Q4 2025 PAVmed Inc Earnings Call

March 30, 2026

Speaker #2: If at any time during this call you require me to assist you, please press star zero for the operator. This call is being recorded on Monday, March 30th, 2026.

Speaker #2: I would now like to turn the conference over to Matt Riley, PAVmed's Vice President of Investor Relations. Please go ahead. Thank you, operator. Good morning, everyone.

Matt Riley: Thank you, operator. 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 CEO of PAVmed, along with Dennis McGrath, Chief Financial Officer. 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.

Speaker #2: Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and CEO of PAVmed, along with Dennis McGrath, Chief Financial Officer.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC. For a list and description of these and other important risks and uncertainties that may affect future operations, see Part One, 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 quarterly reports on Form 10-Q and subsequent Forms 8-K.

Matt Riley: For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part I, 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 quarterly reports on Form 10-Q and subsequent Form 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 Chief Executive Officer of PAVmed. Lishan.

Speaker #2: 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 events, conditions, or circumstances on which the expectations may be based.

Speaker #2: Or that may affect the likelihood that actual results would differ from those contained in the forward-looking statements. I would now turn the call over to Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed.

Speaker #2: Lishan: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before we get into our recent operational highlights, I'd like to kind of frame where PAVmed is today.

Lishan Aklog: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before we get into our recent operational highlights, I'd like to kind of frame where PAVmed is today. On our last quarterly call, I described how over the past now two years, we've undertaken a series of very deliberate and systematic actions to effectively permanently fix PAVmed's legacy capital structure and ultimately strengthen its balance sheet and improve our ability to execute on our strategic plan. I had mentioned that time we had one more step to go, and that step was completed in February with the completion of a restructuring, recapitalization, and financing.

Speaker #2: On our last quarterly call, I described how, over the past now two years, we've undertaken a series of very deliberate and systematic actions to effectively and permanently fix PAVmed's legacy capital structure and ultimately strengthen its balance sheet and improve our ability to execute on our strategic plan.

Speaker #2: I had mentioned that, at that time, we had one more step to go, and that step was completed in February with the completion of a restructuring, recapitalization, and financing.

Lishan Aklog: The toxic convertible securities that had held us down for a while were removed and, upon completion of this financing exercise, we'll have a very clean cap table. With PAVmed now fixed, we believe we're now very well-positioned, exceptionally well-positioned, to execute on our founding mission. What's that mission? It's to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries that are operating under a shared services model. With that work now complete, we're executing that model across our core businesses, which you can see here in three different buckets. The most prominent one, of course, is Lucid, which is our publicly traded diagnostic company. Lucid continues to succeed at raising its own capital. It's obviously our strongest and most advanced asset.

Speaker #2: The toxic convertible securities that had held us down for a while were removed, and we, upon completion of this financing exercise, will have a very clean cap table.

Speaker #2: So, with PAVmed now fixed, we believe we are now very well positioned—exceptionally well positioned—to execute on our founding mission. What's that mission?

Speaker #2: It's to operate as a high-growth, diversified commercial life sciences company, with multiple independently financed subsidiaries that are operating under a shared services model.

Speaker #2: With that work now complete, we're executing that model across our core businesses, which you can see here in three different buckets. The most prominent one, of course, is Lucid, which is our publicly traded diagnostic company.

Speaker #2: Lucid continues to succeed at raising its own capital. It's obviously our strongest and most advanced asset. As we discussed in the Lucid earnings call, and as we'll highlight later today, Lucid is on the cusp of transformative milestones, which include a very important recent VA win and impending Medicare coverage.

Lishan Aklog: As we discussed in our Lucid earnings call, we'll highlight later today. Lucid is on the cusp of transformative milestones, which include a very important recent VA win and a pending Medicare coverage. A reminder that PAVmed remains Lucid's largest shareholder, holding approximately 31 million shares of Lucid common stock. As such, it's positioned now under this new capital structure to benefit from Lucid's upcoming major value inflection points. Moving on to Veris. Veris is our majority-owned digital health company that's advancing a cancer care platform that's designed to enhance personalized cancer care, along with an implantable physiologic monitor. As we'll discuss in more detail again, we are continuing to see early commercial traction with our major strategic partner and are advancing the implantable towards FDA submission plan for later this year.

Speaker #2: A reminder that PAVmed remains Lucid's largest shareholder, holding approximately 31 million shares of Lucid common stock, and as such, it's positioned now under this new capital structure to benefit from Lucid's upcoming major value inflection points.

Speaker #2: Moving on to Veris. Veris is our majority-owned digital health company that's advancing a cancer care platform that's designed to enhance personalized cancer care, along with an implantable physiologic monitor.

Speaker #2: As we'll, again, discuss in more detail, we are continuing to see early commercial traction with our major strategic partner, and are advancing the implantable towards FDA submission planned for later this year.

Lishan Aklog: We're poised to accelerate execution of an expanded strategic plan, as we'll discuss in a bit. Having completed the steps to fix PAVmed with the new capital structure and resources available, a very important part of our future plan is to relaunch our med tech portfolio. For those of you who've been with us for a long time, we started in medical devices, and we've always intended to reengage in that sector.

Speaker #2: We're poised to accelerate execution of that expanded strategic plan, as we'll discuss in a bit. Having completed the steps to fix PAVmed with the new capital structure and resources available, a very important part of our future plan is to relaunch our MedTech portfolio.

Speaker #2: For those of you who've been with us for a long time, we started in medical devices, and we've always intended to re-engage in that sector.

Lishan Aklog: We've taken a couple of steps towards doing that, the most important of which is that we've engaged a new leader, chief business officer, that will have oversight over this portfolio, and that will involve bringing in the technology that we've licensed from Duke, an endoscopic imaging technology, reinvigorating PortIO and looking at an exciting pipeline of opportunities in the medical device space that we really do believe will enhance long-term shareholder value. Again, more on this in a bit. Let's start with Lucid's operational highlights from the Q4 and recent weeks. As always, I encourage you to listen to Lucid's business update call for greater detail on each of these areas, and I'll keep these comments high level.

Speaker #2: So we've taken a couple of steps towards doing that, the most important of which is that we've engaged a new leader, Chief Business Officer, that will have oversight over this portfolio. That will involve bringing in the technology that we've licensed from Duke—an endoscopic imaging technology—reinvigorating Port IO, and looking at an exciting pipeline of opportunities in the medical device space that we really do believe will enhance long-term shareholder value.

Speaker #2: Again, more on this in a bit. So let's start with Lucid's operational highlights from the fourth quarter and recent weeks. As always, I encourage you to listen to Lucid's business update call for greater detail in each of these areas, and I'll keep these comments high level.

Lishan Aklog: Lucid reported Q4 2025 EsoGuard revenue of approximately $1.5 million and EsoGuard test volume of 3,664 EsoGuard tests. The volume has increased by 29% from Q3, and revenue was increased by 24% over Q3. The volume exceeded our target range of approximately 2,500 to 3,000 tests per quarter, and we're entering 2026 with really solid momentum on that front. A very important highlight that we're incredibly excited about at Lucid is that Lucid was awarded a U.S. Department of Veterans Affairs contract for EsoGuard that expands our access across the nation's largest integrated healthcare system.

Speaker #2: Lucid reported fourth quarter 2025 EsoGuard revenue of approximately $1.5 million and EsoGuard test volume of 3,664 tests. The volume has increased by 29% from the third quarter, and revenue has increased by 24% over the third quarter.

Speaker #2: The volume exceeded our target range of approximately 2,500 to 3,000 tests per quarter, and we're entering 2026 with really solid momentum on that front.

Speaker #2: A very important highlight that we're incredibly excited about at Lucid is that Lucid was awarded a U.S. Department of Veterans Affairs contract for EsoGuard that expands our access across what's the nation's largest integrated healthcare system.

Lishan Aklog: That gives Lucid the opportunity to engage with numerous medical centers across the country and target the 9 million enrolled veterans who have a particularly high elevated risk of gastroesophageal disease. Another exciting development that we discussed is the announcement of positive data for the largest real-world experience of esophageal precancer detection that evaluated EsoGuard and EsoCheck. As we discussed, in these 12,000 patients, we were able to show excellent performance across multiple metrics, technical success, the procedural times, safety, et cetera, and also the appropriateness of physician use. We contrasted that with other technologies that purport to be capable of operating in this space. Now let's discuss Veris.

Speaker #2: That gives Lucid the opportunity to engage with numerous medical centers across the country and target the 9 million enrolled veterans who have a particularly high elevated risk of GERD and esophageal disease.

Speaker #2: Another exciting development that we discussed is the announcement of positive data for the largest real-world experience of esophageal precancer detection that evaluated EsoGuard and EsoCheck. And as we discussed, in these 12,000 patients we were able to show excellent performance across multiple metrics, technically assessed.

Speaker #2: The procedural times, safety, etc., and also the appropriateness of physician use—and we contrasted that with other technologies that purport to be capable of operating in this space.

Speaker #2: So now let's discuss Veris. So Veris is now—well, the commercial phase of our engagement with Ohio State University is well underway, and it had just initiated when we, during our last call.

Lishan Aklog: Veris is now well, the commercial phase of our engagement with The Ohio State University is well underway, and it just initiated during our last call. An important, very important step of that in recent weeks, we completed the full Epic integration with OSU. The feedback in this early phase has been extremely positive, starting from the senior leadership all the way down to the clinician leaders and the clinicians in the individual departments within OSU. The integration with Epic is really a critical part of this. This is a bidirectional flow of information, so Veris data is available to the clinicians within Epic.

Speaker #2: An important, very important step of that: in recent weeks, we completed the full Epic integration with OSU. The feedback in this early phase has been extremely positive, starting from the senior leadership all the way down to the clinician leaders and the clinicians in the individual departments within OSU.

Speaker #2: The integration with Epic has really been a critical part of this. This is a bi-directional flow of information, so Veris data is available to the clinicians within Epic but, as importantly—and perhaps more importantly—the clinician and the patients can access their record within the workflow that we offer within our platform.

Lishan Aklog: As importantly, and perhaps more importantly, the clinician and the patients can access their record within the workflow that we offer within our platform. That's been really helpful in improving engagement with the clinical team. We expect to really leverage that and show increasing growth and increasing adoption across an increasing number of departments within the OSU Cancer Center. In addition, as we discussed at the last earnings call, we're making really solid progress with the implantable physiologic monitor and expect to have a submission in the latter part of this year to the FDA under the 510(k) designation.

Speaker #2: And so that's been really helpful in improving engagement with the clinical team, and we expect to really leverage that and show increasing growth and increasing adoption across an increasing number of departments within the OSU Cancer Center.

Speaker #2: In addition, as we discussed at the last earnings call, we're making really solid progress with the implantable physiologic monitor and expect to have a launch date and file for submission in the latter part of this year to the FDA under the 510(k) designation.

Lishan Aklog: Right around the time of our last call, we had engaged with a new vendor that was capable of not just the design and development of all aspects of the electronics and the structure of the device itself, of the implantable device, but is also the entity that will be the early manufacturer of this device. That work is going extremely well. It's under budget, and it's focused on completing all of the design work to capture the physiologic signal, and put us in a position to enter design freeze, a completion of the development process, and a submission to FDA for clearance and subsequent commercial launch.

Speaker #2: Right around the time of our last call, we had engaged with a new vendor that was capable of not just the design and development of all aspects of the electronics and the structure of the device itself—the implantable device—but is also the entity that will be the early manufacturer of this device.

Speaker #2: That work is going extremely well. It's under budget, and it's focused on completing all of the design work to capture the physiologic signal.

Speaker #2: We are and put us in a position to enter design freeze, completion of the development process, and submission to FDA for clearance and subsequent commercial launch.

Lishan Aklog: Veris is sufficiently capitalized to fund that development as Veris raised capital last year to do so. In addition, to highlight again the topic we've discussed before, as we're gearing up on the commercial phase with our strategic engagement with OSU and as we're making solid progress on the development of the implantable device we're developing and looking forward to executing on an expanded strategic vision for Veris. Really fundamentally, this is a transformation of Veris from a pure play remote patient monitoring company to one that's more broadly focused on AI and AI-based tools, clinical decision tools. We have a project that we're launching on developing risk stratification tools for cancer patients to identify those at risk of developing complications and readmissions.

Speaker #2: Veris is sufficiently capitalized to fund that development, as Veris raised capital last year to do so. In addition, to highlight again a topic we've discussed before, as we're gearing up to on the commercial phase with our strategic engagement with OSU and as we're making solid progress on the development of the implantable device we're developing and looking forward to executing on an expanded strategic vision for Veris.

Speaker #2: Really, fundamentally, this is a transformation of Veris from a pure-play remote patient monitoring company to one that's more broadly focused on AI and AI-based clinical decision tools.

Speaker #2: We have a project that we're launching on developing risk stratification tools for cancer patients to identify those at risk of developing complications and readmissions. In addition, we're expanding the offering to include clinical support services, so that our own clinical team will be able to provide the ability to offer triage services for alerts as they come into the system.

Lishan Aklog: In addition, we're expanding the offering to include clinical support services so that our own clinical team will be able to provide the ability to offer triage services for alerts as they come into the system. We've learned that that's an important part of adoption as physicians, sorry, the clinicians are already somewhat overwhelmed with data. That activity as well as the learnings and our experience with OSU will put us in a position later this year to begin leveraging that commercial success to additional systems, initially additional large cancer centers in the form of OSU. We're also looking to explore engagements with PE-backed networks of smaller oncology practices. That work is ongoing.

Speaker #2: We've learned that that's an important part of adoption, as physicians and, sorry, the clinicians are already somewhat overwhelmed with data. That activity, as well as the learnings and our experience with OSU, will put us in a position later this year to begin leveraging that commercial success to additional systems.

Speaker #2: Initially, additional large cancer centers in the form of OSU, but we're also looking to explore engagements with PE-backed networks of smaller oncology practices.

Lishan Aklog: We're really excited both on the development of the implantable, on expanding our activities with OSU and putting us in a position to execute on this expanded strategic vision as we enter H2. Now let's talk about some details of our relaunching of our med tech portfolio. As I mentioned, we feel like a key aspect of this, a key element of this has been hiring the right leader for this. We're excited, and we'll announce this in more detail in the coming days, that Joe Virgilio is joining us as Senior Vice President and Chief Business Officer for medical devices for PAVmed. He will lead as Chief Executive Officer the medical device subsidiaries under PAVmed.

Speaker #2: So that work is ongoing, and again we're really excited both on the development of the implantable, on expanding our activities with OSU, and putting us in a position to execute on this expanded strategic vision as we enter the latter half of the year.

Speaker #2: Now, let's talk about some details of our relaunching of our MedTech portfolio. As I mentioned, we feel like a key aspect of this—a key element of this—has been hiring the right leader for this, and so we're excited and we'll announce this in more detail in the coming days.

Speaker #2: That Joe Virgilio is joining us as Senior Vice President and Chief Business Officer for Medical Devices for PAVmed, and he will lead as Chief Executive Officer the medical device subsidiaries under PAVmed.

Lishan Aklog: That will start with two companies, PortIO, which we've talked about before. We made some effort to raise capital there, but we clearly realized that in order to do so, in order to reboot PortIO and reengage on the IDE study that will lead to FDA submission clearance and commercial launch, that we need dedicated leadership for that. With Joe, we now have that. We previously announced that we had engaged with Duke University to license exciting technology in the endoscopic space, in the GI endoscopy space that allows the operator to diagnose late-stage precancerous stages without the need for biopsy. That license agreement has now been fully executed, and it now resides within a new subsidiary called Arcteris, and we'll be providing additional details on that.

Speaker #2: That will start with two companies: Port IO, which we've talked about before. We've made some effort to raise capital there, but we clearly realize that in order to do so—in order to reboot Port IO and re-engage on the IDE study that will lead to FDA submission, clearance, and commercial launch—we need dedicated leadership for that. And with Joe, we now have that.

Speaker #2: We had previously announced that we had engaged with Duke University to license exciting technology in the endoscopic space and the GI endoscopy space that allows the operator to diagnose late-stage precancerous stages without the need for biopsy.

Speaker #2: That license agreement has now been fully executed, and it's now resided within a new subsidiary called Octarus. We'll be providing additional details on that, and Joe Virgilio will be running that project as well, which is now proceeding along a sponsored research agreement with the laboratory at Duke that's been developing this technology.

Lishan Aklog: Joe Virgilio will be running that project as well, which is now proceeding along a sponsored research agreement with the laboratory at Duke that's been developing this technology. Our vision here goes beyond these two entities. We have an active and expanding pipeline. I do have to say, upon completion of the restructuring that we immediately started getting inbound inquiries from bankers from other companies that have sought to partner with us on various medical technologies. We are actively evaluating those and looking for ones that fit nicely within our pipeline. Those will enter our pipeline and our portfolio under Joe Virgilio's leadership. With that, I'll hand the call over to Dennis for an update on the financials.

Speaker #2: And our vision here goes beyond these two entities. So we have an active and expanding pipeline. I do have to say upon completion of the restructuring that we immediately started getting inbound inquiries from bankers, from other companies that have sought to partner with us on various medical technologies. And we are actively evaluating those and looking for ones that fit nicely within our pipeline, and those will enter our pipeline or our portfolio under Joe Virgilio’s leadership.

Speaker #2: With that, I'll hand the call over to Dennis for an update on the financials. Thanks, Lishan, and good morning, everyone. Our summary financial results for the fourth quarter and the year were reported in our press release that has been distributed.

Dennis McGrath: Thanks, Lishan, and good morning, everyone. Our summary financial results for Q4 and the year were reported in our press release that has been distributed. On the next 4 slides, I'll emphasize a few key highlights from Q4 and the year. I encourage you to consider those remarks in the context of the full disclosures covered in our annual report on Form 10-K as filed with the SEC. A couple of reminders as our financials, particularly the income statement with year-over-year comparisons, will for this last annual report illustrate periods before 10 September 2024, with Lucid's operating results being consolidated into the presented PAVmed results. First, the 2025 periods without Lucid's operating results being consolidated into the PAVmed financials. We do present some supplementary information in footnote 4 of the 10-K that will provide some help in the comparisons.

Speaker #2: On the next four slides, I'll emphasize a few key highlights from the fourth quarter and the year. But I encourage you to consider those remarks in the context of the full disclosures covered in our annual report on Form 10-K as filed with the SEC.

Speaker #2: A couple of reminders, as our financials—particularly the income statement with year-over-year comparisons—will, for this last annual report, illustrate periods before September 10, 2024, with Lucid's operating results being consolidated into the presented PAVmed results. First, the 2025 periods without Lucid's operating results being consolidated into the PAVmed financials.

Speaker #2: We do present some supplementary information and a footnote for the 10-K that will provide some help in the comparisons. So, with regard to the balance sheet, you'll recall from our investor update call since this time last year that the company is engaged in a multi-step process to regain compliance with the NASDAQ listing standard for minimum equity, which it did in February of last year.

Dennis McGrath: With regard to the balance sheet, you'll recall from our investor update call since this time last year that the company is engaged in a multi-step process to regain compliance with the NASDAQ listing standard for minimum equity, which it did in February of last year, and again this year in January for compliance with the minimum bid price standard. Our focus throughout was to position the company for longer-term financial stability. This was a multi-step process that Lishan highlighted that spanned nearly 18 months with 3 key recapitalization steps landing PAVmed on firm financial footing with its recent financing that closed on 3 February.

Speaker #2: And again this year in January, for compliance with the minimum bid price standard. Our focus throughout was to position the company for longer-term financial stability.

Speaker #2: This was a multi-step process that Lishan highlighted that spanned nearly 18 months, with three key recapitalization steps landing PAVmed on firm financial footing with its recent financing that closed on February 3rd.

Dennis McGrath: The steps included deconsolidating Lucid from PAVmed's consolidated financial statements in September 2024, and an interim phase of restructuring our convertible debt in January 2025, whereby we exchanged about 80% of our outstanding convertible debt for a new Series C preferred equity. Lastly, just recently in February, redeeming the convertible debt and the Series C with an infusion of equity capital plus some long-term debt. This slide reflects the balance sheets for year-end 2025 and 2024, both after deconsolidation, which occurred on 10 September 2024. A couple key things to point out on each of these balance sheets.

Speaker #2: The steps included deconsolidating Lucid from PAVmed's consolidated financial statements in September 2024, and an interim phase of restructuring our convertible debt in January 2025, whereby we exchanged about 80% of our outstanding convertible debt for a new Series C preferred equity.

Speaker #2: And lastly, just recently in February, redeeming the convertible debt and the Series C with an infusion of equity capital, plus some long-term debt.

Speaker #2: This slide reflects the balance sheets for year-end 2025 and 2024, both after deconsolidation, which occurred on September 10, 2024. So, a couple key things to point out on each of these balance sheets.

Dennis McGrath: Cash burn rate of $1.5 million for Q4 reflects the Veris operating costs, including approximately $600,000 of outside contractor development costs associated with the implantable device, which has been funded by the two Veris-related financings, namely $2.3 million in Q1 2025 and $2.5 million in Q2 2025 to support the development toward the FDA submission of Veris's implantable device. Additionally, there was approximately $200,000 in Delaware franchise taxes and $300,000 of annual compensation expenses that were paid. The equity method investment balance of $34 million at the end of last year reflects the $31.3 million Lucid shares mark-to-market and shows an $8.5 million year-over-year increase consistent with the 33% increase in Lucid stock during 2025.

Speaker #2: Cash burn rate of $1.5 million for the fourth quarter reflects the various operating costs, including approximately $600,000 of outside contractor development costs associated with the implantable device, which has been funded by the two various related financings, namely $2.3 million in the first quarter of '25 and $2.5 million in the second quarter of '25, to support the development toward the FDA submission of various implantable device.

Speaker #2: Additionally, there was approximately $200,000 in Delaware franchise taxes and $300,000 of annual compensation expenses that were paid. The equity method investment balance of $34 million at the end of last year reflects the $31.3 million Lucid shares marked to market and shows an $8.5 million year-over-year increase, consistent with the 33% increase in Lucid stock during 2025.

Dennis McGrath: At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with ownership of approximately 18% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed, together with its board and management, still have significant influence over Lucid with approximately 25% voting interest. Shares outstanding today, including unvested RSAs, are approximately 6.4 million shares, including approximately 4.6 million shares issued upon the conversion of the Series D upon the approval from the shareholders this past Friday. The GAAP year-ending outstanding shares of 900,000 are reflected on the slide as well as on the face of the balance sheet in the 10-K. GAAP shares do not reflect unvested RSA amounts. Approximately 433 shares were issued, reflecting conversions of the Series C preferred prior to the redemption on 3 February. Next slide, please.

Speaker #2: At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with ownership of approximately 18% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed, together with its board and management, still have significant influence over Lucid, with approximately 25% voting interest.

Speaker #2: Shares outstanding to date, including unvested RSAs, are approximately 6.4 million shares, including approximately 4.6 million shares issued upon the conversion of the Series D, upon the approval from the shareholders that passed Friday.

Speaker #2: The gap year ending outstanding shares of 900,000 are reflected on the slide as well as on the face of the balance sheet in the 10-K.

Speaker #2: Gap shares do not reflect unvested RSA amounts. Approximately 433 shares were issued reflecting conversions of the Series C preferred prior to the redemption on February 3rd.

Speaker #2: Next slide, please. We thought it might be helpful to walk you through how the recent financing changes the financial strength of the company. So, we put this non-GAAP pro forma balance sheet together to illustrate the changes.

Dennis McGrath: We thought it might be helpful to walk you through how the recent financing changes the financial strength of the company. We put this non-GAAP pro forma balance sheet together to illustrate the changes. What you see in the first column is a condensed balance sheet derived directly from the published Form 10-K without change. Next, we highlight the two securities and their balances that were redeemed and replaced with $30 million of equity in the form of short-term preferred security that has been converted into common concurrent with the shareholder approval. Additionally, $15 million of long-term, 15% interest-only, 3-year debt was put in place to complete the redemption of the convertible securities. Accompanying the Series D preferred security is a $30 million warrant with an exercise price of $6.50 per common share.

Speaker #2: What you see in the first column is a condensed balance sheet derived directly from the published 10-K without change. Next, we highlight the two securities and their balances that were redeemed and replaced with $30 million of equity in the form of a short-term preferred security that has been converted into common, concurrent with the shareholder approval.

Speaker #2: Additionally, $15 million of long-term, 15% interest-only three-year debt was put in place to complete the redemption of the convertible securities. Accompanying the Series D preferred security is a $30 million warrant with an exercise price of $6.50 per common share.

Dennis McGrath: The warrants are callable 30 days after the CMS publication of the draft EsoGuard coverage policy. Additionally, Veris has about 2.5 million of warrants that are exercisable after the implantable device is FDA cleared. We added a Veris column to show the recent pre-money value of $35 million, reflecting the valuation at the time of the direct financing into the subsidiary. Comparatively, the GAAP financials in the 10-K reflect $38 million of assets, which are completely offset by the sum total of the convertible debt and the Series C preferred. After the financing in February, the far right column now illustrates a company with total assets over $100 million and $15 million of long-term debt. There were six key investment themes that were attractive to the investors in this transaction, including valuation disconnect, which presented an opportunity.

Speaker #2: The warrants are callable 30 days after the CMS publication of the draft EsoGuard coverage policy. Additionally, Varian has about $2.5 million of warrants that are exercisable after the implantable device is FDA cleared.

Speaker #2: We added a 'Various' column to show the recent pre-money value of $35 million, reflecting the valuation at the time of the direct financing into the subsidiary.

Speaker #2: Comparatively, the GAAP financials in the 10-K reflect $38 million of assets, which are completely offset by the sum total of the convertible debt and the Series C preferred.

Speaker #2: After the financing in February, the far right column now illustrates a company with total assets over $100 million and $15 million of long-term debt.

Speaker #2: There were six key investment themes that were attractive to the investors in this transaction, including valuation disconnect, which presented an opportunity. PAVmed's market cap did not reflect the sum of the parts of the underlying assets.

Dennis McGrath: PAVmed's market cap did not reflect the sum of the parts of the underlying assets. Second, there was an overhang from legacy securities driving mispricing. The structure of these legacy securities no longer aligned with the company's future development plans. The investors also saw that with recapitalization, they believed that it would unlock value. A clean cap table would align market cap and enterprise value combined with a limited supply of stock in the market. Fourth, inexpensive leverage to Lucid Diagnostics. This was a pure arbitrage opportunity in advance of a Medicare announcement. Fifth, additional optionality across high potential healthcare assets was a driving interest. Veris, Arcteris, PortIO, and others. Lastly, a balanced capital structure to maximize strategic flexibility.

Speaker #2: Second, there was an overhang from legacy securities driving this pricing. The structure of these legacy securities no longer aligned with the company's future development plans.

Speaker #2: The investors also saw that with recapitalization, they believed that it would unlock value. A clean cap table would align market cap and enterprise value, combined with a limited supply of stock in the market.

Speaker #2: Fourth, inexpensive leveraged Lucid Diagnostics. This was a pure arbitrage opportunity in advance of a Medicare announcement. Fifth, additional optionality across high-potential healthcare assets was a driving interest.

Speaker #2: Various various Porto and others. And lastly a balanced capital structure to maximize strategic flexibility. The right mix of equity $60 million in this case for the exercise of the warrants and debt $15 million was a key premise in financially engineering for future success while extending the cash runway of the company to be opportunistic while also developing and commercializing the non-Lucid asset portfolio.

Dennis McGrath: The right mix of equity, $60 million in this case for the exercise of the warrants and debt, $15 million, was a key premise in financially engineering for future success while extending the cash runway of the company to be opportunistic while also developing and commercializing the non-Lucid asset portfolio. Next slide on the P&L. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year over year and quarterly and annual comparisons. As cautioned earlier in my comments, there are some significant differences in how the information is compared between the comparative periods given the changes in PAVmed's financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on 10 September 2024, which somehow somewhat blurs the historical understanding of the information for PAVmed as a standalone entity.

Speaker #2: Next slide on the P&L. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year, and quarterly and annual comparisons.

Speaker #2: As cautioned earlier in my comments, there are some significant differences in how the information is compared between the comparative periods, given the changes in PAVmed's financial control of Lucid.

Speaker #2: Importantly, the GAAP construct for deconsolidating Lucid on September 10, 2024, which somehow somewhat blurs the historical understanding of the information for PAVmed as a standalone entity.

Dennis McGrath: GAAP does not allow the presentation for prior periods on the face of financial statements to be similarly adjusted. Although as mentioned, there are some supplemental information in the footnotes of the financials in the 10-K. On a pro forma basis and purely for illustrative purposes on this slide only, the Veris revenue and the Lucid management fee are combined collectively more than $3 million per quarter. It visually aligns PAVmed's income sources versus its operating expenses. For SEC reporting purposes, the MSA income is below the line item. Furthermore, for Q4, you see on the slide a GAAP net loss of $2.8 million before NCI, non-controlling interest and preferred dividends. This includes non-cash charges of about $1 million, which then reconciles to a non-GAAP loss of $942,000.

Speaker #2: GAAP does not allow the presentation for prior periods on the face of financial statements to be similarly adjusted. Although, as mentioned, there is some supplemental information in the footnotes of the financials in the 10-K.

Speaker #2: So, on a pro forma basis, and purely for illustrative purposes on this slide only, the various revenue and the Lucid management fee are combined.

Speaker #2: Collectively, more than $3 million per quarter, it visually aligns PAVmed's income sources versus its operating expenses. For SEC reporting purposes, the MSA income is below the line item.

Speaker #2: Furthermore, for the fourth quarter, you see on the slide a GAAP net loss of $2.8 million before NCI—non-controlling interest—and preferred dividends. This includes non-cash charges of about $1 million, which then reconciles to a non-GAAP loss of $942,000.

Dennis McGrath: That loss is comprised of about $500,000 of Veris contractor R&D development costs for the implantable device and about $200,000 in annual Delaware franchise taxes that occurs once a year. Happy to answer any detailed questions on this slide in the Q&A, but I think it's more informative to look at the Q4 standalone information presented not only in the slide, but in the full Q4 information presented in our press release. That shows a company baseline basis of operating at near cash flow breakeven and incurring incremental PAVmed expenses for development activities that are offset by dedicated financing or funding. Next slide. With regard to the non-GAAP operating expenses. On this slide, you see a graphic illustration of our operating expenses over time as presented in more detail in our press release.

Speaker #2: That loss is comprised of about $500,000 of various contractor development costs for the implantable device and about $200,000 of annual Delaware franchise taxes that occur once a year.

Speaker #2: Happy to answer any detailed questions on the slide in the Q&A, but I think it's more informative to look at the fourth quarter standalone information presented not only in the slide but in the full fourth quarter information presented in our press release.

Speaker #2: That shows a company baseline bias of operating at near cash flow break-even and incurring incremental PAVmed expenses for development activities that are offset by dedicated financing.

Speaker #2: Or funding. Next slide. With regard to the non-GAAP operating expenses—on this slide, you see a graphic illustration of our operating expenses over time, as presented in more detail in our press release.

Dennis McGrath: Total non-GAAP OpEx since the Lucid deconsolidation in 2024 has been nearly flat for the four previous quarters. The Q4 OpEx were offset by approximately $1.2 million in a one-time reimbursement for Lucid for annual compensation expenses allocable to Lucid, with a balance reflecting the franchise taxes, and the Veris R&D costs just mentioned. OpEx increases moving forward are likely to simply be tied to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA, for which the 2025 Veris-related financings are supporting. With that operator, let's open it up for questions.

Speaker #2: Total non-GAAP OPEX since the Lucid deconsolidation in 2024 has been nearly flat for the four previous quarters. The fourth quarter OPEX was offset by approximately $1.2 million in a one-time reimbursement from Lucid for annual compensation expenses allocable to Lucid, with the balance reflecting the franchise taxes and the various R&D costs just mentioned.

Speaker #2: OPEX increases moving forward are likely to simply be tied to the R&D efforts to get the various implantable devices submitted and cleared by the FDA, for which the 2025 various related financings are supporting.

Speaker #2: With that, operator, let's open it up for questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touch-tone phone.

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press 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 polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Jeremy Pearlman with Maxim Group. Your line is now open.

Speaker #2: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two.

Speaker #2: If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Jeremy Perlman with Maxim Group.

Speaker #2: Your line is now open.

Jeremy Pearlman: Good morning, Dennis.

Dennis McGrath: Morning, Jeremy.

Speaker #3: Good morning, Dennis. Good morning, Lishan. Thank you for taking the question. So, first, I wanted to focus on the commercial relationship with OSU.

Jeremy Pearlman: Good morning, Lishan. Thank you for taking the question. Just first, I wanted to focus on the commercial relationship with OSU. You know, you said you're well underway. What are some of the key metrics you're trying to keep track of and learn before you feel comfortable rolling this out to other large institutions? Is there a timeframe for that? You know, maybe help us understand what you hope the current commercial relationship to become before you roll it out to other institutions. Thanks.

Speaker #3: You know, you said you're well underway. What are some of the key metrics you're trying to keep track of and learn before you feel comfortable rolling this out to other large institutions?

Speaker #3: Is there a time frame for that? You know, maybe help us understand what you hope the current commercial relationship will become before you roll it out to other institutions.

Dennis McGrath: Yeah, that's great. Thanks for the question. Happy to elaborate on that a bit. You know, in terms of the clinical value of the Veris platform, we established that during a pilot that occurred last year, and that's actually when last year, and that was what led to the commercial engagement. The commercial engagement has fairly high expectations, and it involves a target of 1,000, minimum of 1,000 patients within the first year. We are in a very structured plan on rolling out the platform across various departments, starting with the three departments that were under the pilot program and then expanding to new departments along the way. Our internal

Lishan Aklog: Yeah, that's great. Thanks for the question. Happy to elaborate on that a bit. You know, in terms of the clinical value of the Veris platform, we established that during a pilot that occurred last year, and that's actually when last year, and that was what led to the commercial engagement. The commercial engagement has fairly high expectations, and it involves a target of 1,000, minimum of 1,000 patients within the first year. We are in a very structured plan on rolling out the platform across various departments, starting with the three departments that were under the pilot program and then expanding to new departments along the way.

Speaker #3: Thanks.

Speaker #4: Yeah, that's great. Thanks. Thanks for the question. Happy to elaborate on that a bit. So, you know, in terms of the clinical value of the various platforms, we established that during a pilot that occurred—and that's actually what, last year? And that was what led to the commercial engagement.

Speaker #4: The commercial engagement has fairly high expectations and involves a target of a minimum of 1,000 patients within the first year. We are in a very structured plan on rolling out the platform across various departments, starting with the three departments that were under the pilot program and then expanding to new departments along the way.

Speaker #4: So our our internal engagement with with OSU as to how that's proceeding is is really relates to executing on that project plan bringing on the new departments and according to that plan and also the trajectory towards that goal of 1,000 patients during that first year.

Lishan Aklog: Our internal engagement with OSU as to how that's proceeding as it really relates to executing on that project plan, bringing on the new departments, and according to that plan and also the trajectory towards that goal of 1,000 patients during the first year. We call this a strategic partnership because beyond just simply utilizing the platform in a commercial setting, it's also we've also developed a registry, so those patients will be enrolled and data will be collected, and we'll be able to provide future target commercial targets data on you know on this adoption during the commercial phase beyond the pilot phase. So that's that.

Lishan Aklog: Engagement with OSU as to how that's proceeding as it really relates to executing on that project plan, bringing on the new departments, and according to that plan and also the trajectory towards that goal of 1,000 patients during the first year. We call this a strategic partnership because beyond just simply utilizing the platform in a commercial setting, it's also we've also developed a registry, so those patients will be enrolled and data will be collected, and we'll be able to provide future target commercial targets data on you know on this adoption during the commercial phase beyond the pilot phase. So that's that.

Speaker #4: We call this a strategic partnership because beyond just simply utilizing the platform in a commercial setting it's also we've also developed a registry so those patients will be enrolled and data will be collected and we'll be able to provide future target commercial targets data on you know on this adoption during the commercial phase beyond the pilot phase.

Lishan Aklog: We're not, you know, we haven't been reporting the hard, you know, sort of month-to-month numbers with regard to that, but I can, you know, tell you at a high level that we're on track and on schedule to do so. That the planning on that was in fact based on when we completed EHR integration. As should be clear to everybody, being integrated, you know, the EHR is really a central depot, you know, for the flow of information within, particularly within large medical centers.

Speaker #4: So, so that's that. We're not, you know, we haven't been reporting, sort of, hard, you know, sort of, month-to-month numbers with regard to that, but I can, you know, tell you at a high level that we're on track and on schedule to do so.

Speaker #4: That the the planning on that was in fact based on when we completed EHR integration. As should be clear to everybody being integrated you know the EHR is really a central depot you know for the flow of information within particularly within large medical centers and so now that we are on the platform there's a full visibility of the as our preferences for the clinicians to use our platform as their primary primary portal to the patient's care because it provides the real-time physiologic data that that comes through our our platform and it does so in a cancer-specific way beyond what they can get using Epic.

Lishan Aklog: Now that we are on the platform, there's full visibility of the Veris data on Epic, as well as our preferences for the clinicians to use our platform as their primary portal to the patient's care because it provides the real-time physiologic data that comes through our platform, and it does so in a cancer-specific way beyond what they can get using Epic. That's launched fairly recently, and we expect with that launch that we'll be able to now start accelerating the trajectory towards that target of 1,000. Again, their goal, that's the minimum, the goal and expectation is that we will exceed that.

Speaker #4: And so that's that launched fairly recently and we expect with that launch that they'll we'll be able to now start accelerating that the the trajectory towards that target of 1,000 and again their goal that's a minimum the goal and expectations that we will exceed that.

Lishan Aklog: I would just say to your second point about how that relates to expanding our commercial team, we have the information that we need. We have the data, initial data from the pilot program in terms of the clinical benefit that we would need to expand to other sites. What's holding us back on that is really we're focusing our limited capital resources at this point to getting the implantable across the finish line to FDA submission and clearance. That's what the capital that we raised last year was really targeting, and we will...

Speaker #4: I I would I would just to to your second point about how that relates to expanding our commercial team. We have the information that we that we need we have the data initial data from the pilot program in terms of the clinical benefit that we would need to expand other to other sites.

Speaker #4: What's holding us back on that is really we're focusing our limited capital resources at this point on getting the implantable across the finish line to FDA submission and clearance.

Speaker #4: And that's what we've the capital that we raised last year was really targeting that and we will although we have have some legacy engagements with some other about a dozen or so other academic academic cancer centers we're not deploying kind of the commercial resources and hiring the commercial resources that would be necessary to really do a broader a broader commercial launch and we would expect to do that in full force after the clearance of the of the implantable.

Lishan Aklog: Although we have some legacy engagements with about a dozen or so other academic cancer centers, we're not deploying kind of the commercial resources and hiring the commercial resources that would be necessary to really do a broader commercial launch. We would expect to do that in full force after the clearance of the implantable. Although we're not ruling out some limited expansion of that over the interval of time between now and then now that things are well off the ground. One aspect of that that we think will be important, and I've mentioned this in engagement with other centers, and will require some capital resources, although we believe we could charge for this service, is the clinical support side of things.

Speaker #4: Although I'm not—we're not—ruling out some limited expansion of that over the interval of time between now and then, now that things are well off the ground.

Speaker #4: One aspect of that that we think will be important—and I've mentioned this in engagement with other centers—and will require some capital resources, although we believe we can charge for this service, is the clinical support side of things.

Lishan Aklog: OSU has a very sophisticated call center mechanism, so they already have resources in place that can triage and screen alerts and information, so that the individual caring clinicians are not overwhelmed. Many other centers, including major other cancer centers, don't necessarily have that full-fledged system. One of the things that we've concluded and we've learned from our experience with OSU and in previous discussions with other cancer centers is to have that functionality available, so that we can offer our members of our own clinical team to provide some level to various levels, depending on what's desired by the center, various levels of triage.

Speaker #4: OSU has a very sophisticated call center mechanism, so they already have resources in place that can triage and screen alerts and information, so that individual care and clinicians are not overwhelmed.

Speaker #4: And many other centers including major other cancer centers don't necessarily have that that full-fledged system and so one of the things that we've concluded and we've learned from our experience with OSU and in previous discussions with other cancer centers is to have that functionality available so that we can offer our members of our own clinical team to provide sub-level to various levels depending on what what's desired by the center various levels of of triage.

Lishan Aklog: That's something we have. We do have a clinician already on our team that's helping us build that's learning from her engagements with interacting with OSU as to how to develop that. But that's something that would be a real predicate to a broader expansion, and that's something we intend to develop over time. A bit of a long-winded answer, but hopefully gives you some perspective on how we're viewing our future, you know, commercial expansion.

Speaker #4: And so that's something we have. We do have a clinician already on our team that's helping us build that, that's learning from her engagements with interacting with OSU as to how to develop that.

Speaker #4: But that's something that would be a a really a predicate to a broader expansion and that's something we intend to develop over time. So a bit of a long-winded answer but hopefully it gives you some perspective on what we're how we're viewing our future you know commercial expansion.

Jeremy Pearlman: Yeah. Yeah, thank you. That was really helpful. Great information. Maybe just one more question related to the you said you mentioned there's new, you know, risk stratification tools and other tools that you could integrate into the system, to the Veris platform. Are those, I don't know what whenever these tools, when they're ready, are they part of the contract with OSU to allow you to integrate them into already the patients that are using the device or do you have to amend or you're planning on finalizing those and then rolling those out maybe further down the line?

Speaker #4: Yeah. Yeah. Thank you. That that was really helpful. Great information. Then maybe just one more question related to the you said you mentioned there's new you know you risk risk stratification tools and other tools that you could integrate into the system.

Speaker #4: The various platforms—is that, or are those, I don't know, whatever they—whenever these tools, when they're ready, are they part of the contract with OSU to allow them, you, to integrate them into, already, the patients that are using the device, or do you have to amend, or you're planning on finalizing those and then rolling those out maybe further down the line?

Lishan Aklog: Oh, yeah. There's a-- I think there's two aspects to your question. One is kind of the development work, and that's not trivial, so I don't wanna give the impression that we have these tools, you know, ready to go and to implement and to integrate within our platform. Those AI-based tools require extensive data, and we are in discussions with OSU on how exactly to utilize the data that we're collecting as well as legacy data they have to inform the development of these technologies. Part of our strategic engagement with them contemplated a partnership on the development of these kinds of tools.

Speaker #4: Oh yeah. So there's a I think there's two aspects to your question. One is kind of the development work and that's not trivial so I don't want to give the impression that we have we have these tools to you know ready to go and to and to implement and to integrate within our platform.

Speaker #4: Those AI-based tools require extensive data, and we are in discussions with OSU on how exactly to utilize the data that we're collecting, as well as legacy data they have, to inform the development of these technologies.

Speaker #4: And part of our strategic engagement with them contemplated a partnership on the development of these kinds of tools. So, the way I would view this perspective is really a broader kind of strategic vision to evolve VARIOUS from its original vision of being, you know, primarily focused on remote patient monitoring—which is really just serving as a conduit for important physiologic and symptomatic data from the patient to the clinicians—to do so in a very timely way, to bring up and highlight potential risks that may arise.

Lishan Aklog: The way I would view this perspective is really a broader kind of strategic vision to evolve Veris from its original vision of being, you know, primarily focused on remote patient monitoring, which is really just serving as a conduit for important physiologic and symptomatic data from the patient to the clinicians to do so in a very timely way to bring up to highlight potential risks that may arise. We know from our experience to date that Veris works extraordinarily well at doing that. We believe that in this era, the value added from going beyond just being a conduit for information, but to provide truly sophisticated AI-based clinical decision support tools are really, you know, becoming standard practice when it comes to digital health offerings.

Speaker #4: And and and we know from our experience to date that that various works extraordinarily well at doing that. But we believe that in this era the the value added from going beyond just being a conduit for information but to provide truly sophisticated AI-based clinical decision support tools are really you know becoming standard practice when it comes to digital health offerings and and that's what we're we're seeking to do.

Lishan Aklog: That's what we're seeking to do. That requires time, and that does require resources and capital. We're in the early stages of that. I would view that as articulating sort of a near-term and medium-term vision, partnership with OSU on the development of that. Certainly, at the time we would launch that, whether it's in a preliminary phase, you know, on the research side, any patient that was already on the platform, we would integrate it within the platform, and they would have, you know, their care could be impacted by those additional support tools.

Speaker #4: That requires time, and that does require resources and capital. And so we're in the early stages of that. So I would view that as articulating sort of a near-term and medium-term vision partnership with OSU on the development of that.

Speaker #4: Certainly at the time we would launch that, whether it's in a preliminary phase, you know, kind of a research on the research side, any patient that was already on the platform would be—obviously, we would integrate it within the platform, and they would have their care—could be impacted by those additional support tools.

Jeremy Pearlman: Okay. Understood. Great. Just maybe last question, jumping to the new, you know, imaging technology that you licensed from Duke. I know you mentioned you're gonna provide some more information in shortly, but maybe you could just right now on the call, you know, what-

Speaker #4: Okay. Understood. Great. And then just maybe just last question jumping to the new you know imaging technology that you licensed from Duke. I know you mentioned you're going to provide some more information shortly but maybe you could just right now on the call you know what is there anything clinically that needs to be done with that technology and then what before you could roll it out and then maybe what's what type of commercial plans you might have for that?

Lishan Aklog: Yeah.

Jeremy Pearlman: Is there anything clinically that needs to be done with that technology? What before you could roll it out, and then maybe what type of commercial plans you might have for that? Thanks.

Lishan Aklog: Yeah. That's still in the early phases, so let's be clear about that. That's a technology as we described in the sort of the press release when we entered into the letter of intent. We will provide a full press release announcing the full license agreement that was executed and Joe Verghese's role in overseeing Arcteris, well, what falls under that. Just as a reminder, that's a little bit more detail on that technology. The technology is an optical technology that combines well-established technology called OSC with newer technology called a/LCI.

Speaker #4: Thanks. Yeah, that's still in the early phases, so let's be clear about that. That's technology as we described in the sort of press release when we entered into the letter of intent.

Speaker #4: We will provide a full press release announcing the full license agreement that was executed, and Joe Virgilio's role in overseeing Octaris falls under that.

Speaker #4: But just as a reminder, that's a little bit more detail on that technology. The technology is an optical technology that combines well-established technology called OSC with newer technology called ALCI.

Lishan Aklog: The combination of the two, implemented at the end of an endoscope, a tool that can be deployed through an endoscope, can, at the time of an endoscopy of the lower esophagus, image abnormal tissue that appears to have Barrett's esophagus, the precancerous condition, in order to discriminate between early and late precancer. Non-dysplastic Barrett's esophagus, which is the earliest precancer, to dysplastic Barrett's esophagus, which is the later precancer that requires intervention to prevent cancer. Obviously, those of you who follow along on Lucid understand how an important part of the paradigm of the management of esophageal precancer that distinction is, that when someone has this precancerous condition, it's critical to distinguishing early and late because late is where we intervene.

Speaker #4: And the combination of the two implemented at the end of Endoscope a tool that can be deployed through an endoscope can at the time of an endoscopy of the lower esophagus can image abnormal tissue tissue that has that appears to be to have Barrett's esophagus the precancerous condition in order to discriminate between early and late precancer.

Speaker #4: So, non-dysplastic Barrett's esophagus, which is the earliest precancer, to dysplastic Barrett's esophagus, which is the later precancer that requires intervention to prevent cancer.

Speaker #4: Obviously, those of you who follow along on Lucid understand how an important part of the paradigm of the management of esophageal precancer— that distinction— is that when someone has this precancerous condition, it's critical to distinguish early and late, because late is where we intervene.

Lishan Aklog: Right now, that distinction is made purely on a biopsy. The patient gets a biopsy, and then they come back. If the biopsy comes back for dysplasia for the late-stage precancer, they undergo a definitive ablation or eradication therapy to prevent cancer. The promise of this technology is that it's capable, with a very high sensitivity in their early clinical experience, as a part of a partnership between Duke and UNC, at detecting, using these optical techniques, dysplasia. It does that by measuring the diameter of the nuclei in a very clever and sophisticated way with incredibly excellent performance that frankly will likely outperform any molecular diagnostic test, based on initial data.

Speaker #4: Right now, that distinction is made purely on a biopsy. And so the patient gets a biopsy, and then they come back. If the biopsy comes back for dysplasia—for the late-stage precancer—they undergo a definitive ablation or eradication therapy to prevent cancer.

Speaker #4: The promise of this technology is that it's capable with a very very high sensitivity in their early clinical experience at as a part of a partnership between Duke and and UNC at detecting using these optical techniques dysplasia.

Speaker #4: It does that by measuring the diameter of the nuclei in a very clever and sophisticated way, with incredibly excellent performance that, frankly, will likely outperform any electrodiagnostic test.

Speaker #4: Based on initial data, the advantage of that is that if you can diagnose it on the spot on endoscopy, then in the future you can prove that you can bypass biopsies and do an ablation on the spot.

Lishan Aklog: The advantage of that is that if you can diagnose it on the spot on endoscopy, then you can in the future prove that you can bypass biopsies and do an ablation on the spot. That would be very transformational for how esophageal precancer is managed. You would look; you'd have visible evidence of precancer. You would use this technology, the Arcteris technology, to image and determine whether that patient had a high likelihood of that area being dysplastic and then right off the bat, right there, do the ablation procedure on the spot. That'd be transformational. This work is still in the early phases. You know, it was used in a clinical setting that documented, in real patients with real precancer, its efficacy.

Speaker #4: So that would be very transformational for how esophageal precancer is is managed. You would look you'd have visible evidence of of precancer you would use this technology the Octaris technology to image and determine whether that patient had a high likelihood of that area being dysplastic and then right off the right there do the ablation procedure on the spot.

Speaker #4: So that would be transformational. So this work is still in the early phases. You know it was in the it was used in a clinical setting that that documented in real patients with real precancer.

Lishan Aklog: That data is published now. There is work to be done to modify the technology to be more where the form factor, size and form factor can be more applicable to a broad commercial launch. That was the first step, and that's happening under a sponsored research agreement in the laboratory, Dr. Wax's laboratory, at Duke, where those revisions and that redesign of the probe is underway. Once that's done, the probe will be deployed in another round of patients in partnership with Dr. Shaheen at UNC. Once we have design freeze, we've demonstrated that, then we'll complete the product development process, secure what we believe is a 510(k), FDA pathway for clearance and then subsequent commercialization. That's a bit down the road.

Speaker #4: It's efficacy, that that data is published now. And so there is work to be done to modify the technology to be more where the form factor size and form factor can be more applicable to a broad commercial launch.

Speaker #4: So, that was the first step, and that's happening under the sponsored research agreement in the laboratory—Dr. Wax's laboratory at Duke—where those revisions and that redesign of the probe is underway. Once that's done,

Speaker #4: The probe will be deployed in another round of patients in partnership with Dr. Shaheen at UNC. And once we have design freeze and we've demonstrated that, then we'll complete the product development process, secure what we believe is a 510(k) FDA pathway for clearance, and then subsequent commercialization.

Lishan Aklog: Once we have design freeze, we've demonstrated that, then we'll complete the product development process, secure what we believe is a 510(k), FDA pathway for clearance and then subsequent commercialization. That's a bit down the road.

Speaker #4: So that's a bit down the road. Okay, great. Thank you so much for all the information. I'll hop back in the queue.

Jeremy Pearlman: Okay. Great. Thank you so much for all the information. I'll hop back in the queue. Have a nice day.

Speaker #4: Have a nice day. Yeah. Great. Thanks, Jeremy. Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Ed Wu with Ascenda Capital.

Lishan Aklog: Yeah. Great. Thanks, Johnny.

Operator: Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Ed Wu with Ascendiant Capital. Your line is now open.

Speaker #4: Your line is now open. Yeah. Congratulations on all the progress. I had a quick question. You mentioned that you guys are now ready to kind of engage in expanding your medical device portfolio with, you know, new technology.

Edward M. Woo: Yeah. Congratulations.

Lishan Aklog: Good morning.

Edward M. Woo: On all the progress. I had a quick question. You mentioned that you guys are now ready to kind of engage in expanding your medical device portfolio with you know new technology. Is there any particular areas or products that you might be interested in?

Speaker #4: Is there any particular areas or products that you might be interested in? Yeah. Thanks, Ed. Glad you gave me a chance to kind of maybe flesh out my previous comment about that.

Lishan Aklog: Yeah, thanks, Ed. Glad you gave me a chance to kind of maybe flesh out my previous comment about that. It was really quite remarkable, honestly, after we closed the last restructuring and financing, frankly, within days we were getting calls. I'll actually highlight something that wasn't clear in my prepared remarks. It's not just in the medical device side, it's actually across the board. We've gotten inquiries on really interesting diagnostic companies, electrodiagnostic companies, medical devices, as well as pharma assets, a good number. I believe it's just been a month since we completed that transaction.

Speaker #4: It's been—it was really quite remarkable, honestly. After we closed the last restructuring and financing, frankly, within days we were getting calls. And I'll actually highlight something that wasn't clear in my prepared remarks.

Speaker #4: It's not just on the medical device side. It's actually across the board. We've gotten inquiries on really interesting diagnostic companies—electrodiagnostic companies.

Speaker #4: Medical devices, as well as pharma assets. A good number in just—I believe it's just been a month since we completed that transaction.

Lishan Aklog: It's really because this really goes back to the roots of PAVmed, where we were also in a position where people contacted us as possible partners. That's what led to Lucid and Arcteris, having access to those technologies. It's really exciting that folks now view us in a position to be able to continue that legacy that brought those other assets into the fold. I would say on the medical device side, we are. There's obviously interest in technologies that align with the GI space, right?

Speaker #4: And it's really because this really goes back to the roots of PAVmed, where we were also in a position where people contacted us as possible partners—that's what led to Lucid and Barrett's, of us having access to those technologies.

Speaker #4: And it's really exciting that folks now view us in a position to be able to continue that legacy that brought those other assets into the fold.

Speaker #4: I would say on the medical device side we are there's obviously interest in in technologies that align with the GI space, right? So the our interest in Octaris and the interest of the of the folks at Duke in inquiring about that obviously has to do with the fact that we have in Lucid extensive experience with with esophageal disease with Barrett's esophagus and otherwise.

Lishan Aklog: Our interest in Arcteris and the interest of the folks at Duke in inquiring about that obviously has to do with the fact that we have in Lucid extensive experience with esophageal disease, with Barrett's esophagus and otherwise. I would say we're open for inquiries across the board. I mean, PortIO is in the vascular access space. There's been, you know, activity in a broader sense. We're not limiting ourselves to any particular specialty, but certainly GI things related to gastroesophageal reflux, to Barrett's esophagus and so forth obviously capture our attention because we have obviously a substantial amount of internal expertise there.

Speaker #4: And so, I would say we're open for inquiries across the board. I am port I/Os in the vascular access space. There's been, you know, activity in a broader sense.

Speaker #4: So, we're not limiting ourselves to any particular specialty. But certainly, GI things related to gastroesophageal reflux, to Barrett's esophagus, and so forth obviously capture our attention because we have, obviously, a substantial amount of internal expertise there.

Edward M. Woo: Great. Well, thanks for answering my question, and I wish you guys good luck. Thank you.

Speaker #4: Great. Well, thanks for answering my question, and I wish you guys good luck. Thank you. Okay. Thanks, Ed. Appreciate it. There are no further questions at this time.

Lishan Aklog: Okay. Thanks, Ed. Appreciate it.

Operator: There are no further questions at this time. I will now turn the call over to Dr. Lishan Aklog for closing remarks.

Speaker #4: I will now turn the call over to Dr. Lishan Aklog for closing remarks. Great. Hey, thanks, operator, and thank you all for taking the time and for your attention this morning.

Lishan Aklog: Great. Hey, thanks, operator, and thank you all for taking the time and for your attention this morning. We appreciate, as always, the thoughtful, informed comments and questions from our covering analysts, and hopefully you found those, that discussion useful as well. Really, I hope my goal and our hope is that you leave today with a, you know, pretty clear set of takeaways here, that PAVmed's corporate structure and balance sheet is now fixed. It was a long and somewhat painful process to get here, but we're here. Its two subsidiaries, commercial subsidiaries are both making strong commercial progress and approaching key milestones. Obviously, they're at different points in their corporate life cycles, but really good progress on both of those.

Speaker #4: We appreciate, as always, the thoughtful and informed comments and questions from our covering analysts, and hopefully you found that discussion useful as well.

Speaker #4: Really, I hope—I mean, my goal and our hope—is that you leave today with a, you know, pretty clear set of takeaways here: that PAVmed's corporate structure and balance sheet is now fixed.

Speaker #4: It was a long and somewhat painful process to get here. But we're here. Its two commercial subsidiaries are both making strong commercial progress and approaching key milestones.

Speaker #4: Obviously, they are at different points in their corporate life cycles. But really good progress on both of those. Both of them have also been capable of showing their ability to raise capital independent of PAVmed over time.

Lishan Aklog: Both of them have been also capable of showing their ability to raise capital independent of PAVmed over time. The news, obviously, that we're focused on today is that our medical device portfolio is relaunching. We're really excited to have Joe on board, and his leadership not only to move Opterus and PortIO forward, but also puts us in a really good position to evaluate the inflow of opportunities that have been brought to us already in hardly a month after we've been in a position to do so.

Speaker #4: The new, obviously, news that we're focused on today is that our medical device portfolio is relaunching. We're really excited to have Joe on board, and his leadership not only to move Octaris and port I/O forward, but also puts us in a really good position to evaluate the inflow of opportunities that have been brought to us already in hardly a month after we've been in position to do so.

Lishan Aklog: The fact that we're getting those inquiries both from banks and from innovators and from academic medical centers, I think is a testament to, you know, the hard work that's gone into fixing the structure and the balance sheet and the sort of sense of confidence that we're in a good position to go back to our roots there. All I can say is that, you know, we believe PAVmed's back, that our founding mission and this our structure of subsidiaries and their shared services model and the economies of scale that go with that we really feel like we're now in a really good position to take advantage of that structure, of that history, and of the opportunities that are coming before us.

Speaker #4: And so the fact that we're getting those inquiries both from banks and from innovators and from academic medical centers, I think, is a testament to, you know, the hard work that's gone into fixing the structure and the balance sheet, and the sort of sense of confidence that we're in a good position to go back to our roots there.

Speaker #4: So all I can say is that, you know, we believe PAVmed's back. That our founding mission and our structure of subsidiaries, and our shared services model, and the economies of scale that go with that, that we really feel like we're now in a really good position to take advantage of the opportunities that are coming before us.

Lishan Aklog: With that, as always, we encourage you to continue to keep abreast of our progress. Please, follow our news releases, our quarterly updates, calls in the future, as well as through our website and social media. Of course, always feel free to reach out to us if you have any specific questions. With that, I hope everyone has a great day. Thank you very much.

Speaker #4: So with that, as always, we encourage you to continue to keep abreast of our progress. Please follow our news releases and our quarterly update calls in the future, as well as through our website and social media.

Speaker #4: And, of course, always feel free to reach out to us if you have any specific questions. So with that, I'll hope everyone has a great day.

Speaker #4: Thank you very much. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating in NASA. Please disconnect your lines.

Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

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