Relmada Therapeutics announced on Thursday that it would be shifting its focus away from depression treatment and psychedelics after acquiring new Phase 2 drug candidate.
This clinical stage biotechnology firm announced that it will soon release topline data from Phase 2 for NDV-01. It describes this formulation as an intravesical sustained-release formulation for non-muscle-invasive high-grade bladder cancer. The data will be presented at the American Urological Association’s meeting, which is scheduled for late April.
In a press release, CEO Sergio Traversa stated that “at the end of the last year we began a transformation process by exploring strategic acquisition opportunities in order to maximize shareholder values.” The recent acquisition of Phase 2 programs with high potential is a great step forward in our efforts.
Relmada switched to the new formulation in January after it halted Phase 3 trials of REL-1017, a depression treatment drug. The decision was made following an evaluation by a data-monitoring committee. At the time, Relmada had stated that REL-1017, a modified psilocybin being tested for metabolic disease, would be continued development. But the company’s new report on earnings also indicates a move away from this focus.
In a news release issued on Thursday, CFO Maged Shenouda stated that the company was “reevaluating” further development of REL P11 due to “the increasing competitiveness in clinical development in metabolic diseases”, despite good Phase 1 data.
Sepranolone – a neurosteroid for Tourette Syndrome – is being studied for its potential application in other compulsion disorders such as Prader Willi Syndrome.
This redirection is the result of difficult financial circumstances. Relmada announced an accumulated loss of $622.2 millions in September with only $54.1 remaining. Investors warned the company that it expected “insufficient liquidity to sustain its operation through one full year.” Green Market Report Previous reports have been made.
Relmada’s net loss for the year 2024 was $80,000,000 ($2.65 per common share), down from $98.8,000,000 ($3.28 par share) reported in 2023. The research and development costs decreased from $54.8 to $46.2, and the general and administrative costs fell from $48.9 to $37.7.
The company’s materials state that the U.S. non-muscle-invasive bladder cancer market represents “multibillion opportunities” for approximately 450,000 Americans, while Tourette Syndrome affects about 350,000 Americans.
Registration-track studies could begin as early as 2025 or later in 2026. The FDA expects the company to engage with them on their regulatory strategy.