Arcturus Therapeutics (ARCT) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Strategic partnerships and technology

• Significant partnerships with CSL, CF Foundation, and BARDA support vaccine and therapeutic programs.

• Over 400 patents and proprietary LUNAR delivery technology differentiate the mRNA platform.

• Self-amplifying mRNA technology offers longer-lasting protection, higher antibody response, and lower dosing.

• Strong IP position through combined expertise with CSL, covering mRNA constructs, manufacturing, and delivery.

• LUNAR delivery system is chemically distinct and biodegradable, providing a competitive edge.

Clinical and regulatory progress

• Phase II interim data for lead programs expected in Q4, with completed dosing in key cohorts.

• Phase II IND for the CF program filed in the U.S., with trial initiation and data collection set for the second half of the year.

• KOSTAIVE launch in Japan on track, with 4 million doses to be delivered in Q3 and Q4.

• MAA filed in Europe for KOSTAIVE, the first self-amplifying mRNA product in the region.

• Multiple phase III trials underway to support global regulatory filings for KOSTAIVE.

Manufacturing and commercialization

• ARCALIS, a new 75,000 sq ft facility in Japan, is nearing GMP certification and will support global supply.

• ARCALIS can produce up to 1 billion doses annually, with no current capacity constraints.

• Transition from CDMO partners to ARCALIS expected to improve supply economics due to a favorable agreement.

• Japanese government has invested $165 million in ARCALIS, highlighting its strategic importance.

• Meiji, the exclusive distributor in Japan, anticipates strong KOSTAIVE sales growth and a successful Q4 launch.