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Relmada Therapeutics Inc (RLMD)
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Relmada Therapeutics (RLMD) AI Stock Analysis

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RLMD

Relmada Therapeutics

(NASDAQ:RLMD)

Rating:41Neutral
Price Target:
Relmada Therapeutics' overall score reflects its high-risk, high-reward profile typical of biotechnology firms in developmental stages. The company's financial performance is weakened by zero revenue and significant cash burn, tempered by strong cash reserves. Strategic pipeline developments and recent acquisitions offer potential upside, but are countered by challenges such as discontinued projects and reliance on external financing. Technical analysis shows short-term momentum, but the overall outlook remains speculative.
Positive Factors
Clinical Trial Success
NDV-01 for high-grade non-muscle invasive bladder cancer showed an overall response rate of 85% and high-grade recurrence-free survival in patients with papillary disease of 83%.
Market Potential
Relmada announced in-licensing of Trigone's NDV-01 for treating NMIBC, which is seen as a multi-billion opportunity.
Safety and Administration
NDV-01 was well-tolerated with no treatment-related adverse events greater than grade 1.
Negative Factors
Development Prioritization
The company is re-evaluating further development of ‘P11 (novel psilocybin) as part of its prioritization efforts.
Pipeline Uncertainty
The company ended the year with $27M in cash, and additional data and updates from the pipeline are awaited before making any substantive comments regarding the pipeline assets.
Valuation Concerns
At this point, the product is not being added into the valuation, and the recommendation remains Market Perform.

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:Aug 07, 2025
(Q2-2025)
|
% Change Since: -5.00%|
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Positive
The earnings call conveyed positive momentum for Relmada Therapeutics, with significant achievements in clinical trials, strategic product additions, and financial management. The impressive Phase II results for NDV-01, strategic expansions, and a robust financial position were key highlights. However, concerns about decreased cash reserves and reduced R&D spending were noted. Despite these concerns, the positive developments and strategic positioning of the company outweigh the challenges.
Q2-2025 Updates
Positive Updates
Impressive Phase II Results for NDV-01
The 6-month follow-up from the Phase II study of NDV-01 for non-muscle invasive bladder cancer showed a 91% complete response rate at any time point, with a favorable safety profile and no treatment-related adverse events greater than grade 3.
Strategic Product Additions
Relmada added two promising product candidates: NDV-01 for non-muscle invasive bladder cancer and sepranolone for compulsivity disorders, both aligning with the company's strategic objectives and addressing significant, underserved markets.
Strong Financial Management
Relmada reported a cash balance of $20.6 million as of June 30, 2025, and a decreased net loss compared to the previous year, indicating effective cost management and resource allocation.
Expansion of Expert Team
The company expanded its team by adding Dr. Raj Pruthi as Chief Medical Officer and Dr. Yair Lotan as Chair of the Clinical Advisory Board, strengthening its expertise in bladder cancer and urologic oncology.
Negative Updates
Decreased Cash Reserves
Cash, cash equivalents, and short-term investments decreased from $44.9 million at the end of 2024 to $20.6 million as of June 30, 2025, reflecting the company's ongoing investment in R&D and operations.
Reduced R&D Spending
Research and development expenses decreased significantly from $10.7 million in Q2 2024 to $2.8 million in Q2 2025, primarily due to the winding down of clinical trials for REL-1017, which may delay future developments.
Company Guidance
During the Relmada Therapeutics Second Quarter 2025 Earnings Conference Call, the company outlined several key metrics and guidance for its future developments. Relmada reported a cash balance of $20.6 million as of June 30, 2025, compared to $44.9 million at the end of 2024, with cash used in operations totaling $6.4 million for the second quarter. The company highlighted its focus on two promising product candidates, NDV-01 and sepranolone, which showed significant potential in treating non-muscle invasive bladder cancer (NMIBC) and compulsivity disorders, respectively. Notably, the six-month follow-up data from the Phase II study of NDV-01 showed an impressive 91% response rate in high-grade NMIBC patients, reinforcing confidence in its efficacy. R&D expenses decreased by $7.9 million to $2.8 million, primarily due to the wind-down of clinical trials for REL-1017, while general and administrative expenses slightly decreased to $7.4 million. The company plans to initiate Phase III studies for NDV-01 and Phase II studies for sepranolone in the first half of 2026, working towards FDA interactions and production scale-up. The net loss for the quarter was reported at $9.9 million, or $0.30 per basic and diluted share, marking a decrease from the previous year's loss of $17.8 million or $0.59 per share.

Relmada Therapeutics Financial Statement Overview

Summary
Relmada Therapeutics is in a precarious financial state with no revenue and high research and development expenses leading to continuous losses. While the company benefits from strong cash reserves, the persistent negative cash flow emphasizes the need for successful product development to ensure sustainability.
Income Statement
10
Very Negative
Relmada Therapeutics has consistently reported zero revenue over the years, indicating that the company is still in the development stage, typical for biotech firms. The net income has been negative, showing significant losses, primarily due to high research and development expenses. There is no revenue growth, gross profit, or positive EBIT margin, which are critical for long-term sustainability.
Balance Sheet
40
Negative
The company's balance sheet shows adequate liquidity, with significant cash reserves compared to its liabilities, resulting in a negative net debt. However, the lack of revenue generation could pose a long-term risk if cash reserves are depleted without incoming revenue. The equity ratio is strong, but the absence of debt may limit financial leverage for expansion once products reach commercialization.
Cash Flow
20
Very Negative
Relmada Therapeutics has experienced negative operating and free cash flows due to ongoing operational expenses without revenue offset. The persistent negative free cash flow indicates dependency on external financing, which could be a concern if capital markets become less favorable. The cash flow situation highlights a need for strategic planning towards revenue generation.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit0.000.000.000.00-1.26K-3.75K
EBITDA-70.11M-79.98M4.91M-157.04M-125.75M-59.45M
Net Income-67.81M-79.98M-98.79M-157.04M-125.75M-59.46M
Balance Sheet
Total Assets21.12M45.82M97.55M152.91M223.33M118.19M
Cash, Cash Equivalents and Short-Term Investments20.62M44.91M96.32M148.32M211.91M117.09M
Total Debt0.000.000.000.000.000.00
Total Liabilities5.17M10.30M12.19M12.47M15.06M12.60M
Stockholders Equity15.95M35.52M85.36M140.44M208.26M105.58M
Cash Flow
Free Cash Flow-49.92M-51.76M-51.66M-103.80M-91.87M-27.81M
Operating Cash Flow-49.92M-51.76M-51.66M-103.80M-91.87M-27.81M
Investing Cash Flow49.53M51.56M50.45M19.73M-54.12M-34.45M
Financing Cash Flow-335.11K-40.34K-98.46K45.02M187.94M28.47M

Relmada Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.57
Price Trends
50DMA
0.65
Negative
100DMA
0.53
Positive
200DMA
0.84
Negative
Market Momentum
MACD
-0.01
Positive
RSI
44.30
Neutral
STOCH
21.74
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 0.57 is below the 20-day moving average (MA) of 0.61, below the 50-day MA of 0.65, and below the 200-day MA of 0.84, indicating a bearish trend. The MACD of -0.01 indicates Positive momentum. The RSI at 44.30 is Neutral, neither overbought nor oversold. The STOCH value of 21.74 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

Overall Rating
UnderperformOutperform
Sector (60)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
HK$18.14B5.30-4.00%3.33%10.16%-17.39%
46
Neutral
$11.97M-52.79%82.77%-87.95%
41
Neutral
$19.52M-175.12%23.17%
38
Underperform
$14.53M-53.42%18.73%
37
Underperform
$41.18M82.91%-63.88%77.72%
37
Underperform
$10.31M-105.79%-82.54%-12.53%
36
Underperform
$15.18M-103.80%47.99%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RLMD
Relmada Therapeutics
0.57
-2.00
-77.82%
IMRN
Immuron
1.73
-0.77
-30.80%
BTAI
Bioxcel Therapeutics
5.60
-5.28
-48.53%
CTXR
Citius Pharmaceuticals
1.28
-13.38
-91.27%
HOOK
Hookipa Pharma
0.85
-4.03
-82.58%
ATHA
Athira Pharma
0.39
-2.60
-86.96%

Relmada Therapeutics Corporate Events

Product-Related Announcements
Relmada Therapeutics Announces Positive Phase 2 Study Results
Positive
Apr 28, 2025

On April 28, 2025, Relmada Therapeutics announced positive initial data from its Phase 2 study of NDV-01, a novel delivery formulation for treating non-muscle invasive bladder cancer, at the American Urology Association 2025 Annual Meeting. The study showed that 90% of patients achieved high-grade disease-free status, demonstrating strong clinical activity and supporting further development of NDV-01. The treatment was well tolerated with no significant adverse events, suggesting a promising future for NDV-01 as a potential class-leading therapy for NMIBC.

Spark’s Take on RLMD Stock

According to Spark, TipRanks’ AI Analyst, RLMD is a Neutral.

Relmada Therapeutics’ stock is currently speculative, characterized by significant financial challenges including zero revenue and high cash burn. While recent strategic acquisitions and pipeline developments offer potential for future growth, the current financial performance and valuation indicate high risk. Technical analysis suggests short-term momentum, but volatility remains a concern.

To see Spark’s full report on RLMD stock, click here.

Product-Related AnnouncementsBusiness Operations and Strategy
Relmada Therapeutics Secures Exclusive License for NDV-01
Positive
Mar 26, 2025

On March 24, 2025, Relmada Therapeutics entered into an exclusive license agreement with Trigone Pharma for NDV-01, a novel sustained-release formulation of gemcitabine and docetaxel for treating Non-Muscle Invasive Bladder Cancer. This agreement grants Relmada worldwide rights, excluding India, Israel, and South Africa, and involves a $3.5 million upfront payment, potential milestone payments up to $200 million, and a 3% royalty on net sales. NDV-01 is expected to be a first-line therapy for NMIBC, offering significant clinical benefits, and its Phase 2 data will be presented at the American Urological Association meeting in April 2025.

M&A TransactionsBusiness Operations and Strategy
Relmada Therapeutics Acquires Sepranolone for CNS Portfolio
Positive
Feb 6, 2025

Relmada Therapeutics has entered into an Asset Purchase Agreement with Asarina Pharma AB to acquire Sepranolone, a Phase 2b ready neurosteroid being developed for Tourette Syndrome and other compulsive disorders, for €3 million. This acquisition aligns with Relmada’s strategy to enhance its CNS disorder treatment portfolio, as Sepranolone has shown promising Phase 2a results, offering significant tic reduction and quality of life improvements without serious side effects, potentially positioning it as a first-line treatment for Tourette Syndrome.

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: Apr 30, 2025