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Arcturus Therapeutics Announces Third Quarter 2020 Financial Results and Positive Clinical Updates for ARCT-810 Phase I Study and Additional ARCT-021 Interim Data Investor conference call at 4:30 p.m. ET today San Diego,

Key Takeaway: Arcturus Therapeutics Announces Third Quarter 2020 Financial Results and Positive Clinical Updates for ARCT-810 Phase I Study and Additional ARCT-021 Interim Data Investor conference call at 4:30 p.m. San Diego, Calif, Nov 9, 2020 - Arcturus Therapeutics Holdings Inc. (the

Full Press Release Details

Arcturus Therapeutics Announces Third
Quarter 2020 Financial Results and
Positive Clinical Updates for ARCT-810
Phase I Study and Additional ARCT-021 Interim Data
Investor conference call at 4:30 p.m.
San Diego, Calif, Nov 9, 2020 -
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 quarter and nine months ended September 30,
2020, and provided a corporate update.
"This has been an exciting period
for Arcturus highlighted by our preliminary ARCT-021 Phase 1/2 COVID-19 vaccine study results. These data, as well as those from
our ARCT-810 Phase 1 study, illustrate a highly productive period of clinical advancement of our novel mRNA based therapeutic candidates.
The ARCT-021 Phase 1/2 data provide clinical validation for our unique vaccine candidate and suggest that our self-replicating
mRNA-based investigational vaccine could have a differentiated clinical profile and may allow vaccination at low doses. We believe
that ARCT-021 could play an important role in the massive global vaccination campaigns that will be necessary to control the COVID-19
pandemic. We look forward to rapidly moving ARCT-021 forward in later stage clinical studies." said Joseph Payne, President
"The initial ARCT-810 Phase 1/2 study
results, showing good tolerability and favorable pharmacokinetics, provide support for the further development of this drug candidate
in Ornithine Transcarbamylase (OTC) deficiency, a severe monogenic rare disease where new medicines are urgently needed. These
data also provide additional validation for the systemic administration of Arcturus' novel LUNAR technology. We believe that
we have developed a powerful and broadly applicable mRNA delivery approach that may be useful for the treatment of numerous serious
diseases, and we look forward to continuing to advancing the development of our investigational therapeutics" said Pad Chivukula,
Ph.D., Chief Scientific Officer and Chief Operating Officer of Arcturus.
ARCT-021, Vaccine Candidate for SARS-CoV-2
ARCT-810, Therapeutic Candidate for
Ornithine Transcarbamylase (OTC) Deficiency
Financial results for the quarter ended September 30, 2020
Revenues in conjunction with strategic
alliances and collaborations: Arcturus' primary source of revenues is from license fees and collaborative payments received
from research and development arrangements with pharmaceutical and biotechnology partners. For the three months ended September
30, 2020, the Company reported revenue of $2.3 million, compared with $3.3 million in the three months ended September 30, 2019.
The decline in collaboration revenues primarily relates to a $0.8 million decrease in reimbursements from CureVac associated with
the OTC collaboration that ended in the third quarter of 2019.
Operating expenses: Total operating
expenses for the three months ended September 30, 2020 were $23.3 million compared with $10.9 million for the same period of 2019.
The current quarter operating expenses were partially offset with $3.7 million of funds earned under the Singapore vaccine grant
and $0.7 million in funds awarded by the CF Foundation. Research and Development expenses increased approximately $10 million sequentially
from the June 30, 2020 quarter driven primarily by an approximate increase of $4 million in each of our Lunar-OTC (ARCT-810) and
Lunar-Covid19 (ARCT-021) programs mostly due to clinical and manufacturing expenses. Additionally, approximately $2 million was
driven by increased personnel expenses and costs of our two new pipeline programs Lunar-Lung and Lunar CV.
Net loss: For the three months ended
September 30, 2020, Arcturus reported a net loss of approximately $21.0 million, or ($0.92) per basic and diluted share, compared
with a net loss in the three months ended September 30, 2019 of $7.4 million, or ($0.56) per basic and diluted share.
Our cash balance totaled $307.1 million
as of the end of Q3, compared to cash and cash equivalents of $71.5 million at December 31, 2019. The increase in cash, cash equivalents,
and investments is primarily due to successfully raising approximately $262.1 million in net proceeds through two public equity
offerings in 2020. Based on our current pipeline, the Company's cash position is expected to be sufficient to support
operations for more than two years.
Monday, Nov 9th @ 4:30 p.m. ET
Domestic: 877-407-0784
International: 201-689-8560
Conference ID: 13712208
Webcast: http://public.viavid.com/index.php?id=142081
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
self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine
Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Cardiovascular Disease 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 (200
patents and patent applications, issued 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, Synthetic Genomics Inc., Duke-NUS, 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, including
those regarding strategy, future operations, collaborations, the likelihood of success, and the efficacy or safety, of our pipeline,
including ARCT-021 or ARCT-810, the ability to initiate or complete preclinical and clinical development programs, including as
a result of the COVID-19 pandemic, the supply and delivery of any product or substance, the likelihood that clinical data will
be predictive of future clinical results or sufficient for regulatory approval, the ability to enroll subjects in clinical trials,
the Company's efforts to develop a vaccine against COVID-19 and therapeutic potential thereof based on the Company's
mRNA therapeutics, the ability of the Company to scale up manufacturing of vaccine doses, the amount and timing of any drawn down
loan amounts with the EDB, our current cash position and expected cash burn and the impact of general business and economic conditions
are forward-looking statements. 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. Such statements are based on management's current expectations and involve risks and uncertainties,
including those discussed under the heading "Risk Factors" in Arcturus' Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, filed with the SEC on March 16, 2020 and in subsequent filings with, or submissions to, the SEC.
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.
IR and Media Contacts
Arcturus Therapeutics
Kendall Investor Relations
ARCTURUS THERAPEUTICS HOLDINGS INC. AND
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
September 30, 2020 December 31, 2019
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 307,023 $ 71,353
Accounts receivable 2,447 2,179
Prepaid expenses and other current assets 4,630 758
Total current assets 314,100 74,290
Property and equipment, net 3,451 2,349
Operating lease right-of-use asset, net 4,862 5,134
Equity-method investment - 263
Non-current restricted cash 107 107
Total assets $ 322,520 $ 82,143
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 6,478 $ 5,793
Accrued liabilities 15,838 7,134
Deferred revenue 5,698 8,397
Total current liabilities 28,014 21,324
Deferred revenue, net of current portion 13,645 15,182
Long-term debt 15,076 14,995
Operating lease liability, net of current portion 4,155 4,850
Total liabilities $ 60,890 $ 56,351
Stockholders' equity
Common stock: $0.001 par value; 30,000 shares authorized; 24,473 and 15,138 issued and outstanding at September 30, 2020 and December 31, 2019, respectively. 25 15
Additional paid-in capital 374,317 97,445
Accumulated deficit (112,712 ) (71,668 )
Total stockholders' equity 261,630 25,792
Total liabilities and stockholders' equity $ 322,520 $ 82,143
ARCTURUS THERAPEUTICS HOLDINGS INC. AND
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2020 2019 2020 2019
Collaboration revenue $ 2,333 $ 3,318 $ 7,301 $ 17,821
Operating expenses:
Research and development, net 17,699 7,053 33,560 21,646
General and administrative 5,572 3,881 14,183 10,871
Total operating expenses 23,271 10,934 47,743 32,517
Loss from operations (20,938 ) (7,616 ) (40,442 ) (14,696 )
Loss from equity-method investment - 303 (263 ) 15
Finance expense, net (66 ) (120 ) (339 ) (321 )
Net loss $ (21,004 ) $ (7,433 ) $ (41,044 ) $ (15,002 )
Net loss per share, basic and diluted $ (0.92 ) $ (0.56 ) $ (2.19 ) $ (1.33 )
Weighted-average shares outstanding, basic and diluted 22,938 13,201 18,766 11,248
Comprehensive loss:
Net loss $ (21,004 ) $ (7,433 ) $ (41,044 ) $ (15,002 )
Comprehensive loss $ (21,004 ) $ (7,433 ) $ (41,044 ) $ (15,002 )
Last updated: Nov 9, 2020