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. director Reed N. Wilcox was granted a stock option for 3,720 shares of common stock on 08/14/2025 at an exercise price of $3.60 per share. The option was granted under the Clene Inc. Amended 2020 Stock Plan, vests immediately, and expires on 08/13/2035. Following the grant, the reporting person beneficially owns 3,720 underlying shares through this option. The Form 4 was signed by a power of attorney, Jerome T. Miraglia, and filed on 08/15/2025.
Clene Inc. amended its December 2024 senior secured convertible notes and sold a new series of senior secured convertible notes totaling $1,500,000. The amendment extends the maturity window to the earlier of 18 months following the amendment or February 13, 2027, and postpones $1,000,000 monthly principal repayments so they begin on the 13-month anniversary of the amendment (commencing September 13, 2026). Interest from August 1, 2025 through maturity will be capitalized and added to principal, and holders may elect to convert up to 65% of capitalized interest into common stock at $4.44 per share.
The new August 2025 notes bear 12% annual interest, require monthly principal repayments of $150,000 beginning 13 months after issuance, allow conversion of up to 65% of initial principal (subject to an aggregate conversion cap of $975,000), and provide holders in a change-in-control scenario options to convert, receive 115% cash, or a combination. Kensington is the collateral agent and several note purchasers have pre-existing relationships with the company, including board-affiliated parties. A press release with second quarter 2025 results is furnished as an exhibit.
Clene Inc. is a clinical-stage pharmaceutical company developing clean-surfaced nanocrystal therapeutics for central nervous system disorders. For the quarter ended June 30, 2025, cash and cash equivalents were $7.3 million (down from $12.2 million at 12/31/2024), total assets were $22.1 million, and total liabilities were $30.7 million, producing a stockholders' deficit of $(8.6) million. Revenue remained minimal at $27 thousand for the quarter and $108 thousand for the six months ended June 30, 2025, while net loss for the six months was $8.17 million (net loss per share, basic and diluted, $0.89).
The company disclosed substantial doubt about its ability to continue as a going concern, citing recurring operating losses, negative operating cash flow of $9.8 million for the six months, and an accumulated deficit of $290.3 million. Material financing and liquidity items include a $45.1 million NIH grant with up to $30.9 million of subawards to Clene (reimbursements recognized; $6.4 million recognized in the six months), equity distribution proceeds of $5.1 million in the six months (plus $1.9 million subsequent to period end), and convertible senior secured notes with covenants requiring at least $2.0 million of unrestricted cash to avoid acceleration. Management is pursuing additional financing and has implemented cost-saving measures, but concluded these plans do not alleviate the substantial doubt about operations beyond one year.