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Relmada Therapeutics (RLMD)
NASDAQ:RLMD

Relmada Therapeutics (RLMD) AI Stock Analysis

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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 Results
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.
Product Differentiation
Sepranolone is the first Tourette syndrome agent to demonstrate an improvement in quality of life with a favorable safety profile, making it a potentially differentiated treatment option.
Negative Factors
Financial Position
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:May 12, 2025
(Q1-2025)
|
% Change Since: 85.00%|
Next Earnings Date:Aug 12, 2025
Earnings Call Sentiment Positive
The earnings call highlighted strong progress in product development with promising Phase 2 data for NDV-01 and sepranolone, as well as a disciplined financial approach. However, there are concerns about increased cash usage and a decreased cash position.
Q1-2025 Updates
Positive Updates
Addition of Promising Product Candidates
Relmada added two unique product candidates, NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome and Tourette syndrome, both with very encouraging Phase 2 data.
Positive Phase 2 Data for NDV-01
Initial proof-of-concept Phase 2 data for NDV-01 showed an overall response rate of 90% and a complete response in carcinoma in situ patients at 100%.
Strong Safety Profile for NDV-01
NDV-01 was well tolerated with no treatment-related adverse events greater than Grade 1.
Financial Position and Cost Management
Relmada has a $27.1 million cash balance and reported a decrease in net loss from $21.8 million in Q1 2024 to $17.6 million in Q1 2025.
Sepranolone's Potential in Treating Neurobehavioral Disorders
Sepranolone, with a broad safety database and promising Phase 2 results in Tourette syndrome, is expected to address sizeable underserved markets including Prader-Willi syndrome.
Negative Updates
Increased Cash Usage
Cash used in operations increased from $13 million for Q1 2024 to $18.1 million for Q1 2025.
Decreased Cash Position
Relmada's cash, cash equivalents, and short-term investments decreased from $44.9 million as of December 31, 2024, to $27.1 million as of March 31, 2025.
Company Guidance
During the Relmada Therapeutics First Quarter 2025 Earnings Call, the company provided guidance for its two primary product candidates, NDV-01 and sepranolone. NDV-01, a novel bladder cancer treatment, demonstrated promising Phase 2 data with an 85% overall response rate at three months and 100% disease-free status in seven evaluable patients at six months. The company highlighted NDV-01's potential to improve non-muscle invasive bladder cancer care due to its sustained-release formulation and impressive safety profile, with no treatment-related adverse events greater than Grade 1. Meanwhile, sepranolone, aimed at treating Prader-Willi syndrome and Tourette syndrome, showed a competitive 28% peak reduction in the primary clinical endpoint in Phase 2 trials. With a cash balance of $27 million and a clean balance sheet, Relmada is focused on advancing these programs through key clinical and regulatory milestones in 2025 and beyond.

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
Positive
Last Price0.74
Price Trends
50DMA
0.43
Positive
100DMA
0.38
Positive
200DMA
1.44
Negative
Market Momentum
MACD
0.09
Negative
RSI
67.47
Neutral
STOCH
81.78
Negative
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 0.74 is above the 20-day moving average (MA) of 0.55, above the 50-day MA of 0.43, and below the 200-day MA of 1.44, indicating a neutral trend. The MACD of 0.09 indicates Negative momentum. The RSI at 67.47 is Neutral, neither overbought nor oversold. The STOCH value of 81.78 is Negative, 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

Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
53
Neutral
$5.25B3.24-45.38%2.81%16.79%-0.06%
48
Neutral
$10.14M-52.79%82.77%-87.95%
41
Neutral
$23.14M-160.26%19.21%
38
Underperform
$8.90M-60.06%8.99%
37
Underperform
$8.30M82.91%64.20%73.71%
36
Underperform
$11.80M-110.70%18.61%
33
Underperform
$19.26M-105.79%-82.54%-12.53%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RLMD
Relmada Therapeutics
0.74
-2.30
-75.66%
IMRN
Immuron
1.76
-0.54
-23.48%
BTAI
Bioxcel Therapeutics
1.53
-22.15
-93.54%
CTXR
Citius Pharmaceuticals
0.87
-14.92
-94.49%
HOOK
Hookipa Pharma
1.58
-6.52
-80.49%
ATHA
Athira Pharma
0.33
-2.21
-87.01%

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
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.