Clene Stock Price, News & Analysis

Clene Inc. (NASDAQ: CLNN) has enrolled over 50% of participants in its Phase 2 study evaluating CNM-ZnAg, a zinc-silver ionic solution, for treating COVID-19 in Brazil. The study, with 276 planned participants, aims to determine the drug's efficacy in preventing hospitalization and achieving symptom resolution. Topline results are anticipated in 1H 2022. Clene's President emphasized the need for new therapeutic options due to ongoing virus mutations, highlighting CNM-ZnAg's potential if proven effective.

Clene Inc. (NASDAQ: CLNN) announced the validation of key patents from the European Patent Office that protect its innovative processes for treating neurodegenerative diseases. The patents enhance the company's lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at treating amyotrophic lateral sclerosis (ALS). This significant development supports a Phase 3 registration study expected to reveal topline results in H2 2022. The patents offer extensive coverage for Clene's manufacturing methods and treatment approaches, bolstering its position in major global healthcare markets.

Clene Nanomedicine, a clinical-stage biopharmaceutical company, has received a $1 million grant from the Maryland Department of Housing and Community Development to support redeveloping its manufacturing facility in Elkton, MD. This expansion aims to boost manufacturing capacity for the anticipated commercialization of its lead drug candidate, CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). Clene expresses gratitude for the state's support and emphasizes its commitment to community infrastructure growth.

Clene Inc. (NASDAQ: CLNN) presented significant findings from its RESCUE-ALS Phase 2 trial of CNM-Au8 at the 32nd International Symposium on ALS/MND on December 10, 2021. The trial demonstrated that CNM-Au8 significantly slowed disease progression and improved quality of life in early ALS patients. Notable results included a reduced risk of major functional decline and no serious adverse effects observed. While the primary endpoint regarding motor unit index changes was not met, the therapy showed potential as a breakthrough treatment for ALS.

Clene Inc. (NASDAQ: CLNN) presented key findings from its Phase 2 RESCUE-ALS trial of CNM-Au8 at the 32nd International Symposium on ALS/MND. The trial indicated that CNM-Au8 significantly slowed disease progression in early-stage ALS patients, demonstrating reduced risk of decline in the ALSFRS-R score and improved quality of life. Notably, the treatment was well-tolerated with no serious adverse events. While the primary endpoint was not met, the results suggest potential neuroprotective effects and long-term survival benefits for patients with limb onset ALS.

Clene Inc. (NASDAQ: CLNN) has reported promising results from the RESCUE-ALS Phase 2 study of its drug candidate CNM-Au8® for amyotrophic lateral sclerosis (ALS). Data presented at the ALS ONE Research Symposium indicates that CNM-Au8 has a favorable impact on ALS progression, meeting FDA-recommended endpoints. Key findings include consistent efficacy in both limb and bulbar onset patients, with an average Combined Assessment of Function and Survival (CAFS) score improvement of +4.4 compared to a decline of -4.6 in the placebo group. Long-term survival data suggests potential benefits compared to estimated median survival rates.

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.