Arcturus Therapeutics Holdings Inc. Q4 FY2024 earnings call

• Vaccine program: KOSTAIVE, the world's first approved self-amplifying mRNA COVID-19 vaccine, received European Commission approval. Meiji Seika Pharma submitted a manufacturing and marketing application for a 2-dose vial of KOSTAIVE in Japan. - Therapeutics pipeline: ARCT-032 initiated Phase II study in CF patients; ARCT-810 initiated Phase II study in OTC deficient participants. - Appointments: Dr. Moncef Slaoui appointed Chair designate.

For the year ended December 31, 2024, Arcturus reported revenues of $152.3 million, a decrease from $166.8 million in 2023. The Q4 2024 revenues were $22.8 million, down from $30.9 million in the same period in 2023. Total operating expenses for 2024 were $248 million vs. $245 million in 2023. R&D expenses increased to $195.2 million in 2024 from $192.1 million in 2023, driven by clinical trials. Cash and cash equivalents and restricted cash were $293.9 million as of December 31, 2024.

• Cash runway is expected to extend until the end of Q1 2027. - Anticipates interim Phase II data readout for OTC and CF programs by the end of Q2 2025. - Burn is expected to increase in the next 2 years due to CF and OTC trials.

• Uncertainties in clinical trial outcomes for CF, OTC, and vaccine programs. - Regulatory approval challenges for new product formulations. - Market adoption risks for new therapeutics and vaccines.

Q: How should we think about the cadence of development milestones within the CSL collaboration?

A: Andrew Sassine stated they will continue to receive milestones from CSL throughout the year, with more details on European regulatory filing milestones to be provided in the first quarter call.

Q: How does the CF program differentiate from competitors in the mRNA space?

A: Joseph Payne mentioned differences in mRNA sequence stability, LUNAR lipid nanoparticle delivery technology, and manufacturing/purification know-how.

Q: What is the enrollment status of the CF Phase II study?

A: Joseph Payne stated they remain on track to provide interim data by end of Q2 2025, with multiple sites active and engaging several more.

Q: When can we expect visibility into KOSTAIVE orders in Japan?

A: Andrew Sassine said Meiji will provide guidance on Japanese sales, but they can't comment specifically on order quantities.