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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): March 3, 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 March 3, 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 and year ended December 31, 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 that clinical data, including interim data, will be predictive of future
clinical results, the likelihood of and timing for achieving alignment with regulators on the clinical strategy for ARCT-810, plans to
broaden the development strategy for ARCT-810, the timing for Type C regulatory meetings for ARCT-810 and feedback therefrom, the likelihood
of initiation, and size, scope, and timing, of a Phase 2, 12-week study for ARCT-032, the ongoing development of a self-amplifying mRNA
pandemic influenza vaccine under its contract with BARDA, the likelihood that general and administrative expenses will continue to decrease
slightly, 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 March 3, 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: March 3, 2026 |
Arcturus Therapeutics Holdings Inc. |
| |
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
Arcturus
Therapeutics Announces Fourth Quarter and Fiscal Year 2025 Financial Results and Pipeline Progress
ARCT-032
(CF) Phase 2 third cohort (28 days, 15 mg) generally safe and well tolerated
ARCT-032
permitted to proceed into 12-week Phase 2 study; dosing to begin H1 2026
Cash
runway extended into Q2 2028
Investor
conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE) --Mar. 3, 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 fourth quarter and
fiscal year 2025, and provided corporate updates.
“Arcturus continues to progress its rare
disease therapeutic portfolio. We look forward to aligning with regulators on our clinical development strategy for the ornithine transcarbamylase
(OTC) deficiency program, and to initiating our Phase 2, 12-week cystic fibrosis (CF) study in the first half of 2026,” said Joseph
Payne, President & CEO of Arcturus. “We remain firmly committed to advancing our once-daily inhaled mRNA therapy for people
with cystic fibrosis Class I mutations.”
Recent Corporate Highlights
| · | Arcturus’ ARCT-032, a once-daily inhaled
mRNA therapeutic candidate for CF, is on track to initiate a new 12-week Phase 2 clinical study in H1 2026 enrolling up to 20 Class I
CF participants in the U.S. and abroad. The study will assess safety and early clinical benefits, including potential lung function improvements
(ppFEV1, LCI), alongside validated quality-of-life outcomes and high-resolution computed tomography (HRCT) imaging. |
| o | Arcturus has completed once-daily dosing of 15 mg of ARCT-032 over 28 days in the third dosing cohort,
among four Class I adults with CF, and observed no safety or tolerability issues in this higher dosing cohort. |
| o | The safety review committee has reviewed all data from the first three 28-day study cohorts (5, 10, 15
mg) and permitted the program to proceed into the Phase 2, 12-week study. |
| · | Arcturus’ ARCT-810 program, an mRNA therapeutic
candidate for ornithine transcarbamylase (OTC) deficiency, is broadening its development strategy to address the needs of both adults
with late-onset disease and young children affected by the most severe forms of OTC deficiency. The Company is actively engaged in complementary
regulatory interactions and strategic planning to support pivotal studies across pediatric and adult populations, including those for
whom liver transplantation remains the only current option for survival beyond early childhood. The scheduled Type C regulatory meetings
with health authorities, along with the associated feedback, remain on track for the first half of 2026. |
| · | In January 2026, the UK Medicines and Healthcare
products Regulatory Agency (MHRA) granted approval for KOSTAIVE®, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, for use in individuals
aged 18 and older. |
| · | Arcturus continues to develop a self-amplifying
mRNA pandemic influenza (A/H5N1) vaccine under its ongoing contract with BARDA. Recent data from an eight-month follow-up period after
the first vaccination indicate that all three tested dose levels (1.5, 5, and 12 mcg) elicit a durable immune response against the vaccine's
hemagglutinin and neuraminidase components. The data also supports the sa-mRNA platform's ability to induce meaningful cell-mediated
immunity. All tested vaccine doses were well tolerated and did not raise safety concerns. |
| · | Arcturus’ lawsuit against AbbVie Inc.,
and Capstan Therapeutics, Inc.—filed on September 23, 2025, in the U.S. District Court for the Southern District of California—remains
ongoing. |
Financial Results for the Fourth Quarter and
Fiscal Year 2025
Revenue in conjunction with strategic alliances
and collaborations:
Arcturus’ primary revenue streams include
license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and
development arrangements with pharmaceutical and biotechnology partners. Revenue for the fourth quarter and fiscal year 2025, was $7.2
million and $82.0 million, respectively, representing decreases of $15.6 million and $70.3 million compared to the same periods in 2024.
These declines were driven by reductions in revenue from the CSL collaboration, reflecting lower supply agreement activity and a reduced
number of development-based milestone achievements as KOSTAIVE® was commercialized.
Operating expenses:
Operating expenses for the fourth quarter and
fiscal year 2025 amounted to $38.5 million and $158.3 million, respectively, representing decreases of $17.7 million and $89.7 million
compared with the same periods in 2024.
Research and development expenses:
Research and development expenses consist primarily
of external manufacturing costs, in vivo research studies and clinical trials performed by contract research organizations, clinical and
regulatory consultants, personnel-related expenses, facility-related expenses and laboratory supplies related to conducting research and
development activities. Research and development expenses were $24.5 million for the fourth quarter of 2025, compared with $43.8 million
for the same period in 2024. The decrease was primarily driven by lower manufacturing costs for the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF
programs, as well as reduced clinical trial expenses for LUNAR-COVID and LUNAR-CF. Lower payroll and employee benefits further contributed
to the decrease. These reductions were partially offset by higher facilities and equipment costs due to lease impairment in the current
period.
Research and development expenses were $112.2
million for fiscal year 2025, compared with $195.2 million for fiscal year 2024. The decrease was primarily driven by lower manufacturing
and clinical costs related to the LUNAR-COVID program, reflecting the program’s transition from a development program to the commercial
phase. Additional decreases relate to lower manufacturing costs for the LUNAR-CF and LUNAR-FLU programs, as well as lower clinical costs
associated with the LUNAR-OTC program. These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program.
Additional decreases resulted from lower payroll and benefits expenses following the operational restructuring.
General and Administrative Expenses:
General and administrative expenses primarily
consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional fees for legal
and accounting services. General and administrative expenses for the fourth quarter of 2025 were $14.0 million compared with $12.4 million
for the same period in 2024. The increase in fourth quarter expenses relates to the acceleration of employee stock options.
General and administrative expenses for fiscal
year 2025 were $46.1 million compared with $52.8 million for fiscal year 2024. The decrease was primarily due to reduced share-based compensation
expense as well as reduced payroll and benefits. We expect general and administrative expenses to continue to decrease slightly during
the next twelve months driven by lower share-based compensation costs.
Net Loss:
For the fourth quarter of 2025, Arcturus reported
a net loss of $29.1 million, or ($1.03) per diluted share, compared with a net loss of $30.0 million, or ($1.11) per diluted share for
the same period in 2024. For fiscal year 2025, Arcturus reported a net loss of $65.8 million, or ($2.40) per diluted share, compared with
a net loss of $80.9 million, or ($3.00) per diluted share for fiscal year 2024.
Cash Position and Balance Sheet:
Cash, cash equivalents
and restricted cash were $232.8 million as of December 31, 2025, and $293.9 million as of December 31, 2024. Through disciplined execution
and a strategic refocus on existing rare disease clinical programs in fiscal year 2025, Arcturus has extended its cash runway into the
second quarter of 2028.
Arcturus
Therapeutics Fourth Quarter and Fiscal Year 2025 Earnings Conference Call
·
Tuesday, March 3, 2026 @4:30 p.m. ET
·
Domestic: 1-800-274-8461
·
International: 1-203-518-9814
·
Conference ID: ARCTURUS
·
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1748831&tp_key=1fb027c6a4
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) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus),
the likelihood that clinical data, including interim data, will be predictive of future clinical results, the likelihood of and timing
for achieving alignment with regulators on the clinical strategy for ARCT-810, plans to broaden the development strategy for ARCT-810,
the timing for Type C regulatory meetings for ARCT-810 and feedback therefrom, the likelihood of initiation, and size, scope, and timing,
of a Phase 2, 12-week study for ARCT-032, the ongoing development of a self-amplifying mRNA pandemic influenza vaccine under its contract
with BARDA, the likelihood that general and administrative expenses will continue to decrease slightly, 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.
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.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| | |
As of December 31, |
| (in thousands, except per share data) | |
2025 | |
2024 |
| Assets | |
| |
|
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 230,909 | | |
$ | 237,028 | |
| Restricted cash | |
| — | | |
| 55,000 | |
| Accounts receivable | |
| 5,564 | | |
| 3,974 | |
| Prepaid expenses and other current assets | |
| 4,973 | | |
| 9,977 | |
| Total current assets | |
| 241,446 | | |
| 305,979 | |
| Property and equipment, net | |
| 6,736 | | |
| 9,531 | |
| Operating lease right-of-use asset | |
| 21,081 | | |
| 26,674 | |
| Non-current restricted cash | |
| 1,885 | | |
| 1,885 | |
| Total assets | |
$ | 271,148 | | |
$ | 344,069 | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 4,235 | | |
$ | 7,194 | |
| Accrued liabilities | |
| 23,898 | | |
| 38,781 | |
| Deferred revenue | |
| 8,246 | | |
| 19,514 | |
| Total current liabilities | |
| 36,379 | | |
| 65,489 | |
| Deferred revenue, net of current portion | |
| — | | |
| 12,604 | |
| Operating lease liability, net of current portion | |
| 20,784 | | |
| 24,998 | |
| Total liabilities | |
| 57,163 | | |
| 103,091 | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock: $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 28,414 at December 31, 2025 and 27,000 at December 31, 2024 | |
| 28 | | |
| 27 | |
| Additional paid-in capital | |
| 728,547 | | |
| 689,758 | |
| Accumulated deficit | |
| (514,590 | ) | |
| (448,807 | ) |
| Total stockholders’ equity | |
| 213,985 | | |
| 240,978 | |
| Total liabilities and stockholders’ equity | |
$ | 271,148 | | |
$ | 344,069 | |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
| | |
Year Ended December 31, |
| (in thousands, except per share data) | |
2025 | |
2024 | |
2023 |
| Revenue: | |
| |
| |
|
| Collaboration revenue | |
$ | 67,221 | | |
$ | 138,389 | | |
$ | 157,748 | |
| Grant revenue | |
| 14,810 | | |
| 13,921 | | |
| 9,051 | |
| Total revenue | |
| 82,031 | | |
| 152,310 | | |
| 166,799 | |
| Operating expenses: | |
| | | |
| | | |
| | |
| Research and development, net | |
| 112,212 | | |
| 195,156 | | |
| 192,133 | |
| General and administrative | |
| 46,079 | | |
| 52,823 | | |
| 52,871 | |
| Total operating expenses | |
| 158,291 | | |
| 247,979 | | |
| 245,004 | |
| Loss from operations | |
| (76,260 | ) | |
| (95,669 | ) | |
| (78,205 | ) |
| Gain (loss) from foreign currency | |
| 382 | | |
| (471 | ) | |
| (229 | ) |
| Finance income, net | |
| 10,095 | | |
| 15,195 | | |
| 16,591 | |
| Gain on debt extinguishment | |
| — | | |
| — | | |
| 33,953 | |
| Net loss before income taxes | |
| (65,783 | ) | |
| (80,945 | ) | |
| (27,890 | ) |
| (Benefit) provision for income taxes | |
| — | | |
| (4 | ) | |
| 1,835 | |
| Net loss | |
| (65,783 | ) | |
| (80,941 | ) | |
| (29,725 | ) |
| Net loss per share, basic and diluted | |
$ | (2.40 | ) | |
$ | (3.00 | ) | |
$ | (1.12 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 27,386 | | |
| 27,000 | | |
| 26,628 | |
| Comprehensive loss | |
$ | (65,783 | ) | |
$ | (80,941 | ) | |
$ | (29,725 | ) |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (UNAUDITED)
| | |
Three Months Ended |
| | |
December 31, |
| (in thousands, except per share data) | |
2025 | |
2024 |
| Revenue: | |
| |
|
| Collaboration revenue | |
$ | 3,081 | | |
$ | 21,000 | |
| Grant revenue | |
| 4,115 | | |
| 1,766 | |
| Total revenue | |
| 7,196 | | |
| 22,766 | |
| Operating expenses: | |
| | | |
| | |
| Research and development, net | |
| 24,476 | | |
| 43,780 | |
| General and administrative | |
| 14,027 | | |
| 12,380 | |
| Total operating expenses | |
| 38,503 | | |
| 56,160 | |
| Loss from operations | |
| (31,307 | ) | |
| (33,394 | ) |
| Gain from foreign currency | |
| 701 | | |
| 171 | |
| Finance income, net | |
| 1,523 | | |
| 3,214 | |
| Net loss before income taxes | |
| (29,083 | ) | |
| (30,009 | ) |
| Benefit for income taxes | |
| (4 | ) | |
| (4 | ) |
| Net loss | |
$ | (29,079 | ) | |
$ | (30,005 | ) |
| Net loss per share, basic and diluted | |
$ | (1.03 | ) | |
$ | (1.11 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 28,112 | | |
| 27,000 | |
| Comprehensive loss | |
$ | (29,079 | ) | |
$ | (30,005 | ) |
Contacts
Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
