RELMADA THERAPEUTICS, INC. Q3 FY2024 earnings call

• Relmada’s top priority is advancing CNS disorder treatments, with focus on completing Phase 3 program and NDA for REL-1017 for MDD. Expect interim analysis outcome of Reliance 2 Phase 3 study by year-end 2024. - Psilocybin-based metabolic disease program: Phase 1 safety study screening subjects, first randomization soon, Phase 2a in 2025. - Financials: R&D expense increase due to ramp-up of 302 and 304 studies; G&A expense decrease due to lower stock-based comp; cash position supports operations into 2025.

As of September 30, 2024, Relmada had cash, cash equivalents and short-term investments of approximately $54.1 million compared to $96.3 million as of December 31, 2023. Cash used in operations in the third quarter ended September 30, 2024, was $16.7 million compared to $11.6 million for the same period in 2023. Total research and development expense was approximately $11.1 million as compared to $10.5 million for the comparable period of 2023, an increase of approximately $0.6 million. Total general and administrative expense for the third quarter was approximately $11.9 million as compared to $12.2 million for the comparable period of 2023, a decrease of approximately $0.3 million. The net loss for the third quarter of 2024 was $21.7 million or $0.72 per basic and diluted share compared with a net loss of $22 million or $0.73 per basic and diluted share in the comparable period of 2023.

• Expect to report interim analysis outcome for Reliance 2 Phase 3 study by year-end 2024. - Current cash position expected to support operations through key milestones into 2025. - Plan to enroll first subject in Phase 1 study for P11 soon.

Q: What exactly can we expect you to say in the interim release? Will it be just a few sentences, or could it be something more detailed than that?

A: It’s difficult to decide in advance. We’ll see what the outcome will be. We will give as many details as we can on the outcomes.

Q: And I heard 2.2 points somewhere earlier in your prepared remarks, but is that for statistical significance? Just to clarify.

A: It was about around 2 point’s delta. It depends on the standard deviation, so it can be slightly higher or lower than two.

Q: What threshold are you setting for the futility? What kind of placebo-adjusted delta – below what placebo-adjusted delta will you hit futility?

A: It’s about two points. Below 2 points plus/minus a little due to standard deviation, it’s probably going to be futile.

Q: Regarding the interim readout, are you going to be able to have access to any other information such as baseline characteristics of the patients or unblinded data of [indiscernible] changes, for instance? Or is it mainly going to be the information related to the futility or not?

A: The DMC will only share the three outcomes (futility, continue with preplanned, continue with added patients). They won’t provide additional color or details.

Q: If the DMC recommends no change, would you continue to enroll to 300? Or would that be that 400 or 340 number mentioned?

A: It’s difficult to give a straight answer. Usually, you tend to enroll a little bit more than the planned number, around the 300-340 range.

Q: From a statistical perspective, can you confirm you’re not taking a hit to alpha by conducting the interim analysis? And then secondly, just wondering if you have any updates on the percent screen failure rates in Reliance II compared to those from the prior studies?

A: There is no alpha penalty paid in the interim analysis as there is no plan to stop the trial early. Dropout rate is mid-single digit, lower than prior trials, but it’s about compliance and adherence, not indicative of efficacy.