ARCT — Arcturus Therapeutics Holdings Inc.

Summary of Arcturus Therapeutics Q3 2025 Earnings Call

1. Key Financial Results and Metrics:

• Revenue: For Q3 2025, revenues were $17.2 million, a decrease of $24.5 million year-over-year. Year-to-date revenues totaled $74.8 million, down $54.7 million compared to the same period in 2024.
• Operating Expenses: Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024. Year-to-date operating expenses were $119.8 million, down from $191.8 million in the previous year.
• Net Loss: The net loss for Q3 2025 was approximately $13.5 million, or $0.49 per diluted share, compared to a net loss of $6.9 million, or $0.26 per diluted share, in Q3 2024.
• Cash Position: Cash, cash equivalents, and restricted cash stood at $237.3 million as of September 30, 2025, down from $293.9 million at the end of 2024. The company expects its cash runway to extend into 2028 due to planned cost reductions.

2. Strategic Updates and Business Highlights:

• ARCT032 Program: The Phase II clinical trial for ARCT032 (mRNA therapeutic for cystic fibrosis) showed safety and tolerability in a small cohort, with some participants experiencing mucus burden reduction. A third cohort is enrolling to assess a higher dose, with a larger twelve-week study planned for 2026.
• ARCT810 Program: Positive interim Phase II data for ARCT810 (for OTC deficiency) is prompting preparations for regulatory meetings in 2026 to discuss pivotal trial strategies.
• COVID-19 Vaccine Program: The Costave vaccine has been launched in Japan, with a two-dose vial approved for the JN1 variant. A Phase III manuscript was published demonstrating robust immune responses.

3. Forward Guidance and Outlook:

• The company anticipates continued support from CSL for the commercialization of Costave in Asia and Europe.
• Further details regarding regulatory meetings for ARCT810 and updates on the cystic fibrosis program will be provided in 2026.
• The company aims to initiate the twelve-week study for ARCT032 in early 2026.

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

• Costave BLA Filing Delay: The filing has been delayed indefinitely due to regulatory changes by the FDA, impacting commercial visibility in the U.S.
• Revenue Declines: Significant year-over-year revenue declines raise concerns about the sustainability of current operations and the impact of reduced collaboration activity.
• Clinical Trial Risks: The reliance on upcoming clinical trial data for ARCT032 and ARCT810 introduces uncertainty regarding future approvals and market potential.

5. Notable Q&A Insights:

• Cystic Fibrosis Program: Questions focused on the expected outcomes from the fifteen mg cohort and the metrics for go/no-go decisions, emphasizing the importance of both mucus plug reduction and FEV1 improvements.
• Regulatory Discussions: The company is preparing for pivotal trial discussions with regulatory agencies, particularly regarding the pediatric population for ARCT810, with hopes of aligning on trial protocols without needing additional studies.
• Enrollment Pace: There is an expectation of increased enrollment rates for the upcoming twelve-week study due to the addition of more sites and a broader patient population.

Overall, Arcturus Therapeutics is navigating a challenging financial landscape while advancing its clinical programs, with a focus on strategic partnerships and regulatory engagements to drive future growth.