Clene (CLNN) AI Stock Analysis

• Market Cap: $22.01M
• Dividend Yield: N/A
• Average Volume (3M): 67.61K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.22
• Revenue Growth: -43.55%
• EPS Growth: -293.22%
• Country: US
• Employees: 75
• Sector: Healthcare
• Sector Strength: 42
• Industry: Biotechnology
• EPS (TTM): -0.09
• Shares Outstanding: 8,982,747
• 10 Day Avg. Volume: 74,376
• 30 Day Avg. Volume: 67,610
• PEG Ratio: 0.07
• Price to Book (P/B): -2.06
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -1.11
• Enterprise Value/Market Cap: 1.47
• Enterprise Value/Revenue: 17.71
• Enterprise Value/Gross Profit: -218.33
• Enterprise Value/Ebitda: -0.25
• 1Y Price Target: $28.80
• Price Target Upside: 1115.19% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5

• Rating: 32 Underperform
• Price Target: $2.50 ▲( 5.49% Upside)

Clene's stock score reflects significant financial distress characterized by declining revenues, persistent net losses, and negative equity. The bearish technical indicators and negative valuation metrics further weaken investor confidence. While corporate announcements about advancements in neurological treatments provide a slight positive outlook, they are insufficient to offset the company’s broader financial challenges and delisting risks.

Positive Factors

Clinical Efficacy

Treatment for 48 months with 30 mg CNM-Au8 demonstrated an improvement in overall survival when compared to the control arm of the Regimen A in the HEALEY ALS.

Financial Management

Clene has significantly reduced expenses to manage the cash balance.

Regulatory Progress

CNM-Au8 has Orphan Drug Designation which should qualify for Priority Review (6-month review).

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 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.

Mixed Clinical Results

Clene's lead asset, CNM-Au8, has generated mixed clinical results in ALS with indications of benefit in survival and period without disease progression.

Clene Business Overview & Revenue Model

Company Description

Clene 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 Money

Clene Inc. generates revenue primarily through research and development activities, which may include grant funding and partnerships for the advancement of its nanotherapeutic products. The company's revenue model is largely dependent on the successful development and commercialization of its lead product candidate, CNM-Au8. Clene may also engage in strategic collaborations with other pharmaceutical companies to co-develop or license its technology, which could provide additional revenue streams through milestone payments and royalties. As Clene's products are still in the clinical trial phase, product sales revenue is not currently a significant source of income.

Clene Financial Statement Overview

Summary

Clene faces severe financial challenges with declining revenues, significant net losses, and negative equity. This financial instability is exacerbated by substantial operating losses and cash flow issues, necessitating strategic restructuring or capital infusion to ensure sustainability.

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
	EBIT
-33.09M	-40.54M	-45.33M	-45.28M	-17.00M
	EBITDA
-33.69M	-43.24M	-25.21M	-8.22M	-16.92M
	Net Income Common Stockholders
-39.40M	-49.50M	-15.28M	-9.74M	-19.28M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
12.15M	35.00M	23.32M	50.29M	59.27M
	Total Assets
27.34M	52.34M	44.49M	63.06M	68.24M
	Total Debt
20.84M	32.16M	31.82M	24.04M	4.32M
	Net Debt
8.69M	3.34M	13.49M	-26.25M	-54.95M
	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: 2.37
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

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 2.37 is below the 20-day moving average (MA) of 2.71, below the 50-day MA of 3.08, and below the 200-day MA of 4.52, indicating a bearish trend. The MACD of -0.18 indicates Positive momentum. The RSI at 30.32 is Neutral, neither overbought nor oversold. The STOCH value of 14.88 is Positive, 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 *	53 Neutral	$5.14B	3.03	-43.89%	2.83%	16.75%	-0.06%
PULM	53 Neutral	$24.87M	―	-93.19%	―	6.96%	32.32%
MDAI	45 Neutral	$37.59M	―	256.43%	―	238.96%	35.96%
CASI	41 Neutral	$28.97M	―	-1094.50%	―	11.40%	-18.18%
PYPD	41 Neutral	$28.43M	―	-853.05%	―	―	34.97%
GBIO	39 Underperform	$24.81M	―	-70.06%	―	146.47%	57.85%
CLNN	32 Underperform	$22.01M	―	-1738.36%	―	-43.55%	-293.22%

Clene Corporate Events

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.

Clene Showcases CNM-Au8® Advancements at Neurology Session

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.