RELMADA THERAPEUTICS, INC.
RLMD evidence brief
What we can confirm
- BioSniper Score:
- 6.5 / 10
- Market Cap:
- $466.7M
- Next Catalyst:
- Phase3_Start · Feb 1, 2027
What it means
What to watch
Prepared research question
What matters most for RLMD—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · RLMD
Relmada Therapeutics is a clinical-stage biopharmaceutical company that, after discontinuing its lead candidate in late 2024, pivoted to in-license two clinical-stage assets: NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome and other indications.
Key risk: Cash runway limited
BioSniper Score
Based on 2 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Tracking 5 clinical trials · 1 catalyst for RELMADA THERAPEUTICS, INC..
Relmada Therapeutics is a clinical-stage biopharmaceutical company that, after discontinuing its lead candidate in late 2024, pivoted to in-license two clinical-stage assets: NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome and other indications.
- Relmada terminated its former lead program REL-1017 after a December 2024 interim analysis indicated the trial was unlikely to succeed [sec · filed 2026-04-17].
- The company in-licensed NDV-01, a sustained-release formulation of gemcitabine and docetaxel for NMIBC, with early Phase II proof-of-concept data [sec · filed 2026-04-17].
- Relmada acquired sepranolone, a Phase 2b-ready neurosteroid, for potential treatment of Prader-Willi syndrome, Tourette syndrome, and essential tremor [sec_mda · as of 2026-05-12].
- Cash & equivalents were $11.3M as of 2026-06-30, with net income of -$12.9M and shareholders' equity of $206.6M [sec].
- The company completed a $100 million secondary offering in November 2025, enabling its pipeline development [sec · filed 2026-04-17].
What works
- Relmada successfully executed a strategic pivot after the REL-1017 failure, acquiring two clinical-stage assets with existing proof-of-concept data [sec · filed 2026-04-17].
- The company raised $100 million in a secondary offering at no discount, including a strategic investor, providing capital to advance its new pipeline [sec · filed 2026-04-17].
- NDV-01 targets a large market (NMIBC) with a novel extended-delivery formulation of an established chemotherapy regimen, potentially offering a differentiated treatment option [sec · filed 2026-04-17].
- Sepranolone has a well-established safety and pharmacodynamic profile and addresses a high-unmet-need indication (Prader-Willi syndrome) with a potential rapid development path [sec · filed 2026-04-17].
What to weigh
- Relmada has no approved products and its entire pipeline is at early clinical stages (Phase 2/3), with no guarantee of regulatory success [sec · filed 2026-04-17].
- Cash reserves are limited ($11.3M as of 2026-06-30) relative to the cost of advancing two Phase 2/3 programs, raising the need for additional financing [sec].
- The company's history includes a failed pivotal trial (REL-1017) and a severely depressed share price (24 cents in March 2025), indicating high execution risk [sec · filed 2026-04-17].
- Both NDV-01 and sepranolone are in-licensed assets, meaning Relmada depends on third-party originators for intellectual property and may face future royalty or milestone obligations [sec · filed 2026-04-17].
From the filings
Quoted directly from source documents.
Relmada's strategic pivot after REL-1017 failure
“Management conducted a thorough strategic review subsequent to the disappointing news in December 2024 when a planned interim analysis of the more advanced pivotal trial of its lead pipeline candidate, REL -1017 , indicated that the trial was unlikely to succeed.”
SEC filings · April 17, 2026
Cash position and financing
“Cash jumped from a low of less than $10 million to approximately $100 million after the November financing”
SEC filings · April 17, 2026
Catalyst timeline
- 2027-02-01 · Phase3_Start — Phase3_Start: A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE) — This is the planned start date for the Phase 3 trial of NDV-01 in NMIBC, which will test the drug's efficacy and safety in a pivotal setting.
Risks & what to watch (4)›
Key risks
- Cash runway limited — Cash of $11.3M as of 2026-06-30 may not be sufficient to complete planned Phase 3 trials without additional financing [sec].
- No approved products — Relmada has no marketed products and its pipeline is entirely preclinical or early clinical, with no guarantee of regulatory approval [sec · filed 2026-04-17].
- Dependence on in-licensed assets — Both NDV-01 and sepranolone are in-licensed, exposing the company to potential IP disputes, milestone payments, and reliance on third-party originators [sec · filed 2026-04-17].
- Historical execution failure — The company's prior lead candidate failed a pivotal interim analysis, and its share price fell to $0.24, indicating significant operational and market risk [sec · filed 2026-04-17].
What to watch
- IND filing for NDV-01 with the FDA by year-end 2026 [sec_mda · as of 2026-08-06]
- Initiation of Phase 3 trials for NDV-01 in high-risk BCG-unresponsive NMIBC upon IND clearance [sec_mda · as of 2026-08-06]
- IND filing for sepranolone with the FDA by year-end 2026 [sec_mda · as of 2026-08-06]
- Initiation of Phase 2 clinical trial for sepranolone in Prader-Willi syndrome upon IND clearance [sec_mda · as of 2026-08-06]
Sources: SEC filings · SEC MD&A · Generated October 7, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 2 of 6 signals · derived from public data
Pipeline inputs are unavailable for this score. It uses only the available signals shown below.
Cash runway data unavailable
D/E 0.06 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
1 upcoming, next in ~110d
No insider transactions in the last 180 days
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
103
Total value held
$580.6M
| Holder | Shares | Value |
|---|---|---|
| janus henderson group plc | 11,063,862 | $76.9M |
| squadron capital management llc | 8,474,571 | $59.0M |
| spruce street capital lp | 6,262,114 | $43.0M |
| venrock adviser, llc | 4,843,380 | $33.7M |
| adage capital partners gp, l.l.c. | 4,763,158 | $33.2M |
| orbimed advisors llc | 4,715,864 | $32.8M |
| marshall wace, llp | 4,481,606 | $31.2M |
| millennium management llc | 3,907,265 | $27.2M |
| vanguard capital management llc | 3,076,570 | $21.4M |
| ra capital management, l.p. | 2,947,369 | $20.5M |
Showing top 10 of 103 institutional holders of RELMADA THERAPEUTICS, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 28, 2026- % of float
- 6.3%
- Days to cover
- 4.6
- Shares short
- 6,193,292
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
RLMD short interestGovernance
Frequently asked questions
What is the AI investment thesis for RELMADA THERAPEUTICS, INC.?
Relmada Therapeutics is a clinical-stage biopharmaceutical company that, after discontinuing its lead candidate in late 2024, pivoted to in-license two clinical-stage assets: NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome and other indications.
What is RELMADA THERAPEUTICS, INC.'s next catalyst?
RELMADA THERAPEUTICS, INC.'s next tracked catalyst is a Phase3_Start event — "Phase3_Start: A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)" — expected February 1, 2027.
Who is the CEO of RELMADA THERAPEUTICS, INC.?
Dr. Sergio Traversa M.B.A., Pharm.D. is the chief executive officer of RELMADA THERAPEUTICS, INC. (RLMD).
Where is RELMADA THERAPEUTICS, INC. headquartered?
RELMADA THERAPEUTICS, INC. (RLMD) is headquartered in Coral Gables, FL, United States.
What therapeutic areas does RELMADA THERAPEUTICS, INC. focus on?
RELMADA THERAPEUTICS, INC. develops therapies across Oncology, Rare Disease, Neurology, Psychiatry.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.