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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 (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
Clene Inc. (NASDAQ: CLNN) reported Q3 2024 financial results with cash and equivalents of $14.6 million as of September 30, 2024. The company completed a $7.3 million registered direct offering in October 2024 and amended its debt agreement with Avenue Capital, extending maturity to Q2 2025. R&D expenses decreased to $4.5 million from $6.0 million year-over-year, while G&A expenses reduced to $3.4 million from $3.7 million. The company reported a net loss of $8.0 million ($1.22 per share) compared to $2.4 million ($0.38 per share) in Q3 2023.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases like ALS and MS, has announced its participation in two upcoming investor conferences in October 2024.
The company will attend the 2024 Maxim Healthcare Virtual Summit from October 15-17, with a fireside presentation scheduled for October 15 at 2:30 p.m. E.T. Clene will also participate in The ThinkEquity Conference 2024 on October 30 in New York City, presenting at 3:30 p.m. E.T.
Both events will feature presentations and one-on-one meetings. For the Maxim Healthcare Virtual Summit, interested parties can sign up to become M-Vest members. The ThinkEquity Conference presentation will be accessible via webcast.
Clene Inc. (Nasdaq: CLNN) has announced the closing of a $7.3 million registered direct offering and concurrent private placements of common stock and warrants. The offering was led by a healthcare-focused institutional investor with participation from existing shareholders, including insiders. Additionally, Clene amended its debt facility with Avenue Venture Opportunities Fund, L.P., reducing or deferring future monthly principal payments and extending the maturity date into the first half of 2025.
The combined financing is expected to fund the company's operations into the first quarter of 2025, enabling key milestones such as a face-to-face meeting with the FDA to discuss the potential filing of a new drug application for CNM-Au8® under an accelerated approval pathway. This funding also allows continued provision of CNM-Au8 to ALS patients under compassionate use programs while Clene discusses its data with the FDA.
Clene Inc. (Nasdaq: CLNN) announced a $7.3 million registered direct offering and concurrent private placements on September 30, 2024. The company is issuing:
- 742,626 shares (or pre-funded warrants) to a healthcare-focused institutional investor at $4.713 per share
- 681,469 shares (or pre-funded warrants) to existing stockholders at $4.713 per share
- 122,819 shares to directors and officers at $4.875 per share
All offerings include warrants to purchase an equal number of shares at $4.82 per share, exercisable immediately and expiring in five years. Clene plans to use the proceeds for general corporate purposes, including funding the clinical development of CNM-Au8®, potential commercialization efforts, and regulatory activities. Canaccord Genuity is acting as the sole placement agent, with the offerings expected to close around October 1, 2024.
Clene Inc. (Nasdaq: CLNN) has secured an in-person meeting with senior FDA leadership to discuss its CNM-Au8 development for ALS. The meeting, scheduled before the end of November 2024, will include key FDA officials and opinion leaders in ALS, biostatistics, and biomarkers. This development comes after the FDA initially communicated that Clene's briefing package did not support an NDA submission under the accelerated approval pathway. However, the FDA agreed to reassess the submission in person.
Clene will present data on ALS biomarkers, clinical endpoints, and survival data for CNM-Au8. The company has accumulated over 700 patient-years of safety data for CNM-Au8, showing no significant safety concerns or trends. No serious adverse events related to CNM-Au8 treatment have been identified by clinical trial investigators to date.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company, which specializes in improving mitochondrial health and protecting neuronal function, will present virtually on September 9, 2024, at 7:00 am EST.
Clene's management will deliver a presentation and host one-on-one investor meetings during the conference. Investors interested in scheduling meetings are advised to contact their H.C. Wainwright representative. A webcast of the presentation will be accessible through the 'Events' section of Clene's website, with an additional online registration option available for viewing.
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