BioCardia, Inc. (NASDAQ:BCDA) Q2 2023 Earnings Call Transcript

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Peter Altman: Yes. So as far as trial wind down, the information we receive from this will impact the data that we have. So we are still randomizing patients today. And because all of the data supports that this is safe and all the past data that we see supports this is efficacious, we’re still bullish on the direction that we’re going. And so those patients will be randomized, expectation is all the outstanding patients will be randomized in the next six weeks to eight weeks. And then we’ll follow them for a period of a year before we get to the true data readout from this trial. The interim readout that we may have, if data is viewed, we’ll have the challenges that many of the endpoints have not yet been monitored, and so they will be looking at that.

What I would expect to look for here is I follow the primary endpoint. I mean, the mortality data is going to be important. I mean, if we’re losing on that for some reason that I can’t explain, that would be a surprise. The MACE data will be this next thing to look at. And if we’re losing on that, that will also be interesting to look at. But I think the primary feature since those two are so low already in this treated population; I don’t expect either of those to have any interesting signals. Again, I’m not privy to the data. So I’m providing you my best guess work here all. And my expectation is that if there’s something, it’s the six-minute walk is problematic. When we look at the other pre-specified endpoints, quality of life, all of the extensive echo data we have from our core laboratory at Yale, there may be some interesting observations in there that enhance our comfort level.

And then also two-year data follow-up, we haven’t really looked at two years, but understanding how these patients are doing long-term is also going to be really important. And I would, again, I look at the survival data, I look at the MACE data and then I look at the functional endpoints of six-minute walk, quality of life, and all the — actually all of the echocardiography data such as LV ejection fraction, LV end diastolic dimensions, the end systolic dimensions. And those are really important endpoints and are quite objective, and we’ll see where we go from there. I think right now, it’s interesting. I mean, we don’t have clarity on why they would pause it. If they don’t think we’re going to hit the primary endpoint, maybe their perception is these guys pause this and stopped this trial and restarted with another variable other than six-minute walk, maybe they’ll be successful, I don’t know.

It’s all guesswork. But we’re being prudent as we’re moving forward. We are stewards of the value that this trial has in it for all of our shareholders and for patients, and so we have to take the steps that we’re taking and the order we’re taking, and we’re doing it with world-class folks, so that we’ll get to the right answers hopefully sooner rather than later.

Joe Pantginis: Peter, thanks a lot. I appreciate the color and the speculation for this pretty unique situation and looking forward to the outcomes. Thanks a lot.

Peter Altman: Yeah, appreciate the question, Joe.

Operator: At this time, we are showing no further questioners in the queue, and this does conclude our question-and-answer session. I would now like to turn the conference back over to Peter Altman for any closing remarks.

Peter Altman: I want to thank all of you for participating in today’s call and for your interest in BioCardia and our primary mission to treat heart disease. We look forward to sharing our continued progress, and as I always say, stay healthy, be kind and have a wonderful day. Thank you.

Operator: The conference has now concluded. Thank you for attending today’s presentation and you may now disconnect.

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