Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
Clene Inc. (NASDAQ: CLNN) has launched a second FDA expanded access program (CNMAu8.EAP02) for its investigational therapy CNM-Au8 to assist ALS patients unable to enroll in the Healey ALS Platform Trial. This initiative aims to provide critical access to CNM-Au8, which is being investigated for treating amyotrophic lateral sclerosis, while the primary trial's results are expected in mid-2022. The program is supported by key trial sites and is part of Clene's ongoing commitment to address the needs of ALS communities.
Clene Inc. (NASDAQ: CLNN) announced significant results from its Phase 2 REPAIR-PD clinical trial for CNM-Au8, a gold nanocrystal suspension aimed at treating Parkinson's disease. The trial demonstrated a statistically significant increase in the brain NAD+/NADH ratio, a crucial marker for energy metabolism, with a p-value of 0.037. This improvement corresponds to reversing about 20 decades of normal aging. There were no serious adverse events, further reinforcing CNM-Au8's safety profile. The company presented these findings at the International Parkinson and Movement Disorder Society Virtual Congress.
Clene Inc. (NASDAQ: CLNN) announced the completion of the final patient visit in its Phase 2 RESCUE-ALS study, with close-out activities now underway. The trial involved 45 ALS patients and aimed to evaluate the efficacy and safety of CNM-Au8, a gold nanocrystal suspension. Interim results demonstrated improvements in neurophysiology endpoints, contrasting prior worsening in ALS data sets. Notably, 90% of eligible participants have chosen to continue treatment under a long-term extension of the study. Unblinded topline data are expected in Q4 2021.
Clene Inc. (NASDAQ: CLNN) announced its participation in several investor conferences in September 2021. The events include the Citi’s 16th Annual BioPharma Virtual Conference from September 8-10, the H.C. Wainwright 23rd Annual Global Investment Conference on September 13 with a pre-recorded corporate presentation, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21 for a live presentation, and the 2021 Cantor Virtual Global Healthcare Conference on September 27. Webcasts of the presentations will be available on Clene's website.
Clene Inc. (NASDAQ: CLNN) has finalized lease agreements that will more than quadruple its manufacturing capacity for CNM-Au8, a leading treatment for neurodegenerative diseases. The first lease is for a 74,210 sq. ft. facility in Elkton, Maryland, set to be redeveloped within weeks, with partial occupancy anticipated in months. Additionally, a seven-year lease will expand existing capacity at another Maryland site to 32,229 sq. ft. This expansion responds to the upcoming Phase 3 trial data for ALS, enhancing Clene's readiness for potential commercialization.
Clene Inc. (NASDAQ: CLNN) reported positive Phase 2 REPAIR trial results, indicating that its nanotherapy, CNM-Au8, significantly enhances brain energy metabolism in patients with neurodegenerative diseases. CNM-Au8 showed 10.4% improvement in the NAD+/NADH ratio in MS and PD patients. The RESCUE-ALS trial is on track for top-line data in H2 2021, suggesting neuro-reparative potential in ALS. As of June 30, 2021, the company had $63 million in cash and expects sufficient funds for over 12 months. The company incurred a net loss of $3.4 million for the quarter, an improvement from the previous year.
Clene Inc. (NASDAQ: CLNN) has appointed Dr. Vallerie V. McLaughlin to its board as the seventh independent director. Dr. McLaughlin, a renowned cardiovascular expert from the University of Michigan, has significant experience in rare diseases, particularly pulmonary arterial hypertension. Her addition is expected to strengthen Clene's leadership as it approaches the commercialization phase of its lead candidate, CNM-Au8, for ALS treatment. This move reflects Clene's strategy to enhance its clinical pipeline with medical leadership.
Clene Inc. (NASDAQ: CLNN) announced positive top-line results from its Phase 2 REPAIR clinical trials for the energy-enhancing nanotherapeutic CNM-Au8 in patients with Parkinson's disease (PD) and multiple sclerosis (MS). The primary endpoint showed a statistically significant increase in the brain NAD+/NADH ratio by 10.4% after 12 weeks of treatment (p=0.037). The trials demonstrated consistent brain target engagement, enhancing the potential for meaningful neurological improvements in neurodegenerative disorders. Furthermore, CNM-Au8 was well tolerated, with no serious adverse events reported.
Clene Inc. (NASDAQ: CLNN) announced its participation in Canaccord Genuity's 41st Annual Growth Conference, scheduled for August 11, 2021, at 3:30 p.m. EDT. The virtual presentation will focus on Clene's innovative efforts in treating neurodegenerative diseases using nanotechnology. Their lead candidate, CNM-Au8, aims to enhance cellular energy to support neurorepair, currently being evaluated through multiple clinical trials for conditions such as amyotrophic lateral sclerosis and multiple sclerosis. More information is available on Clene's official website.
Clene Inc. (NASDAQ: CLNN) will host a webinar on July 14, 2021, at 4:30 p.m. ET, focusing on 'Cellular Energetic Failure' related to ALS and MS. Expert speakers include Professors Matthew Kiernan and Benjamin Greenberg, who will discuss current treatment options and unmet needs in these conditions. Clene's management will present their lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at improving neuroprotection and energy in cells. The webinar will also cover milestone expectations, including data from the Phase 2 RESCUE-ALS trial.