Clene Announces Q1 2024 Financial Results and Recent Highlights

Clene Inc., a late clinical-stage biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, has released its first quarter 2024 financial results and highlighted recent progress in its CNM-Au8 clinical program for multiple sclerosis (MS). The company, headquartered in Salt Lake City with operations in Maryland, focuses on diseases such as amyotrophic lateral sclerosis (ALS) and Parkinson’s disease.

In the first quarter of 2024, Clene made significant strides in its research and discussions with the FDA regarding CNM-Au8, an investigational therapy designed to improve mitochondrial health and neuronal function. The company is optimistic about upcoming FDA meetings and aims to file a New Drug Application in the latter half of the year.

A notable highlight from the first quarter is the data from the VISIONARY-MS clinical trial extension, which was presented at the 2024 American Academy of Neurology (AAN) Annual Meeting. The long-term treatment with CNM-Au8 showed substantial evidence of repair and remyelination, particularly in vision and cognitive functions. Participants on CNM-Au8 exhibited significant improvements in vision, with some showing enhancements in low-contrast letter acuity by up to 38 letters. Additionally, cognitive and working memory improvements were observed, as measured by the Symbol Digit Modality Test (SDMT), with participants showing up to 29 points of improvement.

Clene also secured a $7.3 million sub-award from a National Institute of Health (NIH) grant for an ALS Expanded Access Program in collaboration with Columbia University. This funding, available through August 2024, supports the CNM-Au8 treatment for ALS. This follows a previous announcement of a four-year, $45.1 million NIH grant to support the same program.

In March, Clene published a study titled “Protein Corona Composition of Gold Nanocatalysts” in ACS Pharmacology & Translational Science. This study details the protein corona of CNM-Au8, which plays a crucial role in the drug’s mechanism of action, promoting neuroprotection without eliciting an inflammatory response.

Financially, Clene reported cash, cash equivalents, and marketable securities totaling $27.9 million as of March 31, 2024, down from $35.0 million at the end of 2023. The company believes these resources will sustain operations into the fourth quarter of 2024. Research and development expenses decreased to $5.9 million from $7.4 million year-over-year, mainly due to reduced costs in various clinical trials, offset by increased expenses for ongoing Expanded Access Programs (EAPs). General and administrative expenses remained steady at $3.4 million. The company faced a net loss of $11.1 million, or $0.09 per share, an improvement from the $11.8 million net loss, or $0.15 per share, reported in the same period last year.

Clene concluded the quarter with total liabilities of $40.8 million and stockholders’ equity of $4.3 million, compared to $38.9 million and $13.4 million respectively, at the end of 2023.

Clene remains committed to leveraging its innovative therapies to make significant strides in treating neurodegenerative diseases, with CNM-Au8 at the forefront of its research and development efforts.