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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): May 1, 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 2.02. | Results of Operations and Financial Conditions. |
On May 7, 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 March 31, 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 (the “Exchange Act”), or otherwise subject to the liability of that section
or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). 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 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 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 the Company will continue to advance its rare disease therapeutics portfolio including its inhaled mRNA
therapy, the likelihood that the Company will be able to advance ARCT-810 into a pivotal trial or pediatric clinical development, the
planned EOP2 meeting and its timing, the size and scope of the open label Phase 2 study of ARCT-032, the outcomes of regulatory
interactions and strategic planning for the ARCT-810 program, the likelihood that the Company will be able to collect exploratory data
sufficient to progress to a pivotal pediatric study for ARCT-810, 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 5.02.
|
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Effective May 1, 2026,
Dennis Mulroy, 71, was appointed Chief Financial Officer of the Company. Mr. Mulroy will become the Company’s principal financial
officer on the date immediately following the date on which the Company files its Quarterly Report on Form 10-Q for the period ended March
31, 2026. The Board of Directors of the Company approved Mr. Mulroy’s appointment on April 15, 2026.
Mr. Mulroy served as
the Chief Financial Officer of AnaptysBio, Inc from July 2020 to April 2026. From April 2015 to May 2020, Mr. Mulroy served as Chief Financial
Officer of La Jolla Pharmaceutical Company. From 2005 to 2015, Mr. Mulroy served as Chief Financial Officer of Taxus Cardium Pharmaceuticals
Group, Inc. From 2004 to 2005, Mr. Mulroy served as Chief Financial Officer of Molecular Imaging, Inc. Mr. Mulroy began his career at
Ernst & Young LLP. Mr. Mulroy received a B.B.A. degree in accounting from the University of San Diego and is a Certified Public Accountant
(inactive) in the state of California.
In connection with Mr.
Mulroy’s appointment, Mr. Mulroy and the Company entered into an employment agreement dated effective May 1, 2026 (the “Employment
Agreement”), providing for (i) an annual base salary of $520,000; (ii) eligibility to participate in the Company's annual discretionary
bonus plan for executives, with the potential to earn a cash bonus of up to forty (40%) percent of Mr. Mulroy’s base salary; (iii)
eligibility to participate in the Company’s benefit plans; (iv) reimbursement for certain reasonable out-of-pocket expenses; and
(v) options to acquire 100,000 shares of the Company’s common stock, par value $0.001 per share (the “Options”) subject
to a four-year vesting schedule with 25% of the Options vesting on the one-year anniversary date from Mr. Mulroy’s start date, and
the remaining 75% vesting on a monthly basis thereafter in thirty-six equal installments. The Employment Agreement provides that Mr. Mulroy's
employment is at-will. In the event Mr. Mulroy's employment is terminated by the Company without Cause or Mr. Mulroy resigns for Good
Reason (each as defined in the Employment Agreement), and subject to his execution of a general release of claims, Mr. Mulroy will be
entitled to (i) continuation of his base salary for twelve (12) months, (ii) a pro rata portion of his annual bonus for the year of termination
based on actual performance, and (iii) payment of COBRA premiums for up to twelve (12) months. In the event such termination occurs during
the eighteen (18)-month period following a Change in Control (as defined in the Employment Agreement), the foregoing severance payments
will be paid in a lump sum and all unvested time-based equity awards held by Mr. Mulroy will accelerate and become fully vested. In addition,
as a condition of employment, Mr. Mulroy entered into the Company's standard form of Employee Confidential Information and Invention Assignment
Agreement.
There are no arrangements
or understandings between Mr. Mulroy and any other persons pursuant to which Mr. Mulroy was selected as Chief Financial Officer. There
are no family relationships between Mr. Mulroy and the directors, nor between Mr. Mulroy and any executive officer, of the Company. There
is no related transaction that would be required to be disclosed with respect to Mr. Mulroy pursuant to Item 404(a) of Regulation S-K.
The above description
of the Employment Agreement is a summary only and is qualified in its entirety by the full text of the Employment Agreement, a copy of
which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
In connection with Mr.
Mulroy’s appointment, Joe Roberts, who has been serving as interim principal financial officer and interim principal accounting
officer of the Company since December 2025, will continue to serve as interim principal accounting officer and as the Company’s
Controller.
| Item 7.01. |
Regulation FD Disclosure. |
On May 7, 2026, the Company issued the Press Release,
which included the announcement of the appointment of Mr. Mulroy. 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 Exchange Act, or
otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act. 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 of Exhibit |
| |
|
| 10.1 |
Employment Agreement between Arcturus Therapeutics Holdings Inc. and Dennis Mulroy dated as of April 27, 2026. |
| 99.1 |
Press Release dated May 7, 2026 |
| 104 |
Cover Page Interactive Data File-the cover page XBRL tags are 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: May 7, 2026 |
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
Arcturus
Therapeutics Announces First Quarter 2026 Financial Results and Pipeline Progress
Initiated enrollment
(Q1 2026) earlier than expected for 12-week cystic fibrosis (CF) open label Phase 2 study; lung function (ppFEV1 and LCI) is being monitored
in Class I CF subjects
Received regulatory
direction on pediatric development strategy from FDA (Type C meeting) for ornithine transcarbamylase (OTC) deficiency program; End of
Phase 2 (EOP2) meeting H2 2026
Investor
conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE) -- May 7, 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 March
31, 2026, and provided corporate updates.
“Arcturus continues to advance its rare
disease therapeutics portfolio. We have initiated enrollment of our 12-week CF Phase 2 study in the first quarter of 2026, earlier than
originally anticipated. We remain committed to advancing our inhaled mRNA therapy for people with CF Class I mutations,” said Joseph
Payne, President & CEO of Arcturus. “Also, during the first quarter of 2026, we met with the FDA regarding the pediatric clinical
development strategy for our OTC deficiency program and we now have a clear path toward initiating a pivotal trial which we will align
further at the EOP2 meeting later this year. We welcomed two seasoned C-suite leaders, Alan H. Cohen, MD, Chief Medical Officer and Dennis
M. Mulroy, Chief Financial Officer to strengthen the executive team.”
“We are pleased to announce a strong balance
sheet and runway of over two and a half years, allowing our company to reach important clinical and regulatory milestones for its rare
disease pipeline,” said Dennis M. Mulroy, Chief Financial Officer of Arcturus.
Recent Corporate Highlights
| · | Arcturus’ ARCT-032, an inhaled mRNA therapeutic
candidate for CF initiated enrollment of a new cohort in March 2026. This open label Phase 2 clinical study is currently enrolling up
to 20 Class I CF participants in the U.S. and abroad. The study will monitor 10 mg dosing – over 12 weeks – for safety and
evidence of early clinical benefits, including assessment of lung functional improvements (as measured by ppFEV1 and LCI),
along with two validated quality-of-life outcome measures and evaluation of any changes in high-resolution computed tomography (HRCT)
imaging. |
| · | Arcturus’ ARCT-810 program, an mRNA therapeutic
candidate for OTC deficiency, is broadening its development strategy to address the unmet medical needs of newborns 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 studies across both adult and pediatric populations, including those for whom liver transplantation remains the only
current option for survival beyond early childhood. In March 2026, the FDA provided a clear path forward in a Type C meeting toward a
pivotal pediatric study that requires additional exploratory data to establish the optimal dose and therapeutic effect. The Company is
collecting additional exploratory data in its preparation for an EOP2 meeting in second half of this year. |
| · | Meiji, partner to Arcturus and CSL Seqirus in
Japan, is actively preparing KOSTAIVE®, a self-amplifying mRNA COVID-19 vaccine, for the 2026/2027 season using a 2-dose vial presentation. |
| · | Arcturus strengthened its executive team with
the appointments of Chief Medical Officer and Chief Financial Officer to support the advancement of the Company’s therapeutic pipeline
and financial strategy. |
| o | Alan H. Cohen, MD, Chief Medical Officer, brings extensive clinical, medical affairs, and drug
development leadership, with deep experience across rare diseases, pulmonology, cardiovascular medicine, infectious diseases, vaccines,
and pediatrics. He has held senior medical leadership roles at global pharmaceutical and biotechnology companies and has a strong track
record advancing clinical programs from early development through post-approval commercialization, supporting clinical and therapeutic
strategies. He has served on the faculty of many highly regarded Pulmonary Centers of Excellence, including those at the University of
Colorado/National Jewish Center for Immunology & Respiratory Diseases, where he also was a resident and fellow, Washington University
School of Medicine, Emory University as well as the Morehouse School of Medicine, Johns Hopkins and most recently at Stanford University
School of Medicine. |
| o | Dennis M. Mulroy, Chief Financial Officer, brings more than 40 years of extensive financial and
operational leadership, with deep expertise in SEC reporting, capital markets, and commercialization where he supported numerous public
company transformations, value-creating transactions, and commercial product launches. Most recently he served as the CFO at AnaptysBio,
which recently completed a strategic transaction that resulted in two public companies, and greatly enhanced shareholder value. |
Financial Results for the three months ended
March 31, 2026
Cash Position and Balance Sheet:
Cash, cash equivalents
and restricted cash were $213.4 million as of March 31, 2026, and $232.8 million as of December 31, 2025. Through continued disciplined
execution and focus on our existing rare disease clinical programs, we continue to have a cash runway extending beyond the second quarter
of 2028.
Revenue in conjunction with strategic alliances
and collaborations:
Arcturus’ current primary revenue stream
relates to our grant agreement with BARDA. The year over year $27.3 million decrease in revenue was driven by lower revenue recognized
under the CSL collaboration as we pivot from infectious disease vaccine development toward rare disease clinical programs.
Operating expenses:
Total operating expenses for the three months
ended March 31, 2026, were $31.0 million compared to $46.2 million for the three months ended March 31, 2025.
Research and development expenses:
Research and development expenses were $21.5 million
for the three months ended March 31, 2026, compared to $34.9 million in the comparable period last year. The decrease was primarily driven
by lower manufacturing costs related to LUNAR-COVID and BARDA, as well as reduced clinical trial costs associated with the LUNAR-COVID
program. Additional decreases were attributable to lower payroll and benefits costs associated with lower stock-based compensation expense
and a reduction in headcount. These reductions were partially offset by higher manufacturing costs related to LUNAR-OTC.
General and Administrative Expenses:
General and administrative expenses were $9.5
million for the three months ended March 31, 2026, compared to $11.3 million in the comparable period last year. The decrease was primarily
due to reduced share-based compensation expense as well as reduced payroll and benefits costs associated with reductions in headcount.
Net Loss:
For the three months ended March 31, 2026, Arcturus
reported a net loss of approximately $27.0 million, or ($0.95) per diluted share, compared to a net loss of $14.1 million, or ($0.52)
per diluted share in the three months ended March 31, 2025.
Earnings Call: Thursday, May 7, 2026 @ 4:30
p.m. ET
- Domestic: 1-800-579-2543
- International: 1-785-424-1789
- Conference ID: ARCTURUS
- Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1758350&tp_key=71f69e33e5
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, 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 the Company will continue to advance its rare disease therapeutics portfolio including its inhaled mRNA therapy, the
likelihood that the Company will be able to advance ARCT-810 into a pivotal trial or pediatric clinical development, the planned EOP2
meeting and its timing, the size and scope of the open label Phase 2 study of ARCT-032, the outcomes of regulatory interactions and strategic
planning for the ARCT-810 program, the likelihood that the Company will be able to collect exploratory data sufficient to progress to
a pivotal pediatric study for ARCT-810, 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
| | |
March 31,
2026 | |
December 31,
2025 |
| (in thousands, except par value information) | |
| (unaudited) | | |
| | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 211,375 | | |
$ | 230,909 | |
| Accounts receivable | |
| 1,343 | | |
| 5,564 | |
| Prepaid expenses and other current assets | |
| 4,164 | | |
| 4,973 | |
| Total current assets | |
| 216,882 | | |
| 241,446 | |
| Property and equipment, net | |
| 6,078 | | |
| 6,736 | |
| Operating lease right-of-use assets, net | |
| 20,423 | | |
| 21,081 | |
| Non-current restricted cash | |
| 2,028 | | |
| 1,885 | |
| Total assets | |
$ | 245,411 | | |
$ | 271,148 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 4,093 | | |
$ | 4,235 | |
| Accrued liabilities | |
| 22,666 | | |
| 23,898 | |
| Deferred revenue | |
| 7,610 | | |
| 8,246 | |
| Total current liabilities | |
| 34,369 | | |
| 36,379 | |
| Operating lease liability, net of current portion | |
| 19,680 | | |
| 20,784 | |
| Total liabilities | |
| 54,049 | | |
| 57,163 | |
| Stockholders’ equity | |
| | | |
| | |
Common stock, $0.001 par value; 60,000 shares authorized; issued and
outstanding shares were 28,423 at March 31, 2026 and 28,414 at December 31, 2025 | |
| 28 | | |
| 28 | |
| Additional paid-in capital | |
| 732,888 | | |
| 728,547 | |
| Accumulated deficit | |
| (541,554 | ) | |
| (514,590 | ) |
| Total stockholders’ equity | |
| 191,362 | | |
| 213,985 | |
| Total liabilities and stockholders’ equity | |
$ | 245,411 | | |
$ | 271,148 | |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(unaudited)
| | |
Three Months Ended |
| | |
March 31, |
| (in thousands, except per share data) | |
2026 | |
2025 |
| Revenue: | |
| |
|
| Collaboration revenue | |
$ | 610 | | |
$ | 25,477 | |
| Grant revenue | |
| 1,451 | | |
| 3,905 | |
| Total revenue | |
| 2,061 | | |
| 29,382 | |
| Operating expenses: | |
| | | |
| | |
| Research and development, net | |
| 21,527 | | |
| 34,893 | |
| General and administrative | |
| 9,465 | | |
| 11,315 | |
| Total operating expenses | |
| 30,992 | | |
| 46,208 | |
| Loss from operations | |
| (28,931 | ) | |
| (16,826 | ) |
| Finance income, net | |
| 1,932 | | |
| 2,771 | |
| Other income (expense) | |
| 35 | | |
| (21 | ) |
| Net loss | |
$ | (26,964 | ) | |
$ | (14,076 | ) |
| Net loss per share, basic and diluted | |
$ | (0.95 | ) | |
$ | (0.52 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 28,421 | | |
| 27,107 | |
| Comprehensive loss: | |
| | | |
| | |
| Net loss | |
$ | (26,964 | ) | |
$ | (14,076 | ) |
| Comprehensive loss | |
$ | (26,964 | ) | |
$ | (14,076 | ) |
Contacts
Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
