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Relmada Therapeutics Inc (RLMD)
NASDAQ:RLMD

Relmada Therapeutics (RLMD) AI Stock Analysis

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RLMD

Relmada Therapeutics

(NASDAQ:RLMD)

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Neutral 57 (OpenAI - 5.2)
Rating:57Neutral
Price Target:
$4.00
▲(1.27% Upside)
The score is held back primarily by weak financial performance (no revenue, ongoing large losses, and sustained cash burn with a shrinking equity base). Offsetting this, recent communications were notably positive with strong NDV-01 clinical results, FDA alignment, and a $100M raise extending runway into 2028, while technicals also show improving price momentum; valuation remains difficult to support given negative earnings and no dividend.
Positive Factors
NDV-01 Phase 2 Efficacy
A 92% Phase 2 response materially raises the probability NDV-01 can reach approval and become a meaningful clinical asset. Durable, high efficacy strengthens partner interest, supports favorable label potential and pricing discussions, and meaningfully de-risks the core oncology program long-term.
Regulatory Alignment
FDA alignment on Phase 3 design and acceptance of two registrational tracks reduces regulatory uncertainty and shortens the path to approval. This structural de-risking improves trial planning, investor and partner confidence, and the likelihood of efficient global development and commercialization planning.
Extended Runway from Financing
The $100M underwritten financing extends operational runway into 2028, materially reducing near-term funding pressure. This allows execution of pivotal trials, strategic hires and program investments without immediate dilutive raises, supporting continuity of development through key inflection points.
Negative Factors
No Commercial Revenue
Reporting zero revenue means the company lacks product cashflows and must rely on external financing or partnerships. Over the medium term this structurally increases execution risk: program failures or adverse funding conditions could halt development and threaten corporate viability.
Persistent Cash Burn
Sustained negative operating and free cash flow (~$40M TTM) creates persistent financing needs. Heavy burn increases the frequency and size of capital raises, raising dilution risk, distracting management, and limiting optionality to fund new programs or absorb trial delays or unexpected costs.
Eroded Equity Cushion
Equity erosion from roughly $208M to about $9.5M TTM materially shrinks the capital cushion. This reduces balance-sheet flexibility, increases reliance on market financing, and leaves little room to absorb trial setbacks or invest in parallel opportunities without heavy dilution.

Relmada Therapeutics (RLMD) vs. SPDR S&P 500 ETF (SPY)

Relmada Therapeutics Business Overview & Revenue Model

Company DescriptionRelmada 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, dextromethadone, and REL-1017), a new chemical entity and N-methyl-D-aspartate receptor antagonist that is in Phase 3 clinical trials for the adjunctive or monotherapy treatment of major depressive disorder in adults. The company was founded in 2004 and is headquartered in Coral Gables, Florida.
How the Company Makes MoneyRelmada Therapeutics primarily generates revenue through strategic partnerships, collaborations, and funding related to the research and development of its pipeline therapies. As a clinical-stage company, Relmada does not yet have products on the market generating sales revenue. Instead, it relies on investments, grants, and milestone payments from partners who are interested in the potential of its drug candidates. These collaborations can involve licensing agreements or co-development arrangements, which provide financial support for the ongoing development of their therapies. The company's future revenue streams are expected to depend on the successful clinical trials and subsequent commercialization of its lead candidates, particularly if regulatory approvals are obtained.

Relmada Therapeutics Earnings Call Summary

Earnings Call Date:Nov 13, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 24, 2026
Earnings Call Sentiment Positive
The call was overwhelmingly positive, highlighting significant achievements in clinical trials, regulatory alignment, and financial stability. The only notable concern was the reduction in cash reserves prior to the recent capital raise, which has since been addressed.
Q3-2025 Updates
Positive Updates
Successful Phase Two Study for NDV-01
The phase two study of NDV-01 in non-muscle invasive bladder cancer (NMIBC) reported a 92% overall response rate at any time with favorable safety, showing promise as a potential best-in-class treatment.
FDA Alignment on Phase Three Program for NDV-01
Relmada secured FDA alignment on key elements of the phase three program for NDV-01, allowing two distinct and independent registrational tracks, which is an important de-risking milestone.
Strong Financial Position
Relmada has completed a $100 million underwritten finance, ensuring the company is well-capitalized to support operations into 2028.
Reduction in Operating Expenses
Research and development expenses decreased by $7.1 million and general and administrative expenses decreased by $5.6 million compared to the prior year.
Appointment of Key Personnel
The appointment of Dr. Raj S. Pruthi as Chief Medical Officer and other advisory board members strengthens the company’s focus on advancing novel therapies for NMIBC.
Negative Updates
Decreased Cash Reserves Before Capital Raise
As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.9 million, a drop from $44.9 million at the end of 2024, though this was before the recent capital raise.
Company Guidance
During Relmada Therapeutics' Third Quarter 2025 earnings call, the company provided guidance on its two key clinical programs, NDV-01 and Sepranolone. NDV-01, targeted at non-muscle invasive bladder cancer (NMIBC), demonstrated a 92% overall response rate at any time in its phase two study, with plans to initiate two phase three registrational studies in 2026, backed by FDA alignment. Sepranolone, aimed at Prader-Willi syndrome, is expected to enter phase two studies in 2026. The company reported a net loss of $10.1 million for the third quarter with cash reserves bolstered by a recent $100 million financing, projected to support operations into 2028.

Relmada Therapeutics Financial Statement Overview

Summary
Financials reflect a pre-revenue, cash-burning biotech profile: zero revenue, persistent large net losses, and consistently negative operating/free cash flow. The debt-free balance sheet is a positive, but equity has fallen sharply, signaling erosion of the capital cushion and ongoing funding risk despite some improvement in the pace of losses/cash burn.
Income Statement
8
Very Negative
RLMD reports zero revenue across the annual periods shown and in TTM (Trailing-Twelve-Months), with persistent large operating losses and net losses (TTM net loss of about $56M; 2024 net loss about $80M). Losses improved versus 2022–2023, but profitability remains deeply negative and there is no visible top-line traction in the provided data, keeping earnings quality and operating leverage weak.
Balance Sheet
28
Negative
The company shows no debt, which reduces financial risk and limits balance-sheet leverage concerns. However, equity has fallen sharply (from about $208M in 2021 to about $9.5M in TTM), reflecting sustained losses and a materially thinner capital cushion; returns on equity are strongly negative across periods, signaling ongoing value erosion despite the debt-free structure.
Cash Flow
10
Very Negative
Cash burn remains heavy, with negative operating cash flow and negative free cash flow in every period shown (TTM operating/free cash flow around -$40M; 2024 around -$52M). While burn improved versus 2022 and is better than 2024 in TTM, free cash flow growth is negative in TTM and cash generation is not yet supported by revenue, leaving funding needs and runway risk as key concerns.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit0.000.000.000.000.000.00
EBITDA-38.53M-83.89M4.91M-161.25M-125.70M-59.33M
Net Income-56.17M-79.98M-98.79M-157.04M-125.75M-59.46M
Balance Sheet
Total Assets14.88M45.82M97.55M152.91M223.33M118.19M
Cash, Cash Equivalents and Short-Term Investments13.89M44.91M96.32M148.32M211.91M117.09M
Total Debt0.000.000.000.000.000.00
Total Liabilities5.41M10.30M12.19M12.47M15.06M12.60M
Stockholders Equity9.47M35.52M85.36M140.44M208.26M105.58M
Cash Flow
Free Cash Flow-39.99M-51.76M-51.66M-103.80M-91.87M-27.81M
Operating Cash Flow-39.99M-51.76M-51.66M-103.80M-91.87M-27.81M
Investing Cash Flow40.14M51.56M50.45M19.73M-54.12M-34.45M
Financing Cash Flow-245.51K-40.34K-98.46K45.02M187.94M28.47M

Relmada Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price3.95
Price Trends
50DMA
4.20
Negative
100DMA
3.19
Positive
200DMA
1.91
Positive
Market Momentum
MACD
-0.06
Positive
RSI
45.98
Neutral
STOCH
42.20
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RLMD, the sentiment is Neutral. The current price of 3.95 is below the 20-day moving average (MA) of 4.08, below the 50-day MA of 4.20, and above the 200-day MA of 1.91, indicating a neutral trend. The MACD of -0.06 indicates Positive momentum. The RSI at 45.98 is Neutral, neither overbought nor oversold. The STOCH value of 42.20 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
57
Neutral
$289.67M-196.79%37.37%
57
Neutral
$114.24M-1.56-49.78%-82.16%14.58%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$111.53M-1.18-103.99%250.00%15.15%
45
Neutral
$87.66M-0.94-167.93%-90.18%-17.93%
44
Neutral
$34.63M-0.45-122.43%-100.00%-8.30%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RLMD
Relmada Therapeutics
3.91
3.56
1017.14%
XBIT
XBiotech
2.54
-1.08
-29.83%
RPTX
Repare Therapeutics
2.65
1.46
122.69%
PRLD
Prelude Therapeutics
1.90
0.71
59.66%
SPRB
Spruce Biosciences
79.86
52.40
190.82%
HOWL
Werewolf Therapeutics
0.72
-0.63
-46.37%

Relmada Therapeutics Corporate Events

Executive/Board Changes
Relmada Therapeutics Amends Executive Employment Agreements
Neutral
Dec 15, 2025

On December 12, 2025, Relmada Therapeutics‘ Board of Directors approved amended employment agreements for its executive officers, effective January 1, 2026. The agreements include salary increases for executives and detailed severance packages in cases of termination, highlighting the company’s commitment to retaining key leadership during potential changes in control.

The most recent analyst rating on (RLMD) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.

Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Relmada Therapeutics Reports Q3 2025 Financial Results
Positive
Nov 13, 2025

Relmada Therapeutics reported its third-quarter 2025 financial results and provided updates on its NDV-01 program for non-muscle invasive bladder cancer (NMIBC). The company announced positive 9-month follow-up data for NDV-01, showing a 92% complete response rate, and secured FDA alignment on key elements of its Phase 3 program. Additionally, Relmada completed a $100 million underwritten offering to support its operations into 2028, which will help advance the NDV-01 registrational studies and the development of sepranolone for Prader-Willi Syndrome.

The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.

Private Placements and Financing
Relmada Therapeutics Announces $100M Stock Offering
Neutral
Nov 5, 2025

On November 4, 2025, Relmada Therapeutics announced the pricing of a $100 million underwritten offering of common stock and pre-funded warrants. The proceeds from this offering are intended to support working capital, corporate purposes, and further development of product candidates, as well as potential investments or acquisitions in synergistic technologies. The offering is expected to close on November 5, 2025, and includes participation from notable investors such as Janus Henderson Investors and OrbiMed.

The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.

Business Operations and StrategyFinancial DisclosuresProduct-Related Announcements
Relmada Therapeutics Receives FDA Feedback on NDV-01 Trials
Positive
Nov 4, 2025

On November 4, 2025, Relmada Therapeutics announced FDA feedback on its proposed NDV-01 Phase III trials and shared nine-month safety and efficacy data for its Phase II study in high-risk NMIBC patients. The FDA’s feedback suggests a single-arm trial may be acceptable for BCG-unresponsive patients, and a randomized study for intermediate-risk NMIBC patients is generally acceptable, pending further discussions. The nine-month data showed no new safety signals and a high complete response rate among patients. The company also reported preliminary financial information, indicating approximately $13.9 million in cash and investments as of September 30, 2025.

The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.

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.Date of analysis: Dec 30, 2025