Clene (CLNN) AI Stock Analysis

• Market Cap: $31.35M
• Dividend Yield: N/A
• Average Volume (3M): 53.12K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.36
• Revenue Growth: -43.55%
• EPS Growth: 69.81%
• Country: US
• Employees: 75
• Sector: Consumer Defensive
• Sector Strength: 54
• Industry: Biotechnology
• EPS (TTM): -0.09
• Shares Outstanding: 8,982,747
• 10 Day Avg. Volume: 71,999
• 30 Day Avg. Volume: 53,123
• PEG Ratio: -0.04
• Price to Book (P/B): -6.03
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -1.59
• Enterprise Value/Market Cap: 1.33
• Enterprise Value/Revenue: 279.53
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: -1.32
• 1Y Price Target: $28.50
• Price Target Upside: 716.62% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 4

• Rating: 50 Neutral
• Price Target: $3.50 ▲(0.29%Upside)

Clene's overall stock score is heavily influenced by its poor financial performance, which underscores significant risk. However, recent positive corporate events, such as regulatory progress and Nasdaq compliance, provide potential upside. Technical indicators are mixed, and valuation remains weak due to negative earnings.

Positive Factors

Clinical Trial Results

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.

Regulatory Pathway

Clene will submit a NDA for CNM-Au8 in ALS under an accelerated approval pathway, leveraging CNM-Au8's effects on the NfL levels.

Regulatory Support

The FDA provided supportive feedback on Clene's statistical analysis plans for NfL biomarker analysis.

Negative Factors

Clinical and Regulatory Risks

Clinical and regulatory risks and questions remain (a 40% probability of success is assigned to CNM-Au8 as an adjuvant therapy in ALS).

Clinical Uncertainty

CNM-Au8 did not meet the primary functional endpoint of ALSFRS-R in HEALEY, the improvements have been associated with substantial NfL declines.

Financial Stability

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

Clene Business Overview & Revenue Model

Company Description

Clene 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 Money

Clene 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 experiencing severe financial challenges, including declining revenues, high net losses, and negative equity. The substantial operating losses and cash flow issues necessitate strategic restructuring or capital infusion.

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	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	342.00K	654.00K	473.00K	723.00K	206.00K
Gross Profit	272.00K	533.00K	447.00K	434.00K	141.00K
EBITDA	-33.69M	-43.24M	-25.21M	-8.22M	-16.92M
Net Income	-39.40M	-49.50M	-15.28M	-9.74M	-19.28M
Balance Sheet
Total Assets	27.34M	52.34M	44.49M	63.06M	68.24M
Cash, Cash Equivalents and Short-Term Investments	12.15M	35.00M	23.32M	50.29M	59.27M
Total Debt	20.84M	32.16M	31.82M	24.04M	4.32M
Total Liabilities	36.19M	38.95M	41.26M	50.47M	67.90M
Stockholders Equity	-8.86M	13.39M	3.24M	12.60M	341.00K
Cash Flow
Free Cash Flow	-21.34M	-30.50M	-44.19M	-35.96M	-19.32M
Operating Cash Flow	-21.33M	-30.17M	-39.01M	-34.62M	-18.93M
Investing Cash Flow	6.32M	-1.50M	-10.16M	-1.33M	-387.00K
Financing Cash Flow	-1.53M	42.16M	17.25M	27.11M	69.53M

Clene Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 3.49
• 50DMA: Negative
• 100DMA: Positive
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLNN, the sentiment is Negative. The current price of 3.49 is below the 20-day moving average (MA) of 3.69, below the 50-day MA of 3.75, and below the 200-day MA of 4.17, indicating a bearish trend. The MACD of -0.09 indicates Positive momentum. The RSI at 42.09 is Neutral, neither overbought nor oversold. The STOCH value of 35.05 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CLNN.

Clene Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	64 Neutral	$22.84B	13.40	-0.89%	3.13%	3.00%	-17.67%
CLNN	50 Neutral	$31.35M	―	-1738.36%	―	-43.55%	69.81%
DYAI	46 Neutral	$30.24M	―	-214.26%	―	20.58%	15.90%
AKTX	44 Neutral	$29.74M	―	-197.11%	―	―	―
ANTX	34 Underperform	$31.99M	―	-49.32%	―	―	38.98%

Clene Corporate Events

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.

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.

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.

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.

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.

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.

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.

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.

Clene Faces Nasdaq Delisting Risk Amid Regulatory Pursuits

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.