• $165 million in manufacturing grants awarded to ARCALIS by the Japanese government

SAN DIEGO / Oct 04, 2023 / Business Wire / 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, announced today that ARCALIS, Arcturus’ manufacturing joint venture in Japan to support the production of mRNA vaccines and therapeutics, has been selected by the Japanese Ministry of Economy, Trade and Industry to receive additional financial support to construct a DNA template manufacturing facility along with new state-of-the-art equipment. In total to date, $165 million has been awarded to ARCALIS by the Japanese government to build mRNA Drug Substance, mRNA Drug Product manufacturing capabilities and to construct a DNA template manufacturing facility. The mRNA Drug Substance manufacturing facility was completed in July 2023.

ARCALIS will provide cGMP-integrated vaccine manufacturing, from mRNA drug substance to bulk nanoparticle-formulated drug product. This new capital will fund the development of a DNA plasmid production process to support the rapid manufacture of various vaccines and therapeutics, investigational drugs, and mRNA-based medicines. The new facility is designed to accelerate vaccine production by enabling the manufacturing of DNA plasmid and delivering vaccines within 100 days of the declaration of a target viral strain. The DNA plasmid generated at this facility is intended to be used as the key starting material in the manufacture of mRNA Drug Substance at the neighboring facility.

“We are grateful for the deep commitment and generous financial support provided by the Japanese government to develop and manufacture next-generation mRNA-based vaccines,” said Joseph Payne, President & Chief Executive Officer of Arcturus Therapeutics. “This support has already enabled the completion of a state-of-the-art mRNA Drug Substance manufacturing facility, and we are excited to now extend this collaboration with the construction of an associated DNA manufacturing facility. These facilities, along with additional equipment and manufacturing capabilities, will allow ARCALIS to be leaders in the production of effective novel vaccines and other mRNA-based medicines.”

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR^® lipid-mediated delivery, (ii) STARR^® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. The Company has ongoing collaborations with CSL Seqirus and Meiji Seika Pharma, and a joint venture with ARCALIS. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the issuance of funds by the Japanese government to ARCALIS, the anticipated use of the funds by ARCALIS, the likelihood of successful completion of the ARCALIS facilities, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.