Biora Therapeutics, Inc. (NASDAQ:BIOR) Q4 2022 Earnings Call Transcript

Adi Mohanty: Yes, Sahil. So we have shared this program and you can see it on the website. We’re looking at two doses, a five mg dose and a 10 mg dose in healthy humans, fairly typical SAD and MAD study. So initially it would be a single dose, which will happen pretty quickly. We expect to do this with 10 patients in each arm, and so not a very large study should happen very quickly move on to the multiple ascending dose part. The MAD part of it, both of which we think won’t take very long and like should be able to progress very quickly. And given our thought of potentially filing this IND later in the second half and we start the trial by the end of the year. By the end of the year, we should start seeing some data trickle in.

And given that it’s a €“ there’s no reason we couldn’t share at various stages of this trial, the data and what we’re really keenly interested in is, how much blood is there I mean, how much €“ what’s the PK in the blood? What’s the drug in the tissue? Those are the things that we hope to get fairly quickly. What potentially might be a discussion that we’re thinking of having with the FDA is to add on a arm to that as an extension after the MAD that would have UC patients. And I think it’ll be a little early for me to give you too much detail on that other than if we could get a similar to MAD UC patients actual data in real patients, that could be substantially important in terms of the way the program would be valued in terms of the de-risking as well as what it might do to our future clinical development plans, which could get accelerated.

Sahil Kazmi: Excellent. That’s really helpful. And then maybe one for Eric, can you remind me how you communicated and how you expect the burn rate to change over the next few quarters, including with the filing of the IND some partnerships that may come to fruition et cetera? Thank you.

Eric d’Esparbes: Yes, sure. So we’ve guided that in average we expect to have a monthly cash burn about $4 million or less. It’s probably going to be a little bit below until we actually start the Phase 1, but as Adi said, Phase 1 is a pretty quick study, so it’s not going to be a material increase. I think the average, four, is a pretty good one. The conversation around the pharma collaborations and partnership is an important one because we’ve stated that part of our goal is to raise non-dilutive capital as part of our development plan and that’s the obvious source of non-dilutive capital we can generate. So we’re very encouraged with the enthusiasm of the pharma collaborators with the recent bioavailability data that we shared.

We have one of them who already stepped up to say, hey, I’d like to test my molecules with your platform, and the others are standing by very closely on potentially doing the same. So our hope is as part of the expansion of those agreements, we would have the ability to generate a pretty substantial amount of non-dilutive capital. I can’t size it for you just yet because it’s pretty much related to the data we generate and the range of the conversation, the commercial conversations we’re going to have, whether it’s a based on indication, based on molecule types, based on market in terms of arrangements, we have to go through those conversations first. Hopefully that’s helps, Sahil.

Sahil Kazmi: Yes, that’s very helpful. I appreciate you taking our questions. Thanks.

Adi Mohanty: Thank you.