Lucid Diagnostics Inc. (NASDAQ:LUCD) Q4 2023 Earnings Call Transcript

And we talk at the same time as we are arranging our first event, we talked about engaging in a contract and particularly since most of these unions are self-insured. And those dialogues are going really well. The leaders, particularly the union leaders are motivated, to offer a service to their personnel. They’re very focused on cancer prevention, particularly in the firefighter group. And so, as we start seeing, it’s really similar in some – in many ways, Kyle, as we start seeing increases in realization from realization of revenue from these events, then will be justified in investing in more personnel, to drive our capacity to do these events.

Kyle Mikson: Okay. Yes, that was great. That was a little bit good color there. Maybe just finally, wondering about some of the time lines for the clinical validity studies particularly maybe that the VA study look I know pending publication and everything, but I mean just like the relevant to that, I feel like that’s kind of important – it’s a good proof point. And then with BE-101 and BE-102, I guess 101 is like kind of close to being announced everything with 102 is a little bit further back. So are – yes these important what’s the time line and like when to we – kind of expect some color?

Lishan Aklog: Yes, why don’t I talk about the time lines relative to our plans with MolDX. So on the clinical, what they say, there’s the original STM paper. There’s the BETRNet study, which has released data. It’s on preprint. It’s gone through multiple cycles of review at a leading journal, and we also expect that to be clear for peer review publication very, very shortly. We’re just kind of waiting on what we think is the last round of responses to reviewers’ comments. As soon as that is published and online, then we will request a meeting with MolDX. So that’s what we believe that, that is sort of a linchpin gating item for the publication of that clinical validity study. You mentioned the VA study as being a really important complement to that, which it got posted on preprint.

It’s been submitted. We’re not going to wait for that for being for peer review. I expect that there’s a good chance that when we have our meeting, it will either be in peer review and certainly for any technical, by the time we get around to doing a technical assessment submission, it would be peer reviewed. The key thing I think you were hinting at with the VA study. It’s our first study in a screening population. So the original STM paper as well as the BETRNet study were both case control studies. And you always want to be able to show that you can replicate your performance in the actual intended use population, in a real-world situation, where you’re taking people off the street, who’ve never had endoscopy before that are categorized as having at risk, and recommended for screening by guidelines.

And showing that you can actually identify disease with a high performance. We have a high negative predictive value and really good, solid positive predictive value. So that is on preprint and has been submitted and we’ll wait for that to be published. On the clinical utility side – sorry, the remaining clinical validity studies, the next line is the BE-1 study, which is our study in a screening population. That study that manuscript is complete. The data has been tabulated. I’ll give a preview and that the data is nearly identical to the VA study. So both studies in a screen population have really nearly identical and otherwise excellent results. So that manuscript is being finalized. The lead author is Dr. Shaheen. And so, we’re just getting final sign-off on that, and it should be posted on preprint soon and submitted for publication.

Again, we’re not going to wait for that. But the two screening population studies will be an important supplement to our discussions with MolDX and with payers in general. The BE-2 study, we’re continuing to enroll in that study. That’s not a lunch pin at this point of our market access efforts. We still – enrollment has picked up a bit and it’s slowed down a little bit. We’ve shifted into entirely U.S. studies, U.S. centers. And we’ve added a few. And that will be just sort of additional complementary. That will be a third case control study on top of the STM and BETRNet study, that will be supplemental but – it’s not sort of a linchpin of our market access strategy.

Kyle Mikson: Lishan, the BE-2 is that case control? Or is that the screening population?

Lishan Aklog: Yes, that’s case control, right – so that’s why – it will just be sort of the third such case control study and will be supplementary. But it’s not sort of at the heart of what we think we have sufficient case-control CV data, and now to screening population CV data, to drive our market access efforts.

Kyle Mikson: Yes, all right. I’ll hop off. Thanks so much, guys. Appreciate the time.

Lishan Aklog: All right. Thanks a lot, Kyle for your questions.

Operator: Your next question comes from the line of Joseph Conway from Needham. Your line is open.

Lishan Aklog: Joseph, good morning.

Dennis McGrath: Hi, Joseph.

Lishan Aklog: Are you there, Joseph? Can you hear me?

Dennis McGrath: Operator, why don’t you put Joseph back in the queue and take the next question?

Joseph Conway: My apologies. Can you guys hear me?

Lishan Aklog: Good. Yes, I can hear you now. How are you doing?

Joseph Conway: My apologies. I was on mute. Good morning, everyone. Thanks for taking our questions. Maybe just one on operating expenses. If you guys are planning to keep in volume fairly leveled as well as the sales force before reimbursement comes in. But maybe seeing more traction on these – CheckYourFoodTube events and what have you. I guess with all of that together, is it safe to say that we should expect a modest increase maybe in operating expenses, just on a run rate maybe on the last two quarters. Do you think that’s maybe stabilized, I guess, is the better way to say it or ask that?