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. insider activity: An entity associated with major shareholder Ugwumba Chidozie, identified as SymBiosis II, LLC, reported open-market sales of Clene Inc. common stock. On May 1, 2026, SymBiosis II, LLC sold 5,795 shares at $6.01 per share. On May 4, 2026, it sold an additional 72,884 shares at $6.80 per share. After the May 4 transaction, SymBiosis II, LLC continued to hold 198,890 shares of Clene Inc. common stock indirectly on behalf of Ugwumba Chidozie.
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. is offering 1,000,000 shares of common stock at an offering price of $7.00 per share pursuant to this prospectus supplement and the accompanying base prospectus. Delivery is expected on or about May 6, 2026. Net proceeds to the company are estimated at approximately $6,405,000 after underwriting discounts. The company states it will use proceeds to prepare and file an NDA for CNM-Au8, support ongoing expanded access protocols and a planned Phase 3 trial, expand manufacturing, and for general corporate purposes. The filing discloses substantial doubt about Clene’s ability to continue as a going concern: cash and cash equivalents were $5.2M as of December 31, 2025, operating losses were $23.1M for 2025, and the company expects to need additional financing within the next twelve months. The prospectus supplement also summarizes recent FDA feedback that NfL biomarker changes “may be capable of supporting” an NDA submission under the accelerated approval pathway in ALS and states the company intends to submit an NDA in Q3 2026.
Clene Inc. files a preliminary prospectus supplement under its Form S-3 shelf to offer shares of common stock (Nasdaq: CLNN), with aggregate shelf capacity of $160,000,000. The supplement does not state the number of shares or the public offering price per share; delivery and certain dates are left blank in this draft. The prospectus supplement describes use of proceeds for general corporate purposes, including funding clinical development of CNM-Au8, manufacturing and regulatory activities, and early-stage R&D.
The company reported 11,778,307 shares outstanding as of April 30, 2026. Financial context includes a loss from operations of $23.1M and cash and cash equivalents of $5.2M as of December 31, 2025, and the filing discloses substantial doubt about going concern and plans to seek additional financing.
Symbiosis II LLC reports multiple open-market sales of Common stock of CLNN recorded on Form 144. The filing lists numerous cash transactions from 01/28/2026 through 05/04/2026, including lots such as 67,991 shares on 03/31/2026 and 31,624 shares on 05/04/2026.
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. ten percent owner associated entity SymBiosis II, LLC sold 19,497 shares of Common Stock in open-market transactions. The sales occurred over three days at prices of $5.63, $5.90, and $6.08 per share. After these indirect sales, 277,569 shares of Clene Common Stock remain held through SymBiosis II, LLC.
Symbiosis II LLC reported multiple open-market sales of Common Stock under Rule 144. The filing lists repeated dispositions between 01/28/2026 and 04/21/2026, including large blocks such as 67,991 shares on 03/31/2026 and 61,345 shares on 04/21/2026. The transactions were reported as cash open-market sales.
Clene Inc. insider associated entity sells shares in two open-market transactions. An entity linked to ten percent owner Ugwumba Chidozie, identified as SymBiosis II, LLC, sold 4,318 shares of Clene common stock at $6.12 per share on April 20, 2026, followed by 61,345 shares at $6.14 per share on April 21, 2026. After the April 21 sale, the filing reports 297,066 Clene shares indirectly held by this entity.
Clene Inc. ten percent owner Ugwumba Chidozie, through SymBiosis II, LLC, reported open-market sales of Clene common stock over three days. SymBiosis II, LLC sold 6,374 shares at $6.48 on April 15, 7,748 shares at $6.40 on April 16, and 25,040 shares at $6.43 on April 17, leaving 362,729 shares of indirect ownership after the latest transaction.