Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19

Arcturus 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, and CSL (ASX:CSL), and its vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, announced today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024.

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The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus’ partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV-2 ancestral strain compared to Comirnaty. Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was a key secondary endpoint.

“EMA acceptance of the marketing application for ARCT-154 represents another major achievement in the development of this innovative mRNA vaccine platform. This is also an important milestone for Arcturus and our global exclusive partner, CSL Seqirus, as we work towards achieving approval in Europe,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “ARCT-154 is expected to be efficiently updated as new variants of concern arise and has the potential to be a longer lasting vaccine against the pervasive and ever-changing COVID virus.”