Business
Clene Reports Second Quarter 2023 Financial Results and Operating Highlights
Reported statistically significant reductions in plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) in patients treated
About this update from Clene Inc.
[{"type":"text","content":"Reported statistically significant reductions in plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) in patients treated with CNM-Au8® in the HEALEY ALS Platform trialAnnounced publication of the results of the Phase 2 RESCUE ALS study and its open-label extension in the Lancet journal, eClinicalMedicineReceived one-year grant from the National Multiple Sclerosis Society (NMSS) that will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MSCompany expects multiple near-term data announcements that will further support benefit and safety of CNM-Au8 in people living with ALS Company is preparing for upcoming ALS regulatory discussions with FDACash, cash equivalents and marketable securities of $49.2 million as of June 30, 2023, which includes gross proceeds of $40 million from a recent public offering and that may provide additional capital up to $130 million through future warrant exercises 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. “Our recent financing has strengthened our capital position and provided the runway needed to advance our ALS clinical program with upcoming engagement with regulatory agencies, the initiation of our global Phase 3 in ALS (RESTORE-ALS), and additional clinical trial data read-outs,” said Rob Etherington, President and CEO of Clene. “We look forward to additional long-term clinical data, including survival, time-to-clinical-worsening and additional biomarker data, from the HEALEY ALS Platform trial. We are actively preparing for ALS regulatory discussions with the FDA and EMA, with meetings anticipated later this year. Additionally, we plan to continue advancing our clinical program in MS, while pursuing prospective partnering opportunities in parallel.” Second Quarter 2023 and Recent Operating Highlights CNM-Au8, a gold nanocrys...