Arcturus Therapeutics Announces Clinical Trial Timeline for its COVID-19 Vaccine

GMP-Manufactured Batch to be Delivered in June 2020
Human Dosing Expected to Begin in Summer 2020

SAN DIEGO, April 09, 2020 (GLOBE NEWSWIRE) -- Arcturus Therapeutics (the “Company”, NASDAQ: ARCT), a leading messenger RNA medicines company focused on the discovery, development and commercialization of therapeutics for rare diseases and vaccines, today announced plans to initiate a human clinical trial this Summer for its COVID-19 vaccine, also known as LUNAR-COV19. Under the guidance of the Singapore Health Sciences Authority (HSA), the trial plans to enroll up to 76 healthy volunteer adults including elderly individuals, with follow-up over several months to evaluate extent and duration of immune response. 

“Arcturus had a very productive meeting with the HSA where the clinical development plan was discussed in detail. We foresee continuing to work with the HSA in a collaborative fashion as we approach initiation of the first clinical trial,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

LUNAR-COV19 is a very low dose, potential single-shot (i.m.), self-replicating mRNA vaccine that is devoid of any viral material or co-adjuvants. Utilizing Arcturus processes, the mRNA vaccine product is readily manufactured, with the initial GMP batch to be delivered in June. Preclinical in vitro data shows that administration of LUNAR-COV19 generates effective expression of the COVID-19 virus spike protein – the antigen to which protective antibodies will be formed. 

About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is an mRNA medicines and vaccines company with enabling technologies – LUNAR^® lipid-mediated delivery & STARR™ mRNA – and mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutics includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Coronavirus (COVID-19), Glycogen Storage Disease Type 3, Hepatitis B, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (187 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS, and the Cystic Fibrosis Foundation. For more information visit www.Arcturusrx.com.

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, including those regarding strategy, future operations, collaborations, the likelihood of success of the Company’s Coronavirus (COVID-19) vaccine or other products, the status of preclinical and clinical development programs, the delivery of any product or substance, the likelihood that preclinical data will be predictive of clinical data, and the planned initiation of clinical trials are forward-looking statements. 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. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading "Risk Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 16, 2020 and in subsequent filings with, or submissions to, the SEC. 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.

Contact
Arcturus Therapeutics
Neda Safarzadeh
(858) 900-2682
IR@ArcturusRx.com

LifeSci Advisors LLC
Michael Wood
(646) 597-6983
mwood@lifesciadvisors.com

Source: Arcturus Therapeutics Holdings Inc.