Phase 1/2/3a and 3b study of ARCT-154 COVID-19
vaccine candidate completed enrollment with over 17,000
participants
Initiated ~2,000 participant ARCT-154 Phase 3c
sub-study to compare immunogenicity noninferiority to AstraZeneca
COVID-19 vaccine; enrollment to be completed this week
Preparing to file Emergency Use Authorization
(EUA) application for ARCT-154, pending interim study results, with
the Vietnam Ministry of Health in December 2021; potential for EUA
approval in Q1 2022
Investor conference call at 4:30 p.m. ET
today
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a leading clinical-stage 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, 2021 and provided corporate
updates.
“We are extremely pleased to have rapidly completed full
enrollment of the Phase 1/2/3a and 3b cohorts and are looking
forward to completing enrollment in the Phase 3c sub-study of the
ARCT-154 pivotal trial this week, in collaboration with Vinbiotech.
Assuming favorable data, we look forward to filing for Emergency
Use Authorization as soon as December of this year,” said Joseph
Payne, President and CEO of Arcturus Therapeutics. “ARCT-154 has an
attractive and differentiated profile as a low dose,
self-amplifying mRNA vaccine candidate that targets multiple
SARS-CoV2 variants of concern, and we are working diligently with
our global manufacturing partners to make it available as soon as
possible.”
Recent Corporate Highlights
- In August, Arcturus, together with Vinbiotech, advanced
ARCT-154 into a Phase 1/2/3 study in Vietnam.
- In October, Arcturus received approval to proceed with
enrollment of the Phase 3b cohort of the study following a review
by the Vietnam Ministry of Health of early safety data from the
initial 1,000 participants enrolled in the Phase 1/2/3a
cohorts.
- In November, the Phase 3b cohort of this randomized,
placebo-controlled portion of the trial was modified to enroll
approximately 16,000 participants with a Phase 3c sub-study of
approximately 2,000 participants added to evaluate immunogenicity
noninferiority compared to AstraZeneca COVID-19 vaccine. This
sub-study provides an additional path to potential full
approval.
- The Phase 3b cohort is now fully enrolled. Enrollment in the
Phase 3c sub-study is underway and expected to be completed this
week.
- All phases (1, 2, 3a, 3b and 3c) of the ARCT-154 clinical trial
in Vietnam are sponsored and funded by Arcturus’ partner
Vinbiotech.
- Arcturus and Vinbiotech continue to make progress towards
completion of a manufacturing facility in Hanoi capable of
producing 200 million doses per year, and technology transfer for
commercial manufacturing is in process.
- In August, Arcturus announced approval from the Singapore
Health Sciences Authority (HSA) to advance ARCT-154 and ARCT-165
into a Phase 1/2 clinical trial to evaluate the vaccines both as a
primary vaccination series and as a booster following initial
vaccination with Comirnaty®. This study was also approved by U.S.
Food and Drug Administration (FDA). The Comirnaty booster cohort
(with ARCT-021, ARCT-154, ARCT-165) in this study is now fully
enrolled. Previously disclosed preclinical data demonstrate that
ARCT-154 elicits strong neutralizing immunogenicity in non-human
primates to SARS-CoV-2 Alpha, Beta, Gamma, and Delta variants.
- ARCT-021 has been selected by a global entity for inclusion in
a multinational Phase 3 vaccine trial against COVID-19.
- In October, we successfully achieved a milestone in our ongoing
LUNAR-HBV program licensed by Janssen Pharmaceuticals (a subsidiary
of Johnson and Johnson) and anticipate receiving one million
dollars in the fourth quarter.
- In July, Arcturus announced approval from the UK Health
Research Authority to advance ARCT-810, a novel mRNA-based
therapeutic candidate for Ornithine Transcarbamylase (OTC)
Deficiency, into a multi-dose Phase 2 clinical study. The ARCT-810
Phase 2 study is a randomized, double-blind, placebo-controlled,
nested single and multiple ascending dose study designed to enroll
24 adolescents and adults with OTC deficiency. We anticipate dosing
will commence in the first quarter of 2022 and remain on track for
interim data in the second half of 2022.
- ARCT-032, our mRNA therapeutic candidate for cystic fibrosis,
is on track for a Clinical Trial Application (CTA) in first half of
2022.
- The LUNAR-FLU mRNA vaccine candidate targeting influenza is on
track for a CTA in the second half of 2022.
Financial Results for the Quarter Ended September 30,
2021
Revenues in conjunction with strategic alliances and
collaborations: Arcturus’ primary sources of revenues were from
license fees and collaborative payments received from research and
development arrangements with pharmaceutical and biotechnology
partners. For the three months ended September 30, 2021, the
Company reported revenue of $2.4 million, compared with $2.3
million in the three months ended September 30, 2020 and $2.0
million for the three months ended June 30, 2021.
Operating expenses: Total operating expenses for the three
months ended September 30, 2021, were $56.3 million compared with
$23.3 million for the three months ended September 30, 2020 and
$55.7 million for the three months ended June 30, 2021.
Research and development expenses increased to $45.4 million
year over year compared to $17.7 million from the third quarter of
2020. Research and development expenses were relatively consistent
compared to $45.7 million in the second quarter of 2021.
For the three months ended September 30, 2021, Arcturus reported
a net loss of approximately $54.1 million, or ($2.05) per basic and
diluted share, compared with a net loss of $21 million, or ($0.92)
per basic and diluted share in the three months ended September 30,
2020 and a net loss of $54.6 million, or ($2.07) per basic and
diluted share in the three months ended June 30, 2021.
The Company’s cash balance totaled $413.9 million as of
September 30, 2021, compared to a cash balance of $433.6 million at
June 30, 2021 and $462.9 million at December 31, 2020. The cash
balance includes $40 million received from Vinbiotech Research and
Manufacture Joint Stock Company, of which $30 million was received
during the current quarter ended September 30, 2021. Based on the
current pipeline, the Company’s cash position is expected to be
sufficient to support operations for two years.
Monday, Nov. 8 at 4:30 p.m. ET
Domestic:
877-407-0784
International:
201-689-8560
Conference ID:
13724305
Webcast:
https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47084/indexl.html
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA
medicines and vaccines company with enabling technologies: (i)
LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology 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 3, Hepatitis B Virus, and non-alcoholic steatohepatitis
(NASH). Arcturus’ versatile RNA therapeutics platforms can be
applied toward multiple types of nucleic acid medicines including
messenger RNA, small interfering RNA, replicon RNA, antisense RNA,
microRNA, DNA, and gene editing therapeutics. Arcturus’
technologies are covered by its extensive patent portfolio (with
patents and patent applications, issued and filed in the U.S.,
Europe, Japan, China and other countries). Arcturus’ commitment to
the development of novel RNA therapeutics has led to collaborations
with Janssen Pharmaceuticals, Inc., part of the Janssen
Pharmaceutical Companies of Johnson & Johnson, Ultragenyx
Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited,
CureVac AG, Duke-NUS Medical School, and the Cystic Fibrosis
Foundation. 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 expectations for or likelihood of success of any collaborations
(including with respect to LUNAR-HBV), the likelihood of success
(including safety and efficacy) of the Company’s pipeline
(including LUNAR-FLU, ARCT-021, ARCT-032, ARCT-154, ARCT-165 and
ARCT-810), anticipated sponsorship and/or funding of clinical
trials of the Company’s candidates, the Company’s efforts to
develop a vaccine against COVID-19 and therapeutic potential
thereof based on the Company’s mRNA therapeutics, the planned
initiation, design or completion of clinical trials, the likelihood
that the Company will obtain clearance from regulatory authorities
to proceed with future planned clinical trials, the likelihood that
preclinical or clinical data will be predictive of future clinical
results (including with respect to safety, immunogenicity and
efficacy), the ability to enroll, and timing for enrollment of,
subjects in clinical trials, the timing and nature of any study
results, the likelihood that clinical data will be sufficient for
regulatory approval or completed in time to submit an application
for regulatory approval within a particular timeframe, the
likelihood or timing of any regulatory approval, the Company’s
manufacturing plans or technologies (including with its partner,
Vinbiotech), the likelihood that a patent will issue from any
patent application, its current cash position and adequacy of its
capital to support future operations 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
(in thousands, except par value
information)
September 30, 2021
June 30, 2021
December 31, 2020
(unaudited)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
413,880
$
433,574
$
462,895
Accounts receivable
2,015
2,163
2,125
Prepaid expenses and other current
assets
5,071
2,301
2,769
Total current assets
420,966
438,038
467,789
Property and equipment, net
4,843
3,407
3,378
Operating lease right-of-use asset,
net
5,983
6,341
5,182
Equity-method investment
670
920
—
Non-current restricted cash
2,074
107
107
Total assets
$
434,536
$
448,813
$
476,456
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
8,265
$
10,084
$
10,774
Accrued liabilities
52,358
42,614
20,639
Deferred revenue
57,616
18,071
18,108
Total current liabilities
118,239
70,769
49,521
Deferred revenue, net of current
portion
8,497
9,850
12,512
Long-term debt, net of current portion
42,345
56,309
13,845
Operating lease liability, net of current
portion
4,935
5,359
4,025
Other long-term liabilities
1,394
878
—
Total liabilities
$
175,410
$
143,165
$
79,903
Stockholders’ equity
Common stock: $0.001 par value; 60,000
shares authorized; 26,349 issued and outstanding at September 30,
2021, 26,327 issued and outstanding at June 30, 2021 and 26,192
issued and outstanding at December 31, 2020
26
26
26
Additional paid-in capital
567,927
560,365
540,343
Accumulated deficit
(308,827
)
(254,743
)
(143,816
)
Total stockholders’ equity
259,126
305,648
396,553
Total liabilities and stockholders’
equity
$
434,536
$
448,813
$
476,456
ARCTURUS THERAPEUTICS HOLDINGS
INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands except per share
data)
Three Months Ended
September 30,
June 30,
2021
2020
2021
Collaboration revenue
$
2,437
$
2,333
$
2,001
Operating expenses:
Research and development, net
45,398
17,699
45,679
General and administrative
10,860
5,572
10,042
Total operating expenses
56,258
23,271
55,721
Loss from operations
(53,821
)
(20,938
)
(53,720
)
(Loss) gain from equity-method
investment
(250
)
—
(328
)
(Loss) gain from foreign currency
506
—
(13
)
Finance expense, net
(519
)
(66
)
(520
)
Net loss
$
(54,084
)
$
(21,004
)
$
(54,581
)
Net loss per share, basic and diluted
$
(2.05
)
$
(0.92
)
$
(2.07
)
Weighted-average shares outstanding, basic
and diluted
26,338
22,938
26,323
Comprehensive loss:
Net loss
$
(54,084
)
$
(21,004
)
$
(54,581
)
Comprehensive loss
$
(54,084
)
$
(21,004
)
$
(54,581
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211108006051/en/
IR and Media Contacts Arcturus Therapeutics Deepankar
Roy, Ph.D. (858) 900-2682 IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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