Clene Inc. Reports $39.4 Million Net Loss for 2024, Revenue Decreases by 48%

Clene Inc. reported a net loss of $39.4 million for the year ended December 31, 2024, compared to a net loss of $49.5 million in 2023. Total revenue decreased by 48% to $342,000 from $654,000, primarily due to decreased product and royalty revenue from dietary supplements. Operating expenses decreased by 19% to $33.4 million, reflecting lower research and development and general and administrative costs. The decrease in research and development expenses was partially offset by increased expenses related to ongoing expanded access programs and preparations for a Phase 3 trial.

Significant changes compared to the previous year include a decrease in research and development expenses, primarily due to the completion of several clinical trials, partially offset by increased expenses for ongoing expanded access programs and preparations for a Phase 3 trial. General and administrative expenses also decreased, primarily due to lower insurance and finance fees. The company completed several clinical trials in ALS, MS, and PD, and has ongoing expanded access programs and long-term extensions. The company also received a four-year grant from the National Institutes of Health totaling $45.1 million to support an expanded access program for ALS.

Strategic developments included the completion of a reverse stock split in July 2024, resulting in a 1-for-20 consolidation of outstanding shares. The company also raised $10 million through the issuance of senior secured convertible promissory notes and implemented cost-saving measures, including delaying and reducing certain research and development programs and eliminating staff positions. The company is preparing for a potential NDA submission to the FDA for CNM-Au8 in ALS, based on recommendations from the FDA to include data from ongoing expanded access programs.

Key operational developments include the completion of several clinical trials and the initiation of a Phase 2 clinical trial in progressive MS. The company also reported long-term survival data from expanded access programs and clinical trials in ALS, showing a statistically significant survival benefit associated with CNM-Au8 treatment. As of December 31, 2024, Clene Inc. had 76 employees. The company's manufacturing facilities are compliant with Good Manufacturing Practices.

The company's outlook includes plans to commence a Phase 3 trial for CNM-Au8 in ALS and to meet with the FDA in the first half of 2025 to finalize the statistical analysis plan for expanded access program data. The company also plans to submit an NDA in the second half of 2025, seeking accelerated approval for CNM-Au8 in ALS. The company acknowledges substantial doubt about its ability to continue as a going concern beyond one year from the date the consolidated financial statements are issued, unless it obtains additional financing.