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 Shalom Jacobovitz received a grant of stock options for 4,752 shares of common stock on August 13, 2026 under the Clene Inc. Amended 2020 Stock Plan. The options have an exercise price of $4.19 per share, vest immediately upon grant, and expire on August 12, 2036. Following this award, Jacobovitz holds 4,752 stock options directly.
Clene Inc. director Jonathon Gay received a compensatory grant of 3,794 stock options on August 13, 2026 under the Clene Inc. Amended 2020 Stock Plan. The options have an exercise price of $4.19 per share, vest immediately upon grant, and are exercisable into 3,794 shares of common stock until August 12, 2036. Following this award, Gay holds 3,794 derivative securities directly.
Clene Inc. director Vallerie McLaughlin received a stock option grant for 3,514 shares of common stock on August 13, 2026 under the Clene Inc. Amended 2020 Stock Plan. The option has an exercise price of $4.19 per share, vests immediately upon grant, and expires on August 12, 2036. Following this grant, she holds options for 3,514 shares directly.
Clene Inc. director Reed N. Wilcox reported a grant of stock options for 3,514 shares of common stock on August 13, 2026 under the Clene Inc. Amended 2020 Stock Plan. The options have an exercise price of $4.19 per share, vest immediately upon grant, and expire on August 12, 2036. Following this award, Wilcox holds 3,514 options directly.
Clene Inc. reported second quarter 2026 results and highlighted regulatory and financing developments for its ALS candidate CNM-Au8. The company plans to submit a New Drug Application under the accelerated approval pathway in early fourth quarter 2026, supported by biomarker and clinical data linking reductions in neurofilament light (NfL) to survival and functional outcomes in ALS patients.
In May, Clene raised $7.0 million in an underwritten registered direct common stock offering and amended two senior secured convertible debt facilities totaling $11.5 million to extend maturity to August 2027 and remove principal and interest payments before maturity. Cash and cash equivalents were $9.7 million as of June 30, 2026, and the company expects its resources to fund operations through late fourth quarter 2026.
For the quarter ended June 30, 2026, Clene generated $90 thousand in total revenue and recorded a net loss of $13.4 million, or $1.08 per share, compared with a net loss of $7.4 million, or $0.78 per share, a year earlier. Research and development expense was $3.5 million and general and administrative expense was $1.9 million. Total other expense rose to $8.1 million, driven mainly by changes in fair value of warrant and derivative liabilities and higher interest expense.
Clene Inc. reported that it remains a clinical-stage company with limited revenue and continued losses, and disclosed that conditions raise substantial doubt about its ability to continue as a going concern. For the three months ended June 30, 2026, total revenue was $90 thousand, while the net loss widened to $13.4 million from $7.4 million a year earlier, driven largely by $7.5 million of non-cash losses from changes in fair value of warrant and derivative liabilities and interest expense.
For the six months ended June 30, 2026, the net loss was $21.5 million. Cash, cash equivalents and restricted cash increased to $9.7 million at June 30, 2026 from $5.2 million at December 31, 2025, mainly due to $11.7 million of net proceeds from common stock and warrant offerings, while net cash used in operating activities was $7.1 million, modestly lower than the prior-year period. Total assets were $23.0 million and total liabilities $47.8 million, resulting in a stockholders’ deficit of $24.8 million. The company is subject to covenants on its senior secured convertible notes, including maintaining at least $2.0 million of unrestricted cash, and plans to seek additional financing, partnerships, and use of its at-the-market facility.
Clene Inc. received an amended Schedule 13G filing (Amendment No. 4) from investor Chidozie Ugwumba reporting that he no longer has any beneficial ownership of Clene Inc. common stock. The filing states that, effective July 17, 2026, management of the investment portfolio of SymBiosis II, LLC, the fund through which he was previously deemed to own shares, was transferred to an unaffiliated third-party manager. As a result, Ugwumba no longer has voting or investment power over the fund’s holdings and now reports 0 shares beneficially owned, representing 0.0% of the class, with no sole or shared voting or dispositive power.
Clene Inc. is advancing its ALS program by presenting new post hoc biomarker analyses of CNM-Au8® that will be included in a planned New Drug Application seeking accelerated approval. The analyses focus on neurofilament light chain (NfL), a blood marker of nerve-cell injury that the FDA has acknowledged has established prognostic value in ALS and could potentially serve as a reasonably likely surrogate endpoint.
Across the HEALEY and RESCUE-ALS Phase 2 trials, CNM-Au8-treated patients whose NfL levels declined or stabilized lived significantly longer and showed better combined measures of survival and function than concurrently randomized controls or matched real-world ALS cohorts. In RESCUE-ALS, NfL responders had a 76% lower adjusted risk of death and longer median survival than non-responders, with consistent advantages on composite functional scores and breathing capacity.
A principal stratum analysis in HEALEY indicated that CNM-Au8’s survival benefit was concentrated in patients predicted to be NfL responders, while negative-control biomarkers showed no such effect, supporting a mechanism linked specifically to NfL change. CNM-Au8 has accumulated more than 1,280 participant-years of exposure with no serious adverse events assessed as related and no long-term safety signals, and a Phase 3 RESTORE-ALS trial is planned to test the NfL relationship prospectively.
Clene Inc. insider Chidozie Ugwumba reported an internal restructuring on July 17, 2026, disposing of beneficial ownership of warrants over 799,358 Clene common shares that had been held indirectly through SymBiosis II LLC. Management of the fund’s portfolio shifted to an unaffiliated manager; no warrants were exercised, sold, transferred, or paid for, and Ugwumba ceased to be a ten percent owner subject to Section 16.
Clene Inc. is the subject of a Schedule 13G reporting beneficial ownership of its common stock by Empery Asset Management, LP and Ryan M. Lane. The Reporting Persons collectively report beneficial ownership of 916,532 shares of common stock, representing 7.17% of the class, based on 12,778,307 shares outstanding as of May 11, 2026 as disclosed in a recent quarterly report.
Empery Asset Management, LP, as investment manager to certain funds, and Mr. Lane, through his roles in entities controlling the investment manager, may be deemed beneficial owners of the shares held by those funds. They report shared voting and dispositive power over 916,532 shares and no sole voting or dispositive power. Each Reporting Person disclaims beneficial ownership of shares owned by the others. The filing notes that the underlying Empery funds have the economic interest in dividends and sale proceeds associated with these securities.