May 27th 2021
Axcelead Decided to Build an mRNA Drug Manufacturing Plant in Minamisoma City,Fukushima Prefecture — A worldwide mRNA Vaccine and Therapeutic Drug Substance
Factory is Scheduled to Start Operations in 2023 —Axcelead, Inc. (CEO, Tomoyuki Fujisawa, “Axcelead”) announced today, that ARCALIS, Inc.
(“ARCALIS”), a joint venture entity between Axcelead and Arcturus Therapeutics, Inc.
(“Arcturus”, Nasdaq: ARCT), have decided to build its mRNA manufacturing plant inMinamisoma City, Fukushima Prefecture.
ARCALIS is a company that develops a contract development and manufacturingorganization (CDMO) focused on mRNA vaccines and therapeutics, which would provide
manufacturing service to Arcturus and also to pharmaceutical and biotech companies over theworld. ARCALIS plans to develop the one-stop integrated mRNA vaccines and therapeutics
CDMO business, which promises a stable supply of high-quality mRNA drugs to a wide rangeof customers. The factory to be constructed in Minamisoma City is equipped with state-ofthe-art manufacturing control and quality control systems that meet the current Good
Manufacturing Practices (cGMP), and is equipped with mRNA vaccines and therapeutics forthe entire world, mainly in Japan, the United States and Europe. We plan to manufacture
medicines on a contract basis. As a first step, we plan to start operation of the API plant by
the end of 2023.
Arcturus is a leading clinical-stage messenger RNA medicines company focused on thedevelopment of infectious disease vaccines and significant opportunities within liver andrespiratory rare diseases. Arcturus’s COVID-19 vaccine candidate, ARCT-021, is a single
shot, lyophilized self-amplifying mRNA vaccine, which may show important differences fromcurrently available mRNA vaccines.
"The efficacy and safety of mRNA vaccine, a new drug discovery modality, has already been
demonstrated by Pfizer and Moderna products, and it is expected that the development ofmRNA vaccine will continue to expand and the manufacturing needs for ARCALIS willcontinue to grow. We hope that we can contribute to the reconstruction of the earthquake asmuch as possible through the construction and start of operation of the plant," said Tomoyuki
Fujisawa, CEO of Axcelead. “We believe that establishing a state-of-the-art pharmaceuticalproduction base in Minamisoma will make a significant contribution to the revitalization of
the local economy. We will support this project, to make this enterprise invitation succeed”
said Kazuo Monma, Mayor of Minamisoma.
Regarding to the relationship between this project and government efforts, this project canbe positioned as contributing to the (1)"Fukushima Innovation Coast Concept" promoted by
the government and (2)"strengthening the competitiveness of CDMO for biologics" tofurther improve the competitiveness of the Japanese biotechnology industry.
(1) This project is expected to be a pioneer of industrial agglomeration in the “medicalrelated” category in Fukushima Innovation Coast Concept as a plan for priority promotionof efforts that contribute to the creation of new industries and the strengthening of theinternational competitiveness of industries in Fukushima Prefecture.
(2) Biologics requires special manufacturing technologies and know-how, different fromconventional chemical synthesis, and has a problem that development and manufacturingcosts are higher than those of conventional small molecule drugs. In addition, as the role ofventure companies in the development of new drugs is increasing, cooperation with externalbusinesses is indispensable in order to maximize the vitality of venture companies that havetechnological capabilities but lack financial resources. For these reasons, the government isworking to strengthen the competitiveness of CDMOs such as biologics from theperspective of securing a domestic manufacturing base. This project is expected to be anadvanced and pioneering example of CDMO for biologics.
Regarding the establishment of ARCALIS, it is a part of the project described in " Axcelead
Launches ARCALIS, a Joint Venture to Manufacture mRNA Therapeutics" reported byAxcelead on April 27. This project is described in the joint report by Hitachi, Ltd. and
Axcelead on April 7, "Hitachi and Axcelead have agreed to start joint development of solutions
contributing on more efficient of next-generation biopharmaceuticals" * 2.
*1Press Release URL：
https://www.axcelead-hd.com/wp-content/uploads/2021/04/アクセリードmRNA医薬品CDMO合弁会社「Arcalis」を設立fin２.pdf*2Press Release URL：
https://www.axcelead-hd.com/wp-content/uploads/2021/04/20210407_AHDHITACHI_newsrelease_JP-1.pdf

About Axcelead, Inc.
Axcelead is a group of companies that develops a drug discovery platform business centeredon Axcelead Drug Discovery Partners, Inc. (ADDP), Japan's first integrated drug discovery
solution provider, which took over Takeda's drug discovery platform business in 2017.
Axcelead, is the flagship portfolio company of Drug Discovery Gateway Fund, which wasjointly established by Whiz Partners, Inc., and Takeda Pharmaceutical Company, Co., Ltd.,in 2018, with the aim of promoting the drug discovery ecosystem in Japan and will makevarious contributions to healthcare broadly and globally. For more information on Axceleadand Whiz Partners, please visit the company's website at https://www.axcelead-hd.com/, andat http://www.whizp.com/.
About Minamisoma city
Minamisoma City was born on January 1, 2006 by merging 1 city and 2 towns of the former
Odaka Town, the former Kashima Town, and the former Haramachi City.
Minamisoma City is located in the northern part of Hamadori, Fukushima Prefecture, facing
the Pacific Ocean, and has an area of 398.58 square kilometers. The distance from Tokyo is292 kilometers, which is approximately halfway between Iwaki City in Fukushima Prefectureand Sendai City in Miyagi Prefecture.
Minami soma city is promoting town development through the "100 years based Minamisoma
City Reconstruction Comprehensive Plan Late Basic Plan" formulated in 2019 with the aimof recovering from the Great East Japan Earthquake that occurred on March 11, 2011 and theaccident at the Fukushima Daiichi Nuclear Power Station of Tokyo Electric Power Company.
In addition, in line with the Fukushima Innovation Coast Initiative promoted by thegovernment, we are implementing various initiatives such as attracting companies in priority
fields such as medical care, the robot and drone field.

■Contacts
Axcelead, Inc.
hd_contact@axcelead.com
Minamisoma Citysyokorosei@city.minamisoma.lg.jp