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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): August 11, 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
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 2.02. Results of Operations and Financial Conditions.
On August 11, 2025, Arcturus Therapeutics
Holdings Inc. (the “Company” or “Arcturus”) issued a press release, a copy of which is furnished herewith as Exhibit
99.1, announcing the Company’s financial results for the quarter ended June 30, 2025 and providing a corporate update (the “Press
Release”).
The information contained in Item 2.02 of
this Current Report on Form 8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of
the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of
the Securities Act of 1933, as amended. In addition, this information shall not be deemed incorporated by reference into any of the Company’s
filings with the Securities and Exchange Commission (the “SEC”), except as shall be expressly set forth by specific reference
in any such filing.
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K and the Press Release
contain 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 and the Press Release, are forward-looking statements, including those regarding strategy, future operations, the likelihood
of success of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs
partnered with CSL Seqirus), the likelihood of and timing for providing interim data from the ARCT-032 Phase 2 CF study, the likelihood
of and timing for completion of enrollment in the ARCT-032 Phase 2 CF study, the likelihood of and timing for Phase 3 trial design alignment
with regulatory agencies for ARCT-810, the timing for Phase 1 results from the BARDA pandemic flu Phase 1 study, the likelihood of and
timing for meetings with the FDA and other regulatory agencies relating to the CF and OTC programs, the likelihood of and timing for initiation
of Phase 3 studies for the CF and OTC programs, the timing for completion of enrollment in the ARCT-032 (CF) Phase 2 study, the likelihood
of and timing for approval of the MAA on KOSTAIVE filed by CSL to the UK MHRA, the likelihood and timing for approvals of NDA applications
for KOSTAIVE filed by Meiji Seika Pharma with Japan’s PMDA, the planned U.S. BLA filing and expected approval decision for KOSTAIVE,
efforts for optimization and testing for seasonal influenza program, the timing for Phase 1 results for the pandemic influenza vaccine
candidate, the likelihood that general and administrative expenses will decrease, the likelihood that preclinical or clinical data will
be predictive of future clinical results, its current cash position and expected cash burn and runway, 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 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 |
| |
|
|
| 99.1 |
|
Press Release dated August 11, 2025 |
| 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: August 11, 2025 |
|
| |
|
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
