Relmada Therapeutics (RLMD)
NASDAQ:RLMD
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Relmada Therapeutics
(NASDAQ:RLMD)
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Rating:59Neutral
Price Target:
$7.00
▼(-0.14% Downside)
Action:ReiteratedDate:03/21/26
Score is held back primarily by weak financial performance (no revenue, ongoing losses and cash burn), partially offset by a debt-free balance sheet. Technicals are supportive with strong price trend and positive momentum indicators. The latest earnings call adds meaningful upside due to strong NDV-01 clinical data, FDA-aligned Phase III plans, and extended cash runway, while valuation signals are limited due to the lack of meaningful P/E and no dividend yield provided.
Positive Factors
Clinical Efficacy (NDV-01)
Robust 12-month and anytime complete response rates with an absence of high-grade safety events represent a durable clinical advantage. Such efficacy and tolerability materially raise the probability of regulatory success and support a differentiated, potentially best-in-class profile that underpins long-term commercial potential if confirmed in Phase III.
Negative Factors
No Revenue and Persistent Losses
Being a development-stage biotech with no product revenue means long-term viability depends on successful trials or continued funding. Persistent multi-year losses erode equity and make the company sensitive to capital markets and execution risk unless and until commercialization occurs.
Read all positive and negative factors
Positive Factors
Negative Factors
Clinical Efficacy (NDV-01)
Robust 12-month and anytime complete response rates with an absence of high-grade safety events represent a durable clinical advantage. Such efficacy and tolerability materially raise the probability of regulatory success and support a differentiated, potentially best-in-class profile that underpins long-term commercial potential if confirmed in Phase III.
Read all positive factors
Relmada Therapeutics (RLMD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$735.28M
Dividend YieldN/A
Average Volume (3M)2.57M
Price to Earnings (P/E)―
Beta (1Y)1.68
Revenue GrowthN/A
EPS Growth37.37%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.27
Shares Outstanding104,890,220
10 Day Avg. Volume1,214,759
30 Day Avg. Volume2,570,498
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 Cap0.75
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-9.38
Forecast
1Y Price Target
$13.25Price Target Upside89.02% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
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:Mar 19, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 13, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and corporate progress: compelling Phase II 12-month efficacy and a favorable safety profile for NDV-01, FDA-aligned Phase III plans with two registrational pathways, a strengthened leadership team, and substantial financing that extends runway through 2029. Offsetting items include higher G&A and operating cash burn, a modestly larger net loss in Q4, competitive enrollment risks in a crowded NMIBC landscape, and limited subgroup sizes in the Phase II dataset which introduce some uncertainty. On balance, the positives—particularly the best-in-class efficacy signals, regulatory alignment, and significant financing—outweigh the near-term financial and competitive challenges.Positive Updates
Strong 12-Month Phase II Efficacy for NDV-01
NDV-01 demonstrated a 12-month complete response (CR) rate of 76% in the Phase II study and an 80% 12-month CR in the BCG-unresponsive population. CR anytime was 95% in the overall population (n=38) and 94% in the BCG-unresponsive subgroup.
Negative Updates
Rising Operating and G&A Costs
General and administrative expense for Q4 2025 was $12.3M versus $8.1M in Q4 2024, an increase of $4.2M (≈51.9%), primarily driven by higher compensation costs.
Read all updates
Q4-2025 Updates
Positive
Negative
Strong 12-Month Phase II Efficacy for NDV-01
NDV-01 demonstrated a 12-month complete response (CR) rate of 76% in the Phase II study and an 80% 12-month CR in the BCG-unresponsive population. CR anytime was 95% in the overall population (n=38) and 94% in the BCG-unresponsive subgroup.
Read all positive updates
Company Guidance
The company guided that it will initiate the Phase III RESCUE program for NDV‑01 in mid‑2026 (after U.S. IND clearance) at an estimated ~80 North American sites with two FDA‑aligned registrational pathways: a randomized adjuvant intermediate‑risk post‑TURBT study (target two‑year RFS ~75%, event‑driven with ~128 events; U.S. population ~70,000–75,000/year) and a single‑arm BCG‑unresponsive second‑line CIS/refractory study (U.S. population ~5,000/year) with CR anytime as the primary endpoint and initial 3‑month response data expected by the end of 2026 and subsequent ~3‑month cadence updates (3, 6, 9, 12 months); they reported Phase II 12‑month results showing a 76% 12‑month CR (80% in BCG‑unresponsive), 95% CR anytime (n=38) and 94% CR anytime in BCG‑unresponsive, with no progression to muscle‑invasive disease, no radical cystectomies, no grade ≥3 treatment‑related AEs and mostly grade‑1 AEs; cipranolone PoC in Prader‑Willi is planned to begin mid‑2026; financially, cash was $93M at 12/31/2025 (including ~ $94M net from a Nov 2025 offering), the company completed a $160M private financing (net ≈ $150M) on Mar 9, 2026 expected to fund operations through 2029 and completion of Phase III, and Q4 2025 results included R&D expense $8.1M (vs $11.0M prior year), G&A $12.3M (vs $8.1M), net cash used in operations $14.6M (vs $8.8M), and net loss $19.9M (‑$0.27 per share) vs $18.7M (‑$0.06) in Q4 2024.Relmada Therapeutics Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
46
Neutral
Cash Flow
18
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -59.10M | -83.89M | 4.91M | -161.25M | -125.70M |
| Net Income | -57.39M | -79.98M | -98.79M | -157.04M | -125.75M |
Balance Sheet | |||||
| Total Assets | 94.00M | 45.82M | 97.55M | 152.91M | 223.33M |
| Cash, Cash Equivalents and Short-Term Investments | 93.01M | 44.91M | 96.32M | 148.32M | 211.91M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 7.49M | 10.30M | 12.19M | 12.47M | 15.06M |
| Stockholders Equity | 86.51M | 35.52M | 85.36M | 140.44M | 208.26M |
Cash Flow | |||||
| Free Cash Flow | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Operating Cash Flow | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Investing Cash Flow | -48.14M | 51.56M | 50.45M | 19.73M | -54.12M |
| Financing Cash Flow | 93.56M | -40.34K | -98.46K | 45.02M | 187.94M |
Relmada Therapeutics Technical Analysis
Positive
7.01
Price Trends
5.17
Positive
4.68
Positive
3.01
Positive
Market Momentum
0.49
Positive
63.63
Neutral
62.26
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 7.01 is above the 20-day moving average (MA) of 6.46, above the 50-day MA of 5.17, and above the 200-day MA of 3.01, indicating a bullish trend. The MACD of 0.49 indicates Positive momentum. The RSI at 63.63 is Neutral, neither overbought nor oversold. The STOCH value of 62.26 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 |
|---|---|---|---|---|---|---|---|
59 Neutral | $735.28M | -3.32 | -170.83% | ― | ― | 37.37% | |
56 Neutral | $265.87M | -2.24 | -129.98% | ― | 250.00% | 15.15% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
47 Neutral | $87.33M | -1.71 | -305.39% | ― | -90.18% | -17.93% | |
44 Neutral | $47.84M | -0.48 | -122.43% | ― | -100.00% | -8.30% |
* Healthcare Sector Average
RLMD
Relmada Therapeutics
7.01
6.72
2351.05%
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2.34
-0.54
-18.75%
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Relmada Therapeutics Corporate Events
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.