PAVmed Inc. (PAVM) Q2 2026 Earnings Call Transcript

Good morning, and welcome to the PAVMED Second Quarter 2026 Business Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. 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. Alicia Aklok, Chairman and Chief Executive Officer of PADMED, along with Dennis McGrath, Chief Financial Officer. The press release announcing our business update and financial results is available on PADMED's website. Please take a moment to read the disclaimers about forward-of-mean statements in the press release. The business update, press release, and conference call all include forward-of-mean statements, and these quarters and 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 of the SEC. For a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors, and PADMED's most recent annual report on Forms 10-K filed with the SEC, and then the subsequent updates filed in quarter reports on Forms 10-Q and subsequent Forms 8-K. Except as required by law, Padma 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. Well, 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 portfolios moving PortIO and Octaris forward under Joe Regilio's meters. We believe this progress across our portfolio positions admin to create meaningful long-term shareholder value. So let me walk through the key developments, beginning with Lucid. LUCIF continues to advance its reimbursement and commercial initiatives, as LUCIF's larger shareholder, PadMed, remains well-positioned to benefit from LUCIF's continued progress and future value creation. I encourage you to listen to yesterday's LUCIF business update call for greater detail on these developments. Of course, Medicare coverage remains LUCIF's most important near-term milestone, and we're confident in draft coverage. LUCIF's coverage expanded recently with a new positive VisaGuard coverage policy from the laboratory benefit manager, LBM, concert. Multiple client health plans of concert have already adopted the policy. VA commercialization is progressing well, and we expect success as the new federal budget cycle. Continued progress across health systems and health economics is further strengthening the foundation for future growth. So let's now move on to VAERS. 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 workflow friction and driving adoption within participants. Our implantable physiologic monitor development is also progressing well. We're targeting an early 2027 FDA 510K submission. The design enhancements have now increased the project battery life beyond the two-year target, and design freeze remains targeted for this month with full verification and validation tests. Ability testing has already been initiated. A new contract manufacturer has successfully completed its trial build with devices perform intraosseous ports or access, supporting continued advancement of our study, evaluated port I.O. in 10 patients across multiple sites. 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 Port IL would be subject to the de novo path. With outside regulatory consultants, it suggests that the publication of our first human studies may give us a shot. And now let's finish up with Octaris. And as a reminder, Octaris is developing a multimodal endoscopic imaging probe. development work is ongoing at Duke. These technical advances set the stage for our upcoming clinical validation work at UFC, which we're preparing for. IRB approval is expected in October, and our initial FDA pre-submission draft is complete. With that, I'll hand the call over to Dennis for an update on our financials.

Thanks, Lee Sean, and good morning, everyone. Our summary financial results for the second quarter were reported in our press release that has been distributed. On the next three slides, I'll emphasize a few key highlights from the 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 secure 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 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 $450 per share. It was done this way to protect the investor's tax status, but in every substantive sense, this is a long-term three-year turn note with interest-only quarterly payments and a balloon payment at maturity in February 2029. Upon shareholder approval obtained on March 27th, the Series D preferred shares were mandatorily converted into Padman 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 ESO guard LCD. So a couple key things to point out on the balance sheet. Cash at June 30th 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 virus warrants issued last year that are callable upon the virus 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 30th, down from $1.09 at year end and $1.15 at March 31st. At present, PadMed continues to be the single largest common shareholder of Lucid Diagnostics, with ownership of approximately 15% of the common shares outstanding. Although PadMed no longer has voting control, PadMed, together with its board and management, still has significant influence over Lucid with approximately 25% voting interest. Shares outstanding today, including unvested RSA, are approximately 7.3 million shares. The gap quarter and outstanding shares of 6.3 million are reflected on the slide as well as the face of the balance sheet and the 10-Q. Gap shares do not reflect the 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 Padmin's income sources versus its operating expenses. For SEC reporting purposes, the MSA, the Management Service Agreement, that income is recorded below the line. Furthermore, for the second quarter, you'll see on the slide a gap 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 increased by approximately $650,000 sequentially and $1.3 million year-over-year. The GAAP net loss attributable to PadMed as reflected in 10Q 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 four quarters by about $400,000, all of which reflects incremental various R&D expenditures. expenditures. OPEX increases moving forward are likely to be tied mostly to the R&D efforts to get virus implantable device submitted and cleared by the FDA. With that, operator, let's open it up for questions.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touchstone phone. You will hear prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speaker phone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Ed Wu with Ascendient Capital. Your line is now open.

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

Yeah, so we're going to be, 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 had said in my prepared comments about regulatory pathway. Those of you who have been with us before and saw the progress with me on Port.io prior to us pausing that project, our previous engagement with FDA prior to our publication of the first human data was firmly in the de novo pathway, which is longer and takes more capital. As we've been preparing with the relaunch of the portfolio and the relaunch of Porn.io, as we've been preparing to update our regulatory strategy and 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 510k 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, then, as I mentioned in my comments, that would be a big win as the, we'll still need a clinical trial, but the cost and the time associated with that would be significantly less.

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

Yeah, the Port.io is an internal IP, so it's not a license, so PadMed owns the full rights to that. And the license with Duke University for the Octaris technology includes worldwide rights as well.

Great. Well, thanks for answering my questions, and I wish you good luck. Thank you. Thanks, Ed.

Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Jeremy Perlman with Maxim Group. Your line is now open.

Good morning, Jeremy. Good morning. How are you doing?

First question on the Verus platform. I know it seems like commercialization is going well. Are there any metrics maybe you could provide, you know, 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?

Yeah, we're not providing hard numbers on that, but I can give you a pretty good qualitative sense. So things did not, 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 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, two and then three 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 within the first year is still, both us and the folks at OSU, 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 Aftaris. you mentioned you're preparing for a clinical validation. Just 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?

Yeah. So, yeah, 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 precancer esophageal dysplasia. So that work had been completed. So the basic core principles around using this combination of advanced OCT to do those measurements, and really outstanding ability to discriminate that has 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 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. And is there a, you know, you mentioned that if you get a 510K pathway for the Port I.O., it might speed up the potential approval. And do you have a commercialization plan in place for that? Are you working on that, or it's still a little early?

Yeah, we outlined a pretty clear plan. The Port I.O. commercialization is actually fairly straightforward. The target physician specialties are pretty straightforward. There are folks who do, 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 PadMed is, and again, sort of our access to research 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.

Okay, great. Thank you for all the information. I'll hop back in the queue. Have a nice day. Great. Thanks, Jim.

I don't know for the questions at this time. I will now turn the call over to Dr. Lishan Akwag for closing remarks.

So, great. Thanks, Operator, and thank you all for taking the time and for your attention this morning. Obviously, I appreciate the questions and enjoy 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 PadMed's strategic plan and its mission. Our two 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 Port.io and Octaris. So we remain firmly committed to PadMed's diverse-led 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