Relmada Therapeutics, Inc.

Relmada reported cash, cash equivalents, and short-term investments of $217.7 million at June 30, 2026, up from $93 million at December 31, 2025. For the second quarter, R&D expense was $8.4 million versus $2.8 million a year ago, G&A expense was $6.6 million versus $7.4 million, net cash used in operating activities was $9.6 million versus $6.4 million, and net loss was $12.9 million, or $0.11 per basic and diluted share, versus a net loss of $9.9 million, or $0.30 per basic and diluted share in Q2 2025. Management said current cash resources are expected to fund operations through 2029, including completion of the Phase III RESCUE program for NDV-01. For guidance, the company expects to file the NDV-01 IND by year-end 2026 and initiate Phase III RESCUE upon IND clearance; it also expects to file the sepranolone IND by year-end 2026 and start a Phase II proof-of-concept study upon clearance.

Sergio Traversa framed the quarter as a transition into execution, saying Relmada now has a strong balance sheet, an experienced team, and a clear plan to move NDV-01 into registrational development. He emphasized that the formulation and process are locked and that the remaining work is to complete manufacturing to GMP standards and file the IND by year-end. His tone was confident and upbeat, but practical, repeatedly stressing that the company is focused on execution rather than near-term data disclosures.

Maged Shenouda focused on the balance sheet and spending profile. He said cash, cash equivalents, and short-term investments totaled $217.7 million at quarter-end, compared with $93 million at December 31, 2025, and that this should fund operations through 2029, including Phase III RESCUE. He also quantified quarterly spending: R&D rose to $8.4 million from $2.8 million mainly due to higher NDV-01 and sepranolone study costs plus manufacturing and drug storage costs, while G&A declined to $6.6 million from $7.4 million due mainly to lower stock-based compensation and employee compensation.

Analysts focused on the main bottlenecks for NDV-01, including whether manufacturing issues were scientific or operational, whether FDA input is needed before filing the IND, and how quickly dosing could begin after IND clearance. Management said the formulation and process are locked, the work is now about getting on the manufacturer’s schedule and producing GMP batches, and they do not believe additional FDA input is needed before filing. They also said around 80 sites are planned and that enrollment could begin about 30 days after filing, once the IND is cleared. On data timing, management said the earlier 3-month CR disclosure may be pushed back or reframed because they want a meaningful patient count and because 6-month data may be more informative.