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Arcturus Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Positive Clinical Updates ARCT-021 single-shot COVID-19 STARR mRNA vaccine to be advanced to Phase 3 clinical development - on track

Key Takeaway: Arcturus Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Positive Clinical Updates ARCT-021 single-shot COVID-19 STARR mRNA vaccine to be advanced to Phase 3 clinical development - on track to initiate Phase 3 study in Q2 ARCT-021 single shot

Full Press Release Details

Arcturus Therapeutics Announces Fourth
Quarter and Full Year 2020 Financial Results and Positive Clinical Updates
ARCT-021 single-shot COVID-19 STARR
mRNA vaccine to be advanced to
Phase 3 clinical development -
on track to initiate Phase 3 study in Q2
ARCT-021 single shot immunogenicity profile
compares favorably with new data generated from recipients of a single dose of an approved conventional mRNA vaccine
ARCT-810 mRNA therapeutic for ornithine
transcarbamylase deficiency to be advanced to
Phase 2 clinical development -
on track to file CTA for Phase 2 multiple dose study in Q2
ARCT-032 mRNA therapeutic for cystic
fibrosis: completed successful
pre-IND interaction with FDA -
on track to file CTA in Q4
Investor conference call at 4:30 p.m.
San Diego, Calif, March 1, 2021
- 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 full year ended December 31, 2020
and provided a corporate update.
"Based on highly promising clinical
data from our Phase 1/2 study and emerging mRNA vaccine immunological data, we are advancing ARCT-021 for further development in
Phase 3. We are presently preparing to move forward a 5 g single dose regimen, to be confirmed based on pending Phase 2
data. Our self-amplifying mRNA-based investigational vaccine may provide a differentiated clinical profile and characteristics
that support widespread distribution across the globe. Our expectation is that successful protection from COVID-19 will require
repeated vaccination of billions of individuals for years to come and that ARCT-021 will be re-dosable. We believe that a re-dosable,
more easily distributable single shot mRNA vaccine would be a valuable option for many countries," said Joseph Payne, President
and CEO of Arcturus.
"In addition to advancing our vaccine
franchise, we have made continued progress advancing our pipeline of promising liver and lung mRNA therapeutic candidates. After
successfully beginning enrollment in the U.S. for our Phase 1b study for ARCT-810, a therapeutic candidate for Ornithine Transcarbamylase
(OTC) Deficiency, we have now also received approval from Health Canada to enroll subjects. We look forward to obtaining clinical
data this year," concluded Mr. Payne.
Recent Corporate Highlights
ARCT-021, Vaccine Candidate for SARS-CoV-2
ARCT-810, Therapeutic Candidate for
Ornithine Transcarbamylase (OTC) Deficiency
ARCT-032, Therapeutic Candidate for
Acquisition of Exclusive License to
mRNA Manufacturing Technology from Alexion Pharmaceuticals
Financial results for the quarter and
full year ended December 31, 2020
Revenues in conjunction with strategic alliances and
collaborations: Arcturus' primary source of revenues is from license fees and collaboration payments received
from research and development arrangements with our pharmaceutical and biotechnology partners.
On a quarterly basis, total revenue for the three months ended
December 31, 2020 was $2.2 million and was relatively flat when compared to the $2.3 million of the quarter ended September 30,
On a yearly basis, reported revenues of $9.5 million during
the year ended December 31, 2020, decreased from $20.8 million in the year ended December 31, 2019. The decline in collaboration
revenues primarily relates to three factors: a $5.6 million decrease in reimbursements from CureVac associated with the OTC collaboration
that ended in the third quarter of 2019, a decrease in one-time license revenue of $3.3 million from Synthetic Genomics that occurred
in 2019, and lower activity with other collaboration partners.
Operating expenses: On a quarterly basis,
total operating expenses for the three months ended December 31, 2020 were $33.3 million compared with $23.3 million for quarter
ended September 30, 2020, and $13.8 million in same period of 2019. Approximately $8 million of the sequential increase in operating
expenses during the quarter ended December 31, 2020 was due to the ramp in the Covid-19 program related expenses, which included
additional personnel, manufacturing and clinical trial expenses. The current quarter operating expenses were partially offset by
$2.7 million in funds awarded under the Singapore vaccine grants and by the Cystic Fibrosis Foundation.
On a yearly basis, total operating expenses were $81.1 million
for the year-ended December 31, 2020 compared with $46.3 million for the year ended December 31, 2019. The current year operating
expenses were partially offset by $15.2 million of funds earned under the Singapore vaccine grants and funds awarded by the Cystic
Fibrosis Foundation. The increase in net expenditures for the year ended December 31, 2020 as compared to the prior year was due
primarily to the increased activity in clinical and manufacturing expenditures related to the Company's Covid-19 and OTC
programs as well as increased personnel costs and other facility costs related to the organizational growth of the Company.
Net loss: For the three months ended December
31, 2020 Arcturus reported a net loss of approximately $31.1 million, or ($1.25) per basic and diluted share, compared with a net
loss in the three months ended September 30, 2020 of $21.0 million, or ($0.92) per basic and diluted share, and three months ended
December 31, 2019 of $11.0 million, or ($0.76) per basic and diluted share.
For the year ended December 31, 2020, net loss was approximately
$72.1 million, or ($3.55) per basic and diluted share, compared with a net loss for the year ended 2019 of $26.0 million, or ($2.15)
per basic and diluted share.
Cash and Cash Equivalents: The Company's
cash balance was $463.0 million as of December 31, 2020, compared to cash and cash equivalents of $301.1 million on September 30,
2020. The increase in cash and cash equivalents compared to the prior year is primarily due to the receipt of approximately $162
million in net proceeds from our December 2020 public offering. Subsequent to the end of the quarter, in January 2021 the Company
received $46.6 million in funds under a manufacturing loan from Singapore EDB for our Covid-19 vaccine program. Based on our current
pipeline, the Company's cash position is expected to be sufficient to support operations for more than two years.
Monday, March 1 @ 4:30 p.m. ET
Domestic: 877-407-0784
International: 201-689-8560
Conference ID: 13716298
Webcast: http://public.viavid.com/index.php?id=143486
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 (209 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 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, collaborations, the likelihood of success, and the efficacy
Last updated: Mar 1, 2021