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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.
Clene Inc. reported that Chief Science Officer Mark Mortenson received a grant of stock options covering 45,000 shares of common stock. The options have an exercise price of $5.53 per share and expire on June 10, 2036. According to the grant terms, 25% of the options vest on June 11, 2027, with the remaining shares vesting in 36 equal monthly installments starting July 11, 2027. This is a compensation-related award, not an open-market stock purchase or sale.
Clene Inc. reported that President and CEO Robert Dee Etherington received a grant of stock options covering 65,000 shares of common stock. The options have an exercise price of $5.53 per share and expire on June 10, 2036. According to the grant terms, 25% of the options vest on June 11, 2027, with the remaining shares vesting in 36 equal monthly installments starting on July 11, 2027 until fully vested. This is a compensation-related award rather than an open-market purchase or sale.
Clene Inc. reported that Chief Financial Officer Morgan R. Brown received a grant of stock options covering 15,000 shares of common stock. The options have an exercise price of $5.53 per share and expire on June 10, 2036. They vest 25% on June 11, 2027, with the remaining shares vesting in 36 equal monthly installments beginning July 11, 2027. This is a compensation-related award rather than an open‑market share purchase or sale.
Clene Inc. amended its senior secured convertible promissory notes with AE Capital Limited, A Global Chorus Foundation, and Glenn and Shelina Way. The maturity date was extended to the earlier of August 13, 2027 or a change in control, and monthly principal and interest payments of $150,000 that were set to begin on September 13, 2026 will instead be paid in full at maturity.
Stockholders approved the Clene Inc. Amended 2020 Stock Plan, increasing the shares of common stock reserved for issuance by 1,000,000. At the May 21, 2026 annual meeting, they also elected three directors and approved the remaining proposals by wide margins, with one item receiving 7,737,513 votes in favor.
Clene Inc. director Vallerie McLaughlin received stock option awards as equity compensation. On May 21, 2026, she was granted options covering a total of 3,564 shares of common stock at an exercise price of $6.81 per share under the Clene Inc. Amended 2020 Stock Plan.
One option grant for 2,064 shares vests immediately, giving her the right to purchase those shares at the set price. A second option grant for 1,500 shares vests in 12 equal monthly installments on the 21st of each month starting June 21, 2026, extending through the following year. Both option series expire on May 20, 2036 if not exercised.