Lishan Aklog
Analyst · Lake Street Capital Markets
Thank you, Dennis and good afternoon, everyone. Thank you for joining our quarterly update call. Before proceeding, a couple of things. As yesterday, I'd like to apologize for my scratchy voice. I'm a little bit under the weather. I'd also like to thank our long-term shareholders for your ongoing support and commitment. We've been together through some challenging times. And as we'll discuss in greater depth, we continue to leave no stone unturned to enhance long-term shareholder value. Lucid clearly remains PAVmed's strongest and most promising asset and we're very pleased by its commercial progress and Lucid's ability to finance its operations despite challenging market conditions. We're looking to replicate the model more broadly and have raised PAVmed's -- revised PAVmed's overall strategy to drive shareholder value through independently financed subsidiaries which like Lucid, can leverage PAVmed's shared infrastructure. Consistent with this approach, we've updated Veris' commercial strategy accordingly. We've launched our PMX incubator in partnership with Hatch Medical. And we've aggressively sought ground-breaking independently financeable technologies with large market opportunities agnostic of center. So a couple of -- let's just start with some recent highlights, starting with Lucid Diagnostics. A reminder that, yesterday, we had a full presentation regarding Lucid, so I would encourage everyone to view that webinar or the transcript of that webinar to get further details with Lucid. I'll just give some highlights. Quarterly revenue rose nicely at 33% from the prior quarter. And these health fair high-volume CYFT events continue to gain traction. Our out-of-network reimbursement is improving with stable pricing and we've expanded our clinical validity and clinical utility data to support in-network coverage, including Medicare. As I mentioned and I'll talk about it in further -- in more depth in a bit. For Veris Health, we've shifted our strategy to target large academic and regional cancer centers and our first such engagement is expected in the very near term. We had a final and successful FDA pre-submission meeting for the implantable monitor and we feel we have a clear path to FDA clearance, pending independent financing. As we announced last week, we launched -- PAVmed launched its wholly owned incubator, PMX, in partnership with Hatch Medical to complete development and commercialization of its existing medtech portfolio technologies, starting with PortIO. Next slide. So a bit more about our updated strategy or revised strategy. As I mentioned, given the success of Lucid and Lucid's ability to independently finance itself, we've decided to -- moving forward to focus on driving shareholder value through our holdings in independently financed subsidiaries managed through our PAVmed shared services structure. Following Lucid's successful path of seeking -- and we'll seek financing opportunities directly to Veris and our subsidiaries based on the PAVmed -- on the PMX incubator technologies as well as future subsidiaries. As I mentioned, Veris is shifting to large academic centers in order to drive -- in order to enhance its financeability. The PMX launch has proceeded and the initial effort will be to independently finance PortIO as a subsidiary. We're also actively seeking new ground-breaking independently financeable technologies and have several targets that we're working on. These have large market opportunities that we're -- we've been agnostic to center and we're looking to leverage PAVmed's existing infrastructure. So a summary of the corporate structure as follows. With PAVmed providing shared services. We have Lucid Diagnostics. We have Veris Health as our digital health platform. We have our medtech products within our privately held incubator, PMX. And we're looking, again, to add additional assets consistent with the structure, each of them independently financiable. Just a couple of brief slides on Lucid. Again, I would recommend reviewing the further details in our webinar. As I mentioned in that slide, the -- we had -- we've stabilized our test volume, expected to remain in the 2,300 to 2,500 range, pending improvements in reimbursement as well as driving revenue through our early efforts at direct contracting. And you can see revenue has grown nicely since we took over and updated our revenue cycle management. This is all in -- out-of-network reimbursement. Next slide. And just a couple of highlights on Lucid on the commercial execution side. As I mentioned, we're making great progress with our CYFT health fair testing events and are fully booked through July. We're increasing our activity in strategic accounts and now have over a dozen. These are large academic medical centers and other regional centers. And on the revenue cycle management side, we're getting about approximately 50% of our claims are now being allowed by commercial payers. And the payment amount has stabilized out of network at about $1,800. So it's just shy -- a bit shy of the Medicare price. Some of the key strategic accomplishments; we strengthened Lucid, strengthened its balance sheet by raising $18.1 million in the preferred stock financing. I'll note, again, to put it in the broader context of Lucid's financeability. We've been gratified that Lucid has been able to raise its own capital and this financing puts that number well over $100 million, including the IPO. The clinical validity and clinical utility data now are well positioned to support a broad medical policy coverage for EsoGuard. They are positioning us to engage with the MolDx Group that works on local coverage determinations on behalf of Medicare. We're looking for that reengagement to happen quite soon upon publication and peer review publication of one of the CV studies. We've just started in the last month or so to hold meetings with major commercial payers using our -- using this data to formally request positive medical policy determinations and look forward to the outcomes of that. As I mentioned, we're really bullish on this direct contracting program where, with EsoGuard offered as a covered benefit and have expanded our team pursuing these. And we have a robust pipeline of employers, self-insured entities, working with brokers and third-party administrators, to offer EsoGuard in this fashion. Next slide. So a bit of an overview on Veris. Next slide. Veris Health is a commercial-stage digital health company that seeks to enhance personalized cancer care, has 2 components. The Veris Cancer Care platform which has a smartphone app that the patient interacts with and enters patient-reported outcome, information; along with a platform that the physicians and other caretakers use to track physiologic parameters that are collected currently using Bluetooth-connected external devices. The long-term plan is to market an implantable monitor that works with this platform that would be inserted at the time of the implantation of a vascular access port for chemotherapy, immunotherapy. And the goal is to utilize modern remote patient monitoring tools to improve care through early detection of complications, longitudinal trends and risk management. Next slide. So a bit about our revised commercial strategy. Again, the goal here is to advance Veris to the point where it can raise its own independent capital. We've had strong interest in that regard. And we felt that the commercial strategy that targeted large, prestigious academic and regional cancer centers was the best path to get there. These tend to be centers that have large staff, a large number of oncologists and a large number of patients on infusion therapy, thousands and thousands of such of patients. These tend to be concentrated in metropolitan areas. They are typically NCI-designated comprehensive cancer centers. And actually, many of them have venture arms. And in our conversations with them, we've had interest in the centers investing directly into Veris and that's something we're pursuing. So among these centers, we have a robust pipeline. We have over a dozen targets with multiple active discussions. And as I mentioned at the beginning, we have one engagement that in it's very late stages and we expect it to consummate in the near term. Our approach with these is very different than with the smaller -- as we initially approached the smaller oncology practices. And these are more comprehensive engagements, so they start with pilot programs and they involve long-term commercial partnerships as well as other strategic collaborations, so research and development activities, shared collaborations in this regard, that include developing care pathways, digital biomarkers and other innovations on our platform. Next slide. So the Veris implantable monitor is an important future part of this endeavor. We think ultimately will play a central role in advancing this technology. Among other things, it assures a 100% compliance with -- patient compliance to fulfill the requirements necessary for remote patient monitoring billing. Again, it's designed to be implanted at the time of a vascular access port and provides many of the necessary physiologic parameters -- relevant physiologic parameters you can see listed there continuously without the need for external devices. This device has gone through multiple -- we've had multiple engagements with the FDA. We held our final and ultimately successful FDA presubmission meeting a few weeks ago. And now we believe we have a clear path to FDA clearance and commercial launch and we will push forward on that once Veris secures independent financing which we hope to accomplish soon. Next, the final area that we announced recently is our new incubator, PMX. Next slide. So we launched PMX, as we announced last week, to complete development and commercialization of products -- existing portfolio technologies which many long-term PAVmed shareholders will remember. The PortIO implantable intraosseous vascular access device; EsoCure esophageal ablation device which has been licensed to Lucid for commercialization once completed; the CarpX minimally invasive device for carpal tunnel syndrome. Each of these technologies have advanced quite far, with CarpX device having been cleared and was undergoing second-generation product development. These had been put on the back burner at the time of a restructuring about a year ago and we're very excited to have launched these again in the context of this incubator through a joint venture with Hatch Medical, a very experienced group of medtech veterans who have long history of advancing medtech technologies as well as brokering partnerships and strategic acquisitions. So we're really looking forward to that. The structure is that we will seek to independently finance a separate subsidiary, the incubator, to develop and commercialize each technology. And our first target and we're just getting started on seeking financing for this, is PortIO. It's the first such device, the first implantable intraosseous vascular access device. It offers solutions for patients with poor veins or the need to preserve veins for dialysis and eliminates the need for regular maintenance with flushes and is resistant to occlusion and infections compared to traditional access devices. The estimated market opportunity, not including the dialysis population, is about $500 million. We completed the first in-human study in Colombia in 2022 and that study in nine patients demonstrated excellent device function, operated just as designed and there were no complications in any of those patients. Using this data, we hope to add to extensive engagement we've had already with the FDA and we believe we now have a clear path to a U.S. IDE or investigational device exemption clinical study will be necessary to get a de novo regulatory clearance. So looking forward to getting this financed and moving forward to fulfill its commercial potential and then in series or in parallel, pursue similar pathways for EsoCure and CarpX. And with that, I'll pass things over to Dennis to talk about our financial update.