BioCardia, Inc. (NASDAQ:BCDA) Q4 2023 Earnings Call Transcript

Peter Altman: Right now, we have so just a broad-brush stroke, we have our three programs that we’re advancing and we have two partners under this structure that we’ve been public about. There’s other folks we do work with that we’re not public about, and the other two players are CellProthera and StemCardia. But we have said in the press release in the targeted milestones that we expect to enter into two additional biotherapeutic delivery partnerships in the year ahead. And I think we’ve also said that the first one of those, we expect to close in Q2 of this year. Now, so that’s and the idea is to create this long-term value and everything that we do is trying to we have these platforms and the challenge is always how do you create all the value that’s inherent in the platform?

How do you so for CardiAMP, it goes into a number of indications or advancing two of those? For our allogeneic platform, it goes in many directions and we’re focused in on the one where we have the most experience in data, but we’ve had discussions around taking that into a number of indications already. And the third platform we have is our Helix Biotherapeutic Delivery platform and this is this biotherapeutic partnering business. And what’s nice is the data I shared with our lead program utilizes our Helix platform and so that safety data is really compelling for folks developing their own cell gene or protein-based therapy for the heart. And these clinical indications we’re going after are so enormous that it’s in our investors’ ethical interest as a group trying to help these patients to enable these partners.

I like to say that at the end of the day, if there’s two therapeutics competing for the same patient, I think that the market penetration will accelerate because the clinical consideration will be not should I treat or should I not treat, but which should I treat with when and how often will become the new mindset. So that’s sort of the nature on the partnering. And then the last piece, this is we’re talking partnering and getting value from platforms. Our Helix system uses our state-of-the-art Morph DNA, steerable introducer platform for all of the procedures. So every Helix procedure and every cell therapeutic procedure were advancing uses are more FDA clear product and so we are going to be securing this year a product family based on that design for broad indications in cardiac and peripheral vascular disease and I know it doesn’t have the same value proposition as our biotherapeutic development efforts, it’s a way we can take our existing product because it’s already FDA cleared and expand that platform design into other indications where it can have value.

And I share with you, with a previous version of this, we’ve done more than 10,000 procedures with our Morph platform. And we had a great relationship with the customer. It just didn’t make sense financially. But today, we’ve done some things that this has potential to have some really nice legs on it. So, it shows you that even though our cash is extremely tight, we are getting enormously valuable things done for shareholders.

Unidentified Analyst: I just had one other question regarding BCDA-01 with the interim data that was presented at the Heart Conference this month. There was a reduction in the arrhythmias for the treated group. And I was curious, is there any thought of why that reduction? Where those results came from? I know that was something like the University of Washington had worked on years ago, to try to reduce that with the stem cells. Any thoughts there or that you can provide?

Peter Altman: I do. So, George, and by the way, great question. The arrhythmia signal is actually, a pretty strong signal in our data and it’s remarkable. We presented a safety data, but one of the, in this field where people are putting things, cells, genes and proteins into the heart. One of the greatest concern from a safety issue is the arrhythmias. And if you trigger a cardiac arrhythmia, it actually can be life threatening. That’s basically what a heart attack is. It’s a cardiac arrhythmia that’s caused by an obstruction in a blood vessel that once your heart starts fibrillating, you have basically two minutes to live because you’re not pumping blood anymore. So that arrhythmia data is compelling data. Our investigators have been quite excited about it.

Reduction in cardiac arrhythmias will be a pre-specified secondary endpoint in the Cardiac Heart Failure II trial because that’s an efficacy claim in its own right. And you mentioned the group in Seattle, interesting enough that that’s the same group I expect that’s behind StemCardia. The idea with some of those other cell types, the great concern has been arrhythmias, because when you and our cells don’t become heart cells, but when you put a cell into the heart and it becomes a heart cell, all heart cells have what they call automaticity. And that means it can create what’s called an ectopic foci and trigger an arrhythmia. And so the fact that we can go into the heart with our cells in CardiAMP or BCDA-01 and deliver at 10 different locations, I think we’ve shared, let’s just say, hundreds of millions of cells and we don’t have any issues with arrhythmias, but rather we’re seeing a great reduction in arrhythmias, suggests that perhaps and I’m just, I’m going to hypothesize here because you asked, perhaps what’s happening is the enhanced microvascular impacts of what we’re delivering increases the healthiness of the cells locally so that we’re reducing the number of ectopic foci in our own patients without trying to make heart cells.

I also note that the result that reduced arrhythmia burden that we see in the patients could also be supporting why we have reduced mortality and reduced major adverse cardiac events in these studies. All of these things are linked together, but I’m sort of going out on a limb here and one of the difficulties in medicine is always proving why something is happening in one way. I guess the end result of that signal is it’s a nice signal. It has excited our investigators and, we think it’s quite valuable for these patients.