Clene Inc. reported a net loss of $8.8 million for the third quarter of 2025, translating to a loss of $0.85 per share. The loss widened from the $8.0 million ($1.22 per share) reported for the same quarter in 2024, but the per‑share loss narrowed, reflecting a modest improvement in earnings per share despite a higher absolute loss. Revenue for the quarter was $15,000, a steep 82.8 % decline from the $87,000 recorded in Q3 2024, driven almost entirely by a drop in royalty income as the company’s licensing agreements expired and no new royalty‑generating contracts were signed.
The company’s cost structure shifted in the quarter. Research and development expenses fell to $3.5 million from $4.5 million, a 22 % reduction largely attributed to grant revenue and a lower manufacturing spend. General and administrative costs dropped to $2.2 million from $3.4 million, a 35 % cut driven by lower legal fees and personnel expenses. In contrast, other expenses surged to $3.1 million from $0.2 million, largely due to fair‑value adjustments of warrant and derivative liabilities. The net effect was a higher operating loss, but the company’s cost‑control measures in R&D and G&A helped limit the loss’s growth.
Cash and cash equivalents stood at $7.9 million as of September 30, 2025, down from $12.2 million at the end of 2024. With the current burn rate, the company’s cash runway extends only into the second quarter of 2026, raising substantial doubt about its ability to continue as a going concern. The company has raised an additional $1.2 million after September 30 to support operations, but the short runway underscores the need for further financing to sustain its clinical program.
Regulatory activity in the quarter included a second Type C meeting with the FDA to review long‑term survival data for CNM‑Au8 in ALS, with the agency focusing on biomarker evidence. Clene plans to request another Type C meeting in the first quarter of 2026 and intends to file a new drug application in the fourth quarter of 2025, contingent on confirmatory data. A Type B end‑of‑Phase 2 meeting for multiple sclerosis confirmed the FDA’s openness to alternative endpoints beyond the Expanded Disability Status Scale, and the company presented Phase 2 REPAIR‑MS results at the 41st ECTRIMS Congress. In September, the company disclosed new preclinical data for Parkinson’s disease, expanding the therapeutic scope of CNM‑Au8.
The combination of a widening loss, a steep revenue decline, and a shrinking cash runway signals significant financial pressure. While regulatory milestones suggest progress in the clinical pipeline, the company’s limited liquidity and the “going concern” uncertainty highlight the urgency of securing additional capital. The earnings miss relative to analyst expectations—EPS of –$0.85 versus a consensus of –$0.60 and revenue of $15,000 versus an estimate of $87,000—underscores the gap between the company’s current performance and market expectations. Management’s focus on regulatory engagement and cost discipline indicates a strategy to extend the runway while advancing the drug development program, but the lack of new guidance or a clear path to profitability remains a concern for stakeholders.
The company has not issued new financial guidance for the next quarter. Management’s stated intent to file an NDA for CNM‑Au8 in the fourth quarter of 2025 and to pursue additional Type C meetings reflects confidence in the clinical data, but the short cash runway and the need for further financing suggest that the company’s near‑term outlook remains uncertain. Stakeholders will likely monitor the company’s ability to secure additional funding and the outcomes of upcoming regulatory meetings as key indicators of its future trajectory.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.