Arcturus Therapeutics (ARCT) Q3 2024 earnings summary

Executive summary

• Achieved the world's first approval and commercial launch of a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, in Japan in September 2024, triggering a $25 million milestone payment.

• Advanced mRNA therapeutics pipeline with ARCT-032 (cystic fibrosis) and ARCT-810 (OTC deficiency), both on track for interim phase 2 proof-of-concept data in the first half of 2025.

• Positive phase 3 data for KOSTAIVE® supports global regulatory filings, with a pending CHMP opinion in Europe and plans to file a BLA in the U.S. in the first half of 2025.

• Expanded ARCT-810 phase 2 program into the U.S. and completed dosing in the European study.

• Manufacturing process transfer for cystic fibrosis program to ARCALIS planned.

Financial highlights

• Q3 2024 revenue was $41.7 million, down from $45.1 million in Q3 2023, mainly due to lower milestone payments.

• Q3 2024 net loss was $6.9 million ($0.26 per diluted share), improved from a $16.2 million loss ($0.61 per share) in Q3 2023.

• Cash, cash equivalents, and restricted cash totaled $294.1 million as of September 30, 2024; cash runway expected to extend through Q1 2027.

• Operating expenses for Q3 2024 were $52.4 million, down from $64.5 million in Q3 2023; R&D expenses decreased to $39.1 million.

• Achieved $462.1 million in upfront and milestone payments from CSL as of Q3 2024.

Outlook and guidance

• Anticipates CHMP opinion for KOSTAIVE® in Europe in December 2024, with formal approval expected in Q1 2025.

• Plans to file a BLA for KOSTAIVE® in the U.S. in the first half of 2025, supported by positive phase 3 data.

• Interim phase 2 data for ARCT-032 and ARCT-810 expected in the first half of 2025.

• General and administrative expenses expected to remain consistent with current pipeline.

• Cash runway projected to extend through Q1 2027 based on current programs.