SECURITIES AND EXCHANGE COMMISSION
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Item 7.01. Regulation FD Disclosure.
On April 28, 2023, Meiji Seika Pharma Co., Ltd., a subsidiary of Meiji Holdings Co., Ltd. (“Meiji”) announced that it submitted a New Drug Application for ARCT-154 for primary immunization to prevent COVID-19 in adults (two doses of ARCT-154) in Japan.
As previously announced on April 11, 2023, Meiji entered into a distribution agreement with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited, and one of the world’s leading influenza vaccine providers, for the distribution and sales of ARCT-154, Arcturus Therapeutics Holdings Inc.’s (the “Company” or “Arcturus”) self-amplifying mRNA vaccine candidate against COVID-19, in Japan.
Also as previously announced, in November 2022, the Company entered into a Collaboration and License Agreement (the “CSL Collaboration Agreement”) with CSL Seqirus, for the global exclusive rights to research, develop, manufacture and commercialize Arcturus’ self-amplifying mRNA vaccines against COVID-19, influenza and three other respiratory infectious diseases with nonexclusive rights to pandemic pathogens. The CSL Collaboration Agreement became effective on December 8, 2022.
A copy of Meiji’s press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The information set forth in this Item 7.01, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such a filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K 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 Current Report on Form 8-K, are forward-looking statements, including those regarding the collaboration with CSL Seqirus, Meiji, or any collaborations, and the outcomes of clinical trials involving ARCT-154. 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 Securities and Exchange Commission (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.
Item 9.01 Financial Statements and Exhibits.
|Exhibit No.||Description of Exhibit|
|99.1||Press Release dated April 28, 2023|
|104||Cover Page to this Current Report on Form 8-K in Inline XBRL|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Arcturus Therapeutics Holdings Inc.|
|Date: April 28, 2023|
/s/ Joseph E. Payne
|Name:||Joseph E. Payne|
|Title:||Chief Executive Officer|
|April 28, 2023|
Name of Company: Meiji Holdings Co., Ltd.
Name of Representative: Kazuo Kawamura, CEO, President and Representative Director
Code Number: 2269, Prime Market, Tokyo Stock Exchange
Submitted New Drug Application to Manufacture and Market ARCT-154,
Next Generation mRNA Vaccine against COVID-19, in Japan
Meiji Holdings Co., Ltd. announces that its subsidiary, Meiji Seika Pharma Co., Ltd., submitted a New Drug Application to manufacture and market ARCT-154 for primary immunization to prevent COVID-19 in adults (two doses of ARCT-154) in Japan. ARCT-154, a next generation mRNA vaccine against COVID-19, was developed by Arcturus Therapeutics Inc*1 and in April, Meiji obtained exclusive rights to distribute ARCT-154 in Japan from CSL Seqirus.*2
ARCT-154 uses next-generation mRNA technology which offers strong immune response, a favorable tolerability profile and the potential for extended duration of protection while using lower doses of mRNA compared to existing mRNA vaccines.
Meiji Seika Pharma submitted an NDA for primary immunization of ARCT-154 based on results of a Phase III clinical trial (NCT05012943) conducted in Vietnam involving more than 16,000 subjects. The trial evaluated safety, immunogenicity and efficacy of primary immunization of ARCT-154 and the results met its primary endpoint of prevention of COVID-19. Meiji Seika Pharma has been conducting a Phase III study in Japan since December 13, 2022, to evaluate the safety and immunogenicity of ARCT-154 as a booster against COVID-19, and completed enrollment in February 2023.
Under the terms of an agreement with CSL Seqirus, Meiji Seika Pharma will be responsible for obtaining regulatory approval, and for distribution, sales and marketing of ARCT-154 in Japan.
Meiji Seika Pharma is collaborating with ARCALIS, Inc.*3 to establish an integrated mRNA vaccine manufacturing from drug substance to drug product in Japan. ARCALIS is building a manufacturing facility in Minami-soma City, Fukushima Prefecture.
Meiji Seika Pharma is working to supply ARCT-154 in Japan as soon as possible following approval. If approved, ARCT-154 will become a new vaccination option against COVID-19. The impact on the consolidated financial results forecast for the fiscal year ending March 31, 2024, has not been determined at this time. We will closely examine the situation and disclose the impact as soon as it is recognized.
Disclaimer: This English translation is prepared for the readers’ convenience. When there are any discrepancies between the original Japanese version and English translation version, the original Japanese version always prevails.
|*1:||Arcturus Therapeutics Holdings Inc. founded in 2013, is 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. (https://arcturusrx.com/)|
|*2:||CSL Seqirus, a subsidiary of CSL Limited, is one of the world's largest suppliers of influenza vaccines. The company has state-of-the-art manufacturing facilities in the U.S., U.K., and Australia. It also has excellent research and development capabilities. (https://www.cslseqirus.com/)|
|*3:||ARCALIS, Inc. is a joint venture company between Axcelead Inc. and Arcturus Therapeutics Inc., which owns a group of world-class drug-discovery and healthcare platform companies. The company provides drug discovery support, as well as a contract development and manufacturing business (CDMO business), for mRNA medicines and vaccines. (https://corp.arcalis.co.jp/en)|