Clene Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $56,000, compared to $15,000 in the same period in 2025.
• Product revenue was $43,000 for the quarter, up from $0 in 2025; royalty revenue was $13,000, down from $15,000 in 2025.
• Net income for the quarter was $3.9 million ($0.30 basic, $0.05 diluted per share), reversing a net loss of $8.8 million ($0.85 per share) in the prior year period.
• Cash and cash equivalents totaled $9.9 million as of September 30, 2026, compared to $5.2 million as of December 31, 2025.
• Net cash used in operating activities was $11.7 million for the nine months ended September 30, 2026, compared to $13.7 million for the same period in 2025.
• Research and development expenses were $4.4 million for the quarter, a 27% increase from $3.5 million in 2025.
• General and administrative expenses were $1.9 million for the quarter, a 10% decrease from $2.2 million in 2025.
• Total other income, net, was $10.3 million for the quarter, compared to a total other expense, net, of $3.1 million in 2025, driven primarily by changes in the fair value of warrant and derivative liabilities.
• Total liabilities increased to $36.965 million as of September 30, 2026, from $35.723 million as of December 31, 2025.
• Stockholders' deficit improved to $(14.808) million as of September 30, 2026, from $(17.592) million as of December 31, 2025.

Guidance and Future Outlook:

• Proceeds from a September $4.0 million registered direct offering are expected to fund operations through the mid-first quarter of 2027.
• Subject to FDA acceptance of the NDA, the company could receive $6.7 million to $7.8 million in proceeds from common stock warrants issued in January 2026.
• The company plans to randomize the first participants for the Phase 3 RESTORE-ALS trial in the second quarter of 2027.
• The NDA submission for CNM-Au8 in ALS is pending FDA review, with the company expressing confidence in the Agency's constructive engagement.

Business Segments and Product Lines:

• Clene submitted a New Drug Application (NDA) to the FDA in October 2026 seeking accelerated approval for CNM-Au8 in amyotrophic lateral sclerosis (ALS).
• The NDA is supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial, its open-label extension, the Phase 2 RESCUE-ALS Trial, and an NIH-sponsored Expanded Access Protocol.
• The Phase 3 RESTORE-ALS trial will evaluate the effect of CNM-Au8 on survival (primary endpoint) and time to ALS clinical worsening events (secondary efficacy endpoint).
• Lower clinical expenses were recorded for both ALS and multiple sclerosis (MS) clinical programs during the quarter.

Market and Competitive Landscape:

• The company operates in the late clinical-stage biopharmaceutical sector focused on neurodegenerative diseases, including ALS, Parkinson's disease, and multiple sclerosis.
• CNM-Au8 is described as an investigational first-in-class therapy targeting mitochondrial function and the NAD pathway to reduce oxidative stress.
• The company notes that people living with ALS urgently need additional treatment options.

Risks and Challenges:

• Actual results may differ from forward-looking statements due to risks including general market conditions, clinical trial results, regulatory actions, and the ability to obtain additional funding.
• The company faces risks related to the potential inability to achieve commercial success for drug candidates if approved.
• The company has a limited operating history and faces uncertainties regarding the development and commercialization of its drug candidates.
• Forward-looking statements regarding FDA review, accelerated approval, trial timing, and cash runway are subject to significant uncertainties.

Management Commentary and Tone:

• Rob Etherington, President and CEO, characterized the NDA submission as a "pivotal achievement" and a "meaningful step toward bringing new treatment options to people living with ALS."
• Management expressed appreciation for the FDA's constructive engagement and confidence that CNM-Au8 has the capacity to restore neuronal health and improve survival.
• The tone reflects optimism regarding the pending review and the potential benefits of the therapy.

Other Key Points:

• In September, Clene closed a $4.0 million registered direct offering of common stock priced at $3.28 per share.
• The offering was led by Chairman David Matlin, with participation from founding investor Kensington Capital Holdings, CEO Rob Etherington, and other existing stockholders.
• The company reported a change in fair value of common stock warrant liabilities of $7.493 million and derivative liabilities of $3.368 million for the quarter, contributing to the net income.
• Weighted average common shares used to compute basic net income per share were 13,079,599 for the quarter, compared to 10,284,674 in the prior year period.