RELMADA THERAPEUTICS, INC.
RLMD · Pharmaceutical Preparations · 104.9M shares · +20%/yr ↑ dilution · EDGAR filings ↗
Reference price $4.12 · est. market cap ~$432M — last insider purchase, 2025-12-15 (estimated from the dated SEC Form 4 price × shares outstanding — not a live quote)
Grade
C58Pre-revenue biotech that terminated its failed lead but is well-capitalized and pivoting to a promising in-licensed Phase 2 bladder-cancer asset.
Strengths
- Strong balance sheet: $93M cash, current/quick ratio ~14.6 (~90th pct)
- NDV-01 Phase 2 NMIBC shows high complete-response rates (95% anytime; 84% 12-mo KM in BCG-UR) with FDA Phase 3 alignment
- Diversified risk via sepranolone (Phase 2b-ready)
Risks
- Lead REL-1017 failed pivotal MDD trials and was terminated; ~$698M accumulated deficit
- No revenue; ~$46M annual operating cash burn against finite cash
- NDV-01 efficacy is single-arm/early and unconfirmed in Phase 3
Notable findings
- Fund exitedNotable fund(s) exited this quarter: VANGUARD GROUP INC
- Chronic dilutionShare count +20%/yr over 3y (dilution, book value/share -64%)
- Notable holderHeld by 4 notable fund(s): GOLDMAN SACHS GROUP INC, STATE STREET CORP, RENAISSANCE TECHNOLOGIES LLC +1 more (as of 2026-03-31)
- Trial resultTrial topline data reported — see 8-K for outcome 8-K ↗
Quarterly revenue
Last 4 quarters · from SEC filings.
Key metrics
Return on equity
-66.3%
Return on assets
-61.0%
Revenue growth (QoQ)
9.2%
Current ratio
14.6×
Tangible book value
$87M
Cash & investments
$93M
Insider transactions · last 18 months
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| 2025-12-15 | TRAVERSA SERGIO | Buy | 28K | $4.12 |
| 2025-12-15 | Shenouda Maged | Buy | 12K | $4.12 |
| 2025-11-05 | Ence Chuck | Buy | 136K | $2.20 |
| 2025-11-05 | TRAVERSA SERGIO | Buy | 272K | $2.20 |
| 2025-11-05 | Shenouda Maged | Buy | 500K | $2.20 |
| 2025-11-05 | Kelly Paul Edward | Buy | 90K | $2.20 |
| 2025-08-28 | TRAVERSA SERGIO | Buy | 56K | $0.74 |
| 2025-08-27 | TRAVERSA SERGIO | Buy | 129K | $0.67 |
| 2025-08-26 | TRAVERSA SERGIO | Buy | 81K | $0.62 |
| 2025-05-20 | TRAVERSA SERGIO | Buy | 148K | $0.56 |
| 2025-05-20 | Shenouda Maged | Buy | 60K | $0.52 |
| 2025-05-19 | Shenouda Maged | Buy | 90K | $0.49 |
| 2025-05-19 | TRAVERSA SERGIO | Buy | 30K | $0.50 |
| 2025-05-16 | Kelly Paul Edward | Buy | 200K | $0.43 |
| 2025-05-16 | Ence Chuck | Buy | 229K | $0.45 |
| 2025-05-16 | TRAVERSA SERGIO | Buy | 172K | $0.45 |
| 2025-05-16 | Shenouda Maged | Buy | 50K | $0.44 |
All non-derivative Form 4 activity (SEC), newest first.
Clinical trials
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT06663137 ↗ | Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC Non Muscle Invasive Bladder Cancer | PHASE2 | Recruiting | 2025-08-01 |
| NCT07313891 ↗ | A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer | PHASE3 | Withdrawn | 2029-09-01 |
| NCT07464145 ↗ | A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) | PHASE3 | Not Yet Recruiting | 2029-09-01 |
| NCT07342517 ↗ | A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) | PHASE3 | Withdrawn | 2027-06-30 |
| NCT04855760 ↗ | Safety of REL-1017 for Major Depressive Disorder Major Depressive Disorder | PHASE3 | Completed | 2023-07-27 |
| NCT04688164 ↗ | A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) Major Depressive Disorder | PHASE3 | Completed | 2022-11-01 |
| NCT05081167 ↗ | A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD) Major Depressive Disorder | PHASE3 | Completed | 2022-09-13 |
| NCT03051256 ↗ | Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant | PHASE2 | Completed | 2019-07-30 |
| NCT03638869 ↗ | Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone) Neuropathic Pain | PHASE1 | Completed | 2015-11-16 |
| NCT03637361 ↗ | Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone) Neuropathic Pain | PHASE1 | Completed | 2015-06-02 |
| NCT06009003 ↗ | Individual Patient Esmethadone (REL-1017) Expanded Access Program Major Depressive Disorder, Depression | — | Temporarily Not Available |
Source: ClinicalTrials.gov (U.S. NIH) · active studies first.
Notable events (8-K)
| Date | Items | |
|---|---|---|
| 2026-05-28 | 5.03Shareholder voteExhibits | filing ↗ |
| 2026-05-12 | ResultsReg FDExhibits | filing ↗ |
| 2026-03-20 | ResultsReg FDExhibits | filing ↗ |
| 2026-03-09 | Material agreement3.02Reg FDOtherExhibits | filing ↗ |
| 2025-12-15 | Exec/director changeExhibits | filing ↗ |
| 2025-11-13 | ResultsReg FDExhibits | filing ↗ |
| 2025-11-05 | Material agreementReg FDExhibits | filing ↗ |
| 2025-11-04 | Reg FDOtherExhibits | filing ↗ |
Recent filings
| Form | Filed | Period | Accession |
|---|---|---|---|
| 8-K | 2026-05-28 | 2026-05-27 | 0001213900-26-062184 ↗ |
| 10-Q | 2026-05-12 | 2026-03-31 | 0001213900-26-055059 ↗ |
| 8-K | 2026-05-12 | 2026-05-12 | 0001213900-26-055164 ↗ |
| 8-K | 2026-03-20 | 2026-03-19 | 0001213900-26-032403 ↗ |
| 10-K | 2026-03-19 | 2025-12-31 | 0001213900-26-031862 ↗ |
| 8-K | 2026-03-09 | 2026-03-09 | 0001213900-26-024918 ↗ |
| 8-K | 2025-12-15 | 2025-12-12 | 0001213900-25-121461 ↗ |
| 8-K | 2025-11-13 | 2025-11-13 | 0001213900-25-110088 ↗ |
| 10-Q | 2025-11-13 | 2025-09-30 | 0001213900-25-109983 ↗ |
| 8-K | 2025-11-05 | 2025-11-04 | 0001213900-25-106398 ↗ |
| 8-K | 2025-11-04 | 2025-11-04 | 0001213900-25-105593 ↗ |
| 8-K | 2025-09-17 | 2025-09-17 | 0001213900-25-088360 ↗ |