Clene Stock Price, News & Analysis

Clene Inc. (CLNN) reported Q1 2025 financial results and provided updates on its CNM-Au8 programs. The company is preparing for an FDA meeting in Q2 2025 to discuss the statistical analysis plan for neurofilament light chain (NfL) biomarker data, with plans to submit a New Drug Application (NDA) for CNM-Au8 in ALS treatment by Q4 2025. Key highlights include new data showing CNM-Au8 significantly extends ALS patient survival, with a 4.1-month improvement in overall survival and up to 11.9 months in severe cases. The company also presented promising MS treatment results at the AAN 2025 Annual Meeting. Financially, Clene reported cash position of $9.8M as of March 31, 2025, a net loss of $0.8M ($0.09 per share), and reduced R&D expenses to $1.5M from $5.9M year-over-year. The current cash runway extends into Q3 2025.

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.