services of $251000.
Pete Connolly: Research and development expense for Q2 fiscal 'twenty 'twenty, four was $2 $1 $8 million as compared to $2.56 million in Q2 fiscal 2023, a decrease of 15, 1% year over year.
Pete Connolly: The decrease in R&D expense was related to decreased personnel in the use of external consultants to reduce the cost for product development.
Pete Conley: Selling General and Administrative Expense for Q2 Fiscal 2024 was $2.55 million, which was higher by $308,000 than the $2.24 million in the year-ago period, an increase of 13.7%, reflecting key hires made in the quarter, as well as an increase in legal expenses related to intellectual property and financing activity. Turning now to the balance sheet, as of March 31, 2024, we had cash and cash equivalents of $4.71 million, compared to $8.02 million at the end of September 30, 2023. Net cash used in operations for the first six months of FY24 was $7.05 million, compared with $6.34 million in the six-month period of fiscal 2023.
Pete Connolly: Selling general and administrative expense for Q2 fiscal 2024 was 2.55 million, which was higher by 308000.
Pete Connolly: $2 million to $4 million in the year ago period, an increase of 13, 7%.
Pete Connolly: Selecting key hires made in the quarter as well as an increase in legal expenses related to IP and financing activities.
Pete Connolly: Turning now to the balance sheet as of March 31, 2024, we had cash and cash equivalents of $4 seven $1 million compared to $8.0 million to $2 million at the end of September 32023.
Pete Connolly: Net cash used in operations for the first six months of FY 'twenty, four with seven points or $5 million compared with 6.3 $400 million in the six months period of fiscal 2023.
Pete Conley: During the year ended September 30, 2023, the company made adjustments to its fixed expenses, and the impact of those adjustments has significantly reduced our monthly burn rate. Given the significant reduction in fixed expenses, the company believes it has enough cash and flexibility with its operating expenses to operate until at least October 31, 2024. As we have stated in our fiscal 2024. To that end, on March 20, 2024, we entered into an at-the-market offering agreement with the Benchmark Company, pursuant to which we may, from time to time, offer and sell shares of our common stock through or to the Benchmark Company as our sales agent or manager in an aggregate amount of up to $5 million.
Pete Connolly: During the year ended September 32023, the company made adjustments towards fixed expenses and the impact of those adjustments have significantly reduced our monthly burn rate.
Pete Connolly: Given the significant reduction in fixed expenses. The company believes it has enough cash and flexibility.
Pete Connolly: With its operating expenses to operate until at least October 31 2024.
We have stated in our fiscal 2024.
Pete Connolly: Our 10-Q, we expect to raise additional funds through the issuance of equity preferred stock and convertible debentures. Two that ends on March 20th 2024, we entered into an at the market offering agreement with the benchmark company pursuant to which we may.
Pete Connolly: From time to time offer and sell shares of our common stock through or to the benchmark company as our sales region.
Pete Connolly: Manager in an aggregate amount of up to $5 million.
Pete Conley: In addition, we have an $18 million S3 shelf registration statement, which was subsequently declared effective on January 11, 2024, to facilitate our liquidity needs. Finally, shareholder equity for Q2 fiscal 2024 was a negative $1.75 million versus $3.74 million in fiscal 2023 ending September 30, 2023. We are actively taking steps to address our negative shareholder equity through the conversion of convertible debt to equity, as well as new equity issuance, as previously mentioned. That concludes my review of our financial highlights, and I'll return the call to Ron for closing remarks.
Pete Connolly: In addition, we have an 18 million dollar S. Three shelf registration statement, which was subsequently declared effective on January 11, 2024, two facility our liquidity needs.
Pete Connolly: Finally shareholder equity for Q2 fiscal 2024 was a negative 1.75 million versus 3.74 million in fiscal 'twenty three ending September 32023.
Pete Connolly: We are actively taking steps to address our negative share holder equity through the conversion of convertible debt to equity as well as new equity issuance as previously mentioned.
Pete Connolly: It concludes.
My review of our financial highlights and I'll return the call to Ron for closing remarks. Thanks, Pete will now dedicate the next 10 to 15 minutes to questions submitted through the webcast portal.
Ron Erickson: Thanks, Pete. We'll now dedicate the next 10 to 15 minutes to questions submitted through the webcast portal. And bear with me a second as I take a look at the screen. Let me start here.
Ron Ericsson: And bear with me a second as I take a look at the screen.
Ron Ericsson: Let me start here as they come out.
Ron Erickson: As they come in, they scroll in. The first question is, what is the status? One of our work streams we've talked about is time over time and joint development agreements. And we've talked about those with medical device manufacturers, big pharmaceutical companies, and consumer electronics companies. One thing that I have said in the past, we don't mention who those companies are. I would say that we continue to engage in dialogue with those companies. And as those evolve over time, there will be an opportunity to let the market know who those companies are and what the transactions involved. But at this point in time, I'll say we're just continuing to nurture a number of relationships that have the potential to be very significant.
Ron Ericsson: This girl in the firm.
Ron Ericsson: First question is.
Ron Ericsson: What is the status.
Ron Ericsson: One of our work streams that we've talked about is it.
Ron Ericsson: Over time that joint development agreements and we've talked about those with medical device manufacturers big pharmaceutical companies consumer electronic companies. One thing that I have said in the past, we don't mention who those companies are I.
Ron Ericsson: I would say that that we continue to engage in dialogue with those companies and as a as those evolve over time, there will be an opportunity to let the market know.
Ron Ericsson: Who those companies are and what our transactions involved but at this point in time I'll say, we're just continuing to nurture.
Ron Ericsson: Nurture a number of relationships that have the potential would be very significant.
Ron Erickson: One of the questions is, what happened to the wrist-worn device similar to a smart watch? We've gone through, as I indicated, a process of miniaturization. The KnowU, our Generation 2 device, is significantly smaller than the Gen 1.
Ron Ericsson: One of the.
Ron Ericsson: One of the questions is what happens under the risks worn device similar to a smartwatch.
Ron Ericsson: We've gone through as I indicated we've been going through a process of miniaturization that no you are generation two devices significantly smaller than that the gen. One we.
Ron Erickson: We think between here and delivering that product to the FDA for FDA clearance and FDA-approved clinical trials, there will be future miniaturization. Among other things, I've talked to people about the fact that this device, the KnowU, has an off-the-shelf battery that is larger than it ultimately would be.
Ron Ericsson: We think between here and the and delivering that product to the FDA for FDA clearance in FDA approved clinical trials, there will be future miniaturization among other things I've talked to people about the fact that this device that know you has an off the shelf battery.
Ron Ericsson: Batteries is larger than it ultimately be we can have a custom battery I think there's some other opportunities for miniaturization there.
Ron Erickson: We can have a custom battery. I think there are some other opportunities for miniaturization there. Between here and a wrist-worn device that's much, much smaller would be the need for an ASIC. And that takes time.
Ron Ericsson: But between here and a wrist worn device if that's much much smaller would be the need for an <unk> and that takes time that takes money. So I think there's a transition period to be.
Ron Erickson: That takes money. So, I think there's a transition period to where we are now, future miniaturization, and ultimately getting to something that is literally watch-like. But meanwhile, the current product, the product that we announced and showcased in Florence, Italy, in early March, is a wearable product that can be worn, as I indicated, with an adhesive or a wristband.
Ron Ericsson: Where we are now future memorization of ultimately getting to something that is literally watch flight, but meanwhile, the current product the product that we announced.
Ron Ericsson: And showcased in Florence, Italy in early March is a wearable product can be worn as I indicated with adhesive or a wristband. So.
Ron Erickson: So, the process of miniaturization is ongoing, but we have a wearable today. This is a good question because we get a lot of inquiries about this. And the inquiries deal with the fact that there are many, many... wearables, wrist-type wearables, in the marketplace, being advertised in the marketplace as doing non-invasive blood glucose monitoring. I've seen them for as little as $29.95. It's very inexpensive.
Ron Ericsson: <unk> is ongoing but we have a wearable today.
Ron Ericsson: This is a good question.
Ron Ericsson: Because we have a lot of inquiries about this.
Ron Ericsson: And the inquiries.
Deal with the fact that.
Ron Ericsson: There are many many.
Ron Ericsson: Wearables risk type wearables in the marketplace being advertised in the marketplace is doing noninvasive blood glucose monitoring I've seen them for as little as 29 95.
Ron Ericsson: We're very inexpensive.
Ron Erickson: Just a couple of months ago, the FDA issued an advisory warning that none of these devices are FDA-approved, and none of these devices meet the FDA medical device clearance criteria. So I'd say there's a lot of confusion in the market around that. They, I think, are acknowledged by the FDA, by clinicians, and others, that they do not have a degree of accuracy that is sufficient to allow a person to manage their diabetes. They're simply a marketing effort for a very inexpensive and interactive device.
Ron Ericsson: Just a couple of months ago, the FDA issued an advisory warning.
Ron Ericsson: That none of these devices are FDA approved none of these devices meet the F D a medical device clearance criteria.
Ron Ericsson: So I'd say, there's a lot of confusion in the market around that they they I think are acknowledged by the F. D. A by clinicians and others that these do not have the degree of accuracy that is sufficient to allow a person to manage their diabetes.
Ron Ericsson: There is simply a marketing effort, a very inexpensive and interact or device.
Ron Ericsson: Yes.
Ron Ericsson: Oh.
Ron Erickson: Are you pursuing alternative financing to eliminate LINZ and obtain less dilutive terms? Speak calmly. I'll take that one. Yes, Ron.
Speaker Change: Are you pursuing alternative financing to eliminate lands and obtained less dilutive terms.
Speaker Change: The economy I'll take that one yes, where are we.
Pete Conley: Yes, Ron. We are, as disclosed in our 10-Q and on this call, have indicated we are seeking additional equity financing. And we are very, very sensitive to deletion for several reasons. One of them is our shareholder base, who have seen us through multiple rounds of funding since 2019, six rounds in total, or a foundation for our shareholder ownership, and we are very mindful of their loyalty to us and their support of us.
Speaker Change: We are as disclosed in our 10-Q and on this call have indicated we are seeking additional equity financing.
Speaker Change: And we are very very sensitive to dilution.
Speaker Change: Several reasons one of them is our shareholder base, who has seen us through multiple rounds of funding since 2019 six rooms in total.
Speaker Change: Will.
R E.
Speaker Change: The foundation to our shareholder ownership.
Speaker Change: We are very mindful of there.
Speaker Change: Loyalty to us and our support of us and so dilution is something we take very seriously. So while we are currently seeking additional equity financing.
Pete Conley: And so dilution is something we take very seriously. So while we are currently seeking additional equity financing, I'll say for the record, we will not do any sort of structured finance; there won't be any penny warrants or anything of that nature, which could potentially harm our current investors. We are in the process, and have been in the process, of talking to institutional investors, long only, fundamentally focused, and that is where we intend to raise equity capital.
I'll state for the record we will not do any sort of structured finance there won't be any penny warrants or anything of that nature, which could potentially harm our current investors.
We are in the process and have been in the process of talking to institutional investors long only fundamentally focus.
Speaker Change: But that is where we intend to raise equity capital.
Ron Erickson: Here's a question that said that we had announced an N of 100 clinical trial to be completed at the end of February. When can investors expect to see the result of the N of 100 study? Well this is really, this is an interesting one because the IRB protocol, as you know, when we send these out, these get, these are independently approved. Our protocols are independently approved. So it's independently approved for up to 100 participants. Once we got into the study and collected the data and analyzed the data from 30 participants in 85 sessions, we looked at all that data.
Speaker Change: Or is that here's a question that's it.
Speaker Change: Said that we had announced a an N of 100 clinical trial.
Speaker Change: To be completed end of February when can investors expect to see the result of the end of 100 study well. This is really this is an interesting one because the.
The IRB protocol as you know when we send these out with these get into these are independently approved our protocols are independently approved so as independently approved for up to 100 participants.
Speaker Change: Once we got into the study and collected the data and analyze the data from 30 participants and 85 sessions.
Speaker Change: We and we looked at all that data.
Ron Erickson: We saw that the performance was satisfactory and at a level that was significant enough for us to shift our attention to testing with our Gen 2 KnowU. So basically, we were approved to go to 100. We got great data using our Gen 1 because, as you recall, the IRB was approved before we had the Gen 2, and so we made great progress and loved the data, and so we didn't have to do the whole 100, and then we made the decision to shift our focus on testing to the KnowU, the Gen 2 device that we had in our hands starting early March.
Speaker Change: We we saw that the performance was satisfactory at a level that was significant enough for us to shift our attention to testing with our Gen. Two no you. So basically we were approved to go to 100, we got great data using our Gen. One because you know it is you.
Speaker Change: Recall the IRB was approved before we had the gen. Two and so we made great progress and loved the data and so we didn't have to do the whole hundreds and then.
Speaker Change: Made the decision to shift our focus on testing to the no you. The Gen. Two device that we had in our hands starting early March.
Ron Erickson: Ron, I might add, we have presented interim results at ATTD and last week at the American Association for Clinical Endocrinology annual meeting. The results can be found on the research and development page of our website. And as the analysis concludes, we will continue to publish accordingly. There's a question about international markets. As I indicated during my formal remarks, we will be announcing the hiring of Chris Somogyi tomorrow morning. Chris's title is President of International.
Speaker Change: We have presented interim results at a T T D and last week at the American Association for clinical Endocrinology annual meeting the results can be found on the research and development page of our website.
Speaker Change: So your analysis concludes we will continue to publish accordingly.
There's a question about international markets as I indicated during my formal remarks, we will be announcing tomorrow morning, the hiring of Chris Emoji.
Ron Erickson: And given Chris's background, as you'll see from the materials that we released tomorrow morning, he's going to be focusing on international business and also focusing on monetization of our intellectual property in fields of use outside of diagnostics. So he's got a big area of responsibility, but his title is President International, and that's going to be a core focus of his. Here's a great question, you know, and this is an unusual question. One of the individuals... Are you feeling fatigued? Are you getting enough rest, work, and family balance?
Speaker Change: As Chris Christmas title as President International.
Speaker Change: And given chris's background as you'll see from the materials that we released tomorrow morning, He is going to be focusing on international and also focusing on monetization of our intellectual property in fields of use outside of.
Speaker Change: Diagnostics so.
Speaker Change: He's got a big big area of responsibility, but it gets titles president of international and that's going to be a core focus of this.
Speaker Change: Okay.
Speaker Change: Here's a great question and this is an unusual question, but what.
Speaker Change: What are the individuals.
Speaker Change: Are you feeling fatigued are you getting enough rest work family pallets I E L F.
Ron Erickson: You know, that's a rare question from a shareholder. And I'm going to say we appreciate, I can't mention the individual's name unless he can be seen out there by everybody, but I want to appreciate the empathy. I think that, truth be known, we are so energized and excited about what we're doing, about the developments that we have internally, the way things are going. Now, I'm going to say, listen, we don't. I know that people would like to see more press announcements.
Speaker Change: Rare question from a shareholder.
Speaker Change: And I'm going to say, we appreciate I can't mention the individual's name unless it can be seen out there by everybody but.
Speaker Change: I want to appreciate the empathy I think that truth be known we are so energized and excited about what we're doing about the developments that we have internally the way things are going now.
Speaker Change: To say listen we don't.
Speaker Change: I know that people would like to see more press announcements, we make up we'd make it up.
Ron Erickson: We make it up; we make it up, sort of the way we operate. We don't like to do press announcements unless we have something material to talk about that is really important. But I'll just say that our level of energy, excitement, and enthusiasm internally is really tremendous. So, short answer, we're not fatigued.
Speaker Change: Sort of a way we operate we don't like to do press announcements unless we have something material to talk about that is really important but I'll, just say that our level of energy and excitement and enthusiasm internally is really tremendous so short answer we're not fatigue I think always there is that when.
Ron Erickson: There's that when you're building a business and everybody's moving fast, we are all alert to that work-family balance. And I would say that we make sure that that happens, right? We really make sure that's one of the core values of this company. We really care about our people, we care about their lives, we care about the work they do, we care about their commitment to the vision for the enterprise, and that vision is to create a non-invasive diagnostic device with a first focus on glucose that literally can make a difference in the world and make a difference in people's lives.
Speaker Change: You're building a business.
Speaker Change: And everybody's moving fast we're all alert to that that work family balance and I would say that that.
Speaker Change: We make sure that that happens right. We've really made sure that said that that would be that's one of the core values of this company.
Speaker Change: We really care about our people we care about their lives we care about the work they do we care about their commitment to.
Speaker Change: To the vision for the enterprise and that vision is to create.
A noninvasive diagnostic device with a first focus on glucose that literally can make a difference in the world and make a difference in people's lives and the whole teams committed to that.
Ron Erickson: And the whole team's committed to that. And so that we can give 100%, we've got to have that work-life balance. And I think we work hard toward that. So thanks for the question, by the way. Ron, if I could just amplify on what?
Speaker Change: And so that we get 100% you've got to have that work life balance and I think we work hard towards that so thanks for the question by the way for one if I could just amplify on what Youre seeing a part of what drives our excitement and enthusiasm literally every day is not a week goes by when we don't learn something.
Pete Conley: Part of what drives our excitement and enthusiasm literally every day is that not a week goes by when we don't learn something new, and I'll give you an example of that. Two weeks ago, the first week of May, in the Journal of Diabetes Science and Technology, a peer-reviewed publication, a study was included in the journal comparing the performance of the Dexcom G7 and the Abbott Freestyle Lever. And we learned, contrary to Dexcom's stated MARD of 8.2%, that in the study, the overall rate was 15.1%. Now, we look at what we're doing.
Speaker Change: New.
Speaker Change: And I'll give you. An example of that two weeks ago. The first week of May in the journal of diabetes Science and technology. The peer reviewed publication a publication.
Speaker Change: <unk> was included in the journal comparing the performance of the <unk> seven and the Abbott freestyle Libre.
Speaker Change: We learned contrary to <unk> Coms stated M. A R. D of eight 2% net in the study the overall REIT was 15, 1%.
Speaker Change: We look at what we're doing are most recently disclose Amy or do you use in the 11% range.
Pete Conley: Our most recently disclosed MARD is in the 11% range, and we've come to realize that there is a very high failure rate for the Dexcom G7. Depending on the source, in that same period of publication, it indicated the failure rate was 35%. Call it 1 in 3. We've seen from other postings and other sources a failure rate of 23%. Call it 1 in 4. When you combine those facts with the fact that, in the world, nearly 600 million people have diabetes, and the combined installed base of Dexcom, Abbott, and Medtronic is only about 4 million, you realize the CGM penetration worldwide is less than 1%.
Speaker Change: And then we come to realize that Theres, a very high failure rate of the VIX Com G. Seven depending on the source and the same peer reviewed publication indicated with failure rate was 35% call. It one and three.
Speaker Change: We've seen from other postings and other sources daily rate of 23% call. It one and four.
Speaker Change: When you combine those facts.
Speaker Change: The fact that in the world nearly 600 million people, who have diabetes and the combined installed base of Dicks Com Abbott and Medtronic is only about $4 million you realize the CGM penetration worldwide was less than 1%.
Pete Conley: So when you look at accuracy, reliability, and the fact that 99% of the world still doesn't have a viable solution, that gets us very excited and very energized to bring the next generation of CGM to the world.
Speaker Change: So when you look at accuracy reliability, and the fact that 99% of the world still doesn't have a viable solution that gives us very excited and very energized to bring the next generation of CGM to the world.
Speaker Change: Thanks Pete.
Ron Erickson: So, here's a question, is our non-invasive technology a trade secret or patent? And what countries is it patented or pending in, aside from the USA? Pete, by the way, as everybody knows, Pete's our Senior VP of Intellectual Property and has core responsibility for that. So, Pete, would you respond to this, please? Sure.
Speaker Change: So here's a question is our noninvasive technology, a trade secret or patent then what.
Speaker Change: And what countries visit patented pending.
And aside from the USA.
Speaker Change: Pete by the way you know as everybody knows pizza, our senior VP intellectual property and has core responsibility for that so Pete would you respond to this please sure.
Pete Conley: As of March 31, 2024, we have 332 patent assets that are either issued patents, pending patents, or in process patents, meaning patents in the process of being filed. Of those patents, they are in 18 jurisdictions; the majority of them, 215 of the 332 are in the United States. And then we have patent coverage through PCT, the Patent Cooperation Treaty, where we're able to file patents in multiple countries. We also have coverage in the EU, the UK, and literally a whole host of other countries, China, Japan, South Korea, and so forth.
Pete Connolly: As of March 31, 2024, we have 332.
Pete Connolly: Patent assets that are either issued patents and pending patents or in process patents meeting patents in the process of being filed.
Pete Connolly: Of those patents. They are an 18 jurisdictions. The majority of them 215 of the 332 or <unk> in the United States and then we have patent coverage through the PCT patent cooperation Treaty, where we're able to file in multiple countries. We also have coverage in the EU.
Pete Connolly: U K and.
Pete Connolly: Literally a whole host of other countries, China, Japan, South Korea and.
Pete Connolly: And so forth so we have global coverage.
Pete Conley: So we have global coverage, we have dominant coverage in our core technology of RF spectroscopy, and we look at this as a strategic asset that we plan to monetize in future discussions with potential JV partners and the like. I would just want to add to that trade secrets. We have a significant body of trade secrets that may be, by actual number, twice the number of patents we hold. So we don't talk a lot about trade secrets because they are secret. We have them organized internally; we acknowledge they exist internally. I'm gonna call it, it's our secret sauce. And that is a significant part of our intellectual property.
Pete Connolly: We have dominant coverage in our core technology of our spectroscopy, and we look at this as a strategic asset that we plan to monetize and future discussions with potential JV partners and the like I would just want to add to that trade secrets.
Pete Connolly:
Okay.
Pete Connolly: We have a significant body of trade secrets that may be.
Pete Connolly: By actual number be.
Pete Connolly: Twice the number of patents we hold.
Pete Connolly: So we don't talk a lot about trade secrets, because they are secret secret. We we have them organized internally we acknowledged they exist internally.
Pete Connolly: I'm going to call it that its our secret sauce.
Pete Connolly: And that is a significant part of our intellectual property.
Pete Connolly: But.
Ron Erickson: Can I say, it's a secret, right? And it's a significant trade secret that's a... a really big part of our intellectual property asset. I want to thank everyone for their questions. I do want to say there are a couple of questions that are very precise questions, and as a consequence of being precise and asking for some things that are really... We can't disclose them. I'm not able to respond to some of those more detailed questions, and I apologize for that. Those are the kinds of things that I could only disclose if we had a nondisclosure agreement with people.
Pete Connolly: Can I say, it's a secret right and it's a significant trade secret that's a.
Pete Connolly: Real big part of our intellectual property asset base.
Pete Connolly: Mitch was there.
Pete Connolly: I want to thank everyone for their questions I do want to say there are a couple of questions that asked some that are very precise questions and as a consequence of being precise and asking for some things that are really.
Pete Connolly: We can't disclose I'm not able to respond to some of those more detailed questions and I apologize for that.
Pete Connolly: Those are the kinds of things that I can only disclose if we had a non disclosure agreement with people.
Ron Erickson: There is one final question that has to do with the FDA and the FDA process. We have already started the process of, I'll say, socializing our technology with the FDA. And the next step will be a pre-submission meeting with the FDA, which we hope to have during fiscal year 24. And thereafter, with the final product, the refined Gen 2, if you will, that's a product that we take to the FDA and go through clinical trials with them, sort of organized with and through them pursuant to our protocols.
Pete Connolly: There is one final question that has to do with the FDA and the FDA process.
Pete Connolly: We have already started the process of I'll say socializing, our technology with the F D. A.
Pete Connolly: And the next step will be a pre submission meeting with the FDA.
Pete Connolly: Which which we have which we hope to have.
Pete Connolly: During fiscal year 'twenty four.
Pete Connolly: And thereafter with with the.
Pete Connolly: The final product the refined Gen. Two if you will.
Pete Connolly: That's the product that we take to the the F D. A and go through clinical trials with them.
Pete Connolly: Organized with them through them pursuant to our protocols and so that's that's in undertakings.
Ron Erickson: And so that's an undertaking that we are eager to get underway and have already begun, as I indicate, this process of socializing our technology with the FDA, which is the most appropriate thing to do. All that being said, I want to thank everybody for all their questions. Thank you for your engagement. We will try to be available. I will say we've been extremely busy lately. So if we've been unresponsive to some of you, it's not because we don't care. It's just that we've been very, very busy. So, thanks so much for your continuing support. I really appreciate it.
Pete Connolly: That we are eager to get underway and have already begun through as I indicated this process of socializing, our technology with the FDA, which is the most appropriate thing to do.
Pete Connolly:
Pete Connolly: All that being said I want to thank everybody for all your questions. Thank you for your engagement, we try to be available I will say, we've been extremely busy lately. So if we've been unresponsive to somebody use it as some of you it's not because we don't care. It's just that we've been.
Pete Connolly: We've been very very busy so thanks, so much for your continuing support really appreciated.
Ron Erickson: And with that, that concludes our Q&A. I want to thank you for joining us. There's a lot to look forward to in the balance of fiscal 2024.
Pete Connolly: And with that that concludes our Q&A I want to thank you for joining us.
Speaker Change: I look forward to in the balance of fiscal 2024, we're excited to report today on our progress.
Ron Erickson: We're excited to report today on our progress. We look forward to telling you more. Meanwhile, thanks to you. Thanks to the efforts of all our employees, our board members, our advisors, our strategic partners, and, candidly, diabetes clinicians and people in the world suffering from type 1 and type 2 diabetes who get in touch with us daily, who are eager for this non-invasive solution.
Speaker Change: We look forward to telling you more Meanwhile, thanks to you. Thanks to the efforts of all of our employees our board members, our advisers, our strategic partners and candidly.
Speaker Change: Diabetes clinicians and people in the world suffering from type one and type two diabetes, who get in touch with this daily.
Speaker Change: We're eager for this noninvasive solution, we're here to to work for them to work for all of you and I want to thank you.
Ron Erickson: We're here to work for them, to work for all of you, and I want to thank you. Have a great day and all the very best.
Speaker Change: Have a great day and all the very best.
Operator: The conference call replay will be available on our website in the coming days. Thank you for your participation.
Speaker Change: The conference call replay will be available on our website in the coming days. Thank you for your participation.
Operator: This concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.
Speaker Change: This concludes today's conference you may disconnect your lines at this time and thank you for your participation.
Speaker Change: Okay.
Speaker Change: [music].
N/A: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Okay.
Speaker Change: [music].