ARCT — Arcturus Therapeutics Holdings Inc.

Summary of Arcturus Therapeutics Q4 2025 Earnings Call

1. Key Financial Results and Metrics:

• Revenue Decline: Q4 2025 revenue decreased by $15.6 million, with annual revenue down $70.3 million, primarily due to reduced activity in the CSL collaboration and fewer development milestones as the Costave vaccine transitioned to commercialization.
• R&D Expenses: Year-over-year R&D expenses decreased by $83 million for the year and $19.3 million for the quarter, attributed to lower manufacturing and clinical costs associated with the LUNAR-COV19 program.
• G&A Expenses: Annual G&A expenses fell by $6.7 million, while quarterly expenses rose by $1.6 million due to accelerated employee stock options.
• Cash Position: As of December 31, 2025, cash and equivalents totaled $232.8 million, down from $293.9 million a year prior. The company projects a cash runway extending into Q2 2028.

2. Strategic Updates and Business Highlights:

• ARCT-032 (Cystic Fibrosis): The Phase II trial is set to start in H1 2026, focusing on a 12-week study with a higher 10 mg dose. The study aims to evaluate safety and early clinical benefits in CF patients.
• ARCT-810 (OTC Deficiency): The program is moving towards pivotal development, with Type C regulatory meetings scheduled for H1 2026 to clarify next steps for both adult and pediatric populations.
• COVID-19 Vaccine (Costave): The U.K. approved Costave for adults, but U.S. approval remains challenging due to regulatory hurdles.
• ARCT-2304 (Influenza Vaccine): Phase I study results showed durable immune responses across all tested doses, reinforcing the STARR® sa-mRNA platform's efficacy.

3. Forward Guidance and Outlook:

• The company anticipates generating meaningful clinical data from the CF program in 2026 and expects to clarify regulatory pathways for the OTC program in the coming months.
• General and administrative expenses are expected to continue decreasing over the next year due to lower share-based compensation.

4. Bad News, Challenges, or Points of Concern:

• Revenue Declines: The significant drop in revenue raises concerns about the sustainability of current operations and reliance on collaborations.
• Regulatory Hurdles: Ongoing challenges in advancing the Costave vaccine in the U.S. could impact future revenue streams.
• Clinical Risks: The complexity of the CF and OTC programs presents risks related to patient enrollment and achieving desired clinical outcomes, particularly in the context of varying patient responses.

5. Notable Q&A Insights:

• Cohort 4 Study Design: The upcoming 12-week CF study will implement stricter enrollment criteria to ensure patient stability at baseline, which may extend the screening period.
• Dosing Flexibility: The company retains the option to adjust dosing based on ongoing data collection, with an emphasis on balancing efficacy and manufacturing costs.
• Regulatory Engagement: Discussions with the FDA regarding the OTC program are ongoing, with the goal of establishing clear endpoints and objectives for both adult and pediatric trials.
• Patient Enrollment Strategy: The company is expanding its recruitment strategy internationally to target populations with higher incidences of specific CF mutations, aiming for quicker patient enrollment.

Overall, while Arcturus Therapeutics is making progress in its clinical programs and maintaining a healthy cash position, it faces significant challenges related to revenue generation and regulatory approvals that could impact its future growth trajectory.