Summary of Arcturus Therapeutics Q3 2025 Earnings Call

1Key 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.

2Strategic 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.

3Forward 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.

4Bad 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.

5Notable 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.