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10-Q2026-05-14· deepseek-chat

CLNN · Clene Inc.

0001437749-26-016878

SEC filing

Summary

A challenging quarter marked by a steep revenue decline and a significantly widened net loss, driven by non-cash charges from equity issuance and warrant revaluation, while the company advances its NDA submission for ALS.

Key takeaways

Full analysis

Revenue Decline Driven by Partner Order Timing

Revenue for the first quarter of 2026 was $15,000, an 81.5% decrease from $81,000 in the same period last year. The decline was primarily due to the timing of dietary supplement purchases by our distribution partner, 4Life. Cost of revenue, which includes production and distribution costs for Gold Factor, Zinc Factor, and rMetx dietary supplements, remained minimal, resulting in a gross margin of 100%.

Operating Loss Narrows on Cost Discipline

Operating loss improved 49.4% to $2.1 million from $4.1 million in the prior year quarter. This improvement reflects lower research and development expenses and general and administrative costs as we continue to manage cash carefully. We anticipate that research and development expenses will increase in future years if and when we advance our assets into Phase 3 trials.

Net Loss Widens on Non-Cash Equity Charges

Cash Burn Moderates; Liquidity Remains Tight

NDA Submission for ALS as Key Catalyst

We are planning to submit a New Drug Application (NDA) for CNM-Au8 in amyotrophic lateral sclerosis (ALS) in the third quarter of 2026 under the accelerated approval pathway. This represents a significant milestone for the company and could provide a path to commercialization. The valuation of certain liabilities involves estimates using a Black-Scholes option-pricing model with probability weights for dissolution, change of control, or held to maturity scenarios.