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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.
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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