ARCTURUS THERAPEUTICS HOLDINGS INC. Form 8-K (Dec. 8, 2022)

Summary

Current report on Form 8-K of Arcturus Therapeutics Holdings Inc., date of report December 8, 2022, filed under Items 7.01 and 9.01. It states that on December 12, 2022 Meiji Seika Pharma Co., Ltd. announced it started a Phase III clinical trial in Japan of ARCT-154, targeted to include a total of 780 adult participants, half in the ARCT-154 group and half in a comparator group. It also states that CSL Seqirus published a press release on December 12, 2022 announcing that the November 1, 2022 collaboration agreement became effective on December 8, 2022. The information is furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934. The signature block shows /s/ Joseph E. Payne.

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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): December 8, 2022

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

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 December 12, 2022 (December 13, 2022
(JST)), Meiji Seika Pharma Co., Ltd. (“ Meiji ”) announced it has started a
Phase III clinical trial in Japan of ARCT-154, Arcturus Therapeutics Holdings Inc.’s (the “ Company ”
or “ Arcturus ”) self-amplifying mRNA vaccine candidate
against COVID-19. The trial is targeted to include a total of 780 adult participants, with half in the ARCT-154 group and half in a comparator
group, and to evaluate non-inferiority of ARCT-154 as a booster series.

On December 12, 2022, CSL Seqirus (“ CSL ”)
published a press release announcing that the previously announced collaboration agreement dated November 1, 2022 between the Company
and CSL, became effective on December 8, 2022.

The information set forth in this Item 7.01 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 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.

(d) Exhibits.

Exhibit No. | Description of Exhibit
104 | Cover Page to this Current Report on Form 8-K in Inline XBRL

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: December 13, 2022
By: | /s/ Joseph E. Payne
Name: | Joseph E. Payne
Title: | Chief Executive Officer

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