Vaxart, Inc. (NASDAQ:VXRT) Q4 2022 Earnings Call Transcript

Mayank Mamtani: Yeah, it that does. And maybe just one more question. Could you also touch on the requirement for you to initiate the breast-feeding mothers and infant study? And if you can comment quantitatively on how much funding you have or will receive from the Gates Foundation?

James Cummings: Well, I’ll leave the funding questions to those people who dabble in those arts. But from my standpoint, that look at study in lactating postpartum women, where we would give our oral tableted vaccine to women who’ve already delivered babies, so they have a breast feeding infants to measure a couple of things; one, looking, of course, to ensure that we’re safe, but looking at the amount of antibody that we find in the breast milk. I think that’s very important, and that’s part of this study. And then the second piece is looking at the amount of antibodies against norovirus, we find in the infants faeces or stool. So looking at passage or transfer, of those antibodies in breast milk, I think, is very important.

And from our standpoint, this may be a way to protect some of the most vulnerable populations by implementing a vaccination strategy on the lactating mom. I’ll leave the question of dollar amounts, et cetera, to others on the call. Andrei, Sean, Phil, would you like to comment?

Andrei Floroiu: Yeah. So, Mayank, we’re not going to provide details on the dollar amount here. We just said that this trial is — was co-founded by the Gates Foundation and us. And we’re just going to leave it there.

Operator: We have reached the end of the phone questions-and-answers. We now turn the conference back over to Brant for any online questions.

Brant Biehn: Fabulous. Yeah, we’ve got a number of online questions. I’m going to start off. Andrei, this one is going to be for you. The question is why prioritize norovirus, why make that decision now, and why didn’t we make the decision earlier? Andrei.

Andrei Floroiu: Yeah. Thank you, Brant. So we really believe that we have one of the leading norovirus vaccine candidates, and it’s important to emphasize that, and our decision to focus on the norovirus program followed an extensive strategic review of our business and a review of our entire pipeline candidates, including looking at what would be the fastest path to commercial product for us, as well as the most efficient way for us to maximize our current resources. So the reason we prioritize norovirus is because overall, it presents the best risky worth profile for us in the near-term. As we mentioned, we have two very important data readouts this year, one midyear and one in the third quarter. And we do see progressing or advancing the norovirus program as being the best way for us to validate our program, our platform and to position us for long-term success.

And importantly, the updated cash runway extends well beyond those two data readouts. So I think that’s important for investors to know.

Brant Biehn: Excellent. Thanks, Andrei. So focusing on the cash runway, there’s a number of questions on norovirus. Still, this is going to be for you. And they all relate to norovirus try and summarize the scope of all the questions that we’re getting. So can you complete a Phase 3 study in norovirus without additional funding? What’s the projected cost and duration of a Phase 3 study? And does your cash runway include a Phase 3 study? Phil, passing that over to you.

Phil Lee: Sure. Thanks, Brant. So the guidance of our cash runway is into Q2 2024. And that does include the cost associated with all our existing norovirus Phase II studies as well as the Gates Foundation-funded study planned for later this year. What it doesn’t include is the projected cost to conduct a Phase 3 trial, and we aren’t really providing guidance on the cost of a potential Phase 3 trial at this time.

Brant Biehn: Excellent. Thanks, Phil.