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Investor releaseQuarter not tagged2026-08-15PAVmed (PAVM) Q2 2026 Earnings Call Transcript
Motley Fool
PAVmed (PAVM) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Friday, Aug. 14, 2026 at 8:30 a.m. ET Vice President of Investor Relations - Matthew Riley Chairman and Chief Executive Officer - Lishan Aklog Chief Financial Officer - Dennis McGrath Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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. Matthew Riley: 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. 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 reimb…Read full documentShow less
Image source: The Motley Fool. Friday, Aug. 14, 2026 at 8:30 a.m. ET Vice President of Investor Relations - Matthew Riley Chairman and Chief Executive Officer - Lishan Aklog Chief Financial Officer - Dennis McGrath Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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. Matthew Riley: 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. 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. Dennis McGrath: 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: [Operator Instructions] Your first question comes from Ed Woo with Ascendiant Capital. Edward Woo: 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? Lishan Aklog: 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. Edward Woo: 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.? Lishan Aklog: 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: [Operator Instructions] Your next question comes from Jeremy Pearlman with Maxim Group. Jeremy Pearlman: 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? Lishan Aklog: 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. Jeremy Pearlman: 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? Lishan Aklog: 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. Jeremy Pearlman: 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? Lishan Aklog: 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. Operator: There are no further questions at this time. I will now turn the call over to Dr. Lishan Aklog for closing remarks. Lishan Aklog: 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. Operator: Ladies and gentlemen, this concludes the conference call for today. We thank you for participating and ask that you please disconnect your lines. Before you buy stock in PAVmed, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and PAVmed wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $421,943!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,382,819!* Now, it’s worth noting Stock Advisor’s total average return is 983% — a market-crushing outperformance compared to 216% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 14, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. PAVmed (PAVM) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-14PAVmed Inc (PAVM) (Q2 2026) Earnings Call Highlights: Narrowing Losses and Strategic Progress ...
GuruFocus.com
PAVmed Inc (PAVM) (Q2 2026) Earnings Call Highlights: Narrowing Losses and Strategic Progress ...
This article first appeared on GuruFocus. GAAP Net Loss: $6.6 million for Q2 2026, compared to a $12.3 million loss in the prior year quarter. GAAP Net Loss Attributable to PAVmed: $5.5 million, or $0.87 per share, for the second quarter. Non-GAAP Net Loss: $1.7 million, or $0.27 per share, for the second quarter. Non-GAAP Operating Expenses: $6.1 million in Q2 2026, up approximately $200,000 from the previous quarter. R&D Expenses (Non-GAAP): Increased by approximately $650,000 sequentially and $1.3 million year-over-year, largely for the Veris implantable device. Cash Position: $3.8 million at June 30, 2026. Equity Method Investment Balance: $33 million, reflecting the mark-to-market of Lucid shares at $1.07 per share on June 30. Shares Outstanding: Approximately 7.3 million shares including unvested RSAs; GAAP quarter-end shares were 6.3 million. Fair Value Changes: Non-cash charge of approximately $3.1 million in Q2 2026, compared to $10.8 million in the prior year quarter. Warning! GuruFocus has detected 6 Warning Signs with PAVM. Is PAVM fairly valued? Test your thesis with our free DCF calculator. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lucid's new positive EsoGuard coverage policy from Concert, with multiple client health plans adopting it, expands commercial coverage. VARIS commercial phase at Ohio State University is accelerating, with patient onboarding increasing and a large purchase order secured. PortIO's first-in-human results published in the Journal of Vascular Access, showing 100% device patency and no device-related adverse events. Potential shift to a 510(k) regulatory pathway for PortIO could shorten timeline and reduce capital requirements for commercialization. PAVmed's financial position improved with a $30 million Series D preferred stock offering and a $15 million senior secured note, reducing net loss year-over-year. Cash at June 30 is only $3.8 million, which may not be sufficient to fund operations without additional financing. The company's net loss, though reduced, remains significant at $5.5 million GAAP for the quarter. R&D expenses increased by $1.3 million year-over-year, primarily for the VARIS implantable device, putting pressure on cash flow. The equity method investment in Lucid decreased in value, with shares dropping from $1.09…Read full documentShow less
This article first appeared on GuruFocus. GAAP Net Loss: $6.6 million for Q2 2026, compared to a $12.3 million loss in the prior year quarter. GAAP Net Loss Attributable to PAVmed: $5.5 million, or $0.87 per share, for the second quarter. Non-GAAP Net Loss: $1.7 million, or $0.27 per share, for the second quarter. Non-GAAP Operating Expenses: $6.1 million in Q2 2026, up approximately $200,000 from the previous quarter. R&D Expenses (Non-GAAP): Increased by approximately $650,000 sequentially and $1.3 million year-over-year, largely for the Veris implantable device. Cash Position: $3.8 million at June 30, 2026. Equity Method Investment Balance: $33 million, reflecting the mark-to-market of Lucid shares at $1.07 per share on June 30. Shares Outstanding: Approximately 7.3 million shares including unvested RSAs; GAAP quarter-end shares were 6.3 million. Fair Value Changes: Non-cash charge of approximately $3.1 million in Q2 2026, compared to $10.8 million in the prior year quarter. Warning! GuruFocus has detected 6 Warning Signs with PAVM. Is PAVM fairly valued? Test your thesis with our free DCF calculator. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lucid's new positive EsoGuard coverage policy from Concert, with multiple client health plans adopting it, expands commercial coverage. VARIS commercial phase at Ohio State University is accelerating, with patient onboarding increasing and a large purchase order secured. PortIO's first-in-human results published in the Journal of Vascular Access, showing 100% device patency and no device-related adverse events. Potential shift to a 510(k) regulatory pathway for PortIO could shorten timeline and reduce capital requirements for commercialization. PAVmed's financial position improved with a $30 million Series D preferred stock offering and a $15 million senior secured note, reducing net loss year-over-year. Cash at June 30 is only $3.8 million, which may not be sufficient to fund operations without additional financing. The company's net loss, though reduced, remains significant at $5.5 million GAAP for the quarter. R&D expenses increased by $1.3 million year-over-year, primarily for the VARIS implantable device, putting pressure on cash flow. The equity method investment in Lucid decreased in value, with shares dropping from $1.09 to $1.07, reflecting market volatility. The Octeris project is still several years away from commercialization, requiring ongoing investment without near-term revenue. Q: What is the anticipated regulatory pathway for PortIO, and could a 510(k) pathway be possible?A: Lishan Aklog, Chairman and CEO, stated that while prior FDA engagement suggested a De Novo pathway, consultations with regulatory experts and the publication of successful first-in-human data may allow for a straight 510(k) pathway. This would significantly shorten the timeline and reduce capital requirements. The company plans to submit a pre-submission meeting request in Q4 2026, with the actual meeting potentially occurring in early 2027. Q: Can you provide more details on the commercial traction and patient onboarding for the Veris platform at Ohio State University?A: Lishan Aklog, Chairman and CEO, noted that while hard numbers aren't being disclosed, the strategic partnership with OSU's James Cancer Hospital involves a commitment to enroll 1,000 commercial patients in a registry within a year. With EHR integration complete and two-thirds of planned departments onboarded, patient onboarding is accelerating, and the 1,000-patient target is considered attainable. Q: What will the upcoming clinical validation study for Octeris demonstrate, and what is the timeline to FDA submission?A: Lishan Aklog, Chairman and CEO, explained that the validation study will confirm the modified, smaller probe's performance and ergonomics, building on prior clinical work that established the technology's ability to measure nuclear size to detect esophageal dysplasia. The study is a step toward design freeze, and the overall project remains several years away from FDA submission, with console development potentially running in parallel. Q: Does PAVmed hold global rights for PortIO and the Octeris technology?A: Lishan Aklog, Chairman and CEO, confirmed that PAVmed owns full rights to PortIO as it is internal IP, and the license with Duke University for Octeris includes worldwide rights. Q: What is the commercialization plan for PortIO if the 510(k) pathway is successful?A: Lishan Aklog, Chairman and CEO, stated that a clear plan is in place, targeting vascular surgeons and interventional radiologists who currently implant vascular access devices. The company is working on pricing and coding and has flexibility to launch with a small sales team or partner with distributors active in the vascular access space. Q: What is the current financial position and how has the company's capital structure changed?A: Dennis McGrath, CFO, reported cash of $3.8 million at June 30, 2026. The company completed a $30 million Series D preferred offering and issued a $15 million senior secured note to redeem all Series C preferred shares and retire existing convertible debt. The Series D shares were mandatorily converted to common stock, and $30 million in warrants are callable upon a positive EsoGuard LCD, with an additional $2.5 million from Veris warrants callable upon FDA clearance of the implantable device. Q: What were the key financial results for the second quarter of 2026?A: Dennis McGrath, CFO, reported a GAAP net loss of $6.6 million, improved from a $12.3 million loss in the prior year quarter, driven by lower non-cash fair value charges. The GAAP net loss attributable to PAVmed was $5.5 million, or $0.87 per share, while the non-GAAP loss was $1.7 million, or $0.27 per share. Non-GAAP operating expenses were $6.1 million, with increases tied to Veris R&D. Q: What is the status of the Lucid Diagnostics investment and its impact on PAVmed?A: Dennis McGrath, CFO, noted that PAVmed remains the largest common shareholder of Lucid with ~15% ownership and ~25% voting interest. The equity method investment balance is $33 million, reflecting Lucid's mark-to-market value. PAVmed continues to benefit from Lucid's progress, including new positive EsoGuard coverage policies and VA commercialization efforts. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-14PAVmed Inc. Q2 2026 Earnings Call Summary
Moby
PAVmed Inc. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing a diversified 'multiple shots on goal' model, leveraging two independently financed subsidiaries alongside a relaunched internal medical device portfolio. Veris is transitioning from pilot to full-scale commercial engagement at Ohio State University, with two-thirds of planned departments now onboarded following successful EHR integration. The PortIO regulatory strategy is being aggressively re-evaluated; management believes recent first-in-human data publication may allow for a 510(k) pathway instead of the more capital-intensive De Novo route. Lucid Diagnostics remains the primary near-term value driver, with management focused on securing a positive Medicare Local Coverage Determination (LCD) as the critical catalyst. Operational focus for the Veris implantable monitor has shifted to verification and validation testing following design enhancements that extended battery life beyond the 2-year target. The Octeris imaging platform is undergoing technical refinement at Duke University to improve processing speeds, aiming to support real-time clinical analysis during endoscopic procedures. Management targets an early 2027 FDA 510(k) submission for the Veris implantable physiologic monitor, with design freeze expected by the end of the current month. A formal FDA pre-submission meeting request for PortIO is planned for the fourth quarter, which will determine if the shorter 510(k) regulatory path is viable. Operating expense increases are expected to be primarily driven by R&D requirements for the Veris implantable device through its submission and clearance phases. The Veris commercial strategy assumes reaching a target of 1,000 patient enrollments within the first year of the Ohio State University strategic partnership. Octeris clinical validation work is contingent on IRB approval expected in October, though management notes the overall project remains several years from commercialization. The company completed a complex recapitalization, redeeming Series C preferred stock and retiring old debt through a $30 million Series D offering and a $15 million Senior Secured Note. A critical liquidity bridge exists in the form of $30 million in warrants that are only callable by the compan…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing a diversified 'multiple shots on goal' model, leveraging two independently financed subsidiaries alongside a relaunched internal medical device portfolio. Veris is transitioning from pilot to full-scale commercial engagement at Ohio State University, with two-thirds of planned departments now onboarded following successful EHR integration. The PortIO regulatory strategy is being aggressively re-evaluated; management believes recent first-in-human data publication may allow for a 510(k) pathway instead of the more capital-intensive De Novo route. Lucid Diagnostics remains the primary near-term value driver, with management focused on securing a positive Medicare Local Coverage Determination (LCD) as the critical catalyst. Operational focus for the Veris implantable monitor has shifted to verification and validation testing following design enhancements that extended battery life beyond the 2-year target. The Octeris imaging platform is undergoing technical refinement at Duke University to improve processing speeds, aiming to support real-time clinical analysis during endoscopic procedures. Management targets an early 2027 FDA 510(k) submission for the Veris implantable physiologic monitor, with design freeze expected by the end of the current month. A formal FDA pre-submission meeting request for PortIO is planned for the fourth quarter, which will determine if the shorter 510(k) regulatory path is viable. Operating expense increases are expected to be primarily driven by R&D requirements for the Veris implantable device through its submission and clearance phases. The Veris commercial strategy assumes reaching a target of 1,000 patient enrollments within the first year of the Ohio State University strategic partnership. Octeris clinical validation work is contingent on IRB approval expected in October, though management notes the overall project remains several years from commercialization. The company completed a complex recapitalization, redeeming Series C preferred stock and retiring old debt through a $30 million Series D offering and a $15 million Senior Secured Note. A critical liquidity bridge exists in the form of $30 million in warrants that are only callable by the company upon the publication of a positive EsoGuard LCD. PAVmed has transitioned from voting control to 'significant influence' over Lucid Diagnostics, maintaining a 25% voting interest despite owning 15% of common shares. First-in-human study results for PortIO published in the Journal of Vascular Access showed 100% device patency and no device-related adverse events, serving as the primary evidence for regulatory reclassification. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that while the FDA previously suggested a De Novo pathway, they will now argue for a 510(k) using existing short-term intraosseous devices as predicates. If the FDA accepts the 510(k) argument during the upcoming pre-submission process, it would significantly reduce both the capital requirements and the time to commercialization. Management declined to provide specific hard numbers but confirmed they are on track to reach the 1,000-patient registry goal at Ohio State University within the first year. Enrollment has reportedly accelerated over the last two months as onboarding expanded to two-thirds of the hospital's departments. The upcoming validation study will focus on refining the probe's ergonomics and its ability to measure nuclear size in mucosal cells to detect esophageal dysplasia. Management clarified that while validation is a key step toward design freeze, the project still requires console development and is 'several years away' from completion. PAVmed owns 100% of the internal IP for PortIO and worldwide rights for the licensed Octeris technology. The commercial plan for PortIO involves a flexible mix of a small internal sales team and partnerships with established distributors in the vascular access space.
Investor releaseQuarter not tagged2026-08-14PAVmed Provides Business Update and Reports Second Quarter 2026 Financial Results
PR Newswire
PAVmed Provides Business Update and Reports Second Quarter 2026 Financial Results
Veris Health accelerated its commercial engagement with OSU-The James Veris Health implantable physiological monitor achieved development milestones towards upcoming FDA submission Lucid Diagnostics secured first laboratory benefit manager coverage policy for EsoGuard ® Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2026 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid"), Veris Health Inc. ("Veris"), and Octeris Medical Inc. ("Octeris"), and reported financial results for the second quarter ended June 30, 2026. Conference Call and Webcast The webcast will take place on Friday, August 14, 2026, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. Business Update Highlights "PAVmed saw tangible progress across its core businesses during this past quarter and recent weeks," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "Veris accelerated its commercial engagement with OSU-The James while progressing development of its implantable physiological monitor toward FDA submission. Lucid secured an important new commercial coverage policy for EsoGuard while continuing to advance its broader commercial initiatives. And, our relaunched medical device portfolio is on track with PortIO and Octeris progressing toward key milestones." Highlights from the second quarter and recent weeks: Veris Health: Lucid Diagnostics announced second quarter 2026 financial results and key business developments, including: PAVmed Medical Device Portfolio: Financial Results: For the three months ended June 30, 2026, operating expenses were approximately $7.1 million, which included stock…Read full documentShow less
Veris Health accelerated its commercial engagement with OSU-The James Veris Health implantable physiological monitor achieved development milestones towards upcoming FDA submission Lucid Diagnostics secured first laboratory benefit manager coverage policy for EsoGuard ® Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2026 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid"), Veris Health Inc. ("Veris"), and Octeris Medical Inc. ("Octeris"), and reported financial results for the second quarter ended June 30, 2026. Conference Call and Webcast The webcast will take place on Friday, August 14, 2026, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. Business Update Highlights "PAVmed saw tangible progress across its core businesses during this past quarter and recent weeks," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "Veris accelerated its commercial engagement with OSU-The James while progressing development of its implantable physiological monitor toward FDA submission. Lucid secured an important new commercial coverage policy for EsoGuard while continuing to advance its broader commercial initiatives. And, our relaunched medical device portfolio is on track with PortIO and Octeris progressing toward key milestones." Highlights from the second quarter and recent weeks: Veris Health: Lucid Diagnostics announced second quarter 2026 financial results and key business developments, including: PAVmed Medical Device Portfolio: Financial Results: For the three months ended June 30, 2026, operating expenses were approximately $7.1 million, which included stock-based compensation expenses of $0.9 million. GAAP net loss attributable to common stockholders was approximately $5.5 million, or $(0.87) per common share on a diluted basis. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted net loss was approximately $1.7 million or $(0.27) per common share. PAVmed had cash and cash equivalents of $3.8 million as of June 30, 2026, compared to $1.5 million as of December 31, 2025. The unaudited financial results for the three and six months ended June 30, 2026 were filed with the SEC on Form 10-Q on August 13, 2026, and are available at www.pavmed.com or www.sec.gov. PAVmed Non-GAAP Measures To supplement our financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and six months ended June 30, 2026 and 2025 are as follows: About PAVmed and its Subsidiaries PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. For more information about PAVmed, please visit pavmed.com. For more information about Lucid Diagnostics, please visit luciddx.com. For more information about Veris Health, please visit verishealth.com. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed's and Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed's and Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance PAVmed's and Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's and Lucid's clinical and preclinical studies; whether and when PAVmed's and Lucid's products are cleared by regulatory authorities; market acceptance of PAVmed's and Lucid's products once cleared and commercialized; PAVmed's and Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed's and Lucid's future operations, see Part I, Item 1A, "Risk Factors," in PAVmed's and Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by PAVmed or Lucid after its most recent Annual Report. PAVmed and Lucid disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. 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TranscriptFY2026 Q22026-08-14FY2026 Q2 earnings call transcript
Earnings source - 43 paragraphs
FY2026 Q2 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. 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 one, Item 1-A entitled Risk Factors in PAVmed's most recent annual report on Forms 10-K filed with the SEC, and any subsequent updates filed in quarter 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 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. 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 Joey Virgilio's leadership. We believe this progress across our portfolio positions PAVmed to create meaningful long-term shareholder value. 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.
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 with 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 workflow friction and driving adoption within participating departments. 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 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 his trial build, with devices performing well in preliminary verification testing, and we completed our first phase of animal testing. This was also successful. 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 has 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. 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's been 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 510K. This would create a much shorter timeline and lower capital requirements to get to commercialization. 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 University of Southern California, 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 Aklog, 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. Currently, 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 on 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 term 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 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. 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 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 30th, down from $1.09 at year-end and $1.15 at March 31st.
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 RSA, 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 service agreement, net income is recorded below the line. Furthermore, for the second quarter, you will 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 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, $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 this slide, you will 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 Veris R&D expenditures. OpEx increases moving forward are likely to be tied mostly to the R&D efforts to get Veris implantable device submitted and cleared by the FDA. With that, operator, let us 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 touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Ed Woo with Ascendiant Capital Markets. Your line is now open.
Morning, Ed. Good morning, Ed.
Yeah. Congratulations on all the progress. You mentioned that you're going to have an FDA meeting with PortIO in the fourth quarter. Do you anticipate news shortly thereafter? And what do you think of the regulatory pathway may be in 2027?
Yeah. We'll be ready to submit for a request for 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 the regulatory pathway. Those of you who have been with us before and saw the progress we've made on PortIO prior to us pausing that project, our previous engagements with FDA prior to our publication of the first-in-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 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 510K pathway with existing short-term intra-office devices as a predicate. This would, again, based on the fact that we've, in the interim, had a successful first-in-human study. 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 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. Do those include global rights, or are they only rights in the U.S.?
Yeah. The PortIO is an internal IP, so it's not a license, so PAVmed owns the full rights to that. The license with Duke University for the Octeris technology includes worldwide rights as well.
Great. Well, thanks for answering my questions, and I wish you good luck. Thank you.
Yeah. Thanks, Ed.
Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Jeremy Pearlman with Maxim Group. Your line is now open.
Good morning, Jeremy.
Hey, Jeremy.
Good morning. How are you doing?
Great.
First question on the Veris platform. I know it seems like commercialization's going well. Are there any metrics maybe you could provide? How many patients have been onboarded? How quickly is the number growing? Then maybe what milestones investors should look forward to as they gauge 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. 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. The gun went off when EHR integration was completed in the spring. Obviously, at the beginning, we started with a limited number of departments, two and then three departments that had participated in the previous pilot. 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.
The target of getting to 1,000 patients within the first year is still, both us and 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. We're on a good path to get to that target.
Okay, great. Then maybe just skipping to the Octeris. You mentioned you're preparing for a clinical validation. Just what specifically will the clinical validation study demonstrate? How should we think about the timeline from that study to a potential FDA submission? Thanks.
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 pre-cancer, 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 have been well-established. 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 a 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 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 wide.
Okay, understood. Just last question, you mentioned that if you get a 510K 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 it's still a little early?
Yeah, we'd outlined a pretty clear plan. The PortIO commercialization's 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. 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.
Okay, great. Thank you for all that information. I'll hop back in the queue. Have a nice day.
Great. Thanks, Jeremy.
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, 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. To summarize, we believe we remain in a strong position to advance PAVmed'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 PortIO and Octeris. 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.
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. 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.
Investor releaseQuarter not tagged2026-08-13Lucid Diagnostics Provides Business Update and Reports Second Quarter 2026 Financial Results
PR Newswire
Lucid Diagnostics Provides Business Update and Reports Second Quarter 2026 Financial Results
Recognized 2Q26 revenue of $1.5 million Processed 2,770 EsoGuard ® tests Secured first laboratory benefit manager (LBM) EsoGuard coverage policy Conference call and webcast to be held today, August 13, at 8:30 AM EDT NEW YORK, Aug. 13, 2026 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM) ("PAVmed"), today provided a business update for the Company and reported financial results for the second quarter ended June 30, 2026. Conference Call and Webcast The webcast will take place on Thursday, August 13, 2026, at 8:30 AM and will be accessible in the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. Business Highlights "Lucid's commercial momentum strengthened throughout the second quarter and in recent weeks," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We continue to advance multiple commercial priorities while awaiting a positive draft Medicare coverage policy for EsoGuard. We secured positive commercial coverage policies, accelerated engagement with the VA and major health systems, and demonstrated the long-term economic value of EsoGuard testing. Progress across these initiatives positions Lucid to capitalize on EsoGuard's significant clinical and commercial opportunity, while increasing the company's visibility and thereby expanding opportunities for broader strategic engagement." Highlights from the second quarter and recent weeks: Recognized $1.5 million in EsoGuard revenue for 2Q26. Processed 2,770 EsoGuard® Esophageal DNA Tests in 2Q26. Secured a commercial coverage policy for EsoGuard from Concert, a healthcare technology company recently acquired by Lyric that establishes laboratory testing policies its client health plans can adopt. The policy recognizes EsoGuard as medically necessary for patients meeting established screening cr…Read full documentShow less
Recognized 2Q26 revenue of $1.5 million Processed 2,770 EsoGuard ® tests Secured first laboratory benefit manager (LBM) EsoGuard coverage policy Conference call and webcast to be held today, August 13, at 8:30 AM EDT NEW YORK, Aug. 13, 2026 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM) ("PAVmed"), today provided a business update for the Company and reported financial results for the second quarter ended June 30, 2026. Conference Call and Webcast The webcast will take place on Thursday, August 13, 2026, at 8:30 AM and will be accessible in the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. Business Highlights "Lucid's commercial momentum strengthened throughout the second quarter and in recent weeks," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We continue to advance multiple commercial priorities while awaiting a positive draft Medicare coverage policy for EsoGuard. We secured positive commercial coverage policies, accelerated engagement with the VA and major health systems, and demonstrated the long-term economic value of EsoGuard testing. Progress across these initiatives positions Lucid to capitalize on EsoGuard's significant clinical and commercial opportunity, while increasing the company's visibility and thereby expanding opportunities for broader strategic engagement." Highlights from the second quarter and recent weeks: Recognized $1.5 million in EsoGuard revenue for 2Q26. Processed 2,770 EsoGuard® Esophageal DNA Tests in 2Q26. Secured a commercial coverage policy for EsoGuard from Concert, a healthcare technology company recently acquired by Lyric that establishes laboratory testing policies its client health plans can adopt. The policy recognizes EsoGuard as medically necessary for patients meeting established screening criteria and has already been adopted by multiple Concert client health plans. Developed a health economic cost-effectiveness model evaluating EsoGuard screening to support commercial payor engagement and coverage decisions, with preliminary results demonstrating improved clinical outcomes and cost-effectiveness. Financial Results For the three months ended June 30, 2026, EsoGuard related revenues were $1.5 million. Operating expenses were approximately $14.3 million, which included stock-based compensation expenses of $1.7 million. GAAP net loss attributable to common stockholders was approximately $14.7 million, inclusive of a deemed Preferred Stock dividend of $3.0 million, or $(0.08) per common share. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted loss for the three months ended June 30, 2026 was approximately $10.9 million or $(0.06) per common share. Lucid had cash and cash equivalents of $33.4 million as of June 30, 2026, compared to $34.7 million as of December 31, 2025. The unaudited financial results for the three and six months ended June 30, 2026, were filed with the SEC on Form 10-Q on August 12, 2026, and available at www.luciddx.com or www.sec.gov. Lucid Non-GAAP Measures To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and six months ended June 30, 2026, and 2025 are as follows: About Lucid DiagnosticsLucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with GERD, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information, please visit luciddx.com and for more information about its parent company PAVmed, please visit pavmed.com. Forward-Looking StatementsThis press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics' management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. View original content to download multimedia:https://www.prnewswire.com/news-releases/lucid-diagnostics-provides-business-update-and-reports-second-quarter-2026-financial-results-302850788.html
Investor releaseQuarter not tagged2026-07-31PAVmed to Hold Second Quarter 2026 Business Update Conference Call and Webcast on August 14, 2026
PR Newswire
PAVmed to Hold Second Quarter 2026 Business Update Conference Call and Webcast on August 14, 2026
Conference Call and Webcast at 8:30 AM ET NEW YORK, July 31, 2026 /PRNewswire/ -- PAVmed Inc. (Nasdaq: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today announced that it will host a business update conference call and webcast on Friday, August 14, 2026, at 8:30 AM ET. During the call, Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer, will provide a business update and discuss the Company's operations and growth strategy. In addition, Dennis McGrath, PAVmed's President and Chief Financial Officer, will discuss the Company's second quarter 2026 financial results. The webcast will be available at the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. About PAVmedPAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics (Nasdaq: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. For more information about PAVmed, please visit pavmed.com. For more information about Lucid Diagnostics, please visit luciddx.com. For more information about Veris Health, please visit veri…Read full documentShow less
Conference Call and Webcast at 8:30 AM ET NEW YORK, July 31, 2026 /PRNewswire/ -- PAVmed Inc. (Nasdaq: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today announced that it will host a business update conference call and webcast on Friday, August 14, 2026, at 8:30 AM ET. During the call, Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer, will provide a business update and discuss the Company's operations and growth strategy. In addition, Dennis McGrath, PAVmed's President and Chief Financial Officer, will discuss the Company's second quarter 2026 financial results. The webcast will be available at the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. About PAVmedPAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics (Nasdaq: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. For more information about PAVmed, please visit pavmed.com. For more information about Lucid Diagnostics, please visit luciddx.com. For more information about Veris Health, please visit verishealth.com. View original content to download multimedia:https://www.prnewswire.com/news-releases/pavmed-to-hold-second-quarter-2026-business-update-conference-call-and-webcast-on-august-14-2026-302838867.html
Investor releaseQuarter not tagged2026-07-30Lucid Diagnostics to Hold Second Quarter 2026 Business Update Conference Call and Webcast on August 13, 2026
PR Newswire
Lucid Diagnostics to Hold Second Quarter 2026 Business Update Conference Call and Webcast on August 13, 2026
Conference Call and Webcast at 8:30 AM ET NEW YORK, July 30, 2026 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that it will host a business update conference call and webcast on Thursday, August 13, 2026, at 8:30 AM ET. During the call, Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer, will provide a business update and discuss the Company's operations and growth strategy. In addition, Dennis McGrath, Lucid's Chief Financial Officer, will discuss the Company's second quarter 2026 financial results. The webcast will be available at the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com. View original content to download multimedia:https://www.prnewswire.com/news-releases/lucid-diagnostics-to-hold-second-quarter-2026-business-update-conference-call-and-webcast-on-august-13-2026-302838737.html
Investor releaseQuarter not tagged2026-05-16PAVmed Inc. Q1 2026 Earnings Call Summary
Moby
PAVmed Inc. Q1 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management has finalized a two-year restructuring process to clean the capital structure, transitioning to a balance sheet consisting primarily of common stock and long-term debt. The company is shifting back to its founding mission as a diversified commercial life sciences incubator, utilizing a shared services model to support independently financed subsidiaries. A dedicated executive has been appointed to lead the relaunch of the medical device portfolio, specifically focusing on PortIO and licensed endoscopic imaging technologies. The business development pipeline has accelerated following the recapitalization, with management currently conducting deep-dive diligence on its second major commercial asset opportunity. Strategic focus remains on high-margin, less-commoditized products that address meaningful unmet clinical needs, particularly at the intersection of gastroenterology and oncology. Operational execution at Veris is centered on a strategic partnership with Ohio State University to refine EHR integration and clinical workflows before broader commercial scaling. The company expects to submit the Veris implantable physiologic monitor for FDA clearance by the end of 2026, following technical optimization of battery life. Future operating expense increases will be primarily driven by R&D efforts for the Veris implantable device, supported by 2025-related financing. Management anticipates that positive Medicare coverage for Lucid's EsoGuard will trigger the ability to call warrants, potentially providing $30 million in additional capital. Commercial expansion for the Veris platform beyond the initial partner is contingent upon securing additional capital to support an expanded footprint. The company is exploring expansion into therapeutics, leveraging its existing clinical research infrastructure to potentially license Phase I or Phase II assets. The company redeemed all Series C convertible preferred stock and retired legacy convertible debt using proceeds from a $30 million Series D offering and a $15 million senior note. PAVmed, together with its board and management, maintains a significant 25% voting interest in Lucid Diagnostics. and remains its largest shareholder with approximately 15% of com…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management has finalized a two-year restructuring process to clean the capital structure, transitioning to a balance sheet consisting primarily of common stock and long-term debt. The company is shifting back to its founding mission as a diversified commercial life sciences incubator, utilizing a shared services model to support independently financed subsidiaries. A dedicated executive has been appointed to lead the relaunch of the medical device portfolio, specifically focusing on PortIO and licensed endoscopic imaging technologies. The business development pipeline has accelerated following the recapitalization, with management currently conducting deep-dive diligence on its second major commercial asset opportunity. Strategic focus remains on high-margin, less-commoditized products that address meaningful unmet clinical needs, particularly at the intersection of gastroenterology and oncology. Operational execution at Veris is centered on a strategic partnership with Ohio State University to refine EHR integration and clinical workflows before broader commercial scaling. The company expects to submit the Veris implantable physiologic monitor for FDA clearance by the end of 2026, following technical optimization of battery life. Future operating expense increases will be primarily driven by R&D efforts for the Veris implantable device, supported by 2025-related financing. Management anticipates that positive Medicare coverage for Lucid's EsoGuard will trigger the ability to call warrants, potentially providing $30 million in additional capital. Commercial expansion for the Veris platform beyond the initial partner is contingent upon securing additional capital to support an expanded footprint. The company is exploring expansion into therapeutics, leveraging its existing clinical research infrastructure to potentially license Phase I or Phase II assets. The company redeemed all Series C convertible preferred stock and retired legacy convertible debt using proceeds from a $30 million Series D offering and a $15 million senior note. PAVmed, together with its board and management, maintains a significant 25% voting interest in Lucid Diagnostics. and remains its largest shareholder with approximately 15% of common shares. Current cash of $6.5 million does not include $32.5 million in potential proceeds from warrants callable upon specific regulatory and coverage milestones. The GAAP net loss attributable to PAVmed was $60,000 for the quarter, driven by non-cash mark-to-market adjustments and one-time financing costs, but this figure excludes $6.9 million in preferred dividends. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management remains open to international opportunities but notes that the majority of high-quality leads originate from U.S. academic medical centers. The company is actively evaluating therapeutics in addition to devices and diagnostics, citing a board member's expertise and existing clinical trial infrastructure as key advantages. The previous 'incubator' model was tweaked after finding it difficult to raise capital for super early-stage technologies without a dedicated leader for the portfolio. The new structure under a dedicated CEO for the device segment is intended to facilitate subsidiary-level capital raises while still utilizing PAVmed's shared services. Enrollment is trending toward the target of 1,000 patients, though the trajectory is non-linear due to initial EHR integration timelines. Current feedback is being used to refine how the platform communicates with clinical teams and call centers to optimize care before expanding to other centers.
Investor releaseQuarter not tagged2026-05-16PAVmed Inc (PAVM) Q1 2026 Earnings Call Highlights: Strategic Restructuring and Growth ...
GuruFocus.com
PAVmed Inc (PAVM) Q1 2026 Earnings Call Highlights: Strategic Restructuring and Growth ...
This article first appeared on GuruFocus. Cash at March 31: USD 6.5 million. Equity Method Investment Balance: USD 36 million, reflecting a USD 1.9 million increase in the quarter. Shares Outstanding: Approximately 7.3 million shares, including unvested RSAs. GAAP Net Loss: USD 1.1 million before noncontrolling interest and preferred dividends. GAAP Net Loss Attributable to PAVmed: USD 60,000 for the quarter, prior to preferred dividends. GAAP Loss Per Share: USD 4.42 per share after preferred dividends; USD 0.04 per share without preferred dividends. Non-GAAP Operating Expenses: USD 5.9 million, above the average of the previous four quarters by about USD 1.1 million. Warning! GuruFocus has detected 6 Warning Signs with PAVM. Is PAVM fairly valued? Test your thesis with our free DCF calculator. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PAVmed Inc (NASDAQ:PAVM) has successfully completed the restructuring of its capital structure, resulting in a clean cap table consisting only of common stock and term debt. The company is well-positioned to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries. Lucid Diagnostics, a subsidiary of PAVmed Inc (NASDAQ:PAVM), is on the cusp of transformative milestones, including impending Medicare coverage. Veris, another subsidiary, is progressing well with its commercial phase at Ohio State University, with positive feedback and successful EHR integration. PAVmed Inc (NASDAQ:PAVM) has raised capital that extends its runway well into 2027, providing financial stability for future operations. There is frustration over the delay in obtaining Medicare coverage for Lucid Diagnostics, which has been dragging on longer than expected. The company has faced challenges in raising capital for early-stage technologies, particularly in the medical device incubator model. PAVmed Inc (NASDAQ:PAVM) reported a GAAP net loss of $1.1 million for the quarter, driven by changes in the fair value of Lucid shares. Operating expenses have increased, with a first-quarter non-GAAP OpEx of $5.9 million, reflecting higher R&D expenditures and professional fees. The company is unlikely to expand its commercial footprint for Veris until additional capital is raised, limiting immediate growth opportunities.…Read full documentShow less
This article first appeared on GuruFocus. Cash at March 31: USD 6.5 million. Equity Method Investment Balance: USD 36 million, reflecting a USD 1.9 million increase in the quarter. Shares Outstanding: Approximately 7.3 million shares, including unvested RSAs. GAAP Net Loss: USD 1.1 million before noncontrolling interest and preferred dividends. GAAP Net Loss Attributable to PAVmed: USD 60,000 for the quarter, prior to preferred dividends. GAAP Loss Per Share: USD 4.42 per share after preferred dividends; USD 0.04 per share without preferred dividends. Non-GAAP Operating Expenses: USD 5.9 million, above the average of the previous four quarters by about USD 1.1 million. Warning! GuruFocus has detected 6 Warning Signs with PAVM. Is PAVM fairly valued? Test your thesis with our free DCF calculator. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PAVmed Inc (NASDAQ:PAVM) has successfully completed the restructuring of its capital structure, resulting in a clean cap table consisting only of common stock and term debt. The company is well-positioned to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries. Lucid Diagnostics, a subsidiary of PAVmed Inc (NASDAQ:PAVM), is on the cusp of transformative milestones, including impending Medicare coverage. Veris, another subsidiary, is progressing well with its commercial phase at Ohio State University, with positive feedback and successful EHR integration. PAVmed Inc (NASDAQ:PAVM) has raised capital that extends its runway well into 2027, providing financial stability for future operations. There is frustration over the delay in obtaining Medicare coverage for Lucid Diagnostics, which has been dragging on longer than expected. The company has faced challenges in raising capital for early-stage technologies, particularly in the medical device incubator model. PAVmed Inc (NASDAQ:PAVM) reported a GAAP net loss of $1.1 million for the quarter, driven by changes in the fair value of Lucid shares. Operating expenses have increased, with a first-quarter non-GAAP OpEx of $5.9 million, reflecting higher R&D expenditures and professional fees. The company is unlikely to expand its commercial footprint for Veris until additional capital is raised, limiting immediate growth opportunities. Q: As you evaluate potential new opportunities, have you considered looking outside of North America or the US? A: Lishan Aklog, Chairman and CEO: We are open to opportunities outside the US, but most technologies come from the US, particularly from academic medical centers. Our strong ties in academic medicine have been a catalyst for inquiries, and while we are open to international opportunities, the majority of our current pursuits are US-based. Q: Have you decided to focus on devices, diagnostics, or therapeutics, or are you open to all three areas? A: Lishan Aklog, Chairman and CEO: We are open to all three areas. Initially, PAVmed focused on medical devices, but we have expanded into diagnostics and digital health. We are also considering therapeutics, leveraging our shared services model and resources for clinical trials, although capital constraints have previously limited our ability to pursue therapeutic assets. Q: How does the new relaunched device portfolio differ from the incubator you had set up? A: Lishan Aklog, Chairman and CEO: The relaunch involves a dedicated leader, Joe Virgilio, managing the entire portfolio, unlike the incubator model which faced challenges in raising capital. The new approach integrates the portfolio within PAVmed's infrastructure, with a focus on advancing medical device technologies like PortIO and Octeris. Q: What criteria do you look for in a potential technology to license or include in your portfolio? A: Lishan Aklog, Chairman and CEO: We seek technologies addressing meaningful unmet clinical needs with substantial market opportunities, high margins, and less commoditization. We are particularly interested in opportunities synergizing with Lucid's resources in molecular diagnostics and those intersecting with gastroenterology and oncology. Q: How is the Veris platform's patient enrollment progressing, and are there any headwinds? A: Lishan Aklog, Chairman and CEO: Enrollment is on target, following a detailed rollout plan with Ohio State University. While initial EHR integration took longer than expected, we are expanding to new departments and learning from the process to optimize care and prepare for future commercial expansion. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-05-15PAVmed (PAVM) Q4 2025 Earnings Transcript
Motley Fool
PAVmed (PAVM) Q4 2025 Earnings Transcript
Image source: The Motley Fool. Monday, March 30, 2026 at 5:30 a.m. ET Chairman and Chief Executive Officer — Dr. Lishan Aklog Chief Financial Officer — Dennis McGrath Need a quote from a Motley Fool analyst? Email [email protected] Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed. Lishan? Lishan Aklog: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before we get into our recent operational highlights, I'd like to kind of frame where PAVmed is today. On our last quarterly call, I described how over the past now 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 ca…Read full documentShow less
Image source: The Motley Fool. Monday, March 30, 2026 at 5:30 a.m. ET Chairman and Chief Executive Officer — Dr. Lishan Aklog Chief Financial Officer — Dennis McGrath Need a quote from a Motley Fool analyst? Email [email protected] Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed. Lishan? Lishan Aklog: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before we get into our recent operational highlights, I'd like to kind of frame where PAVmed is today. On our last quarterly call, I described how over the past now 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. Dennis McGrath: 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: [Operator Instructions] Your first question comes from Jeremy Pearlman with Maxim Group. Jeremy Pearlman: 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. Lishan Aklog: 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. Jeremy Pearlman: 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? Lishan Aklog: 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. Jeremy Pearlman: 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? Lishan Aklog: 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: [Operator Instructions] Your next question comes from Ed Woo with Ascendiant Capital. Edward Woo: 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? Lishan Aklog: 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. Operator: There are no further questions at this time. I will now turn the call over to Dr. Lishan Aklog for closing remarks. Lishan Aklog: 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. Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Before you buy stock in PAVmed, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and PAVmed wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $468,861!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,445,212!* Now, it’s worth noting Stock Advisor’s total average return is 1,013% — a market-crushing outperformance compared to 210% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 15, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. PAVmed (PAVM) Q4 2025 Earnings Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-15PAVmed Provides Business Update and Reports First Quarter 2026 Financial Results
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PAVmed Provides Business Update and Reports First Quarter 2026 Financial Results
Veris Health progressed commercial expansion and advanced implantable physiological monitor development toward FDA submission Lucid Diagnostics continued building commercial momentum and strengthened its balance sheet ahead of key upcoming reimbursement milestones PAVmed advanced its relaunched medical device portfolio; evaluation of additional acquisition opportunities ongoing Conference call and webcast to be held today, May 15, at 8:30 AM EDT NEW YORK, May 15, 2026 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and reported financial results for the first quarter ended March 31, 2026. Conference Call and Webcast The webcast will take place on Friday, May 15, 2026, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. Business Update Highlights "PAVmed now has a significantly simplified capital structure and strengthened balance sheet, positioning the Company to focus on execution across our core businesses and evaluate additional asset acquisition opportunities aligned with our long-term growth strategy," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "Veris continues to expand its commercial engagement with OSU-The James while progressing development of its implantable physiological monitor toward FDA submission, and Lucid continues to build commercial momentum for EsoGuard with a strengthened balance sheet pending Medicare coverage. We are also actively advancing multiple technologies within our relaunched medical device portfolio under Joseph Virgilio's leadership, while increasingly leveraging his experience building and scaling growth-stage businesses."…Read full documentShow less
Veris Health progressed commercial expansion and advanced implantable physiological monitor development toward FDA submission Lucid Diagnostics continued building commercial momentum and strengthened its balance sheet ahead of key upcoming reimbursement milestones PAVmed advanced its relaunched medical device portfolio; evaluation of additional acquisition opportunities ongoing Conference call and webcast to be held today, May 15, at 8:30 AM EDT NEW YORK, May 15, 2026 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and reported financial results for the first quarter ended March 31, 2026. Conference Call and Webcast The webcast will take place on Friday, May 15, 2026, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. Business Update Highlights "PAVmed now has a significantly simplified capital structure and strengthened balance sheet, positioning the Company to focus on execution across our core businesses and evaluate additional asset acquisition opportunities aligned with our long-term growth strategy," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "Veris continues to expand its commercial engagement with OSU-The James while progressing development of its implantable physiological monitor toward FDA submission, and Lucid continues to build commercial momentum for EsoGuard with a strengthened balance sheet pending Medicare coverage. We are also actively advancing multiple technologies within our relaunched medical device portfolio under Joseph Virgilio's leadership, while increasingly leveraging his experience building and scaling growth-stage businesses." Highlights from the first quarter and recent weeks: Relaunched PAVmed medical device portfolio progressed multiple device opportunities under the leadership of Joseph Virgilio, including the PortIO implantable intraosseous vascular access device and endoscopic esophageal imaging technology licensed from Duke University. In addition to overseeing development and commercialization of the current and future device portfolio, Mr. Virgilio is also assuming broader responsibilities aligned with his experience building and scaling growth-stage medtech businesses. Veris continued development of its implantable physiological monitor, with presubmission and testing activities expected to begin soon in support of a planned FDA 510(k) submission. Veris further advanced its strategic engagement with The Ohio State University's James Cancer Hospital, with the commercial phase underway, expansion into additional departments in progress, and continued positive clinical and administrative feedback. Lucid Diagnostics announced first quarter 2026 financial results and key business developments, including: Recognized $1.3 million in EsoGuard® Esophageal DNA Test revenue for 1Q26 and processed 3,177 EsoGuard tests. Strengthened balance sheet with underwritten public offering of common stock, netting approximately $17 million in proceeds; ended 1Q26 with $45 million in proforma cash, extending runway into 2027. Strong presence at Digestive Disease Week (DDW), which included multiple EsoGuard abstracts, extensive engagement with the gastroenterology community, and a preview of a major upcoming clinical practice guideline update recommending EsoGuard and EsoCheck® as the only non-endoscopic test with high certainty of evidence. Financial Results: For the three months ended March 31, 2026, Operating expenses were approximately $8.1 million which include stock-based compensation expenses of $0.2 million. GAAP net loss attributable to common stockholders was approximately $7.0 million, or $(4.42) per common share on a diluted basis. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted net loss was approximately $1.9 million or $(1.17) per common share. PAVmed had cash and cash equivalents of $6.5 million as of March 31, 2026, compared to $1.5 million as of December 31, 2025. The unaudited financial results for the three months ended March 31, 2026 were filed with the SEC on Form 10-Q on May 14, 2026, and are available at www.pavmed.com or www.sec.gov. PAVmed Non-GAAP Measures To supplement our financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three months ended March 31, 2026 and 2025 are as follows: About PAVmed and its Subsidiaries PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. For more and for more information about PAVmed, please visit pavmed.com. For more information about Lucid Diagnostics, please visit luciddx.com. For more information about Veris Health, please visit verishealth.com. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed's and Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed's and Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance PAVmed's and Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's and Lucid's clinical and preclinical studies; whether and when PAVmed's and Lucid's products are cleared by regulatory authorities; market acceptance of PAVmed's and Lucid's products once cleared and commercialized; PAVmed's and Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed's and Lucid's future operations, see Part I, Item 1A, "Risk Factors," in PAVmed's and Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by PAVmed or Lucid after its most recent Annual Report. PAVmed and Lucid disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. 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