Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q3 2022 Earnings Call Transcript

Yatin Suneja: Hey, guys. Just a couple of questions for me, just to clarify. So what percent — how many of the sites that were in the monotherapy study are going to be overlapping in RELIANCE I? I think previously, when we had discussions with you, you seem to imply that there is a possibility of increasing the sample size. I mean, if the study is still not done yet, why not increase the size in order to be statistically significant?

Sergio Traversa: Yes. Thank you, Yatin. I got the question. And the — in terms of overlapping of size, I don’t have the exact number, but there is the best — like I would say that overlapping is pretty high between monotherapy and RELIANCE I. The one that really matters, the sites that have a high — they enrolled a lot of patients, the high enrolling sites, and they are the one that have this paradoxical response where placebo outperformed the drug by quite a bit, and it’s kind of isolated to a few sites. But these are the ones that really could make the difference. We don’t know — I mean the site are in RELIANCE I as well, but we don’t know if the phenomena is going to be the same or not. As Dr. Fava was saying, this is a different patient population.

So this size may have different results, but we won’t know it until we see it. And the — we discussed about expanding the enrollment in RELIANCE I with the DSMB recommendation. If the site — or if the trial is somewhat compromised, adding more patients will just expand time, cost, and probably, unless we tripled or doubled number of patients, won’t make it such a big difference. So it’s much more productive to just see how the results look like, learn from the result. And eventually, you’ll likely start new at least one new trial and — from scratch, applying all what we have learned from the monotherapy and what we will learn from the RELIANCE I. So the decision was really just let’s see how the data look like as the profile of the patient is different.

Yatin Suneja: Got it. And then to clarify, is the RELIANCE II already ongoing? Or that one is also on pause given that you first want to see what RELIANCE I is going to yield?

Sergio Traversa: Well, clearly, RELIANCE — how RELIANCE I will look like, it will have an impact on RELIANCE II. For now, we are just implementing quite a bit of changes from the protocol to limiting the number of patients per site. So in changing the way the rating is done from a localized to most likely a lot less localized rating. So we are implementing these changes, but technically, the trial is open. We only enroll 25% roughly of the full patient population. So RELIANCE II is still a very valuable trial. The site and the similarity with RELIANCE I and III, the site that they affected RELIANCE III that are not in RELIANCE II. And so that’s already an indication the number of patients is low. So that’s a perfectly non — we don’t think it’s a compromised study, that we’ll continue to enroll, and we expect to complete and have data sometime next year, probably. I hope I answered your question.

Operator: And we’ll move to our next caller, and that will be Andrea Tan of Goldman Sachs.

Andrea Tan: Hey, Sergio, thanks for taking my question.

Sergio Traversa: Hi, Andrea.

Andrea Tan: Hi. Maybe one follow-up there. Just wondering if you’ve been able to understand more what happened at those sites where you did observe the paradoxical results? Anything in particular that they may have been doing differently on study execution than the other sites? And do you think additional training is maybe necessary as you look to these improvements that you were speaking about for RELIANCE II?