Arcturus Therapeutics Holdings Inc. Q3 FY2024 earnings call

Vaccine Franchise - KOSTAIVE

• Commercial launch in Japan with a $25 million milestone received. Senior management vaccinated in Tokyo. Regulatory updates: Meiji submitted partial change application for domestic manufacturing in Japan; EMA review of KOSTAIVE marketing authorization application near completion with CHMP opinion expected next month. BLA for KOSTAIVE planned in first half of 2025. Positive Phase 3 results for ARCT-2303, supporting co-administration with influenza vaccines.

mRNA Therapeutics

• ARCT-032: Received IND clearance for Phase 2 study in cystic fibrosis, with plans to enroll patients and measure FEV1. - ARCT-810: Concurrent Phase 2 studies in Europe and US for OTC deficiency, on track for interim Phase 2 POC data in first half of 2025.

Financials

• Q3 2024 net loss was approximately $6.9 million vs. $16.2 million in Q3 2023. Cash, cash equivalents, and restricted cash were $294.1 million as of September 30, 2024. Cash runway extends into Q1 2027.

For the third quarter of 2024, revenues were $41.7 million, a slight decrease from $45.1 million in Q3 2023. This was due to a decrease in CSL revenue (milestone decreased from $35 million in Q3 2023 to $25 million in Q3 2024) offset by increased revenue from the BARDA agreement. The vaccine franchise, led by KOSTAIVE, saw the commercial launch in Japan and regulatory progress in Europe. The mRNA therapeutics segment includes ARCT-032 with IND clearance for Phase 2 and ARCT-810 with concurrent Phase 2 studies in Europe and US.

Vaccine

• Plan to file BLA for KOSTAIVE in first half of 2025. - CHMP opinion for KOSTAIVE expected next month. ### Therapeutics
• Interim Phase 2 POC data for ARCT-032 and ARCT-810 expected in first half of 2025. ### Financial
• Cash runway expected to extend into Q1 2027, not including KOSTAIVE sales in Japan.

Risks

• Forward-looking statements involve known and unknown risks, uncertainties, and assumptions. - Regulatory uncertainties in obtaining approvals for vaccines and therapeutics. - Manufacturing challenges related to scaling up production for various programs.

Q: Could you give more granularity on the commercial launch of KOSTAIVE in Japan?

A: Meiji is planning to sell roughly 4.5 million vaccines during the season, with shipments from ARCALIS expected in December enabling a full launch.

Q: What is needed to demonstrate proof of concept for the CF study?

A: The CF study is open-label, measures FEV1, and multiple doses are evaluated, with more data to be shared later.

Q: When is the EMA approval milestone expected?

A: CHMP opinion for KOSTAIVE is expected next month, with BLA filing planned for first half of 2025.

Q: How is revenue recognized for KOSTAIVE sales in Japan?

A: Revenue is recognized when Meiji reports sales to CSL, and allocation is determined, with 40% of production costs absorbed initially.

Q: What about the H5N1 pandemic flu program?

A: Remains on track to enter clinic this year.