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Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights Clene (Nasdaq: CLNN) reported full-year 2025 results and operational updates on CNM-Au8. Key items: a Type C face-to-face FDA meeting expected by end of Q1 2026, a planned NDA filing by end of June 2026, an oversubscribed registered direct offering of >$28M, and $5.2M cash as of 12/31/2025.R&D was $14.0M and G&A $9.2M for 2025; net loss narrowed to $26.2M ($2.65/share) from $39.4M in 2024.

#CLNN Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights

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Trade Alerts, Monday January 12, 2026 – Crystal Equity Research

Small-cap stocks with declining money flow, Mon Jan 12th - #TLS #STKL #SEPN #RBBN #PRQR #OM #NWL #NAGE #MDWD #IART #HNRG #GEMI #FCCO #EQ #DOMO #CLNN #BTBT #AUTL #SI #OPFI #JBI #CPF #CDRE #AHT - More: crystalequityresearch.com/trade-alerts... - #smallcap

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Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting Clene (Nasdaq: CLNN) announced the FDA granted an in-person Type C meeting in Q1 2026 to discuss biomarker-driven pathways for CNM-Au8. The company submitted a briefing package linking ~9–10% NfL reductions observed in HEALEY and NIH EAP studies to an 8–13% lower mortality risk across large ALS cohorts, and reported a HEALEY long-term survival benefit for CNM-Au8 30 mg 78% mortality risk reduction in responders

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

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Clene Announces Registered Direct Offering of Over $28 Million Oversubscribed registered direct offering priced above market to new, existing and insider investors, including Boxer Capital Management, Coastlands Capital, and Vivo Capital Initial financing tranche of over $6 million, which we expect will provide cash runway into the third quarter of 2026

#CLNN Clene Announces Registered Direct Offering of Over $28 Million

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Leading Indicators, Wednesday December 3, 2025 – Crystal Equity Research

Small-cap stocks with strong volume declines, Wed Dec 3rd - #ARTL #DEVS #IMRN #LOT #WOK #VS #SONN #POLE #OMDA #IPWR #HCMA #CLNN #BWIN #ACHC #ADCT - More: crystalequityresearch.com/leading-indi... - #smallcap

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#CLNN Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®

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Clene (Nasdaq: CLNN) to host Dec. 3 CNM-Au8 ALS program update webcast at 8:30 a.m. ET Clene will provide an update on its CNM-Au8 ALS program during an investor webcast on Dec. 3, 2025 at 8:30 a.m. ET, with an archived replay available online.

#CLNN Clene to Provide CNM-Au8® ALS Program Update

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TVアニメ『キミと越えて恋になる』が遂に放送開始しました! 本日10月14日、CLLENN編集のTVアニメ『キミと越えて恋になる』が放送スタート!甘く切ない獣人との恋物語を堪能しよう。

TVアニメ『キミと越えて恋になる』が遂に放送開始しました! #キミと越えて恋になる #CLNN #獣人

本日10月14日、CLLENN編集のTVアニメ『キミと越えて恋になる』が放送スタート!甘く切ない獣人との恋物語を堪能しよう。

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Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients Clene (NASDAQ:CLNN) presented significant clinical data for CNM-Au8® at the ECTRIMS 2025 Congress, demonstrating improved brain energy metabolism in Multiple Sclerosis patients. The REPAIR-MS study showed a significant increase in brain NAD+/NADH ratio (+0.449 units, p=0.0148) after 12 weeks of treatment across all participants.Key findings revealed that CNM-Au8® improved brain energy efficiency with a 9.49% increase in NAD+/NADH ratio in MS patients (p=0.0275). The study established important correlations between MS disease severity (EDSS scores) and brain energy metabolic deficits. The FDA has shown openness to considering alternative primary endpoints beyond EDSS, including cognitive measures, for future trials.The treatment demonstrated a favorable safety profile, with mostly mild-to-moderate adverse events.

#CLNN Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients

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36% Metabolite Improvement: Clene's CNM-Au8 Drug Shows Breakthrough in Parkinson's Disease Treatment Novel dopaminergic neuron study shows CNM-Au8 improves mitochondrial health, reduces inflammation, and normalizes gene expression in Parkinson's disease. Results support Phase 2 development.

#CLNN Clene Presents Preclinical Data Supporting CNM-Au8® for the Treatment of Parkinson’s Disease

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Leading Indicators, Wednesday August 20, 2025 – Crystal Equity Research

Small-cap stocks with improving money flow, Wed Aug 20th - #WTF #VS #TDUP #PAHC #NEOG #FRBA #CLNN #LZB #GES #EQBK - More: crystalequityresearch.com/leading-indi... - #smallcap

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Clene Posts 70% Revenue Drop in Q2 | The Motley Fool



#CLNN #e3473873-ebf0-4e53-9eb2-42798ee849ea #data-news

Origin | Interest | Match

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Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights Clene (NASDAQ:CLNN) reported Q2 2025 financial results and provided updates on its CNM-Au8 development programs. The company has scheduled key FDA meetings to discuss its ALS treatment program, with plans to submit a New Drug Application (NDA) in Q4 2025 for potential accelerated approval.Financial highlights include cash position of $7.3 million as of June 30, 2025, plus additional $3.4 million raised post-quarter, providing runway into Q1 2026. Q2 2025 showed reduced operating expenses, with R&D expenses at $3.5 million (down from $4.2M) and G&A expenses at $2.4 million (down from $3.3M). Net loss was $7.4 million ($0.78 per share).The company presented promising MS treatment data at AAN 2025, showing significant improvements in cognition and visual function, with evidence of remyelination and neuronal repair in MS patients treated with CNM-Au8.

#CLNN Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights

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FDA Shows Support for Clene ALS Drug: Biomarker Plan Advances, NDA Filing Expected Late 2025 FDA provides positive feedback on Clene's ALS drug biomarker analysis, schedules key meetings for survival data and MS program. See NDA submission timeline.

#CLNN Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings

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SmCpStr Technicals – Technical Indicators for Small-cap Stocks

Small-cap stocks with improving money flow, Mon Jun 2nd - #RMR #NKTR #LOGC #IMRX #HEPS #FTCI #DHAI #CLNN #BYRN #ACIC #XXII #AGM #CLBR #DOLE #ECC #FSLY #GUT #LSPD #OWLT #PINE #YALA #TRML - More: crystalequityresearch.com/SmCpStr/ - #smallcap

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JUST IN: ( NASDAQ: #CLNN ) Study Links Autism to Increased Risk of Developing Parkinson's Disease

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SmCpStr Technicals – Technical Indicators for Small-cap Stocks

Small-cap stocks with bullish moving average convergence divergence crossovers, Wed May 14th - #UNIT #TLS #SRDX #PAL #OMCL #LUCD #KGEI #GURE #ENSC #CLNN #BLUE #AUDC #VOC #UTZ #NCDL #KODK #CIA #ARIS - More: crystalequityresearch.com/SmCpStr/ - #smallcap

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Clene Inc. Announces Participation in the D. Boral Capital Inaugural Global Conference Clene Inc. (NASDAQ: CLNN) has announced its participation in the upcoming D. Boral Capital Inaugural Global Conference. The event will take place on May 14, 2025, at The Plaza Hotel in New York City. Rob Etherington, President and CEO of Clene, will be available for one-on-one meetings with interested parties from 9:00 A.M. to 3:00 P.M. (ET). Those interested in scheduling meetings can contact John Perez at jperez@dboralcapital.com.

#CLNN Clene Inc. Announces Participation in the D. Boral Capital Inaugural Global Conference

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Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights Clene Inc. (CLNN) reported Q1 2025 financial results and provided updates on its CNM-Au8 programs. The company is preparing for an FDA meeting in Q2 2025 to discuss the statistical analysis plan for neurofilament light chain (NfL) biomarker data, with plans to submit a New Drug Application (NDA) for CNM-Au8 in ALS treatment by Q4 2025. Key highlights include new data showing CNM-Au8 significantly extends ALS patient survival, with a 4.1-month improvement in overall survival and up to 11.9 months in severe cases. The company also presented promising MS treatment results at the AAN 2025 Annual Meeting. Financially, Clene reported cash position of $9.8M as of March 31, 2025, a net loss of $0.8M ($0.09 per share), and reduced R&D expenses to $1.5M from $5.9M year-over-year. The current cash runway extends into Q3 2025.

#CLNN Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights

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JUST IN: ( NASDAQ: #CLNN ) Clene Inc. (NASDAQ: CLNN) to Share CNM-Au8(R) Progress at Jones Las Vegas Conference

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Breakthrough: Clene's ALS Treatment Shows 11.9-Month Survival Benefit in Severe Cases Clinical success: ALS treatment demonstrates significant survival benefits. Company advances toward FDA filing with strong efficacy data and secured new financing for development.

#CLNN Clene Reports Full Year 2024 Financial Results and Recent Operating Highlights

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Breakthrough: New ALS Drug Extends Patient Survival by 198 Days in Major Clinical Study Latest analysis reveals CNM-Au8 treatment increased ALS patient survival by 6.5 months, with up to 14.8-month benefit in key subgroups. Phase 3 trial planned for 2025.

#CLNN Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment

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Clene and APST Enter Into an Agreement to Support FDA’s Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®’s Impact on NfL Reduction Clene Inc. (NASDAQ: CLNN) has entered into an agreement with APST Research GmbH to utilize APST's extensive neurofilament light chain (NfL) database to support FDA-recommended analyses of CNM-Au8®'s effect on NfL decline in ALS patients. APST maintains one of the largest ALS repositories with data from over 4,300 patients, including serum NfL and self-reported ALSFRS-R scores.The collaboration will enable Clene to compare NfL changes observed in participants of NIH-sponsored Expanded Access Protocols (EAPs) to matched controls from the APST dataset. This analysis aims to demonstrate that the rate of NfL change is associated with survival in ALS patients.Clene has supported nearly 500 ALS patients through three EAP programs to collect Real-World Evidence of CNM-Au8's effects. The company plans to submit a statistical analysis plan to the FDA soon and, if results are positive, will support a New Drug Application (NDA) for potential Accelerated Approval of CNM-Au8 in ALS, planned for the second half of 2025.Across over 800 participant years of treatment with CNM-Au8, no significant safety concerns or trends have been identified, with no serious adverse events related to the treatment reported to date.

#CLNN Clene and APST Enter Into an Agreement to Support FDA’s Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®’s Impact on NfL Reduction

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Clene Secures $10M Financing to Advance ALS Drug Development, Restructures Debt with Premium Conversion Terms Biotech firm Clene strengthens financial position with new $10M debt facility, featuring premium stock conversion terms and extended runway for ALS drug development program.

#CLNN Clene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior Loan

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JUST IN: ( NASDAQ: #CLNN ) Clene Inc. (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Pathway for CNM-Au8(R) for ALS

#StockMarket #News

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JUST IN: ( NASDAQ: #CLNN ) New Technology Programs Immune Cells to Combat Brain Cancer, MS

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NEWS: ( NASDAQ: #CLNN ) InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Advances CNM-Au8 in ALS with FDA Guidance on Accelerated Approval Pathway

#StockMarket #News

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News; ( NASDAQ: #CLNN ) FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8 Biomarker Data in ALS

#StockMarket #News

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FDA Opens Accelerated Approval Path for Clene's Breakthrough ALS Treatment After 78% Survival Benefit Clene receives FDA guidance for CNM-Au8® ALS treatment approval, showing promising 78% survival benefit. Company plans NDA submission in 2025 with additional data collection.

#CLNN FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS

#investing #stocks #news

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