ARCT 8-K
Arcturus Therapeutics Holdings Inc. (ARCT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 26, 2025, Meiji Holdings Co., Ltd. announced that its subsidiary, Meiji Seika Pharma Co., Ltd. (“Meiji”), announced today that it launched a new presentation of KOSTAIVE®, a self-amplifying mRNA vaccine against COVID-19. The product targets the SARS-CoV-2 Omicron sub lineage JN.1 variant XEC. In non-clinical studies, it induced neutralizing antibodies not only against Omicron JN.1 and XEC, but also against LP.8.1 and the currently circulating variants XFG and NB.1.8.1. The formulation is supplied as a two-dose vial, with one vial per carton.
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 Arcturus Therapeutics Holdings Inc.’s (the “Company” or “Arcturus”) self-amplifying mRNA vaccine candidate against COVID-19 in Japan.
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 partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood that non-clinical data will be predictive of future results, the potential supply of KOSTAIVE® in 2025 and timing therefor, 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 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. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated September 26, 2025 |
SIGNATURES
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: September 26, 2025 | ||
| By: |
/s/ Joseph E. Payne | |
| Name: | Joseph E. Payne | |
| Title: | Chief Executive Officer | |
September 26, 2025
Meiji Seika Pharma Launches Two-Dose Vial of KOSTAIVE®, a Self-Amplifying mRNA COVID-19 Vaccine, in Japan
Meiji Seika Pharma Co., Ltd. (Headquarter: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) announced today that it launched a new presentation of KOSTAIVE®, a self-amplifying mRNA vaccine against COVID-19, supplied in vials, each containing two doses.
The product targets the SARS-CoV-2 Omicron sublineage JN.1 variant XEC. In non-clinical studies, it induced neutralizing antibodies not only against Omicron JN.1 and XEC, but also against LP.8.1 and the currently circulating variants XFG and NB.1.8.1. The formulation is supplied as a two-dose vial, with one vial per carton.
Meiji Seika Pharma remains committed to contributing to the prevention of COVID-19.
About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Compared to standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and spike protein to generate a more durable immune response
| Brand Name | KOSTAIVE intramuscular injection |
| Antigen strain | SARS-CoV-2 Omicron sublineage JN.1 variant XEC |
| Active ingredient | Coronavirus (SARS-CoV-2) self-amplifying mRNA vaccine |
| Use & Dosage |
Dissolve this drug in 1.5 mL of Japanese Pharmacopoeia physiological saline solution. Administer a single dose of 0.5 mL intramuscularly |
| Date of Manufacturing and Marketing Approval | August 28, 2025 |
| Date of Launch in Japan | September 26, 2025 |
| Packaging | 1 vial |
*For further information, please refer to the package insert.