Relmada Therapeutics Inc (RLMD)
NASDAQ:RLMD
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Relmada Therapeutics
(NASDAQ:RLMD)
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Rating:62Neutral
Price Target:
$8.00
▲(6.95% Upside)
Action:Reiterated
Date:05/14/26
The score is held back primarily by weak financial performance (no revenue, ongoing losses and cash burn) and a non-meaningful negative P/E. Offsetting these are constructive technical trends and a strong, positive earnings-call setup driven by Phase 2 results, clear Phase 3 guidance, and a substantially improved cash runway.
Positive Factors
Robust Phase 2 efficacy and safety (NDV-01)
NDV‑01's high and durable complete response rates with a clean safety profile materially strengthen its clinical value proposition. Durable efficacy and low toxicity reduce regulatory and clinical development risk, support potential label advantages, and improve the odds of physician adoption if approved.
Negative Factors
Pre-revenue profile and persistent cash burn
Relmada remains pre‑commercial with no revenue and recurring negative operating and free cash flow. Continued burn makes the company dependent on capital markets; even with current runway, future financing or dilution risk persists until product commercialization or sustained cash generation.
Read all positive and negative factors
Positive Factors
Negative Factors
Robust Phase 2 efficacy and safety (NDV-01)
NDV‑01's high and durable complete response rates with a clean safety profile materially strengthen its clinical value proposition. Durable efficacy and low toxicity reduce regulatory and clinical development risk, support potential label advantages, and improve the odds of physician adoption if approved.
Read all positive factors
Relmada Therapeutics (RLMD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$756.26M
Dividend YieldN/A
Average Volume (3M)1.24M
Price to Earnings (P/E)―
Beta (1Y)1.58
Revenue GrowthN/A
EPS Growth55.59%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.11
Shares Outstanding104,890,220
10 Day Avg. Volume1,137,151
30 Day Avg. Volume1,242,474
Financial Highlights & Ratios
PEG Ratio0.07
Price to Book (P/B)2.20
Price to Sales (P/S)0.00
P/FCF Ratio-4.16
Enterprise Value/Market Cap0.67
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-8.39
Forecast
1Y Price Target
$15.00Price Target Upside100.53% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
EPS Forecast (FY)-0.76
Revenue Forecast (FY)N/A
Relmada Therapeutics Business Overview & Revenue Model
Company Description
Relmada Therapeutics, Inc., a clinical-stage biotechnology company, focuses on developing various products for the treatment of central nervous system (CNS) diseases and other disorders. Its lead product candidate is Esmethadone (d-methadone, dext...
How the Company Makes Money
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Relmada Therapeutics Earnings Call Summary
Earnings Call Date:May 12, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 11, 2026
Earnings Call Sentiment Positive
The call conveyed predominantly positive momentum: robust phase 2 12-month efficacy and safety data for NDV-01, FDA alignment for a two-pathway Phase 3 registrational program, strengthened IP positioning via a provisional patent filing, and a materially improved balance sheet with ~$234M cash (runway into 2029). Operational advantages (office-based, short administration) and a planned Cipranolone proof-of-concept add to the upside. Key challenges include a significant rise in G&A expense, a modestly larger absolute net loss, patent prosecution uncertainty, and potential variability in Phase 3 patient populations which could affect measured efficacy. Overall, the highlights substantially outweigh the lowlights, but successful execution of the planned mid-2026 trial starts and subsequent enrollment/readouts remain critical.Positive Updates
Strong 12-Month Phase 2 Efficacy for NDV-01
NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR at 12 months in high-risk NMIBC patients; in the BCG-unresponsive subpopulation NDV-01 showed a 94% CR at any time and an 80% CR at 12 months. No patients progressed to muscle-invasive disease and no patients underwent radical cystectomy.
Negative Updates
Increased General & Administrative Expense
G&A expense for Q1 2026 was $11.4M versus $6.3M in Q1 2025, an increase of approximately $5.1M (about 81%), primarily driven by higher compensation costs.
Read all updates
Q1-2026 Updates
Positive
Negative
Strong 12-Month Phase 2 Efficacy for NDV-01
NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR at 12 months in high-risk NMIBC patients; in the BCG-unresponsive subpopulation NDV-01 showed a 94% CR at any time and an 80% CR at 12 months. No patients progressed to muscle-invasive disease and no patients underwent radical cystectomy.
Read all positive updates
Company Guidance
Relmada guided that it remains on track to file a U.S. IND and initiate the Phase 3 “rescue” program for NDV‑01 in mid‑2026 across ~80 North American sites, with two registrational pathways (Pathway 1: single‑arm second‑line BCG‑unresponsive CIS—~5,000 U.S. patients/year; Pathway 2: randomized adjuvant post‑TURBT in intermediate‑risk NMIBC—~75,000 U.S. patients/year), expects first 3‑month response readouts around year‑end with ongoing quarterly updates into 2027, and modeled enrollment timelines of ~12 months for the second‑line study and ~15–18 months for the intermediate‑risk study; clinical metrics from the Phase 2 (up to 70 patients; 6 biweekly doses then monthly maintenance ≤1 year) include 95% CR at any time and 76% CR at 12 months in high‑risk NMIBC (BCG‑unresponsive subgroup: 94% CR any time, 80% CR at 12 months; Raj also referenced ~80–84% 12‑month estimates), with no grade ≥3 treatment‑related AEs, no progressions to muscle‑invasive disease, no radical cystectomies, and no dose interruptions; corporate/financial guidance included a $234M cash balance at 3/31/2026 (vs. $94M at 12/31/2025) reflecting ~$150M net financing in March, a stated runway through 2029 to complete Phase 3, a plan to initiate a cipranolone PoC in Prader‑Willi mid‑2026, and selected Q1 metrics (R&D $8.1M vs $12.0M prior year, G&A $11.4M vs $6.3M prior year, net cash used in ops $15.1M vs $18.1M, net loss $19.1M or $0.22/sh vs $17.6M or $0.58/sh); they also filed a provisional patent that, if issued, could extend NDV‑01 protection into 2047 (≈9‑year extension of exclusivity).Relmada Therapeutics Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
66
Positive
Cash Flow
24
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -60.34M | -59.10M | -83.89M | 4.91M | -161.25M | -125.70M |
| Net Income | -58.88M | -57.39M | -79.98M | -98.79M | -157.04M | -125.75M |
Balance Sheet | ||||||
| Total Assets | 235.36M | 94.00M | 45.82M | 97.55M | 152.91M | 223.33M |
| Cash, Cash Equivalents and Short-Term Investments | 233.96M | 93.01M | 44.91M | 96.32M | 148.32M | 211.91M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 16.63M | 7.49M | 10.30M | 12.19M | 12.47M | 15.06M |
| Stockholders Equity | 218.73M | 86.51M | 35.52M | 85.36M | 140.44M | 208.26M |
Cash Flow | ||||||
| Free Cash Flow | -42.79M | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Operating Cash Flow | -42.79M | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Investing Cash Flow | -198.73M | -48.14M | 51.56M | 50.45M | 19.73M | -54.12M |
| Financing Cash Flow | 250.14M | 93.56M | -40.34K | -98.46K | 45.02M | 187.94M |
Relmada Therapeutics Technical Analysis
Positive
7.48
Price Trends
6.99
Positive
5.65
Positive
4.08
Positive
Market Momentum
0.02
Positive
48.65
Neutral
64.88
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RLMD, the sentiment is Positive. The current price of 7.48 is above the 20-day moving average (MA) of 7.28, above the 50-day MA of 6.99, and above the 200-day MA of 4.08, indicating a neutral trend. The MACD of 0.02 indicates Positive momentum. The RSI at 48.65 is Neutral, neither overbought nor oversold. The STOCH value of 64.88 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for RLMD.
Relmada Therapeutics Risk Analysis
Relmada Therapeutics disclosed 82 risk factors in its most recent earnings report. Relmada Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Relmada Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
62 Neutral | $756.26M | -7.91 | -71.22% | ― | ― | 55.59% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $344.86M | -6.79 | -118.24% | ― | 138.86% | 42.14% | |
47 Neutral | $145.05M | -1.83 | -155.40% | ― | -100.00% | 61.98% | |
40 Underperform | $20.53M | -0.75 | -208.23% | ― | -100.00% | 26.30% |
* Healthcare Sector Average
RLMD
Relmada Therapeutics
7.04
6.40
1001.72%
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-0.41
-14.44%
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Relmada Therapeutics Corporate Events
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Relmada Highlights NDV-01 Phase 2 Data, Phase 3 Plans
Positive
May 12, 2026
On May 12, 2026, Relmada Therapeutics reported first-quarter 2026 results and a business update highlighted by strong 12-month Phase 2 data for NDV-01 in high-risk and BCG-unresponsive non-muscle invasive bladder cancer, showing complete response ...
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Relmada Highlights NDV-01 Data, Funding in 2025 Results
Positive
Mar 20, 2026
Relmada Therapeutics reported audited fourth-quarter and full-year 2025 results on March 19, 2026, alongside a business update that underscored strong 12-month Phase 2 data for NDV-01 in high-risk NMIBC, showing a 95% complete response rate at any...
Business Operations and StrategyPrivate Placements and Financing
Relmada Therapeutics Raises Capital, Highlights Promising NDV-01 Data
Positive
Mar 9, 2026
On March 9, 2026, Relmada Therapeutics agreed to raise approximately $160 million through a private placement of common stock and pre‑funded warrants to institutional and accredited investors, with closing expected on March 11, 2026, and pla...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.