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About Clene Inc. (Nasdaq: CLNN)
Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to revolutionizing treatment options for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Headquartered in Salt Lake City, Utah, with research and development facilities in Maryland, Clene is at the forefront of leveraging nanotechnology to address critical unmet medical needs. The company’s patented Clean-Surface Nanocrystal (CSN) Technology enables the production of high-purity nanocrystals that enhance cellular energy metabolism and reduce oxidative stress, key contributors to neurodegeneration.
Core Technology and Innovation
Clene’s proprietary CSN platform represents a paradigm shift in pharmaceutical development, moving beyond traditional small-molecule drugs and biologics. By utilizing high-purity metallic nanocrystals, the technology targets mitochondrial function, the NAD pathway, and oxidative stress, enhancing the survival and functionality of central nervous system cells. This approach is exemplified by Clene’s lead candidate, CNM-Au8®, an oral suspension of gold nanocrystals designed to restore neuronal health and function.
Focus on Neurodegenerative Diseases
Clene is primarily focused on addressing neurodegenerative diseases with limited treatment options. Its flagship product, CNM-Au8®, is being developed for ALS, MS, and Parkinson’s disease. By improving mitochondrial health and reducing biomarkers like neurofilament light (NfL), CNM-Au8® has demonstrated potential in delaying disease progression and improving survival rates in clinical trials. Clene is also exploring the application of CNM-Au8® in rare diseases such as Rett Syndrome, further expanding its therapeutic scope.
Clinical Pipeline and Regulatory Progress
Clene’s clinical pipeline includes multiple Phase 2 and Phase 3 trials for CNM-Au8®. The company has garnered support from the National Institutes of Health (NIH) and other organizations to advance its research. Notably, Clene’s Expanded Access Programs (EAPs) provide real-world evidence of CNM-Au8®’s efficacy, particularly in ALS. These programs, combined with biomarker analyses and survival data, are integral to Clene’s pursuit of an accelerated approval pathway with the U.S. Food and Drug Administration (FDA).
Strategic Partnerships and Market Position
Clene collaborates with leading institutions, including Columbia University and Massachusetts General Hospital, to advance its clinical programs. The company recently partnered with APST Research GmbH to leverage one of the largest ALS biomarker datasets for regulatory submissions. By focusing on mitochondrial health and oxidative stress, Clene differentiates itself from competitors in the neurodegenerative disease space, such as Biogen and Amylyx Pharmaceuticals.
Commitment to Patients and Future Outlook
Clene’s mission is deeply rooted in improving patient outcomes. With over 800 participant-years of safety data and a robust clinical pipeline, the company is well-positioned to address the urgent needs of patients with neurodegenerative diseases. As Clene progresses toward regulatory milestones, its innovative approach to nanomedicine holds promise for transforming the treatment landscape.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, has announced its upcoming presentation at the Emerging Growth Conference on April 17, 2025, at 12:00 p.m. EDT. The virtual presentation will include a corporate update followed by a Q&A session.
The company specializes in developing therapies for conditions including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). Their flagship investigational treatment, CNM-Au8®, is a first-in-class therapy targeting mitochondrial function and the NAD pathway while reducing oxidative stress. The presentation will be accessible through the company's website and the conference portal, with replays available afterward through the Emerging Growth Conference YouTube Channel.
Clene (NASDAQ: CLNN) has presented new evidence of remyelination and neuronal repair in Multiple Sclerosis (MS) patients treated with CNM-Au8® from the VISIONARY-MS Trial long-term extension study. The findings, presented at the AAN 2025 Annual Meeting, demonstrate significant improvements in cognition and visual function.
Key results show that over 90% of participants who experienced improvements in cognition and vision also showed corresponding improvements in MRI and visual electrophysiology tests. Specifically, 96% of LCLA responders showed improvement in MRI DTI metrics, 91% exhibited mf-VEP improvements, and 98% of SDMT responders demonstrated improvements in MRI DTI AD and/or MTR metrics.
The study validates CNM-Au8's therapeutic mechanism in supporting critical repair processes within neurons and oligodendrocytes, leading to improved neurological function and remyelination. These results are consistent with previous findings from the double-blind period of the trial.
Clene (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company specializing in neurodegenerative disease treatments including ALS and MS, has announced its participation in the upcoming Jones Healthcare and Technology Innovation Conference.
The company's management will deliver a presentation on April 9, 2025, at 11:30 am PT at the Venetian Resort in Las Vegas, NV. The event will also feature one-on-one investor meetings, which can be arranged through Jones representatives.
Interested parties can access the presentation webcast through the 'Events' section of Clene's website or via online registration.
Clene (NASDAQ: CLNN) reported its full year 2024 financial results and key operational updates. The company plans to submit a New Drug Application (NDA) for CNM-Au8® in ALS treatment during the second half of 2025 under the accelerated approval pathway. Key financial highlights include cash position of $12.2 million as of December 31, 2024, and a new $10.0 million debt facility secured at a lower interest rate.
The company reported a net loss of $39.4 million ($5.67 per share) for 2024, compared to $49.5 million ($9.43 per share) in 2023. Research and development expenses decreased to $20.1 million from $26.7 million, while general and administrative expenses reduced to $13.3 million from $14.4 million.
Clinical developments include plans to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025. The company is analyzing biomarker NfL data from its NIH-sponsored Early Access Protocol to support FDA requirements. Survival analysis showed a 4.1-month improvement in overall survival, with enhanced benefits observed in severe ALS patients.
Clene (NASDAQ: CLNN) has announced new evidence from a cross-regimen analysis of the HEALEY ALS Platform Trial, demonstrating significant survival benefits for ALS patients treated with CNM-Au8® 30 mg. The analysis compared Regimen C (CNM-Au8) to Regimen A, with up to 48 months follow-up.
Key findings include:
- Median survival increased by 198 days (6.5 months) in the CNM-Au8 group (951 days) versus the comparator group (753 days)
- Restricted Mean Survival Time showed a 124-day improvement
- In moderate to severe ALS patients, median survival improved by 11.9 months with a 44% decreased mortality risk
- The strongest benefits were observed in patients meeting RESTORE-ALS Trial criteria, with median survival improving by 451 days (14.8 months) and a 49% reduction in mortality risk
The company plans to launch its confirmatory Phase 3 RESTORE-ALS study in mid-2025.
Clene Inc. (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company specializing in neurodegenerative disease treatments, has announced its participation in the 37th Annual Roth Conference. The company, which focuses on developing treatments for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), will engage in a virtual fireside chat on March 18, 2025, at 9:20 am PST.
The presentation will be accessible through a webcast on the company's website's 'Events' section. Additionally, Clene's management team will be available for one-on-one investor meetings, which can be arranged through Roth representatives.
Clene (CLNN) has announced its participation in the upcoming Investor Summit Virtual event scheduled for March 11, 2025. The company will be represented by two key executives: Rob Etherington, Chief Executive Officer, and Morgan Brown, Chief Financial Officer, who will be presenting at the virtual conference.
Clene Inc. (NASDAQ: CLNN) has entered into an agreement with APST Research GmbH to utilize APST's extensive neurofilament light chain (NfL) database to support FDA-recommended analyses of CNM-Au8®'s effect on NfL decline in ALS patients. APST maintains one of the largest ALS repositories with data from over 4,300 patients, including serum NfL and self-reported ALSFRS-R scores.
The collaboration will enable Clene to compare NfL changes observed in participants of NIH-sponsored Expanded Access Protocols (EAPs) to matched controls from the APST dataset. This analysis aims to demonstrate that the rate of NfL change is associated with survival in ALS patients.
Clene has supported nearly 500 ALS patients through three EAP programs to collect Real-World Evidence of CNM-Au8's effects. The company plans to submit a statistical analysis plan to the FDA soon and, if results are positive, will support a New Drug Application (NDA) for potential Accelerated Approval of CNM-Au8 in ALS, planned for the second half of 2025.
Across over 800 participant years of treatment with CNM-Au8, no significant safety concerns or trends have been identified, with no serious adverse events related to the treatment reported to date.
Clene Inc. (CLNN) has secured a new $10 million debt facility to replace its existing $7.85 million Avenue Capital debt. The new facility carries a 12% annual interest rate and is secured by all company assets. Notable features include:
- Interest-only payments for the first 12 months
- 18-month maturity period
- 65% of the debt is convertible to common stock at $5.67 per share (130% premium to closing price)
The financing aims to improve Clene's cash position to support additional data generation for CNM-Au8®'s new drug application for ALS through an accelerated regulatory pathway. The debt facility is provided by three Clene-affiliated entities and is expected to close by December 20, 2024.
Clene Inc. (CLNN) received FDA guidance regarding a potential accelerated approval pathway for CNM-Au8® in ALS treatment. The FDA recommended leveraging additional Neurofilament Light (NfL) data from Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier findings. Key developments include:
- Planned NDA submission in mid-2025 following EAP NfL biomarker analyses
- Additional NfL biomarker collection and analyses to be completed by Q2 2025
- Commencement of confirmatory Phase 3 RESTORE-ALS trial before NDA submission
- Demonstrated 78% risk reduction in time to death during Open Label Extension
- Strong safety profile with no significant concerns in over 700 patient years
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