Clene Inc.
CLNN evidence brief
What we can confirm
- BioSniper Score:
- 2.8 / 10
- Market Cap:
- $61.8M
- Lead Asset:
- cnm-au8 (Phase 2)
What it means
What to watch
Prepared research question
What matters most for CLNN—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CLNN
Clene Inc. is a late clinical-stage biopharmaceutical company developing CNM-Au8, an investigational gold nanocrystal therapy for neurodegenerative diseases, primarily amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), and is preparing to submit a New Drug Application (NDA) for accelerated approval in ALS.
Key risk: Low revenue, high burn
BioSniper Score
Based on 4 of 6 signals
Market Cap
$61.8M
Cash Runway
—
Lead Asset
cnm-au8 (Phase 2)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 5 clinical trials for Clene Inc..
Clene Inc. is a late clinical-stage biopharmaceutical company developing CNM-Au8, an investigational gold nanocrystal therapy for neurodegenerative diseases, primarily amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), and is preparing to submit a New Drug Application (NDA) for accelerated approval in ALS.
- Clene's lead drug candidate, CNM-Au8, targets mitochondrial dysfunction by catalyzing NAD+ production and is in Phase 2 for ALS and MS [pipeline].
- The company expects to submit an NDA for CNM-Au8 under the accelerated approval pathway in early Q4 2026 [news · published 2026-08-14].
- As of 2026-06-30, Clene reported cash & equivalents of $9.7M, total revenue of $0.1M, and a net loss of -$13.4M [sec].
- In September 2026, Clene closed a $4 million registered direct offering, extending its capital runway beyond a potential FDA decision on the CNM-Au8 NDA [news · published 2026-09-21].
- Clene has an accumulated deficit and negative shareholders' equity of -$24.8M as of 2026-06-30 [sec].
What works
- Clene has a clear near-term catalyst: an NDA submission for CNM-Au8 in ALS under the accelerated approval pathway expected in early Q4 2026 [news · published 2026-08-14].
- The company secured a $4 million registered direct offering in September 2026, providing funding expected to last beyond a potential FDA decision on the NDA [news · published 2026-09-21].
- CNM-Au8 has shown survival and functional benefit in patients whose neurofilament light (NfL) levels declined or stabilized, supporting the accelerated approval case [news · published 2026-08-14].
What to weigh
- Clene has very low revenue ($0.1M as of 2026-06-30) and a significant net loss (-$13.4M), indicating no approved products generating meaningful sales [sec].
- The company's shareholders' equity is deeply negative (-$24.8M as of 2026-06-30), reflecting accumulated deficits and financial strain [sec].
- CNM-Au8 is still in Phase 2 for both ALS and MS, and the NDA filing relies on the accelerated approval pathway, which is not guaranteed to be accepted by the FDA [pipeline].
- Clene faces a competitive landscape with at least 142 competitors in the ALS and MS space, including other Phase 2 candidates [pipeline].
From the filings
Quoted directly from source documents.
Clene expects to submit an NDA for CNM-Au8 in ALS under accelerated approval in early Q4 2026.
“Clene expects to submit a New Drug Application for CNM-Au8® in ALS under the accelerated approval pathway in early fourth quarter of 2026”
News · August 14, 2026
Clene closed a $4 million registered direct offering in September 2026 to extend capital runway.
“Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA”
News · September 21, 2026
CNM-Au8 targets mitochondrial dysfunction and is in Phase 2 for ALS and MS.
“Mechanism of Action: Targets mitochondrial dysfunction by catalyzing the production of NAD+, alleviating oxidative stress, and reducing the accumulation of misfolded proteins.”
Catalyst timeline
- 2019-12-19 · Phase 2 start for CNM-Au8 in Multiple Sclerosis (31P-MRS study) — This Phase 2 study assesses effects of CNM-Au8 on neuronal redox state in MS patients.
- 2021-11-13 · Phase 2 start for CNM-Au8 in ALS (open-label extension) — This study evaluates CNM-Au8's ability to slow disease progression in early symptomatic ALS patients.
Risks & what to watch (4)›
Key risks
- Low revenue, high burn — Revenue of $0.1M vs. net loss of -$13.4M as of 2026-06-30 indicates no approved product sales and high cash burn [sec].
- Negative equity — Shareholders' equity of -$24.8M as of 2026-06-30 signals accumulated deficits and potential solvency concerns [sec].
- Regulatory uncertainty — NDA submission for accelerated approval is planned but FDA acceptance and decision are not guaranteed [news · published 2026-08-14].
- Competitive pressure — At least 142 competitors in ALS/MS space, including other Phase 2 candidates, may limit market share if approved [pipeline].
What to watch
- FDA acceptance of the CNM-Au8 NDA for review under the accelerated approval pathway, expected after early Q4 2026 submission [news · published 2026-08-14].
- Clene's cash runway and any additional financing needs, given the $4M offering extends only to mid-Q1 2027 [news · published 2026-09-21].
- Clinical data from ongoing expanded access protocols and the confirmatory Phase 3 trial for CNM-Au8 in ALS [news · published 2026-05-05].
- Any FDA feedback from the Type C meeting held earlier in 2026 regarding the accelerated approval pathway [news · published 2026-01-23].
Sources: Catalysts · News · Pipeline · Generated October 4, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$13M
Lead: Phase 2
1 candidate
No upcoming catalysts tracked
0 buys · 10 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
29
Total value held
$10.8M
| Holder | Shares | Value |
|---|---|---|
| boxer capital management, llc | 477,515 | $2.4M |
| symbiosis capital partners, llc | 431,094 | $2.1M |
| vanguard capital management llc | 308,230 | $1.5M |
| scoggin management lp | 300,000 | $1.5M |
| ensign peak advisors, inc | 257,872 | $1.3M |
| geode capital management, llc | 95,874 | $473K |
| lunt capital management, inc. | 52,260 | $258K |
| peak6 llc | 50,012 | $247K |
| vanguard fiduciary trust co | 43,715 | $216K |
| parsons capital management inc/ri | 37,243 | $184K |
Showing top 10 of 29 institutional holders of Clene Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 10.2%
- Days to cover
- 10.4
- Shares short
- 875,026
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CLNN short interestGovernance
Frequently asked questions
What is the AI investment thesis for Clene Inc.?
Clene Inc. is a late clinical-stage biopharmaceutical company developing CNM-Au8, an investigational gold nanocrystal therapy for neurodegenerative diseases, primarily amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), and is preparing to submit a New Drug Application (NDA) for accelerated approval in ALS.
What is Clene Inc.'s lead drug candidate?
Clene Inc.'s most advanced tracked candidate is cnm-au8 (Phase 2) for Multiple Sclerosis; Amyotrophic Lateral Sclerosis; ALS.
Who is the CEO of Clene Inc.?
Mr. Robert Etherington MBA is the chief executive officer of Clene Inc. (CLNN).
Where is Clene Inc. headquartered?
Clene Inc. (CLNN) is headquartered in Salt Lake City, UT, United States.
What therapeutic areas does Clene Inc. focus on?
Clene Inc. develops therapies across Neurology, Immunology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.