 Clene Nanomedicine

Clene, Inc. is a clinical-stage biopharmaceutical company, which focuses on the development of therapeutics for neurodegenerative diseases. It offers a nanotechnology drug platform for the development of a new class of orally administered neurotherapeutic drugs. The company was founded on August 12, 2020 and is headquartered in Salt Lake City, UT.

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Clene, Inc. is a clinical-stage biopharmaceutical company, which focuses on the discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics. It offers a nanotechnology drug platform for the development of a new class of orally administered neurotherapeutic drugs. The company was founded in 2013 and is headquartered in Salt Lake City, UT.

SALT LAKE CITY, Feb. 29, 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 neurodegenerative diseases, including (ALS) and multiple sclerosis (MS), today presented full clinical results for CNM-Au8 ® from the VISIONARY-MS Trial long-term open label extension (LTE) in participants with stable relapsing multiple sclerosis (RMS) totaling nearly three years of follow-up at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in West Palm Beach, Florida.

Clene Presents Clinical Results of CNM-Au8® 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024

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Dec 21 (Reuters) - Clene (CLNN.O) said on Thursday data on its therapy to treat a type of neurological disease did not meet the U.S. drug regulator's target for accelerated approval.

Clene says FDA finds ALS drug data not enough for accelerated nod

SALT LAKE CITY, Dec. 21, 2023 (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 reported new data from the 12-month long-term open label extension (OLE) of the CNM-Au8® treatment arm in the HEALEY ALS Platform Trial.

Clene Reports Reduction in Biomarker Plasma Neurofilament Light (NfL) Levels and Improved Survival With CNM-Au8® Treatment From HEALEY ALS Platform Trial Long-Term Open Label Extension

SALT LAKE CITY, Dec. 21, 2023 (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 provided an ALS regulatory update from its recent meeting with the U.S. Food and Drug Administration (FDA).

Clene Provides Update on ALS Clinical Development Meeting With FDA

SALT LAKE CITY, Dec. 14, 2023 (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 treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson's disease and multiple sclerosis (MS), today announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8®, the company's lead drug candidate. CNM-Au8 is an orally-delivered suspension of clean-surfaced, catalytically-active gold nanocrystals shown to have neuroprotective and neuroreparative properties in multiple preclinical models of neurodegenerative disease.

Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Brain Target Engagement In Neurodegenerative Diseases

SALT LAKE CITY, Nov. 07, 2023 (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 treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson's disease and multiple sclerosis (MS), today announced its third quarter 2023 financial results and provided recent operating highlights for its ALS clinical program.

Clene Reports Third Quarter 2023 Financial Results and Operating Highlights

Funding to Support Research and Expanded Access of Investigational Drug in ALS Funding to Support Research and Expanded Access of Investigational Drug in ALS

National Institutes of Health Awards $45.1 Million NINDS Grant for CNM-Au8® Study in ALS

Novel catalytic mechanism of CNM-Au8 reveals its promise as a versatile new treatment to address multiple assaults on neuronal health in neurodegenerative diseases

Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Catalytic Neuroprotective Mechanism of Action

SALT LAKE CITY, Sept. 25, 2023 (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 treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis, today announced that it will participate in the Cantor Fitzgerald Annual Global Healthcare Conference. Rob Etherington, Chief Executive Officer, and Morgan Brown, Chief Financial Officer, will be participating in the presentation and 1x1 investor meetings.

Clene to Present at Cantor Fitzgerald Annual Global Healthcare Conference

SALT LAKE CITY, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine, Inc. (collectively “Clene”), today announced long-term follow-up data for patients treated with CNM-Au8 30mg for up to 133 weeks in the HEALEY ALS Platform Trial. These post hoc results show significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT) (hazard ratio: 0.510, 95% CI: 0.263 - 0.987, p=0.046).

Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls

SALT LAKE CITY, Aug. 30, 2023 (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 treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis, today announced that it will participate in the following investor conferences in September.

Clene to Present at Upcoming September Conferences

SALT LAKE CITY, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc., today announced the 24-month long-term data cut from the Phase 2 RESCUE-ALS ongoing open-label extension (OLE) as of July 2023, which showed a significant median survival benefit of 19.3 months using the rank-preserving structural failure time model (RPSFTM) and a significant 52% decreased risk of ALS clinical worsening events with CNM-Au8® treatment.

Clene Reports Significantly Improved Survival Benefit of 19.3 Months and Significantly Delayed Clinical Worsening in Rescue-Als Open-Label Extension Two Year Follow-Up

SALT LAKE CITY, Aug. 14, 2023 (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 its second quarter 2023 financial results and provided recent operating highlights for the clinical programs in ALS and MS.

Clene Reports Second Quarter 2023 Financial Results and Operating Highlights

SALT LAKE CITY, Aug. 02, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today announced that it will present at the Canaccord Genuity 43rd Annual Growth Conference. Rob Etherington, Chief Executive Officer, and Morgan Brown, Chief Financial Officer, will participate in the presentation and investor meetings.

Clene to Present at the Canaccord Genuity 43rd Annual Growth Conference

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SALT LAKE CITY, June 26, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today announced that The Lancet's journal eClinicalMedicine has published combined detailed analyses of the Phase 2 RESCUE-ALS study and its open-label extension trial. The article can be accessed via the following link: https://authors.elsevier.com/sd/article/S2589537023002134.

Clene Announces Publication of Phase 2 CNM-Au8® Clinical Data for the Treatment of ALS in LANCET's eClinicalMedicine

SALT LAKE CITY, June 21, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today announced the closing of an underwritten public offering of common stock and warrants with certain healthcare-focused institutional investors with total gross proceeds of $40 million and that may provide additional capital in the future through the exercise of warrants with accelerated expiration dates tied to satisfaction of regulatory milestones.

Clene Welcomes New Shareholder Base and Announces Closing of Underwritten Public Offering of $40 Million

SALT LAKE CITY, June 16, 2023 (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 revolutionizing the treatment of neurodegenerative disease, today announced the pricing of an underwritten public offering of (i) 50,000,000 shares of its common stock and (ii) two tranches of warrants (each warrant to purchase one share of common stock). The combined offering price to the public of each share of common stock and accompanying warrant is $0.80.

Clene Announces Pricing of $40 Million Public Offering

SALT LAKE CITY, June 15, 2023 (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 revolutionizing the treatment of neurodegenerative disease, today announced  a proposed underwritten public offering in which it intends to offer and sell (i) shares of its common stock and (ii) accompanying warrants to purchase shares of common stock. The shares of common stock and the accompanying warrants will be issued separately but can only be purchased together in the offering. All of the shares of common stock and accompanying warrants are being offered by Clene. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Clene Announces Launch of Proposed Public Offering

SALT LAKE CITY, June 15, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today reported new data demonstrating a statistically significant reduction of plasma neurofilament light chain (NfL) levels for CNM-Au8® treated participants compared to placebo after 24 weeks of treatment in the double-blind, placebo-controlled period of the HEALEY ALS Platform Trial.

Clene's CNM-Au8® Shows Statistically Significant Difference in Plasma Neurofilament Light (NfL) levels in the HEALEY ALS Platform Trial

SALT LAKE CITY, June 15, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today announced that Rob Etherington, Chief Executive Officer, will participate in a fireside chat with Naz Rahman, Senior Biotech Research Analyst, at the Maxim Group Virtual Healthcare Conference on June 22, 2023 at 1:00 PM ET.

Clene to Participate in the Maxim Group Virtual Healthcare Conference

Clene Inc. (CLNN) came out with a quarterly loss of $0.15 per share versus the Zacks Consensus Estimate of a loss of $0.16. This compares to loss of $0.21 per share a year ago.

Clene Inc. (CLNN) Reports Q1 Loss, Misses Revenue Estimates

SALT LAKE CITY, May 12, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, today announced its first quarter 2023 financial results and provided recent operating highlights for the clinical programs in amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”).

Clene Reports First Quarter 2023 Financial Results and Recent Operating Highlights

SALT LAKE CITY, April 25, 2023 (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 revolutionizing the treatment of neurodegenerative diseases, announced that CNM-Au8® results in multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) were presented in plenary sessions at the 2023 American Academy of Neurology (AAN) Annual Meeting, currently taking place in Boston. The MS platform presentation and ALS survival poster highlight the results from multiple clinical trials that demonstrated clinical benefit and safety of treatment with CNM-Au8, a cellular energetic nanocatalyst.

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