Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
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
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.