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Arcturus Therapeutics Joint Venture mRNA Manufacturing Partner, ARCALIS, Awarded $115 Million in Grants from the Japanese Government LUNAR-FLU collaboration with CSL Seqirus achieves additional $17.5 million development

Key Takeaway: Arcturus Therapeutics announced that its joint venture ARCALIS has been awarded $115 million in grants from the Japanese government to support mRNA vaccine production. This funding will be utilized for constructing a new factory in Minamisoma City, Japan, aimed at cGMP manufacturing of mRNA products. Additionally, the LUNAR-FLU program, developed in collaboration with CSL Seqirus, has reached a $17.5 million milestone aimed at advancing flu vaccine development. This progress underscores the strategic partnerships and advancements within Arcturus' initiatives in mRNA technology.

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POSITIVE FACTORS

  • ARCALIS received $115 million in grants from the Japanese government for mRNA production.
  • The new factory in Japan supports cGMP manufacturing of next-generation mRNA vaccines.
  • LUNAR-FLU program secured an additional $17.5 million funding, indicating strong collaboration with CSL Seqirus.

Full Press Release Details

Arcturus Therapeutics Joint Venture mRNA Manufacturing
Partner, ARCALIS, Awarded $115 Million in Grants from the Japanese Government
LUNAR-FLU collaboration with CSL Seqirus achieves additional $17.5
million development milestone
SAN DIEGO--(BUSINESS WIRE)--Aug. 14, 2023-- 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, today
announced that ARCALIS Co., Ltd., its manufacturing joint venture in Japan to support the production of mRNA vaccines and
therapeutics, has been awarded $115 million in two separate grants from the Japanese government. The grants will be used to
fund the construction of a factory and the purchase of capital equipment to support current Good Manufacturing Practice (cGMP) production
of mRNA drug substance and mRNA drug product operations.
ARCALIS is a joint venture between Axcelead and Arcturus, wherein
Arcturus holds a 49% equity position that is subject to dilution. The factory, located in Minamisoma City, Japan, is designed
to provide cGMP integrated vaccine manufacturing, from mRNA drug substance to bulk nanoparticle-formulated drug product.
"It was an honor to welcome senior Japanese government officials
and dignitaries to the opening ceremonies for ARCALIS' state-of-the-art factory which will support the cGMP manufacturing of Arcturus'
next-generation STARR mRNA vaccines," said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics.
Arcturus also announced today that the LUNAR-FLU program continues
to progress with funding and operational support from CSL-Seqirus, including an additional $17.5 million milestone which will
be used to fund flu program development activities. The LUNAR-FLU program utilizes Arcturus' clinically validated next-generation
STARR mRNA platform technology.
"We are pleased with the progress of the LUNAR-FLU program with
CSL Seqirus, our exclusive global licensee for the development of novel mRNA vaccines, and the significant role that Arcturus is playing
in the development activities," said Joseph Payne, President and CEO of Arcturus Therapeutics. "The LUNAR-FLU program
could represent a major advance in vaccination efforts against flu, potentially providing higher levels of efficacy and greater durability
compared to current flu vaccine approaches. We look forward to advancing this promising program."
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 (samRNA) 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 potential manufacture by ARCALIS of Arcturus vaccines, the continued progress of the LUNAR-FLU program,
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.
IR and Media Contacts
Arcturus Therapeutics
VP, Head of IR/PR/Marketing
Kendall Investor Relations
Source: Arcturus Therapeutics

Frequently Asked Questions

What funding did ARCALIS receive from the Japanese government?

ARCALIS was awarded $115 million in grants to support mRNA vaccine production.

How is ARCALIS supporting mRNA manufacturing?

ARCALIS aims to provide cGMP integrated manufacturing for mRNA vaccines.

What is the LUNAR-FLU program's milestone funding?

The LUNAR-FLU program received an additional $17.5 million in funding.

Who is collaborating with Arcturus on mRNA vaccines?

CSL Seqirus is a key partner in the development of novel mRNA vaccines.

What technologies does Arcturus utilize in its products?

Arcturus employs LUNAR lipid delivery and STARR mRNA technology in its therapies.

Last updated: Aug 14, 2023