Q2 2025 PAVmed Inc Earnings Call and Business Update
Speaker #1: Please go ahead.
Speaker #3: Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call and joining me today on the call are Dr. Lishan Aklog, Chairman and CEO of PAVmed, along with Dennis McGrath, CFO.
Matt 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 CEO of PAVmed, along with Dennis McGrath, CFO of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release, and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made.
Matt 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 CEO of PAVmed Inc., along with Dennis McGrath, CFO of PAVmed Inc. The press release announcing our business update and financial results is available on PAVmed Inc.'s website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release, and the conference call all include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC.
Speaker #3: PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release.
Speaker #3: The business update press release and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made.
Speaker #3: Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC. For our list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled "Risk Factors" in PAVmed's most recent annual report on Form 10-K, filed with the SEC, and any subsequent updates filed in the quarterly reports on Form 10-Q and subsequent Form 8-K.
Matt Riley: 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 1A entitled Risk Factors in PAVmed's most recent annual report on Forms 10-K filed with the SEC, and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K. Except as required by law, PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
Matt Riley: For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors in PAVmed Inc.'s most recent annual report on Forms 10-K filed with the SEC and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K. Except as required by law, PAVmed Inc. disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statement. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed Inc. Lishan?
Speaker #3: Except as required by law, PAVmed's claims and the intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations, or in events, conditions, or circumstances on which the expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
Speaker #3: I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Lishan?
Matt Riley: I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Lishan?
Speaker #4: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment.
Lishan Aklog: Thank you, Matt, good morning, everyone. Thank you for joining our quarterly update call. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. We'll be diving into our operational highlights in a bit, but before doing that, just a reminder that we've taken some critical steps over the past year to stabilize PAVmed's corporate structure and balance sheet. There's some still work to be done on that front. Despite that, you know, we believe we remain well-positioned to operate as a diversified commercial life sciences company with multiple independently financed subsidiaries that operate under our shared services model. Let me just give a brief overview of PAVmed's portfolio. PAVmed is a vehicle to deliver innovative medical technologies.
Lishan Aklog: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. As always, I would like to thank our long-term shareholders for your ongoing support and commitment. We will be diving into our operational highlights in a bit, but before doing that, just a reminder that we have taken some critical steps over the past year to stabilize PAVmed Inc.'s corporate structure and balance sheet. There is still some work to be done on that front. Despite that, we believe we remain well-positioned to operate as a diversified commercial life sciences company with multiple independently financed subsidiaries that operate under our shared services model. Let me just give a brief overview of PAVmed Inc.'s portfolio. PAVmed Inc. is a vehicle to deliver innovative medical technologies. As I mentioned, we operate under a shared services model. As our subsidiaries succeed, PAVmed Inc. will also succeed.
Speaker #4: We'll be diving into our operational highlights in a bit, but before doing that, just a reminder that we've taken some critical steps over the past year to stabilize PAVmed's corporate structure and balance sheet.
Speaker #4: There's some still work to be done on that front, but despite that, you know, we believe we're now we remain well-positioned to operate as a diversified, commercialized scientist company with multiple independently financed subsidiaries that operate under our shared services model.
Speaker #4: So let me just give a brief overview of PAVmed's portfolio. So PAVmed is a vehicle to deliver innovative medical technologies. As I mentioned, we operate under shared services model, and as our subsidiaries succeed, PAVmed will also succeed.
Lishan Aklog: As I mentioned, we operate under a shared services model, and as our subsidiaries succeed, PAVmed will also succeed. Lucid is our publicly traded diagnostics company. It's obviously our strongest, most advanced asset, and it's on the cusp of key reimbursing milestones, including Medicare, which we'll talk about in more, in a little more detail later. Lucid has been able to raise its own capital and has sufficient runway to accelerate commercialization once we secure Medicare coverage. Veris Health is our digital health company that has a cancer care platform that enhances personal personalized care, and we'll go over some of the updates in a bit.
Speaker #4: The Lucid is our publicly traded diagnostics company. It's obviously our strongest, most advanced asset, and it's on the cusp of key reimbursing milestones, including Medicare, which we'll talk about in a little more detail later, and Lucid has been able to raise its own capital and has sufficient runway to accelerate commercialization once we secure Medicare coverage.
Lishan Aklog: Lucid Diagnostics is our publicly traded diagnostics company. It is obviously our strongest, most advanced asset, and it is on the cusp of key reimbursement milestones, including Medicare coverage, which we will talk about in a little more detail later. Lucid Diagnostics has been able to raise its own capital and has sufficient runway to accelerate commercialization and wants to be secure Medicare coverage. Veris Health is our digital health company that has a Veris Cancer Care platform that enhances personalized care, and we will go over some of the updates in a bit. Veris Health has also been able to secure some financing, and that has given us the ability to restart development of the device, the implantable physiologic monitor, which works in conjunction with the Veris Cancer Care platform.
Speaker #4: Ferris Health is our digital health company that has a cancer care platform that enhances personalized care, and we'll go over some of the updates in a bit.
Lishan Aklog: Veris has also been able to secure its own financing, and that has given us the ability to restart development of the device, the implantable physiologic monitor, which works in conjunction with the cancer care platform. PMX, our incubator, which houses some internal projects like PortIO. We've been working to try to raise capital for these internal projects. That really remains an ongoing challenge. However, we also, in parallel, continue to be solicited regarding other very promising assets which we continue to aggressively pursue. We do remain active in this front and are trying to find, trying to balance incorporating new assets with the availability of capital. On the biopharma side, we talked a bit last, on our last call about us exploring opportunities within the biopharma space.
Speaker #4: Ferris has also been able to secure its own financing and that has given us the ability to restart development of the device, the implantable physiologic monitor, which works in conjunction with the cancer care platform.
Speaker #4: PMX, our incubator, which houses some internal projects like Port.io, we've been working to try to raise capital for these internal projects that really remains an ongoing challenge.
Lishan Aklog: PMX, our incubator, which houses some internal projects like PortIO, we have been working to try to raise capital for these internal projects. That really remains an ongoing challenge. However, we also, in parallel, continue to be solicited regarding other very promising assets, which we continue to aggressively pursue. We do remain active in this front and are trying to balance incorporating new assets with the availability of capital. On the biopharma side, we talked a bit last call about us exploring opportunities within the biopharma space. At our last call, we thought we were close with regard to one asset that fits well within our shared services model and could leverage our clinical research team, which is one of the reasons why we have decided, in conjunction with one of our board members, to explore in this space.
Speaker #4: However, we also in parallel continue to be solicited regarding other very promising assets, which we continue to aggressively pursue. So we do remain active in this front and are trying to find trying to balance incorporating new assets with the availability of capital.
Speaker #4: And on the biopharma side, we talked a bit last call about us exploring opportunities within the biopharma space at our last call. We thought we were close with regard to one asset, that fits well within our shared services model and could leverage our clinical research team, which is one of the reasons why we did we have decided in conjunction with one of our board members to explore in this space.
Lishan Aklog: At our last call, we thought we were close with regard to one asset that fits well within our shared services model and could leverage our clinical research team, which is one of the reasons why we have decided, in conjunction with one of our board members, to explore in this space. Unfortunately, that asset fell through, the pipeline actually remains robust, and we continue to explore interesting assets in this vertical. Let's just do a brief update on Lucid. Obviously, I encourage you to listen to yesterday's Lucid business update call for greater detail on each of these areas. The main takeaway is that Lucid is now better positioned than ever to capitalize on the large market opportunity that EsoGuard profiles.
Speaker #4: Fortunately, that asset fell through, but the pipeline actually remains robust and we continue to continue to explore interesting assets in this in this vertical.
Lishan Aklog: Fortunately, that asset fell through, but the pipeline actually remains robust, and we continue to explore interesting assets in this vertical. Let's just do a brief update on Lucid Diagnostics. Obviously, I encourage you to listen to yesterday's Lucid Diagnostics business update call for greater detail on each of these areas. The main takeaway is that Lucid Diagnostics is now better positioned than ever to capitalize on the large market opportunity that EsoGuard provides. There are some real concrete near-term milestones that we believe will drive Lucid Diagnostics' success and therefore will positively impact PAVmed Inc. Just to highlight some numbers, EsoGuard test volume was 2,756 tests, which was within the target range of 2,500 to 3,000 tests per quarter. Revenue was up about 40% from Q1 at a record level of $1.2 million for the quarter.
Speaker #4: So let's just do a brief update on Lucid. Obviously, I encourage you to listen to yesterday's Lucid business update call for greater detail on each of these areas.
Speaker #4: But the main takeaway is that Lucid is now better positioned than ever to capitalize on the large market opportunity that has occurred profoundly. And there are some some real concrete near-term milestones that we believe will drive Lucid's success and therefore will positively impact PAVmed.
Lishan Aklog: There are some real concrete near-term milestones that we believe will drive Lucid's success and therefore will positively impact PAVmed. Just to highlight some numbers, EsoGuard test volume was 2,756 tests, which was within the target range of 2,500 to 3,000 tests per quarter. Revenue was up about 40% from Q1, at a record level at $1.2 million for the quarter. As I went through in a lot of detail on our call yesterday, the big upcoming event for Lucid is this MolDX Contractor Advisory Committee Meeting, the CAC meeting, which is a critical step in the LCD process for Medicare coverage.
Speaker #4: Just to highlight some numbers: e-cigar test volume was 2,756 tests, which was within the target range of 100 to 3,000 tests per quarter, and revenue was up about 40% from Q1.
Speaker #4: At our record level of $1.2 million for the quarter, as I went through in a lot of detail on our call yesterday, the big event coming up for Lucid is the MOL-DX contractor advisory meeting.
Lishan Aklog: As I went into a lot of detail on our call yesterday, the big event, the upcoming event for Lucid Diagnostics, is this MOLX contractor advisory meeting, the CAC meeting, which is a critical step in the LCD process for Medicare coverage. We believe we're in the final stages of that and it indicates strong evidence of progress towards positive Medicare coverage policy. Lucid Diagnostics also announced a partnership with Hoag Health, a world-class health system in Southern California, to launch a comprehensive integrated EsoGuard esophageal precancer testing program across the entire hospital healthcare delivery network, including gastroenterologists, primary care physicians, and concierge medicine. We're very excited about this model. We're excited about this engagement, which really provides a model for additional health systems, which we are now engaging with to try to replicate the Hoag Health model. Dennis McGrath will talk about it in more detail.
Speaker #4: The CAC meeting which is a critical step in the LCD process for Medicare coverage. We believe we're in the final stages of that, and it indicates a strong evidence of progress towards positive Medicare coverage policy.
Lishan Aklog: We believe we're in the final stages of that and indicates a strong evidence of progress towards positive Medicare coverage policy. Lucid also announced a partnership with Hoag, a world-class health system in Southern California, to launch a comprehensive integrated EsoGuard esophageal pre-cancer testing program across these higher hospital healthcare delivery network, including gastroenterologists, primary care physicians, and concierge medicine. We're very excited about this model. We're excited about this engagement, which really provides a model for additional health systems which we are now engaging with to try to replicate the Hoag model. As Dennis will talk about in more detail, Lucid also strengthened its balance sheet with an underwritten public offering and has sufficient capital to get through these upcoming milestones.
Speaker #4: Lucid also announced a partnership with Hogue, a world-class health system in Southern California, to launch a comprehensive integrated e-cigar esophageal precancer testing program. Across the entire hospital and healthcare delivery network, including gastroenterologists, primary care physicians, and concierge medicine, and we're very excited about this model and we're excited about this engagement, which really provides a model for additional health systems which we are now engaging with to try to replicate the Hogue model.
Speaker #4: As Dennis will talk about in more detail, we've also strengthened our Lucid also strengthens its balance sheet with an underwritten public offering and has sufficient capital to get through these upcoming milestones.
Lishan Aklog: We've also strengthened, Lucid Diagnostics also strengthened its balance sheet with an underwritten public offering and has sufficient capital to get through these upcoming milestones. Consistent with the PAVmed Inc. model, Lucid Diagnostics continues to succeed at raising its own capital. Finally, on the commercial side, Lucid Diagnostics secured its first private commercial coverage policy from Highmark Blue Cross Blue Shield, and that became effective in late May. As I noted on the call, this has been a very positive experience for us. It establishes a precedent both with regard to our commercial insurance engagements and with Medicare as well. It really points to the value of our clinical evidence, clinical validity, utility, as well as the economic arguments supporting EsoGuard. We remain deeply engaged with our commercial payers and are already seeing traction within the Highmark Blue Cross Blue Shield coverage area. Let's move on to Veris Health.
Speaker #4: And consistent with the PAVmed model, Lucid continues to succeed at raising its own capital. Finally, on the commercial side, Lucid secured its first private commercial coverage policy from Highmark Blue Cross Blue Shield, and that became effective in late May.
Lishan Aklog: Consistent with the PAVmed model, Lucid continues to succeed at raising its own capital. Finally, on the commercial side, Lucid secured its first private commercial coverage policy from Highmark Blue Cross Blue Shield, and that became effective in late May. As I noted on the call, this has been a very positive experience for us. It establishes a precedent both with regard to our commercial insurance engagements and with Medicare as well. It really points to the value of our clinical evidence, clinical validity, utility, as well as the economic argument supporting EsoGuard. We remain deeply engaged with our commercial payers and are already seeing traction within the Highmark coverage area. Let's move on to Veris Health.
Speaker #4: And as I noted on the call, this has been a very positive experience for us. It establishes a precedent both with regard to our commercial insurance engagements and with Medicare as well.
Speaker #4: And it really points to the value of our clinical evidence, clinical validity, utility, as well as the economic arguments supporting e-cigar. So we remain deeply engaged with our commercial payers and are already seeing traction within the Highmark coverage area.
Speaker #4: So let's move on to Ferris Health, some recent highlights include that Ferris completed a second financing, a $2.5 million direct equity financing that supplemented an earlier $2.4 million financing, at a very attractive pre-money valuation of $35 million.
Lishan Aklog: Some recent highlights include that Veris completed a second financing, a $2.5 million direct equity financing that supplemented an earlier $2.4 million financing at a very attractive pre-money valuation of $35 million. We're very excited about that. It really shows investor confidence in Veris' commercial potential and the progress we've made to date. Most importantly, it provides sufficient capital to fund the development of the implantable physiologic monitor, which had been on pause, and to get that through FDA clearance and subsequent commercial launch, so we can serve its purpose as a value-added in conjunction with the platform. That development has restarted as soon as we completed that financing, we have a clear path with FDA. We had our final meeting with FDA.
Lishan Aklog: Some recent highlights include that Veris Health completed a second financing, a $2.5 million direct equity financing that supplemented an earlier $2.4 million financing at a very attractive pre-money valuation of $35 million. We are very excited about that. It really shows investor confidence in Veris Health's commercial potential and the progress we have made to date. Most importantly, it provides sufficient capital to fund the development of the implantable physiologic monitor, which had been on pause, and to get that through FDA clearance and subsequent commercial launch so it can serve its purpose as a value-added in conjunction with the platform. That development has restarted as soon as we completed that financing. We have a clear path with FDA. We had our final meeting with FDA, as many, many meetings we have had with them. That feedback was favorable.
Speaker #4: We're very excited about that. It really shows investor confidence in Ferris' commercial potential and the progress we've made to date. And most importantly, it provides sufficient capital to fund the development of the implantable physiologic monitor, which had been on pause and to get that through FDA clearance and subsequent commercial launch so it can service purpose as a value-added in conjunction with the platform.
Speaker #4: That development has restarted as soon as we completed that financing, and we have a clear path with FDA. We had our final meeting with FDA many, many meetings we've had with them that feedback was favorable.
Lishan Aklog: As many meetings we've had with them, that feedback was favorable. We were actually able to bypass an in-person meeting, and we look forward to completing the development work and filing for FDA in 2026. Our long-term strategic partnership with Ohio State University, The James Cancer Center, really progressed nicely during this quarter. We completed our partnership agreement with them and are heading towards a commercial launch. Right now the electronic health record integration step is in process. It's gone a little bit slower than we expected, but should be wrapping up.
Speaker #4: We were actually able to bypass it in person meeting and we look forward to completing the development work and filing for FDA in 2026.
Lishan Aklog: We were actually able to bypass an in-person meeting, and we look forward to completing the development work and filing for FDA in 2026. Our long-term strategic partnership with The Ohio State University’s James Cancer Center really progressed nicely during this quarter. We completed our partnership agreement with them and are heading towards a commercial launch. Right now, the EHR integration step is in process. It is going a little bit slower than we expected, but it should be wrapping up. It will allow us to do a broad launch across the cancer center to onboard patients across a variety of condition-specific groups with a target of enrolling over 1,000 patients within the first year. We have also begun on a variety of components of a longer-term strategic plan that we look to start implementing upon completion of the submission and clearance of the implantable monitor.
Speaker #4: Our long-term strategic partnership with Ohio State University and the James Cancer Center really progressed nicely during this quarter. We completed our partnership agreement with them and are heading towards commercial launch.
Speaker #4: Right now, the electronic health record integration step is in process. It's going a little bit slower than we expected but should be wrapping up.
Speaker #4: And it will allow us to do a broad launch across the cancer center to onboard patients across a variety of conditions, specific groups with a target of enrolling over a thousand patients within the first year.
Lishan Aklog: It'll allow us to do a broad launch across the across the cancer center to onboard patients across a variety of condition-specific groups with a target of enrolling over 1,000 patients within the first year. We've also begun on a variety of components of a longer-term strategic plan that we look to start implementing upon completion of the submission and clearance of the implantable. This includes a commercial strategy that builds on the model that we've established with The James Cancer Center at Ohio State and continue to target new accounts.
Speaker #4: We've also begun on a variety of components of a longer-term strategic plan. That we look to start implementing upon completion of the submission and clearance of the implantable.
Speaker #4: This includes a commercial strategy that builds on the model that we've established with the James Cancer Center at Ohio State and continue to target new accounts.
Lishan Aklog: This includes a commercial strategy that builds on the model that we have established with The Ohio State University’s James Cancer Center and continue to target new accounts. It also includes the commercial model for the implantable, and we are working through pricing and our commercial strategy on the implantable. So far, that looks very attractive, very attractive from a pricing point of view. Then we look towards commercial expansion after the implantable is clear. Beyond that, we are also hard at work at developing an internal program to put us in a position where we can expand beyond simple remote patient monitoring to embrace AI, artificial intelligence-based clinical decision support tools that are targeted towards cancer care.
Speaker #4: It also includes the commercial model for the implantable, and we're working through pricing and our commercial strategy on the implantable, and so far that looks very attractive from a pricing point of view.
Lishan Aklog: It also includes the commercial model for the implantable, we're working through pricing and our commercial strategy on the implantable, so far that looks very attractive, very attractive from a pricing point of view. Then we look towards commercial expansion after the implantable is clear beyond that. We're also hard at work at developing an internal program to put us in a position where we can expand beyond simple re-remote patient monitoring to embrace AI, Artificial Intelligence-based clinical decision support tools that are targeted towards cancer care. We really believe we have a good opportunity to do that and are putting in the resources and the effort to develop a strategic plan that we would seek to launch upon completion of the implantable.
Speaker #4: And then we look towards commercial expansion after the implantable is clear beyond that. We're also hard at work at developing an internal program to put us in a position where we can expand beyond simple remote patient monitoring to embrace AI, artificial intelligence-based clinical decision support tools that are targeted towards cancer care.
Speaker #4: And we really believe we have a good opportunity to do that and are putting in the resources and the effort to develop a strategic plan that we would seek to launch upon completion of the implantable.
Lishan Aklog: We really believe we have a good opportunity to do that and are putting in the resources and the effort to develop a strategic plan that we would seek to launch upon completion of the implantable. Our focus right now, as I mentioned, is to complete the LSU engagement and to get the implantable across the finish line. That is the primary focus of our team. There is a lot of strategic work going on behind the scenes to make sure when that is completed, that we will be in a position to really, really create some significant value over the long term. With that, I will pass the call on to Dennis.
Speaker #4: Our focus right now, as I mentioned, is to complete the LSU engagement and to get the implantable across the finish line. That's the primary focus of our team, but there's a lot of strategic work going on behind the scenes to make sure that when that's completed, we will be in a position to really create some significant value over the long term.
Lishan Aklog: Our focus right now, as I mentioned, is to complete the OSU engagement and to get the implantable across the finish line, and that's the primary focus of our team. There's a lot of strategic work going on behind the scenes to make sure when that's completed, that we'll be in a position to really create some significant value over the long term. With that, I'll pass the call on to Dennis.
Speaker #4: So with that, I'll pass the call on to Dennis.
Speaker #5: Thanks, Lishan, and good morning, everyone. A 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.
Dennis McGrath: Thanks, Lishan, good morning, everyone. A summary financial results for Q2 were reported in our press release that has been distributed. On the next 3 slides, I'll emphasize a few key highlights from Q2, 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. A couple of reminders as our financials, particularly the income statement with year-over-year comparisons, will for the next couple of quarters illustrate periods before 10 September 2024, with Lucid's operating results being consolidated into the presented PAVmed results first, this year's the 2025 periods, without Lucid's operating results being consolidated into PAVmed's financials.
Dennis McGrath: Thanks, Lishan, 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 will 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. A couple of reminders, as our financials, particularly an income statement with year-over-year comparisons, will for the next couple of quarters illustrate periods before September 10, 2024, with Lucid's operating results being consolidated into the presented PAVmed results, versus this year's the 2025 period without Lucid's operating results being consolidated into PAVmed financials. We do present some supplementary information in the footnotes of financial statements, particularly footnote four of the 10-Q that helps with some of the comparisons.
Speaker #5: A couple of reminders, as our financials, particularly in income statement with year-over-year comparisons, will for the next couple of quarters illustrate periods before September 10th, 2024, with Lucid's operating results being consolidated into the presented PAVmed results.
Speaker #5: First, this year's the 2025 periods without Lucid's operating results being consolidated into PAVmed financials. We do present some supplementary information in the footnote of financial statements, particularly footnote 4 of the 10-Q that helps with some of the comparisons.
Dennis McGrath: We do present some supplementary information in the footnote, footnotes of financial statements, particularly footnote 4 of the 10-Q, that helps with some of the comparisons. With regard to the balance sheet, you will recall from our last 3 investor update calls in November, March, and May that the company was engaged in a multi-step process to regain compliance with NASDAQ listing standard for the minimum equity level, which it did in February. Also positioned the company for longer term financial stability. The 2 key components were deconsolidating Lucid from PAVmed's consolidated financial statements and restructuring our debt whereby we exchanged about 80% of our outstanding debt for new Series C preferred equity. The slide reflects the balance sheets for Q2 and Q1, both after deconsolidation. Again, that occurred on 10 September 2024.
Speaker #5: With regard to the balance sheet, you will recall from our last three investor update calls in November, March, and May, that the company was engaged in a multi-step process to regain compliance with NASDAQ listing standards for the minimum equity level which it did in February, and also positioned the company for longer-term financial stability.
Dennis McGrath: With regard to the balance sheet, you will recall from our last three investor update calls in November, March, and May that the company was engaged in a multi-step process to regain compliance with the NASDAQ listing standard for the minimum equity level, which it did in February, and also positioned the company for longer-term financial stability. The two key components were deconsolidating Lucid from PAVmed's consolidated financial statements and restructuring our debt, whereby we exchanged about 80% of our outstanding debt for a new Series C preferred equity. The slide reflects the balance sheets for the second quarter and the first quarter, both after deconsolidation. Again, that occurred on September 10, 2024. But now, the March balance sheet also reflects the impact of the debt exchange, which occurred after December 31.
Speaker #5: The two key components were deconsolidating Lucid from PAVmed's consolidated financial statements and restructuring our debt, whereby we exchanged about 80% of our outstanding debt for a new Series C preferred equity.
Speaker #5: The slide reflects the balance sheets for the second quarter and the first quarter, both after deconsolidation. Again, that occurred on September 10th, 2024, but now the March balance sheet also reflects the impact of the debt exchange which occurred after December 31st, notably the liability reduction of about 25 million coming in large part from a significant reduction in the convertible notes.
Dennis McGrath: Now the March balance sheet also reflects the impact of the debt exchange which occurred after 31 December. Notably, the liability reduction of about $25 million coming in large part from a significant reduction in the convertible notes in exchange for an increase of approximately $25 million in preferred stock and the balance sheet inclusion for the first time of the equity value of PAVmed's 31.3 million shares of Lucid stock. The 30 June balance sheet reflects the impact during Q2 of the Lucid stock price changes on the value of the Lucid shares mark-to-market, as well as any conversions of the preferred securities to common stock. A couple key things to point out on each of these balance sheets. Cash does not include any Lucid cash.
Dennis McGrath: Notably, the liability reduction of about $25 million coming in large part from a significant reduction in the convertible notes in exchange for an increase of approximately $25 million in preferred stock and the balance sheet inclusion for the first time of the equity value of PAVmed's 31.3 million shares of Lucid stock. The June 30 balance sheet reflects the impact during the second quarter of the Lucid stock price changes on the value of the Lucid shares marked to market, as well as any conversions of the preferred securities to common stock. So a couple of key things to point out on each of these balance sheets. Cash does not include any Lucid cash.
Speaker #5: An exchange for an increase of approximately 25 million in preferred stock and the balance sheet inclusion for the first time of the equity value of PAVmed's $31.3 million shares of Lucid stock.
Speaker #5: The June 30th balance sheet reflects the impact during the second quarter of the Lucid stock price changes on the value of the Lucid shares marked to market, as well as any conversions of the preferred securities to common stock.
Speaker #5: So a couple of key things to point out on each of these balance sheets: cash does not include any Lucid cash. However, it does include the two Ferris-related financings, namely the $2.4 million in the first quarter and the $2.5 million in the second quarter to support the development of the FDA submission of Ferris' implantable device.
Dennis McGrath: However, it does include the two Veris-related financings, namely the $2.4 million in Q1 and the $2.5 million in Q2 to support the development of an FDA submission of Veris' implantable device. The equity method investment balance of $36 million at 30 June reflects again the $31.3 million Lucid shares mark-to-market, representing a $10 million gain since year-end from a 40% rise in the Lucid stock price between the periods. This amount was previously eliminated from PAVmed's balance sheet prior to deconsolidation. Note there's plenty more information in the Form 10-Q on both the debt exchange, the Series C preferred stock, and the equity method treatment of PAVmed's investment in Lucid shares.
Dennis McGrath: However, it does include the two Veris-related financings, namely the $2.4 million in the first quarter and the $2.5 million in the second quarter to support the development of the FDA and FDA submission of Veris's implantable monitor. The equity method investment balance of $36 million at June 30th reflects again the $31.3 million Lucid shares marked to market, representing a $10 million gain since year-end from a 40% rise in the Lucid stock price between the periods. This amount was previously eliminated from PAVmed's balance sheet prior to deconsolidation. There is plenty more information in the 10-Q on both the debt exchange, a Series C preferred stock, and the equity method treatment of PAVmed's investment in Lucid shares. At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with ownership of approximately 29% of the common shares outstanding.
Speaker #5: The equity method investment balance of $36 million at June 30 reflects, again, the $31.3 million Lucid shares marked to market, representing a $10 million gain since year-end from a 40% rise in the Lucid stock's price between the periods.
Speaker #5: This amount was previously eliminated from PAVmed's balance sheet prior to deconsolidation. Note there's plenty more information in the 10-Q on both the debt exchange, a series C preferred stock, and the equity method treatment of PAVmed's investment in Lucid shares.
Speaker #5: At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with an ownership of approximately 29% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed, its board, and management still have significant influence over Lucid, with more than 27% voting interest.
Dennis McGrath: At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with an ownership of approximately 29% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed, its board, and management still have significant influence over Lucid, with more than 27% voting interest. Shares outstanding today, including unvested RSAs, are approximately 21.9 million shares. The GAAP quarter-ending outstanding shares of 21.1 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. Additionally, we issued 25,000 Series C preferred shares as part of the debt restructure at the beginning of the year. To date, approximately 1,850 Series C have been converted to approximately 4.7 million common shares.
Dennis McGrath: Although PAVmed no longer has voting control of Lucid, PAVmed, its board, and management still have significant influence over Lucid, with more than 27% voting interest. Shares outstanding today, including unvested RSAs, are approximately 21.9 million shares. The GAAP quarter-ending outstanding shares of 20.1 million are reflected on the slide, as well as the face of the balance sheet and 10-Q. GAAP shares do not reflect unvested RSA amounts. Additionally, we issued 25,000 Series C preferred shares as part of the debt restructure at the beginning of the year. To date, approximately 1,850 Series C have been converted to approximately 4.7 million common shares. If the balance of the Series C were converted at the contractual $1.07 conversion price, an additional 21.7 million shares would be issued. The Z-wires, after having been extended for one year beyond their initial five-year term, expired on April 30th. Next slide, please.
Speaker #5: Shares outstanding today, including unvested RSAs, are approximately $21.9 million shares. The gap quarter-ending outstanding shares of $20.1 million are reflected on the slide as well as the face of the balance sheet in the 10-Q.
Speaker #5: Gap shares do not reflect unvested RSA amounts. Additionally, we issued $25,000 theory C preferred shares as part of the debt restructure at the beginning of the year.
Speaker #5: To date, approximately 1,850 series C have been converted to approximately $4.7 million common shares. If the balance of the series C were converted at the contractual $1.7 conversion price, an additional $21.7 million shares would be issued.
Dennis McGrath: If the balance of the Series C were converted at the contractual $1.07 conversion price, an additional 21.7 million shares would be issued. The Z warrants, after having been extended for 1 year beyond their initial 5-year term, expired on 30 April. Next slide, please. 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 compiled between the comparative periods given the change in PAVmed's financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on 10 September of last year somewhat blurs the historical understanding of the information for PAVmed as a standalone entity, and GAAP does not allow the presentation for the prior periods on the face of the financial statements to be similarly adjusted.
Speaker #5: The Z warrants, after having been extended for one year beyond their initial five-year term, expired on April 30th. Next slide, please. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year, quarterly, and annual comparisons.
Dennis McGrath: 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 compiled between the comparative periods, given the changes in PAVmed's financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on September 10th of last year somewhat blurs the historical understanding of the information for PAVmed as a standalone entity, and GAAP does not allow the presentation for the prior periods on the face of the financial statements to be similarly adjusted. Although, as mentioned, there is some supplementary information in the footnotes. On a pro forma basis and purely for illustrative purposes of 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 operating expenses.
Speaker #5: As cautions earlier in my comments, there are some significant differences in how the information is compiled between the comparative periods given the changes in PAVmed's financial controls of Lucid.
Speaker #5: Importantly, the gap construct for deconsolidating Lucid on September 10th of last year somewhat blurs the historical understanding of the information for PAVmed as a standalone entity, and GAAP does not allow the presentation for the prior periods on the face of the financial statements to be similarly adjusted.
Speaker #5: Although, as mentioned, there is some supplementary information in the footnotes. On a pro forma basis and purely for illustrative purposes of this slide only, the Ferris revenue and the Lucid management fee are combined collectively to be more than $3 million per quarter to visually align PAVmed's income sources versus its operating expenses.
Dennis McGrath: Although, as mentioned, there is some supplementary information in the footnotes. On a pro forma basis and purely for illustrative purposes of 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 operating expenses. For SEC reporting purposes, the MSA income is below the line item. For the Q2, you see on the slide and in the Form 10-Q a large GAAP net loss of $12.3 million before NCI, the non-controlling interest and preferred dividends, opposed to the H1 total reflecting $6.3 million of income.
Speaker #5: For SEC reporting purposes, the MSA income is below the line item. Furthermore, for the second quarter, you see on the slide and in the 10-Q a large gap net loss of $12.3 million before NCI, the non-controlling interest, and preferred dividends.
Dennis McGrath: For SEC reporting purposes, the MSA income is below the line item. Furthermore, for the second quarter, you see on the slide and in the 10-Q a large GAAP net loss of $12.3 million before NCI, the non-controlling interest, and preferred dividends, opposed to the six-month total reflecting $6.3 million of income. This results from the mark-to-market of the $31.3 million Lucid shares for the periods, resulting in a second quarter non-cash expense of $10.6 million in the line item titled Change in Fair Value of Equity Investment and an income pickup of $21 million in the first quarter.
Speaker #5: Opposed to the six-month total reflecting $6.3 million of income. This results from the mark-to-market of the $31.3 million Lucid shares for the periods, resulting in a second quarter non-cash expense of $10.6 million in the line item titled "Change in Fair Value of Equity Investment."
Dennis McGrath: This results from the mark to market of the 31.3 million Lucid shares for the periods resulting in a Q2 non-cash expense of $10.6 million in the line item titled Change in Fair Value of Equity Investment and an income pickup of $21 million in the Q1. Happy to answer any detailed questions on the slide in the Q&A, but I think it's more informative to look at the Q2 standalone information presented in this slide and the full Q2 information presented in our press release that shows a company baseline bias of operating at cash flow breakeven and incurring incremental PAVmed expenses for development activities that are offset by the dedicated funding.
Speaker #5: And an income pickup of $21 million in the first quarter. I'm happy to answer any detailed questions on the slide in the Q&A, but I think it's more informative to look at the second quarter standalone information presented in this slide and the full second quarter information presented in our press release. This shows a company baseline bias of operating at cash flow break-even and incurring incremental PAVmed expenses for development activities that are offset by the dedicated funding.
Dennis McGrath: Happy to answer any detailed questions on the slide in the Q&A, but I think it's more informative to look at the second quarter standalone information presented in this slide and the full second quarter information presented in our press release that shows a company baseline bias of operating at cash flow break-even and incurring incremental PAVmed expenses for development activities that are offset by the dedicated funding. So in the second quarter, you see a non-GAAP loss of $845,000, which has been funded in part by the NIH grant proceeds of $900,000 in the fourth quarter and a PAVmed Veris $2.4 million financing in the first quarter and a Veris direct subsidiary financing of $2.5 million in the second quarter. Non-GAAP operating expenses for the first quarter and second quarter were nearly identical at $4.5 million, a change of $53,000 between the two quarters. Next slide, please.
Speaker #5: So in the second quarter, you see a non-gap loss of $845 thousand, which has been funded in part by the NIH grant proceeds of the $900,000 in the fourth quarter, and a PAVmed Ferris $2.4 million financing in the first quarter, and a Ferris direct subsidiary financing of $2.5 million in the second quarter.
Dennis McGrath: In the Q2, you see a non-GAAP loss of -$845,000, which has been funded in part by the NIH grant proceeds of $900,000 in the Q4 and a PAVmed Veris $2.4 million financing in the Q1 and a Veris direct subsidiary financing of $2.5 million in the Q2. Non-GAAP operating expenses for the Q1 and Q2 were nearly identical at $4.5 million, a change of $53,000 between the two quarters. Next slide, please. With regard to 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. The non-GAAP OpEx since the Lucid deconsolidation has been nearly flat for the last nine months.
Speaker #5: Non-gap operating expenses for the first quarter and second quarter were nearly identical at $4.5 million. Change of $53,000 between the two quarters. Next slide, please.
Speaker #5: With regard to non-gap operating expenses, on this slide, you see a graphic illustration of operating expenses over time as presented in more detail in our press release.
Dennis McGrath: With regard to non-GAAP operating expenses, on this slide, you see a graphic illustration of operating expenses over time as presented in more detail in our press release. The non-GAAP OpEx since the Lucid deconsolidation has been nearly flat for the last nine months. OpEx increases moving forward are likely tied directly to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA, for which the recent Veris-related financings are supporting. With that, Operator, let's open it up for questions.
Speaker #5: The non-gap OpEx since the Lucid deconsolidation has been nearly flat for the last nine months. OpEx increases moving forward are likely tied directly to the R&D efforts to get the Ferris implantable device submitted and cleared by the FDA, for which the recent Ferris-related financings are supporting.
Dennis McGrath: OpEx increases moving forward are likely tied directly to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA, for which the recent Veris-related financings are supporting. With that, operator, let's open it up for questions.
Speaker #5: With that, operator, let's open it up for questions.
Speaker #1: Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone.
Operator 2: Thank you. Ladies and gentlemen, we will now begin the question and answer session. One moment, please, for your first question. Your first question comes from Anthony Vendetti from Maxim Group. Please go ahead.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speaker phone, please lift the handset before pressing any key. One moment, please, for your first question. Your first question comes from Anthony Vendetti from Maxim Group. Please go ahead.
Speaker #1: You will hear a prompt that your hand has been raised. Should you wish to decline for the polling process, please press the star followed by the two.
Speaker #1: 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 Anthony Vendetti from Maxim Group.
Speaker #1: Please go ahead.
Dennis McGrath: Anthony.
Speaker #6: Thank you. Good morning. So a couple of things on the rollout with OSU. I know it has to be integration with EHRs and used to follow the healthcare information technology industry very closely and having those integrations with different systems within a hospital sometimes takes longer than expected.
Anthony Vendetti: Thank you. Good morning. A couple of things. On the rollout with The Ohio State University’s James Cancer Center, I know there has to be integration with EHRs. I used to follow the healthcare information technology industry very closely, and having those integrations with different systems within a hospital sometimes takes longer than expected. Where is that specific process with integrating Veris Health's remote monitoring with that EHR? Is that what is taking a little bit longer, or have you overcome that? The AI component, just a little more clarity on that clinical decision support piece of it. It sounds like that is early stage, but could be very interesting going forward to add to the Veris Cancer Care platform.
Dennis McGrath: Thank you. Good morning. A couple things. On the rollout with OSU, I know there has to be integration with EHRs, and used to follow the healthcare information technology industry very closely. Having those integrations with different systems within a hospital sometimes takes longer than expected. Where is that specific process with integrating Veris' remote monitoring in with that EHR? Is that what's taking a little bit longer, or have you overcome that?
Speaker #6: Where is that specific process integrating Ferris' remote monitoring with that EHR? Is that what's taking a little bit longer, or have you overcome that?
Speaker #6: And then the AI component just a little more clarity on that clinical decision support piece of it. It sounds like that's early stage, but could be very interesting going forward to add to the Ferris platform.
Lishan Aklog: Yeah
Anthony Vendetti: The AI component, just a little more clarity on that clinical decision support piece of it. It sounds like that's early stage, but could be very interesting going forward to add to the Veris platform.
Speaker #4: Yeah, both great questions, Anthony. Thanks for the opportunity to flesh those out a little bit. So the EHR integration has been a bit of a gating item for us to kind of transition to a full commercial expansion across the network.
Lishan Aklog: Both great questions, Anthony. Thanks for the opportunity to flesh those out a little bit. The EHR integration has been a bit of a gating item for us to kind of transition to a full commercial expansion across the network. It's not. Yes, it is challenging. It takes some work. It's not quite as onerous as I think the models that you were talking about, where you're really in effect altering their EHR. There are third-party vendors that, one of which we're using, that have a sort of an established turnkey way to take an external platform and have it, you know, communicate with various hooks and links within the EHR system. It's not really built into the EHR.
Lishan Aklog: Yeah, both great questions, Anthony. Thanks for the opportunity to flesh those out a little bit. The EHR integration has been a bit of a gating item for us to transition to a full commercial expansion across the network. It is challenging. It takes some work. It is not quite as onerous as I think the models that you were talking about, where you are really, in effect, altering their EHR. There are third-party vendors, one of which we are using, that have a sort of an established turnkey way to take an external platform and have it communicate with various hooks and links within the EHR system. It is not really built into the EHR. It is just getting these third-party applications that can interrogate and deliver information bidirectionally to the EHR in a streamlined way.
Speaker #4: It's not I don't think it's yes, it is challenging. It takes some work. It's not quite as onerous as I think the models that you were talking about where you were really in effect altering their EHR.
Speaker #4: There are third-party vendors, one of which we're using, that have a sort of an established turnkey way to take an external platform and have it communicate with various hooks and links within the EHR system.
Speaker #4: So it's not really built into the EHR; it's just getting these third-party applications that can interrogate and deliver information bidirectionally to the EHR in a streamlined way.
Lishan Aklog: It's just getting these third-party applications that can interrogate and deliver information bidirectionally to the EHR in a streamlined way. The amount of work is modest or moderate. It's mostly the just the challenge of overcoming kind of bureaucratic hurdles within an academic medical center. We're making progress. We expect it to get wrapped up soon, we'll be able to launch. We're actually actually considering seeing about You know, the goal was to kind of get it up and running before launching at all, we may actually proceed with, you know, with an early rollout as the EHR integration process is proceeding.
Speaker #4: So the amount of work is modest or moderate. It's mostly just the challenge of overcoming kind of bureaucratic hurdles within an academic medical center.
Lishan Aklog: The amount of work is modest or moderate. It is mostly just the challenge of overcoming bureaucratic hurdles within an academic medical center. We are making progress. We expect it to get wrapped up soon, and then we will be able to launch. We are actually considering seeing about, you know, the goal was to get it up and running before launching at all, but we may actually proceed with an early rollout as the EHR integration process is proceeding. It is coming, but it is just taking a little bit longer than we had hoped for. On the strategic side, you are right.
Speaker #4: But we're making progress. We expect it to get wrapped up soon. And then we'll be able to launch. We're actually considering seeing about the goal was to kind of get it up and running before launching at all, but we may actually proceed with an early rollout as the EHR integration process is proceeding.
Speaker #4: But so it's coming, but it's just taking a little bit longer than we had hoped for. On the strategic side, you're right. When we founded this company, the platform itself, the software platform itself, and even the implementation and the platform's utilization of data from an implantable monitor were really firmly rooted in the remote patient monitoring or RPM paradigm where the patient's physiologic information, whether through the external devices that they currently have or through the implantable, are relayed effectively just directly into the platform for the clinical team to see and for them to make clinical decisions.
Lishan Aklog: Well, so it's coming, but it's just taking a little bit longer than we had hoped for. On the strategic side, you're right. You know, when we founded this company, the platform itself, the software platform itself and even the implementation and the platform's utilization of data from an implantable monitor were really firmly rooted in the remote patient monitoring or RPM paradigm, where the patient's physiologic information, whether through the external devices that they currently have or through the implantable, are relayed effectively just directly into the platform for the clinical team to see and for them to make clinical decisions. You know, there are some elements of highlighting and color-coding things to give folks a sense of prioritization of different alerts.
Lishan Aklog: When we founded this company, the platform itself, the software platform itself, and even the implementation and the platform’s utilization of data from an implantable monitor were really firmly rooted in the remote patient monitoring or RPM paradigm, where the patient’s physiologic information, whether through the external devices that they currently have or through the implantable, are relayed effectively just directly into the platform for the clinical team to see and for them to make clinical decisions. There are some elements of highlighting and color-coding things to give folks a sense of prioritization of different alerts. It is really just that. RPM is literally remote patient monitoring. It does include some patients, the patient’s own reported symptoms, and incorporates that in a nice interface that is very user-friendly and allows the clinical team to view the information and utilize it in their decision-making.
Speaker #4: Again, there are some elements of highlighting and color-coding things to give folks a sense of prioritization of different alerts, but it's really just that.
Lishan Aklog: It's really just that. RPM is literally remote patient monitoring. It does include some patient, the patient's own reported symptoms, and incorporates that in a nice, you know, interface that is very user-friendly and allows the clinical team to view the information and utilize it in their decision-making. Obviously, I don't think it's a mystery to anyone that over the years, since we launched Veris, there's been an explosion of power, expertise, and activity in the healthcare space with regard to AI tools.
Speaker #4: RPM is literally remote patient monitoring. It does include some of the patient's own reported symptoms and incorporates that in a nice interface that is very user-friendly, allowing the clinical team to view the information and utilize it in their decision-making.
Speaker #4: But obviously, I don't think it's a mystery to anyone that over the years, since we launched Ferris, that there's been an explosion of power, expertise, and activity in the healthcare space with regard to AI tools.
Lishan Aklog: But obviously, I do not think it is a mystery to anyone that over the years since we launched Veris, there has been an explosion of power, expertise, and activity in the healthcare space with regard to AI tools. We have initiated a really formal process within Veris to map out how we can incorporate more AI into the process and a way to enhance the care of these patients even further. Our target really is not sort of just throwing out an incredibly wide net around operational efficiency or other elements. There are plenty of other companies that are doing that, and that is not our wheelhouse. Our wheelhouse here is really in the clinical care of cancer patients who are being exposed to treatments that can lead to complications. It is primarily focused on clinical decision support tools. That can go anywhere from smart alerts.
Speaker #4: And so we've initiated a really a formal process within Ferris to map out how that can we can incorporate more AI into the process and the way to enhance the care of these patients even further.
Lishan Aklog: We've initiated really a formal process within Veris to map out how that can we can incorporate more you know more AI into the process in a way to enhance the care of these patients even further. Our target really is not sort of just, you know, the sort of a, just, you know, throwing out an incredibly wide net around operational efficiency or other elements. There are plenty of other companies that are doing that, and that's not our wheelhouse. Our wheelhouse here is really in the clinical care of cancer patients who are being exposed to treatments that can lead to complications and it's more narrowly focused on clinical decision support tools.
Speaker #4: And our target really is not sort of just throwing out an incredibly wide net around operational efficiency or other elements. There are plenty of other companies that are doing that, and that's not our wheelhouse.
Speaker #4: Our wheelhouse here is really in the clinical care of cancer patients who are being exposed to treatments that can lead to complications and it's more narrowly focused on clinical decision support tools.
Speaker #4: And that can go anywhere from smart alerts, so you're not just simply saying, "Hey, this the temperature is rising and patient's getting a fever," or there's some report of certain symptoms that might trigger just an alert based on the value of the data.
Lishan Aklog: That can go anywhere from, you know, smart alerts, so you're not just simply saying, Hey, this, you know, the temperature is rising. The patient's getting a fever, or there's some reports of certain symptoms that might trigger just an alert based on the value of the data, but making the alerts smarter so they can provide some level of clinical risk or information, additive information through AI that would be useful to the clinicians. Then it goes all the way to more advanced tools that are actually cropping up quite extensively in other areas and other specialties. Here within cancer, it would be tools that could predict that could utilize data and could train off of data.
Lishan Aklog: You are not just simply saying, "Hey, the temperature is rising and the patient is getting a fever," or there is some purport of certain symptoms that might trigger just an alert based on the value of the data, but make an alert smarter so they can provide some level of clinical risk or information, additive information through AI that would be useful to the clinicians. Then it goes all the way to more advanced tools that are actually cropping out quite extensively in other areas and other specialties. But here within cancer, there would be tools that could predict, that could utilize data, and could train off of data.
Speaker #4: But making alerts smarter so they can provide some level of clinical risk or additive information through AI that would be useful to the clinicians.
Speaker #4: And then it goes all the way to more advanced tools that are actually propping up quite extensively in other areas and other specialties. But here within cancer, it would be tools that could predict and utilize data, and could train off of data. One of the expectations with regard to this partnership at OSU, which is the third-largest cancer center in the country, is to be able to work with them on using their vast data resources to train models that can provide clinical decision support.
Lishan Aklog: One of the expectations with regard to this partnership at OSU, which is, you know, the third-largest cancer center in the country, is to be able to work with them on using their vast data resources to train models that can provide clinical decision support. Let me sort of concrete example of that would be one of the dreaded complications of patients undergoing chemotherapy, for example, is neutropenic sepsis. The white blood count gets low from the chemo, and they have a risk of developing infection.
Lishan Aklog: One of the expectations with regard to this partnership at The Ohio State University’s James Cancer Center, which is the third largest cancer center in the country, is to be able to work with them on using their vast data resources to train models that can provide clinical decision support. A good sort of concrete example of that would be one of the dreaded complications of patients undergoing chemotherapy, for example, is neutropenic sepsis. Their white blood count gets low from the chemo, and they have a risk of developing infection.
Speaker #4: So, I'm going to sort of concrete example of that would be one of the dreaded complications of patients undergoing chemotherapy, for example, is neutropenic sepsis.
Speaker #4: So, under white blood count, it gets low from the chemo, and they have a risk of developing infection. Algorithms that are trained on data in cancer patients undergoing chemotherapy utilize the data that our system provides to create a more comprehensive risk profile. This allows for the prediction of a patient's risk of sepsis well in advance of the typical clinical picture, so that interventions can be made to prevent those complications from going further.
Lishan Aklog: So algorithms that are trained on data in cancer patients undergoing chemotherapy that utilize the data that our system provides to provide a more comprehensive risk profile where a patient, where the risk of sepsis can be predicted well in advance of the typical clinical picture, and interventions can be made in order to prevent those complications from going further. It is tools like that. It is rather narrowly focused on cancer care in these patients who are, you know, the opportunity to get sick and to provide a layer of clinical decision support on top of just the reporting of the physiologic monitors. We are, you know, working internally, mapping it out, identifying potential products and tools, and will be working with The Ohio State University’s James Cancer Center on mapping out ways to use their data and potentially other data sources to start to train models.
Lishan Aklog: Algorithms that are trained on data in cancer patients undergoing chemotherapy that utilize the data that our system provides to provide a more comprehensive risk profile where the risk of sepsis can be predicted well in advance of the typical clinical picture and interventions can be made in order to prevent those complications from going further. Rather than narrowly focused on cancer care in these patients who are, you know, the opportunity to get sick and to provide a layer of clinical decision support on top of just the reporting of the physiologic monitor. We are, you know, working internally, mapping it out, identifying potential products and tools.
Speaker #4: So it's tools like that. It's rather narrowly focused on cancer care in these patients who are the opportunity to get sick and to provide a layer of clinical decision support on top of just the reporting of the physiologic monitor.
Speaker #4: So we are working internally, mapping it out, identifying potential products and tools, and we'll be working with ASU on mapping out ways to use their data, potentially other data sources to start to train models so that's something that we're pretty excited about.
Lishan Aklog: We'll be working with OSU on mapping out ways to use their data and potentially other data sources to start to train models. That's something they were pretty excited about and will be a real value added to the platform, you know. Just to maybe just in closing, the platform now is really great. It's an excellent tool. Even though we are doing EHR integration, frankly, when we've deployed our platform, the clinicians typically use our platform as kind of the front end for the way they care for their patients. That will be supplemented by the physiologic data from the monitor.
Lishan Aklog: So that is something that we are pretty excited about. And it will be a real value added to the platform. You know, just to maybe just in closing, the platform now is really great. It is an excellent tool. Even though we are doing EHR integration, frankly, when we have deployed our platform, the clinicians typically use our platform as the kind of the front end for the way they care for their patients. And that will be supplemented by the physiologic data from the monitor. Then the next step in that would be to supplement the value proposition further by adding AI-based clinical decision support tools. Hopefully, that answers your question, Anthony.
Speaker #4: And we'll be a real value-added to the platform, you know, just to maybe just in closing, the platform now is really great. It's an excellent tool.
Speaker #4: Even though we are doing EHR integration, frankly, when we've deployed our platform, the clinicians typically use our platform as the kind of the front end for the way they care for their patients.
Speaker #4: And that will be supplemented by the physiologic data from the monitor and then the next step in that would be the supplement the value proposition further by adding AI-based clinical decision support tools.
Lishan Aklog: The next step in that would be to supplement the value, proposition further by adding, AI-based clinical decision support tools. Hopefully, that answers your question.
Speaker #4: So hopefully that answers your question, Anthony.
Speaker #6: Yeah, no, that's great. And then just on the funding component, is Ferris still funded at this point through FDA submission and expected clearance? And then any additional color around that timeline in '26 would be helpful.
Dennis McGrath: Yeah, no, that is great. Just on the funding component, is Veris still funded at this point through FDA submission and expected clearance? Any additional color around that timeline in 2026 would be helpful.
Anthony Vendetti: Yeah. No, that's great. Just on the funding component, is Veris still funded at this point through FDA submission and expected clearance? Any additional color around that timeline in 2026 would be helpful. Thank you.
Speaker #4: The answer is yes. I'll let Dennis map out the details of that. There's a including the opportunity to answer these additional cash through a warrant that's linked to one of the financings.
Lishan Aklog: The answer is yes. I'll let Dennis map out the details of that. Including the opportunity to raise additional cash through a warrant that's linked to one of the financings.
Lishan Aklog: Yeah, the answer is yes. I will let Dennis McGrath map out the details of that. There is a warrant including the opportunity to introduce additional cash through a warrant that is linked to one of the financings.
Speaker #6: Yeah, that's correct. With the funding, it certainly through clearance and the warrant exercise, which also has a call feature within 60 days of an FDA clearance, it's expected to support the commercial launch afterwards.
Anthony Vendetti: Okay, great.
Dennis McGrath: Yeah, that's correct. With the funding, it certainly through clearance and the warrant exercise, which also has a call feature within 60 days of an FDA clearance, is expected to support the commercial launch afterwards.
Dennis McGrath: That is correct. With the funding, it certainly through clearance and the warrant exercise, which also has a call feature within 60 days of an FDA clearance, it is expected to support the commercial launch afterwards. Okay, excellent. Thanks so much. I will hop back to meet you.
Speaker #5: Okay, excellent. Thanks so much. I'll hop back in the queue.
Anthony Vendetti: Okay, excellent. Thanks so much. I'll hop back in the queue.
Speaker #4: Great. Thanks, Anthony.
Lishan Aklog: Great. Thanks, Anthony.
Lishan Aklog: Great. Thanks, Anthony.
Speaker #1: Thank you. And the next question comes from Edward Wu from Ascendant Capital. Please go ahead.
Operator 2: Thank you. Your next question comes from Edward Wu from Ascendiant Capital Markets. Please go ahead.
Operator: Thank you. Your next question comes from Edward Woo from Ascendiant Capital. Please go ahead.
Lishan Aklog: Go ahead, Ed.
Speaker #7: Yeah, congratulations on all the progress. My question is on the biopharma opportunity. Is there a specific area that you have been looking at that you may continue to focus on for the next opportunity that you're evaluating?
Ed Woo: Yeah. Congratulations on all the progress. My question is on the biopharma opportunity. Is there a specific area that you have been looking at that you may continue to focus on for the, you know, next opportunity that you're evaluating?
Lishan Aklog: Yeah, congratulations on all the progress. My question is on the biopharma opportunity. Is there a specific area that you have been looking at that you may continue to focus on for the next opportunities that you are evaluating? So, as we said last time in a little bit more detail, we have been, there is a little bit of noise there. Thanks, Ed. As we mentioned last time, we have been sourcing assets at quite a decent clip now, actually, for over a year, and we have made some progress on some. I would say the majority have been in the cancer space. There is just a lot of activity both on small molecules and on biologic immunotherapies in a variety of areas of cancer.
Speaker #4: Sure. So you know, as we said last time in a little bit more detail, we've been there's a little bit of noise there. That's your mic.
Lishan Aklog: Sure. You know, as we said last time in a little bit more detail, we've been. There's a little bit of noise there. Is that Ed? Maybe that's your mic. Yeah, thanks, Ed. As we mentioned last time, we've been sourcing assets at a quite a decent clip now, actually, for over a year. We've made some progress on some. I would say the majority have been in the cancer space. There's just a lot of activity, both on small molecules and on biologic immunotherapies, in a variety areas, cancer. It is attractive because the much more so than med tech and diagnostics, the pathways through FDA, the FDA process and clearance and reimbursement is much more streamlined.
Speaker #4: Yeah, thanks, Ed. As we mentioned last time, we've been sourcing assets at quite a decent clip now, actually, for over a year, and we've made some progress on some.
Speaker #4: And I would say the majority have been in cancer space. There's just a lot of activity both on small molecules and on biologic and immunotherapies in a variety of areas: cancer, and it is attractive because the much more so than medtech and diagnostics, the pathways through FDA the FDA process and clearance and reimbursement is much more streamlined.
Lishan Aklog: It is attractive because much more so than MedTech and diagnostics, the pathways through FDA, the FDA processing firms and reimbursement is much more streamlined. Recently, we have been viewing assets outside that space. The one asset that we were hopeful that we might get across the finish line last time was in cardio immunology and in the cardiac heart failure space. It should be no surprise to anyone that the biopharma initiatives around obesity are exploding. We are getting to view some assets just at the very early stages in that space. It is an interesting process. Again, there is a lot of assets out there. We have a lot to offer. As a public company parent with access to longer-term capital, that is attractive. The devil is in the details.
Lishan Aklog: Recently, we've been viewing as assets outside that space. The one asset that we were hopeful that we might get across the finish line last time was in cardio immunology and in the cardiac heart failure space. It should be no surprise to anyone that the biopharma initiatives around obesity are exploding. We're getting to view some assets just at the very early stages in that space. It's an interesting process. Again, there's a lot of assets out there. You know, we have a lot to offer as a public company parent with access to longer term capital, that's attractive. You know, the devil's in the details.
Speaker #4: Recently, we've been viewing assets outside that space. The one asset that we were hopeful we might get across the finish line last time was in cardioimmunology and in the cardiac and heart failure space.
Speaker #4: And it should be no surprise to anyone that the biopharma initiatives around obesity are exploding. So we're getting to view some assets just at the very early stages in that space.
Speaker #4: So it's an interesting process. Again, there's a lot of assets out there. There's we have a lot to offer. As a public company, parent, with access to longer-term capital, that's attractive, but you know the devil's in the details.
Lishan Aklog: It is really a question of how much upfront capital the holders of these assets are looking for and so forth. We remain optimistic over the long term, and we will keep looking, working our way through that pipeline.
Speaker #4: It's really a question of how much upfront capital these the holders of these assets are looking for and so forth. So we remain optimistic over the long term, and we'll keep looking working our way through that pipeline.
Lishan Aklog: It's really a question of how much upfront capital, these, you know, the, the holders of these assets are looking for and so forth. We remain optimistic over the long term, and we'll keep looking, you know, working our way through that pipeline.
Speaker #7: Great. Thanks for answering my questions. And I wish you guys good luck. Thank you.
Ed Woo: Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.
Anthony Vendetti: Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.
Speaker #4: Thanks, Ed. Have a good day.
Lishan Aklog: Thanks, Ed. Have a good day.
Lishan Aklog: Thanks, Ed. Have a good day.
Speaker #1: Thank you. There are no further questions at this time. I would now like to turn the conference call over to Dr. Lishan Aklog for closing remarks.
Operator 2: Thank you. There are no further questions at this time. I would now like to turn the conference call over to Dr. Lishan Aklog for closing remarks.
Operator: Thank you. There are no further questions at this time. I would now like to turn the conference call over to Dr. Lishan Aklog for closing remarks.
Speaker #5: Great. Thank you, operator. And thank you all for joining today, and thanks, Anthony and Ed, for the great questions. So really just want to close on similar to my opening comments that at the end of the day, PAVmed's success within given the model we have and given that we've stabilized things from a clinical point of view, ultimately is going to depend on the success of its subsidiaries.
Lishan Aklog: Great. Thank you, operator. Thank you all for joining today. Thanks, Anthony and Ed, for the great questions. Really just wanna close on, you know, similar to my opening comments that at the end of the day, PAVmed's success given the model we have and given that we've stabilized things from a corporate point of view, ultimately is gonna depend on the success of its subsidiaries. you know, it's really their commercial success and their ability to finance their operations ultimately through profitability. you know, both Lucid and Veris are on solid footing on both fronts.
Lishan Aklog: Great. Thank you, Operator, and thank you all for joining today. Thanks, Anthony and Ed, for the great questions. I really just want to close on, similar to my opening comments, that at the end of the day, PAVmed Inc.'s success, given the model we have and given that we have stabilized things from a corporate point of view, ultimately is going to depend on the success of its subsidiaries. It is really their commercial success and their ability to finance their operations ultimately through profitability. Both Lucid Diagnostics and Veris Health are on solid footing on both fronts. There are some really important strategic milestones, obviously, especially at Lucid Diagnostics, with the potential to drive significant value at the PAVmed Inc. level over the coming months.
Speaker #5: And you know there is really their commercial success and their ability to finance their operations ultimately through profitability. And you know both Lucid and Ferris are on solid footing on both fronts.
Speaker #5: There are some really important strategic milestones, especially at Lucid, with the potential to drive significant value at the PAVmed level over the coming months.
Lishan Aklog: There are some really important strategic milestones, obviously, especially at Lucid, with the potential to drive significant value at the PAVmed level over the coming months. You know, we do, as I've said again, in response to the last question, we continue to aggressively pursue opportunities with very strong commercial potential. We're always looking to expand the portfolio of subsidiaries to find the next Lucid, the next Veris, to ultimately drive PAVmed's value. I am bullish about one such near-term opportunity with academic medical centers, particularly intriguing because it's around innovative technologies that would leverage both Lucid and PAVmed's expertise in esophageal disease. We're looking forward to see if we can get that opportunity locked down.
Speaker #5: And you know we do, as I've said, again, and just in response to the last question, we continue to aggressively pursue opportunities with very strong commercial potential and we're always looking to expand the portfolio of subsidiaries to find the next Lucid, the next Ferris, to ultimately drive PAVmed's value.
Lishan Aklog: We do, as I have said again, and just in response to the last question, continue to aggressively pursue opportunities with very strong commercial potential. We are always looking to expand the portfolio of subsidiaries to find the next Lucid Diagnostics, the next Veris Health, to ultimately drive PAVmed Inc.'s value. I am bullish about one such near-term opportunity with academic medical centers, and particularly intriguing because it is around innovative technologies that would leverage both Lucid Diagnostics and PAVmed Inc.'s expertise in esophageal disease. We are looking forward to seeing if we can get that opportunity locked down. With that said, again, just to encourage you to remain connected with us and our progress through our press releases, these calls. Please sign up for email alerts if you have not done so already on our website and follow us on social media.
Speaker #5: I am bullish about one such near-term opportunity with academic medical centers. It is particularly intriguing because it's around innovative technologies that would leverage both Lucid and PAVmed's expertise in esophageal disease.
Speaker #5: So we're looking forward to seeing if we can get that opportunity locked down. With that said, again, just to encourage you to remain connected with us and our progress through our press releases and these calls, please sign up for email alerts if you haven't done so already on our website, and follow us on social media.
Lishan Aklog: With that said, again, just do encourage you to remain connected with us and our progress through our press releases, these calls. Please sign up for email alerts if you haven't done so already on our website and follow us on social media. Thank you very much, and everybody, have a great day. Thank you.
Speaker #5: So thank you very much, and everybody, have a great day. Thank you.
Lishan Aklog: Thank you very much, and everybody, have a great day. Thank you.
Operator 2: Ladies and gentlemen, this concludes your conference call for today. We thank you very much for your participation. You may now disconnect. Have a great day.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you very much for your participation. You may now disconnect. Have a great day.