Medical Technology Companies Report Q2 2024 Earnings: Growth, Challenges, and Future Prospects

Earnings call: Perimeter Medical posts strong Q2 growth, eyes B-Series launch By Investing.com

Perimeter Medical (Ticker: PMED), a leading medical technology company, reported a significant 83% year-over-year increase in its Q2 2024 revenue, reaching $246,000. The company, during its recent earnings call, announced the completion of the 1,000th paid patient scan using its Perimeter S-Series OCT technology and discussed the ongoing clinical trial for its next-generation B-Series OCT with ImgAssist AI. With patient enrollment expected to complete in Q3 2024, Perimeter Medical is optimistic about the B-Series OCT's commercial launch, supported by positive trial outcomes. Perimeter Medical's Q2 earnings call highlighted the company's robust growth and strategic focus on advancing its OCT technologies. With the upcoming completion of patient enrollment for the B-Series OCT trial and the anticipated FDA submission, the company is poised for potential market expansion. The enhancements in AI technology, aimed at improving surgical outcomes and reducing procedure times, demonstrate Perimeter Medical's commitment to innovation. Despite the upcoming fundraising needs, the management's proactive approach to balance sheet management and the clear marketing strategy for their devices indicate a path forward for sustained growth and market penetration. Perimeter Medical's recent earnings report shows a promising trajectory in revenue and technological advancements, but a deeper look into the financial health and market performance of the company is crucial for investors. According to InvestingPro data, Perimeter Medical holds a market cap of approximately $17.32 million. While the company is making strides in its operations, it's essential to consider that it has not been profitable over the last twelve months, with a negative adjusted P/E ratio of -1.34. This indicates that investors are valuing the company's earnings negatively, which could be a point of concern for potential investors. However, the company's gross profit margin stands at an impressive 91.64% for the last twelve months as of Q1 2024, suggesting that Perimeter Medical is highly efficient in its production process and retains a significant portion of its sales as gross profit. This is a positive sign for the company's ability to manage costs and could be a factor in its long-term success. InvestingPro Tips reveal that Perimeter Medical holds more cash than debt on its balance sheet, which is a strong indicator of financial stability. This is particularly relevant as the company enters a period of fundraising to support operations beyond early next year. Additionally, the company's liquid assets exceed short-term obligations, suggesting that Perimeter Medical is in a good position to meet its short-term liabilities without financial strain. Investors looking for more detailed analysis and further InvestingPro Tips can find additional insights on InvestingPro's platform, which lists 12 additional tips for Perimeter Medical. These tips provide a comprehensive look at the company's performance metrics and market position, helping investors make informed decisions. InvestingPro Fair Value estimates the stock's value at $0.42, which is higher than the previous close price of $0.29. This suggests that there may be potential for price growth based on fundamental analysis. However, it's important to note that the stock has experienced significant volatility, with a price total return of -75.37% over the last year, indicating that investors should be cautious and consider the risks associated with such fluctuations. Perimeter Medical's focus on innovative OCT technologies and AI integration, combined with its financial stability, presents a narrative of a company with the potential for future growth. As the company moves towards the commercial launch of its B-Series OCT and FDA submission, these financial insights will be pivotal for investors tracking its progress. Operator: Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical Q2 2024 Conference Call. At this time all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions]. This call is being recorded on Wednesday, August 13, 2024. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead. Stephen Kilmer: Thank you. Good afternoon, everyone. Let me start out by pointing out that this conference call will include forward-looking statements within the meaning about applicable securities laws. These may include statements regarding the future financial position, business strategy and strategic goals; commercial activities and timing; competitive conditions; research and development activities; projected costs and capital expenditures; research and clinical testing outcomes; the potential benefits of our products, including Perimeter S-Series OCT, Perimeter B-Series OCT and Perimeter ImgAssist. Perimeter's ability to broaden its user base and the expected approval of its proprietary AI. Expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time-to-time in our public filings and press releases, which are posted on sedarplus.ca. Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter undertakes no obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events or otherwise, other than as required by law. For the benefit of those who are new to the Perimeter story, I would also like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high resolution, real-time advanced imaging tools to address areas of high unmet medical need. Our FDA-cleared Perimeter S-Series OCT system provides real-time cross-sectional visualization of excised tissues at the cellular level. Our breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents our next-generation artificial intelligence technology. B-Series OCT with ImgAssist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-conserving cancer surgeries. On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer; Andrew Berkeley, Perimeter's Chief Innovation Officer; and Sara Brien, the Company's Chief Financial Officer. With that said, I'll now turn the call over to Sara. Sara Brien: Thank you, Steve. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Adrian in a moment for an update on our strategic plans and commercial activities. However, before I do, I'd like to provide a brief update on our Q2 '24 financial results. To streamline things, all of our numbers we refer to today have been rounded, so they are approximate. We also report in U.S. dollars. For the three month period ending June 30, 2024, the company recorded revenue of $246,000. That consisted of the sale of consumables and system leases. For the first time, we entered into an equipment service plan warranty program with two customers, which includes annual preventive maintenance for the OCT equipment. The total contract value was approximately $139,000 and will be recognized over the three year term of the contract as services are rendered starting next quarter. Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023. Second quarter 2024 net loss improved 35% to approximately $3.2 million or $0.05 per common share compared to $4.9 million or $0.08 per common share in the three months ended June 30, 2023. Cash used in operating activities in the three months ended June 30, 2024, was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023. As of June 30, 2024, cash and cash equivalents were approximately $6.5 million. This amount does not include a CPRIT grant receivable of approximately $1.8 million as of the end of the quarter 2024. With that, I'll now turn over the call to Adrian. Adrian? Adrian Mendes: Thanks, Sara, and thanks again, everyone, for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative intraoperative imaging technologies. The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients with the ultimate goal of improving survivability and quality of life. Yes, intraoperative margin assessment remains one of their most pressing problems. We're working hard to change that. Perimeter's S-Series OCT technology gives surgeons the most advanced intraoperative margin visualization available as they strive to reduce re-excisions, clarity on margin status in the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient. In a way, our product promise is greater peace of mind both to the surgeon who, no matter how skilled, currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins and also to their patients who under the current treatment pathway, typically need to wait and worry for two to seven days for their surgeon to receive a post-op pathology report, which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind. But as compelling a clinical value proposition that our S-Series OCT represents, it will be our execution of a well-thought-out and carefully planned market entry strategy that will drive Perimeter's ultimate commercial success. To that end, ever since the company completed a leadership transition in mid-2023, we've been laying down a number of foundational things, and I'm pleased to report that each of the pillars of our strategy are starting to bear fruit. Before elaborating on some of the tangible results we have already seen from the foundational things we've been laying down since Perimeter completed a leadership transition, I would like to take a moment to set the stage of our commercial rollout. As many of you know, we are currently commercializing our first FDA-cleared intraoperative imaging technology, the S-Series OCT, which provides surgeons with image resolutions capable of visualizing tissue structures at the cellular level down to the critical 2-millimeter depth when assessing margins real time in the operating room. It is cleared under a general indication, and it's not been evaluated by the FDA specifically for use in breast tissue, breast cancer or other types of cancer margin evaluation and reduced re-excision rates. Our goal has been to seed the market with S-Series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next-generation system, B-Series OCT with ImgAssist AI. Led by principal investigator, Dr. Alastair Thompson at Baylor College of Medicine, Perimeter is conducting a multi-center, randomized, 2-arm clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Our focus on improving the level and pace of execution across all aspects of Perimeter's business has contributed to, among other things, the acceleration of patient enrollment in the pivotal trial, resulting in a tracking well ahead of schedule. We announced today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations. Moving forward from there, since we have already received FDA Breakthrough Device Designation for our B-Series system, we anticipate the readout from this study will be a significant catalyst for our business. If positive, these data will support the full commercial launch of Series-B OCT technology, representing the next major step in our go-to-market strategy and an opportunity to significantly broaden our user base across the U.S. In the meantime, as you can see from today's press release the growth pillars we've been laying down are starting to produce tangible results. For example, restructuring our sales organization while also implementing some key process improvements have helped drive increased commercial adoption of Perimeter S-Series OCT both in terms of installed base growth and existing system utilization. To put that in perspective, we've already closed six S-Series OCT placement so far this year compared to three in all of 2023. Also, Q2 revenues, which are recurring since they're derived from sales of consumables and system leases, grew 83% year-over-year and 150% sequentially from the first quarter 2024. Finally, just after the end of the quarter, the 1,000th paid Perimeter S-Series OCT patient scan was performed, marking an important clinical and commercial milestone for us. In addition, our strengthened commitment to methodical data collection helped facilitate Dr. Amelia Gunter authoring an exciting white paper in June. It reported reoperation rates among 72 patients on a practice who underwent OCT imaging during breast-conserving surgery. The research demonstrated that OCT helped achieve a reoperation rate of 5.6% as compared to the national average of 19.9%. Also, while the national reoperation rate in patients with a certain type of breast cancer called ductal carcinoma in situ, DCIS, was 30.8% versus 13.3% in patients where OCT was used. And in patients with invasive ductal carcinoma, IDC, the national rate for reoperation was shown to be 18%, while our S-Series OCT operation rate was 0%. Dr. Gunter's white paper is available on our website, and I encourage you to review it there if you haven't already had a chance to do that. Finally, our additional focus on gathering user feedback in order to apply an agile approach to continuously improve our product offering resulted in the first-of-its-kind installation of our new ImgClear AI image enhancement algorithm with a commercial Perimeter S-Series OCT system. ImgClear enables users to achieve better quality images, up to 441% signal-to-noise ratio increase, and importantly, reduce scan times by 28%. We are now working to upgrade all installed S-Series systems with ImgClear before the end of the year. And so to summarize, we're seeing positive commercial traction with S-Series OCT as demonstrated by our installed base and revenue growth in Q2 and the achievement of our 1,000th patient scanned milestone in July. The ongoing pivotal trial evaluating use of our next-gen B-Series OCT with ImgAssist AI during breast-conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter. There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential of our OCT-based technologies to advance the standard of care, improve patient outcomes and reduce health care costs. And finally, we continue to leverage our extensive AI and med tech expertise to find ways to deploy AI models, like ImgClear, throughout our technology stack to improve the customer experience and surgical outcomes. We look forward to keeping you updated on our progress through 2024 and are excited by the important milestones that lay ahead. And with that, I now open up the call for your questions. Operator? Operator: Thank you. Ladies and gentlemen we will now begin the question-and-answer session. [Operator Instructions]. Your first question comes from Scott McAuley of Paradigm Capital. Please go ahead. Scott McAuley: Hi, everyone. Thanks for taking my questions. Great to hear on all the activity and kind of six installations year-to-date. Could you dig into that a little more? Kind of what's the total number of systems that are currently installed and maybe how many kind of net new in Q2? Adrian Mendes: Hey, Scott, thanks for joining, good question. So we're up to 12 systems now that are currently installed and earning revenue for us. And four of them, four of the total have been in the second quarter. So we've been accelerating quarter-after-quarter, four of those six in Q2. Scott McAuley: Yes. Got it. That's great. And then maybe a bit on the type of facilities that those kind of recent installations have been in, are they hospitals, surgical centers? And are these new sites? Are these sites that are acquiring their second system or part of national chains or things like that? Adrian Mendes: Yes, they're all hospitals, hospital systems, they actually follow very similar, the same profile, that we have been winning to date. So it's just sort of expansion into the place we've had success already. Scott McAuley: Got it. That's great. And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle? Adrian Mendes: Yes. Strong pipeline, we expect to see the sort of growth rates continue through the third quarter and fourth quarter, expanding into new facilities, expanding to new states. So I think we're sort of just kind of push -- sort of refer back to something I said earlier is one of the things that we've all been working really hard here, just to make sure we're establishing sort of the foundational structure in the company, that will help us grow sustainably over time. So it's not just like wanting really hard, closing a bunch of deals and then going into a drought. And so we've seen that. When we look at our pipeline, we see things kind of stage nicely through the entire pipeline, through phases and with increasing quantities as time goes on. So we're encouraged that this is a story that's sustainable that we can keep going. Scott McAuley: That's great. I guess on the trial, fantastic to hear that the recruitment is going faster than expected and should be finished soon, so I guess if the recruitments finished in Q3, could you talk through a bit on when we could expect to see the top-line data and then potential FDA submission and approval? Adrian Mendes: Yes. So the hope is that we'll be able to talk about top-line data in the fourth quarter, before year-end, and then with the goal of submitting to the FDA early next year, like early Q1. And then we're planning -- right now, we're anticipating approval sometime towards the end of 2025 or early 2026. We have breakthrough-device-designation. So that, we hope, will help speed things through. Internally, we're sort of preparing everything. I mean we have been preparing everything, continue to prepare everything, just to make sure there is no wait time between our request from the FDA and when we can submit something or the trial ending and when we can submit something. So one of the biggest, highest priorities we've got in the company is just to get through, to get that Series-B on the market as quickly as possible. Scott McAuley: Absolutely. And sorry, you broke up a little bit, you're saying kind of data before the end of the year and then submission in Q1. Adrian Mendes: That's right. Scott McAuley: Got it. And on the white paper, great to see those data in that form. Any other kind of white papers or studies, kind of real-world evidence that you guys are working on to put out there. Adrian Mendes: Yes, absolutely. So like we mentioned, we've got 1,000 patients through right now, and so we've got that data. We've got a few papers going through a peer-reviewed process. The first paper was a white paper. The next ones will be peer-reviewed. We've also set up a registry now, a formal registry. So we're gathering data in a more sort of structured manner, I suppose. So you'll start to see that flow of clinical evidence start to pick up starting later this year and into the future. Scott McAuley: That's great. Yes, good to get more of that data, especially if it's peer-reviewed. Obviously, it's great to reach that 1,000th scan benchmark. Can you kind of speak to either how many procedures were done in the quarter or what you're seeing from a monthly run rate or a bit about that kind of the utilization and what you're hoping to see going forward? Adrian Mendes: I think, I don't have this precise numbers on the -- at the monthly level. It's safe to say that it is increasing. Every new device that we put in the field is also adding. If you recall, one thing that we did throughout, since the time I've been here is we really staffed up the clinical team that helps with customers and helps train them and get them onboarded. So a big part of their focus is just making sure that we're getting more and more customers through and our volumes up. So that has been increasing over time on a monthly basis, and we anticipate it to continue to increase. Scott McAuley: Definitely. That's great. And I guess lastly, ImgClear, certainly kind of new for me, hadn't heard about that, so good to hear that those product improvements are continuing. So that algorithm kind of didn't need FDA approval and there are just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that, I would assume, would be included in the B-Series and that then doesn't impact any kind of the regulatory pathway or any of that process. Adrian Mendes: Yes, that's all correct. Yes, it didn't need to go through any sort of regulatory approval. And the most important thing about that, and one thing that I'm really happy with what the team has been able to do, is really start to get this process of collecting feedback from customers and then having engineers work on some of those challenges and solve them and deploy that in the field. And the big one with ImgClear, frankly, is the fact that it does cut down the scan time in the operating room. Every minute counts in the operating room, so that's really great. The team has ideas on how to make that even faster, so that's good. I think we've got a nice product development trajectory on that as well. Scott McAuley: I guess what would be, with that ImgClear, the kind of average scan time that a surgeon would take? Adrian Mendes: Yes. So from a scan time on the average lump size, it goes from about 12 minutes down to about 9 minutes. Scott McAuley: And that's it. Thanks for taking the questions. I'll hop back in queue. Adrian Mendes: Thanks Scott. Operator: Thank you. Your next question comes from Rahul Sarugaser of Raymond James. Please go ahead. Rahul Sarugaser: Hi, Adrian and Sara. Thanks for taking our questions. Scott covered off most of it with really several questions, so really kind of one for me then today. Could you talk about the balance sheet given sort of the current cash on hand, cash burn and then how you guys are looking at managing the balance sheet? Adrian Mendes: Yes, absolutely. So right now, we've got cash into early next year. We've been managing pretty tightly to make sure that, that runway stays consistent and that's sort of consistent with what we've been planning all year. We will need to fundraise before then. And so that's consistent with what we've talked about before, so that's still part of our plans. So that's a big focus of our management team, and the Board is focused on it right now. Rahul Sarugaser: Perfect. That's helpful. And just maybe one more then, and then I'll get back in the queue. It's good to see the visibility on the top-line data in Q4, calendar Q4, and then hopefully followed by FDA submission and approval. Perhaps you could maybe lean forward a year or so and talk about how you plan on leveraging the data into marketing the device? And that's all. Adrian Mendes: Yes, absolutely. So once we get approval, and we'll build toward this over time, there's really two things that we're preparing for, fundamentally two major things we're preparing for to sort of accelerate growth. One is the fact that having AI makes it a lot easier for surgeons to adopt it. It makes it easier to use. It's like a copilot. And so what we're doing right now and what we will do leading up to that is making sure that we're starting to lay down those railroad tracks, whatever, with surgeons and building out that pipeline. So surgeon adoption will go up, and that's a big thing that will happen once we get B-Series on markets. The other thing that it will do is it will give us labels, like data labels, on breast and breast cancer which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce re-excisions, we will be able to reduce re-excisions with B-Series. We will be able to do it in the breast cancer market. We don't have that evidence right now. The S-Series is not cleared for that, but the B-Series will be. So that's another inflection point that will really help our marketing message, in our commercial sort of messaging and strategy towards the end of next year. Does that answer your question, Rahul? Rahul Sarugaser: Yes, that's perfect. Thanks very much. I'll get back in the queue. Adrian Mendes: Great. Thanks, Rahul. Operator: That concludes our question-and-answer session. I'd like to turn the conference back to Adrian Mendes for closing remarks. Adrian Mendes: Okay. Thank you. Thanks, everyone, for the time and for following us and the support. The team here is extremely excited about what we have coming on. I guess we're sitting here at the start of -- you've seen some good news today. There's more to come. So keep following us, and we look forward to talking to you next quarter. Thank you. Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Perimeter Medical Imaging AI's (PYNKF) Q2 2024 Earnings Call Transcript

Scott McAuley - Paradigm Capital Rahul Sarugaser - Raymond James Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical Q2 2024 Conference Call. At this time all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions]. This call is being recorded on Wednesday, August 13, 2024. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead. Stephen Kilmer Thank you. Good afternoon, everyone. Let me start out by pointing out that this conference call will include forward-looking statements within the meaning about applicable securities laws. These may include statements regarding the future financial position, business strategy and strategic goals; commercial activities and timing; competitive conditions; research and development activities; projected costs and capital expenditures; research and clinical testing outcomes; the potential benefits of our products, including Perimeter S-Series OCT, Perimeter B-Series OCT and Perimeter ImgAssist. Perimeter's ability to broaden its user base and the expected approval of its proprietary AI. Expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time-to-time in our public filings and press releases, which are posted on sedarplus.ca. Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter undertakes no obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events or otherwise, other than as required by law. For the benefit of those who are new to the Perimeter story, I would also like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high resolution, real-time advanced imaging tools to address areas of high unmet medical need. Our FDA-cleared Perimeter S-Series OCT system provides real-time cross-sectional visualization of excised tissues at the cellular level. Our breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents our next-generation artificial intelligence technology. B-Series OCT with ImgAssist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-conserving cancer surgeries. On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer; Andrew Berkeley, Perimeter's Chief Innovation Officer; and Sara Brien, the Company's Chief Financial Officer. Thank you, Steve. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Adrian in a moment for an update on our strategic plans and commercial activities. However, before I do, I'd like to provide a brief update on our Q2 '24 financial results. To streamline things, all of our numbers we refer to today have been rounded, so they are approximate. We also report in U.S. dollars. For the three month period ending June 30, 2024, the company recorded revenue of $246,000. That consisted of the sale of consumables and system leases. For the first time, we entered into an equipment service plan warranty program with two customers, which includes annual preventive maintenance for the OCT equipment. The total contract value was approximately $139,000 and will be recognized over the three year term of the contract as services are rendered starting next quarter. Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023. Second quarter 2024 net loss improved 35% to approximately $3.2 million or $0.05 per common share compared to $4.9 million or $0.08 per common share in the three months ended June 30, 2023. Cash used in operating activities in the three months ended June 30, 2024, was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023. As of June 30, 2024, cash and cash equivalents were approximately $6.5 million. This amount does not include a CPRIT grant receivable of approximately $1.8 million as of the end of the quarter 2024. With that, I'll now turn over the call to Adrian. Adrian? Adrian Mendes Thanks, Sara, and thanks again, everyone, for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative intraoperative imaging technologies. The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients with the ultimate goal of improving survivability and quality of life. Yes, intraoperative margin assessment remains one of their most pressing problems. We're working hard to change that. Perimeter's S-Series OCT technology gives surgeons the most advanced intraoperative margin visualization available as they strive to reduce re-excisions, clarity on margin status in the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient. In a way, our product promise is greater peace of mind both to the surgeon who, no matter how skilled, currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins and also to their patients who under the current treatment pathway, typically need to wait and worry for two to seven days for their surgeon to receive a post-op pathology report, which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind. But as compelling a clinical value proposition that our S-Series OCT represents, it will be our execution of a well-thought-out and carefully planned market entry strategy that will drive Perimeter's ultimate commercial success. To that end, ever since the company completed a leadership transition in mid-2023, we've been laying down a number of foundational things, and I'm pleased to report that each of the pillars of our strategy are starting to bear fruit. Before elaborating on some of the tangible results we have already seen from the foundational things we've been laying down since Perimeter completed a leadership transition, I would like to take a moment to set the stage of our commercial rollout. As many of you know, we are currently commercializing our first FDA-cleared intraoperative imaging technology, the S-Series OCT, which provides surgeons with image resolutions capable of visualizing tissue structures at the cellular level down to the critical 2-millimeter depth when assessing margins real time in the operating room. It is cleared under a general indication, and it's not been evaluated by the FDA specifically for use in breast tissue, breast cancer or other types of cancer margin evaluation and reduced re-excision rates. Our goal has been to seed the market with S-Series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next-generation system, B-Series OCT with ImgAssist AI. Led by principal investigator, Dr. Alastair Thompson at Baylor College of Medicine, Perimeter is conducting a multi-center, randomized, 2-arm clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Our focus on improving the level and pace of execution across all aspects of Perimeter's business has contributed to, among other things, the acceleration of patient enrollment in the pivotal trial, resulting in a tracking well ahead of schedule. We announced today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations. Moving forward from there, since we have already received FDA Breakthrough Device Designation for our B-Series system, we anticipate the readout from this study will be a significant catalyst for our business. If positive, these data will support the full commercial launch of Series-B OCT technology, representing the next major step in our go-to-market strategy and an opportunity to significantly broaden our user base across the U.S. In the meantime, as you can see from today's press release the growth pillars we've been laying down are starting to produce tangible results. For example, restructuring our sales organization while also implementing some key process improvements have helped drive increased commercial adoption of Perimeter S-Series OCT both in terms of installed base growth and existing system utilization. To put that in perspective, we've already closed six S-Series OCT placement so far this year compared to three in all of 2023. Also, Q2 revenues, which are recurring since they're derived from sales of consumables and system leases, grew 83% year-over-year and 150% sequentially from the first quarter 2024. Finally, just after the end of the quarter, the 1,000th paid Perimeter S-Series OCT patient scan was performed, marking an important clinical and commercial milestone for us. In addition, our strengthened commitment to methodical data collection helped facilitate Dr. Amelia Gunter authoring an exciting white paper in June. It reported reoperation rates among 72 patients on a practice who underwent OCT imaging during breast-conserving surgery. The research demonstrated that OCT helped achieve a reoperation rate of 5.6% as compared to the national average of 19.9%. Also, while the national reoperation rate in patients with a certain type of breast cancer called ductal carcinoma in situ, DCIS, was 30.8% versus 13.3% in patients where OCT was used. And in patients with invasive ductal carcinoma, IDC, the national rate for reoperation was shown to be 18%, while our S-Series OCT operation rate was 0%. Dr. Gunter's white paper is available on our website, and I encourage you to review it there if you haven't already had a chance to do that. Finally, our additional focus on gathering user feedback in order to apply an agile approach to continuously improve our product offering resulted in the first-of-its-kind installation of our new ImgClear AI image enhancement algorithm with a commercial Perimeter S-Series OCT system. ImgClear enables users to achieve better quality images, up to 441% signal-to-noise ratio increase, and importantly, reduce scan times by 28%. We are now working to upgrade all installed S-Series systems with ImgClear before the end of the year. And so to summarize, we're seeing positive commercial traction with S-Series OCT as demonstrated by our installed base and revenue growth in Q2 and the achievement of our 1,000th patient scanned milestone in July. The ongoing pivotal trial evaluating use of our next-gen B-Series OCT with ImgAssist AI during breast-conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter. There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential of our OCT-based technologies to advance the standard of care, improve patient outcomes and reduce health care costs. And finally, we continue to leverage our extensive AI and med tech expertise to find ways to deploy AI models, like ImgClear, throughout our technology stack to improve the customer experience and surgical outcomes. We look forward to keeping you updated on our progress through 2024 and are excited by the important milestones that lay ahead. And with that, I now open up the call for your questions. Operator? Thank you. Ladies and gentlemen we will now begin the question-and-answer session. [Operator Instructions]. Your first question comes from Scott McAuley of Paradigm Capital. Please go ahead. Scott McAuley Hi, everyone. Thanks for taking my questions. Great to hear on all the activity and kind of six installations year-to-date. Could you dig into that a little more? Kind of what's the total number of systems that are currently installed and maybe how many kind of net new in Q2? Adrian Mendes Hey, Scott, thanks for joining, good question. So we're up to 12 systems now that are currently installed and earning revenue for us. And four of them, four of the total have been in the second quarter. So we've been accelerating quarter-after-quarter, four of those six in Q2. Scott McAuley Yes. Got it. That's great. And then maybe a bit on the type of facilities that those kind of recent installations have been in, are they hospitals, surgical centers? And are these new sites? Are these sites that are acquiring their second system or part of national chains or things like that? Adrian Mendes Yes, they're all hospitals, hospital systems, they actually follow very similar, the same profile, that we have been winning to date. So it's just sort of expansion into the place we've had success already. Scott McAuley Got it. That's great. And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle? Adrian Mendes Yes. Strong pipeline, we expect to see the sort of growth rates continue through the third quarter and fourth quarter, expanding into new facilities, expanding to new states. So I think we're sort of just kind of push -- sort of refer back to something I said earlier is one of the things that we've all been working really hard here, just to make sure we're establishing sort of the foundational structure in the company, that will help us grow sustainably over time. So it's not just like wanting really hard, closing a bunch of deals and then going into a drought. And so we've seen that. When we look at our pipeline, we see things kind of stage nicely through the entire pipeline, through phases and with increasing quantities as time goes on. So we're encouraged that this is a story that's sustainable that we can keep going. Scott McAuley That's great. I guess on the trial, fantastic to hear that the recruitment is going faster than expected and should be finished soon, so I guess if the recruitments finished in Q3, could you talk through a bit on when we could expect to see the top-line data and then potential FDA submission and approval? Adrian Mendes Yes. So the hope is that we'll be able to talk about top-line data in the fourth quarter, before year-end, and then with the goal of submitting to the FDA early next year, like early Q1. And then we're planning -- right now, we're anticipating approval sometime towards the end of 2025 or early 2026. We have breakthrough-device-designation. So that, we hope, will help speed things through. Internally, we're sort of preparing everything. I mean we have been preparing everything, continue to prepare everything, just to make sure there is no wait time between our request from the FDA and when we can submit something or the trial ending and when we can submit something. So one of the biggest, highest priorities we've got in the company is just to get through, to get that Series-B on the market as quickly as possible. Scott McAuley Absolutely. And sorry, you broke up a little bit, you're saying kind of data before the end of the year and then submission in Q1. Got it. And on the white paper, great to see those data in that form. Any other kind of white papers or studies, kind of real-world evidence that you guys are working on to put out there. Adrian Mendes Yes, absolutely. So like we mentioned, we've got 1,000 patients through right now, and so we've got that data. We've got a few papers going through a peer-reviewed process. The first paper was a white paper. The next ones will be peer-reviewed. We've also set up a registry now, a formal registry. So we're gathering data in a more sort of structured manner, I suppose. So you'll start to see that flow of clinical evidence start to pick up starting later this year and into the future. Scott McAuley That's great. Yes, good to get more of that data, especially if it's peer-reviewed. Obviously, it's great to reach that 1,000th scan benchmark. Can you kind of speak to either how many procedures were done in the quarter or what you're seeing from a monthly run rate or a bit about that kind of the utilization and what you're hoping to see going forward? Adrian Mendes I think, I don't have this precise numbers on the -- at the monthly level. It's safe to say that it is increasing. Every new device that we put in the field is also adding. If you recall, one thing that we did throughout, since the time I've been here is we really staffed up the clinical team that helps with customers and helps train them and get them onboarded. So a big part of their focus is just making sure that we're getting more and more customers through and our volumes up. So that has been increasing over time on a monthly basis, and we anticipate it to continue to increase. Scott McAuley Definitely. That's great. And I guess lastly, ImgClear, certainly kind of new for me, hadn't heard about that, so good to hear that those product improvements are continuing. So that algorithm kind of didn't need FDA approval and there are just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that, I would assume, would be included in the B-Series and that then doesn't impact any kind of the regulatory pathway or any of that process. Adrian Mendes Yes, that's all correct. Yes, it didn't need to go through any sort of regulatory approval. And the most important thing about that, and one thing that I'm really happy with what the team has been able to do, is really start to get this process of collecting feedback from customers and then having engineers work on some of those challenges and solve them and deploy that in the field. And the big one with ImgClear, frankly, is the fact that it does cut down the scan time in the operating room. Every minute counts in the operating room, so that's really great. The team has ideas on how to make that even faster, so that's good. I think we've got a nice product development trajectory on that as well. Scott McAuley I guess what would be, with that ImgClear, the kind of average scan time that a surgeon would take? Adrian Mendes Yes. So from a scan time on the average lump size, it goes from about 12 minutes down to about 9 minutes. And that's it. Thanks for taking the questions. I'll hop back in queue. Thank you. Your next question comes from Rahul Sarugaser of Raymond James. Please go ahead. Rahul Sarugaser Hi, Adrian and Sara. Thanks for taking our questions. Scott covered off most of it with really several questions, so really kind of one for me then today. Could you talk about the balance sheet given sort of the current cash on hand, cash burn and then how you guys are looking at managing the balance sheet? Adrian Mendes Yes, absolutely. So right now, we've got cash into early next year. We've been managing pretty tightly to make sure that, that runway stays consistent and that's sort of consistent with what we've been planning all year. We will need to fundraise before then. And so that's consistent with what we've talked about before, so that's still part of our plans. So that's a big focus of our management team, and the Board is focused on it right now. Rahul Sarugaser Perfect. That's helpful. And just maybe one more then, and then I'll get back in the queue. It's good to see the visibility on the top-line data in Q4, calendar Q4, and then hopefully followed by FDA submission and approval. Perhaps you could maybe lean forward a year or so and talk about how you plan on leveraging the data into marketing the device? And that's all. Adrian Mendes Yes, absolutely. So once we get approval, and we'll build toward this over time, there's really two things that we're preparing for, fundamentally two major things we're preparing for to sort of accelerate growth. One is the fact that having AI makes it a lot easier for surgeons to adopt it. It makes it easier to use. It's like a copilot. And so what we're doing right now and what we will do leading up to that is making sure that we're starting to lay down those railroad tracks, whatever, with surgeons and building out that pipeline. So surgeon adoption will go up, and that's a big thing that will happen once we get B-Series on markets. The other thing that it will do is it will give us labels, like data labels, on breast and breast cancer which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce re-excisions, we will be able to reduce re-excisions with B-Series. We will be able to do it in the breast cancer market. We don't have that evidence right now. The S-Series is not cleared for that, but the B-Series will be. So that's another inflection point that will really help our marketing message, in our commercial sort of messaging and strategy towards the end of next year. Does that answer your question, Rahul? Rahul Sarugaser Yes, that's perfect. Thanks very much. I'll get back in the queue. That concludes our question-and-answer session. I'd like to turn the conference back to Adrian Mendes for closing remarks. Adrian Mendes Okay. Thank you. Thanks, everyone, for the time and for following us and the support. The team here is extremely excited about what we have coming on. I guess we're sitting here at the start of -- you've seen some good news today. There's more to come. So keep following us, and we look forward to talking to you next quarter. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Earnings call: HeartBeam anticipates AIMIGo launch, reports $5M loss By Investing.com

HeartBeam, a company specializing in advanced cardiac diagnostic technology, has announced that it is preparing for a limited launch of its AIMIGo system by the end of 2024, pending FDA clearance. The company reported a net loss of $5 million for the second quarter of 2024, which is an increase from the $3.2 million loss in the same quarter the previous year. Despite the losses, HeartBeam has completed the VALID-ECG study and is getting ready for a second FDA submission for its AI algorithms that have shown effectiveness in detecting atrial flutter. The company is actively working towards regulatory and clinical milestones and has ended the quarter with $9.2 million in cash and cash equivalents. In conclusion, HeartBeam is navigating through a critical period as it approaches the commercialization of its AIMIGo system. The company remains committed to its vision of integrating AI into cardiac care, despite reporting increased losses compared to the previous year. With a focus on regulatory approvals and clinical studies, HeartBeam aims to make significant strides in the cardiac diagnostic market. The company's ticker and name were not provided in the context given. As HeartBeam gears up for the launch of its AIMIGo system, it's important for investors to consider the company's financial health and market performance. According to InvestingPro data, HeartBeam has a market capitalization of $59.77 million, which reflects the current investor valuation of the company. Despite the reported losses, one of the InvestingPro Tips highlights that HeartBeam holds more cash than debt on its balance sheet, which is a positive sign of the company's liquidity and its ability to fund ongoing operations without relying heavily on external financing. Another relevant metric is the stock's recent performance, with a 26.11% price uptick over the last six months. This suggests a growing investor confidence in the company's future prospects, possibly buoyed by the anticipated FDA clearance and commercialization of the AIMIGo system. However, the stock has fared poorly over the last month, with a 21.72% decrease in price total return, indicating some market volatility or investor concerns in the short term. Additionally, HeartBeam does not pay a dividend to shareholders, which is not uncommon for companies focused on growth and reinvesting earnings into research and development. For investors looking for income-generating stocks, this could be a consideration. For those interested in a deeper dive into HeartBeam's financials and stock performance, there are additional InvestingPro Tips available at https://www.investing.com/pro/, which can provide further guidance and insight into the company's market position and investment potential. Operator: Greetings, and welcome to the HeartBeam Second Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important facts relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our website, heartbeam.com. Your host today Branislav Vajdic, Chief Executive Officer and Founder; Rob Eno, President; and Ravi Malhotra, Senior Director and Corporate Controller, will present results of operations for the second quarter ended June 30, 2024. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Vajdic. Please go ahead. Branislav Vajdic: Thank you, operator. I'd like to start by reminding you of the vision for HeartBeam's unique technology. HeartBeam is developing AIMIGo, a credit card sized, cable-free cardiac monitoring device that will be capable of producing a 12-Lead ECG by leveraging the company's core vector technology, which captures 360-degree signals of the heart's electrical activity. AIMIGo has the potential to create new applications for patients and physicians, specifically heart attack detection upon symptom onset, identification of complex arrhythmias that existing variables cannot detect and the opportunity to monitor chronic conditions such as heart failure and to be used prevention and screening through the use of AI. In addition, HeartBeam's has broad IP protection on its core technology on novel form factors. These include implementing our vector technology on extended wear cardiac monitor or a mobile cardiac telemetry device, bringing on-demand 12-lead ECG technology to establish market with reimbursement and novel watch form factor that will combine a continuous monitor and a 12-lead on-demand wrist worn device. As we have mentioned previously, 12-lead ECG is one of the most commonly performed diagnostic tests and is the standard of care in hospitals and clinics. There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide. They are not 12-lead ECGs. Instead, there are 1-lead, 3-lead or 6-lead devices. This is adequate, perhaps for detecting many arrhythmias, but is not sufficient to detect heart attack or complex arrhythmias. In contrast, HeartBeam AIMIGo is an easy-to-use cable-free credit card size system that synthesizes the 12-lead ECG. The key aim of the HeartBeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including the heart attack outside of a medical institution. Today, patients experiencing heart attacks delay seeking care on an average of 3 to 4 hours, which can lead to death and to serious and costly complications such as heart failure. Next, we would like to share a video that demonstrates how easy it will be for patients to use AIMIGo in the real world. Please note that those of you who are dialed into this call by phone will not hear the audio. So you will be experiencing approximately 50 seconds of silence. [Video] And now I will turn the call over to HeartBeam President, Rob Eno. Rob Eno: Thank you, Branislav. HeartBeam technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with AIMIGo, where its 12-lead capabilities and advanced AI could outperform existing ambulatory cardiac ECGs. Expansion into heart attack detection where 12-lead is needed, accesses the 20 million patients with coronary artery disease and is a $12 billion opportunity. Incorporating our proprietary technology into the patch market, access is a market with established reimbursement that's estimated to grow to $4.8 billion in 2030. Over time, HeartBeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease where 12-lead ECG, coupled with deep learning algorithms could provide valuable insights. And ultimately, a simple, easy-to-use 12-lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease. We're incredibly excited about the long-term potential of the technology. And in addition, we're making steady progress on our near-term milestones. Our initial clearance for the AIMIGo system will be a major milestone for the company and is important for several reasons. To start, we anticipate this will be the first patient held device leveraging vector technology to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for HeartBeam, so it's the cornerstone of our efforts. The vector approaches an excellent platform for AI algorithms. In the longer run, we believe that applying AI algorithms on top of the rich 360-degree signals could result in unsurpassed predictive and diagnostic capabilities. Our 510(k) submission for the AIMIGo system is an active review by the agency. We're in the substantial review phase of answering questions posed by the FDA on this submission. We have successfully resolved the vast majority of the questions the FDA has asked. Since our last update, the FDA requested additional information, which we're in the process of providing. The company is working with the FDA to address the small number of remaining questions. We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clearance. The company continues to plan for a limited launch of AIMIGo by the end of 2024, which will provide us with valuable feedback on the user experience and functionality of the system in a real-world setting. We continue to make significant progress on other fronts. We're preparing materials for our second FDA 510(k) submission on the algorithms that convert the 360-degree signals captured by the AIMIGo system into a synthesized 12-lead ECG. On June 20, we completed enrollment in VALID-ECG, the 198 patient trial comparing simultaneously placed AIMIGo and 12-lead ECGs. We completed enrollment in just 3 months, which is extremely fast for a study of this size. The data are currently being analyzed. VALID-ECG will be the basis of the 12-lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the AIMIGo system. Prior to enrolling VALID-ECG, we conducted an 80-patient pilot study utilizing the same protocol. That study has been accepted for presentation at the American Heart Association meeting in November. We've also made great progress on our AI program. In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrate the ability of HeartBeam's AI to detect atrial flutter, an important arrhythmia that's difficult to identify with a single read ECG. These studies demonstrated that HeartBeam's AI algorithm applied to vector cardiography or VCG, greatly outperformed AI on a single lead ECG. Also, HeartBeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single lead ECGs and impressively an expert panel reviewing 12-lead ECGs with a statistically significant improvement in the detection of atrial flutter cases. The development of the AI algorithms has progressed. We're getting close to freezing our multiple AI models powering HeartBeam AI that once cleared by the FDA will provide a comprehensive set of diagnostic suggestions. This powerful AI-based tool, combined with the 12-lead ECG provided to the cardiologist will make, we believe, an offering beyond anything that's available in patient obtained ECGs, both in terms of diagnosis covered and diagnostic accuracy. We've gained significant experience with AIMIGo and believe that technology is derisked. We've conducted multiple clinical studies enrolling more than 500 patients. These include the VALID-ECG study described previously, as well as the 80-patient pilot study. We've previously discussed the study published last year in JAK Advances, demonstrating equivalent to 12-lead ECG in detecting coronary occlusions and also showing a significant improvement in accuracy when comparing the HeartBeam approach with a baseline reporting to a single 12-lead ECG, which is often the case in an emergency room. We've completed another study on the performance of our ECG technology together with symptoms and patient history compared to the standard of care. These results also will be presented at the American Heart Association meeting in November, along with the results of the 12 lead synthesis pilot study mentioned area. So a total of 2 presentations at this strategic scientific conference later this year. Beyond the clinical protocols, we have usability experience in a real-world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the systems functionality. I'd now like to hand the call over to our Corporate Controller, Ravi Malhotra to present selected financials. Ravi Malhotra: Thank you, Rob. I'll now give a brief overview of our financial results. A full breakdown is available in our regulatory filings and in the press release that crossed the wire after market close today. General and administrative expenses for the second quarter of 2024 were $2.2 million compared to $1.8 million for the second quarter of 2023. The increase in G&A expense is primarily related to noncash stock-based companion expense associated with additional awards, which the company granted since June 30, 2023, and also higher consulting costs, primarily offset by lower legal costs in the current period. Research and development expenses for the second quarter of 2024 were $2.8 million compared to $1.5 million for the second quarter of 2023. The increase in R&D expense is primarily related to an increase in headcount, increase of clinical and AI-related costs and increase in consulting spend, which is offset by a decrease in product development consulting cost spending, primarily driven by completion of milestone projects in the prior period. Net loss for the second quarter of 2024 was $5 million compared to a net loss of $3.2 million for the second quarter of 2023. We ended the quarter with approximately $9.2 million in cash and cash equivalents as we close to carefully manage spending. I will now turn the call back to Branislav for closing thoughts. Branislav Vajdic: In conclusion, we remain extremely excited about the potential at HeartBeam and progress. AIMIGo will be smallest, easiest to use and first cable-free 12-lead ECG device enabled by HeartBeam's unique IP-protected vector technology. It has the potential to disrupt numerous large markets and clinical applications, starting with the ability to detect complex arrhythmias, expanding to heart attack detection and then to monitor it for complex diseases such as heart failure. Ultimately, we believe that the combination of the small form factor, powerful 360-degree ECG technology and advanced AI algorithms will have significant applications in prediction and screening of cardiac conditions. We continue to make progress towards key regulatory and clinical milestones. Our initial 510(k) application for the AIMIGo system is under active FDA review with productive discussions underway. The company is working with the FDA to address the small number of remaining questions. We believe that we are progressing toward clearance. We anticipate a limited launch by the end of the year, focused on the AIMIGo system, which will provide the company with valuable feedback on the user experience and functionality of the system in a real-world setting. We are preparing materials for our second FDA submission that will be a 510(k) submission on the algorithms that convert the vector signal captured by our AIMIGo system into a synthesized VALID-ECG. We have completed enrollment in the VALID-ECG study and anticipate submitting the 510(k) application soon after the clearance of AIMIGo system. We presented positive new data on our deep learning algorithm HeartBeam AI, demonstrating excellent performance in detecting atrial flutter, even outperforming a panel of three electrophysiologists reviewing 12-lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithms. We ended the quarter with approximately $9.2 million in cash and cash equivalents, enabling the company to execute on upcoming clinical and regulatory milestones. I look forward to providing our shareholders with further updates in the near term. I thank you all for attending. And now the HeartBeam team would like to answer your questions. Operator? Operator: We will now begin the question-and-answer session. [Operator Instructions] Currently, I do not see any questions on the phone. Unidentified Company Representative: Our first webcast question. Can you just provide some more detail on the timing of the FDA clearance? Branislav Vajdic: Yes. Let me comment on that. We are under active review with the FDA, and we really can't give any more details than what we said in the call and in our earnings materials. To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked. And last quarter, FDA requested additional information, which we are now in the process of providing. We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance. We still anticipate a limited launch before end of the year. Again, this will provide us with valuable feedback on the user experience as well as functionality of the system in the real-world setting, extremely valuable to us. Unidentified Company Representative: Thank you. Let's see. Our next question. You showed market sizes for HeartBeam's technology. Can you explain just where you're going with those? Branislav Vajdic: Rob? Rob Eno: Sure. Yes, thanks. That was a new framework. So I can elaborate. The main point there really is to show that HeartBeam's technology, which, again, is a credit card-sized cable-free device that produces a 12-lead ECG can have a wide range of applications. So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection. We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on-demand 12-week capabilities. And with both that form factor and with AIMIGo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease. And then ultimately, beyond that, we think that patients taking frequent 12-lead ECGs over time, especially when combined with AI algorithms can enable prevention and screening for a very large number of patients. So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention and screening. Unidentified Company Representative: Thanks. Our next question. You mentioned that the VALID-ECG study has completed enrollment. What are the results of the study? Branislav Vajdic: Yes, Rob, please shed some light on that. Rob Eno: Sure. So first, as a reminder, VALID-ECG was a study with simultaneously collected ECGs. So the patient had both a standard 12-les ECG and AIMIGo at the same time. And the goal was to demonstrate the similarity between the standard 12-lead signals and our synthesized 12-lead signals. And we've had 2 pre-submission meetings with FDA that are largely focused on the endpoints of the study. So we've -- where we are right now is we've completed enrollment back in June, as I mentioned, but the data is currently being analyzed. So the results are not available. We do anticipate completing that analysis soon as that will be the basis for the second FDA submission that we plan to submit shortly. I would note that we did complete this 80-patient pilot study with the same protocol. We can't say the results of that because it's been accepted for a presentation in November at the American Heart Association. But based on the results of those studies, that study, we did proceed with VALID-ECG. Unidentified Company Representative: Great. Thank you. The next question, if the 12-L ECG is being evaluated by a physician, why do you need AI? Branislav Vajdic: Yes. Let me answer that question. Our vision is that with HeartBeam AI, the user will get an automated arrhythmia classification, and that's going to happen immediately after every use. However, of course, it is important that a physician review patient clinical picture, the complete clinical picture, which includes ECG. We actually anticipate like having two workflows here. If the user is experiencing symptoms, the ECG will be automatically sent to the user's physician or to a physician breathing [ph] service for evaluation. On the other hand, if the user is not experiencing symptoms but is taking a routine recording to add to their database or ECGs, the ECG will not automatically go to a physician for interpretation. This is asymptomatic recording, but the user will have the option to do so. In either case, symptomatic or not symptomatic, AI will play a key role in informing the patient and helping physicians diagnose the patient. Unidentified Company Representative: Great. Thanks. Next question. Will the initial AIMIGo product to be able to detect heart attacks from the get-go? Or will there need to be further R&D before that claim can be made? Branislav Vajdic: We have actually done a lot of research, and we've done two studies related to heart attach detection. So in terms of the development, there is still some work to do. But fundamentally, we believe that we have a technology that's going to provide leading insight into the patients with chest pain. So all in all, at this point, we are focusing on arrhythmia detection, especially complex arrhythmias that other technologies cannot detect. And our plan is, as soon as that is productized, as soon as that is in the marketplace that we will apply all our resources to enable the product to detect heart attack. Unidentified Company Representative: Thanks. Next question, is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fibrillation? Rob Eno: Yes, it's just similar to what Branislav said before, we're taking a stepwise approach with FDA. And so the initial indications are for arrhythmia and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation, and we'll have clinical data on that. So yes, pursuing those are within the scope of the initial clearance. Unidentified Company Representative: Great. That is the final question there. I'll turn now the call back over to Dr. Vajdic for his closing remarks. Branislav Vajdic: Thank you, operator. I would like to thank each of you for joining our earnings conference today and look forward to continuing to update you on our ongoing progress and growth. If you were not able to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you, again. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Earnings call: Predictive Oncology reports Q2 2024 results, focuses on innovation By Investing.com

Predictive Oncology (Ticker: POAI), a leader in the application of artificial intelligence to personalized medicine and drug discovery, has reported its financial results for the second quarter ended June 30, 2024. The company highlighted the successful completion of an ovarian cancer study with UPMC Magee-Womens Hospital and the launch of a 3D cell culture technology. Despite a decrease in revenue to $279,000 from $490,000 in the same quarter of the previous year, the company has managed to reduce its net loss per share to $0.68 from $0.98. Predictive Oncology also emphasized its focus on biomarker discovery and the development of next-generation therapies. Predictive Oncology's Q2 2024 earnings call revealed a mixed financial performance, with notable advancements in technology and strategic initiatives to reduce costs and optimize operations. The company's efforts in biomarker discovery and the development of next-generation therapies remain central to its mission. Despite a decrease in revenue and an ongoing deficit, the reduction in net loss per share and controlled expenses reflect a company striving for efficiency and innovation in the challenging field of oncology. Predictive Oncology (Ticker: POAI) has been navigating a complex financial landscape, as evidenced by the latest metrics from InvestingPro. The company's market capitalization stands at a modest $3.5 million, which is indicative of its small-cap status in the biotechnology sector. Notably, POAI's revenue growth over the last twelve months as of Q1 2024 was 36.98%, showcasing a significant uptick that may align with its strategic initiatives in drug discovery and development. InvestingPro Tips highlight two contrasting aspects of POAI's financial health. On one hand, the company holds more cash than debt on its balance sheet, which is a positive sign for liquidity and financial stability. On the other hand, analysts are concerned about POAI's cash burn rate, as the company is quickly depleting its cash reserves. This could be a point of caution for investors considering the company's ability to fund ongoing research and operations without additional capital infusions. Moreover, POAI's stock has been subject to high price volatility, which could be attributed to market reactions to its financial performance and the inherently uncertain nature of drug development outcomes. The stock is trading near its 52-week low, which might be reflective of investor sentiment and the broader challenges faced by the company. For a more comprehensive analysis and additional InvestingPro Tips on POAI, interested readers can explore further at https://www.investing.com/pro/POAI, where 14 more tips are available to provide deeper insights into the company's financial and operational prospects. Operator: Good day, and thank you for standing by. Welcome to the Predictive Oncology Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' prepared presentation, there will be an opportunity to ask questions. Please be advised that today's conference is being recorded. I would now like to hand the call over to your speaker, Mr. Glenn Garmont, Investor Relations. Thank you. You may begin. Glenn Garmont: Welcome, and thank you, everyone, for dialing into the Predictive Oncology second quarter 2024 financial results call. First, you'll hear from our Chief Executive Officer and Chairman of the Board, Raymond Vennare; and our Chief Financial Officer, Josh Blacher, who will review our financials. Certain matters discussed on this call contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements other than statements of historical facts included in the call regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors, including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the company disclaims any intent or obligation to update these forward-looking statements. Now I'd like to turn the call over to Raymond Vennare, Chief Executive Officer. Raymond? Raymond Vennare: Thank you, Glenn, and good morning, everyone. I would like to begin this morning with a recap of a significant announcement that we made just a few weeks ago regarding the successful retrospective multiyear ovarian cancer study that we completed with UPMC Magee-Womens Hospital conducted over the past five years. As a result of this study, the findings of which were presented at the American Society of Clinical Oncology Annual Meeting in June, we have expanded our artificial intelligence and machine learning offering to independently pursue the discovery of novel biomarkers that can predict patient outcomes and drug responses in oncology. With these capabilities, we are very well positioned to play a significant role, not only in validating biomarkers that have already been discovered by potential partners, but also in discovering our own unique biomarkers and playing a more active and direct role in drug discovery and development. Please recall that the Magee study was designed to identify key features that drive overall survival endpoints in ovarian cancer, a very serious cancer type with a very high rate of recurrence. This study included data from 235 ovarian cancer patients from 2010 through 2016, a broad array of inputs, including patient data, whole exome sequencing, whole transcriptome sequencing, drug response profile and digital pathology profiles were used to train the 160 models that were included in the study. As we previewed during our first quarter conference call, we were able to obtain an end-of-life data that supports novel ovarian cancer biomarker discovery and development. We are very pleased to report that we were able to deliver strong predictive models with high levels of accuracy, and our machine learning capabilities demonstrated the ability to identify prognostic subgroups within ovarian cancer patient population. This progress represents a natural extension of our core artificial intelligence capabilities, where we employ our active machine learning and diverse patient tumor samples preserved in our extensive biobank to predict responses to drugs with a very high degree of accuracy. We are now taking this one step further by applying state-of-the-art deep learning approaches for biomarker discovery for both overall survival and drug responses. This includes our ability to extract differentiating features from our digitized pathology slides, which, in and of themselves, are potential biomarkers. Our platform now enables us to pursue deep learning as a methodology to accelerate the initial stages of biomarker discovery and stratify patient cohorts and further extend our capabilities, either independently or in partnership with our biopharma companies. Ovarian cancer represents a significant unmet need in oncology, with epithelial ovarian cancer being the deadliest of all gynecologic malignancies. While these cancers are sensitive to front-line chemotherapy in approximately 75% of cases, these women will ultimately experience disease relapse in an equal percentage, which is incurable. Outside of primary chemotherapy, there is no universal treatment decision path to determine the agent, sequence and timing of the standard of care for chemotherapeutic agents. These capabilities extend well beyond ovarian cancer and can be used in the discovery of biomarkers for other cancer types as well as diseases outside of oncology. External sources have valued the biomarker discovery market at more than $51 billion in 2024. So this is a very significant opportunity for us to leverage our unique set of assets and capabilities to play a role in the discovery of next-generation therapeutics, while creating enduring value for our shareholders. We look forward to further validating these capabilities through development collaborations with leading biopharmaceutical partners and health care networks. Also during the second quarter, in addition to our biomarker discovery initiative, we launched a novel organ-specific 3D cell culture technology that more closely mimics human tissue architecture than 2D assays. It does this by preserving critical interactions between a tumor and its cellular and extracellular surroundings and creates a more representative method for in vivo clinical testing for drug candidates. This allows for more robust predictions of clinical outcomes and can be used to optimize candidate selection for subsequent clinical development. The potential benefits to drug developers are numerous. They decrease the cost of new drug development and the time to market, but also reducing the need for animal testing and time-consuming iterations during clinical trials. The 3D cell market is estimated by third parties to grow 14% annually from $1.4 billion in 2022 to $5.3 billion in 2032. Also worth mentioning is the progress that we have made with our Accelerating Compound Exploration program, otherwise known as the ACE initiative. This program, as you may remember, is geared toward novel discovery through partnerships with universities and academic institutions and was created to provide early-stage academic development groups access to Predictive Oncology's artificial intelligence platform, which, as you also know, leverages our extensive and diverse biobank of heterogenous tumor samples. The ACE program is designed to enable academic investigators to evaluate their drug compounds and facilitate more informed selections of drug tumor type combinations to increase the probability of future clinical success by efficiently addressing tumor heterogeneity earlier in development. This program, which we have been nurturing for more than a year, has resulted in our first collaboration with the University of Michigan. The library created by University of Michigan's Natural Products Discovery (NASDAQ:WBD) Core is one of the largest collections of pharmaceutically viable extracts in the United States. This library which has been meticulously constructed over the past decade, in the laboratory of Dr. David H. Sherman at the University of Michigan's Life Sciences Institute, is comprised of strains from Asia Pacific, Middle East, South America, North America and the Antarctic. Most importantly, this collaboration represents Predictive Oncology's foray into true drug discovery. With the addition of University of Michigan's natural products and drug candidates, we are very well positioned to expand our small molecule capabilities to include development of large molecule models using our proprietary AI and ML platform. Several publications will definitely come out of this drug discovery initiative. To ensure that we remain nimble and able to capitalize on this and other new opportunities that continue to emerge, we announced more recently that we implemented a comprehensive and strategic cost reduction initiative aimed at streamlining our operations and extending our cash runway. As a key part of this initiative, we made the challenging decision to consolidate our Birmingham operations, which houses our Biologics business into Pittsburgh, which as you know, also serves as our corporate headquarters. From a strategic perspective, it is important to understand the context of this action. First and foremost, it is incumbent on the company to remain laser focused on its core capabilities with respect to the application of artificial intelligence to drive drug discovery. Second, the very thing that enables our ability to model and predict drug tumor responses identify biomarkers and predict outcomes with such accuracy is the quality of the tumor samples in our biobank and the significance of the pristine longitudinal data that has been generated from those samples. This has now been externally validated and was presented at the Association of Surgical Oncology. The ability to deliver on the accuracy of our predictions and relevance of our models requires constant sequencing, characterizing, curating and digitization of tissue samples, drug response data and pathology slides. This is an ongoing effort and one which drives the precision with which our AI-generated models are perfected. In the absence of these silent endeavors, we cannot possibly distinguish ourselves in the marketplace. All of this requires dedicated resources and in this case, the reallocation of those resources from Birmingham to Pittsburgh. Lastly, innovation perpetuates value creation, and adding value to the company impacts valuation of the company. By adding value, we are signaling our relevance to the market with respect to the significance of our core assets. This initiative, once fully implemented in Q4 of this year, is expected to reduce our run rate for cash used in operating activities by approximately $2.5 million annually, which equates to roughly 20% of our cash burn based on our stated 2023 cash used in operating activities of $13.2 million. As a point of preference, the Birmingham segment generated a net loss of $2.0 million in 2023 and $1.8 million in 2022, with de-minimis-supporting revenue. Moreover, since Birmingham has become essential to our core focus in Pittsburgh over time, and in light of its lack of profitability, this simply became the right decision for the company and the shareholders moving forward. We would be remiss not to extend our gratitude to our partners in Birmingham, especially Dr. Larry DeLucas, Senior Vice President of Biologics, for his years of leadership and dedication. Thank you, Larry. To further strengthen our financial position, we've announced over the last few months a couple of significant capital raises, $5.0 million in total that also helped to bolster our cash balance sheet and extend our runway. In May, the company raised $3.7 million, net of $0.6 million of issuance costs or $3.1 million in net proceeds through its at-the-market facility through the issuance of 1.6 million shares. And in July, the company raised an additional $1.3 million in gross proceeds through the exercise of 958,000 warrants through our warrant inducement transaction. And now I would like to turn this call over to Josh Blacher, our Chief Financial Officer to review our second quarter financials in detail. Josh? Josh Blacher: Thank you, Raymond. We concluded the second quarter of 2024 with $5.3 million in cash and cash equivalents compared to $8.7 million as of December 31, 2023, and $4.1 million in stockholders' equity compared to $8.3 million as of December 31, 2023. Note that our cash balance as of June 30, 2024 includes net proceeds of $3.1 million that we raised from our ATM facility in May, but excludes amounts raised subsequent to the end of the second quarter from the warrant inducement transaction that Raymond described earlier. Our net loss per share for the second quarter of 2024 was $0.68 per basic and diluted share as compared to $0.98 per basic and diluted share for the second quarter of 2023. The company recorded revenues of $279,000 for the second quarter of 2024 compared to $490,000 for the comparable period in 2023. Revenues for the quarter ended June 30, 2024, and June 30, 2023, were primarily derived from the company's EGAN operating segment. General and administrative expenses primarily consist of management salaries, professional fees, consulting fees, administrative fees and general office expenses. G&A expenses decreased by $567,000 to $2.1 million in the three months ended June 30, 2024, compared to $2.7 million in the comparable period 2023. The decrease was primarily due to lower employee compensation and decreased investor relation costs, offset by increased consulting fees. Operation expenses primarily consist of expenses related to product development and prototyping and testing. Operations expenses decreased by $100,000 to $893,000 for the three months ended June 30, 2024, compared to $993,000 in the comparable period in 2023. The decrease was primarily due to decreased cloud computing expenses related to our Pittsburgh operating segment. We expect these types of savings to continue going forward. Sales and marketing expenses consist of expenses required to market and sell our products, including staff-related expenses, for individuals performing such work. Sales and marketing expenses decreased by $145,000 to $284,000 for the three months ended June 30, 2024, compared to $429,000 in the comparable period in 2023. The decrease was primarily due to lower employee compensation, including sales commissions. As a part of the cost savings initiative, we've taken a hard look at marketing, spending in general as it relates to ROI hurdles, so you can expect that such reductions will continue going forward. Net cash used in operating activities was $6.6 million for the six months ended June 30, 2024, down from $7.0 million for the comparable period in 2023. The company incurred net losses of $3.2 million and $3.9 million for the quarters ended June 30, 2024, and June 30, 2023, respectively. As of June 30, 2024, the company had an accumulated deficit of $175 million as compared to $168 million as of December 31, 2023. That concludes the financial overview. We will now open the call up for questions. Operator? Q -: Operator: Thank you. [Operator Instructions] Mr. Vennare, I'd like to turn the floor back to you and close the question-and-answer session. Raymond Vennare: Thank you very much, and thanks, everyone, for being on the call. So that concludes our call for today. We hope that you take away from this call that we are extremely excited to actively pursue novel biomarker discovery and play a more direct role in the discovery and development of next-generation therapies, either independently or with a partner. This represents a tremendous opportunity for us to bring new hope to millions of patients worldwide in cancer and other high-need indications, while creating long-lasting value for our shareholders. Thank you again for your support and your patience, and I look forward to the next quarterly update in November. Have a great day. Operator: Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Movano Inc. (MOVE) Q2 2024 Earnings Call Transcript

Greetings and welcome to Movano Health Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Jay Cogan, Chief Financial Officer. Thank you, Mr. Cogan. You may begin. Jay Cogan Thanks, Operator. Good afternoon, everyone, and thank you for joining us today. Movano Health's CEO John Mastrototaro will open today's call with prepared remarks about the progress the company has made during the second quarter of 2024 and in recent weeks. Our CMO, Tyla Bucher, will provide some remarks on the company's upcoming B2C plans, followed again by John, and then I'll provide highlights on the company's quarterly operating results and current financial position. Then we'll open the call for Q&A. John, Jay, and Tyler will be joined by our Chief Technology Officer and Founder, Michael Leabman, Chief Commercial Officer, Michael Soule, and Vice President of Product and Strategy, Stacy Salvi. Movano Health issued a news release this afternoon detailing second quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's Forms 10-Q and 10-K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions, and circumstances. With that, I'll turn the call over to our CEO, John Mastrototaro. John Mastrototaro Good afternoon, everyone. Since we last reported earnings in May, we have been working diligently to prioritize the efficient use of our recent capital infusion while continuing to make progress on our key business initiatives as follows. Preparing for expansion of the direct-to-consumer launch at Evie Ring and taking orders again starting September 17. Continuing to work with the FDA to secure a 510(k) clearance for the EV Med Ring. Delivering our first B2B commercial opportunities with healthcare partners. And lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device, incorporating our proprietary RF solution. We continue to be judicious with our capital and methodical in our approach to building out our direct-to-consumer and business-to-business market opportunities. I will provide an update on our progress with the FDA and preparations for B2B launch at EV Med. And we'll then turn the call over to our CMO, Tyla Bucher, to discuss plans for the D2C business, including our plan to begin taking orders again and shipping product in September. In preparation for the launch of EV Med, we're working closely with the FDA to secure a 510(k) clearance. As we highlighted in a press release last week, we plan to meet with the FDA this month. You'll recall the EV Med Ring is designed to not only provide medical device functionality with its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. Subsequent to our April 510(k) filing, in May and early June, the FDA review team requested two minor clarifications and our team promptly responded. In late June, the FDA review team requested some additional information related to the wellness aspects of Evie Med. Along with our regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10 and requested a meeting with the agency to review our draft response, which is now scheduled, as I noted earlier. We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with the review process. We remain steadfast in our commitment to the opportunity Evie Med could unlock, given the clinical evidence provided as part of the filing related to the pulse oximetry feature and our desire to work collaboratively with the agency. With regard to the Evie opportunity, we have three new B2B commercial opportunities to highlight for you today. In anticipation of an expected 510(k) clearance, we are engaged with two global pharmaceutical companies that could leverage Evie Med in building unique solutions for both clinical and consumer applications. In the first case, we are in the agreement phase for a program that could begin in late 2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, Evie Med is expected to be evaluated this fall by a Tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025. We are also engaged with a large payer looking to better manage high-risk populations utilizing Evie Med. This opportunity is expected to kick off around the New Year and, assuming a positive outcome, the commercial opportunity could build into 2025. All three of these strategic partners, as well as the others in our funnel, see Evie Med as a game-changing solution that is not currently available in the market. This is in addition to our recent announcement of the partnership with the Tal Research Group at MIT to use Evie Ring for its MAESTRO clinical study on the long-term health impacts of Lyme disease and lung COVID. To explain these health care opportunities in more depth, we recently hosted our first virtual event titled B2B, The Next Wearables Boom, where Managing Director of Allele Capital, Matt Hughes, moderated a panel that included myself, our Chief Commercial Officer, Michael Soule; and Stanford Cardiologist, Doctor Fatima Rodriguez. During the event, we identified and discussed the significant B2B possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following a 510(k) clearance. As you'll recall, the clinical trials market we seek to address consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We've identified the TAM for FDA-cleared wearables in this market to be as much as 5 billion annually. Currently, trials are offering cumbersome, expensive and suboptimal requiring in-person checkups, which can result in poor compliance. We believe Evie Med's unique offering and design aesthetic would improve compliance lower cost significantly and enable quicker enrolment, better data and improved quality of results. The three examples I highlighted a few minutes ago speak to this need and we are aggressively pursuing opportunities across clinical trials and post-market surveillance. For Remote Patient Monitoring or RPM market barely existed four years ago, However, COVID unlocked the reality that RPM can reduce the need for in-office visits, expand access and reduce costs. We believe Evie Med will be able to automate the collection of more complete and accurate data resulting in an RPM solution with meaningful advantages over RPM products on the market today. During our conversation, Doctor Rodriguez also validated the need for RPM in her role as a physician, which would enable her to manage our patients in between visits and easily identified patterns. We recently completed beta testing our wearable technology with a leading U.S. RPM company that serves over 450 health care organizations and is the exclusive platform for one of the largest medical device companies in the world. In anticipation of these partnerships and more, we are preparing our back-end operations to be able to meet our partners' requirements including positioning the company to scale efficiently, establishing app and labelling modifications to support a medical device and building our API and data sharing framework. I will now turn it over to our CMO, Tyla Bucher, to provide an update on our D2C plans for the Evie Ring. Tyla Bucher Thanks, John. As you all know, we've been out of stock on the Evie Ring since Q1 and we've been using this time to implement a series of improvements for our existing and prospective customers, including operational and delivery time lines, better and more accurate ring functionality, best-in-class customer service and finalizing some new and necessary features. From an operations standpoint, we improved production yields and cycle times as well as our logistics and warehouse management system. This will result in greater efficiency on the production floor and allow us to keep more accurate real-time track of inventory and the flow of orders. From a software perspective, we updated our Ring algorithms, improving accuracy across sleep and wake times, sleep stages, heart rate measurement during activity and steps. In addition, we expanded our proprietary AI generated insights engine to include hundreds of new insights for our users, customized for individual wellness journey and informed by a combination of track and log data. An example of one of our newer insights would be, when you beat your average step by more than 1,000, you tend to report a better mood. Regarding customer service, we built out a new team of representatives with a combined 25-plus years of service in the direct-to-consumer space. Who have a solid understanding of the pace and real-time knowledge delivery that a product like ours required. This team is currently responding live to all inquiries within 48 hours and has drafted a comprehensive library of useful articles and tips and tricks that can be shared with Evie Ring consumers as they work through any issues together or the customers can use to if they prefer. In addition, these articles feed into our AI-powered chatbot who can mitigate many easily solvable issues and get smarter as it ingests both the inquiries and our information, responding quickly and accurately to customers in friendly and native language. In addition to all these enhancements, we are also working on an auto activity detect workout feature, which will allow you to understand that you're working out even if you have not started to work out on the app. And following the work out, we'll be able to provide you with your results. Users will also be able to modify the details of their work out after the fact. And finally, we expect to have an Android version of the app ready for our prospective Android users, of which there are quite a few to purchase by Black Friday in November of this year. We are pleased to announce that we'll be back in stock on September 17. This is post summer season and time for when consumers begin turning their attention to the holidays and gift giving. We have a full paid in organic social campaign prepared to support our launch which includes influencer and user-generated content across Instagram, Facebook, YouTube and TikTok as well as Google Search and Shop. We also have a robust e-mail lead list that has grown exponentially with consumers ready to buy, and we will be engaging them with a comprehensive outreach strategy. And we have a satellite press are lined up with key tech and consumer press as well as a pitch campaign for holiday gift guides across print and television. And finally, we could be more excited to share the introduction of our brand partnership with digital creator, wife, mom and entrepreneur Heidi D'Amelio. Heidi has been using the Evie Ring for several months and has really become a true fan. Aligned with our mission of empowering women with better data and insights to help them live healthier lives, we have formed a strategic partnership with Heidi where we'll continue to grow the brand, drive awareness around women's health and improve the ring experience together. We couldn't be more excited to welcome Heidi to the Evie family. As you can see, we've been working around the clock to get the ring back in the hands of consumers, and we truly believe it will be worth the wait. Thanks, Tyla. As you are aware, our product development plan extends far beyond Evie and Evie Med. We are deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research in respiration rate, core temperature and a solution to address sleep disturbances. Some of these metrics may only require a software update, while others may require new hardware components or potentially different form factors. We are in the planning stages now for several clinical trials related to these valuable analytes. As a follow-on to the successful blood pressure study we conducted in Q4 '23, we completed our most recent blood pressure clinical study in June, which included the use of an arterial blood pressure line. We learned a great deal about improved ways to collect data, and we'll be redesigning for the next study with better placement of the sensors on the body to maximize their utility. We're also in the process of designing a more consumer-friendly form factor as we focus on commercializing the solution. We will continue to develop this into Q4 with another study plan before year-end. In summary, we remain committed to improving health monitoring through the introduction of additional analyte sensing, including blood pressure and glucose using our millimeter wave radio frequency and AI technology. With that, I'll now hand the call over to Jay for the financial review. Jay Cogan Thanks, John. We shipped 1,837 Evie Ring in the second quarter of 2024 as we completed fulfilment of our initial launch phase. You'll recall that we shipped approximately 5,300 Rings in the first quarter and stopped taking orders in mid-February given capital market conditions. The company did not report any revenue for the second quarter as previously deferred revenues offset by refunds. As we noted earlier in the call, we expect to begin taking orders and shipping rings again in September. We plan to have ample inventory prior to taking orders again in September. And as Tyla highlighted, we have made important strides across product manufacturing and customer service that should position us well for both an expanded launch of Evie Ring in D2C and eventual launch of Evie Med in B2B upon an FDA clearance decision. Following our successful type of placement in April, where the company raised $24.1 million in gross proceeds, including a strategic seed investment from a Tier 1 multibillion-dollar medical device company, we recently executed a turnkey agreement with our production partner, which should free up both working capital and people resources for Movano Health going forward. The company reported an operating loss of $6.4 million in the second quarter of 2024 versus an operating loss of $7.4 million in the year ago period. And we had $16.9 million in cash and cash equivalents on our balance sheet at June 30, which takes into account our catching up on more than $3 million of outstanding payables following the April private placement putting us in good standing with our partners as we position the company to execute against key future milestones. Excluding the catch-up, our cash burn in the quarter was approximately $4.4 million as managing resources continues to be a priority for the company. Now I'll turn it back over to John for final remarks. John Mastrototaro Thanks, Jay. The team and I couldn't are excited about all of the progress we just highlighted. We are nearing an inflection point for the company as we close in on key Evie and Evie Med milestones. We are laser focused on the expansion of our D2C business, bullish on the B2B opportunities for Evie Med and optimistic about the potential of our RF chip. We look forward to continuing to share our progress as we head into the back half of the year. Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question comes from the line of Bruce Jackson with Benchmark Company. Please go ahead. Bruce Jackson Hi, good afternoon. Thank you for taking my questions. With the new Evie that's going to launch with the auto activity detect features, is that the same thing as the new heart rate and motion algo that you just developed? John Mastrototaro Michael Leabman, would you like to go ahead and respond to that question from Bruce? Michael Leabman Yeah, sure. I think the first big fix we've added is we've changed our heart rate algorithm to be really based on machine or deep learning to get much more accurate heart remotion if you're walking, jogging, running et cetera. That's kind of stand-alone algorithm. The auto activity is really to twofold. One, to kind of identify what activities you're doing as well as Tyla mentioned, to be able to start to work out and start collecting this data, even if you don't tell your watch or your ring or your app to start collecting. So there are kind of two separate things that combine to give you much better results for a workout. Bruce Jackson Okay. Great. And then moving over to the business-to-business side. With the provider organization where you've got an engagement, can you maybe go into a little bit more detail about that as to the depth of the engagement? Is it like on parallel activities? Or do they have any like minimum orders attached to the engagement? John Mastrototaro Thanks Bruce. Michael Soule, do you want to go ahead and take that question? Michael Soule Yeah. So we are -- as we said earlier, we are engaged with a number of different channels, providers as one of them payers, remote patient monitoring. In the anticipation of our FDA approval they are working with us in various formats through beta testing. We're also in the initial agreement conversations with a number of folks, including providers, payers and the remote patient monitoring channels as well. Bruce Jackson Okay. Great. And then last question for me. Any changes on the mid-August date for meeting with the FDA? John Mastrototaro I'll take that one, Bruce. Thanks for the question. No, no changes there. I'd just like to make a couple of comments about it. We still are very optimistic with regard to our ability to work with the agency for a few reasons. First off, we've got a pretty seasoned and deep regulatory team in the company itself, but we've gone one step beyond that. And in fact, we're also working with the leading regulatory firm in the U.S. and probably the principle of whom has probably had more meetings with the FDA than anyone ever so through their career. So we've really got the top team that we could possibly have working on this to assure that we're complying with all the FDA policies. When you're doing something new, with our Ring and we've got the wellness and medical devices in the product. It can raise some new questions of the agency, but we feel really good about where we stand. We've had some already recent communication in preparation for the meeting, and it's all trending in the right direction. So that is all positive. And then lastly, one thing we always kind of remember is that the whole filing is built on a really strong foundation of incredibly strong clinical data and results for the pulse oximetry feature. So because of all of these reasons, we still feel really good about where we are and being able to work through the FDA and gain a clearance. Bruce Jackson Okay. Great. Congratulations on all of the progress. And thank you for taking my questions. Thanks, Bruce. Operator, it looks like we have some questions on the webcast. I can go ahead and ask those and we'll see what happens with the phone lines thereafter. John, I guess, if there's anything else, there's a question here about the 510(k) submission. If there's anything else you wanted to add in terms of our confidence in securing or just anything else beyond the press release that we issued last week, if there's anything to discuss otherwise, we can move on to the next question. John Mastrototaro Yeah, I saw that question. I saw that question online, and I tried to answer it at the same time that I answered Bruce. So I think that covered it pretty well. Bottom line is we still feel really confident and optimistic in where we stand and are very much looking forward to meeting with the agency soon to resolve this and move on to the next topic. Jay Cogan Okay, great. I think the next couple of questions can be for Tyla. Tyla, there's a couple of questions about the press and marketing plan for the expanded launch of Evie Ring? And then also, what are the biggest changes that we've made to the ring and app heading into this expanded launch? Tyla Bucher Sure. So I think as I noted on the call, we've obviously spent the last few months focusing on improvements across the board, including updating and fine-tuning the algorithms. I think the big focus has also been on our insights engine because really that is a key differentiator for us. And then I talked a little bit about our improved processes that we have on the operations side. But I think the other pieces are the auto activity detect that Bruce just mentioned as well as an Android version of the app. Both of these are key features that consumers have been asking for. And we really do want our community to know that we're listening and we're really excited to actually roll out these enhancements. So those, I think, are the big pieces on the experience side. And then as it relates to marketing, we have a full campaign ready to go that includes influencer and user-generated content across Instagram, Facebook, YouTube, all the other things I said, Google Search and Shop. We have a really engaged, leadless and a comprehensive outreach strategy. But above and beyond, we're just thrilled with the announcement of our partnership with influencer and digital creator, Heidi D'Amelio. Not only does she have a passion for fitness, but she has a highly and wonderfully engaged audience, and she really shared the vision of improving women's health with better data and insights. I think the idea that we'll be able to work closely with someone like Heidi who, again, has such an engaged audience to drive awareness around the Evie Ring as well as the importance of a wellness device for women is a big step forward for us. Jay Cogan Great. All right. Michael Soule, you might have answered some of this or most of this in the prior question from Bruce. But a question on the webcast relates to taking a deeper dive into the first Evie Med commercial opportunities that we've announced recently and how they position the company for growth with pharma and other health partners in the future. Michael Soule Yeah. Sure. Yeah. And I saw that as well online. I think in the last call, we talked a little bit about our data partners, right? And we ran the gamut across various channels with our beta partners. But since coming out of that data phase, other large strategic partners have come to us looking to work with us. And so they ran channels for medical device to pharma, to payers who are looking forward to our FDA clearance. And so we -- when that clearance comes, we expect to unlock a host of initiatives across clinical trials, remote patient monitoring. And we're also, as John had mentioned earlier, building the back-end systems required for these partnerships so we can hit the ground running. So in advance of that clearance, we've moved, as I said, into some agreement discussions with a number of folks, and we're very excited about the pace with which this is happening. Jay Cogan Perfect. Next question for Michael Leabman. What did you learn in your most recent blood pressure clinical study? Michael Leabman Yeah. Great. So I think as John mentioned, we concluded our study in June, and we've been analyzing the data using arterial line, which is really new to us giving us continuous data. And it's really allowed us to kind of fine tune our device, including new antennas that we've already completed designing as well as accommodating different risk sizes with a smaller form factor, which gets us closer and closer to commercializing it. I think all these changes will really allow us to begin testing with B2B customers when we're ready and the expected new design, we expect to arrive somewhere at the end of September, early October as we get ready for our next clinical arterial line study in November. And I think everything is kind of coming together nicely with this first study, and we really look forward to getting this hardware back and taking the next step. Jay Cogan Okay. Thanks, Michael. John and Tyla, there's a question about the company taking the path of being a medical device company and with blood pressure and glucose on horizon specific to of gender, is Movano planning to expand its marketing to target beyond women? John Mastrototaro Yeah. From the Med Device perspective, I'll take that aspect. Certainly, as you're aware and alluded to for direct-to-consumer, we have had a female focus and Tyla can expand upon that in a moment. But for these opportunities that we have in the health care space, there are some which are products that are specific for women. So this dovetails in very nicely, but many of the opportunities that we've been looking at are for anyone. And just because we've targeted women with some aspects of the app experience and design and whatnot. It doesn't mean that it's not of tremendous value for anyone. And so all of our partners, no one said, well, this won't suit all of our customers or subscribers to a plan or whatever it may be. They're looking at using it universally. And you're right, whether it's work related to continuous glucose monitoring in the future or the blood pressure and what we have today with heart rate, Sp02 and other future analytes, they're important to measuring everybody. And we're all suffering from chronic conditions and in the U.S., it's a major problem. We've got half of people over age 20 in the U.S. have high blood pressure are pre-hypertensive, and diabetes is about a third of the people. And so having products like this that can be worn and used at home in a very user-friendly way, that feel good and look good on the finger, something that doesn't interfere with your lifestyle and is able to collect just a wealth of important data and can bring to light changes in your health are needed. And I think it's going to change the way health care is delivered in the future to bring more of this into the home with folks. And I think we're all more aware of our health than ever before after what's happened through the course of COVID and whatnot. So it's -- we're finding it to just be a massive opportunity, quite frankly, and are speaking to all the who's whom in the health care space about products like this that can be leveraged seamlessly and help support the health and wellness of people. Tyla, do you have anything to add specifically about the D2C and the female focus there that you want to comment on? Tyla Bucher Sure. I mean I think you captured it really well. I think the only comment that I would make is to sort of echo your notes about we didn't design the Evie Ring to the exclusion of the male gender, but rather to really be present for an opportunity that we see among women who prioritize their health prior to the health of their family, control the pulse strings, make decisions for the family and really coming up with a solution for them to make sure that they're taking good care of themselves and that they're prioritizing their wellness. You can wear the Evie Ring now if you are whatever gender you are. And I think what we tried to do is really take into consideration how women would like to receive the data, how they want to see it displayed in their app, a comfortable fit and make sure that we're delivering insights that make them feel like this is a worthwhile endeavor and that they understand what to do with that data. So I think as we move forward, nothing is necessarily off the table, but certainly, the priority was to make something available to women where we see a tremendous, tremendous opportunity. But again, having said that, anyone came wear the ring. And it will still work, and it will still track your health and well-being. Jay Cogan Thanks, Tyla, thanks John. I'll take the last question. It looks like you've made some good progress on reducing your quarterly burn rates, how we see the trend in our expanded launch of Evie Ring and eventually Evie Med? We appreciate the feedback. We continue to be focused as an organization on the highest and best use of our capital and the margin profile of the D2C and B2B businesses that we're rolling out. We believe the product manufacturing and customer service improvements that we've implemented over the past few months should definitely help position us for growth and cash flow. In addition, the turnkey agreement, which -- we've mentioned a couple of times over the last few calls, and which we've now executed with our contract manufacturing partner, that should very much improve our company's cash flow profile, better lining up sales and the actual cost of goods. Operator, I'm just saying in closing, if investors like to stay up to date on Movano Health please continue to check into ir.movano.com. We look forward to staying in touch to see you next quarter, and thank you for your support. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Earnings call: LogicMark reports steady growth with new products By Investing.com

In the second quarter earnings call of LogicMark, a company specializing in personal emergency response systems (PERS), Chief Executive Officer Chia-Lin Simmons highlighted the company's transformation into a broader personal safety solutions provider. The company reported a slight increase in revenue to $2.3 million, with a higher average selling price offsetting a decrease in unit sales. LogicMark has expanded its product offerings, including the innovative Freedom Alert Mini and the Aster safety app, while also focusing on building a strategic intellectual property portfolio with 14 patents filed since mid-2021. Chief Financial Officer Mark Archer detailed financial results, including a net loss of $2.1 million, a decrease from the previous year, and a secondary offering that raised approximately $4.5 million. Key Takeaways Company Outlook Bearish Highlights Bullish Highlights Misses Q&A Highlights In conclusion, LogicMark (ticker not provided) is navigating a period of transformation with a focus on innovation and market expansion. The company's strategic efforts in product development and intellectual property are poised to address the growing personal safety and elder care markets. With new products and a robust IP portfolio, LogicMark is positioning itself for future growth despite current financial losses. InvestingPro Insights As LogicMark navigates its transformation into a broader personal safety solutions provider, its financial metrics and market performance provide a deeper understanding of the company's positioning. Based on recent InvestingPro data, LogicMark holds a market capitalization of $0.65 million, which reflects its size and market value within the industry. Despite the company's innovation efforts, it has experienced significant price declines, with a one-month total return of -70.83% and a one-year total return of -92.76%, indicating substantial market skepticism about its future prospects. InvestingPro Tips highlight a few critical aspects of LogicMark's current situation. The company holds more cash than debt on its balance sheet, which suggests a level of financial stability and the ability to weather short-term financial challenges. However, analysts do not anticipate the company will be profitable this year, underscoring the importance of LogicMark's strategic initiatives to drive revenue and achieve profitability. In the context of valuation, LogicMark is trading at a low Price / Book multiple of 0.06 as of the last twelve months leading up to Q1 2024, which could indicate that the stock is undervalued relative to its assets. This could be of interest to investors seeking potential value opportunities. For readers interested in a more comprehensive analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/LGMK, which could further inform investment decisions regarding LogicMark. Full transcript - LogicMark Inc (LGMK) Q2 2024: Operator: Good afternoon, and thank you for participating in today's Second Quarter 2024 Conference Call. Joining me from LogicMark today are Chia-Lin Simmons, Chief Executive Officer; and Mark Archer, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address LogicMark's expectations for future performance or operational results and anticipated product launches. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information of these risks, please refer to the risk factors described in LogicMark's most recent filed annual report on Form 10-K and subsequent periodic reports filed with the SEC and LogicMark's press release that accompanies this call, particularly the cautionary statements in it. The content of this call contains time-sensitive information that is accurate only as of today August 13, 2024. Except as required by law, LogicMark disclaims any option to publicly update or revise any information to reflect events or circumstances that could occur after this call. It is now my pleasure to turn the call over to Chia-Lin Simmons. Chia-Lin Simmons: Thank you, Olivier. I'd like to start by congratulating the team for the progress that we've made thus far in transforming ourselves to a personal safety company, a solutions provider that meets the needs of a much broader audience of people at various stages and with various needs in their lives. When I first joined as CEO, we were hardware company generating one-time revenue from sale of our personal emergency response systems to the government's Veterans Administration. What we had and still do have a long-standing relationship, meeting the needs of our valued veterans, I knew there was a greater potential. So as the team came together, we laid out our vision for Care Village, a connected care ecosystem that is both reactive and predictive. For those of you familiar with the technology space, you know that it takes time to upgrade a technology stack. When I arrived, the company's focus was very narrow, and innovation has stagnated with nothing new introduced since 2015. Today, we are very different. We had our heads down since mid-2021, focusing on paving the right path to expand our footprint in a much larger personal safety and elder care market. As a result, we have modernized existing products and developed new solutions. We now offer five PERS solutions that include features such as advanced fall detection, geofencing for memory care, connect the cloud and caretaker app support. This also includes the use of big data, sensors, artificial intelligence and machine learning. We've also introduced -- apologies, we've also introduced a personal safety solution with the Aster safety app, which comes with a Bluetooth button. With our new technology stack, there are now opportunities to expand and add on features that could be tied to a partner's technology or services, and it also allows us to accommodate white labeling and other opportunities for partnerships. We've also been building a strategic intellectual property fence around our Care Village. Since I arrived at the company in mid-2021, we filed 14 patents. Our newest patent filed this week relates to risk and safety metrics calculation and assessment using sensors and algorithms, which integrate with our PERS and personal safety products and services. Other patents cover areas such as artificial intelligence, game theory, digital twins, environmental sensing, personalized behavior monitoring and more. So, we built a robust IP portfolio, which is remarkable for a team of our size and in such a short period of time, and this asset will serve as another catalyst to grow sales through potential licensing agreements. In the months ahead, we'll be focusing on expanding sales and marketing efforts across all our customer channels, including government, B2C and B2B. I'm proud of the fact that we have been both -- we have both at home and on-the-go solutions at varying price points. And with both reactive and predictive solutions, we now have opportunities for both one-time and recurring revenue solutions with higher margins. I encourage everyone to visit our logicmark.com website and take the product quiz to see which solutions fits your needs. One of our latest products is the Freedom Alert Mini. It's sleek, convenient and less than 2 ounces and packed with innovative features, so it's the perfect on-the-go safety device. It uses patented fall detection, GPS location services, water resistance and free caregiver companion app. The device also supports geofencing, allowing caretakers to establish a predefined area for their loved ones' safety. This is especially crucial for those with Alzheimer's or early -- or other forms of dementia who may tend to wander. The Freedom Alert Mini is a monitored device that is iOS or Android compatible and runs on any 4G LTE cellular network and is supported by a 24/7 US-based care team. Another one of our products is this Aster safety app, which is a real game changer for personal safety. This turns your smartphone into a personal safety device with 24/7 monitoring where you can select which friends and family members can follow your jogging route or track your attendance at an event for additional safety support. Whether you're a college student on-campus, a loan worker, a real estate agent hosting an open house by yourself, an adventurous senior exploring nature or a caregiver in a sandwich generation, Aster's innovative features offer unparalleled peace of mind. These are great examples of the work that we have done to expand our product offerings in personal safety and elder care. At this point, I'll hand over the call to Mark to summarize our financial results, including the recent capital raise that we completed. Mark Archer: Yeah. Thank you, Chia-Lin. Revenue for the second quarter ended June 30, 2024 was $2.3 million, up slightly compared with the same period last year. A higher average selling price more than offset softness in unit sales. The gross margin was a more normalized 67% for the three months ended June 30, 2024, down from the 69% for the three months ended in June of 2023. Gross profit in the second quarter of this year was relatively unchanged at $1.6 million compared with $1.6 million in the same period last year. Total operating expenses for the second quarter were $3.6 million versus $3.9 million last year, a decrease of 6%. Reduced operating expenses were driven by lower spending in product development and technical engineering, partially offset by higher spending in sales, marketing and advertising as the company pivots from developing new products to putting those products in the hands of our customers. General and administrative costs also fell due to lower recruiting, professional and legal fees. The net loss attributable to common shareholders for the second quarter was $2.1 million compared with a net loss of $2.3 million in the same period last year. On a fully diluted basis, the net loss per share was $0.96 compared with a net loss of $1.83 per share in the prior period. As of June 30, 2024, our cash balance was $3.0 million. As Chia-Lin referenced, on August 5, we closed on a registered secondary offering priced at the market. Gross proceeds before deducting placement agent fees and estimated offering expenses were approximately $4.5 million. We intend to use the net proceeds from the offering for working capital and general corporate purposes. We also plan on holding a special meeting of stockholders on October 1, which, among other things, will seek approval for: first, a reverse split of the company's shares of common and Series C preferred stock, allowing us to regain compliance with NASDAQ's minimum bid price requirement; as well as, two, approval for the issuance of 20% or more of our shares of common stock in connection with the just completed secondary offering. Shareholders of record as of August 5, 2024, will be entitled to vote. With that, I'd like to open the call up to any questions. Operator: Thank you. [Operator Instructions] We have a question coming from the line of M. Marin with Zacks. Your line is open. Marla Marin, your line is open. Marla Marin: Yes. Thank you very much. Sorry. So, I think that you've said in the past that the DTC channel is viewed as an important new channel going forward. Can you give us any color on how you see that channel gaining traction? And what your plans are to try to promote sales through DTC? Chia-Lin Simmons: Yes. Thank you for the question, Marla. Hope you're well. So, yes, DTC, I think, is a very important channel for us. And when we talk about D2C, we're really talking about not just sales from our website or even app store downloads and sales for our Aster product, but we're also talking about the work that we're doing on Amazon. And for anybody who has ever worked with Amazon, they are a behemoth, and they are not an easy organization to work with often as a corporate entity. And so, we continue to make strides there, reducing our cost, participating in the Amazon programs for shipping to ensure that we actually get products into the hands of the customers as quickly as possible. And we have now launched our Mini product as well as regarding the 911 product, which is one of our key heritage sort of products on that particular platform as well. So, we will continue to basically promote and look for ways to increase those opportunities. We also are very focused on working with a number of different sort of D2C ad opportunities, always constantly looking at, of course, increasing the lifetime value, LTV, of the customer and basically doing acquisition as well as possible. We are a team of start-up people with corporate background, but in our hearts, we're sort of startup people, and so our interest has always been to basically deal with acquisition to be nimble, because that's the size of our company, and to basically acquire customer with as much low cost as we can in a very competitive market. I think we have to note here that our competitors, Medical Guardian, which is a privately held company, and some of these folks have been in the market D2C for more than 10 years, right? And so, D2C is extremely very, very new for us. And so, we continue to make very good strides along those lines. Marla Marin: Okay. Thank you. And then, one last question, which is about Aster, now you've had not a very long timeline, but some time on your belt. Aster represents a new target market, I believe, a new demographic. So, in terms of addressing that demographic going forward, are you thinking that there will be other opportunities to provide services and/or new products for that particular demographic or for the demographics, I should say, that fall outside of your traditional core demographic? Chia-Lin Simmons: Yes. It's -- to be candid, the Aster launch is an exciting one for us. I mean, we have been and continue to love the silver tsunami that comes along with our PERS marketplace, right? There's nothing -- it's nothing to see that when one-fourth is -- when your customers make up one-fourth of the US demographic and that's nothing compared to a global sort of like look in terms of how many people are turning 65 and over, and of that 65, one in four falling. So, we continue to be very bullish on the aging silver tsunami market. But the Aster market really opens us up to a completely new TAM for the company. It really also allows us to do a lot of things that I think are very different in terms of the type of partnerships that we can participate in. The reality is that 66% of Americans are afraid to do outdoor activities. I mean, I'm saddened. I have friends who actually had tickets to go see Taylor Swift in Austria of all places and it was canceled. And so, I think that for a lot of people, personal safety is really top of mind for a lot of them from big events like that to going to a festival. People don't feel safe anymore. And so, the Aster product actually opens up -- us up to a marketplace of people -- I mean, 66% of Americans not feeling good about doing outdoor activities like concerts, events, going jogging, that's really rather shocking. And so, we think that, that marketplace represents a very solid opportunity for us to grow our pie. But also that -- this is a market and the Aster product allows us to also partner in a B2B2C side. And so, you will see us actually talking about partnerships in this category a heck of a lot more in terms of who we could work with to make these products available to sort of business partnerships and distribution partnerships. So, it's a very exciting spot to be in. Marla Marin: Okay. Thank you very much. Operator: Thank you. And I'm showing no further questions in the queue at this time. I will now turn the call back over to Chia-Lin for any closing remarks. Chia-Lin Simmons: Thank you, Olivia. In summary, I'd like to say that I'm more encouraged than ever about our future prospects. Studies show that the elderly population is living longer and prefer to age in place, and personal safety concerns are all-time high. We've made great strides in transforming LogicMark into a supplier of innovative, reactive as well as predictive solutions to improve personal safety and quality of life. This is the right time for us to continue investing in the personal safety and elder care markets. We appreciate the support that all of our stock -- stakeholders have provided thus far, and we look forward to keeping you updated on our developments. Thank you. Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.