Full Press Release Details
Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress
Kostaive anticipated to launch in Japan
ARCT-032 remains on track for Phase 1b interim
ARCT-810 remains on track for Phase 2 interim
data by the end of Q2
ARCT-2138 (Quadrivalent LUNAR-FLU) Phase 1 study
for seasonal influenza vaccine initiated
New STARR vaccine discovery programs initiated
for Lyme Disease and Gonorrhea
Cash runway extended to Q1 2027
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--March. 7, 2024-- Arcturus
Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global 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 fourth quarter ended December 31, 2023, and provided corporate updates.
"I am excited about the continued pipeline
progress and efforts toward commercialization achieved by Arcturus in 2023," said Joseph Payne, President & CEO of Arcturus
Therapeutics. "Alongside our global vaccine partner CSL Seqirus and their COVID vaccine partner in Japan, Meiji, Kostaive
was granted historic approval as the world's first self-amplifying mRNA (sa-mRNA) product. Recently released clinical trial data,
demonstrated Kostaive induced a stronger, broader, and more
durable immune response compared to an approved conventional mRNA vaccine."
Mr. Payne continued: "We are especially
pleased to announce the U.S. FDA and the European Commission recently granted Orphan Drug Designation for ARCT-032, an inhaled mRNA therapeutic
candidate for individuals with cystic fibrosis. These regulatory designations will help advance ARCT-032 to become a potential treatment
for the segment of the CF population who are not candidates for any of the currently approved drugs for this disease."
Andy Sassine, Chief Financial Officer of Arcturus
said, "I am pleased to announce the cash runway was extended to the first quarter 2027 due to disciplined cost management and progression
of the CSL collaboration. This is the second sequential quarter our runway was extended without including any contributions from Kostaive
revenues or commercial milestones."
Recent Corporate Highlights
Financial Results for the
Year Ended December 31, 2023
Revenues in conjunction
with collaborations and grants:
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 year ended December 31, 2023,
we reported revenue of $169.9 million compared with $206.0 million for the year ended December 31, 2022. Revenue recognized from CSL in
2023 was $157.4 million which slightly increased by $3.0 million compared to 2022. We made significant progress with the BARDA grant agreement
that led to an increase in revenue of $8.8 million. The majority of the annual decrease in revenue was driven by the discontinuation of
our collaboration agreements with Vinbiocare and Janssen. For the three months ended December 31, 2023, revenue recognized was $34.0 million
compared with $160.3 million for the three months ended December 31, 2022. The $200.0 million up front payment for the execution of the
CSL collaboration drove the majority of the revenue recognition during the three months ended December 31, 2022.
Total operating expenses
for the year ended December 31, 2023, were $245.0 million compared with $193.8 million for the year ended December 31, 2022. For the three
months ended December 31, 2023, operating expenses were $49.1 million compared with $38.8 million for the three months ended December
Research and Development
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. Research
and development expenses were $192.1 million for the year ended December 31, 2023, compared with $147.8 million for the year ended December
31, 2022. The increase in research and development expenses were primarily driven by the CSL and BARDA programs as well as our internal
OTC and Cystic Fibrosis programs. Additionally, we have increased investments in early stage and discovery technologies. The Company initiated
preclinical research related to its Lyme Disease and Gonorrhea vaccine discovery programs. Research and development expenses were $36.6
million for the three months ended December 31, 2023, compared with $27.0 million for the three months ended December 31, 2022. This increase
was due to higher professional and personnel-related expenses as well as lower contra research and development expense from grants.
General and Administrative
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. For the year ended December 31, 2023,
general and administrative expenses were $52.9 million compared with $46.1 million for the year ended December 31, 2022. The annual increase
was primarily due to personnel expenses as a result of increased headcount and salaries, travel and consulting expenses. Additionally,
we incurred higher rent expenses associated with the new headquarters facility. General and administrative expenses were $12.5 million
for the three months ended December 31, 2023, compared with $11.8 million for the three months ended December 31, 2022. The slight increase
was due to personnel-related expenses.
For the year ended December
31, 2023, we reported a net loss of approximately $26.6 million, or ($1.00) per diluted share, compared with net income of $9.3 million,
or $0.35 per diluted share for the year ended December 31, 2022. For the three months ended December 31, 2023, we reported a net loss
of approximately $8.6 million or ($0.32) per diluted share, compared with net income of $117.4 million or $4.33 per diluted share for
the three months ended December 31, 2022.
Cash Position and Balance
Cash, cash equivalents
and restricted cash were $348.9 million at December 31, 2023, and $394.0 million at December 31, 2022. We have achieved a total of approximately
$396.0 million in upfront payments and milestones from CSL as of December 31, 2023. We expect to continue to receive future milestone
payments from CSL that will support the ongoing development of the covid and flu programs and three additional vaccine programs by CSL.
The expected cash runway extends at least three years based on the current pipeline and programs.
Earnings Call: Thursday, March 7, 2024 @ 4:30 pm
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California,
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global 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. Arcturus developed the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine (Kostaive ) in the world to be approved.
Arcturus 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 (over 400 patents and patent applications 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 preclinical
or clinical data will be predictive of future clinical results, including that the results from Kostaive
(or ARCT-154) will be predictive of results for updated versions of the vaccine, the potential commercial launch of Kostaive ,
the continued advancement ARCT-032 or its potential as a treatment for any of the CF population, the continued advancement of ARCT-810,
the anticipated timing and sharing of clinical data including for the Company's ARCT810 Phase 2 study and the ARCT-032 Phase 1b
study, the continued efforts for our vaccine discovery programs for lyme disease or gonorrhea, the potential of the Company's platform
technology to be meaningfully differentiated from other technologies, the continued progress of the LUNAR-FLU program, the ability to