Recent 8-K filings for CLNN

• May 22, 2026, 4:37 PM ET debt materiality 0.60 neutral item 1.01item 5.02item 5.07item 9.01

  Clene extends maturity of convertible notes to Aug 2027, defers $150k monthly payments

  Maturity date extended to earlier of Aug 13, 2027 or change in control; monthly principal and interest payments of $150k deferred.

• May 14, 2026, 8:02 AM ET earnings materiality 0.85 positive item 1.01item 2.02item 9.01

  Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M

  FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.

• May 5, 2026, 7:59 PM ET other material materiality 0.60 neutral item 1.01item 8.01item 9.01 ◈ Material Agreements

  Clene announces $7M underwritten offering of 1M shares at $7.00 per share

  Offering of 1,000,000 shares of common stock at $7.00/share; gross proceeds ~$7M.

• May 4, 2026, 7:59 PM ET regulatory materiality 0.85 positive item 7.01item 8.01item 9.01

  Clene announces FDA agrees CNM-Au8 data may support accelerated approval NDA for ALS

  FDA stated proposed data may support NDA submission under accelerated approval pathway for ALS.

• March 12, 2026, 7:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  Clene reports FY2025 net loss $26.2M; cash $5.2M; FDA type C meeting planned

  Net loss of $26.2M ($2.65 per share) vs $39.4M ($5.67) in 2024.

• February 24, 2026, 6:59 PM ET regulatory materiality 0.75 positive item 8.01item 9.01

  Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026

  Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.

• January 13, 2026, 6:59 PM ET other material materiality 0.75 positive item 1.01item 8.01item 9.01 ◈ Material Agreements

  Clene raises $28M in registered direct offering from Boxer, Coastlands, Vivo Capital

  Offering totals $28M in three tranches; initial $6.03M closed Jan 13, 2026 at $6.50/unit.

• January 12, 2026, 6:59 PM ET regulatory materiality 0.75 positive item 8.01item 9.01

  Clene reports CNM-Au8 biomarker data supporting potential accelerated approval; FDA meeting in Q1 2026

  FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.

• December 3, 2025, 6:59 PM ET other material materiality 0.85 positive item 8.01item 9.01

  Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval for CNM-Au8

  FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.

• November 13, 2025, 6:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Clene Q3 net loss $8.8M; plans ALS NDA accelerated approval in Q1 2026

  Cash $7.9M at Sep 30; +$1.2M raised post-quarter; runway into Q2 2026.

• October 17, 2025, 7:59 PM ET other material materiality 0.60 neutral item 8.01item 9.01

  Clene Inc. files prospectus supplement for up to $18.88M additional common stock under ATM facility

  Previously sold ~$6.12M of common stock under the April 2025 Equity Distribution Agreement.

• September 25, 2025, 7:59 PM ET other material materiality 0.65 positive item 7.01item 8.01item 9.01

  Clene reports CNM-Au8 improves brain NAD+/NADH ratio in MS patients at ECTRIMS 2025; FDA open to cognition endpoints

  Mean brain NAD+/NADH ratio increased +0.449 units (p=0.0148) across full REPAIR population (n=39) after 12 weeks of CNM-Au8.

• August 14, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 1.01item 2.02item 2.03item 9.01 ◈ Debt Financings ×2

  Clene reports Q2 net loss $7.4M, cash $7.3M, plans NDA submission for CNM-Au8 in ALS by end of 2025

  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.

• June 30, 2025, 7:59 PM ET regulatory materiality 0.65 positive item 8.01item 9.01

  Clene receives constructive FDA feedback on NfL biomarker analysis plan; ALS NDA on track for Q4 2025

  FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.

• May 7, 2025, 7:59 PM ET regulatory materiality 0.85 negative item 2.02item 3.01item 9.01

  Clene receives Nasdaq MVLS deficiency notice; reports Q1 2025 net loss of $0.8M, cash $9.8M

  Nasdaq notified Clene that MVLS of common stock is below $35M minimum; has until Nov 3, 2025 to regain compliance.

• April 28, 2025, 7:59 PM ET other material materiality 0.60 neutral item 1.01item 9.01

  Clene enters $25M at-the-market equity facility with Canaccord Genuity

  Up to $25M of common stock may be sold from time to time through Canaccord as placement agent.

• April 8, 2025, 7:59 PM ET other material materiality 0.65 positive item 7.01item 8.01item 9.01

  Clene: 96% of CNM-Au8-treated MS patients with vision gains also showed MRI remyelination evidence

  96% of LCLA visual responders had improved MRI DTI metrics (AD/MTR), confirming remyelination and neuronal repair.

• March 24, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Clene reports FY2024 net loss $39.4M ($5.67/sh); plans NDA for CNM-Au8 in ALS in H2 2025

  Net loss $39.4M ($5.67/sh) vs. $49.5M ($9.43/sh) in FY2023.

• March 12, 2025, 7:59 PM ET other material materiality 0.75 positive item 8.01item 9.01

  Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control

  Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.

• January 30, 2025, 6:59 PM ET other material materiality 0.60 positive item 1.01item 9.01

  Clene enters subaward amendment for up to $8M from NIH for ALS Expanded Access Program

  Amendment with Columbia University on Jan 28, 2025, extends funding for Year 2 of ACT-EAP from Sep 1, 2024 to Aug 31, 2025.

• December 20, 2024, 6:59 PM ET debt materiality 0.75 neutral item 1.01item 1.02item 2.03item 8.01item 9.01

  Clene signs $10M secured convertible note with affiliates; repays $7.9M Avenue loan

  Note purchase agreement for $10M principal; 12% fixed interest, 18-month maturity, interest-only first 12 months.

• December 10, 2024, 6:59 PM ET regulatory materiality 0.85 positive item 7.01item 8.01item 9.01

  FDA provides roadmap for accelerated approval of Clene's CNM-Au8 in ALS via additional NfL biomarker data

  FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.

• November 13, 2024, 6:59 PM ET earnings materiality 0.70 negative item 2.02item 7.01item 9.01

  Clene reports Q3 net loss of $8.0M; cash $14.6M; awaits FDA meeting on accelerated ALS approval

  Met with FDA on Nov 1 to discuss accelerated approval pathway for CNM-Au8 in ALS; awaiting meeting minutes.

• September 30, 2024, 7:59 PM ET other material materiality 0.60 neutral item 1.01item 3.02item 8.01item 9.01

  Clene announces $7.3M registered direct offering and concurrent private placements

  Gross proceeds ~$7.3M; shares/pre-funded warrants at $4.713 combined with warrants ($4.82 strike, 5-year term).

• September 30, 2024, 7:59 PM ET debt materiality 0.65 neutral item 1.01item 9.01

  Clene amends loan with Avenue; Oct payment cut to $2M, interest-only period tied to equity raise and ALS NDA progress

  October 2024 principal payment reduced from $3.33M to $2M.

• September 16, 2024, 7:59 PM ET regulatory materiality 0.75 neutral item 8.01item 9.01

  Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval

  FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.

• August 7, 2024, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  Clene Q2 net loss narrows to $6.8M; ALS survival data shows 60% risk reduction vs controls

  Net loss of $6.8M ($1.06 per share) vs $25.1M ($5.84) in Q2 2023; cash and equivalents $21.7M.

• August 6, 2024, 7:59 PM ET regulatory materiality 0.85 positive item 7.01item 8.01item 9.01

  Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders

  CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).

• July 26, 2024, 7:59 PM ET regulatory materiality 0.65 positive item 3.01

  Clene regains Nasdaq minimum bid-price compliance; delisting risk resolved

  Received Nasdaq notice July 25, 2024 that closing bid price was ≥$1.00 for 10 consecutive business days (July 11-24).

• July 11, 2024, 7:59 PM ET regulatory materiality 0.70 neutral item 8.01item 9.01

  Clene to submit FDA briefing book for CNM-Au8 accelerated approval in ALS by July 13

  Briefing book submission due July 13, 2024, for Type C interaction with FDA in Q3 2024.

• July 9, 2024, 7:59 PM ET other material materiality 0.70 negative item 3.03item 5.03item 7.01item 9.01

  Clene (CLNN) to effect 1-for-20 reverse stock split on July 11 to regain Nasdaq compliance

  Reverse stock split effective July 11, 2024; shares reduce from ~128.7M to ~6.4M.

• June 18, 2024, 7:59 PM ET other material materiality 0.75 positive item 7.01item 8.01item 9.01

  Clene: CNM-Au8 shows 60% reduced death risk (HR 0.431, p=0.0002) and 28% NfL reduction in ALS trial OLE

  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).

• May 30, 2024, 7:59 PM ET other material materiality 0.60 neutral item 5.02item 5.03item 5.07item 9.01

  Clene stockholders approve doubling authorized shares, reverse split authorization, and stock plan amendment

  Authorized common shares increased from 300M to 600M via certificate amendment.

• May 8, 2024, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01 ◈ Earnings Releases

  Clene Q1 net loss $11.1M ($0.09/shr); cash $27.9M; VISIONARY-MS data positive

  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.

Materiality & sentiment trend

Max materiality 0.85 · Median 0.65 · Most common event other_material

16 positive 3 negative 25 neutral

source · CLNN on sec.gov