Clene Inc. reported its financial results for the three and nine months ended September 30, 2024, revealing significant changes in revenue, expenses, and overall financial health compared to the previous fiscal period. For the third quarter of 2024, total revenue was $87,000, a decrease from $108,000 in the same period of 2023. For the nine months ended September 30, 2024, total revenue was $251,000, down from $484,000 in 2023. The company continues to generate revenue primarily from dietary supplements through its subsidiary, dOrbital, Inc., and an exclusive license with 4Life Research LLC.

Operating expenses for the third quarter of 2024 were $7.9 million, a reduction from $9.7 million in 2023. For the nine-month period, operating expenses totaled $24.7 million, down from $31.1 million in the prior year. The loss from operations for Q3 2024 was $(7.8 million), an improvement from $(9.5 million) in Q3 2023. For the nine months, the loss from operations was $(24.4 million), compared to $(30.6 million) in 2023. Despite these reductions, the net loss before income taxes for Q3 2024 increased to $(7.99 million) from $(2.42 million) in 2023, while the nine-month net loss decreased to $(25.85 million) from $(39.33 million).

The company’s accumulated deficit rose to $(268.57 million) as of September 30, 2024, compared to $(242.72 million) at the end of 2023. Total current assets decreased to $19.70 million from $38.85 million, and total assets fell to $31.57 million from $52.34 million. Cash and cash equivalents also saw a significant decline, dropping to $14.65 million from $28.82 million at the end of 2023.

Clene Inc. has implemented cost-saving initiatives, including delaying certain R&D programs and reducing staff positions. The company raised $2.1 million from an equity distribution agreement in Q3 2024 and secured an additional $3.5 million from a registered direct offering after the quarter. Furthermore, it received $3.8 million from private placements of equity securities on October 1, 2024.

The company is focused on advancing its clinical programs, particularly for its lead drug candidate, CNM-Au8, targeting conditions such as amyotrophic lateral sclerosis (ALS). A Phase 3 trial is planned for Q2 2025, pending FDA discussions. Clene has also received a $45.1 million NIH grant for an expanded access program for CNM-Au8, with subawards potentially totaling up to $30.9 million.

Overall, Clene Inc. continues to navigate a challenging financial landscape while pursuing strategic initiatives to enhance its clinical development and operational efficiency.