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

Michael Rosol: Yes, this is Mike. So the numbers, I think, are solid numbers in terms of the market potential and the growth curves even. Those are always based on modeling. In terms of the time lines, I mean the — we’re doing our best to meet the time lines that are on the investor deck that is out there right now. But to be honest, some of these projections were based on opening up a full suite of sites or a larger number of sites at a certain stage and then going forward from that period. And we’ve been, frankly, in a resource limited environment for a while now. So some of these things are just naturally going to be pushed forward unless — and this is where it gets very complicated. So I’m not giving you double talk, I’m giving you real talk.

Unless the — we could open up more sites than we built into the original model. Enrollment is always something that we have some control over but not full. And then there are several other factors that are — including the trial size, which is variable based on the response rate to the anti-TNF alpha therapies. So you put all of that into the hopper, the resource limited environment where we have not been able to open up all the sites we wanted to yet and some of these other variables, and they can kind of counteract each other. So you end up with the same resolution of everything at the same time or might be driven forward or even happen earlier. So more likely than not, it gets pushed forward a little bit if you have to run a long time without a full complement of clinical trial sites open.

And that’s kind of where we are now. So I hope that doesn’t sound hand-wavy. But like those — the first revenue generated may be pushed off a bit, but the numbers themselves and the trajectory, once it happens, we still stand by and believe because we have a good idea of the competitive landscape. And the data that we’re bringing to the table so far are significantly better than anything I’ve seen out there. That make sense?

Edward English: Yes. If I could summarize, I think you’re telling me the potential is still there and it’s very robust, but the timing could go either way.

Michael Rosol: You got it. Yes.

Edward English: Okay. Well, I’ll end it there and just say certainly looking forward to some news soon on your financing.

Operator: And the next question is a follow-up from , private investor.

Unidentified Analyst: Yes. Dr. Rosol, 2 follow-up questions. You mentioned briefly that as you advance the science engagement, future funding partners improve. Are those still active talks ongoing on the RA partner potential? Is that still in the works and still progressing?

Michael Rosol: Thanks, Mike. Yes, that’s a — and there’s a complicated answer behind that. The answer is yes, we’re still in — and I’ve said this, so I can say it now. We’re in discussions related to the implementation of — or the use of tilmanocept in partnership with other drug development companies. And those are — there’s a lot of interest in the NAV3-32 Phase IIb study for that. In terms of the overall business partner for RA, I think there are opportunities to discuss as we roll with other possible — with possible business partners as we roll into — through the trials. But really, and again, to be honest, what I think, Mike Rosol, the place where you’re in the best position to get the most bang for your buck is when you’ve completed the trials and have strong data in hand.