Core Points - Clene Inc. is expanding its National Institutes of Health (NIH)-funded Accelerating Access to Critical Therapies Expanded Access Program (ACT-EAP) for its investigational drug CNM-Au8 in ALS, increasing enrollment by 80% to a maximum of 180 participants [1][2][3] - The ACT-EAP aims to collect 'real-world' drug efficacy data, monitoring potential effects on survival and disease progression, alongside safety data [1][2] - The first patient visit for the ACT-EAP is scheduled for early June 2024 [1][3] Company Updates - Clene has received a four-year grant from the National Institute of Neurological Disorders and Stroke (NINDS) to support the EAP for CNM-Au8 in ALS [2] - The company has implemented significant efficiencies in manufacturing, operations, and personnel to accommodate the expanded program without increasing the budget [2] - Clene's ACT-EAP is designed to contribute to the understanding of ALS disease progression and response to therapy, adding to the clinical safety database for CNM-Au8 [2][3] Drug Efficacy and Safety - CNM-Au8 treatment has shown a lowered risk of death and delayed clinical worsening in independent Phase 2 clinical studies [3] - The EAP will provide broader data on ALS patients compared to traditional clinical trials, enhancing the understanding of the drug's safety and efficacy [3] - The study will also collect biomarker data to analyze alongside the efficacy data [2] Collaboration and Innovation - Clene is collaborating with Columbia University and Synapticure to enhance the reach of the EAP through a telehealth platform, making it accessible to more ALS patients across the US [3] - The ACT-EAP is not a standard program; it is designed to yield important insights into the real-world impact of CNM-Au8 treatment on ALS [3] Background on Clene - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS, Parkinson's disease, and multiple sclerosis [5] - CNM-Au8 is a first-in-class investigational therapy aimed at improving mitochondrial health and reducing oxidative stress in central nervous system cells [5]

Clene Inc. (CLNN) came out with a quarterly loss of $0.09 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.07 per share when it actually produced a loss of $0.06, delivering a surprise of 14.29%.Over the last four quarters, the company has surpassed consensus EPS estimates three times.Clene, which belongs to the Zacks Medical - B ...

Exhibit 99.1 CLENE REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05) ● Peer-reviewed publication characterized the protein corona of CNM-Au8 ● Company received sub-award of $7.3 million from NIH grant for ALS Expanded Access Program ● Cash, cash equivalents and ...

Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)Peer-reviewed publication characterized the protein corona of CNM-Au8Company received sub-award of $7.3 million from NIH grant for ALS Expanded Access ProgramCash, cash equivalents and marketable securities of $27.9 million as of March 31, 2024 SALT LAKE CITY, May 08, 2024 (GLOBE NEWSWIRE) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 | --- | --- | --- | --- | |------------------------------------------------------------------- ...

LOS ANGELES, May 01, 2024 (GLOBE NEWSWIRE) --  via IBN – IBN, a multifaceted communications organization engaged in connecting public companies with the investment community, today announces that Rob Etherington, President, Director and CEO of late clinical-stage biopharmaceutical company Clene Inc. (NASDAQ:CLNN), recently appeared on From Lab to Launch, a podcast sharing the inspiring stories of founders, investors, scientists, engineers and pioneers in the life sciences sector. The podcast, hosted by Meg ...

Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8® 30 mg treatment (change from original baseline; p<0.05)Long-term CNM-Au8 treatment, encompassing up to three years, was well-tolerated; no significant safety findings were observedFirst Phase 2 clinical MS trial ...

LOS ANGELES, March 19, 2024 (GLOBE NEWSWIRE) -- via IBN – IBN, a multifaceted communications organization engaged in connecting public companies with the investment community, today announces that Rob Etherington, President, Director and CEO of late clinical-stage biopharmaceutical company Clene Inc. (NASDAQ:CLNN), recently appeared on First in Human, a biotech-focused podcast featuring interviews with industry leaders and investors to learn about their journeys to in-human clinical trials. The podcast, hos ...

Proprietary catalytic gold nanocrystals comprising Clene's investigational drug CNM-Au8® develop a protein corona upon exposure to human blood plasma comprised of proteins that promote blood-brain barrier penetration, an important feature of the drug's neuroprotective mechanism of actionThe protein corona attracted by CNM-Au8 nanocrystals prevents aggregation upon entering the bloodstream, enabling the drug's longevity in circulation without provoking an inflammatory response SALT LAKE CITY, March 15, 2024 ...

Clene Inc. (CLNN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.02, delivering a surprise of 80%.Over the last four quarters, the company has surpassed consen ...