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Arcturus Therapeutics (ARCT) investor relations material

Arcturus Therapeutics Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary11 Aug, 2025

Executive summary

  • Advanced Phase II trials for inhaled mRNA therapy in cystic fibrosis and OTC deficiency, with positive interim data and ongoing enrollment; regulatory filings for KOSTAIVE® in the UK, Japan, and US progressing, with approvals anticipated in late 2025 and 2026.

  • Achieved key regulatory milestones for KOSTAIVE, the first approved self-amplifying mRNA COVID-19 vaccine, with commercial launches in Japan and Europe and a marketing application filed in the UK.

  • Next-generation flu and pandemic influenza vaccine candidates advanced in clinical trials, with promising safety and immunogenicity data; ARCT-2304 received FDA Fast Track Designation.

  • Restructuring and pipeline focus, along with CSL Seqirus collaboration, extended cash runway into 2028, supporting ongoing clinical and commercial activities.

  • Appointment of Dr. Moncef Slaoui as Chairman of the Board effective July 1, 2025.

Financial highlights

  • Q2 2025 revenue was $28.3M, down over 40% year-over-year, mainly due to lower CSL collaboration revenue as KOSTAIVE transitioned to commercial phase.

  • Q2 2025 operating expenses were $39.9M, down from $71M in Q2 2024; six-month operating expenses were $86M, down from $139M.

  • R&D expenses for Q2 2025 were $29.6M, down from $58.7M year-over-year, reflecting lower manufacturing and clinical costs.

  • Net loss for Q2 2025 was $9.2M ($0.34/share), improved from $17.2M ($0.64/share) in Q2 2024.

  • Cash, cash equivalents, and restricted cash totaled $253.4M as of June 30, 2025, supporting operations into 2028.

Outlook and guidance

  • Interim Phase II data for cystic fibrosis program expected in September 2025, with full study enrollment by year-end and Phase III initiation targeted for 2026.

  • Regulatory alignment for OTC deficiency and KOSTAIVE programs expected in 2026, with approvals anticipated in major markets.

  • General and administrative expenses expected to decrease slightly over the next twelve months; continued focus on CF, OTC, and vaccine programs.

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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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