Relmada Therapeutics Inc at Jefferies Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Andrew Tsai - Jefferies LLC - Analyst : Sounds good. Thanks. Thanks. Sergio if you are, we talk about your new set of Phase 3 studies. Maybe give us even more context about the market opportunity. What profile do you think REL-1017 can become down at the end of the day? And how would that profile compare to the existing drugs out there?

Question: Andrew Tsai - Jefferies LLC - Analyst : Understood. And speaking of safety of -- safety risk of the antipsychotics, I think you did recently presented at a medical conference your Phase 3 studies from last year. What did you end up seeing on safety? How does the safety profile look?

Question: Andrew Tsai - Jefferies LLC - Analyst : Got it. Got it. Okay. So moving forward, you have these Phase 3 studies underway and maybe perhaps safety is less of a thing to worry about for investors. We just think of -- so the question is you had this Phase 3 studies readout last year. What are some of the lessons that you learned and how are you -- how do you -- why do you think you can do it differently this time? What's changed?

Question: Andrew Tsai - Jefferies LLC - Analyst : Got it. And I think you mentioned earlier, COVID also hurt the study. But luckily, fortunately, hopefully, COVID goes down basically and that should be a positive tailwind for you guys as well.

Question: Andrew Tsai - Jefferies LLC - Analyst : And so within the verifiable sources, I think you've mentioned there are four different areas, past patients at site. Based on my notes, current patients, site database, HCP referral. Would you rank order any of them in general? Which could be the best?

Question: Andrew Tsai - Jefferies LLC - Analyst : Got it. And you know, unfortunately, also the prior Phase 3 studies, you did see some outlier sites that showed paradoxical results, placebo skyrocketing over the drug arm. So how do you ensure or minimize that risk? Because I believe you might be choosing maybe different sites going forward? How do you make sure those sites will not become outlier sites?

Question: Andrew Tsai - Jefferies LLC - Analyst : Got it. Got it.

Question: Andrew Tsai - Jefferies LLC - Analyst : Right. Okay. And so now you've been resumed enrollment recently for both -- for your RELIANCE II. And then I believe you started up RELIANCE IV or not yet? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 08, 2023 / 7:00PM, RLMD.OQ - Relmada Therapeutics Inc at Jefferies Healthcare Conference

Question: Andrew Tsai - Jefferies LLC - Analyst : Great. And so RELIANCE IV just completely new. RELIANCE II technically resumed after, I believe 100 patients have been enrolled. So the question is how do we know those existing 100 patients are okay, they are not outliers?

Question: Andrew Tsai - Jefferies LLC - Analyst : Okay. And if someone were to ask you, it doesn't make sense, do you take an early peek just to make sure you've got things right? That you are controlling for placebo? What would you say to that? Or at the end of the day, do we wait for the data in 2024?

Question: Andrew Tsai - Jefferies LLC - Analyst : Yeah. I mean, bigger picture, I think the beauty here is safety of the drug looks good. You don't necessarily have to truly worry about it. Efficacy across these studies, to me, it seems like it's active. So the last variable is placebo and it seems like you guys have learned and are trying to control for it. So --

Question: Andrew Tsai - Jefferies LLC - Analyst : Okay.

Question: Andrew Tsai - Jefferies LLC - Analyst : And so, for these two Phase 3 studies, what are they powered to show drug versus placebo?

Question: Andrew Tsai - Jefferies LLC - Analyst : 3.3 and 3.7?

Question: Andrew Tsai - Jefferies LLC - Analyst : Got it. Got it. And at the end of the day, I believe you would need two Phase -- positive Phase 3 studies to file to the FDA, unless you think otherwise? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 08, 2023 / 7:00PM, RLMD.OQ - Relmada Therapeutics Inc at Jefferies Healthcare Conference

Question: Andrew Tsai - Jefferies LLC - Analyst : And does it make sense to start a third one, just as a clinical backup? The third Phase 3?

Question: Andrew Tsai - Jefferies LLC - Analyst : Right.

Question: Andrew Tsai - Jefferies LLC - Analyst : Makes sense. And speaking of the open-label data, like you said, you'll have some data later this year. So what can we expect to see? What is good data to you? How much will you share?

Question: Andrew Tsai - Jefferies LLC - Analyst : And it could be interesting as I think about it to kind of even dissect the data between verifiable versus non-verifiable patients or patients pre-COVID, post-COVID. A lot of ways to analyze the data to support your case it goes after. Maybe, very last 30 seconds, I think you did say earlier. Cash position and are you --

Question: Andrew Tsai - Jefferies LLC - Analyst : Okay, Very good. Thanks. Thanks, both of you for joining me today. And thanks, everyone, for listening in.