$200 million upfront payment received in
December 2022 from CSL collaboration
Achieved $90 million in development milestones
in March 2023 under CSL collaboration
ARCT-154 Phase 3 COVID-19 booster trial
enrollment completed in Japan
Multiple patients enrolled in ARCT-810 Phase 2
multiple ascending dose trial for OTC deficiency
ARCT-032 Phase 1 Cystic Fibrosis trial
initiated and enrollment of first two cohorts successfully
completed
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 fourth quarter ended
December 31, 2022, and provided corporate updates.
“Arcturus has continued to make remarkable operational and
pipeline progress. This was recently exemplified by the completion
of the initial objectives with our partnered COVID-19 and Flu
vaccine programs with CSL,” said Joseph Payne, President and CEO of
Arcturus Therapeutics. “We are also pleased to report the
completion of full enrollment ahead of schedule in the Phase 3
study being conducted by Meiji Pharma to evaluate ARCT-154 as a
booster vaccine for COVID-19.”
“Within the first four months of our CSL collaboration, we
successfully achieved multiple program objectives, triggering $90
million in milestone payments,” said Andrew Sassine, CFO of
Arcturus Therapeutics, “Additionally, with the elimination of $33.3
million of non-recourse debt to Singapore, our cash runway now
extends into the beginning of 2026.”
Recent Corporate Highlights
- In December 2022, the Company received a $200 million upfront
payment associated with the exclusive global collaboration and
license agreement with CSL Seqirus, for the research, development,
manufacture, and commercialization of next generation mRNA
vaccines. Arcturus is eligible to receive up to $4.3 billion in
potential development and commercial milestones if all products are
registered in the licensed fields, 40% profit sharing for COVID-19
vaccines and up to low double-digit royalties on influenza vaccine
revenues.
- Arcturus achieved development milestones in March 2023,
including milestones associated with nominating next generation
vaccine candidates, resulting in $90 million invoiced to CSL
Seqirus.
- In December 2022, the Company announced an agreement with Meiji
Pharma to conduct a Phase 3 comparative study to evaluate the
safety and immunogenicity of ARCT-154, a self-amplifying mRNA
vaccine, as a booster for COVID-19. The ARCT-154 Phase 3
non-inferiority study, now fully enrolled, is being conducted in
Japan to compare the immunogenicity of ARCT-154 to Comirnaty®
(Pfizer/BioNTech) in over 800 adult participants. Meiji Pharma and
the Japanese government are funding the study.
- ARCT-810, the Company’s mRNA therapeutic candidate for OTC
deficiency, is being evaluated in a Phase 2 study, presently
enrolling up to 24 adolescents and adults with OTC deficiency. The
Phase 2 study is being conducted in the UK and Europe and 9 sites
in 6 countries have been activated to date. Multiple patients have
been enrolled. The study is designed to evaluate two dose levels
and allow for six (6) bi-weekly administrations for each
participant. The Company expects 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, has advanced to a Phase 1 study, presently enrolling up
to 32 participants in New Zealand. The primary objective of this
study is to assess safety and tolerability at four (4) dose levels.
The first two cohorts have been dosed successfully with no
significant adverse events reported to date. The Company expects to
complete the full 32 subject study enrollment in Q2 2023.
- Arcturus will present LUNAR-HBV pre-clinical gene editing mRNA
platform data for Hepatitis B Virus on April 27, 2023, at the 18th
annual Global Hepatitis Summit Conference in Paris, France.
Financial Results for Fourth Quarter and Year Ended December
31, 2022
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. For the three months ended December 31, 2022, the Company
reported revenue of $160.3 million compared with $5.8 million for
the three months ended December 31, 2021, and $13.4 million for the
three months ended September 30, 2022. Total revenue for the year
ended December 31, 2022, was $206.0 million compared with $12.4
million for the year ended December 31, 2021. The increase in
fourth quarter and year-over-year revenues primarily relates to the
$200 million upfront payment we received from the CSL
transaction.
Operating expenses: Total operating expenses for the
three months ended December 31, 2022, were $38.8 million compared
with $43.4 million for the three months ended December 31, 2021,
and $50.2 million for the three months ended September 30, 2022.
The decline in operating expenses when compared to the three months
ended December 31, 2021, was primarily due to lower Covid-19
manufacturing and clinical related expenses. Total operating
expenses for the year ended December 31, 2022, were $193.8 million
compared with $215.2 million for the year ended December 31,
2021.
Research and development expenses: Research and
development expenses for the three months ended December 31, 2022,
were $27.0 million compared with $32.6 million for the three months
ended December 31, 2021, and $37.7 million for the three months
ended September 30, 2022. The decline in research and development
expenses when compared to the three months ended December 31, 2021,
was primarily due to lower Covid-19 manufacturing and clinical
related expenses. Research and development expenses for the year
ended December 31, 2022, were $147.8 million compared with $173.8
million for the year ended December 31, 2021.
Net Income: For the three months ended December 31, 2022,
Arcturus reported net income of approximately $117.3 million or
$4.33 per diluted share, compared with a net loss of $38.7 million,
or $1.47 per diluted share in the three months ended December 31,
2021, and a net loss of $35.3 million, or $1.33 per diluted share
in the three months ended September 30, 2022. For the year ended
December 31, 2022, Arcturus reported a net income of approximately
$9.3 million, or $0.35 per diluted share, compared with a net loss
of $203.7 million, or $7.74 per diluted share in the year ended
December 31, 2021.
Cash Position and Balance Sheet: The Company’s cash
balance totaled $391.9 million at December 31, 2022, compared to a
cash balance of $370.5 million at December 31, 2021. In March 2023,
the Company repaid Singapore $17.1 million which triggered the
elimination of $33.3 million in non-recourse debt pertaining to the
ARCT-021 program.
Earnings Call: Tuesday, March 28, 2023 @ 4:30 pm ET
Domestic: 1-877-407-0784 International: 1-201-689-8560 Conference
ID: 13735876 Webcast: Link
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage
clinical mRNA medicines and vaccines company with enabling
technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA
Technology (samRNA) and (iii) mRNA drug substance along with drug
product manufacturing expertise. Arcturus’ pipeline includes RNA
therapeutic candidates to potentially treat ornithine
transcarbamylase (OTC) deficiency and cystic fibrosis, 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 (patents
and patent applications issued 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 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
anticipated receipt of $90 million in milestone payments from CSL
Seqirus, the period of the Company’s cash runway, the anticipated
timing and filing of a J-NDA submission and opportunity for
Japanese regulatory PMDA approval of ARCT-154, the sharing of
interim Phase 2 data for ARCT-810, the anticipated timing and
completion of study enrollment in the ARCT-032 Phase 1 study, the
likelihood of success of the collaboration with CSL Seqirus or any
collaborations including the achievement of any milestones or other
payments, the likelihood that preclinical or clinical data will be
predictive of future clinical results, the likelihood that results
to date for ARCT-154 or any other clinical candidate 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, 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
CONSOLIDATED BALANCE
SHEETS
December 31,
September 30,
December 31,
(in thousands, except par value
information)
2022
2022
2021
Assets
(unaudited)
Current assets:
Cash and cash equivalents
$
391,883
$
237,676
$
370,492
Accounts receivable
2,764
2,044
3,367
Prepaid expenses and other current
assets
8,686
6,960
5,102
Total current assets
403,333
246,680
378,961
Property and equipment, net
12,415
11,347
5,643
Operating lease right-of-use asset,
net
32,545
33,519
5,618
Equity-method investment
—
—
515
Non-current restricted cash
2,094
2,081
2,077
Total assets
$
450,387
$
293,627
$
392,814
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
7,449
$
17,962
$
10,058
Accrued liabilities
30,232
25,529
23,523
Current portion of long-term debt
60,655
27,702
22,474
Deferred revenue
28,648
4,656
43,482
Total current liabilities
126,984
75,849
99,537
Deferred revenue, net of current
portion
20,071
5,179
19,931
Long-term debt, net of current portion
—
32,038
40,633
Operating lease liability, net of current
portion
30,216
31,218
4,502
Other non-current liabilities
2,804
3,676
—
Total liabilities
180,075
147,960
164,603
Stockholders’ equity:
Common stock: $0.001 par value; 60,000
shares authorized; issued and outstanding shares were 26,555 at
December 31, 2022, 26,492 at September 30, 2022 and 26,372 at
December 31, 2021
27
26
26
Additional paid-in capital
608,426
601,129
575,675
Accumulated deficit
(338,141
)
(455,488
)
(347,490
)
Total stockholders’ equity
270,312
145,667
228,211
Total liabilities and stockholders’
equity
$
450,387
$
293,627
$
392,814
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited)
Three Months Ended
December 31,
September 30,
(in thousands, except per share data)
2022
2021
2022
Revenue:
Collaboration revenue
$
160,049
$
5,794
$
13,369
Grant revenue
244
—
—
Total revenue
160,293
5,794
13,369
Operating expenses:
Research and development, net
26,981
32,633
37,688
General and administrative
11,860
10,806
12,488
Total operating expenses
38,841
43,439
50,176
Income (loss) from operations
121,452
(37,645
)
(36,807
)
(Loss) gain from equity-method
investment
—
(156
)
—
(Loss) gain from foreign currency
(3,835
)
(337
)
1,862
Finance expense, net
1,025
(525
)
(321
)
Net income (loss) before income taxes
118,642
(38,663
)
(35,266
)
Provision for income taxes
1,295
—
—
Net income (loss)
$
117,347
$
(38,663
)
$
(35,266
)
Earnings (loss) per share:
Basic
$
4.43
$
(1.47
)
$
(1.33
)
Diluted
$
4.33
$
(1.47
)
$
(1.33
)
Weighted-average shares used in
calculation of earnings (loss) per share:
Basic
26,508
26,359
26,467
Diluted
27,080
26,359
26,467
Comprehensive income (loss):
Net income (loss)
$
117,347
$
(38,663
)
$
(35,266
)
Comprehensive income (loss)
$
117,347
$
(38,663
)
$
(35,266
)
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
Year Ended December
31,
(in thousands, except per share data)
2022
2021
Revenue:
Collaboration revenue
$
205,755
$
12,359
Grant revenue
244
—
Total revenue
205,999
12,359
Operating expenses:
Research and development, net
147,751
173,760
General and administrative
46,071
41,451
Total operating expenses
193,822
215,211
Income (loss) from operations
12,177
(202,852
)
(Loss) gain from equity-method
investment
(515
)
515
(Loss) gain from foreign currency
(598
)
584
Finance expense, net
(420
)
(1,921
)
Net income (loss) before income taxes
10,644
(203,674
)
Provision for income taxes
1,295
—
Net income (loss)
$
9,349
$
(203,674
)
Earnings (loss) per share:
Basic
$
0.35
$
(7.74
)
Diluted
$
0.35
$
(7.74
)
Weighted-average shares used in
calculation of earnings (loss) per share:
Basic
26,445
26,317
Diluted
27,093
26,317
Comprehensive income (loss):
Net income (loss)
$
9,349
$
(203,674
)
Comprehensive income (loss)
$
9,349
$
(203,674
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230328005818/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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