Every 8-K that Clene Inc. Warrant (CLNNW) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CLNNW and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CLNNW filings page.
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. reported first quarter 2026 results and amended its senior secured convertible notes to push all principal and interest to a new maturity no later than August 13, 2027. Revenue was modest at $15,000, while the company posted a net loss of $8.1 million, or $0.69 per share, compared with a $0.8 million loss a year earlier. Operating expenses fell sharply as research and development dropped to $0.3 million and general and administrative costs to $1.7 million. Cash and cash equivalents were $5.9 million as of March 31, 2026, and with recent $28 million and $7 million equity financings plus the amended $10 million convertible facility, Clene expects runway into late 2026 and potentially into 2027. The company plans to submit an NDA for its ALS candidate CNM-Au8 under the FDA’s accelerated approval pathway in the third quarter of 2026 and begin a confirmatory Phase 3 trial in early 2027.
Clene Inc. entered into an underwriting agreement to sell 1,000,000 shares of common stock at $7.00 per share in an underwritten registered direct offering, for gross proceeds of about $7 million and estimated net proceeds of approximately $6.4 million.
The company will pay underwriting discounts and commissions equal to 6.5% of gross proceeds plus about $140,000 of other offering expenses. Clene plans to use the cash, together with existing funds, for general corporate purposes and key development work on its lead drug candidate CNM-Au8, including regulatory filing preparation, ongoing and future Phase 3 clinical activities, manufacturing expansion, potential commercialization efforts, and early-stage R&D.
Canaccord Genuity LLC is the sole bookrunner, and the deal is expected to close on or about May 6, 2026, subject to customary conditions. The company and certain insiders agreed to 60-day lock-up restrictions on additional share sales, supporting short-term trading stability around this capital raise.
Clene Inc. announced that after a constructive Type C meeting, the FDA stated its proposed data "may be capable of supporting" an accelerated approval New Drug Application (NDA) for ALS drug candidate CNM-Au8, based on neurofilament light (NfL) biomarker data.
The FDA acknowledged that NfL could potentially serve as a reasonably likely surrogate endpoint for accelerated approval under Subpart H. Clene intends to submit the NDA in the third quarter of 2026, supported by Phase 2 HEALEY ALS Platform and RESCUE-ALS trials and an NIH-sponsored Expanded Access Protocol, and plans a Phase 3 confirmatory study starting in the first quarter of 2027.
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.