Clene (CLNN) AI Stock Analysis

• Market Cap: $26.07M
• Dividend Yield: N/A
• Average Volume (3M): 51.77K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.37
• Revenue Growth: -47.71%
• EPS Growth: -244.00%
• Country: US
• Employees: 75
• Sector: Healthcare
• Sector Strength: 66
• Industry: Biotechnology
• EPS (TTM): -1.87
• Shares Outstanding: 8,631,374
• 10 Day Avg. Volume: 44,113
• 30 Day Avg. Volume: 51,770
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): 78.47
• Price to Cash Flow (P/CF): -2.70
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $27.00
• Price Target Upside: 800.00% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 3

Clene's precarious financial condition, with declining revenues and persistent losses, is the most significant factor driving the low overall score. Technical analysis supports a bearish outlook, while valuation metrics reflect ongoing financial difficulties. Despite positive developments in product advancements, the stock remains high-risk due to financial instability.

Positive Factors

Clinical Trial Results

New post-hoc analyses from the Phase 2 VISIONARY-MS OLE study demonstrated improved vision, cognition, and global neurological function following treatment for up to three years.

Financial Position

Clene ended the year with $12.2 million in cash, which management believes provides runway to fund ongoing operations through 2Q25.

Regulatory Progress

Clene's lead asset, CNM-Au8, has Orphan Drug Designation, which should qualify for Priority Review, potentially speeding up the approval process.

Negative Factors

Regulatory Hurdles

Clene still has to conduct a confirmatory Phase 3 trial for the Accelerated Approval pathway, which introduces an additional step before potential approval.

Trial Setbacks

Regimen A was prematurely halted for futility after zilucoplan was found to have a low probability of meaningfully slowing disease progression vs. placebo.

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 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
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: 3.00
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• 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 is below the 20-day moving average (MA) of 3.13, below the 50-day MA of 3.93, and below the 200-day MA of 4.81, indicating a bearish trend. The MACD of -0.29 indicates Negative momentum. The RSI at 38.44 is Neutral, neither overbought nor oversold. The STOCH value of 71.85 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
PULM	53 Neutral	$20.14M	―	-70.96%	―	6.96%	32.32%
Sector *	50 Neutral	$5.51B	2.95	-43.70%	2.78%	16.94%	3.59%
CASI	41 Neutral	$30.04M	―	-301.80%	―	-13.78%	-34.45%
MDAI	41 Neutral	$30.63M	―	256.43%	―	238.96%	35.96%
CLNN	35 Underperform	$26.07M	―	-1738.36%	―	-47.71%	-244.00%
GBIO	30 Underperform	$23.25M	―	-91.02%	―	236.92%	-0.57%
PYPD	30 Underperform	$27.92M	―	-1038.73%	―	―	-85.67%

Clene Corporate Events

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.

Spark’s Take on CLNN Stock

According to Spark, TipRanks’ AI Analyst, CLNN is a Underperform.

Clene’s overall stock score reflects its precarious financial condition, underscored by declining revenues and persistent losses. Technical analysis signals a bearish trend, and the company’s negative valuation metrics further weaken investor confidence. Without any positive guidance from earnings calls or corporate events, the stock remains high-risk.

To see Spark’s full report on CLNN stock, click here.