Relmada Therapeutics (RLMD) investor relations material

Executive summary

• Achieved 92% overall response rate at any time in 9-month follow-up for NDV-01 in NMIBC, with favorable safety profile and no progression to muscle-invasive disease.

• Secured FDA alignment for two distinct Phase III registrational tracks for NDV-01, de-risking the program and broadening market potential; studies to begin in H1 2026.

• Strategic pivot in early 2025 included acquisition of Sepranolone and licensing of NDV-01, while terminating esmethadone and psilocybin programs.

• Completed $100 million underwritten offering in November 2025 to fund operations and clinical programs into 2028.

• Appointed leading urologic oncologist to Clinical Advisory Board, enhancing clinical expertise.

Financial highlights

• Cash, cash equivalents, and short-term investments were $13.9 million as of September 30, 2025, excluding $94 million net proceeds from a recent offering.

• Q3 2025 net loss was $10.1 million ($0.30 per share), improved from $21.7 million ($0.72 per share) in Q3 2024.

• Nine months ended September 30, 2025: net loss $37.5 million ($1.16 per share), down from $61.3 million ($2.03 per share) year-over-year.

• R&D expenses for Q3 2025 were $4 million (down from $11.1 million), and G&A expenses were $6.3 million (down from $11.9 million) year-over-year.

• Cash used in operations for Q3 2025 was $6.7 million, down from $16.7 million in Q3 2024.

Outlook and guidance

• NDV-01 Phase III registrational studies for NMIBC and Sepranolone Phase II study in Prader-Willi syndrome are planned to start in the first half of 2026.

• Twelve-month Phase II NDV-01 data expected Q1 2026; IND clearance targeted for H1 2026.

• Current cash position, including recent offering, expected to fund operations and planned studies into 2028.