VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Q1 2024 Earnings Call Transcript

Shawn Singh: Sure. So we’ll do open-label extensions on each of the 2, the PALISADE-3 and the FEARLESS study, so that there still has to be a safety database that gets established. And then the readout study that you mentioned, so I think that’s something we’ve reported before. FDA wants to see what happens if someone uses the drug twice instead of just once in that acute setting. So that’s something we will – before NDA, that’s a small study that we’d likely be completing and most likely they’d be using a public speaking challenge as well. So not too many subjects, not too expensive, but again, trying to – not so much for safety, and we don’t really worry about multiple uses in a short period of time, but I think there is some interest at the agency and wondering whether more is better.

We’ve certainly established the 3.2 micrograms used PRN is good in PALISADE-2. So if better is available, great, but it won’t be an essential component for going forward in PALISADE-3 or the FEARLESS study.

Andrew Tsai: Got it. Actually, very last one, because you don’t have much opportunity on conference calls. So in the study results, did PH94B work equally as well between male and females? And that’s the last question. Thank you.

Shawn Singh: I think that’s something we’ll be able to unpack. We don’t have the full data set fully unpacked. We have the top line results. So that takes a little bit of time. But I don’t think we see – and we’ve long held since – that was, I think, long, long time ago that, that was a question. But we think – we don’t think there’s any reason to believe the drug doesn’t work as well in women as in men or men as an women, whichever way you want to put it. But FEARLESS will give us – okay.

Andrew Tsai: Okay. Thanks. Congrats.

Shawn Singh: Thank you.

Operator: And there are no other sell-side analysts in queue. You may proceed to closing comments.

Mark Flather: Excellent. Thank you, Jennifer for your help today. And thank you, Andrew, and Joanne. We appreciate your questions. If there are any additional questions, please do not hesitate to contact us by e-mailing ir@vistagen.com or contacting the individuals listed in our press release issued today or on our website. We are – we also encourage you to sign up on our website to stay connected with the latest news from Vistagen. Thank you for participating in our call today. We appreciate everybody’s attention and support. We look forward to keeping you current on our continuing progress. This concludes our call. Have a fantastic day. You may all disconnect now.