Relmada Therapeutics (RLMD) investor relations material

Executive summary

• Entered a critical execution phase with a strong balance sheet and experienced leadership, advancing NDV-01 for NMIBC and sepranolone for Prader-Willi syndrome, after terminating esmethadone and psilocybin programs in 2025.

• NDV-01 demonstrated 95% complete response at any time and 76% durable response at 12 months in phase II, with favorable safety; phase III trials planned post-IND filing by year-end 2026.

• Sepranolone formulation development is complete, with IND filing and phase II/IIb study in Prader-Willi syndrome targeted by year-end 2026.

• Strengthened leadership with the appointment of Bipin Dalmia as Chief Business Officer, bringing extensive uro-oncology and manufacturing experience.

• Added to the Russell 2000 and 3000 Indexes effective June 26, 2026.

Financial highlights

• Ended Q2 2026 with $217.7 million in cash, cash equivalents, and short-term investments, up from $93 million at year-end 2025.

• Research and development expense rose to $8.4 million from $2.8 million year-over-year, driven by NDV-01 and sepranolone study costs and manufacturing expenses.

• General and administrative expense decreased to $6.6 million from $7.4 million year-over-year, mainly due to lower stock-based and employee compensation.

• Net loss for Q2 2026 was $12.9 million ($0.11 per share), compared to $9.9 million ($0.30 per share) in Q2 2025.

• Operating expenses for Q2 2026 totaled $15.0 million, with interest/investment income at $2.3 million.

Outlook and guidance

• IND filings for both NDV-01 and sepranolone targeted by year-end 2026, with phase III and phase II/IIb studies to begin upon clearance.

• Cash resources expected to fund operations through 2029, including completion of NDV-01 phase III.

• Initial clinical data disclosure for NDV-01 phase III likely in the first half of 2027, aiming for a meaningful patient sample.