Welcome to our dedicated page for Clene SEC filings (Ticker: CLNN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Clene Inc. (CLNN) SEC filings page provides access to the company’s official regulatory disclosures as a Nasdaq-listed, late clinical-stage biopharmaceutical issuer. These documents offer detailed insight into Clene’s development of CNM-Au8, its financial position, and the financing structures that support its ALS, MS, and Parkinson’s disease programs.
Investors can review current reports on Form 8-K that Clene files to describe material events. Recent 8-K filings have covered quarterly financial results and operating highlights, equity distribution agreements for at-the-market common stock offerings, prospectus supplements for additional share issuances, amendments to senior secured convertible promissory notes, and new note purchase agreements. Other 8-Ks reference press releases and scientific presentations, such as new clinical data from the REPAIR-MS and REPAIR-PD studies and regulatory updates following FDA Type C and Type B meetings.
Alongside 8-Ks, Clene’s broader SEC reporting (including Forms 10-K and 10-Q, when accessed through EDGAR) details research and development expenses, general and administrative costs, limited product and royalty revenue, and the impact of warrant and derivative liabilities. Filings also describe the terms of convertible notes, including maturity dates, interest capitalization, conversion prices into common stock, and change-of-control provisions, which are important for understanding potential dilution and capital structure.
On Stock Titan, CLNN filings are updated in near real time as they appear on EDGAR. AI-powered summaries highlight key elements of each filing, such as new financing terms, regulatory milestones, or changes in clinical development plans, helping readers quickly interpret complex legal and financial language. Users can also focus on items related to capital raises, note amendments, and other direct financial obligations that shape Clene’s runway for advancing CNM-Au8 through clinical trials and potential regulatory review.
Clene Inc. insider filing shows an indirect share sale by a large holder. On April 2, 2026, SymBiosis II, LLC, an entity associated with ten percent owner Ugwumba Chidozie, completed an open-market sale of 24,925 shares of Clene common stock at $4.81 per share. Following this transaction, the entity continued to hold 401,891 shares of common stock indirectly, indicating the sale represented only a portion of its overall position.
Clene Inc. ten percent owner associated entity sells shares. An entity linked to Ugwumba Chidozie, SymBiosis II, LLC, completed an open-market sale of 4,278 shares of Clene Inc. common stock at $4.97 per share. After this transaction, the entity still holds 426,816 shares indirectly.
CLNN reports multiple proposed and executed sales of Common Stock by Symbiosis II LLC as disclosed on Form 144. The filing lists numerous open-market dispositions on dated entries, including 31,297 shares on 03/31/2026 for $152,316.52 and 32,705 shares on 01/12/2026 for $179,867.17. Transactions are shown across January–March 2026 with individual trade sizes and cash amounts reported per line item.
Clene Inc. ten-percent owner Ugwumba Chidozie, through Symbiosis II, LLC, reported open-market sales of Clene common stock. The LLC sold 67,991 shares at $4.88, 15,536 shares at $5.10, and 17,470 shares at $4.75 per share. Following these transactions, Symbiosis II, LLC continued to hold 431,094 shares of Clene common stock indirectly attributed to Chidozie.
Clene Inc. disclosed that an entity associated with ten percent owner Ugwumba Chidozie, identified as SymBiosis II, LLC, sold a total of 17,909 shares of Clene common stock in three open-market transactions at prices between $5.40 and $5.78 per share. After these indirect sales, SymBiosis II, LLC continued to hold 532,091 Clene shares.
CLNN affiliate submitted a Form 144 notice to sell 477,000 shares of Common Stock.
The filing lists multiple recent open‑market dispositions by Symbiosis II LLC from 12/22/2025 through 02/03/2026, with per‑trade share counts and gross proceeds reported for each trade.
Clene Inc. is a clinical-stage pharmaceutical company focused on clean-surfaced nanocrystal (CSN) therapeutics targeting neurodegenerative diseases such as ALS, multiple sclerosis, and Parkinson’s disease. Its lead asset, CNM-Au8, is an orally delivered gold nanocrystal suspension designed to boost cellular energy and reduce oxidative stress.
The company reports extensive preclinical and Phase 1–2 data suggesting neuroprotective, remyelinating, and biomarker effects, including NAD+/ATP increases and reduced neurofilament light chain in ALS. Clene is pursuing an accelerated approval pathway for CNM-Au8 in ALS, aiming to submit an NDA by June 2026 and planning a Phase 3 RESTORE-ALS trial as a confirmatory study, subject to funding.
Clene Inc. entered into a third-year subaward agreement tied to its previously announced four-year, $45.1 million NIH grant supporting an Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis. The new agreement with New York University covers up to $8.0 million from September 1, 2025 to August 31, 2026.
Clene will receive reimbursements from NYU based on submitted invoices, not more often than monthly, and either party may terminate the agreement with 30 days’ written notice. The company preserves control over its background intellectual property, providing no license to NYU or the U.S. government and requiring satisfactory confidentiality safeguards before sharing proprietary data.
Clene Inc. reported full year 2025 results showing a narrower net loss of $26.2 million, or $2.65 per share, compared with a $39.4 million loss, or $5.67 per share, in 2024. Revenue was modest at $0.2 million, down from $0.3 million.
Research and development expenses declined to $14.0 million from $20.1 million and general and administrative costs fell to $9.2 million from $13.3 million, helped by higher grant revenue. Cash and cash equivalents were $5.2 million as of December 31, 2025, with an oversubscribed registered direct offering of over $28 million expected to extend operating runway into 2027. Clene highlighted statistically significant ALS biomarker and survival data for CNM-Au8, reported more than 1,100 patient-years of exposure with no treatment-related serious adverse events, and plans a Type C FDA meeting followed by an accelerated-approval NDA filing for ALS by the end of June 2026 and initiation of Phase 3 trials in ALS and MS.
Clene Inc. filed an 8-K after issuing a stockholder letter that maps out 2026 milestones for its ALS drug candidate CNM-Au8 and its funding plan. The company completed an oversubscribed registered direct offering of over $28 million, with an initial tranche of over $6 million expected to fund operations into the fourth quarter of 2026. Two additional tranches totaling over $22 million are structured around potential FDA NDA acceptance and approval milestones and are expected to support operations into 2027. Clene plans an in-person Type C FDA meeting by the end of the first quarter of 2026, aims to submit a New Drug Application for CNM-Au8 via an accelerated pathway in the second quarter of 2026, and sees potential for FDA acceptance, a PDUFA decision date, and possible 2027 commercial launch. The letter highlights survival and biomarker data in ALS, a favorable safety profile over more than 1,000 patient years, and plans to start the confirmatory Phase 3 RESTORE-ALS trial later in 2026.