Relmada Therapeutics (RLMD) Q2 2024 earnings summary

Executive summary

• Advanced two pivotal Phase III studies (Reliance II and RELIGHT) for REL-1017 as adjunctive treatment for major depressive disorder, with key milestones and enrollment completion expected by year-end 2024.

• Initiated preparations for a Phase I study of REL-P11, a proprietary psilocybin formulation for metabolic diseases, with Phase IIa planned for H1 2025 and clinical studies set to start in Canada.

• Enhanced patient enrollment criteria in ongoing trials, resulting in a higher screen failure rate (80%) to ensure appropriate patient selection.

• No commercial products or revenues; operations funded by cash, investments, and equity.

Financial highlights

• Q2 2024 net loss was $17.8 million ($0.59 per share), improved from $25.3 million ($0.84 per share) in Q2 2023; net loss for the six months ended June 30, 2024 was $39.6 million ($1.31 per share), down from $51.6 million ($1.72 per share) year-over-year.

• Research and development expenses for Q2 2024 were $10.7 million, down from $13.7 million in Q2 2023.

• General and administrative expenses for Q2 2024 were $8.1 million, down from $12.3 million year-over-year, mainly due to reduced stock-based compensation.

• Cash, cash equivalents, and short-term investments totaled $70.4 million as of June 30, 2024, down from $96.3 million at year-end 2023.

• Net cash used in operating activities for Q2 2024 was $13.3 million, unchanged from Q2 2023.

Outlook and guidance

• Cash position expected to support operations into 2025, including through key milestones such as Reliance II top-line data.

• Reliance II interim analysis and enrollment completion targeted by year-end 2024; RELIGHT enrollment completion expected about six months later.

• Phase I study for REL-P11 to begin in Canada by year-end 2024, with Phase IIa initiation planned for H1 2025.

• Management may seek additional financing depending on future clinical trial scope and operations.