Arcturus Therapeutics (ARCT) Q1 2026 earnings summary

Executive summary

• Advanced rare disease pipeline with key progress in cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs, including early initiation of a 12-week open-label Phase 2 CF study and ongoing Phase 2 trials for both indications.

• Received clear FDA guidance for pediatric development of ARCT-810 for OTC deficiency, with a pivotal trial path and end of phase II meeting planned for H2 2026.

• Expanded executive leadership team with new Chief Medical Officer and Chief Financial Officer appointments.

• KOSTAIVE, the first approved self-amplifying mRNA vaccine, is commercialized in Japan, EU, and UK for COVID-19, with Japanese partner Meiji preparing for the 2026/2027 season.

• Collaboration with CSL Seqirus for global vaccine development, with significant upfront and milestone payments, though CSL reported a $430 million write-down due to declining COVID-19 burden and regulatory challenges.

Financial highlights

• Cash, cash equivalents, and restricted cash totaled $213.4 million as of March 31, 2026, down from $232.8 million at year-end 2025.

• Total revenue for Q1 2026 was $2.1 million, a 93% decrease from $29.4 million in Q1 2025, mainly due to lower CSL collaboration and BARDA grant revenue.

• Net loss for Q1 2026 was $27.0 million (or $0.95 per diluted share), compared to $14.1 million ($0.52 per share) in Q1 2025.

• Research and development expenses fell by $13.4 million year-over-year to $21.5 million, and general and administrative expenses decreased by $1.8 million to $9.5 million.

• Maintains a cash runway extending beyond Q2 2028.

Outlook and guidance

• Cash runway expected to support operations and clinical milestones through at least Q2 2028.

• Anticipates sufficient enrollment and data from the CF phase II study by year-end 2026 to inform next steps.

• Plans to align pivotal pediatric OTC deficiency trial at end of phase II meeting in H2 2026.

• Expects to achieve multiple near-term milestones in both therapeutic programs with current cash position.

• Anticipates continued losses and need for additional capital to support long-term plans and product development.