8-K: Clene Inc. Announces First Quarter 2025 Financial Results and Provides Update on CNM-Au8 Programs

Clene Inc. reports its first quarter 2025 financial results, highlighting progress with CNM-Au8 for ALS and MS treatments, and plans for upcoming FDA meetings and NDA submission.

Summary

• Clene Inc. announced its first quarter 2025 financial results, reporting a net loss of $0.8 million, or $0.09 per share, compared to a net loss of $11.1 million, or $1.73 per share, for the same period in 2024.
• The company's cash and cash equivalents totaled $9.8 million as of March 31, 2025, which is expected to fund operations into the third quarter of 2025.
• Clene is preparing for a meeting with the FDA in the second quarter of 2025 to finalize its statistical analysis plan (SAP) for neurofilament light chain (NfL) biomarker data.
• The company plans to submit a New Drug Application (NDA) in the fourth quarter of 2025 for potential Accelerated Approval of CNM-Au8 in ALS.
• New data supports remyelination and neuronal repair associated with CNM-Au8 treatment in MS, presented at the American Academy of Neurology (AAN) 2025 Annual Meeting.
• Clene also released new data from a cross-regimen analysis of the HEALEY ALS Platform Trial, showing that CNM-Au8 significantly extends survival in patients with ALS.

Sentiment

Score: 7

Explanation: The sentiment is cautiously optimistic. While the company is still operating at a loss, there's significant progress in clinical trials and regulatory pathways, suggesting potential for future growth. However, the limited cash runway and Nasdaq compliance issues temper the optimism.

Positives

• The company's net loss decreased significantly year-over-year, from $11.1 million to $0.8 million.
• Clene has a scheduled meeting with the FDA to finalize its statistical analysis plan for CNM-Au8 NfL biomarker data.
• The company is planning to submit an NDA for potential Accelerated Approval of CNM-Au8 in ALS in the fourth quarter of 2025.
• New data supports the remyelination and neuronal repair associated with CNM-Au8 treatment in MS.
• CNM-Au8 significantly extends survival in patients with ALS, according to data from the HEALEY ALS Platform Trial.

Negatives

• Clene reported a net loss of $0.8 million for the quarter ended March 31, 2025.
• The company's cash and cash equivalents totaled $9.8 million as of March 31, 2025, providing cash runway only into the third quarter of 2025.
• Clene received a notice from Nasdaq that it does not meet the minimum Market Value of Listed Securities (MVLS) requirement for continued listing.

Risks

• There is no assurance that the Company will regain compliance with the Minimum MVLS Requirement or maintain compliance with any of the other Nasdaq continued listing requirements.
• The company's ability to demonstrate the efficacy and safety of its drug candidates is uncertain.
• Clinical results for its drug candidates may not support further development or marketing approval.
• Actions of regulatory agencies could impact the company's plans.
• The company has a limited operating history and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates is uncertain.

Future Outlook

Clene anticipates submitting an NDA for CNM-Au8 in ALS in the fourth quarter of 2025 and expects its current cash resources to fund operations into the third quarter of 2025.

Management Comments

• Prolonging survival for people living with ALS is the critical mission for Clene.
• We continue to collect NfL biomarker data from our ongoing NIH-sponsored EAP in ALS patients which we still plan to analyze in the third quarter of 2025, in alignment with FDAs proposal, as announced in December 2024.
• Using this data, alongside our data showing CNM-Au8 improved survival over time, we are in active preparations to potentially submit an NDA under the Accelerated Approval pathway for ALS in the fourth quarter of 2025.
• To discuss this possibility, we remain in active dialogue with the Division of Neurology at the FDA, who we believe also prioritizes alleviating the burden of neurodegenerative diseases for patients and their families.

Industry Context

Clene is focused on addressing unmet needs in neurodegenerative diseases like ALS and MS, where there is a high demand for effective treatments. The company's focus on mitochondrial health and neuronal function aligns with emerging research in these areas.

Comparison to Industry Standards

• Clene's CNM-Au8 is being developed as a potential treatment for ALS, a disease with limited treatment options, where the standard of care typically involves drugs like riluzole and edaravone, which have shown modest effects on survival.
• The reported 4.1-month improvement in overall survival with CNM-Au8 in the HEALEY ALS Platform Trial is a clinically meaningful outcome that could potentially position it favorably compared to existing treatments.
• Clene's focus on remyelination and neuronal repair in MS with CNM-Au8 aligns with the industry's growing interest in therapies that can address the underlying pathology of the disease, rather than just managing symptoms, similar to companies like Biogen and Novartis who are also exploring remyelinating agents.

Stakeholder Impact

• Shareholders: The potential approval of CNM-Au8 could positively impact the company's stock price.
• Patients: CNM-Au8 could provide a new treatment option for ALS and MS patients.
• Employees: The company's progress could lead to job security and potential growth opportunities.

Next Steps

• Clene will meet with the FDA in the second quarter of 2025 to finalize its statistical analysis plan (SAP) for neurofilament light chain (NfL) biomarker data.
• Clene will analyze NfL biomarker data from its NIH-sponsored Expanded Access Protocol (EAP) in the third quarter of 2025.
• Clene plans to submit a New Drug Application (NDA) in the fourth quarter of 2025 for potential Accelerated Approval of CNM-Au8 in ALS.
• Clene plans to discuss the entire VISIONARY-MS trial at an end-of-Phase 2 meeting with FDA in the third quarter of 2025.
• Clene intends to actively monitor the MVLS of its Common Stock between now and November 3, 2025, and will consider its available options to regain compliance with the Minimum MVLS Requirement.

Key Dates

Keywords

CNM-Au8, ALS, MS, FDA, NDA, NfL biomarker, Clinical trials, Neurodegenerative diseases, Clene Inc., Financial results