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Arcturus Therapeutics (ARCT) investor relations material

Arcturus Therapeutics Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary10 Nov, 2025

Executive summary

  • Advanced ARCT-032 (CF mRNA therapy) with positive interim Phase 2 data showing safety and mucus plug reduction in class one CF adults; 15mg cohort ongoing, 12-week study planned for 2026.

  • ARCT-810 (OTC deficiency mRNA therapy) progressing toward pivotal trial discussions with regulators in 2026 for both pediatric and adult populations.

  • Achieved commercial sales of the world's first approved self-amplifying mRNA (sa-mRNA) vaccine, KOSTAIVE, in Japan and received European approval for KOSTAIVE (ARCT-154) for adults 18+ in February 2025.

  • KOSTAIVE US BLA filing delayed indefinitely due to regulatory changes; commercial focus shifts to Asia and Europe.

  • Strong cash position and extended runway into 2028 following cost reductions and delayed trial starts.

Financial highlights

  • Q3 2025 revenue was $17.2M, down $24.5M year-over-year; nine-month revenue was $74.8M, down $54.7M year-over-year, mainly due to lower CSL collaboration revenue.

  • Q3 operating expenses were $33.7M, down from $52.4M last year; nine-month operating expenses were $119.8M, down from $191.8M.

  • R&D expenses for Q3 were $23.3M, down from $39.1M; nine-month R&D was $87.7M, down from $151.4M.

  • Net loss for Q3 was $13.5M ($0.49/share), compared to $6.9M ($0.26/share) last year.

  • Cash and equivalents were $237.3M as of September 30, 2025.

Outlook and guidance

  • 12-week ARCT-032 CF study to begin in 2026, with expanded global enrollment and additional sites outside the US.

  • Regulatory meetings for ARCT-810 pivotal trial design expected in the first half of 2026.

  • General and administrative expenses expected to decrease slightly in fiscal 2026.

  • Cash runway guidance includes global trial expansion and is expected to last into 2028.

  • Future capital needs will depend on regulatory approvals, milestone achievements, and commercialization success.

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Frequently asked questions

Arcturus Therapeutics Holdings Inc. is a biotechnology company focused on developing RNA-based therapeutics for the treatment of infectious diseases, rare diseases, and other medical conditions. The company utilizes its proprietary self-amplifying mRNA technology and lipid nanoparticle delivery system to develop vaccines and therapies. Arcturus' pipeline includes treatments for diseases such as COVID-19 and other RNA-based therapies targeting unmet medical needs. The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.

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