Press release
Arcturus Therapeutics Announces First Quarter 2023 Financial Update and Pipeline Progress
New Drug Application (NDA) for ARCT-154, a next generation COVID-19 vaccine, was submitted in Japan, leading to potential approval in 2023 $23.6 Million
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nNew Drug Application (NDA) for ARCT-154, a next generation COVID-19 vaccine, was submitted in Japan, leading to potential approval in 2023\n\n\n$23.6 Million advanced for the manufacturing and supply of ARCT-154\n\n\nARCT-032 Phase 1 enrollment and administration completed successfully; trial expansion to include Cystic Fibrosis patients planned in third quarter\n\n\nInvestor conference call at 4:30 p.m. ET today\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical 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 first quarter ended March 31, 2023, and provided corporate updates.\n\n\n“We are very pleased to announce the first NDA submission for the COVID-19 vaccine, ARCT-154, in Japan by Meiji Seika Pharma Co., Ltd., leading to potential approval later this year. ARCT-154 has the potential to offer effective and longer-lasting protection against COVID-19. We believe this meaningful milestone is indicative of the broader platform opportunity for our mRNA medicine technologies to result in novel vaccines and therapeutics over the coming years,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “We have also made meaningful operational and pipeline progress across several clinical and pre-clinical mRNA therapeutic programs with the completion of enrollment of a Phase 3 study evaluating the safety and immunogenicity of ARCT-154 as a booster against COVID-19 conducted by Meiji Seika Pharma in Japan, with interim results expected later this quarter.”\n\n\nIn April 2023 we received an advance payment of $23.6 million for the manufacturing and supply of ARCT-154 from CSL Seqirus. The advance payment was for specified manufacturing runs of ARCT-154 which includes the drug substance utilized, as well as the reservation fees and related manufacturing requirements.\n\n\n“As we mentioned on the year end conference call last month, we took a number of positive steps to improve our balance sheet this quarter with the elimination of $34 million in principal and accrued interest on the Singapore Loan,” stated Andrew Sassine, Chief Financial Officer of Arcturus Therapeutics. “On March 31, 2023, we...