Relmada Therapeutics (RLMD) Jefferies London Healthcare Conference summary

Clinical program overview

• Focused on CNS diseases, especially depression, with lead candidate Relmada 1017 (esmethadone) in late-stage clinical development.

• Relmada 1017 targets adjunctive treatment for major depressive disorder (MDD), aiming to be the first oral antidepressant approved for this indication.

• The U.S. market for adjunctive MDD therapy is estimated at 4–5 million patients, with similar numbers in Europe.

• Previous phase 3 trials narrowly missed statistical significance, attributed largely to COVID-19 disruptions and high placebo response.

• Current phase 3 trial is in its final stages, with interim data expected within weeks.

Adjustments and trial design improvements

• Protocols have been simplified to reduce placebo response, and problematic sites from prior trials were excluded.

• Patient selection now requires medical and pharmacy records to ensure authenticity and reduce bias from social media recruitment.

• Oversight has increased significantly compared to earlier COVID-impacted trials.

• The trial is powered to detect a minimum two-point delta between drug and placebo, the threshold for clinical significance.

• Dropout rates have decreased, and screening is more stringent, enrolling one in five screened patients.

Interim analysis and next steps

• Interim analysis covers over 70% of planned patients (~300), with three possible outcomes: futility, continue as planned, or add more patients.

• A delta above three points means continuing as planned; two to three points may require modest patient upsize.

• No alpha spending at interim, as there is no early stop option.

• Final data readout expected in the first half of next year, with NDA filing timing dependent on results.

• A second phase 3 trial is ongoing, with data expected about six months after the first.