Clene

CLNN

Market cap $59.5M

SALT LAKE CITY, Jan. 16, 2026 (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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference.

SALT LAKE CITY, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that the U.S. Food and Drug Administration (FDA) has granted Clene an in-person Type C Meeting later this quarter.

Oversubscribed registered direct offering priced above market to new, existing and insider investors, including Boxer Capital Management, Coastlands Capital, and Vivo Capital Initial financing tranche of over $6 million, which we expect will provide cash runway into the third quarter of 2026 enabling funding through potential NDA acceptance decision by the FDA, with two additional financing tranches totaling over $22 million contingent on NDA acceptance and NDA approval by the FDA Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into early 2027, which we expect will allow potential commercialization of CNM-Au8 in ALS SALT LAKE CITY, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary, Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced a registered direct offering priced above market under Nasdaq rules of over $28 million by new and existing investors. “We are happy to welcome top-tier investors Boxer Capital, Coastlands Capital and Vivo Capital, along with other current insider investors, who share our excitement and enthusiasm for the important work that Clene has undertaken in ALS,” said Rob Etherington, CEO of Clene, Inc. “Their investment further validates the promise and potential of ALS biomarkers and survival data for a planned New Drug Application in ALS in 2026 for CNM-Au8, on which Clene has been focused.

SALT LAKE CITY, Dec. 09, 2025 (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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference.

FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8 Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8's potential disease modifying activity Company has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathway Clene is hosting an investor webcast today at 8:30 am ET SALT LAKE CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced completion of the FDA-recommended biomarker analyses for CNM-Au8® in people living with ALS. The results demonstrate statistically significant reductions in both neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) and provide compelling evidence linking biomarker decline to improved survival.

SALT LAKE CITY, Dec. 02, 2025 (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 revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced it plans provide an update on its CNM-Au8 program in ALS, and to host an investor call and webcast at 8:30 am ET on Wednesday, December 3, 2025. The webcast is accessible via the link below or the Investors section of the Company's website located here.

SALT LAKE CITY, Nov. 20, 2025 (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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference by hosting 1x1 investor meetings.

Clene Inc. (CLNN) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $0.6. This compares to a loss of $1.22 per share a year ago.

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly  The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company's MS clinical development program and ongoing plans for MS development of CNM-Au8 Cash and cash equivalents of $7.9 million as of September 30, 2025 Cash runway extended into the second quarter of 2026, including $1.2 million additionally raised following the third quarter close SALT LAKE CITY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its third quarter 2025 financial results and provided recent updates on its CNM-Au8 programs. “The three potential biomarker paths that could be leveraged to increase the persuasiveness of our ALS data, as outlined by the FDA, include: a) the NfL analysis of our ongoing NIH-sponsored Expanded Access Program (EAP); b) additional ALS disease-specific biomarker changes (in addition to NfL) from the HEALEY ALS Platform Trial; and c) NfL analysis of subjects in the open-label extension (OLE) of the HEALEY ALS Platform Trial who were initially treated with placebo during the placebo-controlled portion of the trial and then received CNM-Au8 during the OLE,” said Rob Etherington, President and CEO of Clene.

SALT LAKE CITY, Oct. 20, 2025 (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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference. Virtual Presentation Details Date: October 23, 2025 Time of Presentation: 3:10 p.m.