Arcturus Therapeutics (ARCT) Q1 2025 earnings summary

Executive summary

• Prioritized mRNA therapeutics pipeline, focusing on cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs, and streamlined resources due to market and regulatory conditions.

• Achieved EU and Japan approvals for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, with commercial sales initiated in Japan and milestone payment received.

• Advanced Phase II studies for CF (ARCT-032) and OTC (ARCT-810), with interim data expected mid-2025 for CF and Q2 2025 for OTC.

• Extended cash runway into Q1 2028 through cost reductions, program prioritization, and facility consolidation.

Financial highlights

• Q1 2025 revenue was $29.4 million, down from $38 million year-over-year, mainly due to lower milestone revenues as KOSTAIVE transitions to commercialization.

• Research and development expenses decreased to $34.9 million from $53.6 million year-over-year, reflecting lower manufacturing costs and increased investment in CF and OTC.

• General and administrative expenses fell to $11.3 million from $14.9 million year-over-year, driven by reduced share-based compensation.

• Net loss for Q1 2025 narrowed to $14.1 million ($0.52 per diluted share) from $26.8 million ($1.00 per share) in Q1 2024.

• Cash, cash equivalents, and restricted cash totaled $273.8 million as of March 31, 2025, down from $293.9 million at year-end 2024.

Outlook and guidance

• Cash runway expected to extend into 2028 due to resource reallocation and cost reductions.

• Phase II CF study enrollment expected to complete by year-end, with interim data for two cohorts in mid-2025; OTC Phase II interim data expected in Q2 2025.

• KOSTAIVE marketing authorization application in the UK planned for Q2 2025, and U.S. BLA filing in Q3 2025.

• Anticipates additional milestone payment from CSL for KOSTAIVE; further updates to be provided in Q2.

• General and administrative expenses expected to decrease slightly over the next twelve months.