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

Andrew Tsai: Got it. Okay. And speaking PALISADE-2, going back to the data, when could we expect you to share detailed results at a medical meeting or a publication? I mean it would be great to see the curves of SUDS and so forth. And secondly, you’ve compared PALISADE-2 to PALISADE-1, explained the differences. But can you also compare to the prior Phase 2 study and maybe compare and contrast any efficacy differences that you saw? Were there different baseline SUDS scores, for instance, between these two studies? Help us reconcile any differences.

Shawn Singh: Thanks. Well, first to your question about the data, this obviously falls into industry standard breaking news, so we’re trying to find a nice place to present the Phase 2 data in a breaking news context. Hopefully, sometime this fall, I think would probably be the earliest. So we’ll have more information on that as we go forward. Certainly, abstracts and the like are already in circulation. So – and then as to your questions about has the PALISADE-2 – or the Phase 2 studies, I mean, obviously, it’s a different environment. That’s the three study – or 3-site study. But Josh Prince, I want you to actually just address this just briefly, some of the things that we see.

Joshua Prince: Yes. Thanks, Shawn. Just to fill in the space there, I think the key is the time difference. So when we think about how long it’s been since those earlier Phase 2 studies were done and you think about just the environment that we live in today versus then and through the pandemic, we think that has effect. But overall, the efficacy seen for both PH94B and placebo in that Phase 2 study was everything was kind of shifted up compared to what we’ve seen with PALISADE-2 and PALISADE-1. I mean we really do think it has to do with kind of the – again, the times and the types of patients and conducting a study through the pandemic.

Andrew Tsai: Thank you very much.

Joshua Prince: Thanks Andrew.

Operator: And our next question is from the line of Joanne Lee from Maxim Group. Please go ahead.

Joanne Lee: Hi. Good afternoon. Thanks for taking the questions and congratulations on the successful outcomes of the recent Phase 3. The results were truly remarkable. Just given fasedienol achieved positive results in now both PAL-2 and the open label study, could you provide some insight on the rationale behind choosing to pursue both SUDS and LSAS as primary measures in the PAL-3 and FEARLESS studies? Was this decision influenced by any guidance from the FDA? Just curious on that.

Shawn Singh: No, no. Well, Thanks, Joanne, first of all, for the question. It’s a great question. Look, we long held the way that we think fasedienol can help people. It’s two distinct ways. It can certainly help people, as we’ve shown in PALISADE-2, in an acute setting. And as they take it out of their pocket or their purse or their backpack and they use it on demand in a patient-tailored way, has the ability to knock down very rapidly those symptoms. That’s what PALISADE-2 showed. We also have placebo-controlled Phase 2 data and some exploratory data from the open label. Lots of subjects that also when it’s used acutely but used over time, it increases the confidence of a person and increases their resilience, and it reduces their tendency to avoid situations that could benefit their lives.

It reduces the opportunity costs in their life. And that avoidance – a reduction in avoidance of engaging in social and performance situations is important. The Liebowitz scale captures both of those. So we’re at a perfect spot right now because we’ve got one successful study in Phase 3, and you only need two adequate and well-controlled studies to get an approval of a drug. And so it could either be from a PALISADE-3 or it could be from a FEARLESS. Either way, what we’re trying to do is look to the most efficient path to get this drug to patients as soon as possible. And it’s one of those two tracks. It could be both, but you only need one other besides the one we’ve got. At least that’s our opinion at this point. So doing the LSAS-based study, again, it’s consistent with the only three drugs ever approved for treatment of social anxiety disorder.