PAVmed Inc. (NASDAQ:PAVM) Q3 2023 Earnings Call Transcript

Lishan Aklog: Right. So, thanks for the opportunity to kind of flesh that out a little bit. So there’s been an evolution in our strategy and our thinking about this as we’ve engaged a bit deeper. You know, as you sort of hinted at, our initial focus was on pre-submission and being engaged during the development process during clinical trials in the Phase 2 and Phase 3 sides of this so that it actually becomes part of the package FDA submission. And we still think that there’s a big opportunity there. The logistics are more complicated. We have to sort of interface with CROs and have our platform work within the CRO platforms where the data is being collected. But we think it’s a big opportunity, but the lifetime of those are going to be greater, right?

Before we actually see potential commercial value in that, we have to follow the drug through its development phase through FDA submission until ultimate FDA approval. So that opportunity is still there and the work we’ll be doing in the early phases of this will, in the module, will be very similar to what it would be for there. But what we’ve noticed as we dug further into this is that, there really is an immediate opportunity on the post-market surveillance side. So these are drugs that have already been approved, so we’re not waiting for that process. They’re in the market, and one of the — several of the contingencies of their approval is that they have — that they undergo this market surveillance and they have actual — they have very well defined care pathways that patients have to go through to be — to qualify for receiving these new drugs.

And the process of collecting that data is critical for the drug to move up the chain of treatment. So many of these drugs start as third or fourth line after patients have failed other drugs that have been around for longer periods of time. And so the goal of the company is to move up that food chain in order to do that — to go to first or second line, exponentially expanding the market opportunity. In order to do that they have to demonstrate that they’ve collected the appropriate post-market surveillance data and documented their safety profile, replicated that in real world. So there’s a strong — there’s an immediate opportunity and there’s a strong motivation commercially for them to collect that data quickly and collect data in a way that maximizes the likelihood that they’ll hit the safety benchmarks.

There’s also and significant opportunity — commercial opportunity with the practices which is not really the case in the pre-submission phases of this, which is that, with these new drugs CAR-T and others the practices that’s actually quite lucrative for a practice to administer that and practices are seek to be certified to administer this, which is important for their bottom line and for their patients to get access to this. And so, by having the practice have the opportunity to be on a platform that facilitates the participation in this post-market surveillance phase is a win for the practice as well. So in terms of timing, we’re — as I said, we have active discussions with several large pharma companies that you would — those names you would recognize, and we’re still in those early phases, but those are active.

And so we certainly hope to see one or more of those consummate in the near future.

Frank Takkinen: Okay. That’s good color. I’ll stop there. Thanks for taking the question and congrats on all the progress.

Lishan Aklog: Thanks, Frank.

Operator: [Operator Instructions] Our next question here will come from Ed Woo with Ascendiant Capital. Please go ahead.

Ed Woo: Yes, congratulations on all the progress. You mentioned that for Veris, a big opportunity in the pharma is post-FDA approval. How big of that opportunity is versus drugs that are in clinical trials?

Lishan Aklog: I think it’s a large, if not, larger opportunity, but most importantly, it’s a more immediate opportunity as opposed to sort of the longer timelines for commercial traction in the pre-submission phase. So as anybody who’s paying attention knows, there’s been a boon, really almost a revolution that’s going on right now in oncology therapeutics. There are drugs that are leveraging breakthroughs in science and immunotherapy and other scientific breakthroughs to deliver drugs at sort of a record pace. So there are numerous oncology drugs that are working their way, that have been approved, that are working their way into real world practice and are where the motivation to move up to first and second line is extremely high.

So I would say that the opportunity at least is great, if not greater. But most importantly, the opportunity — the timelines of the opportunity for near-term engagement and commercial value is substantially greater in the post-market phase.