Clene (CLNN) AI Stock Analysis

• Market Cap: $72.20M
• Dividend Yield: N/A
• Average Volume (3M): 63.69K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.51
• Revenue Growth: -49.17%
• EPS Growth: 23.37%
• Country: US
• Employees: 75
• Sector: Consumer Defensive
• Sector Strength: 42
• Industry: Biotechnology
• EPS (TTM): -0.93
• Shares Outstanding: 11,778,307
• 10 Day Avg. Volume: 59,789
• 30 Day Avg. Volume: 63,693
• PEG Ratio: 0.04
• Price to Book (P/B): -3.29
• Price to Sales (P/S): 289.36
• P/FCF Ratio: -3.11
• Enterprise Value/Market Cap: 1.14
• Enterprise Value/Revenue: 384.04
• Enterprise Value/Gross Profit: 466.95
• Enterprise Value/Ebitda: -3.10
• 1Y Price Target: $32.25
• Price Target Upside: 426.10% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 4
• EPS Forecast (FY): -1.85
• Revenue Forecast (FY): $260.00K

• Rating: 50 Neutral
• Price Target: $6.00 ▼(-2.12% Downside)
• Action: Reiterated Date: 03/17/26
• Date: Action: Reiterated 03/17/26

The score is held down primarily by very weak financial performance (large losses, sustained cash burn, and negative equity). Offsetting factors include improving technical momentum and supportive corporate developments (financing/runway extension and regulatory steps), while valuation remains unfavorable due to losses and no dividend.

Positive Factors

Regulatory pathway progress

A scheduled in-person Type C FDA meeting and explicit plans to seek accelerated approval create a clear regulatory path. If FDA accepts biomarker/survival data as a surrogate, this materially shortens time to market and de-risks near-term development milestones, improving strategic clarity for the company.

Robust clinical dataset & biomarker signals

Extensive clinical experience and consistent biomarker reductions plus survival signals strengthen the scientific case for CNM-Au8. Durable safety and surrogate biomarker evidence increase the probability regulators accept expedited pathways and reduce late-stage technical risk across ALS and other neurodegenerative targets.

Non-dilutive funding and financing runway

A significant NIH subaward provides non-dilutive capital and helps preserve IP while reimbursing trial costs. Coupled with multi-tranche registered offerings, this structural funding support extends operational runway, enabling planned FDA interactions and Phase 3 initiation without immediate reliance solely on dilutive equity issuances.

Negative Factors

Negative equity / shrinking balance sheet

Negative equity and a materially shrunken asset base signal solvency and capital-structure stress, limiting borrowing capacity and strategic flexibility. Over a multi-month horizon this raises the risk that unplanned delays force dilutive financings or unfavorable deal terms, constraining long-term corporate options.

Persistent cash burn

Sustained negative operating and free cash flow indicate ongoing dependency on external capital to fund clinical and regulatory programs. If approvals or milestone-driven financing are delayed, the company faces heightened refinancing risk and potential interruptions to pivotal trials, making execution vulnerable over the coming months.

Minimal and declining revenue base

Very small, falling revenue and absence of commercial product sales mean Clene cannot self-fund development. Long-term sustainability depends on successful approval/commercialization or external funding; this structural revenue gap magnifies the consequences of any regulatory or clinical setback.

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

As a clinical-stage biopharmaceutical company, Clene has not consistently generated product sales from approved therapies; its ability to generate operating revenue is primarily tied to clinical development and financing activities. The company’s potential long-term revenue model (if CNM-Au8 or other candidates obtain regulatory approval) would typically include commercialization revenues from product sales (directly and/or via marketing/distribution partners), and may also include licensing arrangements such as upfront payments, milestone payments tied to development/regulatory/commercial events, and ongoing royalties. Specific, company-reported breakdowns of current revenue streams (e.g., amounts from collaboration revenue, grants, or other sources), and any material revenue-generating partnerships, are not available in the information provided here and should be sourced from Clene’s most recent SEC filings (e.g., 10-K/10-Q) and investor disclosures; therefore those specific figures and partner-driven revenue contributions are null.

Clene Financial Statement Overview

Summary

Financials are very weak: revenue is minimal and declining, losses are large (2025 net loss about -26.2M), and cash burn remains heavy (2025 FCF about -18.6M). The balance sheet adds solvency risk with negative equity (~-17.6M) despite reduced debt versus 2023.

Income Statement

Revenue remains very small and volatile (down from 654k in 2023 to 200k in 2025), and the company is deeply unprofitable with large operating losses each year (2025 EBIT about -23.1M; net loss about -26.2M). Gross margin is strong (roughly 79% in 2025), but it is overwhelmed by heavy operating expenses, resulting in extremely negative net margins and no clear path to profitability based on the provided trend.

Balance Sheet

Leverage and capital structure are pressured: total debt is ~21.7M in 2025 while stockholders’ equity is negative (~-17.6M), which is a meaningful solvency red flag and limits financial flexibility. Total assets also declined materially from 2023 to 2025 (about 52.3M to 18.1M), suggesting a shrinking balance sheet. Debt fell versus 2023, which is a modest positive, but negative equity dominates the risk profile.

Cash Flow

Cash generation is consistently negative, with operating cash flow and free cash flow remaining deeply in the red (2025 operating cash flow about -18.5M; free cash flow about -18.6M). While cash burn improved versus 2022–2023 levels, the business is still reliant on external funding to sustain operations, and there is no evidence of self-funding capacity in the period provided.

Breakdown	TTM	Dec 2025	Dec 2024	Dec 2023	Dec 2022	Dec 2021
Income Statement
Total Revenue	214.00K	200.00K	342.00K	654.00K	473.00K	723.00K
Gross Profit	176.00K	157.00K	272.00K	533.00K	447.00K	434.00K
EBITDA	-26.50M	-23.08M	-33.69M	-43.24M	-25.60M	-8.34M
Net Income	-30.50M	-26.17M	-39.40M	-49.50M	-29.92M	-9.74M
Balance Sheet
Total Assets	22.31M	18.13M	27.34M	52.34M	44.49M	63.06M
Cash, Cash Equivalents and Short-Term Investments	7.92M	5.19M	12.15M	35.00M	23.32M	50.29M
Total Debt	21.31M	21.67M	20.84M	32.16M	31.82M	24.04M
Total Liabilities	34.67M	35.72M	36.19M	38.95M	41.26M	50.47M
Stockholders Equity	-12.36M	-17.59M	-8.86M	13.39M	3.24M	12.60M
Cash Flow
Free Cash Flow	-18.61M	-18.59M	-21.34M	-30.50M	-44.19M	-35.96M
Operating Cash Flow	-18.60M	-18.55M	-21.33M	-30.17M	-39.01M	-34.62M
Investing Cash Flow	-12.97K	-39.00K	6.32M	-1.50M	-10.16M	-1.33M
Financing Cash Flow	11.96M	11.52M	-1.53M	42.16M	17.25M	27.11M

Clene Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 6.13
• 50DMA: Positive
• 100DMA: Negative
• 200DMA: Positive
• 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 Positive. The current price of 6.13 is above the 20-day moving average (MA) of 5.29, above the 50-day MA of 5.04, and above the 200-day MA of 5.90, indicating a bullish trend. The MACD of 0.28 indicates Negative momentum. The RSI at 65.97 is Neutral, neither overbought nor oversold. The STOCH value of 62.95 is Neutral, 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 *	62 Neutral	$20.33B	14.63	-3.31%	3.23%	1.93%	-12.26%
CAMP	52 Neutral	$288.15M	-2.32	-162.49%	―	―	5.51%
CLNN	50 Neutral	$72.20M	-1.57	240.83%	―	-49.17%	23.37%
ANTX	49 Neutral	$137.01M	-0.98	-47.80%	―	―	44.59%
DYAI	46 Neutral	$29.03M	-5.15	-537.20%	―	-0.66%	-8.43%
AKTX	42 Neutral	$7.04M	―	-68.21%	―	―	―

Clene Corporate Events

Clene Secures Third-Year NIH Subaward for ALS Program

On March 13, 2026, Clene entered into a third-year subaward agreement with New York University for up to $8.0 million under a previously announced four-year, $45.1 million National Institutes of Health grant supporting an Expanded Access Program for CNM-Au8 in amyotrophic lateral sclerosis. The funds, covering the period from September 1, 2025 to August 31, 2026, will be reimbursed based on invoicing, the agreement is terminable on 30 days’ notice by either party, and Clene preserves full control over its background intellectual property, requiring confidentiality safeguards before sharing any proprietary data.

The most recent analyst rating on (CLNN) stock is a Buy with a $48.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Clene outlines 2026 regulatory milestones and ALS strategy

On February 24, 2026, Clene issued a letter to stockholders outlining key regulatory and clinical milestones it expects for CNM-Au8 in 2026, anchored by an operating cash runway projected into the fourth quarter of 2026 after a January capital raise. The company said its financing structure, tied to potential regulatory milestones, is expected to support operations through a prospective FDA decision on an accelerated approval, with additional capital potentially extending into 2027.

Clene detailed that an in-person Type C meeting with the FDA’s neurology division is scheduled by the end of the first quarter of 2026 to review extensive CNM-Au8 data submitted in late 2025. Contingent on this interaction, the company plans to file a New Drug Application via an accelerated pathway in the second quarter of 2026, targeting possible FDA acceptance and a PDUFA decision date in the second half of 2026 and positioning for a potential commercial launch in 2027.

Management highlighted clinical findings from multiple Phase 2 trials and open-label extensions in ALS, reporting prolonged survival, slowed clinical worsening, and statistically significant reductions in neurofilament light chain and GFAP biomarkers associated with neurodegeneration. Clene argues that these data, along with regulatory precedent for using NfL as a surrogate endpoint, support CNM-Au8’s candidacy for accelerated approval and strengthen the company’s negotiating stance with regulators.

The company also emphasized CNM-Au8’s safety profile, citing more than 1,000 patient-years of exposure with predominantly mild-to-moderate adverse events, no drug-related serious adverse events, and no long-term safety signals observed. Clene contends that this benign tolerability could bolster the therapy’s benefit–risk assessment in ALS, a setting where unmet need remains high and previous drugs with favorable safety have secured accelerated approvals based on Phase 2 data.

To satisfy confirmatory requirements for accelerated approval and reinforce the observed survival benefit, Clene plans to initiate dosing in its Phase 3 RESTORE-ALS trial later in 2026. The double-blind, placebo-controlled study, whose design has already been reviewed with the FDA, is intended to evaluate CNM-Au8’s impact on survival and clinical worsening events, adding pivotal-scale evidence that could shape its long-term commercial profile.

Beyond ALS, Clene noted that CNM-Au8 has shown promising signals in multiple sclerosis and Parkinson’s disease and that it expects to finalize a Phase 3 MS trial design focused on cognition in 2026 following FDA feedback. These pipeline plans suggest the company is preparing to leverage any regulatory traction in ALS to expand CNM-Au8’s addressable market, potentially enhancing its future revenue prospects and strategic positioning in neurodegenerative therapeutics.

The most recent analyst rating on (CLNN) stock is a Hold with a $4.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

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.