Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2022 Earnings Call Transcript

So with regards to learning from the 301 study, obviously, we can work to — if one were to assume that maybe the beginning of 302 was similar to 301, obviously, there are ways that we feel confident having discussed it internally and with clinical trialists, design a more efficient second leg of this ongoing study, if you like, to bring us to a positive study. And so that’s what we have set out to do by amending this protocol. And with regards to, at this point, powering a statistical analysis, we just would not be ready at this moment to get into those details.

Guofang Li: Got it. Thanks.

Operator: Our next question is from Andrea Tan with Goldman Sachs. Please proceed with your question.

Andrea Tan: Hi, everyone. Thanks for taking my question. Maybe another one for Cedric, if you don’t mind. Just curious given the receptivity for MDD so far, just wondering if you could speak on updated thoughts on how you would see REL-1017 existing in the treatment landscape there? And are there any learnings that you can take from the early launch so far?

Sergio Traversa: Hi, Andrea, thank you for the question. Cedric, that’s definitely for you.

Cedric O’Gorman: Well, I just — I think it’s tremendous to see new drugs being approved with new mechanisms of action. The MDD patient population continues to be underserved. And so I think it’s terrific, the more opportunities we have for approvals, the better. And obviously, there are some similarities between REL-1017 being NMDA receptor antagonist. And I think it’s very exciting for that particular realm of mechanisms that there’s greater access and people are willing to develop these drugs. And no, I don’t think I would — I haven’t really any learnings or insights based on early launch activity or anything like that. I focus on the clinical trial design here.

Sergio Traversa: Andrea, if I may add, Sergio here. Yes, the position in the marketplace that you mentioned and REL-1017, if REL-1017 will be approved, it will be quite a bit different. The REL-1017 is going to be adjunctive. So it will be one single tablet that can be added to any other antidepressant use. And there is no antidepressant approved for that indication, right? The other drug is already a combination, so it’s unlikely that would be widely used as an adjunctive to a third to the present. I hope this answers your question.

Andrea Tan: Thanks Sergio.

Operator: Our next question is from Andrew Tsai with Jefferies. Please proceed with your question.

Andrew Tsai: Hi, thanks. Good afternoon. Thanks for taking my question. I appreciate you walking us through these analysis that you did. First question is, what would the very first 303 monotherapy study look if you were to do a similar set of post-talk analysis? Would you get a similar type of signal or a favorable signal for 1017? And then secondly, as we think about RELIANCE II, is there a way to know if the first 100 patients indeed are not tainted. There’s no issues basically? Or said another way, why should we feel confident the first 30% of patients or so who have been enrolled in RELIANCE II won’t hurt the study outcome because technically some of them could have come from unverifiable sources, correct?

Sergio Traversa: Cedric?