Fed’s Powell opens door to potential rate cuts at Jackson Hole
On Thursday, Canaccord Genuity sustained its Buy rating and $86.00 stock price target for Clene Inc. (NASDAQ:CLNN). The firm's stance follows an educational webinar by the Northeast ALS consortium (NEALS), focusing on Clene's CNM-Au8 treatment for amyotrophic lateral sclerosis (ALS).
The webinar, held on Wednesday, featured discussions with key opinion leaders (KOLs) in the field, including Dr. Merit Cudkowicz from the Healey Center at Mass General and Harvard, Dr. Bob Bowser from the Barrow Neurological Institute, and Clene's Head of Medical Dr. Ben Greenberg. Dr. Jinsy Andrews from Columbia University moderated the event. The KOLs shared insights on CNM-Au8's neurofilament light (NfL) biomarker and survival data, which appear promising.
The experts provided additional details on CNM-Au8's action mechanism, focusing on biomarkers like glutathione and nicotinamide adenine dinucleotide (NAD). These are associated with the restoration of metabolic activity and reduction of oxidative stress. In clinical trials, approximately 50% of patients, designated as NfL responders, showed a strong association with these biomarkers.
The KOLs also linked the biomarker results to long-term clinical outcomes, including survival rates for NfL responders versus non-responders and propensity-matched controls, as well as improved scores on the ALSFRS-R standard scale.
Clene Inc. anticipates an in-person meeting with the FDA before the end of November to discuss the potential submission of a new drug application (NDA) for CNM-Au8 through the accelerated approval pathway. While the outcome of the FDA meeting is uncertain, the NEALS webinar provided a positive outlook, especially with the experts' ability to convey these points to the FDA.
Additionally, during the webinar, Clene revealed a proposed design for a global Phase 3 trial named RESTORE-ALS for CNM-Au8. Canaccord Genuity's reiteration of the Buy rating reflects the firm's optimism following the insights shared at the webinar and the upcoming milestones for Clene Inc.
In other recent news, Clene Inc. has been the center of several significant developments. The biopharmaceutical company recently secured approximately $7.3 million through stock and warrant sales, the proceeds of which are expected to support the clinical development of its lead drug candidate, CNM-Au8.
Clene has also revised its loan agreement with Avenue Venture Opportunities Fund, L.P., reducing the principal payment due in October 2024 from $3.33 million to $2 million.
Clene's drug, CNM-Au8, has shown promising results in Phase 2 clinical trials for treating ALS and Rett Syndrome. The company is set to meet with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss the development of CNM-Au8. Canaccord Genuity has revised its price target for Clene, reducing it to $86.00 from the previous $94.00 while still maintaining a Buy rating on the stock.
Clene Inc. has been the recipient of Buy ratings from both EF Hutton and H.C. Wainwright, with price targets set at $23.00 and $31.00 respectively. The company has also implemented a 1-for-20 reverse stock split, reducing the common stock from approximately 128.7 million shares to around 6.4 million shares. These are among the recent developments for Clene Inc.
InvestingPro Insights
Recent InvestingPro data provides additional context to Clene Inc.'s (NASDAQ:CLNN) current financial situation and market performance. The company's market capitalization stands at $46.58 million, reflecting its status as a small-cap biotech firm. Despite the positive outlook from Canaccord Genuity, CLNN's financial metrics reveal some challenges. The company's revenue for the last twelve months as of Q2 2023 was only $0.44 million, with a significant revenue decline of 43.62% over the same period.
Two relevant InvestingPro Tips highlight important aspects for investors to consider. Firstly, CLNN is "quickly burning through cash," which is not uncommon for biotech companies in the development stage but underscores the importance of successful clinical trials and potential FDA approval for CNM-Au8. Secondly, the company has seen a "significant return over the last week," with a 18.18% price increase, possibly reflecting market optimism following the NEALS webinar and upcoming FDA meeting.
It's worth noting that InvestingPro offers 5 additional tips for CLNN, providing a more comprehensive analysis for interested investors. These insights can be particularly valuable given the company's current stage and the potential impact of regulatory decisions on its future.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.