Arcturus Therapeutics (ARCT) Q4 2025 earnings summary

Executive summary

• Advanced ARCT-032 (CF) to a 12-week phase II study starting H1 2026, with dosing for up to 20 patients and optimized design for stable baseline and reproducible endpoints.

• ARCT-810 (OTC deficiency) expanded to address both adult and pediatric populations, with regulatory meetings scheduled for H1 2026 to clarify pivotal trial design.

• KOSTAIVE COVID-19 vaccine approved in the UK for adults in January 2026, but US commercialization delayed due to regulatory environment.

• Durable immune response and safety demonstrated for BARDA-funded pandemic influenza vaccine candidate in phase I.

• Strategic focus on rare disease programs and disciplined financial management extended cash runway into Q2 2028.

Financial highlights

• Fiscal year 2025 revenue was $82.0 million, down $70.3 million year-over-year, mainly due to lower CSL collaboration activity and milestone achievements.

• Q4 2025 revenue was $7.2 million, down $15.6 million from Q4 2024.

• Annual R&D expenses fell by $83.0 million and quarterly by $19.3 million year-over-year, reflecting transition of LUNAR-COV19 to commercial phase and reduced manufacturing/clinical costs.

• Operating expenses for 2025 were $158.3 million, down $89.7 million year-over-year.

• Net loss for 2025 was $65.8 million ($2.40 per share), improved from $80.9 million ($3.00 per share) in 2024.

• Cash and equivalents were $232.8 million at year-end 2025, down from $293.9 million at end of 2024.

Outlook and guidance

• 12-week phase II ARCT-032 study to initiate in H1 2026, targeting up to 20 CF patients with Class 1 mutations in US and internationally.

• Type C regulatory meetings for ARCT-810 scheduled for H1 2026 to clarify pivotal trial design for both adult and pediatric OTC deficiency populations.

• General and administrative expenses expected to decrease slightly over the next 12 months.

• Cash runway extended into Q2 2028 through disciplined execution and strategic refocus.