Relmada Therapeutics (Nasdaq: RLMD) announced Thursday it was shifting away from its previous focus on depression treatments and psychedelics, after acquiring two new Phase 2 drug candidates.
The clinical-stage biotechnology company highlighted its upcoming release of topline Phase 2 data for NDV-01, which it describes as a sustained-release intravesical formulation for high-grade non-muscle invasive bladder cancer. The firm plans to present the data at an American Urological Association meeting in late April.
“At the end of last year, we initiated a process to transform the company through the exploration of strategic product acquisition opportunities to maximize shareholder value,” CEO Sergio Traversa said in a statement. “We are pleased to report excellent progress in this effort, with the recent acquisition of two high-potential Phase 2 programs.”
The switch-up comes after Relmada halted its Phase 3 studies of depression treatment REL-1017 in December following a data monitoring committee evaluation. At that time, the company had indicated it would continue development of REL-P11, its modified psilocybin compound being investigated for metabolic diseases. However, the new earnings report signals a shift away from that focus as well.
CFO Maged Shenouda noted in Thursday’s news release that the company is “reevaluating further development of REL-P11,” citing “the increasingly competitive clinical development landscape in metabolic disease” despite positive Phase 1 safety data.
The company is now focusing on NDV-01 for bladder cancer and sepranolone, a novel neurosteroid being developed for Tourette syndrome with potential applications in other compulsion-related disorders, including Prader-Willi syndrome.
The redirection follows rough financial challenges. In September, Relmada reported an accumulated deficit of $622.2 million with just $54.1 million in cash remaining. The company warned investors it projected “insufficient liquidity to sustain its operations through one year,” Green Market Report previously reported.
For the full year 2024, Relmada reported a net loss of $80 million ($2.65 per share), versus a net loss of $98.8 million ($3.28 per share) in 2023. Research and development expenses decreased to $46.2 million from $54.8 million, while general and administrative expenses fell to $37.7 million from $48.9 million year-over-year.
According to company materials, the U.S. market for non-muscle invasive bladder cancer represents a “multibillion opportunity” with approximately 450,000 patients, while Tourette syndrome affects an estimated 350,000 Americans.
The company expects to interact with the FDA later this year on its regulatory strategy for both lead programs, with registration-track studies potentially beginning between late 2025 and early 2026.
[[{“value”:”The biotech firm reported fourth-quarter results after halting further research into its psilocybin-based therapy.
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