PAVmed, Inc. Aktie

Good morning, and welcome to the PAVmed second quarter 2026 Business Update conference call. [Operator Instructions] Please note, this event is being recorded. 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, and good morning, everyone. Thank you for participating in today's Business Update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer. 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 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 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 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 these 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.

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. So we're seeing tangible progress across each of our core businesses. Lucid continues to advance key reimbursement and commercialization initiatives. Veris is building commercial momentum while advancing its implantable towards FDA submission, and our relaunched medical device portfolio is moving PortIO and Octeris forward under Joe Virgilio's leadership. We believe this progress across our portfolio positions PAVmed to create meaningful long-term shareholder value.

So let me walk through the key developments, beginning with Lucid. Lucid continues to advance its reimbursement and commercial initiatives. As Lucid's largest shareholder, PAVmed remains well-positioned to benefit from Lucid's continued progress and future value creation. I encourage you to listen to yesterday's Lucid Business Update call for greater detail on these developments. Of course, Medicare coverage remains Lucid's most important near-term milestone, and we're confident that we will ultimately secure positive draft coverage.

Commercial coverage expanded recently with a new positive EsoGuard coverage policy from the Laboratory Benefit Manager, LBM Concert. Multiple health plans of Concert have already adopted the policy. VA commercialization is progressing well, and we expect success as the new federal budget cycle progresses. Continued progress across health systems and health economics is further strengthening the foundation for future growth.

Let's now move on to Veris. The commercial phase of our Ohio State University strategic engagement is accelerating with patient onboarding steadily increasing since EHR integration went live. We also secured a large purchase order to support ongoing commercial patient onboarding for the rest of the year. The clinical rollout is continuing across additional departments. Approximately two-thirds of the planned departments have now been onboarded.

Additional departments continue to move through the implementation process. Our current efforts are focused on reducing workload friction and driving adoption within participating departments. Our implantable physiologic monitor development is also progressing well. We're targeting an early 2027 FDA 510(k) submission. The design enhancements have now increased the project battery life beyond the 2-year target, and design freeze remains targeted for this month, with full verification and validation testing to follow.

The long lead time biocompatibility testing has already been initiated in line with our FDA pre-submission guidance. Our new contract manufacturer has successfully completed this trial build with devices performing well in preliminary verification testing, and we completed our first phase of animal testing. This was also successful.

So now let's move on to our medical device portfolio, starting with PortIO. As a reminder, PortIO is an implantable intraosseous port that's designed to provide long-term vascular access through the bone marrow cavity, particularly for patients with difficult or compromised venous access. The positive first-in-human results were published in the Journal of Vascular Access, supporting continued advancement of our regulatory strategy.

Briefly, the first-in-human study evaluated PortIO in 10 patients across multiple clinical sites, and it demonstrated 100% device patency, with 90% of patients completing the full intended implant duration. No device-related adverse events were reported. Peer review publication now provides us with an important foundation as we advance PortIO towards its next development and regulatory milestones. The primary focus right now is on the FDA pre-submission process, and we expect to submit a meeting request in the fourth quarter.

The history has been that the regulatory pathway, based on our prior engagement with FDA, it was our expectation that PortIO would be subject to the De Novo pathway. However, engagements with outside regulatory consultants suggest that the publication of our first-in-human studies may give us a shot at proceeding to a straight 510(k). This would create a much shorter timeline and lower capital requirements to get to commercialization.

And now let's finish up with Octeris. As a reminder, Octeris is developing a multimodal endoscopic imaging platform licensed from Duke University that's designed to identify esophageal dysplasia during upper endoscopy and help guide more accurate biopsy and treatment. The multimodal imaging probe development work is ongoing at Duke. There's continued refinement of the probe. Processing speeds have improved substantially.

And these improvements are intended to support real-time imaging and analysis during the procedure. These technical advances set the stage for our upcoming clinical validation work at USC, which we're preparing for. IRB approval is expected in October. And our initial FDA pre-submission draft is completed, and the regulatory work is now focused on preparing for that submission. With that, I'll hand the call over to Dennis for an update on our financials.

Thanks, Lishan. Good morning, everyone. Our summary financial results for the second 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 second 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.

With regard to the balance sheet, you will recall from our last investor update that in February we completed a $30 million Series D preferred stock offering. Concurrently, the company issued a $15 million Senior Secured Note to an existing investor. The company used the proceeds from these financings, consisting of a $22.3 million cash payment and a $15 million Senior Secured Note with a February 2029 maturity date, to redeem all the outstanding shares of its Series C convertible preferred stock and fully retire its previously existing convertible debt.

The $15 million replacement note nominally has a conversion price of $4.50 per share. It was done this way to protect the investor's tax status, but in every substantive sense, this is a long-term 3-year term note with interest-only quarterly payments and a balloon payment at maturity in February 2029. Upon shareholder approval obtained on March 27, the Series D preferred shares were mandatorily converted into PAVmed common stock. As a result, the Series D preferred stock has been eliminated.

In connection with this financing, the company also issued $30 million in warrants now convertible into common stock, which are callable by the company upon publication of a positive EsoGuard LCD. So, a couple of key things to point out on the balance sheet. Cash at June 30 is $3.8 million, which obviously is not inclusive of the expected $30 million to be received upon the warrants being exercised post-LCD publication, nor does it reflect the $2.5 million from the Veris warrants issued last year that are callable upon the Veris implantable device being cleared by the FDA.

The equity method investment balance of $33 million reflects the 31.3 million Lucid shares mark-to-market, indicative of a closing price of $1.07 on June 30, down from $1.09 at year-end and $1.15 at March 31. At present, PAVmed continues to be the single largest common shareholder of Lucid Diagnostics, with ownership of approximately 15% of the common shares outstanding. Although PAVmed no longer has voting control, PAVmed, together with its board and management, still has significant influence over Lucid, with approximately 25% voting interest.

Shares outstanding today, including unvested RSAs, are approximately 7.3 million shares. The GAAP quarter-end outstanding shares of 6.3 million are reflected on the slide as well as the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested RSA amounts. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year quarterly comparisons. 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, to visually align PAVmed's income sources versus its operating expenses.

For SEC reporting purposes, the MSA, the Management Services Agreement, that income is recorded below the line. Furthermore, for the second quarter, you'll see on the slide a GAAP net loss of $6.6 million, both before the NCI and preferred dividends, versus the prior year loss of $12.3 million. The driving force of this difference is the change in the fair value of the Lucid shares and the convertible debt, both non-cash amounts, reflecting a charge of approximately $3.1 million in the current quarter compared to $10.8 million in the prior year quarter.

Other than the fair value changes, the most significant change between the reflected periods is the increased R&D expenses, largely for the Veris implantable device. R&D on a non-GAAP basis increased by approximately $650,000 sequentially and $1.3 million year-over-year. The GAAP net loss attributable to PAVmed as reflected in the 10-Q is $5.5 million for the second quarter, or $0.87 per share. On a non-GAAP basis, the loss is $1.7 million, or $0.27 per share.

Next slide, please. With regard to the non-GAAP operating expenses on the slide, you'll see a graphic illustration of our operating expenses over time as presented in more detail in our press release. Second quarter non-GAAP OpEx of $6.1 million is above the previous quarter by about $200,000 and above the average of the last 4 quarters by about $400,000, all of which reflects incremental Veris R&D expenditures. OpEx increases moving forward are likely to be tied mostly to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA.

With that, operator, let's open it up for questions.

[Operator Instructions] Your first question comes from Ed Woo with Ascendiant Capital.

Yes, congratulations on all the progress. You mentioned that you're going to have a FDA meeting with PortIO in the fourth quarter. Do you anticipate news shortly thereafter? And what do you think the regulatory pathway may be in 2027?

Yes, so we'll be ready to submit for a request for a pre-submission meeting. So the actual meeting may end up leaking into the beginning of 2027. But I will take the opportunity to kind of flesh out a little bit what I said in my prepared comments about the regulatory pathway. Those of you who have been with us before and saw the progress we've made on PortIO prior to pausing that project, our previous engagement with FDA prior to our publication of the first-in-human data was firmly in the De Novo pathway framework, which is longer and takes more capital.

As we've been preparing with the relaunch of the portfolio and the relaunch of PortIO, as we've been preparing to update our regulatory strategy and in consultation with some outside consultants as well as our very strong internal team, it appears that we may, there's no certainty yet, but that we may be able to pursue a 510(k) pathway with existing short-term intraosseous devices as a predicate.

This would, again, based on the fact that we've, in the interim, had a successful first-in-human study, this would be, and this is how we're going to pursue our re-engagement with the FDA. If that's successful, well, then, as I mentioned in my comments, that would be a big win as we'll still need a clinical trial, but the cost and the time associated with that would be significantly less.

That sounds good. The last question I would have is on PortIO and also the probe with Duke, does those include global rights or are they only rights in the U.S.?

Yes, the PortIO is an internal IP, so it's not a license. PAVmed owns the full rights to that. And the license with Duke University for the Octeris technology includes worldwide rights as well.

[Operator Instructions] Your next question comes from Jeremy Pearlman with Maxim Group.

Great. First question on the Veris platform. I know it seems like commercialization is going well. Are there any metrics maybe you could provide, how many patients have been onboarded, how quickly is the number growing, and then maybe what milestones investors should look forward to as they gauge, you know, the commercial traction of that platform?

Yes, we're not providing hard numbers on that, but I can give you a pretty good qualitative sense. So the agreement with the strategic partnership with OSU, The James, involves a commitment for them to enroll 1,000 patients in a registry. These are all commercial patients, but enrolled within a registry over a year, and the gun went off when EHR integration was completed in the spring.

So obviously at the beginning, we started with a limited number of departments, 2 and then 3 departments that had participated in the previous pilot. And now we're accelerating with now two-thirds of the departments. The James is a very large cancer hospital with two-thirds of the departments now onboarding and enrolling. So the target of getting to 1,000 patients by within the first year is still both us and the folks at OSU. I believe that's attainable, and we expect to reach that. And the enrollment has really accelerated over the last couple of months. So we're on a good path to get to that target.

Okay, great. And then maybe just skipping to the Octeris, you mentioned you're preparing for a clinical validation. What specifically will the clinical validation study demonstrate? I mean, how should we think about the timeline from that study to a potential FDA submission?

Yes, let me just provide a little bit more color on that. So at the time of our license, the work that had been done, there had been clinical work on a prototype probe that had demonstrated the fundamental findings and value of the technology in terms of its ability to detect, to measure the nuclear size within esophageal and mucosal cells and using that, correlating that nuclear size to the presence or absence of the more advanced precancerous esophageal dysplasia. So that work had been completed.

So the basic core principle around using this combination of advanced OCT to do those measurements and really outstanding ability to discriminate that have been well established. So after the license, the focus has been on modifying the probe, making it smaller and more user-friendly and more applicable to the broad range of patient sizes. That's the active work that's going on now, and that will require validation study, but also just sort of the ease of use in terms of the ergonomics for the clinician.

From that point on, there will still be additional product development work. There's product development work on the console as well as advancing and transitioning the work out of the laboratory into a commercial setting. So there's a reasonable amount of time. So the validation work is really a step in the process of getting to design freeze of the definitive probe, on the probe side of things. We are considering doing some parallel work on the console, depending on sort of our access to capital. We may do some of that in parallel, but this overall project is still several years away.

Okay, understood. And then just last question, you mentioned that if you get a 510(k) pathway for the PortIO, it might speed up the potential approval. Do you have a commercialization plan in place for that? Are you working on that, or is it still a little early?

Yes, we outlined a pretty clear plan. The PortIO commercialization is actually fairly straightforward. The target physician specialties are pretty straightforward. There are folks who currently implant vascular access devices. They tend to be vascular surgeons and interventional radiologists primarily. We have some internal work on pricing, on coding, and the opportunities, depending on sort of where PAVmed is and again sort of our access to resources at the time, we have a lot of flexibility with regard to an early commercial launch that includes building a small sales team and partnering with distributors. Distributors are very active in the vascular access space, so there's a lot of options for us when it comes time to do the initial commercial launch.

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

Great. Thanks, operator. And thank you all for taking the time and for your attention this morning. Obviously, I appreciate the questions and the opportunity to discuss our business and our technology with the covering analysts. Hopefully, you found that informative as well.

So to summarize, we believe we remain in a strong position to advance PAVmed's strategic plan and its mission.

Our 2 independently financed commercial subsidiaries, Lucid and Veris, are progressing well, and each are approaching key milestones. And importantly, we're starting to see traction, and we're quite excited on our relaunched medical device portfolio, including progress on PortIO and Octeris. So we remain firmly committed to PAVmed's diversified model. This model offering multiple opportunities, multiple shots on goal to enhance shareholder value. And we look forward to continued progress on all those fronts.

So with that, as always, we encourage you to continue to keep abreast of our progress. Please follow our news releases, these update calls, and continue to follow us on our website and through social media. As always, also, feel free to reach out with any specific questions.

So with that, I hope everybody has a great day, and thank you so much for your participation.

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

Good morning. I call the Annual Meeting of Stockholders of PAVmed Inc. to order. I'm Dennis McGrath, President and Chief Financial Officer. Also present are Michael Gordon, our General Counsel; Jin Dong of CBIZ CPAs, our auditors; Eric Schwartz of Graubard Miller, our outside counsel; and Alwyn Burton of Continental Stock Transfer & Trust Company, our transfer agent. Mr. Schwartz will act as Secretary of the meeting. In addition, I hereby appoint Mr. Burton to act as the inspector of the meeting and request him to execute his oath of office. Mr. Schwartz, please attach the oath to the minutes of the meeting.

As you all know, we're holding this meeting via live webcast. To help the meeting run smoothly, Mr. Gordon will now review a couple of housekeeping items before we begin.

Thanks, Dennis. First, until the polls are closed towards the end of the meeting, you will have an opportunity to vote through the webcast platform. If you wish to vote, simply click on the voting link and follow the instructions. Voting through the webcast platform will revoke any previously delivered proxy. Second, during the meeting, you will have the opportunity to submit questions to management and our auditors. You may submit questions for us or our auditors through the questions pane in the webcast platform. We will review the questions to management, and if appropriate, we'll respond to them after the meeting. Our auditors will review and respond to the questions directed at them. Third, those attending the meeting via the live webcast may also access a list of the certified stockholders of the company. The certified stockholder list can be accessed by clicking the appropriate link in the webcast platform.

Thank you. With those matters addressed, we will now proceed to the substantive portion of the meeting. Mr. Schwartz, please present the affidavit of mailing.

I present the affidavit sworn to by Robert Zubrycki of Continental Stock Transfer & Trust Company, showing that the notice of Internet availability of proxy materials was mailed on May 4, 2026, to all stockholders of record at the close of business on April 27, 2026.

I order the affidavit to be filed in the minute book immediately following the minutes of this meeting.

I also present the list of stockholders of record as of the close of business on April 27, 2026, as certified by Continental Stock Transfer & Trust Company.

Will the inspector please report on the number of shares eligible to vote, the number present and the presence of a quorum?

As of the close of business on April 27, 2026, there were 7,272,739 shares of common stock outstanding and eligible to vote. A majority of the shares are present at this meeting by proxy or in person, which constitutes a quorum.

Legal notice of the meeting having been given and a quorum being present, the meeting is regularly and lawfully convened and ready to transact business. The polls are now open. The first order of business is to elect 2 members of the Board as Class A directors to hold office until the third succeeding annual meeting and until their respective successors are duly elected and qualified. Management nominates Ronald M. Sparks and Timothy Baxter for reelection as Class A directors. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth in their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a plurality of shares was voted for each of Mr. Sparks and Mr. Baxter, which is sufficient to elect them as directors.

The second order of business is to consider and vote upon a proposal to approve amendments to the company's employee stock purchase plan to: one, increase the total number of shares of the company's common stock available under the ESPP by an additional 200,000 shares from 15,774 shares to 215,774 shares; and two, raise the annual limit for increases under the evergreen provision from 5,556 to 500,000 shares. The amendments and the proposal are more fully described in the proxy statement. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth on their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a majority of the shares present and entitled to vote on this proposal was voted in favor of the proposal, which is sufficient for its approval.

The third and last order of business is to consider and vote upon a proposal to ratify the appointment of CBIZ CPAs as the company's independent registered certified public accounting firm for the year ending December 31, 2026. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of stockholders who have submitted proxies in accordance with the instructions set forth in their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a majority of the shares present and entitled to vote on this proposal was voted in favor of the proposal, which is sufficient for its approval.

The items of business to be considered at this meeting are now completed. The polls are now closed. Based on preliminary vote tallies, management nominees have been elected as directors. The amendments to the ESPP plan have been approved and the appointment of the company's independent registered certified public accounting firm has been ratified.

The exact vote tallies will be publicly disclosed after the meeting in our public filings with the SEC. Once the final tallies are completed, I order that the report of the inspector be filed in the minute book immediately following the minutes of the meeting. Thank you all for your attendance at the meeting. As a reminder, you may submit questions for us or our auditors through the questions pane in the webcast platform. We will respond to appropriate questions after the meeting. I will now entertain a motion to adjourn the meeting.

So moved.

I second the motion. The meeting is now adjourned.

Good morning, and welcome to the PAVmed's First Quarter 2026 Business Update Conference Call.

[Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference call over to Matt Riley, PAVmed's Vice President of Investor Relations. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed; along with Dennis McGrath, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website.

Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update press release and 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 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 the quarterly reports on Form 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 the changes in expectations or 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 today. At our last business update call, we discussed the 2-year process we undertook to permanently fix PAVmed's legacy capital structure and strengthen its balance sheet. The final step has been completed in the last couple of weeks, and the cap table is now clean. Dennis will discuss this in more depth, but our cap table now just consists of common stock and term debt. And with that, we now truly believe that PAVmed is really well positioned to execute on its founding mission for us to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries operating under our shared services model, and that we are well positioned to evaluate new opportunities as they come along. And I'll talk a little bit about how that has accelerated since the restructuring took place.

As we described on our last call, part of one major initiative that's followed this restructuring has been the relaunching of our medical device portfolio under Joe Virgilio. He's been on board now and has hit the ground running. He's actively focusing on advancing multiple medical device opportunities, including PortIO and the endoscopic imaging technology we licensed from Duke under the Octeris umbrella, as well as broader responsibilities across our entire medical device portfolio, utilizing his expertise on building and scaling growth-based businesses and raising capital for these individual medical device initiatives.

As I mentioned, the pipeline has definitely opened up. We are evaluating business development assets that are being brought forth to us. We're on our second major diligence exercise. We did pass on the first opportunity as attractive as it was. And we really do expect those to bear fruit for us to bringing in commercial assets into our portfolio.

So now let's move on to Lucid Diagnostics. So Lucid is on the cusp of transformative milestones, including what we believe is impending Medicare coverage. As we discussed on our previous call, we're awaiting Medicare. We've a bit of frustration that this has dragged on but our confidence has not wavered. And I encourage you to listen to yesterday's Lucid business update call for greater details on this and other aspects of Lucid's business. As a reminder, PAVmed remains Lucid's largest shareholder. Lucid's progress and upcoming major inflection points will benefit PAVmed. Just a couple of highlights from the call yesterday, in addition to Medicare, it's clear that we're not remaining idle on the Lucid front. As we discussed, the VA is off to a good start following us securing the federal supply schedule and pricing.

First orders are being placed. The pipeline is being expanded, and we look forward to driving volume and revenue along that segment. We also discussed our direct engagement with commercial payers that we have received positive coverage under one of the laboratory benefit managers, and that will be public soon. And of course, with all that, Lucid was also able to successfully raise a round of capital that extended our runway well into 2027.

So now let's move on to Veris. So as we discussed in our last call, Veris is now well into the commercial phase of our strategic engagement with Ohio State University. That process is well underway. The clinical rollout has been focused on the 3 clinical departments that had participated in the successful pilot study, and we're now on the cusp of adding additional departments according to our rollout schedule that OSU leadership developed in collaboration with us. As we announced last time, the EHR integration is now live. It's working well. And just overall, the feedback, both on the clinical and the administrative side from our partners at OSU remains excellent, and we look forward to continuing to drive towards the targets that were established with them as part of our strategic partnership with them.

Of course, a major focus right now is on the implantable physiologic monitor. That development is progressing towards planned submission by the end of this year. As we discussed last time, we have a new contract development and manufacturing partner firm. That partnership is going well. That's Valentium. And the design and development efforts leading to design freeze and the transition to the final presubmission development work and testing is going well. A lot of the most recent efforts have been around the technical aspects of optimizing the battery life to get a full 2 years of battery life, and we've made excellent progress on that and look forward to continuing the work towards submitting by the end of the year.

We're also continuing to work on this expanded strategic vision for the company that we spent a bit of time on discussing during our last call. That includes ultimately expanding our commercial efforts beyond our single strategic partner and a variety of initiatives that are focused on transforming Veris beyond simple remote patient monitoring into additional strategic areas. We're looking to leverage our commercial success at OSU to support this expansion into additional centers the other strategic -- the other aspects of the strategic transformation that we are working on, although within the limited confines of our capital resources today, are additional work on clinical support services and development efforts around AI-based projects beyond remote patient monitoring.

So 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 first 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 first 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.

So with regard to the balance sheet, you'll recall from our last investor update that in February, we completed a $30 million Series D preferred stock offering. Concurrently, the company issued a $15 million senior secured note to an existing investor. The company used the proceeds from these financings consisting of $22.3 million cash payment and a $15 million senior secured note with a February 2029 maturity date to redeem all of the outstanding shares of the Series C convertible preferred stock and fully retire its previously existing convertible debt. The $15 million replacement note nominally has a conversion price of $450 per share. It was done this way to protect the investors' tax status but in every substantive sense, this is a long-term 3-year note with interest-only quarterly payments and a balloon payment at the maturity in February of 2029.

Upon shareholder approval obtained just a couple of weeks back on March 27, the newly issued Series D preferred were mandatorily converted to PAVmed common stock. As a result, the Series D preferred stock has been eliminated. In connection with this financing, the company also issued $30 million in warrants now convertible into common stock, which are callable by the company upon publication of a positive EsoGuard LCD.

So a couple of things to point out on each of these balance sheets. Cash at March 31 is $6.5 million, which obviously is not inclusive of the expected $30 million to be received upon the warrants being exercised post LCD publication nor does it reflect the $2.5 million from the Veris warrants issued last year that are callable upon the Veris implantable device being cleared by the FDA. The equity method investment balance of $36 million, that reflects the 31.3 million Lucid shares mark-to-market, indicative of a $1.9 million increase in the quarter.

At present, as Lishan indicated, PAVmed continues to be the single largest shareholder of Lucid Diagnostics with ownership of approximately 15% of the common shares outstanding. And although PAVmed no longer has voting control of Lucid, PAVmed together with its Board and management still have a significant influence over Lucid with approximately a 25% voting interest. Shares outstanding today, including unvested RSAs are approximately 7.3 million shares. The GAAP quarter ending outstanding shares of 6.3 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. You'll recall GAAP shares do not reflect unvested RSA amounts.

Next slide. Similar to past presentations, the P&L slide provides some GAAP and non-GAAP year-over-year quarterly comparisons. On a pro forma basis and purely for illustrative purposes on this slide only, the Veris revenue and the Lucid management fee income are combined collectively more than $3 million per quarter, simply to visually align PAVmed's income sources versus operating expenses. For SEC reporting purposes, the MSA income is a below-the-line item.

Furthermore, for the first quarter, you see on the slide a GAAP net loss of $1.1 million before noncontrolling interest and preferred dividends versus the prior year profit of $18.6 million. The driving force of this difference is the change in the fair value of the Lucid shares mark-to-market for each period. There are a few other income and expense noncash pluses and minuses that all relate to the accounting for the securities issued versus the securities redeemed, but are largely noncash items together with out-of-pocket financing costs related to the Series D issuance and the conversion to common shares.

The GAAP net loss attributable to PAVmed, as reflected in the 10-Q and also shown in the press release is $60,000 for the quarter, and as disclosed, prior to the effect of the preferred dividends of approximately $6.9 million. The result after the preferred dividends is a GAAP loss per share of $4.42 per share. Without the preferred dividend, the pro forma GAAP net loss per share would have been $0.04 per share.

Next slide. With regard to the non-GAAP operating expenses, on this slide, you'll see a graphic illustration of our operating expenses over time as presented in more detail in our press release. The first quarter non-GAAP OpEx of $5.9 million is above the average of the previous 4 quarters by about $1.1 million, which reflects about $300,000 in incremental Veris R&D expenditures and the balance in G&A costs that were incurred in connection with the recapitalization financing and other professional fees.

OpEx increases moving forward are likely to be tied mostly 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.

[Operator Instructions] Our first question is from Ed Woo from Ascendiant Capital.

Congratulations on all the progress. As you guys are evaluating possible new potential opportunities, have you considered looking at opportunities outside of North America or outside of the U.S.?

We've always been open. We have historically gotten inquiries from -- particularly in Europe on occasion. But I would say the source -- and even Israel, the source of most of the technologies that are brought forth to us come from the U.S. Many of them come from academic medical centers. The founders of PAVmed, including myself, have a strong history in academic medicine and have maintained those ties. So that's been a catalyst for inquiries. I'll remind people that Lucid Diagnostics came from a partnership with academic medicine and the Octeris technology that we're launching is in conjunction with Duke and investigators at UNC. Also, the ecosystem for physician-led innovation also is particularly robust here as well. And so those are the sources. But we're open to other sources, but the majority comes from within the U.S., including the ones that I had mentioned that we're actively pursuing. As I mentioned, we did a deep dive on one asset, which we passed on and are in the process of doing another.

And my last question is, have you guys decided to focus either on devices, diagnostics or therapeutics? Or are you open to all 3 areas?

It's a great question, Ed. I think it's maybe a good opportunity to talk a little bit about the history of PAVmed and one of the things we're proud about, which is our willingness to be kind of bold and explore new areas. PAVmed was launched initially exclusively as -- to operate in the medical device space. The initial assets were all focused on traditional medical devices. And -- but because of the way we had set things up in its structure, and frankly, our mission was to look at -- to be open to viewing and looking at and evaluating opportunities across the life sciences. And when just a few years after PAVmed was founded, the opportunity for the technologies underlying Lucid were brought to us from relationships with an academic medical center. Even though this was in the diagnostic space, Lucid obviously has a cell collection device, which is a medical device. But at the heart of it, Lucid is a diagnostic company. And we chose to make that leap, and we're obviously happy we did. And it continued on from there.

When the Veris opportunity was brought to us, again, although Veris obviously has a -- central to its future is an implantable medical device. At the end of the day, the foundation for it is around digital health and software. And the Veris platform is rooted in that. And similarly, we decided, okay, there's a big future here in digital health and expanding the way physicians care for patients with more aggressive monitoring, and we chose to expand our horizons from there into digital health.

So right now, digital health devices, diagnostics are on the table. But I think I've said this on previous calls that we have been open to leverage our model, the shared services model and the resources that are concentrated within PAVmed that are available to its subsidiaries to therapeutics as well. One of our Board members, Sundeep Agarwal, has deep experience in the therapeutic side. And we've relayed previously that we've looked at numerous assets in the therapeutic space. We just haven't pulled the trigger on those. We continue -- we expect to continue to look in the therapeutic space. The challenge is we had -- the opportunity there is that we have the infrastructure with regard to clinical research. So the opportunity to acquire or license a therapeutic asset in a Phase I or early Phase II situation. We have the resources to do that in terms of running the clinical trials necessary to create value there.

The challenge previously prior to this restructuring was that the availability of the capital needed to enter license fees and so forth to acquire assets. We were just -- it was our capital structure just didn't allow it. And so now that we have -- we're in a better position, we feel like we'll have an opportunity to look at therapeutic assets as well.

Your next question is from Jeremy Pearlman from Maxim Group.

Just while we're talking about the new relaunched device portfolio, is that -- how does that differ from the incubator you had set up? Is that -- or is it the same thing just rebranded? I'm just curious.

Yes. I guess fair enough to call it that. The slight difference is as follows that when we were -- as we were going through this, again, 2-year restructuring, ultimately recapitalization, we were obviously motivated to start taking product lines that we had in IP and assets that we had that we had put on the shelf during [indiscernible] if now 3 years ago, we're obviously motivated to do that. And what we sought to do initially was to put those assets in that case, starting with PortIO and an incubator, and that gave us the opportunity to go out and spin assets out of the incubator and try to raise capital accordingly.

It was tough to do that, frankly. We went through multiple angel processes and so forth to try to raise capital for PortIO. And the structure just didn't work. People who are investing in super early-stage technologies really want to know that there's someone dedicated and articulating our shared services model in that funding environment did not yield the results that we were hoping for. And also, we were not well positioned because we hadn't completed the restructuring and the recapitalization.

Now that the latter is completed, we decided to tweak the relaunch of the medical device portfolio, learning the lessons that we acquired during the -- when we were trying to do this in the form of an incubator and the importance of having an experienced highly skilled person at the helm for the entire portfolio. And that's why we went this route, and we were fortunate enough to be able to bring somebody with prior CEO experience and a deep experience in the medical device industry in the form of Joe to manage that relaunch. So he's working on PortIO, which as I mentioned, was the first -- was a technology that we were leading with when we were trying to do this in more of an incubator form. And now in the interim, we've licensed the technology for imaging of dysplastic Barrett's esophagus and the other -- and there will be other opportunities in medical device, but very much integrated within the PAVmed infrastructure.

We still have -- Joe obviously has access to the full shared services model but we have a dedicated person working on those technologies every day. And we expect that, that will facilitate our ability to put capital into subsidiaries that are advancing those individual medical device technology.

Okay. Understood. Then maybe one more on the new device portfolio. What are some of the criteria you look for in a potential technology to license or to take under into this portfolio? Maybe just if you could share some, that would be helpful.

Yes. We've tried to be consistent with that from the very onset from inception of this company. What's changed, as we talked about with that is the expansion of our horizons into areas beyond our traditional medical devices. But it's a little bit cliche, right? It's technologies that address an unmet -- meaningful unmet clinical need. That's important. This is a physician-founded company. We feel like we have really good perspectives on identifying what that is and getting to the heart of that. We look for substantial market opportunities, which both Lucid and Veris have and PortIO and Octeris have as well.

And our bias is towards high-margin, less commoditized products because our infrastructure, we believe, is better suited to that. Other than that, we're pretty open and flexible, and I think that's one of our strengths is that we're willing to look at assets. Obviously, more broadly beyond medical devices, we have a substantial infrastructure through Lucid and the ability to partner with Lucid in the molecular diagnostics space. So many of the assets that we've looked at recently have been really fascinating opportunities in the molecular diagnostic space. So those are the areas. I think medical devices that fulfill the criteria that I mentioned but also opportunities to synergize with the resources we have within Lucid on the diagnostics side.

I guess I'll add one other thing, which is obvious with Octeris that where we've evolved with Lucid and with Veris are 2 clinical areas, gastroenterology. Lucid is at the intersection between gastroenterology and cancer, oncology. And obviously, Veris is focused on cancer. So those technologies that intersect with those spaces, obviously would have an advantage, and we'd have even more acute interest in those. And I think the example of that is Octeris, which is a technology to -- an imaging technology that enhances the diagnosis of an esophageal precancer, right? So that obviously, the synergies there with the work we're doing in Lucid is -- should be obvious.

Understood. Okay. Great. And then just maybe moving to the Veris platform. how many patients have you signed up? I think in the past, you mentioned you had a target enrollment by the end of this year of 1,000 patients. Is that -- how is the ramp trending? Any headwinds you see or everything is smooth sailing?

Yes. No, we're not going to put forth specific numbers. But yes, it's trending and on target. When we launched once the pilot was completed and launched the commercial phase of our strategic engagement with OSU, they put forth a very detailed plan, rollout plan to get to their -- the target of 1,000 patients within the first year of the registry. And obviously, that trajectory is not linear, right? There were certain things at the beginning, particularly some of the delays with regard to getting EHR integration on board that took a little bit more time than we had hoped for.

But overall, on target to hit that -- those goals, as I mentioned just a bit more specifically, we're very soon going to expand to the next phase of departments within the cancer center. So the first 3 departments that were launched in the commercial phase were the same departments that participated in the successful pilot. And now the next phase are new departments that did not participate in the pilot, again, all consistent with the well laid out rollout plan.

Okay. Understood. And I think you mentioned in your prepared remarks, the feedback has been really positive. Is there any feedback that you're getting that you -- that's maybe not so positive that you're just using to incorporate to enhance the platform that you might be in the next iteration or that's a constant learning process?

Yes. I would say the latter, right? Because just if you think about it, what we're doing here to work within the capital constraints that Lucid has is to make sure that we -- that we're pushing full steam ahead on the implantable because as we've said from the very beginning, the value proposition here is deeply rooted in both the software platform as well as the implantable. And so that's where the bulk of our capital resources is going right now. So -- but we wanted to make sure during the period of time that development work and the pathway to submission and clearance was underway that we were engaging with a single large -- third largest cancer center to do exactly what you're saying to show that we can create value.

We can generate enthusiasm locally. We can ramp up to very meaningful numbers for a center of the size and to get the kinks out with regard to the EHR integration, for example, other process issues about how does -- this is not trivial, right? You're taking patients who have newly diagnosed cancer entering into a system, complex therapies, complex clinical events that are going on and how that -- how our platform communicates with the team, there's a lot to be learned in just sort of the real-world use of that.

One particular example with OSU is that they have a dedicated call center. So all alerts go through a call center and just sort of how to manage that, how to staff that, how to get the flow of information correct in a way that optimizes care is as you -- I would absolutely describe it like you said, it's a continuous learning process. And we're focusing those lessons at one center so that when we are in a position, both from development point of view, but also from a capital point of view to expand commercially subsequent centers will benefit from the lessons that we've learned in this initial engagement, commercial engagement with OSU.

Okay. Great. And then just maybe just last question, just segueing right off what your last comment about further commercialization. What -- maybe any sort of time line you can give clarity on when you think that might be, when you could start? Are you still engaged with conversations with other large cancer centers? Or are still...

Yes, yes. We have had conversations certainly with other academic medical centers. We've even had conversations with other entities that are engaged in the care of cancer patients, including sort of practice networks. There are a lot of networks of oncologists out there. And so we've had plenty of discussions. We're unlikely to pull the trigger on another major engagement until we're in a position to raise additional capital that we can allocate so we can do it right, right? So the next phase with regard to commercialization will be aligned with our ability to raise additional capital to support an expanded commercial footprint. That could happen prior to the submission and clearance of the implantable. We're not opposed to that. It really just depends on how well we're positioned to fund commercial expansion.

Thank you. There are no further questions at this time. I will now hand the call back to Dr. Lishan Aklog for the closing remarks.

Great. Thank you, operator, and thanks all of you for taking the time and for your attention this morning. Obviously, I really appreciate the questions and enjoy the opportunity to have substantive discussions with our covering analysts. Hopefully, that you all found that enlightening as well.

Just to kind of summarize, as we discussed, we believe we're really now in a strong position to advance PAVmed's strategic plan and original mission. Our 2 independently financed commercial subsidiaries, Lucid and Veris are progressing well. They're both approaching key milestones. And as importantly, as we've really discussed in some depth, the completion of our restructuring and recapitalization process has allowed us to start beginning to expand our horizons consistent with PAVmed's original mission. And of course, this includes relaunching our medical device portfolio under Joe Virgilio and aggressively evaluating and pursuing additional assets and opportunities that align with our model and growth just as we just discussed with Jeremy and Ed.

So with that, as always, we encourage you to continue to keep abreast of our progress. Please follow our news releases, these update calls and continue to follow us on our website and through social media. As always, obviously, feel free to reach out with any specific questions.

So with that, I hope everybody has a great day, and thanks for your participation.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.

Good morning, and welcome to the PAVmed's Fourth Quarter 2025 Business Update Conference Call. [Operator Instructions] This call is being recorded on Monday, March 30, 2026. 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. 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. For a list and 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 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 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?

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 2 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 have one more step to go, and that step was completed in February with the completion of a restructuring recapitalization and financing. The toxic convertible securities that had held down -- have held us down for a while were removed. And we -- upon completion of this financing exercise, we'll have a very clean cap table. 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? 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 3 different buckets. The most prominent one, of course, is Lucid, which is a publicly traded diagnostic company. 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 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. And 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 again, we'll 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. We're poised to accelerate the execution of that strategic -- 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 MedTech 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. 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, 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.

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 on each of these areas, and I'll keep these comments high level. Lucid reported fourth quarter 2025 EsoGuard revenue of approximately $1.5 million and EsoGuard test volume of 3,664 EsoGuard tests. The volume has increased by 29% from the third quarter and revenue has increased by 24% over the third quarter. 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 health care system, 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 cancer.

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, technical success, the procedural times, safety, et cetera, and also the appropriateness of physician use. And we contrasted that with other technologies that purport to be capable of operating in this space.

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 just initiated when we -- 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. But as importantly and perhaps more importantly, the patient -- the clinician and the patients can access their record within the workflow that we offer within our platform. 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.

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 in late submission in the latter part of this year to the FDA under the 510(k) designation. 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 success -- all of the design work to capture the physiologic signal. 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.

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 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. 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 a risk stratification tool for cancer patients to identify those at risk of developing complications and readmissions. And in addition, we're expanding the offering to include clinical support services so that will -- 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. 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.

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 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. That will start with 2 companies, PortIO, which we've talked about before. We've 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 a dedicated leadership for that. And with Joe, we now have that.

We have 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 precancer stages without the need for biopsy. That license agreement has now been fully executed, and it's now resides within a new subsidiary called [ Arcteris ], and 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.

And our vision here is goes beyond these 2 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 and our portfolio under Joe Virgilio's leadership.

And 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. On the next 4 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. 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 versus 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. So with regard to the balance sheet, you'll recall from our investor update call since this time last year that the company has engaged in a multistep 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 multistep 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 February 3rd.

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. 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. This slide reflects the balance sheets for year-end 2025 and 2024, both after deconsolidation, which occurred on September 10, 2024.

So a couple of key things to point out on each of these balance sheets. Cash burn rate of $1.5 million for the fourth quarter 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 the first quarter of '25 and $2.5 million in the second quarter of '25 to support the development toward the FDA submission of Veris' 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's stock during 2025. 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 February 3rd.

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. 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 2 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. 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 6 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.

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. Investors also saw that with recapitalization, they believe 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 is a pure arbitrage opportunity in advance of the Medicare announcement. Fifth, additional optionality across high potential health care assets was a driving interest, Veris, [ Arcteris ], PortIO 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.

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 and 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 stand-alone entity. 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.

So 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 the fourth quarter, you see on the slide a GAAP net loss of $2.8 million before NCI, noncontrolling interest and preferred dividends. This includes noncash charges of about $1 million, which then reconciles to a non-GAAP loss of $942,000. That loss is comprised of about $500,000 of Veris contractor development costs for the implantable device and about $200,000 of annual Delaware franchise taxes that occurs once a year.

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 stand-alone information presented not only in the slide, but in the full fourth quarter information presented in our press release that shows the company baseline bias 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. Total non-GAAP OpEx since the Lucid deconsolidation in 2024 has been nearly flat for the 4 previous quarters. The fourth quarter OpEx were offset by approximately $1.2 million in a onetime reimbursement for Lucid for annual compensation expenses allocable to Lucid with the 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.

[Operator Instructions] Your first question comes from Jeremy Pearlman with Maxim Group.

So just first, I wanted to focus on the commercial relationship with OSU. 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 time frame for that? Maybe help us understand how -- what you hope the current commercial relationship to become before you roll it out to other institutions.

Yes. That's great. Thanks for the question. Happy to elaborate on that a bit. So in terms of the clinical value of the Veris platform, we established that during a pilot that occurred, and that's actually last year, and that was what led to the commercial engagement. The commercial engagement has fairly high expectations. It involves a target of 1,000 -- a minimum of 1,000 patients within the first year. And we are in a very structured plan on rolling out the platform across various departments, starting with the 3 departments that were under the pilot program and then expanding to new departments along the way.

So 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 this adoption during the commercial phase beyond the pilot phase.

So that's -- we're not -- we haven't been reporting sort of month-to-month numbers with regard to that, but I can tell you at a high level that we're on track and on schedule to do so. The planning on that was, in fact, based on when we completed EHR integration. So it should be clear to everybody being integrated, EHR is really a central depot 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 Veris data on Epic as well as our preferences for the clinicians to use our platform as a 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.

And so that's -- that launched fairly recently, and we expect with that launch that they'll be able to now start accelerating the trajectory towards that target 1,000 and again, their goal -- that's a minimum, the goal and expectation is that we will exceed that. I would just -- 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. And that's what we -- the capital that we raised last year was really targeting that. And we will -- although we have some legacy engagements with some other -- 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, and 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 can charge for this service is the clinical support side of things. 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 care and clinicians are not overwhelmed. And many other centers, including major other cancer centers don't necessarily have that full-fledged system.

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 sublevel to various levels depending on what's desired by the center, various levels of triage. 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 the -- from her engagements with interacting with OSU as to how to develop that. But that's something that would be 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 gives you some perspective on what -- how we're viewing our future commercial expansion.

Yes. That was really helpful. Great information. Then maybe just one more question related to the -- you said you mentioned there's new risk stratification tools and other tools that you could integrate into the system to the Veris platform. Is that -- are those -- I don't know, whenever they -- whenever these tools -- when they're ready, are they -- as 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?

Yes. So there's -- 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 these tools ready to go and to implement and to integrate within our platform. Those AI-based tools require data -- 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. 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 Veris from its original vision of being 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. And we know from our experience to date that Veris works extraordinarily well at doing that.

But we believe that in this era, the value added from going beyond just as being a conduit for information, but to provide truly sophisticated AI-based clinical decision support tools are really becoming standard practice when it comes to digital health offerings, and that's what we're seeking to do. 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.

Certainly, at the time we would launch that, whether it's in a preliminary phase 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.

Okay. Understood. Great. And then just maybe just last question, jumping to the new 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, 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 type of commercial plans you might have for that?

Yes. 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 Virgilio's role in overseeing [ Arcteris ] falls under that. But just as a reminder, that's a little bit more detail on our technology. The technology is an optical technology that combines well-established technology called OSC with newer technology called a/LCI.

And 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 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. 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.

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. So it's critical to distinguish in early and late because late is where we intervene. 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.

The promise of this technology is that it's capable with a very, 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 the initial data. And 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.

So that would be very transformational for how esophageal precancer is managed. You would look, you would 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 -- right there, do the ablation procedure on the spot. So that would be transformational. So this work is still in the early phases. It was used in the clinical setting that documented in real patients with real precancer, its efficacy. 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. So 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, then the probe will be deployed in another round of patients in partnership with Dr. Shaheen at UNC. And once we have design freeze and have 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. So that's a bit down the road.

[Operator Instructions] Your next question comes from Ed Woo with Ascendiant Capital.

Yes. 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 new technology. Is there any particular areas or products that you might be interested in?

Yes. Thanks, Ed. Glad you gave me a chance to kind of maybe flesh out my previous comment about that. 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. It's not just in the medical device side, it's actually across the board. We've gotten inquiries on really interesting diagnostic companies, molecular diagnostic companies, medical devices as well as pharma assets. So a good number.

And just -- I believe it's just been a month since we completed that transaction. 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 Veris of us having access to those technologies. 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.

I would say on the medical device side, we are -- there's obviously interest in technologies that align with the GI space, right? So 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. And so I would say we're open for inquiries across the board. PortIO is in the vascular access space. There's been activity in a broader sense. 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.

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

Great. Thanks, operator, and thank you all for taking the time and for your attention this morning. We appreciate, as always, the thoughtful and 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 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. It's 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. Both of them have been also capable of showing their ability to raise capital independent of PAVmed over time. 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 [ Arcteris ] 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.

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 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. So all I can say is that we believe PAVmed the 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 that structure of that history and of the opportunities that are coming before us.

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

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

I call the Special Meeting of Stockholders of PAVmed Inc. to order. I am Lishan Aklog, the company's Chairman and Chief Executive Officer. Also present are Dennis McGrath, the company's President and Chief Financial Officer; Michael Gordon, the company's General Counsel; Eric Schwartz of Graubard Miller, outside Counsel of the company; and Alwyn Burton of Continental Stock Transfer & Trust Company, the company's transfer agent. Eric will act as the Secretary of the meeting. As you all know, we're holding this special meeting via live webcast. To help the meeting run smoothly, Mr. Gordon will review a couple of housekeeping items before we begin.

Thanks, Lishan. First, until the polls are closed towards the end of the meeting, you will have an opportunity to vote through the webcast platform. If you wish to vote, simply click on the voting link and follow the instructions. Voting through the webcast platform will revoke any previously delivered proxy. Second, during the meeting, you will have the opportunity to submit questions to management. You may submit questions through the questions pane in the webcast platform. We will review these questions and if appropriate, we'll respond to them after the meeting. Third, during the meeting, you may view a list of stockholders of record as of the close of business on the record date as certified by Continental Stock Transfer & Trust Company. Simply click on the corresponding link in the webcast platform.

With those matters addressed, we will now proceed to the substantive portion of the meeting. I hereby appoint Mr. Burton to act as the inspector of this meeting and request him to execute his oath of office. Mr. Schwartz, please attach the oath to the minutes of the meeting. Mr. Schwartz, please present the affidavits of mailing.

I present the affidavits sworn to by a representative of Continental Stock Transfer & Trust Company, showing that notice of the special meeting and proxy statement was mailed on February 26, 2026, to all holders of record of common stock at the close of business on February 13, 2026. I also present the affidavit sworn to by a representative of Continental Stock Transfer & Trust Company, showing that notice of the special meeting and proxy statement was mailed on February 27, 2026, to all holders of record of the Series D preferred stock at the close of business on February 13, 2026.

I order the affidavits to be filed in the minute book immediately following the minutes of this meeting.

I also present the list of stockholders of record as of the close of business on February 13, 2026, as certified by Continental Stock Transfer & Trust Company.

Will the inspector please report on the number of shares eligible to vote, the number present and the presence of a quorum?

As of the close of business on February 13, 2026, there were 1,496,696 shares of common stock outstanding and eligible to vote. In addition, there were 30,000 shares of Series C preferred stock outstanding and eligible to vote, which represented the right to vote the equivalent of an additional 213,272 shares of common stock. A majority of the total voting power is represented at the meeting by proxy or in person, which constitutes a quorum.

Legal notice of the meeting having been given and a quorum being present, the meeting is regularly and lawfully convened and ready to transact business. The polls are now open. The first item of business is to consider a proposal to approve for the purposes of NASDAQ Listing Rule 5635, the issuance of shares of the company's common stock upon conversion of the company's Series D preferred stock and pursuant to the company's amended and restated senior secured convertible note issued on February 3, 2026.

The company sold 30,000 shares of Series D preferred stock in a private placement consummating on February 3, 2026. An additional 30,000 shares of Series D preferred stock are issuable upon exercise of warrants sold in the private placement. The company also issued the note on February 3, 2026, in connection with the redemption of the company's Series C preferred stock and the refinancing of certain of its net existing debt. The proposal is more fully described in the proxy statement. Do I have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth on their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Inspector?

My apologies. I got disconnected. Based on the preliminary vote tallies, a majority of the voting power presented and entitled to vote on the proposal was voted in favor of the proposal. This is sufficient for its approval.

The second item of business is to consider a proposal to approve an amendment to the company's certificate of incorporation to permit the removal of any director with or without cause by an affirmative vote of the holders of the majority of the company's outstanding voting power. The proposal is more fully described in the proxy statement. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth on their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a majority of the voting power entitled to vote on the proposal was voted in favor of the proposal. This is sufficient for its approval.

The third item of business is to consider a proposal to approve an amendment to the company's 2014 long-term incentive equity plan to increase the total number of shares of common stock available under the plan by an additional 1,500,000 shares from 213,517 shares to 1,713,517 shares. The proposal is more fully described in the proxy statement. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth on their proxies. Stockholders who are present may vote on this matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a majority of the voting power present and entitled to vote on the proposal was voted in favor of the proposal. This is sufficient for its approval.

Thank you, Mr. Burton. Because these proposals have been approved, the proposal to adjourn the meeting will not be presented. Accordingly, the business to be considered at this meeting is now completed. The polls are now closed. The exact vote tally on each proposal will be publicly disclosed after the meeting in our public filings with the SEC. Once the final tally is completed, I order the report of the inspector to be filed in the minute book immediately following the minutes of this meeting. As the business of the meeting has been completed, I will entertain a motion to adjourn the meeting.

So moved.

I second the motion. Meeting adjourned. Thank you all for your attendance and your continued support of the company.

I call the Special Meeting of Stockholders of PAVmed Inc. to order. I am Lishan Aklog, the company's Chairman and Chief Executive Officer. Also present is Michael Gordon, the company's General Counsel; Eric Schwartz of Graubard Miller, outside counsel to the company; and Alwyn Burton of Continental Stock Transfer & Trust Company, the company's transfer agent. Eric will act as Secretary of the meeting. As you all know, we are holding this special meeting via live webcast. To help the meeting run smoothly, Mr. Gordon will review a couple of housekeeping items before we begin.

Thanks, Lishan. First, until the polls are closed towards the end of the meeting, you will have an opportunity to vote through the webcast platform. If you wish to vote, simply click on the voting link and follow the instructions. Voting through the webcast platform will revoke any previously delivered proxy. Second, during the meeting, you will have the opportunity to submit questions to management. You may submit questions through the questions pane in the webcast platform. We will review these questions and if appropriate, we'll respond to them after the meeting. Third, during the meeting, you may view a list of stockholders of record as of the close of business on the record date as certified by Continental Stock Transfer & Trust Company. Simply click on the corresponding link in the webcast platform.

With those matters addressed, we will now proceed to the substantive portion of the meeting. I hereby appoint Mr. Burton to act as the inspector of this meeting and request him to execute his oath of office. Mr. Schwartz, please attach the oath to the minutes of the meeting. Mr. Schwartz, please present the affidavit of mailing.

I present the affidavits sworn to by a representative of Continental Stock Transfer & Trust Company, showing that notice of the special meeting and proxy statement was mailed on October 31, 2025, to all stockholders of record at the close of business on October 23, 2025.

I order the affidavit to be filed in the minute book immediately following the minutes of this meeting.

I also present the list of stockholders of record as of the close of business on October 23, 2025, as certified by Continental Stock Transfer & Trust Company.

Will the inspector please report on the number of shares eligible to vote, the number present and the presence of a quorum?

As of the close of business on October 23, 2025, there were 27,887,090 shares of common stock outstanding and eligible to vote. In addition, there were 21,398 shares of Series C preferred stock outstanding and eligible to vote, which represented the right to vote an equivalent of an additional 2,959,178 shares of common stock. A majority of the total voting power and a majority of the common stock is represented at this meeting by proxy or in person, which constitutes a quorum.

Legal notice of the meeting having been given and a quorum being present, the meeting is regularly and lawfully convened and ready to transact business. The polls are now open. The first and only item of business is to consider a proposal to amend the company's certificate of incorporation to effect the following two changes: First, the amendment will affect reverse stock split of the company's outstanding shares of common stock at a specific ratio ranging from 1:10 to 1:30 to be determined by the company's Board of Directors in its sole discretion.

Second, the amendment will affect an associated reduction in the number of shares of common stock the company is authorized to issue from 250 million shares to 25 million shares. The proposal is more fully described in the proxy statement. Do we have a motion?

So moved.

I second the motion. Management has voted on behalf of the stockholders who have submitted proxies in accordance with the instructions set forth on their proxies. Stockholders who are present may vote on the matter through the webcast platform. Inspector, please announce the preliminary results on this matter.

Based on the preliminary vote tallies, a majority of the voting power present and entitled to vote on the proposal was voted in favor of the proposal. In addition, a majority of the votes of common stock present and entitled to vote on the proposal was voted in favor of the proposal. This is sufficient for this approval.

Thank you, Mr. Burton. Because the proposal to amend the company's certificate of incorporation has been approved, the proposal to adjourn the meeting will not be presented. Accordingly, the business to be considered at this meeting is now completed. The polls are now closed.

The exact vote tally on the proposal to amend the company's certificate of incorporation will be publicly disclosed after the meeting in our public filings with the SEC. Once the final tally is completed, I order that the report of the inspector be filed in the minute book immediately following the minutes of this meeting. As the business of the meeting has been completed, I entertain a motion to adjourn the meeting.

So moved.

I second the motion. Meeting adjourned. Thank you all for your attendance and your continued support of the company.

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.