Clene (CLNN) AI Stock Analysis

• Market Cap: $48.17M
• Dividend Yield: N/A
• Average Volume (3M): 99.27K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.44
• Revenue Growth: -49.17%
• EPS Growth: 23.37%
• Country: US
• Employees: 75
• Sector: Consumer Defensive
• Sector Strength: 42
• Industry: Biotechnology
• EPS (TTM): -0.85
• Shares Outstanding: 11,778,307
• 10 Day Avg. Volume: 100,885
• 30 Day Avg. Volume: 99,266
• PEG Ratio: 0.02
• Price to Book (P/B): -4.17
• Price to Sales (P/S): 107.97
• P/FCF Ratio: -1.73
• Enterprise Value/Market Cap: 1.07
• Enterprise Value/Revenue: 240.38
• Enterprise Value/Gross Profit: 292.28
• Enterprise Value/Ebitda: -1.94
• 1Y Price Target: $30.40
• Price Target Upside: 643.28% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5
• EPS Forecast (FY): -2.06
• Revenue Forecast (FY): $250.00K

• Rating: 45 Neutral
• Price Target: $4.00 ▼(-2.20% Downside)

The score is held down primarily by very weak financial performance (minimal and declining revenue, large ongoing losses, negative equity and continued cash burn). Technicals also reflect a bearish trend with weak momentum. Offsetting factors include positive corporate developments (financing that extends runway and FDA engagement around biomarker-driven regulatory strategy), but they do not yet resolve the underlying financial risk.

Positive Factors

Regulatory engagement — FDA Type C meeting

An in-person Type C meeting with the FDA is a material, durable de-risking event: it provides direct regulatory feedback on biomarker-driven NDA strategy, can clarify data requirements for accelerated approval, and may shorten the path to market if surrogate endpoints are accepted.

Biomarker evidence tied to survival

Robust biomarker-survival links strengthen a surrogate endpoint case, which is structurally important for neurodegenerative drug approval. If regulators accept these biomarkers, Clene could pursue accelerated approval pathways reducing trial size and time, enhancing long-term commercial viability.

Financing extends runway via multi-tranche offering

The multi-tranche financing and registered direct offering materially extend operational runway, enabling continued clinical and regulatory work. Contingent warrant structure aligns investor incentives with milestones, supporting sustained development activities through key regulatory inflection points.

Negative Factors

Minimal and declining revenue

Very low, falling revenue indicates Clene is essentially non-commercial and reliant on R&D milestones and external funding. This structural top-line weakness leaves the company unable to self-fund operations, increasing execution risk and lengthening the path to sustainable profitability.

Persistent cash burn and negative free cash flow

Sustained negative operating and free cash flow is a durable constraint: ongoing cash burn necessitates recurring external financing, elevates dilution risk, and limits strategic options. Improved burn versus prior year helps, but structural negative cash generation persists absent commercialization.

Balance-sheet pressure: negative equity and meaningful debt

Negative equity combined with material debt and shrinking assets materially reduces financial flexibility. This structural weakness raises refinancing and solvency risks, can hinder partnership negotiations, and increases the likelihood of dilutive financing ahead of sustainable cash generation.

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 generates revenue primarily through the development and commercialization of its therapeutic products. The company focuses on advancing its lead compounds through clinical trials, which may eventually lead to regulatory approval and market entry. Revenue streams may arise from partnerships with larger pharmaceutical companies, including licensing agreements, milestone payments, and royalties on product sales once therapies are approved. Additionally, Clene may receive funding through grants, public offerings, and private investments to support its ongoing research and development efforts.

Clene Financial Statement Overview

Summary

Financial profile is weak: TTM revenue is extremely small ($0.21M) and down ~25%, while losses remain very large (net margin ~-143%). Balance sheet risk is elevated with negative equity (about -$12.4M TTM) alongside meaningful debt (~$21.3M TTM). Cash burn is still heavy (operating/FCF about -$18.6M TTM), despite modest improvement versus 2024.

Income Statement

TTM (Trailing-Twelve-Months) revenue is very small ($0.21M) and declined about 25% versus the prior period, continuing a multi-year pattern of volatile and generally weak top-line performance. While gross margin remains high (~82% TTM), the company is deeply unprofitable with very large operating and net losses (net margin roughly -143% TTM), indicating a cost structure that is not supported by current revenue levels. Losses improved versus 2024 (net loss ~$30.5M TTM vs. ~$39.4M in 2024), but profitability remains far from breakeven.

Balance Sheet

The balance sheet is pressured by negative stockholders’ equity in both 2024 and TTM (about -$8.9M in 2024 to about -$12.4M TTM), which is a major financial risk signal and reduces flexibility. Total debt is meaningful relative to the company’s size (about $21.3M TTM) and leverage is effectively elevated given the negative equity position. Total assets also declined from 2024 to TTM (~$27.3M to ~$22.3M), suggesting a shrinking capital base.

Cash Flow

Cash burn remains heavy: operating cash flow is negative both annually and in TTM (about -$18.6M TTM; -$21.3M in 2024), and free cash flow is similarly negative (about -$18.6M TTM). The pace of burn improved versus 2024, but cash generation is still structurally negative and dependent on external funding. Free cash flow broadly tracks net loss (free cash flow to net income ~1.0), indicating limited non-cash offsets and reinforcing that losses are translating into cash outflows.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	214.00K	342.00K	654.00K	473.00K	723.00K	206.00K
Gross Profit	176.00K	272.00K	533.00K	447.00K	434.00K	141.00K
EBITDA	-26.50M	-33.69M	-43.24M	-25.60M	-8.34M	-16.96M
Net Income	-30.50M	-39.40M	-49.50M	-29.92M	-9.74M	-19.28M
Balance Sheet
Total Assets	22.31M	27.34M	52.34M	44.49M	63.06M	68.24M
Cash, Cash Equivalents and Short-Term Investments	7.92M	12.15M	35.00M	23.32M	50.29M	59.27M
Total Debt	21.31M	20.84M	32.16M	31.82M	24.04M	4.32M
Total Liabilities	34.67M	36.19M	38.95M	41.26M	50.47M	67.90M
Stockholders Equity	-12.36M	-8.86M	13.39M	3.24M	12.60M	341.00K
Cash Flow
Free Cash Flow	-18.61M	-21.34M	-30.50M	-44.19M	-35.96M	-19.32M
Operating Cash Flow	-18.60M	-21.33M	-30.17M	-39.01M	-34.62M	-18.93M
Investing Cash Flow	-12.97K	6.32M	-1.50M	-10.16M	-1.33M	-387.00K
Financing Cash Flow	11.96M	-1.53M	42.16M	17.25M	27.11M	69.53M

Clene Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 4.09
• 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 4.09 is below the 20-day moving average (MA) of 5.30, below the 50-day MA of 6.51, and below the 200-day MA of 5.57, indicating a bearish trend. The MACD of -0.54 indicates Positive momentum. The RSI at 31.00 is Neutral, neither overbought nor oversold. The STOCH value of 12.71 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 *	62 Neutral	$20.33B	14.63	-3.31%	3.23%	1.93%	-12.26%
ANTX	52 Neutral	$30.96M	-1.00	-45.91%	―	―	44.59%
CAMP	49 Neutral	$191.96M	-1.51	-172.70%	―	―	5.51%
DYAI	46 Neutral	$31.52M	-3.68	-244.15%	―	-0.66%	-8.43%
CLNN	45 Neutral	$48.17M	―	―	―	-49.17%	23.37%
AKTX	42 Neutral	$7.65M	―	-196.60%	―	―	―

Clene Corporate Events

Clene Announces Multi-Tranche Financing to Extend Cash Runway

On January 8, 2026, Clene Inc. entered into securities purchase agreements with institutional, existing and insider investors for a registered direct offering structured in three tranches totaling more than $28 million in potential gross proceeds, anchored by an initial sale of 928,333 common shares and accompanying Series A and Series B warrants at $6.50 per unit, which closed on January 13, 2026 and raised roughly $6 million. The financing, arranged on a best-efforts basis by BTIG, LLC, is expected to extend Clene’s cash runway into the third quarter of 2026 from the first tranche, with additional proceeds from the exercise of Series A and Series B warrants potentially funding the company through the end of 2026 and into early 2027 to support clinical development, regulatory activities, and potential commercialization of CNM-Au8 in ALS; the deal also includes issuance restrictions, director lock-ups, and contingent warrant pricing that ties higher exercise prices and call provisions to future FDA milestones and Clene’s share price performance.

The most recent analyst rating on (CLNN) stock is a Hold with a $6.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Clene Advances CNM-Au8 ALS Program with FDA Meeting

On January 12, 2026, Clene Inc. announced that the U.S. Food and Drug Administration granted the company an in-person Type C meeting in the first quarter of 2026 to discuss biomarker data supporting a potential new drug application for CNM-Au8 in ALS. In preparation, Clene submitted a briefing package detailing statistically significant reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein from prior CNM-Au8 studies, along with new analyses across large ALS cohorts showing that modest NfL reductions of about 9–10% were associated with an 8–13% lower mortality risk, reinforcing NfL trajectory as a prognostic biomarker and potential surrogate endpoint. The company also reported exploratory findings from the HEALEY ALS Platform Trial indicating that CNM-Au8 30 mg treatment was associated with improved survival and that patients showing declines in the biomarker IGFBP7 experienced a 78% reduction in mortality risk compared with controls, aligning with emerging genetic evidence that lower IGFBP7 may protect against ALS progression; collectively, these data aim to strengthen Clene’s regulatory case and could enhance its positioning in the ALS treatment landscape if regulators ultimately accept these biomarkers as part of an approval framework.

The most recent analyst rating on (CLNN) stock is a Sell with a $5.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Clene Updates on CNM-Au8® ALS Program

On December 3, 2025, Clene Inc. hosted a conference call and webcast to provide an update on its CNM-Au8® program for amyotrophic lateral sclerosis (ALS). This event reflects the company’s ongoing efforts to advance its therapeutic solutions in the treatment of ALS, potentially impacting its market positioning and stakeholder interests.

The most recent analyst rating on (CLNN) stock is a Hold with a $9.50 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Clene Announces Positive Biomarker Results for CNM-Au8

On December 3, 2025, Clene Inc. announced statistically significant biomarker results for CNM-Au8 in ALS patients, supporting an accelerated approval pathway. The results showed reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), linked to improved survival, reinforcing CNM-Au8’s potential as a disease-modifying treatment. Clene plans to present these findings to the FDA in a Type C meeting in early 2026, aiming for a New Drug Application submission.

The most recent analyst rating on (CLNN) stock is a Hold with a $9.50 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.