Navidea Biopharmaceuticals, Inc. (AMEX:NAVB) Q3 2022 Earnings Call Transcript

Mike Rigali: Okay. A follow-up on 332. You said you’ve had 15 patients enrolled now. Are you still running at 100% match?

Michael Rosol: Yes, we’re at 100% match. Can’t do better than that, right? Yes. Yes, it’s 14.

Mike Rigali: 14. Okay. Now on that 100% match, that’s excellent. How important is it to now differentiate between the fibroid and the non-fibroid? I know you’re still trying to differentiate between the diffuse and the lympho. Is that really that critical?

Michael Rosol: Yes, great question. So what we’re hearing from the rheumatologists out there, and I was just at the American College of Rheumatology meeting over the weekend, and I met with a number of key opinion leaders in rheumatology and really the big players in rheumatology in the world, not just in the U.S. that’s not me bragging, that’s me giving them compliments. And the words from those folks is primarily the €“ they’re really excited about the fibroid and non-fibroid differentiation because there’s a nice body of literature already suggesting that being able to distinguish between those two types can really give you significant information for helping guide patients to a more appropriate therapy or guide them away from a therapy that is less appropriate for their type of disease.

So that I think is a primary importance. Distinguishing between the diffuse myeloid and the lympho myeloid is important as well, and it depends on who you ask. There are certain scenarios where it’s importance may rise particularly, for example, in the development of therapeutics that may target one of these specific subtypes or two out of three of the subtypes of RA. You can imagine scenarios where it’s important as elevated. And we’ve heard that from key opinion leaders as well as pharmaceutical companies directly. So €“ and there’s a growing body of literature suggesting that some agents work better on one of those two types than the other as well. But that’s more of an evolving field currently. So really the fibroid, non-fibroid is seen kind of across the board is extremely important and very exciting, because right now you can’t do it any other way other than by doing an invasive biopsy.

So our virtual biopsy is a way to do it noninvasively and quickly. And there’s growing emergence of the idea of looking distinguishing between the other two types.

Mike Rigali: Would you still be considered the gold standard if you could only do the fibroid versus the non-fibroid? Would you still be clear

Michael Rosol: Yes. Yes. That is absolutely tremendous value, because again, you can’t do it any other way than doing the biopsies. The biopsies depending on who does them have a 15% plus or minus 5% or so margin of error, they’re difficult to do, patients don’t like to do them, that’s why these trials are hard to recruit for these biopsy trials. So with our scan being able to distinguish fibroid and non-fibroid, the word I heard on the street is that would be tremendous value to the field of rheumatology.

Mike Rigali: Excellent. Well your science is so robust. I’ll go back into the queue and come back in. Thank you.

Michael Rosol: Actually, I think you’re back in the queue. You’re back, number one, Mike, or get back in?

Operator: Thank you. There are no further questions at this time, and I would like to turn the floor back over to Michael for any closing comments.

Michael Rosol: That’s all right. We’ll do, Mike Rigali has one more question. We’ll let him ask now.

Operator: Sorry, I do see that he just re-queued. Thank you. Mike, you are live.

Mike Rigali: Well, thank you. Thanks very much. On the science, you mentioned that being at these conferences and that you did have a lot of feedback particularly the cancer immunotherapies conference. Can you give us some generalization of the type of questions they were probing you with?