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Relmada Therapeutics
(NASDAQ:RLMD)
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Rating:49Neutral
Price Target:
$4.50
▼(-1.96% Downside)
Action:Reiterated
Date:09/08/26
Overall score reflects a development-stage biotech with weak current financial performance (no revenue, ongoing losses and cash burn) and bearish technicals (below key moving averages with negative MACD). These are partially offset by a relatively positive earnings-call outlook driven by strong Phase II NDV-01 data, clear development plans, and stated funding runway into 2029, though execution risk remains concentrated in manufacturing/CMC and timing.
Positive Factors
Strong Phase II efficacy
The reported 12-month Phase II results provide meaningful clinical validation for NDV-01, with both high response rates and durability. If reproduced in registrational development, this efficacy profile could support differentiation, regulatory progress, and future commercial adoption.
Negative Factors
Pre-commercial losses and cash burn
Relmada has no product revenue to offset its research costs and continues to consume substantial cash while reporting significant losses. Even with current resources, the pre-commercial model leaves long-term progress dependent on successful development, disciplined spending, and eventual financing or commercialization.
Read all positive and negative factors
Positive Factors
Negative Factors
Strong Phase II efficacy
The reported 12-month Phase II results provide meaningful clinical validation for NDV-01, with both high response rates and durability. If reproduced in registrational development, this efficacy profile could support differentiation, regulatory progress, and future commercial adoption.
Read all positive factors
Relmada Therapeutics (RLMD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$472.55M
Dividend YieldN/A
Average Volume (3M)1.09M
Price to Earnings (P/E)―
Beta (1Y)1.52
Revenue GrowthN/A
EPS Growth57.98%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.92
Shares Outstanding106,669,846
10 Day Avg. Volume812,457
30 Day Avg. Volume1,090,948
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 Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price Target
$14.33Price Target Upside212.27% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
EPS Forecast (FY)-0.62
Revenue Forecast (FY)N/A
Relmada Therapeutics Business Overview & Revenue Model
Company Description
Relmada Therapeutics, Inc. operates as a clinical-stage biotechnology company in the United States. The company focuses on the development of NDV-01, a controlled-release intravesical formulation of gemcitabine and docetaxel, which is in Phase 2 c...
Relmada Therapeutics Earnings Call Summary
Earnings Call Date:Aug 06, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 05, 2026
Earnings Call Sentiment Positive
Overall the call conveyed a constructive and execution-focused tone: Relmada reported a materially strengthened balance sheet (cash +134% YoY) with a cash runway into 2029, compelling 12-month Phase II efficacy and favorable safety for NDV-01, clear FDA-aligned registration pathways, an experienced new CBO, and engaged clinical sites. Key near-term risks center on manufacturing/CMC execution (GMP batch production and stability data), which shifted IND timing toward year-end 2026 and has increased R&D spend and operating cash use. On balance the company appears well-capitalized and positioned to advance registrational programs, but outcomes hinge on resolving manufacturing scale-up and timing.Positive Updates
Strong Cash Position and Runway
Cash, cash equivalents and short-term investments of $217.7M at 6/30/2026 vs $93.0M at 12/31/2025 (increase of ~134%), with management stating current resources are expected to fund operations through 2029, including completion of the Phase III RESCUE program for NDV-01.
Negative Updates
Manufacturing and CMC Are Primary Near-Term Gating Factors
Management emphasized that manufacturing scale-up to GMP standards for NDV-01 is demanding and is the final piece before IND filing; activities include GMP batch production and stability data. Reliance on external contract manufacturer (Piramal) and schedule availability were cited as reasons for the shift in timing.
Read all updates
Q2-2026 Updates
Positive
Negative
Strong Cash Position and Runway
Cash, cash equivalents and short-term investments of $217.7M at 6/30/2026 vs $93.0M at 12/31/2025 (increase of ~134%), with management stating current resources are expected to fund operations through 2029, including completion of the Phase III RESCUE program for NDV-01.
Read all positive updates
Company Guidance
Relmada reiterated guidance to file INDs for NDV‑01 and sepranolone by year‑end 2026 and to initiate the Phase III RESCUE program for NDV‑01 and a Phase II proof‑of‑concept study for sepranolone upon IND clearance; NDV‑01’s 12‑month Phase II results showed 95% of patients achieved a complete response at any time and 76% had a durable complete response at 12 months, the formulation and process are locked, analytics are complete, and GMP batch production plus stability data (manufacturing partner Piramal) are the remaining CMC gating items; the program has FDA alignment on two registration pathways, ~80 sites engaged (≈60 primary, 20 backup) and can begin dosing after IND clearance (30 days post‑filing), with an office‑based procedure of ~5 minutes; financial guidance and metrics included $217.7M cash, cash equivalents and short‑term investments (vs $93.0M at 12/31/2025) expected to fund operations through 2029 including Phase III, Q2 R&D expense $8.4M (vs $2.8M), G&A $6.6M (vs $7.4M), net cash used in operating activities $9.6M (vs $6.4M), and a Q2 net loss of $12.9M or $0.11 per share (vs $9.9M or $0.30), while market size references included >744,000 U.S. NMIBC patients and 350,000–400,000 people worldwide with PWS; the primary endpoint is response at any time (one re‑induction allowed).Relmada Therapeutics Financial Statement Overview
Summary
Income Statement
9
Very Negative
Balance Sheet
63
Positive
Cash Flow
18
Very 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 | -61.93M | -57.39M | -79.98M | 4.91M | -157.04M | -125.75M |
| Net Income | -61.93M | -57.39M | -79.98M | -98.79M | -157.04M | -125.75M |
Balance Sheet | ||||||
| Total Assets | 219.06M | 94.00M | 45.82M | 97.55M | 152.91M | 223.33M |
| Cash, Cash Equivalents and Short-Term Investments | 217.73M | 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 | 12.50M | 7.49M | 10.30M | 12.19M | 12.47M | 15.06M |
| Stockholders Equity | 206.56M | 86.51M | 35.52M | 85.36M | 140.44M | 208.26M |
Cash Flow | ||||||
| Free Cash Flow | -45.99M | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Operating Cash Flow | -45.99M | -45.79M | -51.76M | -51.66M | -103.80M | -91.87M |
| Investing Cash Flow | -187.82M | -48.14M | 51.56M | 50.45M | 19.73M | -54.12M |
| Financing Cash Flow | 243.79M | 93.56M | -40.34K | -98.46K | 45.02M | 187.94M |
Relmada Therapeutics Technical Analysis
Negative
4.59
Price Trends
5.30
Negative
6.13
Negative
5.48
Negative
Market Momentum
-0.24
Negative
36.81
Neutral
35.32
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RLMD, the sentiment is Negative. The current price of 4.59 is above the 20-day moving average (MA) of 4.59, below the 50-day MA of 5.30, and below the 200-day MA of 5.48, indicating a bearish trend. The MACD of -0.24 indicates Negative momentum. The RSI at 36.81 is Neutral, neither overbought nor oversold. The STOCH value of 35.32 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 |
|---|---|---|---|---|---|---|---|
53 Neutral | $435.73M | -6.71 | -75.35% | ― | 220.34% | 55.73% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $166.49M | -1.45 | -123.53% | ― | -100.00% | 52.43% | |
50 Neutral | $46.96M | -1.33 | -166.98% | ― | ― | 55.37% | |
49 Neutral | $472.55M | -4.62 | -47.52% | ― | ― | 57.98% |
* Healthcare Sector Average
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Relmada Therapeutics Corporate Events
Business Operations and StrategyExecutive/Board Changes
Relmada Therapeutics Announces Urology Chief Medical Officer Exit
Negative
Sep 8, 2026
Relmada Therapeutics, Inc. reported that the employment of Dr. Raj S. Pruthi as Chief Medical Officer – Urology ended on September 3, 2026. The departure marks a change in the company’s senior medical leadership in urology, which may i...
Business Operations and StrategyExecutive/Board ChangesDelistings and Listing ChangesFinancial Disclosures
Relmada Highlights Q2 Results and NDV-01 Pipeline Progress
Positive
Aug 6, 2026
On August 6, 2026, Relmada Therapeutics reported second-quarter 2026 results and detailed progress on its late-stage oncology pipeline, highlighting NDV-01 and sepranolone as key value drivers. The company is advancing manufacturing and CMC work t...
Business Operations and StrategyExecutive/Board Changes
Relmada Therapeutics Appoints New Chief Business Officer
Positive
Jul 28, 2026
On July 28, 2026, Relmada Therapeutics appointed veteran biopharmaceutical executive Bipin Dalmia, PhD, MBA, as Chief Business Officer, reporting to CEO Sergio Traversa. Dalmia brings nearly 30 years of experience in corporate strategy, business d...
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.