Navidea Biopharmaceuticals, Inc. (AMEX:NAVB) Q4 2022 Earnings Call Transcript

From that point on to — all the way to and into or through FDA approval, that puts you in the strongest position, I believe, because then you have a proved-out, to one degree or another, diagnostic. So again, if you want me to be completely honest here, doing deals earlier, you usually — you give up something because there’s more risk, right? It’s all about the rNPV, right? So the longer we can go, if we can be fully funded and drive this towards completion of a trial, good data, FDA NDA submission, believe me, then we’re in the strongest position to do a deal. So I think that’s the strategy that you should pursue, at least if you can, and we’re trying to do that strategy. It doesn’t mean if something happens in the intervening months or so, we’re not turning it away, we’re listening.

But we want to make the best that we can of what we’ve got here. And really, that’s the story. So…

Unidentified Analyst: Well, I think taking that approach of extracting the best value with the most informed and progressed results is — would be the desired way to go. And I think I’ll finish with the comment that you made in the rheumatoid arthritis treatment patent application that should encourage people on this and in 2 of the embodiments in 106 and 111. It was stated that the exciting perfect prediction and remarkable test responses were generated in that testing for the treatment. Can you expand on any of that? Because that just exemplifies and amplifies the potential of this RA, the results you were seeing in the treatment RA — of the RA patent application. Can you comment?

Michael Rosol: Sure. So thanks for that. That patent is primarily about the — using a combinatorial approach for achieving a better prediction capacity for our imaging agent for predicting treatment response in RA. And so we know that our — that in the data so far, tilmanocept imaging is a very good predictor in the data so far of clinical outcome at 3 and 6 months. And what we started to look at after the Phase IIb study was, could — is it an independent and additive predictor to other clinical serological biomarkers, which for the most part or entire part have really kind of failed to be adequate on their own or even in combination? Although there’s a lot of people looking at different combinations. So we looked at our imaging prediction in combination with all sorts of different clinical and blood-based, that’s what I mean by serological, biomarkers that are normally obtained in RA patients.

And we looked at these in all sorts of different cool ways, and what we found was that it looks like — and we only have limited data to date. But it might be that our — if we take our very powerful imaging readout and combine it with some readily available and already validated clinical biomarkers, we might be able to improve our prediction capacity, in some circumstances, the upwards towards a sensitivity of 100, right, or perfect. Never going to be perfect across the world, across everybody, across all time. But it’s really about taking a combinatorial approach of our imaging readout with other biomarkers that are available. And it looks like there might be value there. And by filing that patent, then of course, we have the intellectual property protection.