Clene Inc. - Press Releases

Year

Clene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior Loan

Secures new $10.0 million debt facility to replace remaining $7.85 million of Avenue Capital debt Improves cash position enabling Clene to generate the additional data to support the new drug application of CNM-Au8 ® for ALS via an accelerated regulatory pathway Carries a 12% interest rate per

December 19, 2024

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FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS

FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier presented findings FDA recommends a follow-up meeting to discuss in more detail the analyses needed to support the

December 10, 2024

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Clene Reports Third Quarter 2024 Financial Results and Recent Operating Highlights

Clene met with the U.S. Food and Drug Administration (FDA) on November 1, 2024, in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS and are awaiting meeting minutes Cash, cash equivalents and marketable securities of $14.6 million as of September 30, 2024 Amended

November 13, 2024

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Clene to Present at Upcoming October Conferences

SALT LAKE CITY, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat

October 9, 2024

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Clene Announces Closing of $7.3 Million Registered Direct Offering and Concurrent Private Placements and Amendment of Debt Facility

Investment led by healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene’s Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other

October 1, 2024

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Clene Announces $7.3 Million Registered Direct Offering and Concurrent Private Placements Priced at Market Under Nasdaq Rules

SALT LAKE CITY, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly-owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat

September 30, 2024

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Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data

SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to

September 16, 2024

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Clene to Present at the H.C. Wainwright 26th Annual Global Investment Conference

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat

September 3, 2024

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Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights

Survival analyses with CNM-Au8 ® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated

August 7, 2024

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Clene Announces New CNM-Au8® Biomarker and Clinical Efficacy Data Submitted to FDA In Support of Treatment For ALS

CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores)

August 6, 2024

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