Highest-materiality recent filing
Clene reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA
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).
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.
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.
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.
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.
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.
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.
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.
FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.
FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.
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.
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.
Mean brain NAD+/NADH ratio increased +0.449 units (p=0.0148) across full REPAIR population (n=39) after 12 weeks of CNM-Au8.
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.
FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.
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.
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.
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.
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.
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.
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.
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.
FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.
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.
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).
October 2024 principal payment reduced from $3.33M to $2M.
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.
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.
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).
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).
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.
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.
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).
Authorized common shares increased from 300M to 600M via certificate amendment.
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.
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.
Clene enters $7.3M subaward with Columbia University for NIH-funded ALS Expanded Access Program
Clene Nanomedicine signed subaward for up to $7.3M for initial phase of NIH grant supporting CNM-Au8 EAP in ALS.
Clene posts FY2023 net loss $49.5M; FDA discussions for CNM-Au8 accelerated approval ongoing
Net loss $49.5M ($0.47/share) vs $29.9M ($0.46/share) in FY2022; cash $35.0M, expected to fund ops into Q4 2024.
Clene reports positive long-term results from VISIONARY-MS LTE trial for CNM-Au8 in MS
Long-term CNM-Au8 treatment showed significant improvement in vision (LCLA) through 35 months, p<0.0001, mean +8.70 letters.
Clene reports significant survival benefit with CNM-Au8 in ALS compassionate use programs
68% decreased risk of all-cause mortality vs PRO-ACT matched controls (HR=0.320, p=0.0001).
John H. Stevens, M.D., a Class II director of the Company, informed the Board of his decision to retire from the Board and all committees
appointed Professor Matthew Kiernan AM, Ph.D., DSc, and Arjun (JJ) Desai, M.D., as members of the Board, effective September 18, 2023.
appointed Professor Matthew Kiernan AM, Ph.D., DSc, and Arjun (JJ) Desai, M.D., as members of the Board, effective September 18, 2023.
On March 15, 2023, Robert Glanzman, M.D., FAAN, the Chief Medical Officer of Clene Inc. (the “Company”), notified the Company of his intent to retire from his position, effective as of April 1, 2023 (the “Effective Date”).
On February 15, 2023, Chidozie Ugwumba, a Class II director of Clene Inc. (the “Company”), informed the Board of Directors of the Company (the “Board”) of his decision to resign from the Board and all committees thereof, effective immediately.
On February 1, 2022, Clene Inc. (the “Company”) announced the hiring and appointment of Morgan Brown as its Chief Financial Officer, effective February 1, 2022.
On August 5, 2021, the Board of Directors (the “Board”) of Clene Inc. (the “Company”), upon the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed Vallerie V. McLaughlin, M.D. as a member of the Board, effective August 5, 2021.
Max materiality 0.85 · Median 0.70 · Most common event other_material