Press release
Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2024 Financial Update and Pipeline Progress
Phase 2 interim data for ARCT-032 (CF) & ARCT-810 (OTCD) on track for Q2 2025 Meiji Seika Pharma and ARCALIS received MHLW approval for commercial
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nPhase 2 interim data for ARCT-032 (CF) & ARCT-810 (OTCD) on track for Q2 2025\n\nMeiji Seika Pharma and ARCALIS received MHLW approval for commercial manufacturing of KOSTAIVE®\n\nMeiji Seika Pharma Submitted Application for Two-Dose Vial of KOSTAIVE®\n\nKOSTAIVE® U.S. BLA filing anticipated 2025\n\nInvestor conference call at 4:30 p.m. ET today\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced its financial results for the fourth quarter ended December 31, 2024, and provided corporate updates.\n\n“We continue to progress our flagship rare disease programs and look forward to sharing meaningful Phase 2 interim data from our cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs in Q2 2025,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “Arcturus continues to make excellent progress with our STARR® sa-mRNA vaccines pipeline and platform. We are very pleased to have recently received European Commission approval for KOSTAIVE® and MHLW approval for Meiji Seika Pharma and ARCALIS to add commercial manufacturing sites in Japan. Our team continues to work diligently with CSL Seqirus to prepare KOSTAIVE regulatory filings for the United States and the United Kingdom.”\n\nRecent Corporate Highlights\n\n\nArcturus has advanced the development of ARCT-032, an mRNA therapeutic candidate for cystic fibrosis. In December 2024, the Company initiated dosing of the first CF participant in an open label Phase 2 multiple ascending dose study.\n\n\nEach adult participant in the Phase 2 CF study (NCT06747858) is expected to receive daily inhaled treatments of ARCT-032 over a period of 28 days. The trial involves a relatively low number of study visits and 12 weeks of follow up.\n\n\nThe Company expects to provide interim data from participants who completed dosing in the ARCT-032 Phase 2 study by the end of Q2 2025.\n\n\n\n\nArcturus has advanced the development of ARCT-810, an mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. In December 2024, the Company initiated dosing of the first OTC deficient participant who received 0.5 mg/kg in the Pha...