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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 6, 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
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 6, 2026, 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, 2026 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), the likelihood that the Company will continue to advance
its rare disease therapeutics portfolio including its inhaled mRNA therapy, the likelihood that the ARCT-032 (CF) Phase 2 study enrollment
will remain on schedule, the timing for a decision to proceed into a Phase 3 study for ARCT-032, the communication of a data and regulatory
plan for ARCT-810 and timing thereof, the likelihood that the Company will be able to increase the value of its sa-mRNA vaccine platform
including likelihood that the Company will develop, commercialize or seek partnership opportunities related to KOSTAIVE and its other
infectious disease vaccine programs, the ability of the Company to reach important clinical and regulatory milestones for its rare disease
pipeline, the likelihood that clinical data, including interim 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 6, 2026 |
| 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.
| Date: August 6, 2026 |
Arcturus Therapeutics Holdings Inc. |
| |
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
Arcturus
Therapeutics Announces Second Quarter 2026 Financial Results and Pipeline Progress
ARCT-032 (CF) Phase
2 study enrollment remains on schedule; the decision to proceed into Phase 3 expected Q4 2026
ARCT-810 (OTC Deficiency)
Phase 2 study enrollment and dosing completed; data and regulatory plan to be communicated Q3 2026
Arcturus regains global
rights to KOSTAIVE® and infectious disease portfolio; receives $12 million in cash and $16 million in released liabilities and R&D
credits
Investor
conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE) -- August 6, 2026 --
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a messenger RNA medicines
company focused on the development of liver and respiratory rare disease therapeutics, today announced its financial results for the quarter
ended June 30, 2026, and provided corporate updates.
“We are encouraged by the continued progress
of our ARCT-032 Phase 2 cystic fibrosis study, with active screening and ongoing enrollment across sites in the United States, Israel,
and Turkey. With dosing completed of all subjects in our ARCT-810 Phase 2 OTC deficiency study, we look forward to sharing the data and
regulatory plan later this quarter,” said Joseph Payne, President & CEO of Arcturus. "We are also pleased to regain strategic
control of KOSTAIVE® and our infectious disease vaccine portfolio, enhancing our ability to increase the value of our validated sa-mRNA
vaccine platform."
Recent Corporate Highlights
| · | ARCT-032, an inhaled mRNA therapeutic candidate
for cystic fibrosis, continues to advance in an open-label Phase 2 study in people with Class I CF mutations. Cohort 4 is evaluating 10
mg daily dosing, via inhalation, over 12 weeks and monitoring safety and evidence of early clinical benefit, including pulmonary function
measures such as ppFEV1 and lung clearance index (LCI), quality-of-life measures, and high-resolution computed tomography (HRCT) imaging.
Enrollment is advancing as expected, with active screening and enrollment in the U.S., Israel, and Turkey. Israel and Turkey are geographies
with a high prevalence of individuals with Class I/null CF mutations, supporting recruitment efforts in the ongoing study. The decision
to advance ARCT-032 into Phase 3 is expected in Q4 2026, triggering significant resources and support from Thermo Fisher. |
| · | Arcturus announced a strategic collaboration
with Thermo Fisher Scientific to advance ARCT-032 for cystic fibrosis. 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. |
| · | ARCT-810, an mRNA therapeutic candidate for OTC
deficiency, has completed enrollment of the ongoing Phase 2 study, and all enrolled subjects have completed study drug dosing. The Company
continues to evaluate supplementary data to inform regulatory discussions and preparation for an End-of-Phase 2 meeting regarding the
path forward across adult and pediatric development. Data and the regulatory plan for this program is expected to be communicated later
this quarter. |
| · | Arcturus and CSL Seqirus have concluded their
sa-mRNA collaboration through a termination and settlement agreement following a joint review of the partnership. Under the agreement,
Arcturus regained global rights to KOSTAIVE® and the broader infectious disease vaccine portfolio, including seasonal influenza, pandemic
influenza, RSV, and EBV vaccine programs, subject to existing arrangements with Meiji Seika Pharma for the 2026-2027 season in Japan.
The agreement also resolves the arbitration relating to a European regulatory approval milestone payment. |
| o | Under the agreement, CSL Seqirus will make a one-time cash payment of $12 million to Arcturus. In addition,
Arcturus will be released from liabilities associated with an R&D credit with an aggregate value of approximately $16 million. |
| o | With strategic control of the portfolio returned to Arcturus, the Company intends to evaluate opportunities
to maximize its future value, including development, commercialization, and partnering opportunities related to KOSTAIVE®, and the
broader infectious disease vaccine portfolio. |
“We remain focused on disciplined execution
and capital allocation as we advance our rare disease programs,” said Dennis Mulroy, Chief Financial Officer of Arcturus. “The
CSL Seqirus termination and settlement agreement strengthens our financial position, and the Thermo Fisher collaboration supports execution
of late-stage development for our CF program. We continue to maintain a strong balance sheet and cash runway of over two and a half years
through year end 2028, allowing our company to reach important clinical and regulatory milestones for its rare disease pipeline.”
Financial Results for the three months ended
June 30, 2026
Cash Position and
Balance Sheet
Cash and cash equivalents
were $191.5 million as of June 30, 2026, and $230.9 million on December 31, 2025, for a decrease of $39.4 million. The decrease was primarily
driven by cash used related to ongoing clinical development activities, including the continued advancement of the Company's ARCT-032
cystic fibrosis and ARCT-810 OTC deficiency programs.
Revenue in conjunction
with strategic alliances and collaborations
Revenue was $3.0 million and $5.0 million for
the three and six months ended June 30, 2026, respectively, compared with $28.3 million and $57.7 million in the comparable periods last
year. The decreases in revenue were primarily attributable to lower revenue recognized under the CSL Seqirus collaboration as the Company
progressed toward the termination of the agreement and regaining rights to KOSTAIVE® and its broader infectious disease vaccine portfolio.
Research and development expenses
Research and development expenses were $17.5 million
and $39.0 million for the three and six months ended June 30, 2026, respectively, compared with $29.6 million and $64.5 million for the
corresponding periods in 2025. The decreases were primarily driven by lower research and development spending including reduced salaries,
wages, benefits and facilities costs as the Company continued to advance its highest-priority programs while maintaining a disciplined
approach to capital allocation.
General and administrative expenses
General and administrative expenses were $11.0
million and $20.5 million for the three and six months ended June 30, 2026, respectively, compared with $10.3 million and $21.7 million
in the comparable periods last year. Overall, general and administrative expenses remained relatively consistent across periods with a
slight quarter-to-date increase due to legal fees partly offset by reduced salaries, wages, benefits and facilities costs.
Net loss
Net loss was $23.8 million and $50.7 million for
the three and six months ended June 30, 2026, or a net loss per share of $0.84 and $1.79, compared to a net loss of $9.2 million and $23.3
million for the three and six months ended June 30, 2025, or a net loss per share of $0.34 and $0.86.
Earnings Call: Thursday, August 6, 2026 @ 4:30
p.m. ET
| · | Domestic: 1-800-347-6865 |
| · | International: 1-203-518-9757 |
| · | Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1769554&tp_key=96c7f551a6 |
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' strategic
collaborations include Thermo Fisher Scientific for ARCT-032 manufacturing and development, BARDA for pandemic influenza initiatives,
and ARCALIS, a Japanese joint venture focused on manufacturing mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic
candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency. 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, the likelihood of success of the Company’s
pipeline (including ARCT-032 and ARCT-810), the likelihood that the Company will continue to advance its rare disease therapeutics portfolio
including its inhaled mRNA therapy, the likelihood that the ARCT-032 (CF) Phase 2 study enrollment will remain on schedule, the timing
for a decision to proceed into a Phase 3 study for ARCT-032, the communication of a data and regulatory plan for ARCT-810 and timing thereof,
the likelihood that the Company will be able to increase the value of its sa-mRNA vaccine platform including likelihood that the Company
will develop, commercialize or seek partnership opportunities related to KOSTAIVE and its other infectious disease vaccine programs, the
ability of the Company to reach important clinical and regulatory milestones for its rare disease pipeline, the likelihood that clinical
data, including interim 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.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| | |
June 30, 2026 | |
December 31, 2025 |
| (in thousands, except par value information) | |
| (unaudited) | | |
| | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 191,483 | | |
$ | 230,909 | |
| Accounts receivable | |
| 1,813 | | |
| 5,564 | |
| Prepaid expenses and other current assets | |
| 3,865 | | |
| 4,973 | |
| Total current assets | |
| 197,161 | | |
| 241,446 | |
| Property and equipment, net | |
| 5,363 | | |
| 6,736 | |
| Operating lease right-of-use assets, net | |
| 19,758 | | |
| 21,081 | |
| Non-current restricted cash | |
| 2,028 | | |
| 1,885 | |
| Total assets | |
$ | 224,310 | | |
$ | 271,148 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 4,414 | | |
$ | 4,235 | |
| Accrued liabilities | |
| 22,846 | | |
| 23,898 | |
| Deferred revenue | |
| 6,276 | | |
| 8,246 | |
| Total current liabilities | |
| 33,536 | | |
| 36,379 | |
| Operating lease liabilities, net of current portion | |
| 18,966 | | |
| 20,784 | |
| Total liabilities | |
| 52,502 | | |
| 57,163 | |
| Stockholders’ equity | |
| | | |
| | |
Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 28,423 at June 30, 2026 and 28,414 at December 31, 2025 | |
| 28 | | |
| 28 | |
| Additional paid-in capital | |
| 737,119 | | |
| 728,547 | |
| Accumulated deficit | |
| (565,339 | ) | |
| (514,590 | ) |
| Total stockholders’ equity | |
| 171,808 | | |
| 213,985 | |
| Total liabilities and stockholders’ equity | |
$ | 224,310 | | |
$ | 271,148 | |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(unaudited)
| | |
Three Months Ended | |
Six Months Ended |
| | |
June 30, | |
June 30, |
| (in thousands, except per share data) | |
2026 | |
2025 | |
2026 | |
2025 |
| Revenue: | |
| |
| |
| |
|
| Collaboration revenue | |
$ | 880 | | |
$ | 24,510 | | |
$ | 1,490 | | |
$ | 49,987 | |
| Grant revenue | |
| 2,079 | | |
| 3,791 | | |
| 3,530 | | |
| 7,696 | |
| Total revenue | |
| 2,959 | | |
| 28,301 | | |
| 5,020 | | |
| 57,683 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development, net | |
| 17,515 | | |
| 29,579 | | |
| 39,042 | | |
| 64,471 | |
| General and administrative | |
| 10,989 | | |
| 10,338 | | |
| 20,454 | | |
| 21,654 | |
| Total operating expenses | |
| 28,504 | | |
| 39,917 | | |
| 59,496 | | |
| 86,125 | |
| Loss from operations | |
| (25,545 | ) | |
| (11,616 | ) | |
| (54,476 | ) | |
| (28,442 | ) |
| Finance income, net | |
| 1,819 | | |
| 2,567 | | |
| 3,751 | | |
| 5,339 | |
| Other expense | |
| (59 | ) | |
| (127 | ) | |
| (24 | ) | |
| (149 | ) |
| Net loss before income taxes | |
| (23,785 | ) | |
| (9,176 | ) | |
| (50,749 | ) | |
| (23,252 | ) |
| Provision for income taxes | |
| — | | |
| 4 | | |
| — | | |
| 4 | |
| Net loss | |
$ | (23,785 | ) | |
$ | (9,180 | ) | |
$ | (50,749 | ) | |
$ | (23,256 | ) |
| Net loss per share, basic and diluted | |
$ | (0.84 | ) | |
$ | (0.34 | ) | |
$ | (1.79 | ) | |
$ | (0.86 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 28,423 | | |
| 27,129 | | |
| 28,422 | | |
| 27,118 | |
| Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (23,785 | ) | |
$ | (9,180 | ) | |
$ | (50,749 | ) | |
$ | (23,256 | ) |
| Comprehensive loss | |
$ | (23,785 | ) | |
$ | (9,180 | ) | |
$ | (50,749 | ) | |
$ | (23,256 | ) |
Contacts
Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com