Entered into global partnership with CSL to
develop and commercialize self-amplifying mRNA vaccines targeting
COVID-19, influenza, additional pathogens, and pandemic
preparedness with $200 million upfront and up to $4.3 billion in
potential development and commercial milestones
BARDA award announced for up to $63.2 million
to support development of a self-amplifying mRNA vaccine for rapid
pandemic influenza response
New LUNAR-CF preclinical data demonstrates
effective delivery of ARCT-032 with LUNAR®, resulting in functional
restoration of chloride ion current in CF subject bronchial
epithelial cells
Investor conference call at 4:30 p.m. EST
today
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
“Arcturus Therapeutics”, Nasdaq: ARCT), a global late-stage
clinical messenger RNA medicines company focused on the development
of infectious disease vaccines and significant opportunities within
liver and respiratory rare diseases, today announced its financial
results for the third quarter ended September 30, 2022, and
provided corporate updates.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221109006003/en/
Figure: Bronchial epithelial cells (BECs)
obtained from human CF donors were treated with ARCT-032 and
demonstrated robust restoration of CFTR activity (chloride ion
current) vs. control BECs obtained from human non-CF donors.
(Graphic: Business Wire)
"Arcturus continues to execute on the promise of our
next-generation self-amplifying mRNA vaccine franchise through
engagements with CSL and BARDA," said Joseph Payne, President and
CEO of Arcturus Therapeutics. "These new partnerships expand the
scope of our technology while providing substantial capital to
accelerate the development of our vaccine and therapeutic programs.
In addition, promising new data from ARCT-032, our CF therapeutic
candidate, was recently featured at the North American Cystic
Fibrosis Conference and we expect to file a CTA before year
end."
Recent Corporate Highlights
- Announced a strategic collaboration with CSL Seqirus, one of
the top two global influenza vaccine companies, for the
development, manufacture, and commercialization of mRNA-based
vaccines. Arcturus will receive $200 million upfront, up to $4.3
billion in potential development and commercial milestones, 40%
profit sharing for COVID-19 vaccines and up to double digit
royalties for influenza and three additional respiratory infectious
disease vaccines. The collaboration combines CSL Seqirus’
established global vaccine commercial and manufacturing
infrastructure with Arcturus’ expertise in mRNA design and
modification, LUNAR® lipid nanoparticle (LNP) technology and
manufacturing know-how. Previously reported clinical results from
ongoing ARCT-154 studies have demonstrated a favorable efficacy and
safety profile with sustained neutralizing antibodies against
COVID-19, including recent variants of concern.
- The Biomedical Advanced Research and Development Authority
(BARDA) provided Arcturus with an award valued at up to $63.2
million over three years to support preclinical, manufacturing,
nonclinical safety studies, along with development and regulatory
support for Arcturus’ self-amplifying mRNA vaccine platform
technology for rapid pandemic influenza response through Phase 1
clinical studies.
- ARCT-810, the Company’s mRNA therapeutic candidate for OTC
deficiency is being evaluated in a randomized, double-blind,
placebo-controlled, nested single and multiple ascending dose Phase
2 study in 24 adolescents and adults with OTC deficiency.
Participating sites have identified several dozen patients in
pre-screening with dosing to begin Q4 2022. All subjects in the
Phase 1b single ascending dose (SAD) study have completed dosing,
including the cohort dosed at 0.4 mg/kg, without requiring steroid
co-treatment. The Company will share interim ARCT-810 clinical data
when we announce additional liver therapeutic programs in
2023.
- New preclinical data from ARCT-032, the Company’s inhaled mRNA
therapeutic for cystic fibrosis, demonstrated effective delivery of
mRNA to bronchial and tracheal epithelial cells in the presence of
CF sputum utilizing Arcturus’ proprietary LUNAR® technology (CF
Ferret G551D model). Additional in vitro data demonstrated robust
restoration of CFTR activity. Bronchial epithelial cells (BECs)
obtained from human CF donors were treated with ARCT-032 and
exhibited a significant increase in chloride ion current compared
to control BECs obtained from non-CF donors (see Figure). ARCT-032
remains on track for CTA filing by year end 2022.
Financial Results for Third Quarter Ended September 30,
2022
Revenues in conjunction with strategic alliances and
collaborations: Arcturus’ primary sources of revenues were from
consulting and related technology transfer fees, reservation fees,
license fees and collaborative payments received from research and
development arrangements with pharmaceutical and biotechnology
partners. For the three months ended September 30, 2022, the
Company reported revenue of $13.4 million compared with $2.4
million for the three months ended September 30, 2021, and $27.1
million for the three months ended June 30, 2022. Revenue increased
by $10.9 million during the three months ended September 30, 2022,
as compared to the three months ended September 30, 2021, which
primarily relates to an increase in revenue related to the
agreement with Vinbiocare.
Operating expenses: Total operating expenses for the
three months ended September 30, 2022, were $50.2 million compared
with $56.3 million for the three months ended September 30, 2021,
and $49.2 million for the three months ended June 30, 2022. The
decline in operating expenses when compared to the three months
ended September 30, 2021 was primarily due to lower manufacturing
related expenses.
Research and development expenses: Research and
development expenses for the three months ended September 30, 2022,
were $37.7 million compared with $45.4 million for the three months
ended September 30, 2021, and $38.2 million for the three months
ended June 30, 2022. The decline in research and development
expenses when compared to the three months ended September 30, 2021
was primarily due to lower manufacturing related expenses.
Net Loss: For the three months ended September 30, 2022,
Arcturus reported a net loss of approximately $35.3 million, or
($1.33) per basic and diluted share, compared with a net loss of
$54.1 million, or ($2.05) per basic and diluted share in the three
months ended September 30, 2021, and a net loss of $21.6 million,
or ($0.82) per basic and diluted share in the three months ended
June 30, 2022.
Cash Position: The Company’s cash balance totaled $237.7
million as of September 30, 2022, compared to a cash balance of
$370.5 million at December 31, 2021.
Earnings Call: Wednesday, November 9, 2022 @ 4:30 pm EST
Domestic: 1-888-204-4368 International: 1-323-994-2093 Conference
ID: 2581187 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’ diverse pipeline of RNA
therapeutic and vaccine candidates includes mRNA vaccine programs
for SARS-CoV-2 (COVID-19) and Influenza, and other programs to
potentially treat ornithine transcarbamylase (OTC) deficiency, and
cystic fibrosis, along with partnered programs including glycogen
storage disease type III, and hepatitis B virus. 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, ARCT-810 and ARCT-154) the expectations for beginning the
collaboration with CSL Seqirus, including receiving clearance under
the Hart-Scott-Rodino Antitrust Improvements Act and satisfying
other closing conditions, or the likelihood of success of the
collaboration with CSL Seqirus or any collaborations including the
achievement of any milestones or other payments, the future
activities under and fulfillment of the Company’s contract with
BARDA, the ability of the Company’s influenza vaccine program to
support U.S. government pandemic preparedness goals, the likelihood
that preclinical (including for ARCT-032 therapeutic candidate) or
clinical data will be predictive of future clinical results, the
anticipated timing for filing of a CTA for ARCT-032, the ability of
the Company to initiate, enroll and execute clinical trials
(including the ARCT-810 trial), the timing for sharing interim
ARCT-810 clinical data or announcing additional liver therapeutic
programs, the likelihood that results to date for ARCT-154 or any
other clinical candidate will be predictive of future clinical
results, including with respect to future variants of concern or
sufficient for regulatory approval, the timing and nature of any
study results, the potential administration regimen or dosage, or
ability to administer multiple doses of, any of the Company’s drug
candidates, 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
CONDENSED CONSOLIDATED BALANCE
SHEETS
September 30, 2022
December 31, 2021
(in thousands, except par value
information)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
237,676
$
370,492
Accounts receivable
2,044
3,367
Prepaid expenses and other current
assets
6,960
5,102
Total current assets
246,680
378,961
Property and equipment, net
11,347
5,643
Operating lease right-of-use asset,
net
33,519
5,618
Equity-method investment
—
515
Non-current restricted cash
2,081
2,077
Total assets
$
293,627
$
392,814
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
17,962
$
10,058
Accrued liabilities
25,529
23,523
Current portion of long-term debt
27,702
22,474
Deferred revenue
4,656
43,482
Total current liabilities
75,849
99,537
Deferred revenue, net of current
portion
5,179
19,931
Long-term debt, net of current portion
32,038
40,633
Operating lease liability, net of current
portion
31,218
4,502
Other non-current liabilities
3,676
—
Total liabilities
$
147,960
$
164,603
Stockholders’ equity
Common stock, $0.001 par value; 60,000
shares authorized; issued and outstanding shares were 26,492 at
September 30, 2022 and 26,372 at December 31, 2021
26
26
Additional paid-in capital
601,129
575,675
Accumulated deficit
(455,488
)
(347,490
)
Total stockholders’ equity
145,667
228,211
Total liabilities and stockholders’
equity
$
293,627
$
392,814
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
Three Months Ended
September 30,
June 30,
(in thousands, except per share data)
2022
2021
2022
Revenue
$
13,369
$
2,437
$
27,093
Operating expenses:
Research and development, net
37,688
45,398
38,189
General and administrative
12,488
10,860
10,993
Total operating expenses
50,176
56,258
49,182
Loss from operations
(36,807
)
(53,821
)
(22,089
)
Loss from equity-method investment
—
(250
)
(131
)
Gain from foreign currency
1,862
506
1,217
Finance expense, net
(321
)
(519
)
(560
)
Net loss
$
(35,266
)
$
(54,084
)
$
(21,563
)
Net loss per share, basic and diluted
$
(1.33
)
$
(2.05
)
$
(0.82
)
Weighted-average shares outstanding, basic
and diluted
26,467
26,338
26,425
Comprehensive loss:
Net loss
$
(35,266
)
$
(54,084
)
$
(21,563
)
Comprehensive loss
$
(35,266
)
$
(54,084
)
$
(21,563
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109006003/en/
IR and Media Contacts Arcturus Therapeutics
IR@arcturusrx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617)
914-0008 ctanzi@kendallir.com
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