Clene Announces Q2 2024 Financial Results and Operating Highlights

Clene Inc., a biopharmaceutical company focusing on neurodegenerative diseases, has reported its financial results for the second quarter of 2024, alongside updates on its CNM-Au8® programs. Clene, based in Salt Lake City, operates through its subsidiary Clene Nanomedicine Inc. The company is in the late stages of clinical trials for various treatments, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).

In June, Clene presented enduring treatment data for CNM-Au8 from the HEALEY ALS Platform Trial at the ENCALS meeting in Stockholm, Sweden. The data includes survival follow-up of up to 42 months and long-term neurofilament light (NfL) biomarker results spanning 76 weeks. Notably, CNM-Au8 NfL Responders, a subset of patients who had significant reductions in NfL levels, showed marked improvements in survival and functional status compared to non-responders. Specifically, patients treated with CNM-Au8 exhibited a 60% reduced risk of death over 3.5 years compared to matched controls.

The company's data also revealed a substantial decline in NfL biomarker levels in CNM-Au8 NfL Responders, suggesting decreased axonal loss. These results were based on analyses of plasma NfL from participants treated with CNM-Au8 for up to 76 weeks. A 28% reduction in NfL levels was observed in responders, indicating a positive impact on neuronal health and reduced disease progression.

In July 2024, Clene submitted a briefing book to the FDA ahead of a Type C interaction scheduled for the third quarter of 2024. This submission includes new post-hoc analyses from two Phase 2 clinical trials of CNM-Au8 for ALS treatment. The company's aim is to discuss an accelerated approval regulatory pathway with the FDA, with plans to publicly announce the feedback once the interaction is concluded.

Furthermore, Clene expanded its access program for ALS, enrolling its first patient in June under a NIH-funded project. This program was supported through a four-year grant from the National Institute of Neurological Disorders and Stroke (NINDS).

In another development, Clene showcased preliminary data at the International Rett Syndrome Foundation 2024 Annual Meeting. The data highlighted CNM-Au8's potential as a treatment for Rett Syndrome, a rare pediatric neurodevelopmental disorder. Key findings included significant improvements in neuronal health, neuron survival, and neurite lengths in an in vitro model. CNM-Au8 also demonstrated improvements in mitochondrial function in Rett patient-derived astrocytes.

On the corporate front, Clene completed a 1-for-20 reverse stock split in July, ensuring compliance with Nasdaq's listing requirements. As a result, the company's outstanding shares were reduced from approximately 128.7 million to around 6.4 million. This adjustment also affected stock options, warrants, and other equity securities.

Financially, Clene's cash and cash equivalents totaled $21.7 million as of June 30, 2024, down from $35.0 million at the end of December 2023. Research and development expenses decreased to $4.2 million for the quarter, compared to $6.6 million in the same period of 2023. This reduction was mainly due to reimbursements from the ongoing ALS Expanded Access Program and lower costs associated with several clinical trials.

General and administrative expenses were $3.3 million, down from $3.9 million in the prior year, driven by reductions in insurance premiums, finance, accounting fees, and stock-based compensation costs. Total other income amounted to $0.6 million, compared to an expense of $14.8 million in the second quarter of 2023. The net loss for the quarter was $6.8 million, significantly lower than the $25.1 million loss reported in the same period of the previous year.

Clene Inc. remains committed to advancing its CNM-Au8® programs and exploring innovative treatments for neurodegenerative diseases, with a strong focus on improving patient outcomes through rigorous clinical research and strategic regulatory engagement.