Clene Inc. Reports 11% Revenue Growth and Significant Reduction in Net Loss for Q1 2025

Clene Inc. reported its financial results for the first quarter of 2025, revealing a total revenue of $81,000, which marks an increase of 11% from $73,000 in the same period of 2024. The revenue comprised $64,000 from product sales and $17,000 from royalty income, reflecting a shift in product revenue from $44,000 to $64,000, while royalty revenue decreased from $29,000 to $17,000. The company incurred a net loss of $751,000, significantly reduced from a loss of $11.1 million in the prior year, indicating a 93% improvement in net loss year-over-year.

Operating expenses for Clene Inc. also saw a notable decline, totaling $4.2 million for the quarter, down from $9.3 million in the same quarter of 2024. This reduction was primarily driven by decreased research and development expenses, which fell to $1.5 million from $5.9 million, and a decrease in general and administrative expenses, which dropped to $2.7 million from $3.4 million. The company attributed these changes to cost-saving measures, including the reduction of certain research programs and staff positions.

In terms of operational metrics, Clene Inc. reported a total cash and cash equivalents balance of $9.8 million as of March 31, 2025, down from $12.2 million at the end of 2024. The company utilized $5.0 million in net cash for operating activities during the quarter, a decrease from $7.1 million in the same period last year. Clene's total liabilities decreased to $30.3 million from $36.2 million, while stockholders' deficit improved to $5.0 million from $8.9 million.

Strategically, Clene Inc. is focused on advancing its clinical-stage drug candidates, particularly CNM-Au8, which is being developed for the treatment of neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company is preparing for a potential New Drug Application (NDA) submission to the FDA by the end of 2025, contingent on additional data from ongoing clinical trials. Clene has also received a grant from the National Institutes of Health to support its Expanded Access Program for ALS treatment, which is expected to bolster its research funding.

Looking ahead, Clene Inc. anticipates the need for additional financing to sustain its operations and continue its clinical development efforts. The company plans to explore various funding avenues, including equity financing and collaboration arrangements, to address its liquidity needs. However, there remains substantial doubt about its ability to continue as a going concern without securing further capital, as indicated in its financial disclosures.