Relmada Therapeutics (RLMD) Goldman Sachs 45th Annual Global Healthcare Conference summary

Clinical trial design and protocol improvements

• New Relight trial for adjunctive MDD uses a simple design: two doses, placebo and 25 mg REL-1017, over four weeks with a primary endpoint at day 28.

• Protocol has been simplified, removing unnecessary safety requirements, reducing patient-investigator contact, and aiming to better control placebo effect.

• Site selection now leverages proprietary data to exclude sites with poor placebo control and limit patient numbers per site to avoid skewed results.

• Patient selection includes a four-step adjudication process and requires proof of antidepressant use and diagnosis, aiming to enroll only biologically depressed patients.

• Inclusion criteria require patients to have depression, be on antidepressants for at least six weeks, and show less than 50% improvement; exclusion criteria include certain medications and comorbidities.

Placebo response and data integrity

• Previous trials were impacted by high placebo response, partly due to COVID-related factors and remote assessments.

• Amendments target protocol, site, and patient selection to minimize placebo effect and improve data quality.

• Screening failure rates are now 75-80%, higher than industry average, due to stricter criteria; efforts are ongoing to optimize this without increasing risk.

• Protocol now allows some previously restricted medications, like benzodiazepines for sleep, to reflect real-world patient habits.

• Study is powered to detect a 2–2.5 point delta between placebo and drug, with a primary endpoint at day 28.

Drug profile, regulatory, and market positioning

• REL-1017 is differentiated by rapid onset and favorable tolerability, with no oral antidepressant currently approved as adjunctive treatment.

• FDA prioritizes duration of effect over rapid onset for approval; European regulators value both duration and economic impact.

• Human abuse potential studies show a placebo-like profile, with no observed abuse cases; initial scheduling as IV/V is expected due to parent drug history.

• Schedule IV/V status is not seen as a barrier by prescribers; main competition will be antipsychotics, not first-line antidepressants.

• Medical community values REL-1017’s tolerability and safety, especially compared to antipsychotics used as adjunctive therapy.