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§ Private Profile · Coral Gables, FL, USA
Relmada Therapeutics, Inc is a company.
Relmada Therapeutics, Inc has raised $11.0M across 2 funding rounds.
Key people at Relmada Therapeutics, Inc.
Relmada Therapeutics, Inc has raised $11.0M in total across 2 funding rounds.
Relmada Therapeutics is a clinical-stage biotechnology company developing innovative therapies for oncology and central nervous system disorders. Its approach emphasizes advancing differentiated programs with durable clinical data, favorable safety, and ease of administration. Key pipeline assets include NDV-01 for non-muscle invasive bladder cancer, and sepranolone for compulsive disorders like Tourette syndrome and Prader-Willi syndrome.
Founded in 2004, Relmada Therapeutics was established to address unmet medical needs, driven by the potential of differentiated pharmaceutical assets. A leadership team with deep experience across drug discovery, clinical development, and regulatory strategy guides the company’s disciplined approach, emphasizing rigorous scientific rationale and clinical validation.
Relmada's product candidates aim to benefit patients with non-muscle invasive bladder cancer and various central nervous system conditions, including Tourette syndrome and Prader-Willi syndrome. The company's vision is to advance transformative therapies through capital-efficient development, improving the lives of individuals confronting complex medical challenges.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) is a clinical-stage biotechnology company dedicated to developing innovative therapies for central nervous system (CNS) disorders, oncology, and related conditions with high unmet needs.[1][2][4] Its lead candidates include NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel in Phase 2 for non-muscle invasive bladder cancer (NMIBC), and sepranolone, a Phase 2b-ready neurosteroid for Prader-Willi Syndrome, Tourette syndrome, and other compulsivity disorders like OCD.[2][4][5] Previously focused on esmethadone (REL-1017), an NMDA receptor antagonist for depression, the company has pivoted to these programs while evaluating new acquisitions to maximize shareholder value.[1][2][3] NDV-01 targets BCG-unresponsive NMIBC patients, showing strong complete response rates (e.g., 91% anytime in trials), with convenient in-office administration under 10 minutes without anesthesia.[4][5] Sepranolone modulates GABA-A receptors to address excess GABAergic activity, backed by safety data from over 335 patients.[4] Headquartered in Coral Gables, Florida, Relmada serves patients with CNS and oncology challenges through novel formulations that enhance efficacy and reduce toxicity.[2]
Founded in 2004, Relmada Therapeutics began as a biotech firm exploring novel chemical entities and reformulations of existing drugs to treat CNS disorders.[2] Early efforts centered on candidates like esmethadone (d-methadone, REL-1017), an NMDA channel blocker for depression and other CNS indications, alongside programs such as REL-1015 (LevoCap ER for pain) and others.[1][3] The company evolved through strategic shifts, pivoting from a heavy CNS focus—including sepranolone for Tourette syndrome—to its current emphasis on oncology with NDV-01's Phase 2 advancement in NMIBC and sepranolone's readiness for Prader-Willi trials.[2][4][5] Key milestones include positive Q3 2025 data for NDV-01 in BCG-unresponsive patients and ongoing presentations at events like the Society of Urologic Oncology (Dec 2025) and AUA meetings.[2][4] Leadership features experts like CEO with urology focus, supported by a scientific advisory board from Harvard, Memorial Sloan Kettering, MD Anderson, and others, driving translational research in bladder cancer and intravesical therapies.[8]
Relmada rides the wave of precision oncology and neurosteroid therapies amid rising demand for bladder-sparing NMIBC treatments post-BCG shortages and failures, where standard therapies fall short.[4][5] Timing aligns with advancing intravesical innovations and GABA modulation for rare CNS disorders like Prader-Willi, fueled by market forces such as aging populations driving bladder cancer incidence and unmet needs in compulsivity beyond SSRIs.[2][4] In biotech, Relmada influences the ecosystem by pioneering abuse-deterrent reformulations and NCEs (new chemical entities), contributing to sustained-release tech that reduces treatment burden—echoed in its advisory ties to top institutions shaping guidelines for hematuria, TURBT, and immunotherapy.[1][8] This positions it amid broader shifts toward office-based, non-invasive cancer care and targeted CNS interventions.
Relmada's near-term catalysts include NDV-01 Phase 2 readouts, sepranolone Phase 2b initiation in Prader-Willi, and 2025 conference data, potentially driving partnerships or pivotal trials.[2][4] Trends like AI-optimized formulations, immunotherapy combos for NMIBC, and expanded GABA therapies for OCD/Tourette will shape its path, with pipeline acquisitions accelerating growth.[2] Influence may evolve from CNS pioneer to oncology contender, leveraging its Miami hub and expert network for value inflection—watch for Q4 2025 updates to gauge momentum toward commercialization.[2][4] This builds on its biotech resilience, transforming unmet needs into accessible innovations.
Relmada Therapeutics, Inc has raised $11.0M across 2 funding rounds. Most recently, it raised $8.0M Relmada Therapeutics - Series A in October 2013.
| Date | Round | Lead Investors | Other Investors | Status |
|---|---|---|---|---|
| Oct 1, 2013 | $8M Series A | — | — | Announced |
| Jul 24, 2012 | $3M Series A | — | BEN Franklin Technology Partners OF Southeastern Pennsylvania, BioAdvance, Wonpung Mulsan | Announced |
Relmada Therapeutics, Inc has raised $11.0M in total across 2 funding rounds.
Relmada Therapeutics, Inc's investors include Ben Franklin Technology Partners of Southeastern Pennsylvania, BioAdvance, Wonpung Mulsan.
Key people at Relmada Therapeutics, Inc.
