Full Press Release Details
Arcturus Therapeutics Announces Third Quarter
2023 Financial Update
and Pipeline Progress
Expected cash runway extended to the end of
$35 million milestone achieved under
ARCT-154 remains on track for
Japan-NDA approval in December
Enrollment target reached in Phase 3 bivalent
COVID vaccine comparison trial
Enrollment initiated in ARCT-032 Phase 1b study;
dosing first cystic fibrosis patient this month
ARCT-032 received Rare Pediatric Disease Designation
for cystic fibrosis from the FDA
Investor conference call at 4:30 p.m. ET November
SAN DIEGO--(BUSINESS WIRE)--Nov. 14, 2023-- 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 third quarter ended Sept. 30, 2023, and provided corporate updates.
"We had considerable progress this quarter
expanding our next generation STARR vaccine platform," said Joseph Payne, President & CEO of Arcturus Therapeutics. "Our
monovalent ARCT-154 COVID vaccine remains on track for approval in December and we reached our target enrollment for the bivalent COVID
vaccine Phase 3 study, with PMDA-approval anticipated Q3 2024."
Mr. Payne continued: "We have also advanced
our mRNA therapeutic pipeline with the scheduled dosing of our first participant in our Phase 1b study with ARCT-032, an inhaled mRNA
therapeutic candidate for individuals with cystic fibrosis. This study will advance our understanding of the safety and tolerability of
ARCT-032 in patients. It advances our effort to provide benefit to the CF population with the largest unmet need, including those who
are not candidates for any of the currently approved CFTR modulators."
"We are happy to announce our expected cash
runway was extended to the end of 2026," announced Andrew Sassine, Chief Financial Officer. "A combination of lower
expenses, additional development milestones and accelerated timelines for manufacturing technology transfer to CSL have contributed to
the extended runway. Additionally, substantial funding was obtained by ARCALIS, our joint venture mRNA manufacturing partner, from the
Japanese Government with up to $165 million committed to date. We expect this facility to become a leading manufacturer of mRNA-based
vaccines and therapeutics, with the ability to manufacture vaccines within 100 days of an emerging viral strain."
Recent Corporate Highlights
Financial Results for the Three and Nine
Months Ended September 30, 2023
Revenues in conjunction with strategic
alliances and collaborations:
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 September
30, 2023, we reported revenue of $45.1 million compared with $13.4 million for the three months September 30, 2022. Revenue increased
by $31.7 million during the three months ended September 30, 2023, as compared to the prior year period. The increase was primarily attributable
to revenue recognized from the collaboration agreement with CSL Seqirus and grant revenue recognized from the agreement with BARDA. Revenue
increased by $90.3 million during the nine months ended September 30, 2023, as compared to the nine months ended September 30, 2022. The
increase was attributable to an increase in revenue of $133.0 million primarily related to the collaboration agreement with CSL Seqirus.
This increase was primarily offset by less revenues in 2023 from other COVID program customers.
Total operating expenses
for the three months ended September 30, 2023, were $64.5 million compared with $50.2 million for the three months ended September 30,
2022. Total operating expenses for the nine months ended September 30, 2023, were $195.9 million compared with $155.0 million for the
nine months ended September 30, 2022.
Research and development expenses:
Our research and development
expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by contract research
organizations, clinical and regulatory consultants, personnel related expenses, facility related expenses and laboratory supplies related
to conducting research and development activities. Research and development expenses were $51.1 million for the three months ended September
30, 2023, compared with $37.7 million in the comparable period last year, primarily reflecting increased clinical research and manufacturing
costs of $11.6 million and an increase of $2.0 million in personnel related expenses. Research and development expenses were $155.5 million
for the nine months ended September 30, 2023, compared with $120.8 million in the comparable period last year, primarily reflecting increased
manufacturing costs of $27.8 million.
General and Administrative Expenses:
General and administrative
expenses primarily consist of salaries and related benefits for our executive, administrative, legal and accounting functions and professional
service fees for legal and accounting services as well as other general and administrative expenses. General and administrative expenses
were $13.4 million and $40.4 million for the three and nine months ended September 30, 2023, respectively, compared with $12.5 million
and $34.2 million in the comparable periods last year. The increases resulted primarily from personnel expenses due to increased headcount
and salaries, increased travel, and consulting expenses as well as increased rent expense associated with the new facility.
For the three months
ended September 30, 2023, Arcturus reported a net loss of approximately $16.2 million, or ($0.61) per diluted share, compared with a net
loss of $35.3 million, or ($1.33) per diluted share in the three months ended September 30, 2022. For the nine months ended September
30, 2023, Arcturus reported a net loss of approximately $18.0 million, or ($0.68) per diluted share, compared with a net loss of $108.0
million, or ($4.09) per diluted share in the nine months ended September 30, 2022.
Cash Position and Balance Sheet:
Cash, cash equivalents
and restricted cash were $369.1 million as of September 30, 2023, and $394.0 million on December 31, 2022. We have achieved a total of
approximately $365.0 million in upfront payments and milestones from CSL Seqirus as of September 30, 2023. We expect to continue to receive
future milestone payments from CSL Seqirus that will support the ongoing development of the covid, flu and three other respiratory vaccine
programs. The expected cash runway extends to the end of 2026 based on the current pipeline and programs.
Earnings Call: Tuesday,
November 14, 2023 @ 4:30 pm ET
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 (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. The Company has an ongoing global
collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA
vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase
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 likelihood that ARCALIS will
receive all, or any portion of, the funding under awards from the Japanese government, the continued progress of ARCALIS and expectations
for ARCALIS's facility, the anticipated conduct, including continued enrollment, of the ARCT-032 study, the results of the ARCT-032
study, the likelihood of the CF program to provide benefit to the CF population, the continued progress of the LUNAR-FLU program, the