The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Yeah. So an exciting year for you with upcoming pivotal data coming in the second half of this year. Maybe to level set here, as you think about
Reliance I, your relay trial that's coming next year. Remind the audience how these trials are designed in adjunctive MDD. When can we expect to
see some data here and help frame expectations.
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe you remind us or maybe help provide some context. You referenced your prior Phase 3 trials here. And I think in both of those, you did see
an elevated placebo response. What have you implemented in these trials now to try to control for that?
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JUNE 12, 2024 / 3:20PM, RLMD.OQ - Relmada Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Got it. And as you think about these patients, just remind us what the inclusion, exclusion criteria are for the trial.
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: And what is the baseline cutoff for your HAM-D score for the patient?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: How does 19 -- I guess, maybe if you could provide some context relative to other clinical trials. Because I think that's been a focus that if you have
maybe less severely depressed patients. It may be more difficult to maybe tease out that signal. Help us understand how you came to 19 as the
cutoff.
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affiliated companies.
JUNE 12, 2024 / 3:20PM, RLMD.OQ - Relmada Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Why not have a higher cutoff maybe to help, maybe ensure that you are getting a more severe patient population?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe when you've spoken in the past, you've disclosed -- (inaudible) and that seems to be well above at least your prior trials. How does that
compare to the extent that you're aware of other clinical trials in depression here? And what would you maybe pinpoint as the nature of those
failures?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe on that point as a follow-up. If you are enrolling patients who are taking, say, benzodiazepines maybe even at a low level, how are you
confident that that won't skew your data or maybe skew the response since benzos are used as antidepressants?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: As you think about these protocol amendments that you've put into place now to control the placebo response, I guess how much risk is there
that 30% of your patients in Reliance II were actually enrolled before any of these were implemented as you think about the data that's coming
later this year?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: What are you powering your study to detect?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe on that point, because you have had some, I think, very robust data in the Phase 2 trial. Maybe remind us the profile that you've seen there.
How important is the rapid onset of action you're seeing that be touted as a selling point for some other drugs that are on the market right now?
Where does REL-1017 eventually fit into the treatment paradigm?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: And as the profile of REL-1017 has emerged, whether it's the Phase 2 study, your open-label study, what has been the receptivity from the medical
community as to the profile of this drug?
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affiliated companies.
JUNE 12, 2024 / 3:20PM, RLMD.OQ - Relmada Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe remind us the work you've done with the human abuse potential studies.
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe given the clean signal that you've seen there and the lack of an abuse potential, remind us why the assumption is that you would start with
a Schedule 4 or 5.
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: What are you hearing from the medical community on that front? A Schedule 4 or 5 versus no schedule at all, not a controlled substance. How
would that impact how they think about using this drug?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: I mean, maybe a follow-up there. If you were Schedule 4 or 5, which recognizing it is a much lower bar than a Schedule 2 for these physicians, but
how would that impact it, I guess, maybe as you think about other antidepressants on the market that really minus (inaudible) don't have a schedule
there, what particular patient will be prescribed REL-1017?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Maybe in the last couple of minutes, we can jump over to your REL-P11 program.
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Remind us the genesis of this. Why there's this interest to explore this agent in obesity. Why does that make sense right now?
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affiliated companies.
JUNE 12, 2024 / 3:20PM, RLMD.OQ - Relmada Therapeutics Inc at Goldman Sachs Global Healthcare Conference
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Perfect. Well, we are just up on time, but Sergio, any last remarks as we await Reliance to Reliance II relay data?
Question: Andrea Tan - The Goldman Sachs Group, Inc. - Analyst
: Well, with that, thank you so much, Sergio.
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