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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act
of 1934
Date of Report (Date of earliest
event reported): September 26, 2025
ARCTURUS THERAPEUTICS HOLDINGS
INC.
(Exact name of registrant as
specified in its charter)
| Delaware |
|
001-38942 |
|
32-0595345 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
10628 Science Center Drive, Suite
250
San Diego, California 92121
(Address of principal executive
offices)
Registrant’s telephone
number, including area code: (858) 900-2660
(Former name or former address,
if changed since last report)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of
the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
| Common stock, par value $0.001 per share |
|
ARCT |
|
The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
| 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 |
