Relmada Therapeutics Inc Dossier - Source-backed chat

Relmada Therapeutics Inc

RLMDNASDAQ

SectorHealth Care

IndustryBiotechnology

Beta (adjusted)0.67

Intrinsic Value

Insufficient data for a value estimateNot enough reliable inputs to publish a fair value for this company yet.

Market Price $3.66Price as of 1 Oct 2026

Data confidenceNot applicable

Market Cap $390.4M

Enterprise Value $379.1M

Shares Outstanding 107M diluted

Next Earnings Date31 Dec 2026

All prices and values are periodic snapshots, not live quotes. Source dates are shown for reference.

Thesis

Street consensus, scenarios, merits, risks, and invalidation triggers

AI-assisted

Thesis Summary

Relmada Therapeutics has successfully pivoted its clinical pipeline following the termination of its troubled Phase 3 depression asset, REL-1017 (esmethadone). The company's strategy is now centered on two newly acquired clinical-stage assets: NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer (NMIBC), and sepranolone, a neurosteroid epimer for Prader-Willi syndrome (PWS) and Tourette syndrome. Backed by a robust $160 million PIPE financing in March 2026, Relmada has extended its cash runway through 2029, providing ample resources to complete the Phase 3 RESCUE program for NDV-01. While Phase 2 data for NDV-01 demonstrated highly encouraging efficacy (95% any-time CR rate), the NMIBC market is highly competitive with established standards of care. A Hold rating is maintained as the company transitions these assets into pivotal trials, with initial Phase 3 data expected by year-end 2026.

This section is the 12-month view: analyst targets and the probability-weighted scenarios built from them. The intrinsic value at the top of this page answers a different question: what the business is worth today.

Street view · analyst 12-month targets6 analysts · as of 18 Aug 2026

Low · most bearish analyst$9.00

Mean target$12.67

High · most bullish analyst$19.00

Our research · scenarios, merits, risks, and invalidation triggersResearch as of 20 Jun 2026

Scenarios · 12-month scenario targetsAnchored at research date

Bear CaseDownside scenario

The bear case materializes if the Phase 3 RESCUE program faces clinical delays or fails to replicate the high complete response rates of the Phase 2 trial. Safety concerns or competitive pressures from approved therapies (such as Keytruda, Adstiladrin, or Anktiva) limit NDV-01's commercial potential. Sepranolone fails to show efficacy in PWS, leaving the company with a depleted pipeline and high cash burn.

Base CaseCentral scenario

The base case assumes Relmada successfully initiates the Phase 3 RESCUE program for NDV-01 and the Phase 2 trial for sepranolone in mid-2026. Initial 3-month data from the 2L BCG-unresponsive NMIBC cohort by year-end 2026 confirms the high complete response rates observed in Phase 2, keeping the drug on a viable path toward FDA approval. Cash burn remains controlled within the projected runway through 2029.

Bull CaseUpside scenario

The bull case for Relmada Therapeutics centers on its promising clinical pipeline, highlighted by NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer (NMIBC). NDV-01 features a highly efficient 5-minute clinical visit design that enhances real-world usability and clinical adoption. The program has demonstrated compelling clinical activity with durable responses and a favorable safety profile, and is advancing into Phase 3 registrational development. Additionally, the company maintains a strong balance sheet with a debt-to-equity ratio near zero, providing financial flexibility as it navigates clinical milestones.

Scenarios are anchored to street consensus at the research date, with our probabilities and rationale.

Key Investment Merits

Strong Balance Sheet: Bolstered by a $160 million PIPE financing in March 2026, the company's $234 million cash balance provides a runway through 2029, fully funding the Phase 3 RESCUE program.
Promising Lead Asset: NDV-01 Phase 2 data showed a 95% any-time CR rate and a durable 76% CR rate at 12 months in high-risk NMIBC, with a favorable safety profile and no progression to muscle-invasive disease.
Regulatory Alignment: Relmada has secured written FDA feedback aligning on two registrational pathways for NDV-01, streamlining the clinical development timeline.

Key Investment Risks

Highly Competitive Market: The NMIBC landscape is crowded with established therapies and major pharmaceutical competitors, including Merck's Keytruda, Ferring's Adstiladrin, and ImmunityBio's Anktiva.
Clinical Execution Risk: Relmada must successfully transition from a failed CNS-focused pipeline to executing oncology and neurosteroid clinical trials, with no prior commercial infrastructure.
Single-Asset Dependence: Valuation is heavily reliant on the clinical success of NDV-01, as sepranolone is early-stage and lacks established proof-of-concept in PWS.

Thesis Invalidation Triggers

Failure to obtain FDA IND clearance or initiate the Phase 3 RESCUE program for NDV-01 in mid-2026.
Initial 3-month Phase 3 data for NDV-01 showing a Complete Response (CR) rate significantly below Phase 2 historical benchmarks.
Unexpected severe adverse events or treatment-related discontinuations in the NDV-01 or sepranolone clinical trials.

All scenarios are estimates and subject to change. Past performance is not indicative of future results.

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Explore this dossier

ValuationIntrinsic value, the six-method breakdown, peer medians, and your assumptions sandbox.Financial SnapshotRevenue, profitability, returns, balance sheet, dividends, and the filing-level detail.Qualitative AnalysisBusiness overview, strategic initiatives, and mergers, acquisitions & partnerships.Outlook & Key DatesForward estimates, reporting calendar, and the monitoring framework.