On November 7, 2023, Clene Inc (CLNN, Financial), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function, announced its third quarter 2023 financial results. The company highlighted significant survival benefits from its RESCUE ALS trial and a substantial grant from the National Institute of Neurological Disorders and Stroke (NINDS).
Operational Highlights
Clene Inc (CLNN, Financial) reported significant survival benefits from its RESCUE ALS study, with a median survival benefit of 19.3 months and a 75% decreased risk of long-term all-cause mortality. The company also announced a long-term survival benefit of 70% decreased risk of death associated with CNM-Au8 treatment in the HEALEY ALS Platform Trial compared to PRO-ACT historical controls.
In addition, the company was awarded a $45.1 million grant from NINDS to support research and expanded access of CNM-Au8 in people living with ALS. Clene Inc (CLNN, Financial) also announced the publication of a scientific paper describing the neuroprotective mechanism of action of CNM-Au8 in the nanotechnology-focused journal, Small.
Financial Results
As of September 30, 2023, Clene Inc (CLNN, Financial) had cash, cash equivalents, and marketable securities totaling $42.1 million, compared to $23.3 million as of December 31, 2022. The company expects that its resources as of September 30, 2023, will be sufficient to fund its operations into the third quarter of 2024.
Research and development expenses were $6.0 million for the quarter ended September 30, 2023, compared to $6.4 million for the same period in 2022. General and administrative expenses were $3.7 million for the quarter ended September 30, 2023, compared to $3.6 million for the same period in 2022.
Clene Inc (CLNN, Financial) reported a net loss of $2.4 million, or $0.02 per share, for the quarter ended September 30, 2023, compared to a net loss of $11.0 million, or $0.17 per share, for the same period in 2022.
Looking Ahead
Clene Inc (CLNN, Financial) is looking forward to a meaningful regulatory discussion with the U.S. Food and Drug Administration (FDA) later in the fourth quarter to elucidate key next steps in its ALS regulatory submission of CNM-Au8. The company remains hopeful that the consistent survival, delayed time to clinical worsening, and strong safety profile with CNM-Au8 treatment from two phase 2 independent trials will be compelling enough for the FDA to consider an accelerated path forward.
Explore the complete 8-K earnings release (here) from Clene Inc for further details.
