Relmada Therapeutics Reports $17.6 Million Net Loss, Acquires Sepranolone and Licenses NDV-01

Relmada Therapeutics, Inc. reported a net loss of approximately $17.6 million for the three months ended March 31, 2025, a decrease from a net loss of $21.8 million during the same period in 2024. The loss per share improved to $0.58 from $0.72 year-over-year. Total operating expenses for the quarter were approximately $18.2 million, down from $23.0 million in the prior year, primarily due to reduced research and development costs, which fell to $11.9 million from $13.3 million, and a significant decrease in general and administrative expenses, which dropped to $6.3 million from $9.7 million.

The company experienced a notable decline in cash and cash equivalents, which decreased to $1.1 million as of March 31, 2025, compared to $3.9 million at the end of 2024. Short-term investments also saw a reduction, falling to $25.9 million from $41.1 million. Current liabilities decreased to $5.2 million from $10.3 million, reflecting a reduction in accounts payable and accrued expenses. The accumulated deficit increased to approximately $658.4 million, up from $640.9 million at the end of 2024.

Strategically, Relmada has made significant moves to enhance its product pipeline. The company acquired Sepranolone, a Phase 2b-ready neurosteroid, for €3 million from Asarina Pharma AB, and entered into an exclusive licensing agreement for NDV-01, a novel chemotherapy delivery system for non-muscle invasive bladder cancer, with Trigone Pharma. These acquisitions are part of a broader strategy to diversify its development pipeline following the pause of its esmethadone program, which was deemed unlikely to succeed in pivotal trials.

Operationally, Relmada's focus on clinical development has led to a strategic review of its programs, resulting in the termination of the REL-P11 psilocybin program due to regulatory concerns and the early stage of development. The company is currently evaluating its clinical strategy for Sepranolone and NDV-01, with the latter already in a Phase 2 clinical trial. The company anticipates key milestones in the coming year, including further developments in these programs.

Looking ahead, Relmada faces challenges regarding liquidity, projecting insufficient funds to sustain operations for the next year without additional financing. Management is exploring various funding strategies, including potential public or private sales of equity or debt securities. The company has expressed uncertainty about its ability to secure necessary financing, which raises substantial doubt about its ability to continue as a going concern.