tiprankstipranks
Relmada Therapeutics Inc (RLMD)
:RLMD

Relmada Therapeutics (RLMD) AI Stock Analysis

Compare
335 Followers

Top Page

RL

Relmada Therapeutics

(NASDAQ:RLMD)

42Neutral
Relmada Therapeutics faces significant challenges with its current financial performance, characterized by zero revenue and high operational costs. The company's recent strategic acquisitions and pipeline developments offer potential for future growth, but concerns remain regarding cash burn and the lack of current revenue. The technical analysis indicates a lack of strong momentum, and the valuation remains difficult due to the negative P/E ratio.
Positive Factors
Drug Efficacy
Sepranolone has shown promising efficacy and safety in Phase 2a studies, providing a 69% improvement in quality of life for Tourette syndrome patients.
Market Potential
The in-licensing of NDV-01 for treating NMIBC represents a multi-billion opportunity for Relmada Therapeutics Inc.
Product Development
Relmada's NDV-01 intravesical procedure is quick, requires no anesthesia, and doesn't need new equipment, offering significant advantages over current treatments.
Negative Factors
Financial Outlook
The firm's rating remains neutral, indicating cautious optimism and potential concerns not entirely alleviated by the current developments.
Product Pipeline
The interim analysis concluded futility of REL-1017 in RELIANCE II, which is disappointing given previous evidence and similar approved products.
Stock Rating
Based on current updates, a shift to the sidelines with a Market Perform rating and a new $1 price target is suggested.

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

Relmada Therapeutics Business Overview & Revenue Model

Company DescriptionRelmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for the treatment of central nervous system (CNS) diseases. The company is primarily engaged in the research and development of novel compounds and formulations aimed at addressing unmet medical needs within the CNS sector. Relmada's lead product candidate is REL-1017 (esmethadone), an NMDA receptor antagonist, which is being investigated for the treatment of major depressive disorder (MDD).
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 Financial Statement Overview

Summary
Relmada Therapeutics is in a challenging financial position with zero revenue and high operational expenditures typical for early-stage biotech firms. Despite strong cash reserves, the lack of revenue and negative cash flows highlight the need for successful product development and market entry.
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.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.000.000.000.000.00
Gross Profit
0.000.000.000.00-1.26K-3.75K
EBIT
-91.64M0.00-103.70M-161.25M-125.70M-60.84M
EBITDA
-41.83M0.004.91M-157.04M-125.75M-59.45M
Net Income Common Stockholders
-86.49M0.00-98.79M-157.04M-125.75M-59.46M
Balance SheetCash, Cash Equivalents and Short-Term Investments
7.50K44.91M96.32M148.32M211.91M117.09M
Total Assets
10.19K45.82M97.55M152.91M223.33M118.19M
Total Debt
0.000.000.000.000.000.00
Net Debt
-7.50K-3.86M-4.09M-5.40M-44.44M-2.50M
Total Liabilities
12.00K10.30M12.19M12.47M15.06M12.60M
Stockholders Equity
-1.81K35.52M85.36M140.44M208.26M105.58M
Cash FlowFree Cash Flow
-53.21M0.00-51.66M-103.80M-91.87M-27.81M
Operating Cash Flow
-53.21M0.00-51.66M-103.80M-91.87M-27.81M
Investing Cash Flow
47.96M51.56M50.45M19.73M-54.12M-34.45M
Financing Cash Flow
33.68K-40.34K-98.46K45.02M187.94M28.47M

Relmada Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price0.30
Price Trends
50DMA
0.31
Negative
100DMA
0.86
Negative
200DMA
2.07
Negative
Market Momentum
MACD
-0.01
Negative
RSI
36.82
Neutral
STOCH
31.25
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 0.3 is above the 20-day moving average (MA) of 0.29, below the 50-day MA of 0.31, and below the 200-day MA of 2.07, indicating a neutral trend. The MACD of -0.01 indicates Negative momentum. The RSI at 36.82 is Neutral, neither overbought nor oversold. The STOCH value of 31.25 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 (48)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
76
Outperform
$2.77B12.0038.89%31.85%
68
Neutral
$11.03B32.5114.16%24.81%33.67%
51
Neutral
$5.69B-231.63%42.53%-15.29%
48
Neutral
$6.86B1.11-50.22%2.47%16.71%1.53%
48
Neutral
$483.24M-63.37%-52.30%27.13%
42
Neutral
$9.08M-132.33%19.21%
39
Underperform
$2.57B-27.85%-10.19%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RLMD
Relmada Therapeutics
0.30
-4.41
-93.63%
ACAD
ACADIA Pharmaceuticals
16.62
-1.80
-9.77%
NBIX
Neurocrine
108.31
-29.28
-21.28%
SAGE
SAGE Therapeutics
7.77
-9.38
-54.69%
XENE
Xenon
31.46
-9.84
-23.83%
AXSM
Axsome Therapeutics
109.75
36.25
49.32%

Relmada Therapeutics Earnings Call Summary

Earnings Call Date: Mar 27, 2025 | % Change Since: 0.00% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted Relmada's successful strategic acquisitions and pipeline developments with NDV-01 and Sepranolone, indicating a positive direction for future growth. However, challenges such as the discontinuation of REL-1017, significant cash burn, and reevaluation of REL-P11 development present ongoing hurdles.
Highlights
Strategic Product Acquisition Success
Relmada successfully acquired two new product candidates, NDV-01 and Sepranolone, aligning with their strategic goal to maximize shareholder value through innovation and targeting underserved markets.
NDV-01 Promising Pipeline Development
NDV-01 is currently in Phase 2 for high-grade non-muscle invasive bladder cancer, with top-line data expected at the American Urological Association Meeting in April 2025. It shows potential for innovation and near-term value creation.
Sepranolone Acquisition for Compulsion Disorders
Sepranolone, acquired for Tourette syndrome and other compulsive disorders, is a Phase 2b ready program with promising Phase 2a results and robust safety data from over 350 subjects.
Decreased Operating Expenses
Research and development expenses decreased by $3.7 million and general administrative expenses decreased by $4 million in Q4 2024 compared to Q4 2023, indicating efficient resource management.
Lowlights
Discontinuation of REL-1017 for Major Depression Disorder
Phase 3 studies of REL-1017 were discontinued, prompting a shift in focus towards strategic product acquisition.
Significant Cash Burn and Decreased Cash Reserves
Cash reserves decreased significantly to $44.9 million at the end of 2024 from $96.3 million at the end of 2023, with a cash burn of $8.8 million in Q4 2024.
Reevaluation of REL-P11 Development
The development of REL-P11 for metabolic disorders is being reevaluated due to competitive landscape and regulatory challenges.
Company Guidance
During the fourth quarter 2024 financial results call for Relmada Therapeutics, the company outlined several key metrics and strategic priorities. Relmada reported cash, cash equivalents, and short-term investments of approximately $44.9 million as of December 31, 2024, a decrease from $96.3 million the previous year. Cash used in operations for Q4 2024 was $8.8 million, down from $10.2 million in Q4 2023. The company emphasized its focus on progressing its product pipeline with NDV-01 and Sepranolone, following the discontinuation of Phase 3 studies of REL-1017. Research and development expenses decreased to $11 million from $14.7 million in the same period last year, primarily due to completed clinical trials for REL-1017. General and administrative expenses were also reduced to $8.1 million from $12.1 million, largely due to decreased stock-based compensation. The net loss for Q4 2024 was $18.6 million compared to $25.1 million the previous year. Looking forward, Relmada plans to present initial proof-of-concept data for NDV-01 at the American Urological Association Meeting in April 2025, and is preparing for regulatory discussions with the FDA to advance their clinical programs.

Relmada Therapeutics Corporate Events

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.

Executive/Board ChangesBusiness Operations and Strategy
Relmada Therapeutics Strengthens Leadership with New COO
Neutral
Jan 6, 2025

Relmada Therapeutics has announced the appointment of Paul Kelly as Chief Operating Officer effective January 1, 2025, which is expected to strengthen its leadership team. The company has made strategic adjustments to executive compensation to manage expenses, including suspending retention payments and withholding salary increases and bonuses for fiscal 2025.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.