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.
Clene Inc. filings document regulatory, financing, governance and operating disclosures for a late clinical-stage biopharmaceutical company focused on neurodegenerative diseases. Form 8-K reports cover CNM-Au8 clinical and regulatory communications, operating and financial results, securities purchase agreements, warrant terms and grant-related subaward agreements supporting ALS expanded access activity.
Proxy materials describe annual meeting proposals, director elections, auditor ratification and other shareholder voting matters. The filing record also addresses capital-structure changes, material agreements, Regulation FD disclosures, intellectual-property provisions tied to research funding, clinical and regulatory disclosures, and the role of Clene Nanomedicine Inc. in the company’s development programs.
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.
Clene Inc. director Vallerie McLaughlin was awarded a stock option covering 3,030 shares of Common Stock. The option was granted on February 19, 2026 under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share.
The filing shows this as a derivative acquisition with no cash paid at grant. According to the disclosure, the option vests immediately upon grant and leaves McLaughlin with 3,030 derivative shares following the transaction, reflecting a new equity-based incentive rather than an open-market share purchase.
Clene Inc. director Reed N. Wilcox reported an equity award in the form of stock options. He was granted options covering 3,306 shares of common stock under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share.
The options vest immediately upon grant, giving him the right to purchase these shares at the stated exercise price. Following this grant, his directly held derivative securities position from this option award is reported as 3,306 options.
Clene Inc. director Alison Mosca received a grant of stock options as equity compensation. On February 19, 2026, she was awarded options for 4,201 shares of common stock under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share. The options vested immediately upon grant, giving her the right to purchase the underlying shares at this fixed price.
Clene Inc. director David J. Matlin received a stock option grant covering 5,372 shares of Common Stock. The option was granted on February 19, 2026 under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share and vests immediately upon grant.
Clene Inc. director Arjun JJ Desai reported an award of stock options. On February 19, 2026, he received an option grant for 3,168 shares of common stock under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share. The footnote states these options vest immediately upon grant, giving him the right to purchase Clene shares at that price going forward.
Clene Inc. director Jacobovitz Shalom reported receiving a stock option grant for 4,098 shares of common stock. The option was granted on February 19, 2026 under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share.
The option vests immediately upon grant, meaning it is fully exercisable right away. Following this award, Shalom holds stock options for 4,098 shares, all reported as directly owned. This is a compensation-related equity grant rather than an open-market share purchase.
Clene Inc. director Jonathon Gay reported receiving a grant of stock options. The award covers 3,271 shares of Common Stock, granted on February 19, 2026 under the Clene Inc. Amended 2020 Stock Plan at an exercise price of $4.73 per share. The options vest immediately upon grant, and Gay now directly holds 3,271 stock options following this acquisition.