{"filings":[{"id":610596,"accession_number":"0001437749-26-018267","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-05-22T20:37:23+00:00","items":["1.01","5.02","5.07","9.01"],"status":"ready","headline":"Clene extends maturity of convertible notes to Aug 2027, defers $150k monthly payments","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Maturity date extended to earlier of Aug 13, 2027 or change in control; monthly principal and interest payments of $150k deferred.","Stockholders approved Amended 2020 Stock Plan, increasing authorized shares by 1,000,000.","Directors elected: Robert Etherington, Shalom Jacobovitz, Alison H. Mosca; Deloitte ratified as auditor.","Conversion price of $4.44 per share; up to 65% of principal convertible, capped at $975k aggregate.","Notes originally issued Aug 13, 2025 for up to $1.5M; security and seniority terms unchanged."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":77921,"accession_number":"0001437749-26-016881","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-05-14T12:02:05+00:00","items":["1.01","2.02","9.01"],"status":"ready","headline":"Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.","May 2026: Amended $10M convertible debt; maturity extended to Aug 2027, monthly payments cancelled.","Q1 2026 net loss $8.1M ($0.69/share) vs $0.8M loss in Q1 2025; R&D down, other expense up from financing.","Cash $5.9M at Mar 31; with $7M May offering and $7M warrant exercises, runway expected into 2027."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":15000.0,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":95840,"accession_number":"0001437749-26-014946","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-05-05T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Clene announces $7M underwritten offering of 1M shares at $7.00 per share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering of 1,000,000 shares of common stock at $7.00/share; gross proceeds ~$7M.","Net proceeds estimated at ~$6.4M after underwriting discounts (~6.5%) and expenses (~$140K).","Proceeds to fund NDA preparation for CNM-Au8, Phase 3 trial, manufacturing, and commercialization.","Canaccord Genuity is sole bookrunner; Maxim Group and D. Boral Capital are financial advisors.","Insiders subject to 60-day lock-up; closing expected on May 6, 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":95839,"accession_number":"0001437749-26-014542","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-05-04T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene announces FDA agrees CNM-Au8 data may support accelerated approval NDA for ALS","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA stated proposed data may support NDA submission under accelerated approval pathway for ALS.","FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.","Clene expects to submit NDA for CNM-Au8 in Q3 2026; Phase 3 confirmatory study to start Q1 2027.","NDA supported by NfL and clinical data from Phase 2 trials and NIH-sponsored Expanded Access Protocol.","CNM-Au8 previously received Orphan Drug Designation from FDA for ALS treatment."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109182,"accession_number":"0001437749-26-008482","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-03-17T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene enters third-year NIH subaward with NYU for up to $8M for ALS expanded access program","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Third-year subaward under $45.1M NIH grant; up to $8M for period 9/1/2025–8/31/2026.","Funds support Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis (ALS).","Subaward with New York University as prime awardee; replaces prior subaward with Columbia University for first two years.","Either party may terminate with 30 days' notice; Company retains Background IP and no licenses granted to NYU or US Gov."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109181,"accession_number":"0001437749-26-007828","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-03-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene reports FY2025 net loss $26.2M; cash $5.2M; FDA type C meeting planned","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $26.2M ($2.65 per share) vs $39.4M ($5.67) in 2024.","R&D expenses $14.0M, down from $20.1M; G&A $9.2M, down from $13.3M.","Cash and equivalents $5.2M at Dec 31, 2025; expected runway to Q3 2026 after Jan 2026 offering.","Oversubscribed $28M registered direct offering; initial tranche $6M priced above market.","Type C FDA meeting before end of Mar 2026; NDA filing for CNM-Au8 in ALS by June 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109180,"accession_number":"0001437749-26-005156","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-02-24T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.","In-person Type C FDA meeting scheduled by end of Q1 2026 to discuss data submitted late 2025.","NDA for CNM-Au8 via accelerated pathway planned for Q2 2026; PDUFA date possible in H2 2026.","Confirmatory Phase 3 RESTORE-ALS trial planned to begin later in 2026 after FDA feedback.","Over 800 patients treated; no CNM-Au8-related SAEs; favorable safety profile across 1,000+ patient-years."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109179,"accession_number":"0001437749-26-001196","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-01-13T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Clene raises $28M in registered direct offering from Boxer, Coastlands, Vivo Capital","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering totals $28M in three tranches; initial $6.03M closed Jan 13, 2026 at $6.50/unit.","Additional tranches: $6.7M Series A warrants contingent on PDUFA date, $15.6M Series B on FDA approval.","Warrants exercise price adjustable based on stock price milestones; redeemable if in-the-money.","Investors include Boxer Capital, Coastlands Capital, Vivo Capital; BTIG as sole placement agent.","Proceeds expected to fund operations into early 2027, supporting NDA and potential CNM-Au8 commercialization in ALS."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109178,"accession_number":"0001437749-26-001049","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-01-12T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene reports CNM-Au8 biomarker data supporting potential accelerated approval; FDA meeting in Q1 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.","New analyses across ALS cohorts show ~10% NfL reduction associated with 8-13% lower mortality risk.","In HEALEY trial, IGFBP7 responders to CNM-Au8 30mg had 78% mortality risk reduction (HR 0.22, p=0.01).","CNM-Au8 consistently reduced NfL: HEALEY Week 24 GMR 0.905 (p=0.04) and NIH EAP Week 36 AUC diff -0.090 (p=0.037).","Genetic variant linked to lower IGFBP7 expression correlates with ALS reversals, supporting CNM-Au8 mechanism."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125675,"accession_number":"0001437749-25-036713","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-12-03T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Clene hosts ALS program update call; no specific data disclosed in filing","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Company held conference call on December 3, 2025, regarding CNM-Au8 ALS program.","Presentation furnished as Exhibit 99.1 but not textually included in filing.","No financial results, clinical data, or regulatory milestones reported in the 8-K.","Event type is Regulation FD disclosure; no new materially quantifiable information."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125674,"accession_number":"0001437749-25-036712","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-12-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval for CNM-Au8","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.","CNM-Au8 treatment associated with 73-77% reduction in risk of death at 1 year in HEALEY ALS Platform Trial open-label extension (p=0.0144).","Company requested Type C meeting with FDA in Q1 2026 for planned NDA submission under accelerated approval pathway.","Placebo participants who switched to CNM-Au8 showed NfL decline or stabilization, consistent with active arm trajectory.","Over 1,000 patient years of exposure data show no drug-related serious adverse events."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125673,"accession_number":"0001437749-25-034621","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-11-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene Q3 net loss $8.8M; plans ALS NDA accelerated approval in Q1 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Cash $7.9M at Sep 30; +$1.2M raised post-quarter; runway into Q2 2026.","FDA advised Type C meeting to review ALS biomarker data; NDA submission planned Q1 2026.","First patient dosing in confirmatory Phase 3 RESTORE-ALS trial expected H1 2026.","Net loss $8.8M ($0.85/share) vs $8.0M ($1.22/share) in Q3 2024.","Type B end-of-Phase 2 meeting held for MS; FDA open to cognition as primary endpoint."],"consensus_eps_estimate":-0.5916,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":123000.0,"consensus_period":"2025-Q3","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125672,"accession_number":"0001437749-25-031277","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-10-17T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene Inc. files prospectus supplement for up to $18.88M additional common stock under ATM facility","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Previously sold ~$6.12M of common stock under the April 2025 Equity Distribution Agreement.","New prospectus supplement dated Oct 17, 2025 adds $18.88M of shares available for sale.","Shares offered through Canaccord Genuity LLC as placement agent."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125671,"accession_number":"0001437749-25-030891","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-10-14T23:59:59+00:00","items":["2.02","7.01","7.02","9.01"],"status":"ready","headline":"Clene releases preliminary cash and ATM proceeds update; no specific figures disclosed","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Released updated corporate presentation on Oct 14, 2025 with preliminary unaudited cash balance as of Sep 30, 2025.","Also disclosed gross proceeds from ATM equity distribution agreement from Oct 1 through Oct 14, 2025.","Financial information is preliminary, subject to change upon completion of closing and audit procedures.","No specific dollar amounts provided in the filing text; exhibit content not extracted."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142402,"accession_number":"0001437749-25-029846","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-09-25T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene reports CNM-Au8 improves brain NAD+/NADH ratio in MS patients at ECTRIMS 2025; FDA open to cognition endpoints","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Mean brain NAD+/NADH ratio increased +0.449 units (p=0.0148) across full REPAIR population (n=39) after 12 weeks of CNM-Au8.","In REPAIR-MS participants (n=26), NAD+/NADH ratio increased +0.480 units (p=0.058; percent change +9.49%, p=0.0275).","Baseline EDSS was significantly associated with NAD+/NADH ratio deficit (ρ=0.429, p=0.0127).","Baseline working memory (SDMT) and upper extremity function (9-HPT) correlated with brain ATP levels (p=0.0009, p=0.0032).","FDA acknowledged EDSS limitations and expressed openness to broader primary endpoints, including cognition, for MS trials."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142401,"accession_number":"0001437749-25-028485","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-09-05T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene files prospectus supplement for $6.28M at-the-market equity offering under existing $25M facility","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["On Sept 5, 2025, Clene filed a prospectus supplement to sell up to $6,280,000 of common stock via Canaccord Genuity as placement agent.","Previous sales under the April 28, 2025 equity distribution agreement totaled $3,706,213.","The ATM facility originally covered up to $25,000,000 in aggregate offering price.","Legal opinion from Holland & Knight LLP on share validity was filed as Exhibit 5.1."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142400,"accession_number":"0001437749-25-026690","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-08-14T23:59:59+00:00","items":["1.01","2.02","2.03","9.01"],"status":"ready","headline":"Clene reports Q2 net loss $7.4M, cash $7.3M, plans NDA submission for CNM-Au8 in ALS by end of 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $7.4M ($0.78 per share) vs $6.8M ($1.06) in Q2 2024; R&D expenses $3.5M, G&A $2.4M.","Cash and equivalents $7.3M as of June 30, 2025; post-quarter $1.9M equity and $1.5M convertible debt funding provides runway into Q1 2026.","FDA meetings scheduled: Type C for survival data in Q3 2025, and analysis of NfL biomarker from NIH EAP early Q4 2025.","Plans to submit NDA for CNM-Au8 in ALS under accelerated approval by end of 2025.","End-of-Phase 2 Type B meeting with FDA for MS program planned in Q3 2025."],"consensus_eps_estimate":-0.4828,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":108000.0,"consensus_period":"2025-Q2","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142399,"accession_number":"0001437749-25-022150","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-07-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene files prospectus supplement for $2.015M ATM stock offering under existing equity distribution agreement","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Clene entered equity distribution agreement on April 28, 2025 for up to $25M of common stock through Canaccord Genuity.","Prior to July 3, 2025, sold approx. $1.713M under the ATM facility.","On July 3, 2025, filed prospectus supplement for additional $2.015M of shares.","Legal opinion of Holland & Knight filed as exhibit on validity of shares."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160441,"accession_number":"0001437749-25-021483","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-06-30T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene receives constructive FDA feedback on NfL biomarker analysis plan; ALS NDA on track for Q4 2025","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.","NfL analyses to be conducted early Q4 2025; may support accelerated approval NDA submission for CNM-Au8 in ALS.","Two additional FDA meetings scheduled in Q3 2025: ALS survival data Type C and End-of-Phase 2 MS program Type B.","NDA submission under accelerated approval pathway remains on track for potential submission in Q4 2025.","EAP supports nearly 200 ALS patients treated with compassionate use CNM-Au8; comparator group uses matched controls."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160440,"accession_number":"0001437749-25-020669","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-06-17T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Clene regains Nasdaq compliance on market value of listed securities rule","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["On June 17, 2025, Clene received Nasdaq notice that its MVLS was ≥$35M for 10 consecutive business days (June 2-16, 2025).","Company has regained compliance with Nasdaq Listing Rule 5550(b)(2); the deficiency matter is now closed.","No financial or operational impact reported; listing on Nasdaq Capital Market continues."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160439,"accession_number":"0001437749-25-018336","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-05-23T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"Stockholders approve 800,000-share increase in 2020 Stock Plan; three directors elected","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Stockholders approved amendment to 2020 Stock Plan, increasing authorized shares by 800,000 (3,220,000 total).","Class II directors elected: David J. Matlin (2,923,656 for), Arjun Desai (3,825,997 for), Matthew Kiernan (3,843,377 for).","Deloitte & Touche LLP ratified as auditor for FY2025 (5,567,326 for, 19,540 against).","Advisory say-on-pay approved (3,662,992 for, 137,918 against, 59,789 abstain, 1,744,947 broker non-votes).","Board amended nonemployee director compensation plan to reflect 1-for-20 reverse split; options adjusted to 1,500 shares annual / 2,250 initial."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160438,"accession_number":"0001437749-25-014917","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-05-07T23:59:59+00:00","items":["2.02","3.01","9.01"],"status":"ready","headline":"Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Nasdaq notified Clene that MVLS of common stock is below $35M minimum; has until Nov 3, 2025 to regain compliance.","Cash and equivalents $9.8M as of Mar 31, 2025, expected to fund operations into Q3 2025.","Net loss of $0.8M ($0.09 per share) vs $11.1M ($1.73) in Q1 2024; decrease due to NIH grant revenue and lower expenses.","Planning to submit NDA for Accelerated Approval of CNM-Au8 in ALS in Q4 2025, pending FDA agreement on SAP in Q2.","Presented new remyelination data from VISIONARY-MS trial at AAN; end-of-Phase 2 meeting with FDA planned in Q3 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160437,"accession_number":"0001437749-25-013230","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-04-28T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene enters $25M at-the-market equity facility with Canaccord Genuity","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Up to $25M of common stock may be sold from time to time through Canaccord as placement agent.","Fixed commission of 3.0% of gross proceeds from each sale; use of existing Form S-3 shelf registration.","Sales occur at market prices via Nasdaq or other methods; no obligation to sell any specific amount."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160436,"accession_number":"0001437749-25-011309","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-04-08T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene: 96% of CNM-Au8-treated MS patients with vision gains also showed MRI remyelination evidence","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["96% of LCLA visual responders had improved MRI DTI metrics (AD/MTR), confirming remyelination and neuronal repair.","91% of LCLA visual responders showed multi-focal VEP improvements (latency/amplitude), indicating functional recovery.","98% of SDMT cognitive responders exhibited corresponding MRI DTI improvements, linking cognitive gains to repair.","Data from long-term open-label extension of Phase 2 VISIONARY-MS trial presented at AAN 2025 Late-Breaking Science Session.","Clene plans to confirm findings in a global Phase 3 trial for CNM-Au8 in multiple sclerosis."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178696,"accession_number":"0001437749-25-009484","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-03-27T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene Inc. issues 35,311 shares at $3.54/share to satisfy $125,000 debt","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Issued 35,311 common shares at $3.54 per share to retire $125,000 outstanding indebtedness.","Shares issued under effective S-3 registration statement (333-264299); prospectus supplement to be filed.","Counterparty not named; legal opinion from Holland & Knight LLP filed as Exhibit 5.1.","Transaction closed on March 26, 2025; reduces debt without cash outlay."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178695,"accession_number":"0001437749-25-008869","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-03-24T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene reports FY2024 net loss $39.4M ($5.67/sh); plans NDA for CNM-Au8 in ALS in H2 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $39.4M ($5.67/sh) vs. $49.5M ($9.43/sh) in FY2023.","Cash and marketable securities $12.2M at Dec 31, 2024; expected to fund ops into Q2 2025.","R&D expense $20.1M, down 25% YoY; G&A $13.3M, down 8%.","Planning NDA submission for CNM-Au8 in ALS in H2 2025; confirmatory Phase 3 RESTORE-ALS starts mid-2025.","Secured new $10M debt facility (12% interest, convertible at $5.67) replacing $7.85M Avenue debt."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178694,"accession_number":"0001437749-25-007120","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-03-12T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.","Covariate-adjusted RMST improvement of 124 days (p=0.045); sensitivity analyses including NfL and TRICALS confirm robustness.","In moderate-to-severe ALS (NfL>33, TRICALS -6.5 to -2.5), median survival gain 11.9 months; mortality risk reduced 44% (p=0.006).","RESTORE-ALS-eligible subset: median survival 1079 vs 628 days (451-day gain, 14.8 mo), mortality risk reduced 49% (p=0.006).","Clene to discuss findings with FDA; Phase 3 RESTORE-ALS study launch targeted for mid-2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178693,"accession_number":"0001437749-25-002265","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2025-01-30T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene enters subaward amendment for up to $8M from NIH for ALS Expanded Access Program","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Amendment with Columbia University on Jan 28, 2025, extends funding for Year 2 of ACT-EAP from Sep 1, 2024 to Aug 31, 2025.","Additional $7,976,230 obligated; cumulative funding to date totals $15,324,600.","Supports CNM-Au8 treatment in ALS under the Accelerating Access to Critical Therapies for ALS Act.","Other Subaward terms from April 2024 remain unchanged."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195356,"accession_number":"0001437749-24-038152","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-12-20T23:59:59+00:00","items":["1.01","1.02","2.03","8.01","9.01"],"status":"ready","headline":"Clene signs $10M secured convertible note with affiliates; repays $7.9M Avenue loan","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Note purchase agreement for $10M principal; 12% fixed interest, 18-month maturity, interest-only first 12 months.","Proceeds used to repay Avenue loan of ~$7.9M in full, including prepayment penalty; previous covenants terminated.","Up to 65% of principal convertible at $5.67/share, a 130% premium to Dec. 17 closing price.","Monthly principal payments of $1M begin month 13; note secured by all assets.","Funding supports generation of additional ALS data for CNM-Au8 NDA via accelerated regulatory pathway."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195355,"accession_number":"0001437749-24-037061","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-12-10T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA provides roadmap for accelerated approval of Clene's CNM-Au8 in ALS via additional NfL biomarker data","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.","Additional NfL biomarker analyses planned to complete Q2 2025; NDA submission targeted mid-2025.","Confirmatory Phase 3 RESTORE-ALS trial to start enrollment before NDA submission, evaluating survival benefit.","Key survival data from November meeting: 78% risk reduction in time to death at Month 12 (HR=0.224, p=0.042).","Over 700 patient-years of CNM-Au8 use with no significant safety concerns; no SAEs related to treatment."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195354,"accession_number":"0001437749-24-034668","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-11-13T23:59:59+00:00","items":["2.02","7.01","9.01"],"status":"ready","headline":"Clene reports Q3 net loss of $8.0M; cash $14.6M; awaits FDA meeting on accelerated ALS approval","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Met with FDA on Nov 1 to discuss accelerated approval pathway for CNM-Au8 in ALS; awaiting meeting minutes.","Cash, cash equivalents and marketable securities of $14.6M as of Sep 30, 2024, down from $35.0M at Dec 31, 2023.","Raised $7.3M in October registered direct offering and private placements; runway extended into Q1 2025.","Amended Avenue debt facility to defer principal payments and extend maturity to Q2 2025.","Q3 2024 net loss $8.0M ($1.22 per share) vs net loss $2.4M ($0.38 per share) in Q3 2023."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":251000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195353,"accession_number":"0001437749-24-031805","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-10-23T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Clene presents RESTORE-ALS Phase 3 trial design for CNM-Au8 at NEALS meeting","summary_kind":"llm","event_type":"other_material","confidence":"medium","bullets":["Presented preliminary design for RESTORE-ALS, an international Phase 3 trial of CNM-Au8 30 mg for ALS.","Presentation made at the 2024 Annual NEALS Meeting on October 23, 2024.","No efficacy or safety results disclosed; only the trial design was shared."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.45,"calibrated_materiality_score":0.45,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211621,"accession_number":"0001437749-24-030269","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-09-30T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene amends loan with Avenue; Oct payment cut to $2M, interest-only period tied to equity raise and ALS NDA progress","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["October 2024 principal payment reduced from $3.33M to $2M.","Interest-only period from Nov-Dec 2024 contingent on raising $10M in equity by Oct 31, 2024; $7M raised in Sep 2024.","If FDA allows ALS NDA submission for CNM-Au8 by Dec 31, 2024, loan amortization extends to June 2025; otherwise full repayment by April 2025.","Warrant exercise price lowered from $16.00 to $4.6014 per share for Avenue."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211620,"accession_number":"0001437749-24-030263","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-09-30T23:59:59+00:00","items":["1.01","3.02","8.01","9.01"],"status":"ready","headline":"Clene announces $7.3M registered direct offering and concurrent private placements","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Gross proceeds ~$7.3M; shares/pre-funded warrants at $4.713 combined with warrants ($4.82 strike, 5-year term).","Warrants exercisable immediately; lock-up until later of 45 days or FDA meeting outcome announcement.","Directors/officers bought 122,819 shares at $4.875/warrant package; existing investors also participated.","Proceeds to fund clinical development of lead candidate CNM-Au8 (ALS/MS) and general corporate purposes.","Canaccord Genuity acted as sole placement agent; closing expected on or about October 1, 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211619,"accession_number":"0001437749-24-029205","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-09-16T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.","DN1 previously deemed briefing package unsupportive of accelerated approval NDA, but FDA agreed to re-evaluate.","Meeting includes Directors of Office of New Drugs, Office of Neuroscience, DN1, and ALS key opinion leaders.","Over 700 patient-years of safety data with no SAEs attributed to CNM-Au8 by investigators.","Clene believes biomarkers, clinical endpoints, and survival data support CNM-Au8 for ALS."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211618,"accession_number":"0001437749-24-025020","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-08-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene Q2 net loss narrows to $6.8M; ALS survival data shows 60% risk reduction vs controls","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $6.8M ($1.06 per share) vs $25.1M ($5.84) in Q2 2023; cash and equivalents $21.7M.","R&D expenses fell to $4.2M from $6.6M, partly due to NIH grant reimbursement for ALS expanded access program.","CNM-Au8 30mg showed ~60% decreased risk of death vs matched PRO-ACT controls up to 3.5 years (HR 0.431, p=0.0002).","Submitted briefing book to FDA for Type C meeting in Q3 2024 to discuss accelerated approval pathway for CNM-Au8 in ALS.","Completed 1-for-20 reverse stock split to regain Nasdaq $1.00 minimum bid price compliance."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":164000.0,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211617,"accession_number":"0001437749-24-024726","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-08-06T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).","CNM-Au8 30mg in HEALEY trial: 57% decreased mortality risk vs. PRO-ACT controls (HR 0.431, p=0.0002).","CNM-Au8 30mg in RESCUE-ALS: 70% decreased mortality risk vs. PRO-ACT (HR 0.311, p=0.0035).","NfL Responders showed significantly less ALSFRS-R decline at Weeks 64-100 (p<0.01 vs non-responders).","FDA Type C interaction expected Q3 2024 to discuss accelerated approval pathway based on these results."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211616,"accession_number":"0001437749-24-023618","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-07-26T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"Clene regains Nasdaq minimum bid-price compliance; delisting risk resolved","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Received Nasdaq notice July 25, 2024 that closing bid price was ≥$1.00 for 10 consecutive business days (July 11-24).","Regained compliance with Nasdaq Listing Rule 5550(a)(2); matter now closed.","Common stock (CLNN) and warrants (CLNNW) continue trading on Nasdaq Capital Market."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211615,"accession_number":"0001437749-24-022529","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-07-11T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene to submit FDA briefing book for CNM-Au8 accelerated approval in ALS by July 13","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Briefing book submission due July 13, 2024, for Type C interaction with FDA in Q3 2024.","New post-hoc analyses include NfL biomarker reduction, survival data, and mechanism-of-action evidence.","Data designed to address prior FDA comments from December 2023 meeting on accelerated approval path.","Clene plans to disclose topline FDA feedback after the Type C interaction concludes."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211614,"accession_number":"0001437749-24-022352","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-07-09T23:59:59+00:00","items":["3.03","5.03","7.01","9.01"],"status":"ready","headline":"Clene (CLNN) to effect 1-for-20 reverse stock split on July 11 to regain Nasdaq compliance","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Reverse stock split effective July 11, 2024; shares reduce from ~128.7M to ~6.4M.","Split intended to meet Nasdaq $1.00 minimum bid price requirement for continued listing.","No fractional shares; cash in lieu based on July 10 closing price.","All outstanding options, warrants, convertible debt adjusted proportionally.","Authorized shares unchanged; par value remains $0.0001 per share."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230336,"accession_number":"0001437749-24-020589","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-06-18T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene: CNM-Au8 shows 60% reduced death risk (HR 0.431, p=0.0002) and 28% NfL reduction in ALS trial OLE","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Survival analysis of CNM-Au8 30 mg vs matched PRO-ACT controls up to 3.5 years: HR 0.431 (95% CI 0.276-0.672, p=0.0002).","NfL responder subset (n=55) showed average 28% NfL reduction at Week 76 (GMR 0.72, p<0.0001), indicating decreased axonal loss.","More than 650 patient-years of CNM-Au8 treatment exposure with no identified safety signals.","Data presented at 2024 ENCALS meeting; includes up to 42 months survival follow-up and 76 weeks biomarker results."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230335,"accession_number":"0001437749-24-018759","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-05-30T23:59:59+00:00","items":["5.02","5.03","5.07","9.01"],"status":"ready","headline":"Clene stockholders approve doubling authorized shares, reverse split authorization, and stock plan amendment","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Authorized common shares increased from 300M to 600M via certificate amendment.","Amended 2020 Stock Plan adds 30M shares reserved for issuance; total now 48.4M.","Board authorized to effect reverse stock split at ratio 1:5 to 1:20 at its discretion.","Class I directors elected: Jonathon T. Gay, Vallerie V. McLaughlin, Reed N. Wilcox.","Ratified Deloitte as auditor; advisory vote approved executive compensation with one-year frequency."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230334,"accession_number":"0001437749-24-015212","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-05-08T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene Q1 net loss $11.1M ($0.09/shr); cash $27.9M; VISIONARY-MS data positive","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Cash, equivalents and marketable securities $27.9M at Mar 31, down from $35.0M at Dec 31, 2023; expected to fund operations into Q4 2024.","Net loss $11.1M ($0.09/shr) vs $11.8M ($0.15/shr) YoY; R&D expenses fell to $5.9M from $7.4M.","Long-term VISIONARY-MS extension: significant vision improvement (up to 38 letters, p<0.001) and cognition (SDMT +29 points, p<0.001).","Received $7.3M NIH sub-award for ALS Expanded Access Program; company advancing FDA discussions for NDA filing in H2 2024.","Peer-reviewed publication in ACS journal characterized CNM-Au8 protein corona supporting neuroprotective mechanism."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":73000.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230333,"accession_number":"0001437749-24-013441","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-04-26T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene enters amended supply/license deal with 4Life; waives $960K default","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Amended exclusive supply agreement: price cost +20%; 4Life commits to minimum sales of $5M in 2024, $10M 2025, $20M 2026, $30M 2027–2028.","Amended exclusive license agreement grants 4Life royalty-bearing license (3% of incremental sales) through 2033; renewable for 5-year terms.","Clene waived $960K payment default by 4Life to maintain the long-term relationship.","After Jan 1, 2027, Clene may sell licensed products via third-party retail or its own websites."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":84909294.52245142,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}