Clene (CLNN) AI Stock Analysis

• Market Cap: $53.35M
• Dividend Yield: N/A
• Average Volume (3M): 90.38K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.37
• Revenue Growth: -35.29%
• EPS Growth: 45.18%
• Country: US
• Employees: 75
• Sector: Consumer Defensive
• Sector Strength: 58
• Industry: Biotechnology
• EPS (TTM): -0.78
• Shares Outstanding: 9,990,568
• 10 Day Avg. Volume: 123,804
• 30 Day Avg. Volume: 90,384
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 0.95
• Enterprise Value/Revenue: 177.62
• Enterprise Value/Gross Profit: 220.86
• Enterprise Value/Ebitda: -1.71
• 1Y Price Target: $32.25
• Price Target Upside: 469.79% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 4

• Rating: 54 Neutral
• Price Target: $5.50 ▼(-2.83% Downside)

Clene's overall stock score is primarily impacted by its financial instability, with significant losses and negative equity. However, positive technical indicators and recent corporate events, such as regulatory updates and Nasdaq compliance, provide some optimism. The valuation remains weak due to negative earnings and lack of dividends.

Positive Factors

Financial Stability

Clene has sufficient cash balance to fund operations into the next year and is well-positioned to raise additional capital for NDA filing, providing financial stability for upcoming milestones.

Regulatory Approval

The Orphan Drug Designation for CNM-Au8 should qualify it for Priority Review by the FDA, suggesting a faster review process and potential for quicker market entry.

Regulatory Engagement

Clene continues meaningful engagement with the FDA, which appears to not have been impacted by changes at the agency.

Negative Factors

Cash Position

CLNN ended 1Q25 with a cash position of $9.8M, which provides a cash runway into 3Q25.

Earnings

Clene announced 2Q25 results, posting EPS of ($0.78), compared to estimate of ($0.39), and consensus of (0.46).

Clene Business Overview & Revenue Model

Company Description

Clene Inc. is a biotechnology company focused on developing innovative therapies for neurodegenerative diseases, primarily targeting conditions such as amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The company operates in the biotechnology sector, leveraging its proprietary nanotechnology platform to create drug candidates that aim to restore cellular function and improve patient outcomes. Clene’s core products include CNM-Au8, a gold nanocrystal suspension designed to enhance cellular energy metabolism and protect neuronal health.

How the Company Makes Money

Clene 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

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

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

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	286.00K	342.00K	654.00K	473.00K	723.00K	206.00K
Gross Profit	230.00K	272.00K	533.00K	447.00K	434.00K	141.00K
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 Assets	22.13M	27.34M	52.34M	44.49M	63.06M	68.24M
Cash, Cash Equivalents and Short-Term Investments	7.29M	12.15M	35.00M	23.32M	50.29M	59.27M
Total Debt	20.85M	20.84M	32.16M	31.82M	24.04M	4.32M
Total Liabilities	30.68M	36.19M	38.95M	41.26M	50.47M	67.90M
Stockholders Equity	-8.55M	-8.86M	13.39M	3.24M	12.60M	341.00K
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	-3.00K	6.32M	-1.50M	-10.16M	-1.33M	-387.00K
Financing Cash Flow	3.27M	-1.53M	42.16M	17.25M	27.11M	69.53M

Clene Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 5.66
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Negative
• STOCH: 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 5.66 is above the 20-day moving average (MA) of 3.97, above the 50-day MA of 3.94, and above the 200-day MA of 4.05, indicating a bullish trend. The MACD of 0.38 indicates Negative momentum. The RSI at 77.55 is Negative, neither overbought nor oversold. The STOCH value of 92.58 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CLNN.

Clene Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	63 Neutral	$20.91B	14.58	-4.08%	3.07%	2.70%	-8.71%
CLNN	54 Neutral	$53.35M	―	-1738.36%	―	-35.29%	45.18%
DYAI	46 Neutral	$28.60M	―	-422.64%	―	129.20%	30.36%
AKTX	44 Neutral	$30.17M	―	-112.22%	―	―	―
ANTX	34 Underperform	$31.43M	―	-44.71%	―	―	44.85%

Clene Corporate Events

Clene Amends Notes and Secures New Financing

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.

Clene Files Prospectus for Additional Share Offering

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.

Clene Announces Regulatory Update After FDA Meeting

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.

Clene Regains Nasdaq Compliance as of June 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.

Clene Approves Stock Plan Amendment at Annual Meeting

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.