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Clene Inc. (CLNN-10.16%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details Clene's focus on developing novel clean-surfaced nanotechnology (CSN®) therapeutics for neurodegenerative diseases such as ALS, MS, and PD. The company aims to address high unmet medical needs through its proprietary electro-crystal-chemistry drug development platform.
Clene's lead asset, CNM-Au8, is a gold nanocrystal suspension targeting mitochondrial dysfunction. It is currently in various stages of clinical trials for ALS, MS, and PD. The company also explores other CSN therapeutic candidates like CNM-ZnAg and CNM-AgZn17 for infectious diseases and wound healing.
The filing reports a net loss of $39.4 million for 2024, with research and development expenses totaling $20.1 million. Clene's cash, cash equivalents, and marketable securities were $12.2 million as of December 31, 2024.
Clene has identified material weaknesses in its internal control over financial reporting, which it is addressing. The company acknowledges substantial doubt about its ability to continue as a going concern without additional funding.
Clene's manufacturing facilities are located in Maryland, and the company plans to expand capacity contingent upon successful commercialization and funding. The company holds over 150 issued patents worldwide to protect its CSN therapeutics.
The filing outlines risks related to regulatory approvals, competition, and market acceptance of its drug candidates. Clene is subject to various healthcare laws and regulations, which could impact its operations.
Clene has received grants from organizations like the National Institutes of Health to support its clinical programs. The company is exploring additional funding options to sustain its operations and advance its drug candidates.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Clene Inc. annual 10-K report dated March 24, 2025. To report an error, please email earnings@qz.com.