Good morning, and welcome to PAVmed's Third Quarter 2025 Business Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Thursday, November 13, 2025. I would now like to turn the call over to Mr. Matt Riley, PAVmed Senior Director of Investor Relations. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release, and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in this disclaimer and our filings with the SEC. For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors in PAVmed's Most Recent Annual Report Forms 10-Ks filed with the SEC, and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K. Except as required by law, PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statement. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed.

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. I would like to thank our long-term shareholders for your ongoing support and commitment. Before we delve into our recent operational highlights, as I have in the last couple of calls, I want to just remind you that over the past eighteen months, we've been taking some really critical steps to stabilize PAVmed's corporate structure and balance sheet. We did a restructuring of debt in the early part of this year, and we've been working on that. But there's still work to be done on that front. We have a couple of additional steps we think we're going to be able to consummate in the very near future, whereby following that, we think PAVmed will be fixed and we'll be back to the original proposition where PAVmed will be really well positioned to operate per our vision as a diversified commercial life sciences company. With multiple independently financed subsidiaries operating under a shared services model, it'll give us the opportunity to start building that portfolio beyond our two major commercial subsidiaries right now. So, let me just talk about that briefly. I'll provide a brief overview of PAVmed's portfolio. PAVmed is a vehicle to deliver innovative medical technologies, and we continue to operate under a shared services model. And as our subsidiaries succeed, particularly Lucid, PAVmed should also succeed. So let me just start with Lucid. Lucid's our main asset. It's a publicly traded diagnostic company, and it's on the cusp of a transformative milestone, particularly Medicare coverage. It continues to succeed at raising its own capital, including this past quarter. It has sufficient runway to accelerate its commercialization once Medicare coverage is secured. I'll talk more about Veris in much more detail later. But Veris is our digital health company that offers a cancer care platform to enhance personalized care for cancer patients who are initiating and undergoing systemic treatment with chemotherapy and immunotherapy. We made a big move earlier this year where we were able to secure financing that has allowed us to bring our project plans forward to develop the key implantable device, and an FDA submission is planned for next year. As we talked about on previous calls, we have started to make some effort to bring other technology within our portfolio, as well as others that we have access to. We are in the process of organizing around that and seeking to raise capital around that. And these final steps of our restructuring that I mentioned earlier, we think will put us in a very strong position to be able to continue to build these subsidiaries, to finance them, and to pursue very promising assets across the life science sector that we're actively pursuing. One of those technologies which we mentioned in a press release earlier this year was an exciting technology that involves a licensing agreement, a partnership with Duke University and the University of North Carolina. It's an Endoscopic Imaging Technology for esophageal pre-cancer that can provide real-time detection of dysplasia, or advanced pre-cancer, with the potential to completely transform the way that's treated and to do so at the same time as a diagnostic procedure. We're partnering with Dr. Adam Wax at Duke, who pioneered this technology, and Dr. Nick Shaheen from UNC, who's working with him closely. This fits within our partnership model, the same one that we launched Lucid and Veris. We are in the final stages of finalizing the license agreement and looking for building a team around this technology and a pathway towards the early stages of product development, finalizing regulatory strategy, and really just getting this project, which we're really excited about, off the ground. Let's get into the operational side of things. I do encourage you to, as always, to listen to yesterday's Lucid Business Update Call for greater detail on some of these areas. But the main takeaway for Lucid is that we are now better positioned than ever to capitalize on EsoGuard's large market opportunity, a large clinical opportunity. Their near-term milestones, which we believe will ultimately positively impact PAVmed as PAVmed remains the largest shareholder of Lucid. EsoGuard revenue was $1.2 million for the quarter, and tests were just over 2,800. Both of those are in line with last quarter. Our volume has been consistent with the target range of 2,500 to 3,000 tests that we've articulated that we are seeking to maintain to facilitate our engagement with commercial payers while we await Medicare coverage. The big highlight, as we talked about on our Lucid call, was that Medicare contractor meeting that was held in September. It was wildly successful. The experts unanimously endorsed Medicare coverage for EsoGuard. This is really the final step towards what we believe is near-term Medicare coverage for that test. We also raised capital and strengthened the balance sheet for Lucid, an underwritten public offering of just under $27 million in proceeds. And so, as I mentioned earlier, the extensive runway through 2026 was a very strong investor interest and confidence, including institutional investors and insiders, and bodes well for Lucid's ability to execute on its strategic plan. So let's move on to Veris. The most important development this past quarter was that we launched the commercial phase of our strategic partnership with OSU. If you may recall, we've got a long-standing working relationship with OSU where we completed a pilot study. The study was very successful. The technology was found to be valuable to their patients, meeting all objective measures and predefined performance criteria. We are in the commercial phase. We are finalizing EHR integration, but we've already started to proceed with building the commercial side of things with the initial three departments within OSU's James Cancer Center, now launching this in a broader patient population beyond the pilot. The agreement targets 1,000 patients in the first year that will be enrolled in the registry. We've also, after completing our financing, fully relaunched the development work on the implantable physiologic monitor and are working towards the 2026 FDA submission. We've locked down or restarted or locked down new vendors for that product development, and it's actually going quite well. Veris is sufficiently capitalized to fund that development all the way through FDA clearance and subsequent commercial launch. That's going really extremely well, and we're looking forward to wrapping that up in 2026. Beyond that, now that Veris is stabilized, it's well-capitalized, the implantable is on its way, and we've received really solid proof of concept with our commercial partnership with OSU, we are working on executing an expanded strategy for Veris. We're not going to wait for the implantable to do so. So, we have an opportunity now that we have the template from OSU to expand our commercial offering to include other academic medical centers. As part of that, we are incorporating the lessons that we've learned from our engagement with OSU as we launch engagement with other centers to provide value-added services to these centers, an offering that goes beyond simply remote patient monitoring. The economics and business model around that. So, one of the things we have learned over the past year is that clinical support services are really important. Ohio State has a call center, and we've learned how to interface with them so that the alerts that come from the platform are processed in an efficient way. But many centers don't have that, and any type of digital health tool can actually be somewhat overwhelming to the personnel regarding alerts and so forth. So, we've hired our first full-time physician assistant, and we're looking to build a clinical support team around that to provide such clinical support services as a value-added service to our commercial partners, whereby our team will provide varying levels, a menu of varying levels of clinical support to triage alerts that come through the system. This would make the process of incorporating our platform much more efficient and consistent with the personnel needs that these centers have. That's a really important additional value-added offering we plan to provide. Another one is, we seek to transform Veris beyond just remote patient monitoring to actually become a modern-day AI-based company where we can provide AI-based clinical decision tools that help these physicians manage their patients better, manage them more cost-effectively, and improve outcomes, thereby improving the economics of healthcare delivery. We have had an intense internal process where we mapped out what we intend to do. We are looking to build the stratification tools that will provide AI-based input to the practitioners, and we intend to partner with OSU to build and train such a decision tool that will be ultimately fully integrated within the platform and again provide value to the center beyond the simple billing around remote patient monitoring. So with that, I'll hand the call over to Dennis for an update on our financials.

Thanks, Lishan, and good morning, everyone. Our summary financial results for the third quarter were reported in our press release that has been distributed. On the next three slides, I'll emphasize a few key highlights from the third quarter. But I encourage you to consider those remarks in the context of full disclosures covered in our quarterly report on Form 10-Q as filed with the SEC. As a couple of reminders, as our financials, particularly the income statement with year-over-year comparisons, will illustrate periods before September 10, 2024, with Lucid's operating results being consolidated into the PAVmed results. Versus the presentation of the 2025 periods they are without Lucid's operating results being consolidated into PAVmed's financials. We present some supplementary information in footnote four of the 10-Q that will help with some of those comparisons. With regard to the balance sheet, you'll recall from our investor update call since this time last year that the company was engaged in a multi-step process to regain compliance with Nasdaq listing standard for minimum equity, which it did in February, and also position the company for longer-term financial stability. The two key components were deconsolidating Lucid from PAVmed consolidated finance statements and restructuring our debt whereby we exchanged about 80% of our outstanding debt for a new series C preferred equity. The slide reflects the balance sheets where the third quarter and second quarter of this year, both after deconsolidation which again occurred in 2024. So a couple of key things to point out in each of these balance sheets. First, the cash burn rate of $900,000 for the third quarter reflects the various operating costs, including approximately $500,000 outside contractor development costs associated with the implantable device, which had been funded by the two Veris-related financings, namely $2.4 million in the first quarter and $2.5 million in the second quarter to support the development and FDA submission of Veris's implantable device. Secondly, the equity method investment balance of $32 million as of September 30 reflects the 31.3 million Lucid shares mark to market and reflects a $4.4 million sequential reduction consistent with the change in Lucid stock price. This amount was previously eliminated from PAVmed's balance sheet prior to the deconsolidation for most of the quarterly periods in 2024. Note, there's plenty of information in the 10-Q and 10-K on both the debt exchange series C preferred stock, and the equity method treatment of PAVmed's investment in Lucid shares. At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with ownership of approximately 23% of the common shares outstanding. Although PAVmed no longer has voting control, Lucid, PAVmed, its board, and its management still have significant influence over Lucid with a 28% voting interest. Shares outstanding today, including unvested restricted stock awards, are approximately 29.7 million shares. The GAAP quarter ending outstanding shares of 23.1 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested RSA amounts. Additionally, we issued 25,000 series C preferred shares as part of the debt restructure at the beginning of the year. To date, approximately 4,300 series C have been converted to approximately 11 million common shares. If the balance were converted at the contractual $7 conversion price, an additional 20.5 million common shares would be issued. Next slide, please. Similar to the past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year quarterly and annual comparisons. As cautioned earlier in my comments, there are some significant differences in how the information is compiled between comparative periods given the changes in PAVmed's financial control have boosted. Importantly, the GAAP construct for deconsolidating Lucid on September 10 of last year somewhat blurs the historical understanding of the information for PAVmed as a standalone entity, and GAAP does not allow for the presentation for prior periods on the face of the financial statements to be similarly adjusted. Although as mentioned, there is some supplemental information in the footnotes. On a pro forma basis and purely for illustrative purposes, the slide only includes Veris revenue and the Lucid management fee income combined collectively more than $3 million a quarter to visually align PAVmed's income sources versus its operating expenses. For SEC reporting purposes, the MSA income is a below-the-line item. Furthermore, for the third quarter, you see on the slide and in the 10-Q a GAAP net loss of $6 million before NCI and before preferred dividends. This includes a noncash loss of $4.4 million for the change in fair value of the equity investment. Together with the preferred dividend stock-based comp reconciles to a non-GAAP loss of $446,000. Basically, the equivalent to the incremental contractor development cost for the Veris implantable device. Happy to answer any detailed questions on the slide in the Q&A, but think it's more informative to look at the third quarter standalone information presented in this slide and in the full third quarter information presented in our press release that shows the company baseline bias of operating at cash flow breakeven and incurring incremental PAVmed expenses for development activities that are offset by dedicated funding. In the third quarter, you see a non-GAAP loss of $446,000, which has been funded in part by the NIH grant proceeds of $1.1 million since the end of last year and $4.9 million of PAVmed Veris financing earlier this year. Non-GAAP operating expenses for the last four quarters have averaged approximately $4.4 million with very small variation from quarter to quarter. Next slide, please. With regard to non-GAAP operating expenses, on the slide, you see a graphic illustration of our operating expense over time as presented in more detail in our press release. The non-GAAP OpEx since the Lucid deconsolidation last year has been nearly flat for the last four quarters. OpEx increases moving forward are likely to be tied directly to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA for which the recent Veris-related financings are supported. With that, operator, let's open it up for questions.

Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the following process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any key. At this time, there are no questions. I will now turn the call over to Dr. Lishan Aklog. Please go ahead.

Great. Thank you, operator, and thank you all for joining today. Let me just restate something that I stated earlier that PAVmed was founded to be an engine of innovation that's capable of ingesting groundbreaking technologies and advancing them. Although Lucid is really in a great position and Veris is progressing well, our ability to consummate this broader vision has been constrained by capital markets and structural challenges. It's taken a series of steps which Dennis has outlined over a period of time to address these. We really feel like we are now poised to complete that work, we can reignite the broader vision and continue to pursue the next Lucid, the next Veris. We really have some excellent prospects, some of which we've talked about, the Duke technology and others waiting in the wings for us to finally transition back to the original vision of PAVmed. We look forward to that, and we look forward to continually addressing those opportunities and finalizing this restructuring that has put us in a position to expand those horizons. So with that, oh, actually, it looks like we have somebody back in the Q&A. Should we bring him in? Yeah. Let's go back to the operator. I believe we have one question around the Q&A that we'd like to address.

We do have one question. It does come from Anthony Vendetti from Maxim Group. Please go ahead.

Great. Thank you. Hi, Anthony. Good morning.

Hi, Dennis. Lishan, I was wondering if you could just talk about where you exactly are with the implantable monitor. Are there any other clinical steps necessary other than completing the OSU trials and so forth? Or...

Yeah. Yeah. Let me just jump in if that's okay, Anthony. So the development of the implantable, remember, the implantable is an implantable device that allows the physician to implant an intracardiac cardiac implantable monitor in conjunction with a port at the time of the beginning of therapy. Although we have part of our strategic partnership with OSU involves them being the first site and them doing the initial pilot work once the implantable is cleared. The development work actually is unrelated to our relationship with OSU. With the financing that we secured earlier this year, we have relaunched the development that had been on pause when we were awaiting access to capital to do so. That relaunch included us transitioning to a new development and manufacturing partner who has extensive experience with making such implantable devices such as stimulators and others. We have transitioned and launched that product development work with this new partner, going extremely well. There's a variety of just bread and butter engineering work that's required to get us to a final position to submit to FDA. You had mentioned, you had asked about the clinical trials. One of the things that we have been doing was we've had an ongoing engagement with FDA over many meetings to establish first our preclinical requirements of animal studies that have been ongoing and will continue to be ongoing as part of this work. That was already previously locked down. The final step, which I think we talked about in our last call, was to get a final sign-off from FDA on any clinical work we would need to do. Since the predicate, this is a 510(k). Since the predicate here is an existing implantable cardiac monitor, the clinical requirements were actually quite modest. We did eventually work with the FDA to establish that the only clinical data we'd need is what we refer to as a skin study. Instead of having to implant the device to perform this study, we can actually just stick it on the skin and measure its ability to detect primarily the cardiac rhythm. Show that it's equivalent to the predicate. It's a pretty straightforward simple small study that'll be required. That's not the rate-limiting factor. Frankly, the rate-limiting factor between us and submission is all of the development work, the traditional biocompatibility, packaging, things like that, that typically use up the clock.

Okay. Great. So this should, it sounds like with the predicate, it should be, I'm not saying anything with the FDA's routine, but should be relatively routine versus if you were using a version device.

Yeah. Yeah. I mean, it would, I think it's fair to say that the path is very clear. The requirements are clear. It's just we just need to execute on it. I think there's very little uncertainty as to what's required. There's really good guidance from FDA on what they expect for these kinds of devices. We have a very carefully tuned regulatory strategy that's designed to leverage this predicate carefully. There are always opportunities in the future to seek additional indications, expanded language, and things like that. We're pretty happy, frankly, with the path that we have ahead of us. We expect it to be straightforward.

And I know the focus is on that and OSU, but is it too early to start having commercialization conversations with other cancer centers, or are you going to wait a little bit longer until, even though, like you said, it should be relatively straightforward with the FDA? Are you going to start having those conversations?

That was what I was trying to... Yeah. That was, sorry. I interrupted, Anthony. That was what I was hinting at earlier. The answer is yes. Earlier this year, as we were finally able to secure some capital to develop this, our strategy had been one of just focusing on the OSU partnership, you know, getting a bunch of commercial experience there and waiting until the implantable to broaden our commercial activity. We've shifted that strategy. That is no longer the case. We believe, given how well things have gone with OSU, that we are in a position starting in the first quarter after we've had some volume at OSU to begin looking to expand to other centers. The key factor there, it's not like we haven't had ongoing conversations and solicited other centers. We just didn't do it very aggressively because we knew we had limited capital for commercial expansion over the last couple of years. One of the things we learned will be key in that is to not just offer the software platform, ultimately not just the implantable, which is economically attractive for them, but to offer additional value-added services and have an expanded vision for the offering from Veris. One of those things includes offering clinical support services. As I mentioned earlier, we want to streamline and make more efficient the process of using our platform. Hospitals, cancer centers, including cancer centers, are overwhelmed. The clinicians are generally understaffed. Although there’s clear clinical value in the continuous data sent to them to monitor their patients, they are often strapped for personnel time to interpret these alerts and so forth. It became clear, while we were soliciting other accounts, that our ability to centralize and offer clinical support services to triage alerts would provide an essential value. If there's an alert on our system that says, you know, the patient's temperature is rising, or they're reporting symptoms consistent with a complication of chemotherapy, we want to provide a service where our clinician checks in with the patient and sorts it out before passing the baton to the clinical team. There’s significant interest in that. We are going to start building that. We have our first PA who will be working closely with OSU on that. We think there's a really significant revenue opportunity around that as well. Another thing that we will not wait on is our AI-based tools that can provide value-added services both from a clinical and economic standpoint for our clients. We do expect to work closely with OSU on these products because they require clinical data to train models and so forth. We intend to build a risk stratification tool that predicts which patients on a particular chemotherapy or immunotherapy are at risk of rehospitalization or complications. That's extremely valuable, but will require training with data that we expect to partner with and secure.

Okay. Great. Great. Great. No. That's great clarity. I appreciate that. And then lastly, is the letter of intent for the endoscopic imaging technology. And I know LOIs sometimes, you know, don't result in a definitive agreement. But do you have some exclusivity with this LOI? And what's the timing you believe that it could lead to a definitive agreement? And then would you first take that in, it sounds like because it's, you know, in the PAVmed press release, would that first go into the PAVmed portfolio and then would there be a plan to eventually shift that to Lucid Diagnostics?

Great. Lot to unpack there. So just let me know if I missed anything. The first answer to your question is that this LOI will translate into a licensing agreement. It's forthcoming very, very soon. We're finalizing that language right now. We expect to sign the definitive license agreement for this technology very shortly. This will be within a separate subsidiary of PAVmed to advance the technology through some additional development work and then ultimately through an FDA submission and clearance. That work will begin immediately upon us signing the license agreement. There is development work to be done at the laboratory where this technology is being developed at Duke. To make some adjustments to sizing. Just a little background, this technology has actually been used in humans. One of our long-time colleagues and partners, Dr. Nick Shaheen, is a PI in our studies and is the head of Lucid AB. He is a clinical gastroenterologist who has been working with Duke on this. They've used this in humans and demonstrated its efficacy in detecting dysplasia during diagnostic endoscopy. There will be additional design work needed to adjust its form factor and how it integrates with the endoscope. Once that's completed, we will then transition it to a commercial product development pathway and ultimately submit for clearance. We have finalized our regulatory strategy around how to pursue this. We are convinced this will also be a 510(k). It will likely require a small clinical study but nothing too large or resource-intensive. So that's the plan. We're excited, we're going to get this thing done, just dotting i's and crossing t's on the documents.

Understood. Perfect. You sorry. You had mentioned the relationship with Lucid. Sorry. I forgot.

Yeah. So, you know, obviously, Lucid is in the space. These are patients that EsoGuard will be identifying, right, who will be undergoing a confirmatory endoscopy based on a positive EsoGuard test that will require an endoscopy to determine whether they're a true positive and, if they're true positive, where they are along the spectrum for further follow-up, right? Clearly, the work of Lucid is linked to the application of this technology. We've decided, for the time being, to keep it separate. Lucid has plenty on its plate. It's super late positioned as a molecular diagnostic company. We have an agreement between Lucid and PAVmed for a modest equity position in the subsidiary. Lucid will have upside on that. When it nears commercialization, we'll decide what the right pathway for it is. If there are synergies that make sense at the time with Lucid, we'll pursue that. If it's a distraction to Lucid, we'll pursue it separately.

Okay. Great. Thanks for all that color. Appreciate it.

Great. Thanks, Anthony. With that said, let's wrap things up. Just would like to encourage you to remain connected to us and our progress. So follow our press releases and these quarterly update calls. Subscribe to our email alerts and just contact us by phone if necessary. Thank you very much, and everybody have a great day.

Ladies and gentlemen, this does conclude your conference call for today. We thank you very much for your participation and you may now disconnect. Have a great day.