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<title>Clene Inc. — News on 6ix</title>
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<title>Clene Inc.</title>
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<title>Clene Reports Full Year 2025 Financial Results and Recent Operating Highlights</title>
<link>https://6ix.com/company/clene-inc/news/clene-reports-full-year-2025-financial-results-and-recent-operating-highlights-8</link>
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<pubDate>Thu, 12 Mar 2026 04:00:00 GMT</pubDate>
<description>In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting</description>
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<title>Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts</title>
<link>https://6ix.com/company/clene-inc/news/clene-issues-stockholder-letter-highlighting-upcoming-cnm-au8r-2026-catalysts</link>
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<pubDate>Tue, 24 Feb 2026 05:00:00 GMT</pubDate>
<description>Operating capital runway sufficient into the fourth quarter of 2026 In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the</description>
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<title>Clene to Present at the Emerging Growth Conference</title>
<link>https://6ix.com/company/clene-inc/news/clene-present-emerging-growth-conference-133000585</link>
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<pubDate>Fri, 16 Jan 2026 13:30:00 GMT</pubDate>
<description>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. Virtual Presentati</description>
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<title>Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting</title>
<link>https://6ix.com/company/clene-inc/news/clene-announces-additional-cnm-au8-133000262</link>
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<pubDate>Mon, 12 Jan 2026 13:30:00 GMT</pubDate>
<description>The FDA has granted an in-person Type C meeting during the first quarter of 2026 New independent analyses across large observational ALS cohorts demonstrate that modest (~10%) NfL reductions are significantly associated with lower mortality risk, supporting NfL reduction as a candidate surrogate endpoint for accelerated approvalNew exploratory findings demonstrate that in responders with IGFBP7 biomarker decline, CNM-Au8 30mg was strongly associated with 78% reduced mortality risk (HR 0.22, p=0.</description>
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<title>Clene Announces Registered Direct Offering of Over $28 Million</title>
<link>https://6ix.com/company/clene-inc/news/clene-announces-registered-direct-offering-133000907</link>
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<pubDate>Fri, 09 Jan 2026 13:30:00 GMT</pubDate>
<description>Oversubscribed registered direct offering priced above market to new, existing and insider investors, including Boxer Capital Management, Coastlands Capital, and Vivo CapitalInitial 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 FDACompletion of th</description>
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<title>Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®</title>
<link>https://6ix.com/company/clene-inc/news/clene-announces-statistically-significant-als-130000939</link>
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<pubDate>Wed, 03 Dec 2025 13:00:00 GMT</pubDate>
<description>FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activityCompany 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 pathwayClene is hosting an investor webcast today at 8:30 am ET SALT</description>
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<title>Clene to Provide CNM-Au8® ALS Program Update</title>
<link>https://6ix.com/company/clene-inc/news/clene-cnm-au8-als-program-223900733</link>
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<pubDate>Tue, 02 Dec 2025 22:39:00 GMT</pubDate>
<description>Webcast set for 8:30 a.m. ET on December 3rdSALT 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</description>
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<title>Clene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference</title>
<link>https://6ix.com/company/clene-inc/news/clene-participate-benchmark-14th-annual-130000153</link>
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<pubDate>Thu, 20 Nov 2025 13:00:00 GMT</pubDate>
<description>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</description>
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<title>Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights</title>
<link>https://6ix.com/company/clene-inc/news/clene-reports-third-quarter-2025-130000431</link>
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<pubDate>Thu, 13 Nov 2025 13:00:00 GMT</pubDate>
<description>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 analysesThe Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathwayThe Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 20</description>
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<title>Clene to Participate in a Panel Discussion at the Maxim Growth Summit</title>
<link>https://6ix.com/company/clene-inc/news/clene-participate-panel-discussion-maxim-123000259</link>
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<pubDate>Wed, 15 Oct 2025 12:30:00 GMT</pubDate>
<description>SALT LAKE CITY, Oct. 15, 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 in a panel discussion at the Maxim Growth Summit</description>
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<title>Clene Presents New Clinical Data at ECTRIMS 2025 Meeting Demonstrating CNM-Au8® Improves Brain Energy Metabolism in Multiple Sclerosis Patients</title>
<link>https://6ix.com/company/clene-inc/news/clene-presents-clinical-data-ectrims-120000278</link>
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<pubDate>Thu, 25 Sep 2025 12:00:00 GMT</pubDate>
<description>Late-breaking clinical data presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis Across non-active progressive MS (primary progressive and secondary progressive MS), relapsing MS, and Parkinson’s disease patients, CNM-Au8® improved the brain’s energy metabolism evidenced by improved NAD+/NADH ratio At the Type B end-of-Phase 2 MS meeting with the U.S. Food and Drug Administration, FDA aligned with Clene acknowledging the limitations of the Exp</description>
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<title>Clene Presents Preclinical Data Supporting CNM-Au8® for the Treatment of Parkinson’s Disease</title>
<link>https://6ix.com/company/clene-inc/news/clene-presents-preclinical-data-supporting-123000450</link>
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<pubDate>Thu, 04 Sep 2025 12:30:00 GMT</pubDate>
<description>Novel human preclinical neuronal model for Parkinson’s disease demonstrated CNM-Au8’s ability to improve mitochondrial health, restore cellular metabolism, reduce inflammation, and normalize dysregulated gene expression in both familial and sporadic Parkinson’s disease Results presented today at the H2 Therapeutics Stewardship Meeting in New York City, hosted by the Michael J Fox Foundation Taken together with results from a Phase 2 study that demonstrated orally dosed CNM-Au8 favorably alters c</description>
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<title>Clene to Present at the H.C. Wainwright 27th Annual Global Investment Conference</title>
<link>https://6ix.com/company/clene-inc/news/clene-present-h-c-wainwright-120000847</link>
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<pubDate>Tue, 02 Sep 2025 12:00:00 GMT</pubDate>
<description>SALT LAKE CITY, Sept. 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 that management will present at the H.C. Wainwright 27th Annual Global Investment Conference and host 1x1 investor m</description>
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<title>Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights</title>
<link>https://6ix.com/company/clene-inc/news/clene-reports-second-quarter-2025-123800605</link>
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<pubDate>Thu, 14 Aug 2025 12:38:00 GMT</pubDate>
<description>Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025A second Type C meeting has been scheduled with the FDA in the third quarter of 2025 to review the survival benefit associated with CNM-Au8 dosingThe Company expects to submit a New Drug Application in the fourth quarter of 2025 for potential accelerated approval of CNM-Au8® in ALSA</description>
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<title>Clene to Present at the Canaccord 45th Annual Growth Conference</title>
<link>https://6ix.com/company/clene-inc/news/clene-present-canaccord-45th-annual-123000717</link>
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<pubDate>Tue, 05 Aug 2025 12:30:00 GMT</pubDate>
<description>SALT LAKE CITY, Aug. 05, 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 that management will present at the Canaccord 45th Annual Growth Conference and host 1x1 investor meetings. Date: Aug</description>
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<title>Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings</title>
<link>https://6ix.com/company/clene-inc/news/clene-provides-regulatory-following-constructive-120000467</link>
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<pubDate>Mon, 30 Jun 2025 12:00:00 GMT</pubDate>
<description>FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene’s NIH-sponsored Expanded Access ProgramNfL EAP biomarker analyses to be conducted early in the 4th Quarter of 2025 Clene confirms two additional FDA meetings scheduled for 3rd Quarter of 2025, to discuss ALS survival data and MS clinical development programSubmission of new drug application for ALS under the accelerated approval pathway on track for potential submission in the 4th</description>
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<title>Clene Inc. Chief Executive Officer Rob Etherington to Present at the Investor Summit Virtual on June 10, 2025</title>
<link>https://6ix.com/company/clene-inc/news/clene-inc-chief-executive-officer-rob-etherington-to-present-at-the-investor-summit-virtual-on-june-10-2025</link>
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<pubDate>Mon, 09 Jun 2025 04:00:00 GMT</pubDate>
<description>SALT LAKE CITY, UT / ACCESS Newswire / June 9, 2025 / Clene Inc. announced that Rob Etherington, Chief Executive Officer and President, will be presenting at</description>
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<title>Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights</title>
<link>https://6ix.com/company/clene-inc/news/clene-reports-first-quarter-2025-120000855</link>
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<pubDate>Wed, 07 May 2025 12:00:00 GMT</pubDate>
<description>Clene preparing for upcoming meeting in the second quarter with the U.S. Food and Drug Administration (FDA) to reach agreement on its statistical analysis plan (SAP) regarding analysis of neurofilament light chain (NfL) biomarker dataClene collecting NfL biomarker data from its large National Institute of Health (NIH)-sponsored Expanded Access Protocol (EAP), for evaluation in the third quarter to satisfy the FDA recommendation for additional NfL dataClene reported new data supporting the remyel</description>
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<title>Clene Inc. Announces Participation in the D. Boral Capital Inaugural Global Conference</title>
<link>https://6ix.com/company/clene-inc/news/clene-inc-announces-participation-d-120000772</link>
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<pubDate>Wed, 07 May 2025 12:00:00 GMT</pubDate>
<description>Salt Lake City, Utah--(Newsfile Corp. - May 7, 2025) - Clene Inc. (NASDAQ: CLNN), today announced its participation in the D. Boral Capital Inaugural Global Conference, taking place May 14, 2025, at The Plaza Hotel in New York City.Rob Etherington, President and Chief Executive Officer, will be hosting one-on-one meetings on May 14th from 9:00 A.M. to 3:00 P.M. (ET). To register for one-on-one meetings with management at The Plaza Hotel ...</description>
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<title>Clene Presents Evidence of Remyelination and Neuronal Repair With CNM-Au8® Treatment At the American Academy of Neurology Late-Breaking Science Session</title>
<link>https://6ix.com/company/clene-inc/news/clene-presents-evidence-remyelination-neuronal-120000812</link>
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<pubDate>Tue, 08 Apr 2025 12:00:00 GMT</pubDate>
<description>Analyses of MRI and VEP data confirm anatomical and physiological improvements, indicating remyelination and neuronal repair in the brains of MS patients treated with CNM-Au8 during the long-term extension of VISIONARY-MSOver 90% of participants who showed improvements in cognition and vision also demonstrated corresponding improvements on MRI and visual electrophysiology tests SALT LAKE CITY, April 08, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, I</description>
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