Arcturus Therapeutics Received Approval from Singapore Health Sciences Authority to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate and Provides New and Updated Clinical and Preclinical Data

Arcturus 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 that the Company has received approval from the Singapore Health Sciences Authority to proceed with a Phase 2 clinical study of its vaccine candidate ARCT-021. This study will build upon the favorable Phase 1/2 study results, as well as supportive preclinical data.

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“We are pleased to advance ARCT-021 into a Phase 2 study based upon our promising Phase 1/2 data, which continues to support the potential for Arcturus’ STARR self-replicating mRNA technology to provide a highly effective, and differentiated clinical profile, including a single dose regimen,” said Steve Hughes, M.D., Chief Development Officer of Arcturus. “The Phase 2 study will enable selection of the optimal ARCT-021 vaccination regimen for Phase 3 registrational studies. We look forward to obtaining interim Phase 2 data in early 2021 providing support for the anticipated initiation of a global Phase 3 study in Q2 2021.”

“The Phase 1/2 study results, together with recently generated preclinical data, indicate that ARCT-021 leads to a potent immune response to SARS-CoV-2, and demonstrates a differentiated biological profile whereby the immune response increases in the weeks following vaccination,” said Professor Ooi Eng Eong, Emerging Infectious Diseases Programme, Duke-NUS Medical School and a member of Arcturus’ Vaccine Platform Scientific Advisory Board. “The preclinical finding that ARCT-021 results in protection from SARS-CoV-2, even when humoral immunity is depleted, is particularly notable and suggests that ARCT-021 results in highly potent cellular immunity to the virus. Together, the body of data provides us with confidence that ARCT-021 vaccination will confer substantial protection from SARS-CoV-2 infection and COVID-19.”