PAVmed Inc. (PAVM) Q3 FY2025 Earnings Call Transcript & Summary

Good morning, and welcome to the PAVmed's Third Quarter 2025 Business Update Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 13, 2025. I would now like to turn the call over to Mr. Matt Riley, PAVmed's 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 Pratt, 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 the disclaimer and in 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 on Form 10-K 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 statements. 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. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. Before we delve into our recent operational highlights, as I've done in the last couple of calls, I want to just remind you that over the past now 18 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 that 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 and it will give us the opportunity to start building that portfolio beyond our 2 major main commercial subsidiaries right now. So let me just talk about that briefly and provide a brief overview of PAVmed's portfolio. So PAVmed is a vehicle to deliver innovative medical technologies, and we operate -- 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 is obviously our main asset. It's a publicly traded diagnostic company. And it's on the cusp of a transformative milestone, particularly Medicare coverage and continues to succeed at raising its own capital, including this past quarter, and 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 some big progress earlier in this year where we're able to secure financing that's allowed us to bring our project plan forward to develop the key implantable device and an FDA submission is planned for next year. As we have talked about on previous calls, we have started to make some effort to bring other technologies within our portfolio as well as others that we have access to. And we are in the process of organizing around that and seeking to raise capital around that. And the sort of 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 sciences sector that we're actively pursuing. One of those technologies, which we mentioned in the 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, and it's a breakthrough endoscopic imaging technology for esophageal precancer that can provide real-time detection of dysplasia or advanced precancer 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. Dr. Adam Wax at Duke, who pioneered this technology and Dr. Nick Shaheen from UNC, who is working with them closely. This fits within our partnership model, the same one that we launched Lucid and Veris. We have -- we're in the late 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 sort of getting this project that's what 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 and a large clinical opportunity and 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 test volume is just over 2,800. Both of those are in line with last quarter, and our volume is consistent -- 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 in our Lucid call, was the Medicare contractor meeting that was held in September. It was wildly successful. The experts unanimously endorsed Medicare coverage for EsoGuard, and this is really the final step towards what we believe is a near-term Medicare coverage for that test. We also raised capital, strengthened the balance sheet for Lucid with an underwritten public offering of just under $27 million in proceeds. And so as I mentioned earlier, it extends Lucid runway through 2026 with a very strong investor interest and confidence, including institutional investors and insiders and bodes well for Lucid's ability to execute on a strategic plan. So let's move on to Veris. So 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 had a long-standing working relationship with OSU, where we completed a pilot study. That study was very successful. It was found to be -- the technology was found to be valuable to their patients by all objective measures and predefined performance criteria, and so 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 3 departments within OSUs, James Cancer Center, now launching this in a broader patient population beyond the pilot. And the agreement targets 1,000 patients in the first year that will be enrolled in the registry. We've also, after completing our financing, have fully relaunched the development work on the implantable physiologic monitor to work towards the 2026 FDA submission. We've locked down the -- or restarted or locked down new vendors for that product development, and it's actually going quite well. And there is sufficiently capitalized to fund that development all the way through FDA clearance and subsequent commercial launch. So that's going really extremely well, and we're looking forward to getting that wrapped up in 2026. So beyond that, now that Veris is stabilized, it's well capitalized, the implantable is on its way. We've gotten our -- really a very solid proof of concept with regard to our commercial partnership with OSU. We do -- we are working on executing an expanded vision for Veris, and we're not necessarily going to wait for the implantable to do so. So we have an opportunity to now that we have the template from OSU to expand our commercial offering to include other academic medical centers. And as part of that, we're incorporating the lessons that we've learned from our engagement with OSU to -- as we launch engaging with other centers to provide value added to these centers, an offering that goes beyond simply remote patient monitoring and the economics and the business model around that. So one of the things that we've 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 -- don't have call centers and any type of digital health tool can actually be somewhat overwhelming to the personnel with regard to 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 be able to provide varying levels. We have a menu of varying levels of clinical support to triage alerts that come through the system and to make the process of incorporating our platform much more efficient and consistent with the personnel needs that these centers have. So that's a really important additional value-added offering that we're looking to provide. Another one is really we're seeking to transform Lucid beyond -- sorry, Veris beyond just remote patient monitoring to actually become a modern AI-based company where we can provide AI-based clinical decision tools that help the physicians just manage their patients better, manage them more cost effectively, improve outcomes, improve the economics of health care delivery and so forth. And we've had a very intense internal process where we have mapped out what we intend to do, and we are looking to build risk stratification tools that will provide such input -- AI-based input to the practitioners, and we're looking 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 3 slides, I'll emphasize a few key highlights from the third quarter but I encourage you to consider those remarks in the context of the 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, we'll for this last quarter, 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 the PAVmed financials. We do present some supplementary information in Footnote 4 of the 10-Q that will help with some of those comparisons. So 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 multistep 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 2 key components were deconsolidating Lucid from PAVmed's consolidated financial 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 for the third quarter and second quarter of this year, both after deconsolidation, which again occurred in the third quarter of 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 Veris operating costs, including approximately $500,000 of outside contractor development costs associated with the implantable device, which have been funded by the 2 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' implantable device. Secondly, the equity method investment balance of $32 million at 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 of 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 of Lucid PAVmed, its Board and its management still have significant influence over Lucid with approximately 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 $1.07 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 the comparative periods given the changes in PAVmed's financial control of Lucid 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 stand-alone entity and GAAP does not allow 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 on the slide only, the Veris revenue and the Lucid management fee income are combined collectively more than $3 million per 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 and together with the preferred dividend and 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 I think it's more informative to look at the third quarter stand-alone information presented in this slide and 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. So 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 4 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 expenses 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 4 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.

[Operator Instructions] At this time, there are no questions. I will now turn the call over to Mr. 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 Dennis highlighted. PAVmed was founded to be an engine of innovation that's capable of ingesting groundbreaking technologies and advancing them. And 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 challenges. And we really feel like we are now poised to complete that work so we can reignite the broader vision and continue to pursue the next Lucid, the next Veris. And 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. So we look forward to that, and we look forward to continuing to address those opportunities and finalize this restructuring that has put us in a position to expand those horizons. So with that -- actually, it looks like we have somebody back in the Q&A. Should we bring them -- let's -- so let me go back to the operator. I believe we have one question around the Q&A that we'd like to bring on.

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

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 the OSU trials and so forth?

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

Okay. Great. So it sounds like with the predicate it should be -- I'm not saying anything with the FDA is routine but it should be relatively routine versus if you were using.

Yes, yes. I think it's fair to say that the path is very clear. The requirements are clear. 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. So we have a very carefully tuned regulatory strategy that's designed to really leverage this predicate carefully. And there's always opportunities in the future to seek additional indications, expanded language and things like that. So we're pretty -- we're extremely happy, frankly, with the pathway that we have ahead of us and 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...

So that was what I was trying to -- yes, that was -- sorry, to interrupt, Anthony. That was what I was ending at earlier. So let me just kind of restate it a little bit more directly. So the answer to your question is yes. When earlier in this year, as we were able to finally secure some capital to develop this, our strategy had been one of just sort of sticking to the OSU partnership, getting a bunch of commercial experience there and waiting until implantable to broaden our commercial activity. We've shifted that strategy. So that's no longer -- we really do believe, given how well things have gone with OSU, that we are in a position likely starting in the first quarter after we've had some volume at OSU to start looking to expand at other centers. And the key factor there, it's not like we hadn't had ongoing conversations and solicited other centers. We just didn't do it very aggressively because we knew that we had limited capital to -- for commercial expansion over the last couple of years. But one of the things that we learned will be key in that is one of the things I mentioned, which is to offer not just the software platform ultimately not just the implantable, which is economically a very attractive thing for them, but to offer some additional value added, have a bit of an expanded vision for the offering from Veris. And one of those things includes offering clinical support services, as I mentioned earlier, to really streamline and make more efficient the process of using our platform. Hospitals, cancer centers, including cancer centers are pretty overwhelmed. The clinicians are pretty overwhelmed. They're understaffed. And although there's clear clinical value in the data and having this continuous data that is sent to them to monitor their patients, often they're strapped for personnel time to be able to interpret these alerts and so forth. And within -- while we were soliciting other accounts, it became clear that us being able to centralize that and offer clinical support services was essentially to be able to triage alerts. So if there's alert on our system that says the patient's temperature is rising or they're reporting certain symptoms that may be consistent with the complication of chemotherapy to have -- to be able to offer the account value-added service that they can kind of select from a menu to have a clinician -- our clinician be the frontline to check in with the patient and sort it out and then pass the baton on to the clinical team. Lots of interest in that. And so we're going to start building that. We have our first PA who's going to be working closely with OSU on that, and we think there's a real opportunity and a real revenue opportunity around that as well. And then the other thing which we're going to not wait for the implantable on, and we're going to start working on our AI-based tools that can provide value-added both from a clinical point of view and an economic point of view for the client. That we do expect to work closely with OSU on because those products, as I see you know, require clinical data to train models and so forth. So for us to build a risk stratification tool that can predict, which patients on which -- on a particular chemotherapy and immunotherapy are at risk for rehospitalization or for complications, that's extremely valuable, but that will require training with data that we would expect that we'd be able to partner with -- that we're planning on trying to partner with OSU on that. So all those activities are going to start gearing up in the first quarter even before we have the implantable already.

Okay. 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 LOI sometimes doesn't result in a definitive agreement. But do you have some exclusivity with this LOI? And what's the timing do you believe that it could lead to a definitive agreement? And then would you first take that in -- it sounds like because it's 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. A lot to unpack there. So just let me know if I miss anything. So the first answer to your question is that, no, this LOI will translate into a licensing agreement, and it's -- it will be forthcoming very, very soon. We're in the final stages of ironing out that language. So we expect to sign the definitive license agreement for this technology very, very, very shortly. That will -- and that will be within a subsidiary, a separate subsidiary of PAVmed to advance the technology through some additional development work and then ultimately to -- through an FDA submission and clearance. That work will begin immediately upon us signing the license agreement. There is development work to be done that will be done at the laboratory where this technology is being developed at Duke to try to make some adjustments to sizing. Just maybe a little bit of background. We haven't spent a lot of time on this. This is a technology that has actually been used in humans. One of our long-time colleagues and partners, Dr. Nick Shaheen, who's a PI in our studies and the Head of Lucid MAB, is the clinical gastroenterologists who's been working with on this. So they've used this in humans and have demonstrated its efficacy in being able to detect dysplasia at the time of a diagnostic endoscopy. There's additional design work to kind of from a form factor point of view and how it's sort of snaps together with the endoscope and so forth that will be supporting at Duke. And once that has been completed, we'll transition it into a commercial product development pathway and then ultimately submit. We do have a regulatory -- we've kind of finalized our regulatory strategy around how to pursue this. We are convinced this is also a 510(k). It will likely require a small clinical study but nothing too large or resource intensive. So that's the plan. So it's coming. We're going to get this thing done. It's just dotting i's and crossing t's on the document.

Understood. Perfect.

And sorry, you had mentioned the relationship with Lucid, Sorry, I forgot. So look, the -- obviously, Lucid is in this space, these are patients that EsoGuard will be finding, right, who will be undergoing a confirmatory endoscopy based on a positive EsoGuard test that will require endoscopy to determine whether they're a true positive and if they're a true positive, where they are along the spectrum for further follow-up, right? So 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 really kind of positioned as a molecular diagnostic company. Lucid, there is an agreement between Lucid and PAVmed for a modest equity position in the subsidiary. So Lucid will have upside on that. And then when it's near commercialization, we'll decide sort of what the right pathway for it. 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. Great. Thanks, Anthony. So with that said, let's wrap things up. Just would like to, again, encourage you to remain connected to us and our progress, follow our press releases and these quarterly update calls, subscribe to our e-mail alerts and just contact us by phone if necessary. So 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.