Press release
Arcturus Therapeutics Announces Fourth Quarter and Full Year 2021 Financial Update and Pipeline Progress
Emergency Use Authorization (EUA) application for ARCT-154 submitted to Vietnam Ministry of Health ARCT-154 Phase 1/2 booster study data in U.S. and
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nEmergency Use Authorization (EUA) application for ARCT-154 submitted to Vietnam Ministry of Health\n\nARCT-154 Phase 1/2 booster study data in U.S. and Singapore demonstrated 28-, and 54-fold increases in neutralizing antibody activity against SARS-CoV-2 ancestral and Omicron strains, respectively\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 late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided additional corporate updates.\n\n“We have continued to execute across our organization, highlighted by completion of filing for Emergency Use Authorization of ARCT-154 in Vietnam,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “ARCT-154 has an attractive and differentiated profile as a low-dose, self-amplifying mRNA vaccine candidate that has been generally safe and well tolerated based on review of blinded data from clinical trials to date. The EUA filing is based on safety and immunogenicity data from the ongoing Phase 1/2/3 study. In addition to the Vietnam Ministry of Health, we continue to engage other regulatory authorities to clarify the potential path to product approval as a booster vaccine.”\n\nRecent Corporate Highlights\n\n\nLUNAR-COV19; ARCT-154: Arcturus’ collaborator Vinbiocare has completed filing of an application for EUA with the Vietnam Ministry of Health. The EUA application is based on available safety and immunogenicity data from the first 1,000 participants in the Phase 1/2/3a portions of the ongoing study being conducted in Vietnam. The trial is sponsored by Vinbiocare and has completed enrollment and priming vaccination in all portions of the study with over 19,000 participants.\n\n\nIn January 2022, Arcturus announced data from Phase 1/2 clinical development programs for ARCT-154 and ARCT-165 used as boosters following primary vaccination with Comirnaty®. Data demonstrated robust neutralizing antibody responses against SARS-CoV-2 ancestral D614G strain as well as several variants of concern, including Beta, Delta, and Omicron.\n\n\nArcturus’ gl...