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Clene Inc.

CLNN
Fair ValuePharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$3.89
▲ +0.01 · +0.26%

Financials

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Total Assets
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Quarterly Cash
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52W LOW $3.2552W HIGH $13.50
Volume
1.86 K
Value Traded
1.40 M
Short % Float
8.32%
-4.9%Week
+4.3%1 Month
-38.12%3 Month
-36.5%6 Month
-96.64%5 Year
-96.54%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
49.77 M
EPS (TTM)
-2.78
P/E Ratio
-
Ent. Value
58.35 M
Total Shares
12.99 M
Float Shares
11.01 M
Insiders
22.56%
Institutions
22.64%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA Date
CNM-Au8
Amyotrophic lateral sclerosis (ALS)
Accelerated
PDUFANanomedicineNervous System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

CLNN Catalyst Timeline

Dated clinical, regulatory and corporate events for Clene Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Clene Inc.

398Total events
10Upcoming
86Tier-1 (high impact)
2020 to 2027Coverage

Upcoming catalysts 2

T2Runway Guidance Update
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T1NDA Submission
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CNMAu8Filed

Event history 50

▼Equity OfferingCorporate
Closing of $4 million registered direct offering of common stock
◆Equity OfferingCorporate
Expected closing of the registered direct offering
▼Equity OfferingCorporate
Pricing of $4 million registered direct offering of 1,219,513 shares at $3.28 per share
●Quarterly UpdateCorporate
Second quarter 2026 financial results reported
●NDA SubmissionCNMAu8FiledRegulatory Filing
NDA submission for CNM-Au8 under accelerated approval pathway
◆Timing GuidanceCNMAu8FiledPresentation
Plan to file NDA for CNM-Au8 in ALS under accelerated approval pathway
●Quarterly UpdateCorporate
First quarter 2026 financial results
◆Oral PresentationPresentation
D. Boral Capital Global Conference 1x1 meetings
◆Oral PresentationPresentation
Emerging Growth Conference virtual presentation
▼Equity OfferingCorporate
Pricing of $7 million underwritten offering of common stock
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How CLNN actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2023-06-30CNM-Au8 Phase 2 topline data readout Phase 2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C48 / 100
Pipeline Score
$75M
Pipeline Value
Fair Value
Valuation Signal
3
Drugs Scored
1.5x
rNPV / MCap
Top 21%
Micro Cap
(rank 139 of 658)
Percentile Rank
Clene Inc. carries a moderate pipeline score (48/100), with $2.7B risk-adjusted pipeline value, led by CNMAu8 in Relapsing Multiple Sclerosis (Phase 2), across $81B in total addressable markets.
Showing 1 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
CNMAu8 Small moleculeNCT05299658Amyotrophic Lateral SclerosisPhase 2 ACTIVE NOT_RECRUITING 246Aug 1, 2026
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Clinical Trial Results

Readouts, endpoints and source filings for every CLNN program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
CNM-Au8
Accelerated
Multiple SclerosisPhase 22025-09-25n: 39; cohort 1 n: 11; cohort 2 n: 15; cohort pd n: 13Read MoreClene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis PatientsRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
McLaughlin VallerieDirectorGrant/Award 1,500 1,500 held$0.00 05/21/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Boxer Capital Management, LLC 0.2 % (-33.3 %) 2.94 M 477.51 K
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

CLNN Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How CLNN ranks across every disease it competes in

Competitive Position is a premium feature
See how CLNN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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CLNN News

CLNN
Sep 22, 2026
CLNNConferences/Events

Clene to Present at Upcoming Investor Conferences

Clene Inc. (Nasdaq: CLNN) has announced its participation in two upcoming investor conferences, the 5th Annual ROTH Healthcare Opportunities Conference and the Lytham Partners Investor Conference Fall Event. Both events will feature 1x1 meetings with investors, and Clene will present its investigational therapy, CNM-Au8, which targets mitochondrial health to treat neurodegenerative diseases. The presentations will be accessible via webcast.

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CLNN
Sep 21, 2026
CLNNGeneral

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

Clene Inc. has successfully closed a $4 million registered direct offering, primarily led by its Chairman and existing shareholders. This funding is expected to sustain the company through mid-first quarter 2027, beyond the anticipated FDA decision regarding the CNM-Au8 NDA for ALS treatment. The offering was executed without intermediaries, reflecting a direct approach to capital raising.

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CLNN
Sep 15, 2026
CLNNGeneral
▲ +22.6%on this news· ran to +33% by day 3

Clene Announces $4 Million Registered Direct Offering

Clene Inc. has announced a registered direct offering of 1,219,513 shares at $3.28 each, raising $4 million. The offering, led by the company's Chairman and other insiders, is set to close on September 17, 2026. Proceeds will fund operations through mid-first quarter 2027, supporting regulatory efforts for its investigational therapy, CNM-Au8.

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CLNN
Sep 3, 2026
CLNNConferences/Events

Clene to Present at Upcoming September Investor Conferences

Clene Inc. announced its participation in two upcoming investor conferences in September 2026. The company will present at the Cantor Global Healthcare Conference on September 9 and the H.C. Wainwright 28th Annual Global Investment Conference on September 15. Both events will include 1x1 investor meetings, providing opportunities for direct engagement with management.

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CLNN
Aug 17, 2026
CLNNConferences/Events

Clene to Present at the Emerging Growth Conference

Clene Inc. (Nasdaq: CLNN) will present at the Emerging Growth Conference on August 19, 2026, at 3:10 p.m. ET. The presentation will be available via webcast, allowing investors to access updates on the company's developments. Clene focuses on treating neurodegenerative diseases with its investigational therapy, CNM-Au8.

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CLNN
Aug 14, 2026
CLNNFDA Updates

Clene Reports Second Quarter 2026 Financial Results and Recent Operating Highlights

Clene Inc. reported its second quarter 2026 financial results, highlighting plans to submit a New Drug Application for CNM-Au8 for ALS under the accelerated approval pathway. The company presented new data indicating survival benefits for patients treated with CNM-Au8, which may support their NDA submission. However, Clene also reported a significant net loss during the quarter.

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CLNN
Aug 10, 2026
CLNNFDA Updates

Clene Announces Biomarker Analyses To Be Included in NDA Submission Supporting ALS Accelerated Approval

Clene Inc. announced promising results from biomarker analyses of its ALS treatment, CNM-Au8, indicating that patients with a decline or stabilization in neurofilament light chain (NfL) levels experienced significant survival and functional benefits. These findings will support Clene's New Drug Application (NDA) for accelerated approval from the FDA, which recognizes NfL as a potential surrogate endpoint. The analyses derived from two Phase 2 trials suggest a strong correlation between NfL response and improved clinical outcomes.

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CLNN
Jul 29, 2026
CLNNConferences/Events
▼ -5.4%on this news

Clene to Present at The Canaccord 46th Annual Growth Conference

Clene Inc. will present at the Canaccord 46th Annual Growth Conference on August 11, 2026, at 10:30 am ET in Boston, MA. The presentation will focus on their innovative therapies for neurodegenerative diseases such as ALS and MS. Clene aims to improve mitochondrial health and neuronal function through its investigational therapy, CNM-Au8.

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CLNN
May 14, 2026
CLNNFDA Updates
▲ +8.5%on this news

Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights

Clene Inc. reported its first quarter financial results for 2026, highlighting a successful FDA Type C meeting that indicated the potential for accelerated approval of CNM-Au8 for ALS. The company plans to submit a New Drug Application in Q3 of 2026 and initiate a Phase 3 trial in early 2027. Financially, Clene has raised over $28 million through a registered direct offering and amended its debt facility to enhance liquidity. Despite a reported net loss of $8.1 million, the company remains optimistic about its progress in developing treatments for neurodegenerative diseases.

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CLNN
May 5, 2026
CLNNGeneral
▼ -18.7%on this news

Clene Announces $7 Million Underwritten Offering of Common Stock

Clene Inc. has announced a $7 million underwritten offering of common stock at $7.00 per share. The funds will primarily be used for general corporate purposes, including the preparation of a New Drug Application for its lead drug candidate, CNM-Au8. The offering is set to close on or about May 6, 2026, pending customary conditions.

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CLNN
May 5, 2026
CLNNConferences/Events
▼ -18.7%on this news

Clene to Present at Upcoming May Conferences

Clene Inc. will participate in two investor conferences in May 2026, focusing on its innovative therapies for neurodegenerative diseases. The Emerging Growth Conference will feature a virtual presentation on May 6, while the D. Boral Capital Global Conference will include one-on-one meetings on May 7. Clene aims to highlight its late-stage clinical developments and commitment to improving mitochondrial health.

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CLNN
May 4, 2026
CLNNFDA Updates
▲ +31.8%on this newsshared move

After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS

Clene Inc. has received encouraging feedback from the FDA regarding its investigational drug CNM-Au8 for ALS. The FDA indicated that the data provided may support an NDA submission under the accelerated approval pathway, with NfL biomarker data potentially serving as a surrogate endpoint. Clene plans to submit the NDA in Q3 2026, marking a significant milestone for the company and the ALS community.

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CLNN
Mar 12, 2026
CLNNFDA Updates
▲ +6.1%on this news

Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights

Clene Inc. reported its full year 2025 financial results, highlighting an upcoming Type C meeting with the FDA regarding its CNM-Au8 program for ALS. The company anticipates filing a new drug application (NDA) under an accelerated approval pathway by mid-2026, supported by positive biomarker data. Clene's recent financing efforts aim to extend its operational runway into 2027, despite reporting a significant net loss for the year.

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CLNN
Feb 24, 2026
CLNNFDA Updates
▲ +9.8%on this news

Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts

Clene Inc. has issued a letter to stockholders detailing key regulatory and clinical milestones for its drug CNM-Au8 in 2026. The company plans to submit a New Drug Application (NDA) to the FDA, aiming for accelerated approval based on promising clinical data. Clene has also secured funding to support its operations and plans to initiate a Phase 3 trial later this year.

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CLNN
Jan 19, 2026
CLNNConferences/Events
▼ -6.3%on this news

Clene to Present at the Emerging Growth Conference - January 16, 2026

Clene Inc. will present at the Emerging Growth Conference on January 21, 2026, focusing on their advancements in treating neurodegenerative diseases. The presentation will be available via webcast, allowing broad access for investors. Clene's innovative approach targets mitochondrial health to improve neuronal function.

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CLNN
Jan 13, 2026
CLNNFDA Updates

Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting

Clene Inc. announced that the FDA has scheduled an in-person Type C Meeting to discuss its biomarker data supporting the potential NDA filing for CNM-Au8. The company presented significant reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) linked to survival outcomes in ALS patients. New analyses also identified IGFBP7 as a promising biomarker associated with improved survival, although these findings are exploratory and need further validation.

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CLNN
Jan 9, 2026
CLNNGeneral
▲ +7.1%on this newsshared move

Clene Announces Registered Direct Offering of Over $28 Million

Clene Inc. announced a registered direct offering of over $28 million, aimed at supporting its ongoing efforts in treating neurodegenerative diseases, particularly ALS. The offering attracted notable investors, including Boxer Capital and Vivo Capital. The proceeds will help fund Clene's planned New Drug Application for its investigational therapy, CNM-Au8, expected in 2026.

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About Clene Inc.

Salt Lake City, UT 79 employees clene.com
Headquarters6550 SOUTH MILLROCK DRIVE, SUITE G50, SALT LAKE CITY, UT, 84121
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