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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 5, 2024
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 5, 2024, 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, 2024 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 Press Release,
are forward-looking statements, including those regarding strategy, future operations, the likelihood of success and continued advancement
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 commercialization of Kostaive® and the timing thereof, the continued clinical development
of the rare disease programs, the planned completion of the European Phase 2 ARCT-810 Phase 2 study and availability of interim data from
the study, the likelihood and timing of a European Marketing Authorization application approval decision for Kostaive® , the anticipated
enrollment in the Phase 2 clinical program for ARCT-810, that preclinical or clinical data will be predictive of future clinical results,
the likelihood and timing of clinical study updates, the likelihood or timing of collection of accounts receivables including expected
future milestone and other payments from CSL, 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.
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 5, 2024 |
|
| |
|
|
| |
By: |
/s/ Joseph E. Payne |
| |
Name: |
Joseph E. Payne |
| |
Title: |
Chief Executive Officer |
Arcturus
Therapeutics Announces Second Quarter 2024 Financial Update and Pipeline Progress
IND
submitted for Phase 2 trial of ARCT-032 targeting cystic fibrosis (CF)
ARCT-810
(OTC deficiency) Phase 2 interim data on track for Q4
Kostaive® on
track for Q4 commercial launch in Japan
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--August. 5, 2024--
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines
company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare
diseases, today announced its financial results for the second quarter ended June 30, 2024, and provided corporate updates.
“We are pleased to remain on track for our
first commercial product launch of Kostaive® in Japan later this year,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
“We are also encouraged by the clinical progress of our mRNA therapeutics pipeline, especially the collection of meaningful safety
data for CF and OTC deficiency candidates, ARCT-032 and ARCT-810.”
“The aggregate safety data of ARCT-032 and
ARCT-810 support continuing clinical development of these rare disease programs,” said Dr. Juergen Froehlich, Chief Medical Officer
of Arcturus Therapeutics. “The planned ARCT-032 Phase 2 study advances our efforts to provide a potential treatment for CF patients
who have genotypes making them ineligible for modulator treatment and the additional CF population who are eligible but are not prescribed
modulators.”
Dr. Froehlich added: “We are also pleased
to report that the dosing phase in our European Phase 2 ARCT-810 study is near completion with interim data to be available in Q4. The
additional Phase 2 study in the United States has initiated and is designed to expand our OTC deficiency program into more severe and
younger patients.”
Recent
Corporate Highlights
| · | In July, the Company submitted an IND application for a Phase 2 multiple ascending dose study to evaluate
the safety, tolerability and efficacy of ARCT-032 in subjects with cystic fibrosis (CF). The planned Phase 2 study intends to recruit
CF patients who are ineligible for CFTR modulator treatment and additional CF subjects who are eligible but are not prescribed modulators. |
| · | In June, Arcturus presented Phase 1 interim data of ARCT-032 at the 47th Annual European Cystic
Fibrosis Conference. |
| o | ARCT-032 administration was generally safe and well tolerated with no serious or severe adverse events
in healthy volunteers (N = 32) and the first four dosed participants with CF in Phase 1b, of which one had two Class I mutations and the
other three had F508del mutations and were being treated with Trikafta®. |
| · | In July, the Company announced that the double blind ARCT-810 Phase
2 study in the EU and UK completed enrollment of eight (8) participants with ornithine
transcarbamylase (OTC) deficiency, including adolescents and adults, at the 0.3 mg/kg dose level. |
| · | To access younger patients with more serious disease, the Company expanded the Phase 2 clinical program
of ARCT-810 into the United States. Patient screening has been initiated and the Company expects the Phase 2 clinical program enrollment
to be completed in the United States. |
| · | In May, the Company announced the publication in Nature Communications of pivotal data from a Phase
3 efficacy, immunogenicity and safety study of Kostaive®. |
| o | The results demonstrate that 2-dose primary vaccination (5 µg dose) of Kostaive® (sa-mRNA vaccine)
were well-tolerated and immunogenic, and provided significant protection against COVID-19 disease. The efficacy of Kostaive® against
severe COVID-19 was 100 percent in healthy persons aged 18-59 and more than 90 percent in persons at risk of severe consequences of the
disease due to co-morbidities or older age. |
| · | In May, Meiji initiated a partial change application to Japan’s PMDA to support the use of the updated
Kostaive® JN.1 COVID-19 vaccine for the upcoming 2024/2025 season. |
| · | Kostaive® European Medicine Agency (EMA) review is ongoing as planned. |
| · | Enrollment for the ARCT-2303 (Omicron XBB.1.5 variant version of Kostaive®) Phase 3 study is complete.
The purpose of this Phase 3 study is to generate additional immunogenicity and safety data in multiple ethnicities to support regulatory
filings globally. |
| · | Arcturus is on track to initiate a Phase 1 H5N1 pandemic flu study in Q4. The clinical study is funded
by BARDA and designed to enroll approximately 200 healthy adults in the United States. This vaccine, named ARCT-2304, utilizes the Company’s
proprietary STARR® self-amplifying mRNA and LUNAR® delivery technologies. |
| · | In June, the Company announced the appointment of a new independent director, Moncef Slaoui, Ph.D., to
its Board of Directors. |
Financial Results for the three months ended June 30, 2024
Revenues 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. For the three months ended June 30, 2024, we reported revenue
of $49.9 million, a significant increase of $39.4 million from the $10.5 million reported in the same period in 2023. The increase was
primarily due to the CSL agreement during the second quarter of 2024. This increase in CSL revenue recognized was driven by the recognition
of Kostaive® manufacturing activities and clinical trial expenses. Additionally, revenue related to the BARDA agreement increased
due to advancements in the pandemic flu program.
Revenue decreased by $2.9 million during the six
months ended June 30, 2024, as compared to the same period in 2023. The decrease was primarily due to lower CSL revenue resulting from
the timing and value of milestone achievements. The overall decrease was offset by higher BARDA revenue due to increased progress of the
pandemic flu program.
Operating expenses:
Total operating expenses for the three months
ended June 30, 2024, were $71.0 million compared with $65.9 million for the three months ended June 30, 2023. Total operating expenses
for the six months ended June 30, 2024, were $139.4 million compared with $131.4 million for the six months ended June 30, 2023.
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 $58.7 million for the three months ended June 30, 2024, compared with
$52.7 million for the three months ended June 30, 2023. Research and development expenses were $112.2 million for the six months ended
June 30, 2024, compared with $104.4 million for the three months ended June 30, 2023. The increases in research and development expenses
were primarily driven by higher clinical and manufacturing expenses. Additionally, investments increased in early stage and discovery
technologies, including the initiation of preclinical research related to its Gonorrhea and Lyme disease vaccine discovery programs.
General and Administrative Expenses:
General and administrative expenses primarily
consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional service fees for
legal and accounting services as well as other general and administrative expenses. General and administrative expenses were $12.3 million
and $27.2 million for the three and six months ended June 30, 2024, respectively, compared with $13.2 million and $27.0 million in the
comparable periods last year. These expenses remained relatively consistent between the two periods. The Company does not expect that
general and administrative expenses will increase on a yearly basis.
Net Loss:
For the three months ended June 30, 2024, Arcturus
reported a net loss of approximately $17.2 million, or ($0.64) per diluted share, compared with a net loss of $52.6 million, or ($1.98)
per diluted share in the three months ended June 30, 2023. For the six months ended June 30, 2024, Arcturus reported a net loss of approximately
$44.0 million, or ($1.64) per diluted share, compared with a net loss of $1.8 million, or ($0.07) per diluted share in the six months
ended June 30, 2023.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were $317.2
million as of June 30, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $437.1
million in upfront payments and milestones from CSL as of June 30, 2024, and expects to continue to receive future milestone
payments from CSL supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL. The expected
cash runway extends approximately three years based on the current pipeline and programs through the first quarter of fiscal year 2027.
Arcturus Therapeutics Second Quarter 2024 Earnings
Conference Call
| · | Monday, August 5, 2024 @ 4:30 p.m. ET |
| · | Domestic: 1-877-407-0784 |
| · | International: 1-201-689-8560 |
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company 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 for innovative mRNA vaccines with CSL Seqirus, 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 ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), 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, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.
Arcturus’ technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe,
Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please
connect with us on Twitter 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 and continued
advancement 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 commercialization of Kostaive® and the timing thereof, the continued
clinical development of the rare disease programs, the planned completion of the European Phase 2 ARCT-810 Phase 2 study and availability
of interim data from the study, the likelihood and timing of a European Marketing Authorization application approval decision for Kostaive®,
the anticipated enrollment in the Phase 2 clinical program for ARCT-810, that preclinical or clinical data will be predictive of future
clinical results, the likelihood and timing of clinical study updates, the likelihood or timing of collection of accounts receivables
including expected future milestone and other payments from CSL, 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.
Trademark
Acknowledgements
The Arcturus
logo and other trademarks of Arcturus appearing in this announcement, including LUNAR® and STARR®,
are the property of Arcturus. All other trademarks, services marks, and trade names in this announcement are the property of their respective
owners.
IR and Media Contacts
Arcturus Therapeutics
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| | |
June 30,
2024 | |
December 31,
2023 |
| (in thousands, except par value information) | |
(unaudited) | |
|
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 260,329 | | |
$ | 292,005 | |
| Restricted cash | |
| 55,000 | | |
| 55,000 | |
| Accounts receivable | |
| 24,085 | | |
| 32,064 | |
| Prepaid expenses and other current assets | |
| 7,594 | | |
| 7,521 | |
| Total current assets | |
| 347,008 | | |
| 386,590 | |
| Property and equipment, net | |
| 11,182 | | |
| 12,427 | |
| Operating lease right-of-use assets, net | |
| 28,533 | | |
| 28,500 | |
| Non-current restricted cash | |
| 1,885 | | |
| 1,885 | |
| Total assets | |
$ | 388,608 | | |
$ | 429,402 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 13,905 | | |
$ | 5,279 | |
| Accrued liabilities | |
| 35,450 | | |
| 31,881 | |
| Deferred revenue | |
| 42,362 | | |
| 44,829 | |
| Total current liabilities | |
| 91,717 | | |
| 81,989 | |
| Deferred revenue, net of current portion | |
| 11,344 | | |
| 42,496 | |
| Operating lease liability, net of current portion | |
| 26,964 | | |
| 25,907 | |
| Other non-current liabilities | |
| — | | |
| 497 | |
| Total liabilities | |
| 130,025 | | |
| 150,889 | |
| Stockholders’ equity | |
| | | |
| | |
Common stock, $0.001 par value; 60,000 shares authorized; issued and
outstanding shares were 27,042 at June 30, 2024 and 26,828 at December 31, 2023 | |
| 27 | | |
| 27 | |
| Additional paid-in capital | |
| 670,455 | | |
| 646,352 | |
| Accumulated deficit | |
| (411,899 | ) | |
| (367,866 | ) |
| Total stockholders’ equity | |
| 258,583 | | |
| 278,513 | |
| Total liabilities and stockholders’ equity | |
$ | 388,608 | | |
$ | 429,402 | |
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) | |
2024 | |
2023 | |
2024 | |
2023 |
| Revenue: | |
| | | |
| | | |
| | | |
| | |
| Collaboration revenue | |
$ | 45,976 | | |
$ | 9,565 | | |
$ | 78,574 | | |
$ | 89,294 | |
| Grant revenue | |
| 3,883 | | |
| 954 | | |
| 9,297 | | |
| 1,510 | |
| Total revenue | |
| 49,859 | | |
| 10,519 | | |
| 87,871 | | |
| 90,804 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development, net | |
| 58,669 | | |
| 52,668 | | |
| 112,242 | | |
| 104,436 | |
| General and administrative | |
| 12,316 | | |
| 13,225 | | |
| 27,167 | | |
| 26,987 | |
| Total operating expenses | |
| 70,985 | | |
| 65,893 | | |
| 139,409 | | |
| 131,423 | |
| Loss from operations | |
| (21,126 | ) | |
| (55,374 | ) | |
| (51,538 | ) | |
| (40,619 | ) |
| (Loss) gain from foreign currency | |
| (388 | ) | |
| 149 | | |
| (441 | ) | |
| (179 | ) |
| Gain on debt extinguishment | |
| — | | |
| — | | |
| — | | |
| 33,953 | |
| Finance income, net | |
| 4,148 | | |
| 3,252 | | |
| 8,164 | | |
| 5,729 | |
| Net loss before income taxes | |
| (17,366 | ) | |
| (51,973 | ) | |
| (43,815 | ) | |
| (1,116 | ) |
| Provision for income taxes | |
| (150 | ) | |
| 577 | | |
| 218 | | |
| 680 | |
| Net loss | |
$ | (17,216 | ) | |
$ | (52,550 | ) | |
$ | (44,033 | ) | |
$ | (1,796 | ) |
| Net loss per share, basic and diluted | |
$ | (0.64 | ) | |
$ | (1.98 | ) | |
$ | (1.64 | ) | |
$ | (0.07 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 26,967 | | |
| 26,563 | | |
| 26,923 | | |
| 26,557 | |
| Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (17,216 | ) | |
$ | (52,550 | ) | |
$ | (44,033 | ) | |
$ | (1,796 | ) |
| Comprehensive loss | |
$ | (17,216 | ) | |
$ | (52,550 | ) | |
$ | (44,033 | ) | |
$ | (1,796 | ) |
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