Relmada Therapeutics Reports Decreased Net Loss and Strategic Shift in Drug Development

Relmada Therapeutics, Inc. reported a net loss of approximately $79.98 million for the year ended December 31, 2024, a decrease from a net loss of $98.79 million in 2023. The company's total revenue remains at zero, as it has not yet commercialized any products. The decrease in net loss is attributed to reduced operating expenses, particularly in research and development, which fell to approximately $46.18 million from $54.81 million in the previous year. General and administrative expenses also decreased to about $37.72 million from $48.89 million, primarily due to a significant reduction in stock-based compensation expenses.

In a strategic shift, Relmada has paused its lead development candidate, esmethadone (REL-1017), for the treatment of Major Depressive Disorder (MDD) after interim analysis indicated the pivotal trial was unlikely to succeed. The company is now focusing on two new candidates: NDV-01, a novel delivery formulation for treating non-muscle invasive bladder cancer, and Sepranolone, a neurosteroid for various neurological conditions. The acquisition of Sepranolone was completed in February 2025, and an in-license agreement for NDV-01 was finalized in March 2025, marking a significant pivot in the company’s development strategy.

As of December 31, 2024, Relmada had total assets of approximately $45.82 million, down from $97.55 million in 2023, primarily due to a decrease in short-term investments. The company’s cash and cash equivalents stood at $3.86 million, indicating a need for additional funding to sustain operations. The company has an accumulated deficit of approximately $640.88 million, raising concerns about its ability to continue as a going concern without securing further financing.

Relmada's workforce consisted of 17 employees as of the end of 2024, and the company is actively seeking to expand its team to support its new strategic direction. The company has also faced challenges in maintaining its listing on the Nasdaq Global Select Market, having received a deficiency notice regarding its stock price, which fell below the required minimum of $1.00 per share. The company has until July 21, 2025, to regain compliance.

Looking ahead, Relmada anticipates key milestones, including the presentation of Phase 2a data for NDV-01 at the American Urological Association Meeting in the first half of 2025 and the initiation of clinical trials for Sepranolone by the end of 2025. The company remains focused on leveraging its drug development expertise while navigating the complexities of the biotechnology landscape.