Relmada Therapeutics (RLMD) Jefferies Global Healthcare Conference 2026 summary

Strategic overview and pipeline diversification

• Expanded beyond CNS to oncology, specifically uro-oncology, to manage risk and diversify pipeline.

• NDV-01, an extended-release intravesical gemcitabine plus docetaxel, is the lead asset in oncology.

• Phase II basket trial for NDV-01 showed a 76% 12-month response rate, with 80% in BCG-unresponsive bladder cancer.

• Phase III trials will target both high-risk BCG-unresponsive and intermediate-risk populations.

• Sepranolone program in CNS is advancing to phase II for Prader-Willi syndrome, focusing on safety and efficacy endpoints.

Clinical development and regulatory strategy

• Phase III for NDV-01 will enroll 87 high-risk and 276 intermediate-risk patients across 60 U.S. sites.

• FDA agreed to a single-arm, open-label registrational path for BCG-unresponsive patients.

• Primary endpoint is complete response (CR) at any time, with durability assessed at 12 months.

• Interim analysis planned at 50% of events (64 patients) in the intermediate-risk study to reassess statistical assumptions.

• Fast Track designation will be pursued, but not yet applied for; Breakthrough Therapy requires more data.

Market opportunity and product positioning

• Estimated 5,000 U.S. patients in the BCG-unresponsive setting; current Gem/Doce use is mostly academic due to administration barriers.

• NDV-01’s pre-filled syringe formulation enables rapid administration, potentially expanding use to community settings.

• Product expected to be positioned first for high-risk, second-line patients, then intermediate-risk adjuvant therapy.

• Combination of chemotherapy and immunotherapy seen as future standard; NDV-01 may fit into evolving treatment paradigms.

• Pricing strategy will not rely on discounts; will monitor competitors like Johnson & Johnson for benchmarks.