New Drug Application (NDA) for ARCT-154, a next
generation COVID-19 vaccine, was submitted in Japan, leading to
potential approval in 2023
$23.6 Million advanced for the manufacturing
and supply of ARCT-154
ARCT-032 Phase 1 enrollment and administration
completed successfully; trial expansion to include Cystic Fibrosis
patients planned in third quarter
Investor conference call at 4:30 p.m. ET
today
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines
company focused on the development of infectious disease vaccines
and opportunities within liver and respiratory rare diseases, today
announced its financial results for the first quarter ended March
31, 2023, and provided corporate updates.
“We are very pleased to announce the first NDA submission for
the COVID-19 vaccine, ARCT-154, in Japan by Meiji Seika Pharma Co.,
Ltd., leading to potential approval later this year. ARCT-154 has
the potential to offer effective and longer-lasting protection
against COVID-19. We believe this meaningful milestone is
indicative of the broader platform opportunity for our mRNA
medicine technologies to result in novel vaccines and therapeutics
over the coming years,” said Joseph Payne, President & CEO of
Arcturus Therapeutics. “We have also made meaningful operational
and pipeline progress across several clinical and pre-clinical mRNA
therapeutic programs with the completion of enrollment of a Phase 3
study evaluating the safety and immunogenicity of ARCT-154 as a
booster against COVID-19 conducted by Meiji Seika Pharma in Japan,
with interim results expected later this quarter.”
In April 2023 we received an advance payment of $23.6 million
for the manufacturing and supply of ARCT-154 from CSL Seqirus. The
advance payment was for specified manufacturing runs of ARCT-154
which includes the drug substance utilized, as well as the
reservation fees and related manufacturing requirements.
“As we mentioned on the year end conference call last month, we
took a number of positive steps to improve our balance sheet this
quarter with the elimination of $34 million in principal and
accrued interest on the Singapore Loan,” stated Andrew Sassine,
Chief Financial Officer of Arcturus Therapeutics. “On March 31,
2023, we have no long-term debt on our balance sheet and current
assets increased by $21 million sequentially due to $90 million in
accounts receivable from CSL Seqirus which is expected to be
collected during the second quarter of 2023. Consequently, I am
happy to report that our cash runway continues to extend into the
beginning of 2026 assuming no changes to our clinical programs and
expected development milestones and do not include any expectations
of commercial milestones or revenues.”
Recent Corporate Highlights
- A New Drug Application (NDA) for ARCT-154 was submitted in
April by Meiji Seika Pharma to the Japanese Pharmaceuticals and
Medical Devices Agency (PMDA). This filing included a Phase 3
efficacy and safety study (N > 16,000), conducted in Vietnam
that met its primary endpoint of prevention of COVID-19 disease
during a period when there were multiple variants of concern.
- The ARCT-154 Phase 3 study being conducted by Meiji Seika
Pharma has completed enrollment (N = 828). This non-inferiority
study is designed to evaluate the safety and immunogenicity of
ARCT-154 compared to Comirnaty® (Pfizer/BioNTech), administered as
a booster dose. The interim analysis data will be submitted to the
PMDA to seek registration of the ARCT-154 booster.
- In April, Meiji Seika Pharma entered into an agreement with CSL
Seqirus whereby Meiji Seika Pharma will be responsible for the
distribution and sales of ARCT-154 in Japan.
- ARCT-810, the Company’s mRNA therapeutic candidate for
ornithine transcarbamylase deficiency (OTC), is being evaluated in
a Phase 2 multiple dose study, designed to enroll up to 24
adolescents and adults with OTC deficiency. The Phase 2 study is
being conducted in the UK and Europe. The Company remains on track
to share interim Phase 2 data on a subset of participants later in
2023.
- ARCT-032, the Company’s inhaled mRNA therapeutic for cystic
fibrosis (CF), has achieved the recruitment target and completed
administration in a Phase 1 single ascending dosing study with 32
healthy participants (8 subjects per cohort). The safety and
tolerability data support the study expansion and inclusion of
patients with CF. Arcturus is amending the protocol to allow the
dosing of patients with CF and expects to initiate the enrollment
in Q3 2023.
Financial Results for the First Quarter Ended March 31,
2023
Revenues in conjunction with strategic alliances and
collaborations:
Arcturus’ primary sources of revenues were from license fees,
consulting and related technology transfer fees, reservation fees
and collaborative payments received from research and development
arrangements with pharmaceutical and biotechnology partners. Total
revenue for the three months ended March 31, 2023, was $80.3
million, compared with $5.2 million for the three months ended
March 31, 2022. The increase in revenue is primarily attributable
to an increase in revenue of $78.2 million related to the agreement
with CSL Seqirus and the associated milestones achieved in the
first quarter of 2023.
Operating expenses:
Total operating expenses for the three months ended March 31,
2023, were $65.5 million compared with $55.6 million for the three
months ended March 31, 2022.
Research and development expenses:
Research and development expense was $51.8 million for the three
months ended March 31, 2023, compared with $44.9 million in the
comparable period last year, primarily reflecting increased
manufacturing costs of $5.7 million, an increase of $2.3 million in
personnel related expenses, an increase of travel and consulting
expenses of $0.9 million, and increase in facility expenses of $0.7
million. The increases were offset by a decrease in
clinical-related expenses of $4.4 million. We expect that our
research and development efforts and associated costs will increase
and continue to be substantial over the next several years as our
pipeline progresses. Facilities and equipment expenses continue to
increase as we expand. The three months ended March 31, 2023,
includes increased rent and associated costs related to a new
facility we took possession of in April 2022. Facilities and
equipment expenses are expected to increase in the near term due to
increased rent expenses related to our three facilities.
General and Administrative Expenses:
General and administrative expenses were $13.8 million for the
three months ended March 31, 2023, compared with $10.7 million in
the comparable period last year. The increase resulted primarily
from personnel expenses due to increased headcount and salaries,
increased travel and consulting expenses as well as increased rent
expense associated with the new facility.
Net Income and other income and expense:
For the three months ended March 31, 2023, Arcturus reported net
income of approximately $50.8 million, or $1.87 per diluted share,
compared with a net loss of $51.2 million, or ($1.94) per diluted
share in the three months ended March 31, 2022, and net income of
$117.3 million, or $4.33 per diluted share in the three months
ended December 31, 2022. We recorded a gain on debt extinguishment
related to the Singapore Loan of $34.0 million during the three
months ended March 31, 2023. Additionally, we reported net interest
income of $2.5 million for the three months ended March 31,
2023.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were $330.1 million
as of March 31, 2023, $394.0 million on December 31, 2022, and
$321.8 million on March 31, 2022. Additionally, we expect to
collect $90.0 million in the second quarter of 2023, associated
with the CSL Seqirus milestones which are in accounts receivable on
March 31, 2023. In April we received $23.6 million related to the
manufacturing and supply of ARCT-154 from CSL Seqirus. The cash
runway remains extended through the beginning of 2026 based on the
current pipeline and programs.
Tuesday, May 9, 2023 @ 4:30 p.m. ET
- Domestic: 1-888-886-7786
- International: 1-416-764-8658
- Conference ID: 70942720
- Webcast: Link
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
potential of ARCT-154 to offer effective or long-lasting protection
against COVID-19 disease, the potential for the Company’s platform
to result in novel vaccines or therapeutics, the anticipated timing
and sharing of Phase 3 pivotal ARCT-154 results and data, the
planned production of ARCT-154 doses, the likelihood and timing of
regulatory approvals or orders for, or commercialization of,
ARCT-154 in Japan or anywhere else, the planned submissions to
regulatory authorities relating to ARCT-154 including interim data,
the anticipated enrollment of the ARCT-810 Phase 2 study, the
anticipated sharing of interim Phase 2 data for ARCT-810, the
anticipated expansion of the ARCT-032 study to allow the dosing of
patients with CF and its anticipated enrollment, the potential of
the LUNAR-HBV program, the likelihood of success of the
collaboration with CSL Seqirus or any collaborations including the
achievement of any milestones or other payments, the initiation or
completion of any clinical trial, the likelihood that preclinical
or clinical data will be predictive of future clinical results, the
timing and nature of any study results, the likelihood that a
patent will issue from any patent application, the likelihood or
timing of collection of accounts receivables including expected
payments from CSL Seqirus, its current cash position and expected
cash burn 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.
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
March 31, 2023
December 31, 2022
(in thousands, except par value
information)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
327,935
$
391,883
Accounts receivable
92,483
2,764
Prepaid expenses and other current
assets
4,137
8,686
Total current assets
424,555
403,333
Property and equipment, net
12,635
12,415
Operating lease right-of-use asset,
net
31,557
32,545
Non-current restricted cash
2,116
2,094
Total assets
$
470,863
$
450,387
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
19,344
$
7,449
Accrued liabilities
32,293
30,232
Current portion of long-term debt
—
60,655
Deferred revenue
38,493
28,648
Total current liabilities
90,130
126,984
Deferred revenue, net of current
portion
20,569
20,071
Operating lease liability, net of current
portion
29,187
30,216
Other non-current liabilities
1,729
2,804
Total liabilities
$
141,615
$
180,075
Stockholders’ equity
Common stock, $0.001 par value; 60,000
shares authorized; issued and outstanding shares were 26,555 at
March 31, 2023 and 26,555 at December 31, 2022
27
27
Additional paid-in capital
616,608
608,426
Accumulated deficit
(287,387
)
(338,141
)
Total stockholders’ equity
329,248
270,312
Total liabilities and stockholders’
equity
$
470,863
$
450,387
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited)
Three Months Ended
March 31,
December 31,
(in thousands, except per share data)
2023
2022
2022
Revenue:
Collaboration revenue
$
79,729
$
5,244
$
160,049
Grant revenue
556
—
244
Total revenue
80,285
5,244
160,293
Operating expenses:
Research and development, net*
51,768
44,893
26,981
General and administrative*
13,762
10,730
11,860
Total operating expenses
65,530
55,623
38,841
Income (loss) from operations
14,755
(50,379
)
121,452
Loss from equity-method investment
—
(384
)
—
(Loss) gain from foreign currency
(328
)
158
(3,835
)
Gain on debt extinguishment
33,953
—
—
Finance income (expense), net
2,477
(564
)
1,025
Net income (loss) before income taxes
50,857
(51,169
)
118,642
Provision (benefit) for income taxes
103
—
1,295
Net income (loss)
50,754
(51,169
)
117,347
Earnings (loss) per share:
Basic
$
1.91
$
(1.94
)
$
4.43
Diluted
$
1.87
$
(1.94
)
$
4.33
Weighted-average shares used in
calculation of earnings (loss) per share:
Basic
26,555
26,376
26,508
Diluted
27,149
26,376
27,080
Comprehensive income (loss):
Net income (loss)
50,754
(51,169
)
117,347
Comprehensive income (loss)
$
50,754
$
(51,169
)
$
117,347
*Includes share-based compensation expense
as follows:
Three Months Ended
March 31,
December 31,
(in thousands)
2023
2022
2022
Research and development
$
3,508
$
3,455
$
3,270
General and administrative
4,674
3,916
3,260
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509006157/en/
IR and Media Contacts Arcturus Therapeutics Neda
Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682
IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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