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Clene (CLNN)
NASDAQ:CLNN
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Clene (CLNN) AI Stock Analysis

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CLNN

Clene

(NASDAQ:CLNN)

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Neutral 51 (OpenAI - 4o)
Rating:51Neutral
Price Target:
$10.50
▼(-0.10% Downside)
Clene's overall stock score is primarily impacted by its poor financial performance, characterized by declining revenues, high net losses, and negative equity. Despite strong technical momentum, the overbought indicators suggest caution. The negative P/E ratio and lack of dividends further weigh down the valuation score.
Positive Factors
Innovative Product Development
Clene's proprietary nanotechnology platform and its development of CNM-Au8 position it well in the biotechnology sector, offering potential breakthroughs in treating neurodegenerative diseases.
Strong Gross Profit Margin
A strong gross profit margin indicates efficient production processes and pricing power, which are crucial for sustaining long-term profitability in the biotech industry.
Positive Clinical Trial Results
Positive clinical trial results for CNM-Au8 enhance Clene's credibility and potential for future regulatory approvals, supporting long-term growth prospects.
Negative Factors
Declining Revenue
A significant decline in revenue reflects challenges in commercializing products and may hinder the company's ability to sustain operations without additional funding.
Negative Equity
Negative equity indicates financial distress and potential insolvency risks, which could limit Clene's ability to invest in R&D and growth initiatives.
High Cash Burn
High cash burn rates necessitate frequent capital raises, which can dilute existing shareholders and strain financial resources, impacting long-term viability.

Clene (CLNN) vs. SPDR S&P 500 ETF (SPY)

Clene Business Overview & Revenue Model

Company DescriptionClene Inc., a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN) therapeutics. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2/3 registrational clinical trial for patients with amyotrophic lateral sclerosis (ALS); completed Phase 2 proof of concept clinical trial in patients with early symptomatic ALS; completed two open-label investigator blinded Phase 2 clinical trials on the brain's energy metabolites; ongoing Phase 2 clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing Multiple Sclerosis; and a planned Phase 2 clinical trial for the treatment of patients with Parkinson's Diseases. The company's products also include CNM-AgZn17, a gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; CNM-ZnAg, a broad-spectrum antiviral and antibacterial agent to treat infection disease, such as COVID-19 and to provide immune support for symptom resolution; and CNM-PtAu7, a gold-platinum CSN therapeutic for oncology applications. It also markets and distributes dietary supplements comprising rMetx, an aqueous zinc-silver ion dietary supplement; and KHC46, an aqueous gold dietary supplement of very low-concentration Au nanoparticles. The company is headquartered in Salt Lake City, Utah.
How the Company Makes MoneyClene generates revenue primarily through the development and commercialization of its therapeutic products. The company makes money by advancing its drug candidates through clinical trials, which can lead to licensing agreements, partnerships with larger pharmaceutical companies, and potential product sales once therapies receive regulatory approval. Key revenue streams include milestone payments from collaborations, royalties on future sales, and funding from government grants or research institutions. Additionally, partnerships with academic institutions and biopharmaceutical firms may provide financial support and shared expertise that enhance its revenue-generating capabilities.

Clene Financial Statement Overview

Summary
Clene is facing considerable financial challenges with declining revenues, high net losses, and negative equity. The substantial operating losses and cash flow issues highlight the need for strategic restructuring or additional capital infusion. The biotechnology sector's inherent risk is amplified by Clene's financial instability.
Income Statement
30
Negative
Clene has experienced significant revenue fluctuations with a decline from $654,000 in 2023 to $342,000 in 2024, reflecting a -47.71% revenue growth rate. The gross profit margin is relatively strong at 79.53%, but the company has negative net profit and EBIT margins due to substantial losses, with a net loss of $39.4 million in 2024.
Balance Sheet
20
Very Negative
The company has a negative stockholders' equity of -$8.86 million, indicating financial distress. The debt-to-equity ratio cannot be calculated due to negative equity, but the high total debt of $20.84 million suggests significant leverage. With equity being negative, the equity ratio is also negative, signaling potential insolvency risks.
Cash Flow
35
Negative
Operating cash flow remains deeply negative at -$21.33 million, with a slightly improved free cash flow position over the year. The free cash flow to net income ratio indicates severe cash burn issues, and financing cash flow has decreased, showing potential challenges in raising capital.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue286.00K342.00K654.00K473.00K723.00K206.00K
Gross Profit230.00K272.00K533.00K447.00K434.00K141.00K
EBITDA-29.64M-33.69M-43.24M-25.21M-8.22M-16.92M
Net Income-29.70M-39.40M-49.50M-15.28M-9.74M-19.28M
Balance Sheet
Total Assets22.13M27.34M52.34M44.49M63.06M68.24M
Cash, Cash Equivalents and Short-Term Investments7.29M12.15M35.00M23.32M50.29M59.27M
Total Debt20.85M20.84M32.16M31.82M24.04M4.32M
Total Liabilities30.68M36.19M38.95M41.26M50.47M67.90M
Stockholders Equity-8.55M-8.86M13.39M3.24M12.60M341.00K
Cash Flow
Free Cash Flow-17.64M-21.34M-30.50M-44.19M-35.96M-19.32M
Operating Cash Flow-17.64M-21.33M-30.17M-39.01M-34.62M-18.93M
Investing Cash Flow-3.00K6.32M-1.50M-10.16M-1.33M-387.00K
Financing Cash Flow3.27M-1.53M42.16M17.25M27.11M69.53M

Clene Technical Analysis

Technical Analysis Sentiment
Positive
Last Price10.51
Price Trends
50DMA
5.30
Positive
100DMA
4.47
Positive
200DMA
4.28
Positive
Market Momentum
MACD
0.71
Negative
RSI
85.43
Negative
STOCH
89.58
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLNN, the sentiment is Positive. The current price of 10.51 is above the 20-day moving average (MA) of 6.55, above the 50-day MA of 5.30, and above the 200-day MA of 4.28, indicating a bullish trend. The MACD of 0.71 indicates Negative momentum. The RSI at 85.43 is Negative, neither overbought nor oversold. The STOCH value of 89.58 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CLNN.

Clene Risk Analysis

Clene disclosed 66 risk factors in its most recent earnings report. Clene 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

Clene Peers Comparison

Overall Rating
UnderperformOutperform
Sector (62)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
62
Neutral
$20.33B14.63-3.31%3.23%1.93%-12.26%
51
Neutral
$105.84M-1738.36%-35.29%45.18%
46
Neutral
$41.98M-422.64%129.20%30.36%
44
Neutral
$30.45M-112.22%
34
Underperform
$35.52M-44.71%44.85%
* Consumer Defensive Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CLNN
Clene
10.51
5.19
97.56%
DYAI
Dyadic International
1.16
0.07
6.42%
AKTX
Akari Therapeutics
0.92
-2.12
-69.74%
ESLA
Estrella Immunopharma
1.31
0.20
18.02%
ANTX
AN2 Therapeutics, Inc.
1.30
0.26
25.00%
CAMP
CAMP4 Therapeutics Corporation
3.03
-6.72
-68.92%

Clene Corporate Events

Private Placements and Financing
Clene Expands Equity Distribution to Raise Capital
Neutral
Sep 5, 2025

On April 28, 2025, Clene Inc. entered into an equity distribution agreement with Canaccord Genuity LLC to offer and sell shares of its common stock, aiming to raise up to $25,000,000. By September 5, 2025, the company had already sold shares worth approximately $3,706,213 and filed a prospectus supplement for an additional $6,280,000 of shares, reflecting its ongoing efforts to bolster financial resources.

Private Placements and FinancingFinancial Disclosures
Clene Amends Notes and Secures New Financing
Neutral
Aug 14, 2025

On August 13, 2025, Clene Inc. announced amendments to its December 2024 senior secured convertible promissory notes, extending the maturity date to February 13, 2027, and postponing the commencement of monthly principal repayments to September 13, 2026. Additionally, the company entered into a new note purchase agreement with AE Capital Limited and others, issuing $1.5 million in senior secured convertible promissory notes. These financial maneuvers aim to provide Clene with a cash runway into the first quarter of 2026, supporting its ongoing clinical programs. Clene also reported its second quarter 2025 financial results, highlighting a net loss of $7.4 million and cash reserves of $7.3 million as of June 30, 2025. The company is advancing its CNM-Au8 programs for ALS and MS, with significant FDA meetings scheduled for the third quarter of 2025, aiming for a new drug application submission for ALS by the end of 2025.

Private Placements and FinancingRegulatory Filings and Compliance
Clene Files Prospectus for Additional Share Offering
Neutral
Jul 3, 2025

On April 28, 2025, Clene Inc. entered into an equity distribution agreement with Canaccord Genuity LLC to offer and sell shares of its common stock, aiming to raise up to $25 million. By July 3, 2025, Clene had filed a prospectus supplement for an additional $2,015,000 in shares, indicating ongoing efforts to secure funding for its operations and potentially strengthen its market position.

Product-Related AnnouncementsRegulatory Filings and Compliance
Clene Announces Regulatory Update After FDA Meeting
Positive
Jun 30, 2025

On June 30, 2025, Clene Inc. announced a regulatory update following a constructive Type C meeting with the FDA regarding its neurofilament biomarker analysis plan. The FDA provided supportive feedback on Clene’s proposed statistical analysis plan for its NIH-sponsored Expanded Access Program, which supports ALS patients treated with CNM-Au8®. The company plans to conduct neurofilament light (NfL) biomarker analyses early in the fourth quarter of 2025 and aims to submit a new drug application for ALS under the accelerated approval pathway by the end of 2025. Additionally, Clene confirmed two more FDA meetings in the third quarter of 2025 to discuss ALS survival data and the MS clinical development program, which could further advance its ALS and MS therapeutic initiatives.

Delistings and Listing ChangesRegulatory Filings and Compliance
Clene Regains Nasdaq Compliance as of June 2025
Positive
Jun 17, 2025

On June 17, 2025, Clene Inc. announced that it has regained compliance with Nasdaq Listing Rule 5550(b)(2), as its market value of listed securities has been $35.0 million or greater for 10 consecutive business days from June 2 to June 16, 2025. This compliance ensures Clene’s continued listing on Nasdaq, closing the matter and potentially stabilizing its market position.

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: Oct 04, 2025