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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): June 26, 2026
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.) |
10285 Science Center Drive
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 1.01 |
Entry Into a Material Definitive Agreement. |
On June 26, 2026, Arcturus Therapeutics, Inc. (“Arcturus”),
a wholly-owned subsidiary of Arcturus Therapeutics Holdings Inc., a Delaware corporation (the “Company”), entered into
a series of agreements with Thermo Fisher Scientific Inc. (“Thermo Fisher”) and certain of Thermo Fisher’s affiliates
to establish a strategic collaboration for the provision of contract development and manufacturing organization (“CDMO”)
and contract research organization (“CRO”) services in connection with the development of ARCT-032, the Company’s
investigational mRNA therapeutic for cystic fibrosis (“CF”). The collaboration is structured through (i) a Master Services
Agreement (the “MSA”) between Thermo Fisher and Arcturus and (ii) a Project Addendum for Development Services between
Patheon UK Limited, a Thermo Fisher affiliate (“Patheon”), and Arcturus (the “Project Agreement”,
and together with the MSA, the “Transaction Documents”).
Master Services Agreement
The MSA establishes the framework under which Thermo Fisher and its
affiliates will provide CRO and CDMO services to Arcturus from time to time pursuant to the Project Agreement and any additional individual
project addendums. CRO services will be provided through PPD, Inc., Thermo Fisher’s affiliated contract research organization (“PPD”),
and CDMO services will be provided through Thermo Fisher’s Pharma Services division. Under the MSA, Thermo Fisher will contribute
up to $40 million of clinical manufacturing services for ARCT-032, and Arcturus will engage PPD for up to $40 million in CRO services.
Upon regulatory approval of ARCT-032, Thermo Fisher would receive exclusive commercial manufacturing rights for the product for a specified
duration, on terms to be set forth in a definitive commercial supply agreement to be negotiated in good faith by the parties. Arcturus
may engage an alternative manufacturer only if Thermo Fisher is unable to supply, limited solely to the quantities and duration necessary
to address the supply shortfall. The MSA has an initial term of five years from the effective date and automatically renews for successive
one-year periods unless either party provides at least 90 days’ prior written notice of non-renewal.
Project Agreement
Under the Project Agreement, the services to be provided include technical
transfer, engineering batches, manufacture of clinical trial materials, manufacture of process performance qualification batches, open-label
extension batches, drug product fill and finish, product release, and stability studies. The Project Agreement remains in effect from
its effective date until the completion of all services or earlier termination under the MSA.
The foregoing descriptions of the MSA and the Project Agreement, do
not purport to be complete and are qualified in their entirety by reference to the full text of each such agreement, copies of which the
Company intends to file with the Securities and Exchange Commission (the “SEC”) as exhibits to the Company’s Quarterly
Report on Form 10-Q for the quarter ending June 30, 2026.
| Item 7.01 |
Regulation FD Disclosure. |
On July 2, 2026, the Company issued a press release announcing the
transactions described herein (the “Press Release”). A copy of the Press Release is furnished herewith as Exhibit 99.1.
The information set forth in this Item 7.01 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
SEC, except as shall be expressly set forth by specific reference in any such filing.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description |
| 99.1 |
Press Release dated July 2, 2026 |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: July 2, 2026 |
|
| |
|
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
Arcturus Therapeutics
Announces Strategic Collaboration with Thermo Fisher Scientific to Advance ARCT-032 for Cystic Fibrosis
Strategic manufacturing agreement includes Phase
3 clinical supply and commercial manufacturing rights
SAN DIEGO, Calif. --(BUSINESS WIRE)--July 2, 2026--Arcturus
Therapeutics Holdings Inc. (“Arcturus”, Nasdaq: ARCT), a messenger RNA medicines company focused on the development of
liver and respiratory rare disease therapeutics, today announced a strategic collaboration with Thermo Fisher Scientific, the world
leader in serving science, to help support the Phase 3 development and potential commercialization of ARCT-032, Arcturus’ investigational
mRNA therapy for Cystic Fibrosis.
The collaboration will leverage Thermo Fisher's
Accelerator™ Drug Development solutions, combining manufacturing and clinical research capabilities to support Phase 3 development
through potential commercialization. Thermo Fisher will provide integrated manufacturing, clinical research, and commercial readiness
services to help accelerate development of ARCT-032 while Arcturus continues to advance the program.
“We are pleased to collaborate with Thermo
Fisher to utilize its impressive CDMO capabilities, global infrastructure, and proven ability to support complex mRNA programs from Phase
3 through potential commercialization,” said Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics. “Their
capabilities are aligned with Arcturus’ goal of efficiently advancing our cystic fibrosis program into Phase 3 and preparing for
potential commercial supply.”
“Biotechnology innovators increasingly seek
strategic collaborators that can support complex development programs across clinical and commercial stages,” said Mike Shafer,
Executive Vice President and President, Biopharma Services, Thermo Fisher Scientific. “Through Accelerator™ Drug Development,
Thermo Fisher brings together manufacturing, clinical research, and commercialization expertise to help customers simplify development,
reduce operational complexity, and accelerate the delivery of innovative therapies to patients. Our collaboration with Arcturus demonstrates
the value of this integrated model.”
Under the agreement,
Thermo Fisher will provide Phase 3 manufacturing, clinical research, and related services. If Phase 2 yields positive results, Arcturus
expects to conduct its Phase 3 program through Thermo Fisher's PPD™ clinical research business. Subject to regulatory approval of
ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement.
About Arcturus
Founded
in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines
company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated
delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus
developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an
ongoing global collaboration with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS,
focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially
treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2
(COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines
including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.
Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China,
and other countries). For more information, visit www.ArcturusRx.com. Please connect
with us on X and LinkedIn.
Forward-Looking Statements
This press release 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 press release, are forward-looking statements,
including those regarding strategy, future operations, likelihood of continuation of and positive results of the ongoing Phase 2 clinical
of ARCT-032, the likelihood, timing of and ability to initiate a Phase 3 of ARCT-032, commercialization potential of ARCT-032, the likelihood
of successful collaboration with Thermo Fisher on the strategic collaboration, the likelihood that the Company and Thermo Fisher will
be able to agree upon ancillary agreements related to the collaboration, including commercial supply terms, likelihood of regulatory
approval of ARCT-032, the potential commercial supply of ARCT-032, 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 U.S. 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.
Contacts
Arcturus
Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
