Full Press Release Details
Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress
ARCT-154 Phase 3 COVID-19 booster trial achieved
primary endpoint demonstrating strong immune response and favorable safety profile
Meiji Seika Pharma submitted ARCT-154 New Drug
Application in Japan
New ARCT-154 booster clinical data demonstrate
one-year durability across a panel of variants
Received FDA Fast Track Designation and
Rare Pediatric Disease Designation
for ARCT-810 for OTC deficiency
Received regulatory approval of ARCT-032 to
proceed into a Phase 1b clinical study in CF patients
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--Aug. 7, 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 second quarter and six months ended June 30, 2023 and provided corporate updates.
"Arcturus has continued to achieve significant
operational progress alongside our exclusive global vaccines partner CSL Seqirus, highlighted by the NDA submission of ARCT-154, for the
COVID-19 primary series vaccine and booster, in Japan by CSL Seqirus' partner Meiji Seika Pharma," said Joseph Payne, President
& CEO of Arcturus Therapeutics. "As demonstrated by the recently published ARCT-154 Phase 3 head-to-head booster data versus
Comirnaty , we believe that our next generation STARR mRNA platform is meaningfully differentiated. In addition to ARCT-154,
we have also made significant progress with other clinical and pre-clinical mRNA therapeutic programs, and we look forward to sharing
clinical data from our ARCT-810 and ARCT-032 programs later this year."
Recent Corporate Highlights
Financial Results for the Three and Six Months Ended June 30, 2023
Revenues in conjunction with strategic alliances
Arcturus' primary 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 June 30, 2023, we reported revenue
of $10.5 million compared with $27.1 million for the three months ended June 30, 2022. Revenue decreased by $16.6 million during
the three months ended June 30, 2023 as compared to the prior year period. The decrease was primarily attributable to a decrease
in revenue of $12.7 million related to the termination of the agreement with Vinbiocare and a decrease in revenue of $12.5 million related
to the agreement with the Israeli Ministry of Health. The decrease was primarily offset by an increase in revenue of $8.6 million related
to the collaboration agreement with CSL Seqirus and the grant agreement with BARDA which were both executed in the second half of 2022.
Revenue increased by $58.5 million during the six months ended June 30, 2023 as compared to the six months ended June 30,
2022. The increase was attributable to an increase in revenue of $87.6 million primarily related to the collaboration agreement with CSL
Seqirus and the grant agreement with BARDA which were both executed in the second half of 2022.
Total operating expenses for the three months
ended June 30, 2023 were $65.9 million compared with $49.2 million for the three months ended June 30, 2022. Total operating expenses
for the six months ended June 30, 2023 were $131.4 million compared with $104.8 million for the six months ended June 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 $52.7 million for the three months ended June 30, 2023,
compared with $38.2 million in the comparable period last year, primarily reflecting increased clinical research and manufacturing costs
of $11.4 million and an increase of $2.9 million in personnel related costs. Research and development expenses were $104.4 million for
the six months ended June 30, 2023, compared with $83.1 million in the comparable period last year, primarily reflecting increased
manufacturing costs of $11.1 million, an increase of $5.9 million in personnel related costs, an increase in consulting expenses of $1.8
million, an increase of $1.3 million in facilities expense and a decrease of contra research and development expenses recognized of $2.7
million. The increase was primarily offset by a decrease of clinical-related expenses of $1.2 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 $13.2
million and $27.0 million for the three and six months ended June 30, 2023, respectively, compared with $11.0 million and $21.7 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 June 30, 2023, Arcturus
reported a net loss of approximately $52.6 million, or ($1.98) per diluted share, compared with a net loss of $21.6 million, or ($0.82)
per diluted share in the three months ended June 30, 2022. For the six months ended June 30, 2023, Arcturus reported a net loss of approximately
$1.8 million, or ($0.07) per diluted share, compared with a net loss of $72.7 million, or ($2.75) per diluted share in the six months
ended June 30, 2022.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were
$380.6 million as of June 30, 2023 and $394.0 million on December 31, 2022. We have collected approximately $300.0 million in upfront
payments and milestones from CSL Seqirus as of June 30, 2023. Additionally, we received $23.6 million under the manufacturing and supply
of ARCT-154 from CSL Seqirus during the quarter ended June 30, 2023. We expect to continue to receive future milestone payments from CSL
Seqirus that will support the ongoing development of the covid and flu programs. The cash runway remains extended through the beginning
of 2026 based on the current pipeline and programs.
Earnings Call: Monday, August 7, 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 (samRNA) and (iii) mRNA drug substance along with drug product
manufacturing expertise. 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 mRNA, 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 potential of the Company's
platform technology to be meaningfully differentiated from other technologies, the anticipated timing and sharing of clinical data including
from the Company's ARCT-810 and ARCT-032 programs, the continued progress of the LUNAR-FLU program, the likelihood and timing of
regulatory approvals of any products including ARCT-154 in Japan or anywhere else, the anticipated conduct of the ARCT-032 study
in New Zealand, the likelihood that preclinical or clinical data will be predictive of future clinical results, the likelihood that the
interim study results of the ARCT-154 Phase 3 booster vaccine study will be predictive of, or consistent with, the complete study results,
the likelihood that a patent will issue from any patent application, the likelihood or timing of collection of accounts receivables including
expected payments from CSL Seqirus, its current cash position and expected cash burn and runway, 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'