Press release
Arcturus Therapeutics Announces Third Quarter 2021 Financial Update and Pipeline Progress
Phase 1/2/3a and 3b study of ARCT-154 COVID-19 vaccine candidate completed enrollment with over 17,000 participants Initiated ~2,000 participant ARCT-154
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nPhase 1/2/3a and 3b study of ARCT-154 COVID-19 vaccine candidate completed enrollment with over 17,000 participants\n\nInitiated ~2,000 participant ARCT-154 Phase 3c sub-study to compare immunogenicity noninferiority to AstraZeneca COVID-19 vaccine; enrollment to be completed this week\n\nPreparing to file Emergency Use Authorization (EUA) application for ARCT-154, pending interim study results, with the Vietnam Ministry of Health in December 2021; potential for EUA approval in Q1 2022\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 leading clinical-stage 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 third quarter ended September 30, 2021 and provided corporate updates.\n\n“We are extremely pleased to have rapidly completed full enrollment of the Phase 1/2/3a and 3b cohorts and are looking forward to completing enrollment in the Phase 3c sub-study of the ARCT-154 pivotal trial this week, in collaboration with Vinbiotech. Assuming favorable data, we look forward to filing for Emergency Use Authorization as soon as December of this year,” 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 targets multiple SARS-CoV2 variants of concern, and we are working diligently with our global manufacturing partners to make it available as soon as possible.”\n\nRecent Corporate Highlights\n\n\nIn August, Arcturus, together with Vinbiotech, advanced ARCT-154 into a Phase 1/2/3 study in Vietnam.\n\n\nIn October, Arcturus received approval to proceed with enrollment of the Phase 3b cohort of the study following a review by the Vietnam Ministry of Health of early safety data from the initial 1,000 participants enrolled in the Phase 1/2/3a cohorts.\n\n\nIn November, the Phase 3b cohort of this randomized, placebo-controlled portion of the trial was modified to enroll approximately 16,000 participants with a Phase 3c sub-study of approximately 2,000 participants added to evaluate immunogenicity noninferiority compared to AstraZeneca COVID-19 vaccin...