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Clene (CLNN)
NASDAQ:CLNN

Clene (CLNN) AI Stock Analysis

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Clene

(NASDAQ:CLNN)

Rating:52Neutral
Price Target:
$4.00
▲(2.56%Upside)
Clene's overall score is driven by significant financial challenges, including declining revenues and high net losses. However, positive regulatory updates and improved technical indicators provide some support. Valuation remains a concern due to the negative P/E ratio.
Positive Factors
Clinical Data
Recent Phase 2 VISIONARY-MS long-term results continue to demonstrate CNM-Au8’s favorable neuroprotective properties, including remyelination, neuronal repair, and cognitive and visual improvements in MS patients.
Cost Management
Clene has significantly reduced expenses to manage the cash balance.
Regulatory Progress
The FDA provided supportive feedback on Clene's statistical analysis plans for NfL biomarker analysis.
Negative Factors
Clinical Trial Results
Although CNM-Au8 did not meet the primary functional endpoint of ALSFRS-R in HEALEY, the improvements have been associated with substantial NfL declines.
Regulatory Challenges
Clinical and regulatory risks and questions remain (a 40% probability of success is assigned to CNM-Au8 as an adjuvant therapy in ALS).

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

Clene Business Overview & Revenue Model

Company DescriptionClene Inc. (CLNN) is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for neurodegenerative diseases. The company operates in the biotechnology sector and specializes in the creation of nanotherapeutics to treat conditions such as multiple sclerosis, Parkinson's disease, and amyotrophic lateral sclerosis (ALS). Clene's core product pipeline includes CNM-Au8, a gold nanocrystal suspension designed to enhance neural function and survival, targeting diseases with significant unmet medical needs.
How the Company Makes MoneyClene Inc. generates revenue primarily through the development and commercialization of its proprietary nanotherapeutics. The company's revenue model is based on securing funding through partnerships, grants, and equity financing to support its clinical trials and research and development activities. Clene's future earnings potential is highly dependent on the successful progression and commercialization of its lead product, CNM-Au8, through regulatory approvals and market acceptance. Additionally, the company may engage in strategic partnerships or licensing agreements with larger pharmaceutical companies to expand its market reach and leverage distribution networks. However, as a clinical-stage company, Clene currently does not have significant revenue from product sales and relies heavily on external funding to sustain its operations.

Clene Financial Statement Overview

Summary
Clene is facing considerable financial challenges, including 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.
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 Revenue350.00K342.00K654.00K473.00K723.00K206.00K
Gross Profit276.00K272.00K533.00K447.00K434.00K141.00K
EBITDA-28.35M-33.69M-43.24M-25.21M-8.22M-16.92M
Net Income-29.07M-39.40M-49.50M-15.28M-9.74M-19.28M
Balance Sheet
Total Assets25.31M27.34M52.34M44.49M63.06M68.24M
Cash, Cash Equivalents and Short-Term Investments9.83M12.15M35.00M23.32M50.29M59.27M
Total Debt20.94M20.84M32.16M31.82M24.04M4.32M
Total Liabilities30.29M36.19M38.95M41.26M50.47M67.90M
Stockholders Equity-4.97M-8.86M13.39M3.24M12.60M341.00K
Cash Flow
Free Cash Flow-19.26M-21.34M-30.50M-44.19M-35.96M-19.32M
Operating Cash Flow-19.25M-21.33M-30.17M-39.01M-34.62M-18.93M
Investing Cash Flow6.25M6.32M-1.50M-10.16M-1.33M-387.00K
Financing Cash Flow1.16M-1.53M42.16M17.25M27.11M69.53M

Clene Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price3.90
Price Trends
50DMA
3.39
Positive
100DMA
3.64
Positive
200DMA
4.30
Negative
Market Momentum
MACD
0.12
Positive
RSI
51.67
Neutral
STOCH
36.10
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLNN, the sentiment is Neutral. The current price of 3.9 is below the 20-day moving average (MA) of 4.12, above the 50-day MA of 3.39, and below the 200-day MA of 4.30, indicating a neutral trend. The MACD of 0.12 indicates Positive momentum. The RSI at 51.67 is Neutral, neither overbought nor oversold. The STOCH value of 36.10 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
53
Neutral
$23.85M-93.19%6.96%32.32%
52
Neutral
$35.48M-1738.36%-43.55%69.81%
52
Neutral
$7.50B0.31-61.87%2.27%17.10%1.59%
45
Neutral
$65.14M256.43%238.96%35.96%
42
Neutral
$22.65M-70.06%146.47%57.85%
41
Neutral
$35.67M-853.05%34.97%
39
Underperform
$20.14M-1094.50%11.40%-18.18%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CLNN
Clene
3.90
-3.05
-43.88%
CASI
CASI Pharmaceuticals
1.30
-5.21
-80.03%
PULM
Pulmatrix
6.53
4.43
210.95%
PYPD
PolyPid
3.50
-0.50
-12.50%
GBIO
Generation Bio
0.34
-2.01
-85.53%
MDAI
Spectral AI
2.68
0.69
34.67%

Clene Corporate Events

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.

The most recent analyst rating on (CLNN) stock is a Buy with a $31.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

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.

The most recent analyst rating on (CLNN) stock is a Buy with a $31.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

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.

The most recent analyst rating on (CLNN) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Executive/Board ChangesShareholder MeetingsStock Split
Clene Approves Stock Plan Amendment at Annual Meeting
Neutral
May 23, 2025

On May 22, 2025, Clene Inc. held its Annual Meeting of Stockholders, where the stockholders approved an amendment to the company’s 2020 Stock Plan, increasing the number of shares of common stock reserved for issuance by 800,000 shares. Additionally, the Board of Directors approved an amendment to the compensation program for nonemployee directors, adjusting stock option grants to reflect a reverse stock split from July 2024. These changes are expected to impact the company’s stock management and director compensation structure, potentially affecting shareholder value and governance practices.

The most recent analyst rating on (CLNN) stock is a Buy with a $31.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Delistings and Listing ChangesBusiness Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
Clene Faces Nasdaq Delisting Risk Amid Regulatory Pursuits
Negative
May 7, 2025

On May 6, 2025, Clene Inc. received a notice from Nasdaq indicating that its market value of listed securities had fallen below the required $35 million for 30 consecutive business days, risking delisting if not rectified by November 3, 2025. Meanwhile, Clene is actively pursuing regulatory milestones, including a planned New Drug Application for CNM-Au8 in ALS, supported by recent data showing improved survival rates in ALS patients. The company is also preparing for discussions with the FDA regarding its neurofilament light chain biomarker data and has reported financial results showing a net loss decrease compared to the previous year.

Product-Related AnnouncementsBusiness Operations and Strategy
Clene Showcases CNM-Au8® Advancements at Neurology Session
Positive
Apr 8, 2025

On April 8, 2025, Clene announced the presentation of evidence demonstrating remyelination and neuronal repair with their CNM-Au8® treatment during the VISIONARY-MS LTE at the American Academy of Neurology Late-Breaking Science Session. This announcement highlights Clene’s ongoing efforts in advancing neurological treatments, potentially strengthening its position in the medical research industry and offering promising implications for stakeholders involved in neurological disorder therapies.

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: Jul 03, 2025