Clene Inc. - CLNN STOCK NEWS

Clene Inc. (NASDAQ: CLNN) announced the completion of enrollment in the HEALEY ALS Platform Trial for its leading drug candidate, CNM-Au8®, a gold nanocrystal suspension. This innovative trial is the first of its kind for ALS and aims to facilitate the development of new therapies. Topline data is expected in the second half of 2022, with plans to file a New Drug Application if CNM-Au8 meets its primary endpoint. The trial includes over 50 sites across the U.S., aiming to accelerate research and provide new hope for ALS patients.

Clene Inc. (Nasdaq: CLNN) recently shared its Q3 2021 results and updates on clinical trials. The RESCUE-ALS Phase 2 trial for CNM-Au8 indicated potential benefits for ALS patients, though it did not meet its primary endpoint. Positive exploratory data revealed clinically relevant improvements. The company also launched an FDA Expanded Access Program for ALS patients. Cash and restricted cash stood at $60.6 million. Notably, Clene reported a net income of approximately $28.9 million, influenced by an unrealized gain from contingent liabilities, contrasting with a net loss in Q3 2020.

Clene Inc. (Nasdaq: CLNN) has announced results from the RESCUE-ALS Phase 2 trial, evaluating its drug candidate CNM-Au8 for early amyotrophic lateral sclerosis (ALS). The trial did not meet its primary endpoint (MUNIX) or secondary endpoint (FVC) at week 36, although a trend indicating efficacy was observed at week 12 (p=0.057). Notably, significant improvements were noted in disease progression and quality of life measures. The trial demonstrated potential protective effects on lower motor neurons in limb onset ALS patients, comprising 70% of the ALS population. Results from the Healey ALS Platform Trial are anticipated in late 2022.

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.