Clene 2025 Q2 Earnings Net Loss Widens Despite EPS Improvement

Clene reported its fiscal 2025 Q2 earnings on August 15, 2025, showing a narrowing of its per-share loss to $0.78 from $1.06 in the prior year, despite a 9.3% increase in the total net loss to $-7.42 million. The company also guided its cash runway through Q1 2026, with plans to submit an NDA for ALS in Q4 2025.

Revenue
Clene’s total revenue dropped sharply by 70.3% to $27,000 in Q2 2025, compared to $91,000 in Q2 2024. Product revenue amounted to $1,000, while royalty revenue contributed $26,000. This decline reflects a substantial reduction in revenue generation across its business segments.

Earnings/Net Income
Clene narrowed its per-share loss to $0.78 from $1.06 in the prior year, representing a 26.4% improvement. However, the company’s net loss widened to $-7.42 million for the quarter, a 9.3% increase from the $-6.79 million reported in Q2 2024. Despite the EPS improvement, the company remains unprofitable and has posted losses for six consecutive years in the corresponding fiscal quarter, underscoring ongoing financial challenges.

Price Action
Clene’s stock price edged up by 2.21% during the latest trading day but declined by 1.91% during the most recent full trading week and by 2.70% month-to-date, indicating mixed investor sentiment in the short term.

Post-Earnings Price Action Review
A strategy of buying Clene shares after a revenue increase quarter-over-quarter on the report date and holding for 30 days resulted in a -92.05% return, vastly underperforming the 47.29% benchmark return. The excess return was -139.34%, and the CAGR was -58.22% over a 3-year period. The strategy also recorded a maximum drawdown of 0.00%, suggesting that shares were not sold during the lowest point of the market downturn, potentially worsening losses.

CEO Commentary
Rob Etherington, President and CEO of Clene, emphasized the company's strategic focus on advancing its CNM-Au8 programs for ALS and MS, including upcoming FDA meetings and the planned NDA submission for ALS by year-end 2025. The tone of the commentary was optimistic, reflecting confidence in the therapeutic potential of CNM-Au8 and progress toward regulatory milestones.

Guidance
Clene expects to submit a New Drug Application for CNM-Au8 in the fourth quarter of 2025 for potential accelerated approval in ALS, following a second Type C FDA meeting in Q3 2025 to review survival data. The company also plans to hold an end-of-Phase 2 Type B meeting with the FDA in Q3 2025 to discuss the MS development program. With $7.3 million in cash as of June 30, 2025, and subsequent $1.9 million in equity and $1.5 million in convertible debt, Clene expects sufficient funding to support operations into Q1 2026.

Additional News
1. New Leadership Appointment: On August 10, 2025, the Ministry of Education announced that Dr. Ji Xunming has been appointed as the new president of Beijing协和医学院. This marks a significant leadership change in the institution.
2. Corporate Governance Update: On July 28, 2025, 中日友好医院 announced the replacement of its party committee secretary with a new leader, signaling a shift in leadership and strategic direction for the hospital.
3. Market Policy Shift: On July 25, 2025, the People’s Bank of China released its 2025 Q2 monetary policy report, outlining a more moderate stance to support economic growth amid inflationary pressures.