{"filings":[{"id":3523559,"accession_number":"0001437749-26-032882","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-10-19T12:05:16+00:00","items":["8.01","9.01"],"status":"ready","headline":"Clene submits FDA NDA for ALS drug CNM-Au8, seeking accelerated approval","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["NDA submitted to FDA earlier in October 2026 for CNM-Au8 in ALS; Clene publicly announced the submission on October 19, 2026.","Application seeks accelerated approval based on neurofilament light chain biomarker data plus clinical outcomes.","CEO Rob Etherington cited the FDA's \"constructive engagement\" and said Clene will work closely with the agency during review.","Clene says it continues preparations for the confirmatory Phase 3 RESTORE-ALS study while the NDA is pending.","No PDUFA date or filing-acceptance decision disclosed; FDA must accept the application before substantive review begins."],"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":0.8,"calibrated_materiality_score":0.8,"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":"2026-10-19","daily_digest_url":"/daily/2026-10-19","daily_digest_rank":5},{"id":2909836,"accession_number":"0001437749-26-030581","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-09-16T21:13:06+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Clene raises $4M in registered direct offering at $3.28/share to fund operations to mid-Q1 2027","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["1,219,513 shares at $3.28/share, gross proceeds ~$4.0M; close expected Sept 17, 2026.","Offering led by Chairman David Matlin, CEO Robert Etherington, Kensington Capital Holdings, and other existing shareholders.","No placement agent or underwriting discounts; proceeds for CNM-Au8 regulatory filings, expanded access, commercialization, manufacturing.","Company expects funding to support operations through mid-first quarter 2027."],"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":2253997,"accession_number":"0001437749-26-027837","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-08-14T12:35:24+00:00","items":["2.02","9.01"],"status":"ready","headline":"Clene Q2 net loss $13.4M; NDA for CNM-Au8 in ALS expected early Q4 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["NDA for CNM-Au8 in ALS under accelerated approval expected early Q4 2026; FDA confirmed data may support submission.","Cash $9.7M at June 30 vs $5.2M at Dec 31; runway through late Q4 2026.","Net loss $13.4M ($1.08/share) vs $7.4M ($0.78) in Q2 2025; other expense $8.1M on warrant/derivative fair value.","R&D flat at $3.5M; G&A down to $1.9M from $2.4M.","Closed $7M offering; extended convertible debt maturities to Aug 2027."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":105000.0,"consensus_period":"2026-Q2","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"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":2144718,"accession_number":"0001437749-26-026653","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2026-08-10T12:07:37+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["CNM-Au8 30 mg cut death risk 74% at 12 months vs controls in HEALEY (p=0.0124); 38% lower risk over full follow-up (HR 0.621, p=0.037).","Causal analysis: 41% lower death risk in predicted NfL responders (HR 0.593, p=0.026); no benefit in non-responders.","RESCUE-ALS: NfL responders had 76% lower adjusted death risk vs non-responders (HR 0.24, p=0.008); median survival 43.5 vs 19.9 months.","10% NfL decline linked to 6-10% lower death risk in >2,000 untreated ALS patients (APST, ANSWER ALS).","NDA for ALS accelerated approval planned for early Q4 2026; FDA acknowledged NfL as reasonably likely surrogate in March 2026."],"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":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},{"id":230332,"accession_number":"0001437749-24-012182","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-04-16T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Clene reports positive Phase 2 VISIONARY-MS LTE results for CNM-Au8 at AAN; shows repair and remyelination evidence","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["CNM-Au8 treatment up to 3 years showed significant vision improvement (low contrast letter acuity, p<0.001) and cognition (SDMT, p<0.001) vs original baseline.","Physiologic markers of remyelination improved: mfVEP amplitude p<0.01, latency p=0.06.","MRI measures of T2 lesion myelin water fraction and magnetization transfer ratio improved (p<0.05 and p=0.06), indicating structural repair.","No significant safety findings; CNM-Au8 well-tolerated over long-term."],"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":230331,"accession_number":"0001437749-24-011545","cik":1822791,"company_name":"Clene Inc.","ticker":"CLNN","form_type":"8-K","filed_at":"2024-04-09T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Clene enters $7.3M subaward with Columbia University for NIH-funded ALS Expanded Access Program","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Clene Nanomedicine signed subaward for up to $7.3M for initial phase of NIH grant supporting CNM-Au8 EAP in ALS.","Total subaward potential under $45.1M NIH grant could reach $30.9M through August 2027.","Funds reimburse expenses from Sept 25, 2023 to Aug 31, 2024; invoiced monthly or quarterly.","Agreement protects Clene's background IP; no license granted to Columbia or US Government.","Either party may terminate with 30 days' notice; termination required if NIH terminates grant."],"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":0.7,"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}],"next_cursor":"2024-04-09T23:59:59+00:00|230331"}