Clene Inc. (Nasdaq: CLNN) has released its full year 2024 financial results alongside recent operating highlights that underscore the company's commitment to advancing treatments for neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The announcement reflects a pivotal year of progress as Clene looks towards regulatory advancements and significant clinical trials.

2. Key Highlights from 2024

Regulatory Guidance and Future Steps

Rob Etherington, President and CEO of Clene, expressed optimism about the company’s upcoming engagements with the FDA. “We expect further regulatory guidance in 2025 on the critical next steps required to advance our CNM-Au8 NDA submission for the treatment of ALS under the accelerated approval pathway,” Etherington stated. Clene plans to meet with the FDA in the second quarter of 2025 to align on the statistical analysis plan for NfL biomarker data collected from ongoing NIH-sponsored Expanded Access Programs (EAPs) in ALS patients.

Clinical Program Advancements

Clene has made strides with its lead investigational therapy, CNM-Au8, a gold nanocrystal suspension. In December 2024, the company received written guidance from the FDA regarding a potential accelerated approval pathway for CNM-Au8 in ALS. The agency recommended investigating additional data from ongoing EAPs to substantiate the effect of CNM-Au8 on NfL decline.

The company also announced that it completed new analyses that suggest an overall survival improvement of 4.1 months in participants receiving CNM-Au8 compared to a control group in the HEALEY ALS Platform Trial. In a subset of patients with severe ALS, a median survival improvement of 11.9 months was observed, highlighting the potential for CNM-Au8 to significantly impact patient outcomes.

Upcoming Trials

Clene is gearing up to commence the Phase 3 RESTORE-ALS trial in mid-2025, designed to assess the effects of CNM-Au8 on improved survival and delayed clinical worsening in ALS patients. The trial is planned to serve as a confirmatory study necessary for the FDA's review as part of the NDA submission process anticipated in the second half of 2025.

3. Financial Performance Overview

Year-End Financial Results

Clene's financial position as of December 31, 2024 shows total cash and cash equivalents of $12.2 million, a decrease from $35.0 million at the end of 2023. The company believes its current resources will be sufficient to fund operations into the second quarter of 2025.

Research and Development Expenses: Totaled $20.1 million in 2024, down from $26.7 million in 2023, primarily due to lower costs related to various clinical trials.

General and Administrative Expenses: Decreased to $13.3 million from $14.4 million in 2023, attributed to reduced insurance and financing fees.

Net Loss: Clene reported a net loss of $39.4 million, or $5.67 per share, a notable improvement from a net loss of $49.5 million, or $9.43 per share, in the previous year.

Debt Facility and Capital Management

In December 2024, Clene secured a new $10 million debt facility to replace an existing $7.85 million debt balance, allowing for improved liquidity with a fixed interest rate of 12% and a maturity of eighteen months. This strategic capital management is aimed at supporting ongoing and future clinical operations.

4. Conclusion

Clene Inc.'s 2024 financial results reflect a year of strategic advancement and operational efficiency as the company navigates the complexities of clinical development in neurodegenerative diseases. With promising data from its trials and upcoming regulatory meetings, Clene is poised to make significant strides in its mission to improve the lives of those suffering from ALS and other neurodegenerative conditions. As the company prepares for the critical year ahead, stakeholders will be keenly observing its progress in the second quarter of 2025 and beyond.

Original press release