Good morning, and welcome to the PAVmed's Third Quarter 2024 Business Update Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, PAVmed Director of Investor Relations. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release and 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 the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A entitled Risk Factors in PAVmed's most recent annual report on 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. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Take it away, Lishan.

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. Before we delve into our recent operational highlights, I'd like to make a few high-level points. This has been a transformational quarter for PAVmed. Over the last couple of quarters, we've taken several critical steps related to PAVmed's corporate structure and balance sheet. This strategic transformation, which is now essentially complete, puts PAVmed in a strong position to fulfill its mission on behalf of its shareholders. As a result, PAVmed is now a sustainable vehicle that's capable of doing precisely what it was designed to do, deliver innovative medical technologies that address unmet clinical needs. The first step was the recent deconsolidation of Lucid Diagnostics, Dennis will provide greater context on this later on the call. But the most important thing this step accomplished was to preserve PAVmed's ownership in Lucid without having to absorb Lucid's operating losses on its balance sheet. The second step, which again, Dennis will provide further details on later, was the restructuring of our convertible debt, which will allow us to preserve our NASDAQ listing. So where are we now? PAVmed is now well positioned to operate as a diversified commercial life sciences company with multiple independently financed subsidiary operating under a shared services model. Our portfolio includes Lucid Diagnostics, our publicly traded diagnostics company, which, of course, remains PAVmed's strongest asset. Veris Health is our digital health company, which offers a Cancer Care Platform that enhances personalized cancer care. And our incubator PMX is advancing promising technologies in our portfolio, starting now with the PortIO, an implantable intraosseous device. Our shared services model allows us the flexibility to bring in new assets and technologies in our portfolio, which we continue to actively pursue. With this strategic transformation, I really couldn't be more excited about the future of PAVmed and its subsidiaries. So let's go on to highlights from the third quarter and recent weeks. Let's start with Lucid Diagnostics. First, let me encourage you to listen to yesterday's Lucid business update call for greater details. We are happy to report record revenue in the third quarter. Our revenue increased 20% quarter-on-quarter. We published the ESOGUARD BE-1 clinical validation study, which is accepted for peer review publication, and that is the final piece that now completes our clinical evidence package for us to formally submit seeking Medicare coverage. We've held three productive meetings with the CMS Medicare contractors, MolDX program, focused on this upcoming submission for EsoGuard coverage. Finally, as we recently announced, we've expanded our direct contracting initiative with multiple programs, including newly in concierge medicine and expansion of the employer market side to focus on driving near-term revenue. A lot of great developments with Veris Health. Our pilot with The Ohio State University, The James Cancer Center, is now complete, and we are in active discussions with the institution on long-term commercial and strategic partnerships. We are happy to have received a $1.8 million NIH grant, which will allow us to further optimize the Veris Cancer Care Platform, specifically for our medically underserved patients in partnership with an academic cancer center. We had initiated a capital raise for Veris, but put that on hold during the restructuring process and are looking forward to reinitiating that shortly. We're also preparing to relaunch the development of the implantable monitor. On the PMX incubator side, we're continuing the process of seeking our direct financing to fund the PortIO device. With that, I'm going to hand the baton over to Dennis to give us our financial update.

Thanks, Lishan, and good morning, everyone. The summary of financial results for the third quarter were reported in our press release that has been distributed. On the next four slides, I'll emphasize a few key highlights from the 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, as you can see from the slide, things look very different comparing the third quarter to the previous quarter as a result of the deconsolidation of Lucid from PAVmed. That comment will also hold true for the P&L once I get there as well. Before I dive into the details explaining financial results for the third quarter, it's best to provide some insight as to the master plan and the intentional steps that management and the Board have taken and are continuing to take to both maintain the NASDAQ listing and also move PAVmed to be on a more stable financial footing as I'll demonstrate two slides after this one. On October 29, in a formal hearing, we presented NASDAQ with a two-step plan to satisfy the continued listing for the NASDAQ capital market and therefore, maintain our NASDAQ listing for at least the next 12 months. Structures in place that we believe may allow us to sustain compliance for much longer. The minimum requirement that we had to demonstrate to NASDAQ was that the company could achieve GAAP stockholders' equity greater than $2.5 million and be able to sustain that minimum for more than 12 months. Our starting point was a deficit of $18.6 million as of June 30. We were notified last Friday night that NASDAQ accepted that plan, which I'll describe in a moment, granting an extension through January 31, 2025, to get the final step, which is subject to shareholder approval being completed. Step one was to deconsolidate Lucid from PAVmed, which, as you know, was accomplished on September 10. The details are described in the 8-K filed with the SEC in mid-September are also more fully described in our PAVmed 10-Q. But essentially, the deconsolidation requirement was accomplished by first, changing Board compositions such that the majority of the members of the Lucid Board were no longer also PAVmed directors. And secondly, eliminating a few voting proxies that certain shareholders had granted over their Lucid shares in favor of the PAVmed office. PAVmed continues to be the single largest shareholder of the common stock. However, the controlling voting interest dropped from more than 50% to about 40% as a result of these intentional actions by management and the Board, clearing the pathway to deconsolidate Lucid from PAVmed. This action alone cut the third quarter shareholder deficit in half from the previous quarter's balance. The 10-Q footnote number four to the financial statements provides a lot more detail on this impact. Step two required restructuring the convertible debt. PAVmed and the convertible debt holder have agreed, subject to certain conditions that I'll get into shortly, to exchange $25 million of existing obligations for newly created Series C convertible preferred stock of an equivalent value. Thereby not only wiping out the deficit but also allowing us to demonstrate to NASDAQ a plan for sustainable compliance with the continued listing standard for a meaningful period of time. The effective date of the exchange is subject to a few conditions. First, before the exchange agreement will become effective, our accounting advisors need to complete their final quality review steps of their independent analysis to concur with our internal assessment that after the debt for preferred exchange is completed, the preferred stock will be classified as GAAP permanent equity. The company hired BDO to complete an independent analysis with regard to the likely permanent equity classification. That analysis is being reviewed by our auditors. We are awaiting the completion of that review, which is expected shortly. Upon satisfactory completion of that review and an affirmative conclusion about the likelihood of permanent equity classification, the exchange agreement will become effective. Second, we have agreed with our debt holder that the consummation of the exchange is subject to shareholder approval of certain customary measures that would allow for the full conversion of the Series C preferred stock. We expect to file a shareholder proxy shortly for a special meeting of the shareholders to request approval of these measures and shortly thereafter close the exchange, well in advance of the January 31, 2025, extended deadline for regaining compliance with NASDAQ. Additional tactical steps are being taken by management and the Board. The incurrence of future R&D expenses to advance the next development stages of the Veris Cancer Care Platform and PortIO technology will be largely dependent upon obtaining direct funding into those entities to cover the incremental development costs. Hence, any increased burn from those endeavors will be offset by the incremental financing. As a good start in that direction, we previously announced being awarded a National Institute of Health grant of $1.8 million from Veris. We have also circulated a Veris offering memorandum at a $35 million pre-money valuation and received an indication of interest to fund the first tranche for the implantable devices next steps. This funding effort has been paused pending the outcome of the hearings panel meeting on October 29. Receiving NASDAQ's letter of approval last Friday was a key factor now moving those funding efforts forward. Additionally, for PortIO, we've entered into a term sheet with an angel fund for a direct investment in PortIO Corp at a pre-money valuation of $42 million to cover the final development steps. The angel fund is in the process of conducting its diligence with our team. So now, for the comparative analysis. Two immediate things to notice on PAVmed's balance sheet presentation. One, Lucid's cash is no longer consolidated in the presentation of PAVmed's cash balance. However, equally importantly is that for the first time, PAVmed's balance sheet presents the inclusion of the $25.5 million market value of its 31.3 million Lucid share ownership. Previously, that inclusion was eliminated out of PAVmed's presentation due to GAAP's intercompany consolidation rules. Furthermore, as Lucid's stock price rises, like it has since the September 30 balance sheet date, this amount will increase. For instance, the balance and PAVmed’s related net equity has increased by more than $6 million from the balance sheet date of September 30 through earlier this week. PAVmed’s standalone burn rate for the third quarter is about breakeven once you strip Lucid out of the results. You'll see that illustrated as I address it further in two slides from now. Finishing this slide, the change in other assets is largely related to the Lucid deconsolidation. The amount of convertible notes reflects deconsolidating Lucid's convertible note from the prior balance and before the effect of the proposed $25 million exchange into preferred, which will happen after the shareholder vote. Shares outstanding, including unvested restricted stock awards, 11 million. The GAAP outstanding shares of 10.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP sequential quarterly comparisons as well as year-over-year information. However, there are some significant differences in how the information is compiled between the comparative periods given the changes in PAVmed's financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on September 10, somewhat blurs the understanding of the information for PAVmed as a standalone entity and GAAP does not allow the presentation for the prior periods to be similarly adjusted. The GAAP third quarter results are presented, reflecting inclusion or consolidation of Lucid's results for two and one-third months, July 1 through September 10. And differently, for the two-thirds of the remainder of September, that is September 11 through September 30 because Lucid's results are not included. Furthermore, you can see a large net income of $61 million on the GAAP P&L. This is before the non-controlling interest. And positive primary EPS of $6.43 per share and a positive diluted EPS of $1.44 per share. This is all the result of eliminating Lucid from PAVmed's balance sheet and extracting the impact of Lucid's cumulative historical losses. The net adjustments to the balance sheet create a $72 million gain that then flows through the P&L to obtain the net equity impact of all of the deconsolidation adjustments. Happy to answer any detailed questions on the slide in the Q&A. But I think it's more informative by pulling apart the deconsolidation chaos and illuminating what PAVmed on a standalone basis looks like. That's what I hope to achieve on this next slide.

Good morning, Ross.

Hey, guys. Thanks for taking our questions. Good morning. Maybe starting off, could you share any learnings from your work with The Ohio State?

Sure. To update everyone, we've had a strong engagement with The James Cancer Center at Ohio State University Medical Center for about a year. Earlier this year, we established a memorandum of understanding with them, initiating a pilot program that ran through the summer. This program enrolled 100 patients on the Veris platform and has now been extended for an additional 30 patients due to interest from a clinical site that wanted to participate. The pilot was carefully structured, with key performance indicators related to patient and physician satisfaction among other important metrics, and it was highly successful, receiving positive feedback from all levels of the institution, including administration and leadership. We are currently in discussions with the leadership to explore additional aspects outlined in the Memorandum of Understanding, which could lead to a strategic partnership with increasing commercial engagement. We are actively working together to share the success of the pilot and demonstrate how the Veris platform can improve and personalize care for cancer patients. Our aim is for this project to serve as a model as we engage in similar discussions with other academic cancer centers across the country.

Okay. Great. And then I guess maybe regarding OpEx for PAVmed. How should we think about that in the coming quarters? I'm assuming maybe pretty steady ahead of any incremental financing?

Yeah. So as we presented in that pro forma slide, you can see the kind of the normalized OpEx moving forward. That's our baseline. As we generate the direct financing either in Veris or in PortIO, that will be the gating factor to incur the additional operating expenses. In Veris' case, moving it towards the implantable. That's probably a couple of million dollar efforts over a six to eight month period of time. And likewise, in PortIO, with the financing, it's probably about a $4 million expenditure over a 12-month period of time. And it is those aspects of change in funding that will drive where the OpEx goes. But otherwise, the pro forma that's illustrated on that slide is the baseline and should continue going forward is a likely representation of the fourth quarter and with the funding, the changes that may occur in 2025.

Thanks, Ross. Anthony, good morning.

Good morning. Good morning, Dennis. Good morning, Lishan. Just a little more follow-up on the Veris program. So assuming you get the financing and so forth, is it still on track for submission with the FDA on a 510(k) basis before the first half of '25?

I think the delay in closing the financing, which was necessary due to the restructuring and finalizing efforts to meet the listing requirements, may extend into the early part of the second half, but hopefully not by much.

Okay. Great. And then in terms of the financing for the PMX incubator, you said you have lined up some financing already. How much total funding…

Let me clarify that we have engaged with an angel network and have a term sheet in place. Dennis explained that the terms are attractive for raising $4 million, which will cover the expenses of the second-generation PortIO as well as completing the IDE clinical trial for commercialization. This was set at a $42 million pre-money valuation. The term sheet has been finalized and negotiated, and we are at the very end of the process. They have a thorough diligence process, and we expect the diligence report to be completed soon. After that, the network will present the opportunity to its individual members and start raising funds and collecting subscription agreements in the near term.

Got it. Okay, perfect. That's great. All right. I'll hop back into the queue. Thanks for that color. I appreciate it.

Thanks, Anthony.

Thanks, Anthony.

Yeah. Congratulations on all your progress. My question is on The Ohio State pilot. What does the competitive slate look like? Were you guys competing against other diagnostic, remote diagnostic devices? Or did they have nothing before that?

So the cancer center has not engaged with a digital health platform specific for cancer. I believe there are other products more that are being used broadly and they're actually in the process of trying to figure out what generalized remote patient monitoring platform they're going to use for the broader institution. But my understanding is this is the first foray of the cancer center, which is our direct partner in the digital health care platform arena. And certainly, during the pilot, we were the only product that they were utilizing.

Thanks, Ed.

Thanks a lot, Ed. So great. Thank you, operator, and thank you all for joining today. I hope you leave today with a strong sense that PAVmed has taken the decisive steps that it needed to, to solidify and stabilize our corporate structure and strengthen our balance sheet. We really do look forward to a bright future, positioning PAVmed as a sustainable, diversified commercial life sciences company with multiple independently financed subsidiaries. I do encourage you to stay connected with our progress through our news releases, periodic calls such as this and signing up for e-mail alerts on our IR website, and you can also follow us on Twitter and LinkedIn. So again, thank you for your continued support. And as they say, watch this space. Have a great day.

Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.