Every 8-K that Clene Inc. (CLNN) 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 CLNN 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 CLNN filings page.
Clene Inc. (CLNN) entered into a securities purchase agreement with existing stockholders, including certain directors and officers, for a registered direct offering of 1,219,513 shares of common stock at $3.28 per share, for aggregate gross proceeds of approximately $4.0 million. The offering, made off Clene’s effective Form S-3 shelf registration statement, is being conducted without a placement agent, underwriter, broker or dealer, so no underwriting discounts or commissions will be paid, and only an insignificant amount of offering expenses is expected.
The closing is expected on September 17, 2026, with the transaction led by Clene’s chairman David Matlin, founding investor Kensington Capital Holdings, the chief executive officer and other existing shareholders. Clene expects to use the net proceeds, together with existing cash, for general corporate purposes, primarily to support regulatory dialogue, preparation of regulatory filings and a new drug application for lead candidate CNM-Au8, including expanded access protocols, potential commercialization efforts and manufacturing expansion. The company states the offering is expected to provide sufficient cash to fund operations through mid-first quarter 2027.
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. 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. 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. 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. entered into a securities purchase agreement with institutional investors, existing stockholders, and certain directors to sell 928,333 shares of common stock together with warrants. Each unit consists of one share, one Series A Warrant to purchase up to 1,114,000 shares, and one Series B Warrant to purchase up to 2,599,333 shares, sold at $6.50 per unit. The warrants are immediately exercisable at $6.00 per share, with exercise prices that can step up based on FDA and stock price triggers, and have terms of three years for Series A and five years for Series B.
The transaction, conducted via BTIG as placement agent on a best-efforts basis, is expected to generate aggregate gross proceeds of approximately $6.0 million before fees. Clene plans to use net proceeds, together with existing cash, primarily to fund clinical development, potential commercialization, and regulatory activities for its lead drug candidate CNM-Au8, as well as other early-stage research. The deal includes short-term restrictions on additional equity issuance and director lock-ups limiting share sales for 45 days.
Clene Inc. reported that on January 12, 2026 it issued a press release describing additional biomarker data for its investigational therapy CNM-Au8®. The company states this new biomarker information is intended to support a potential new drug application and preparation for an upcoming in-person meeting with the U.S. Food and Drug Administration. The 8-K mainly serves to make this press release part of the official record by filing it as an exhibit.
Clene Inc. furnished an 8-K announcing third quarter 2025 financial results and recent operating highlights for the quarter ended September 30, 2025. The details are provided in a press release furnished as Exhibit 99.1 and incorporated by reference. The Item 2.02 information is furnished, not filed, and is not subject to Section 18 liabilities. The filing also lists the company’s Nasdaq-listed common stock (CLNN) and warrants (CLNNW).
Clene Inc. (CLNN) expanded its at-the-market equity program. The company previously entered into an equity distribution agreement to offer and sell common stock with an aggregate offering price of up to $25,000,000 through Canaccord Genuity LLC.
As of October 17, 2025, Clene reported prior sales of approximately $6,119,859 under this program and filed a prospectus supplement covering an additional $18,880,000 of common stock. A legal opinion from Holland & Knight LLP regarding the validity of the shares was filed as Exhibit 5.1.
Clene Inc. (CLNN) furnished an updated corporate presentation that includes preliminary unaudited figures for its cash and cash equivalents as of September 30, 2025, and the gross proceeds raised under its at-the-market equity distribution agreement from after September 30, 2025 through October 14, 2025. The presentation is attached as Exhibit 99.1.
The company notes these figures were prepared by management and remain subject to completion of financial closing procedures and potential audit adjustments. The materials are furnished under Items 2.02 and 7.01 and are not deemed “filed” for purposes of Section 18 of the Exchange Act, which means they are not subject to its liability provisions or automatically incorporated by reference into other filings.
Clene Inc. presented new clinical data at ECTRIMS 2025 showing CNM-Au8 improves brain energy metabolism in multiple sclerosis patients. The company furnished a poster as Exhibit 99.1 and a press release as Exhibit 99.2 in an 8-K dated September 25, 2025. The filing states the furnished materials are incorporated by reference for disclosure purposes but are not "filed" under Section 18 of the Exchange Act. No numerical efficacy, patient counts, statistical measures, or detailed clinical results are included in the text of this Current Report.
Clene Inc. has an ongoing equity distribution agreement with Canaccord Genuity LLC dated April 28, 2025, authorizing offers and sales of up to $25,000,000 of common stock. Through this program the company previously sold common stock totaling approximately $3,706,213. On September 5, 2025 Clene filed a prospectus supplement adding $6,280,000 of additional shares available for sale under the agreement. The legal opinion from Holland & Knight LLP regarding the validity of the shares is filed as Exhibit 5.1 and is incorporated by reference.
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.