PAVmed Q2 2026 Earnings Report

PAVmed EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.47
• Beat/Miss: N/A
• One Year Ago EPS: N/A

PAVmed Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $0.05 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

PAVmed Announcement Details

• Quarter: Q2 2026
• Date: 8/14/2026
• Time: Before Market Opens
• Conference Call Date: Friday, August 14, 2026
• Conference Call Time: 8:30AM ET

PAVmed (NASDAQ:PAVM) is a clinical-stage medical technology company focused on acquiring, developing and commercializing innovative medical devices aimed primarily at gastrointestinal endoscopy and related therapeutic areas. Its portfolio includes FDA-cleared products such as EsoFLIP® Distensibility System for the treatment of esophageal strictures and MUSE™ (Medigus Ultrasonic Surgical Endostapler) for endoscopic fundoplication in gastroesophageal reflux disease (GERD). In addition to its gastrointestinal franchise, PAVmed is advancing early-stage programs targeting indications in oncology, urology and dermatology.

Founded in 2012, PAVmed has built its pipeline through internal research and development as well as strategic collaborations and acquisitions. The company completed its initial public offering in 2017 and maintains research, development and regulatory operations in North America and strategic partnerships in Europe. PAVmed’s multidisciplinary team leverages clinical insights, engineering expertise and regulatory know-how to shepherd devices from concept through pivotal studies and commercialization.

PAVmed’s executive leadership brings together seasoned professionals from the medical device, clinical practice and regulatory sectors. The management team emphasizes streamlined regulatory pathways and robust clinical trial design, seeking to deliver less-invasive treatment options that address high unmet needs. Though based in the United States, the company’s regulatory clearances and distribution agreements extend into key international markets.

Looking ahead, PAVmed is focused on driving commercial adoption of its approved devices while advancing its mid- and late-stage programs toward pivotal data readouts and regulatory submissions. By targeting areas where minimally invasive approaches can improve patient outcomes and reduce healthcare costs, the company aims to establish sustainable growth through a diversified pipeline of differentiated medical technologies.

PAVmed Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Lucid Diagnostics continues to advance reimbursement and commercialization efforts, including expanded commercial coverage for EsoGuard through Concert and ongoing VA and health-system adoption. Medicare coverage remains the key near-term catalyst, although positive draft coverage has not yet been secured.
• Positive Sentiment: Veris is gaining commercial traction at Ohio State University, with roughly two-thirds of planned departments onboarded, patient enrollment accelerating, and a large purchase order supporting onboarding through year-end. Management still believes the target of enrolling 1,000 commercial patients in the first year is attainable.
• Positive Sentiment: Veris’s implantable physiologic monitor remains on track for design freeze this month and an early 2027 FDA 510(k) submission, with battery life exceeding the two-year target and successful preliminary verification and animal testing.
• Positive Sentiment: PortIO’s positive 10-patient first-in-human results showed 100% device patency, 90% completion of the intended implant duration, and no device-related adverse events. Consultants believe the device may qualify for a faster, less capital-intensive 510(k) pathway instead of de novo review, though this remains uncertain and subject to FDA discussions.
• Negative Sentiment: PAVmed ended the quarter with only $3.8 million in cash, while second-quarter non-GAAP operating expenses rose to $6.1 million as Veris implantable R&D increased. The company is relying on potential future warrant exercises tied to Lucid Medicare coverage and Veris FDA clearance to add capital.

Presentation

[Operator]

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.

[Matt Riley, VP of Investor Relations at PAVmed]

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.

[Matt Riley, VP of Investor Relations at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Dennis McGrath, CFO at PAVmed]

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.

[Operator]

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

[Lishan Aklog, Chairman and CEO at PAVmed]

Morning, Ed. Good morning, Ed.

[Ed Woo, Analyst at Ascendiant Capital Markets]

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?

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Ed Woo, Analyst at Ascendiant Capital Markets]

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.?

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Ed Woo, Analyst at Ascendiant Capital Markets]

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

[Lishan Aklog, Chairman and CEO at PAVmed]

Yeah. Thanks, Ed.

[Operator]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

Good morning, Jeremy.

[Dennis McGrath, CFO at PAVmed]

Hey, Jeremy.

[Jeremy Pearlman, Analyst at Maxim Group]

Good morning. How are you doing?

[Lishan Aklog, Chairman and CEO at PAVmed]

Great.

[Jeremy Pearlman, Analyst at Maxim Group]

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?

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Jeremy Pearlman, Analyst at Maxim Group]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Jeremy Pearlman, Analyst at Maxim Group]

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?

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Jeremy Pearlman, Analyst at Maxim Group]

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

[Lishan Aklog, Chairman and CEO at PAVmed]

Great. Thanks, Jeremy.

[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, Chairman and CEO at PAVmed]

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.

[Lishan Aklog, Chairman and CEO at PAVmed]

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.

[Operator]

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

Participants

Executives

• Matt Riley, VP of Investor Relations
• Lishan Aklog, Chairman and CEO
• Dennis McGrath, CFO

Analysts

• Ed Woo, Analyst at Ascendiant Capital Markets
• Jeremy Pearlman, Analyst at Maxim Group