Clene (CLNN -2.74%), a clinical-stage biopharmaceutical company developing treatments for neurodegenerative diseases, released its second-quarter 2025 earnings on August 14, 2025. The most important news from this release centers on the company’s financial challenges and continued progress with its lead drug candidate, CNM-Au8, which is advancing toward key regulatory milestones. Clene reported a net loss per share of $(0.78) (GAAP). Revenue (GAAP) totaled $27,000 and declined from $91,000 (GAAP) in Q2 2024. Despite reductions in research and administrative costs, cash levels dropped to $7.3 million, underlining a narrowing operational runway. Overall, the period showed clinical and regulatory momentum but continued financial strain.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.78) | $(0.47) | $(1.06) | 26.4% |
| Revenue (GAAP) | $27,000 | N/A | $91,000 | (70.3%) |
| Research and Development Expenses | $3.5 million | $4.2 million | (16.7%) | |
| General and Administrative Expenses | $2.4 million | $3.3 million | (27.3%) |
Source: Clene. Note: Analyst estimates for the quarter provided by FactSet.
Company Overview and Recent Focus
Clene develops therapeutics for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). Its main asset is CNM-Au8, a gold nanocrystal suspension therapy intended to enhance cell energy and fight oxidative stress. This approach is based on the idea that restoring neuronal activity and cellular health can slow the progression of serious neurological diseases.
The last year has been shaped by progress on multiple fronts. Clene has focused its resources on demonstrating CNM-Au8’s effectiveness and safety through late-stage clinical trials and regulatory readiness. The company’s current priorities are moving key clinical readouts forward, gaining FDA feedback on trial and biomarker analysis plans, and maintaining enough financial runway to deliver on upcoming milestones. Regulatory engagement and efficient cost management remain crucial to its path toward commercialization.
Quarter Highlights and Financial Performance
During the quarter, Clene made several notable advances, especially in its ALS and MS clinical programs. The company received what it described as “constructive FDA feedback” for its neurofilament light chain (NfL) biomarker analysis, an important step as it prepares to use these results to support a future new drug application (NDA) for CNM-Au8 in ALS. An FDA Type C meeting set for the third quarter of 2025 will focus on the therapy’s long-term survival data, marking one of the last pre-NDA hurdles. Additionally, Clene expects to complete key biomarker analyses from a National Institutes of Health (NIH)-sponsored study in early fourth quarter 2025.
For its multiple sclerosis pipeline, Clene presented extended clinical data at this year’s American Academy of Neurology (AAN) meeting. This late-breaking session highlighted improvements in cognitive and visual function among MS patients taking CNM-Au8, backed by biomarker and imaging studies. With these results, the company scheduled an end-of-Phase 2 FDA meeting for the third quarter to discuss designing a larger, pivotal Phase 3 study focused on cognition in MS.
The minimal sales reflect Clene’s status as a late-stage research and development company not yet commercializing its products. The company continues to cut expenses, with research and development costs (GAAP) dropping to $3.5 million. General and administrative costs (GAAP) fell to $2.4 million, both lower than the same period a year ago. Cash and cash equivalents (GAAP) declined by 40.2% from Dec. 31, 2024, to June 30, 2025, ending at $7.3 million in cash and cash equivalents. This decline highlights continued cash burn and shortens the company’s operational funding horizon.
These results were driven by non-cash expenses tied to changes in warrant and derivative liabilities. These non-cash adjustments contributed to a total net loss of $7.4 million (GAAP).
Looking Ahead
Management did not provide formal revenue or earnings guidance for the next quarter or for fiscal 2025. Clear milestones are on the calendar, however, with Clene targeting a new drug application submission for CNM-Au8 in ALS by the end of 2025 and anticipating several FDA meetings in coming months. Clene also disclosed recent small financings after quarter end, including a $1.9 million equity raise and an increase in its convertible debt facility by $1.5 million, which together slightly extend its projected cash runway into the first quarter of 2026.
Investors following Clene should watch for upcoming clinical data releases, especially results related to NfL biomarker analysis in ALS, and feedback from upcoming FDA meetings. These regulatory and clinical events are critical, as successful results and a positive regulatory path could open doors for commercial approval and partnership deals. Until then, attention will remain on Clene’s ability to balance clinical progress with financial resource management in a period of ongoing cash consumption.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
