Full Press Release Details
Therapeutics Announces Second Quarter 2024 Financial Update and Pipeline Progress
submitted for Phase 2 trial of ARCT-032 targeting cystic fibrosis (CF)
(OTC deficiency) Phase 2 interim data on track for Q4
track for Q4 commercial launch in Japan
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--August. 5, 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 addressing unmet medical needs within liver and respiratory rare
diseases, today announced its financial results for the second quarter ended June 30, 2024, and provided corporate updates.
"We are pleased to remain on track for our
first commercial product launch of Kostaive in Japan later this year," said Joseph Payne, President & CEO of Arcturus Therapeutics.
"We are also encouraged by the clinical progress of our mRNA therapeutics pipeline, especially the collection of meaningful safety
data for CF and OTC deficiency candidates, ARCT-032 and ARCT-810."
"The aggregate safety data of ARCT-032 and
ARCT-810 support continuing clinical development of these rare disease programs," said Dr. Juergen Froehlich, Chief Medical Officer
of Arcturus Therapeutics. "The planned ARCT-032 Phase 2 study advances our efforts to provide a potential treatment for CF patients
who have genotypes making them ineligible for modulator treatment and the additional CF population who are eligible but are not prescribed
Dr. Froehlich added: "We are also pleased
to report that the dosing phase in our European Phase 2 ARCT-810 study is near completion with interim data to be available in Q4. The
additional Phase 2 study in the United States has initiated and is designed to expand our OTC deficiency program into more severe and
Corporate Highlights
Financial Results for the three months ended June 30, 2024
Revenues in conjunction with strategic alliances
Arcturus' primary revenue streams include
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, 2024, we reported revenue
of $49.9 million, a significant increase of $39.4 million from the $10.5 million reported in the same period in 2023. The increase was
primarily due to the CSL agreement during the second quarter of 2024. This increase in CSL revenue recognized was driven by the recognition
of Kostaive manufacturing activities and clinical trial expenses. Additionally, revenue related to the BARDA agreement increased
due to advancements in the pandemic flu program.
Revenue decreased by $2.9 million during the six
months ended June 30, 2024, as compared to the same period in 2023. The decrease was primarily due to lower CSL revenue resulting from
the timing and value of milestone achievements. The overall decrease was offset by higher BARDA revenue due to increased progress of the
pandemic flu program.
Total operating expenses for the three months
ended June 30, 2024, were $71.0 million compared with $65.9 million for the three months ended June 30, 2023. Total operating expenses
for the six months ended June 30, 2024, were $139.4 million compared with $131.4 million for the six months ended June 30, 2023.
Research and development expenses:
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 $58.7 million for the three months ended June 30, 2024, compared with
$52.7 million for the three months ended June 30, 2023. Research and development expenses were $112.2 million for the six months ended
June 30, 2024, compared with $104.4 million for the three months ended June 30, 2023. The increases in research and development expenses
were primarily driven by higher clinical and manufacturing expenses. Additionally, investments increased in early stage and discovery
technologies, including the initiation of preclinical research related to its Gonorrhea and Lyme disease vaccine discovery programs.
General and Administrative Expenses:
General and administrative expenses primarily
consist of salaries and related benefits for 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 $12.3 million
and $27.2 million for the three and six months ended June 30, 2024, respectively, compared with $13.2 million and $27.0 million in the
comparable periods last year. These expenses remained relatively consistent between the two periods. The Company does not expect that
general and administrative expenses will increase on a yearly basis.
For the three months ended June 30, 2024, Arcturus
reported a net loss of approximately $17.2 million, or ($0.64) per diluted share, compared with a net loss of $52.6 million, or ($1.98)
per diluted share in the three months ended June 30, 2023. For the six months ended June 30, 2024, Arcturus reported a net loss of approximately
$44.0 million, or ($1.64) per diluted share, compared with a net loss of $1.8 million, or ($0.07) per diluted share in the six months
ended June 30, 2023.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were $317.2
million as of June 30, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $437.1
million in upfront payments and milestones from CSL as of June 30, 2024, and expects to continue to receive future milestone
payments from CSL supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL. The expected
cash runway extends approximately three years based on the current pipeline and programs through the first quarter of fiscal year 2027.
Arcturus Therapeutics Second Quarter 2024 Earnings
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 Kostaive , the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine 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 (OTC) deficiency and cystic fibrosis (CF), 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.
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 and continued
advancement 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 of commercialization of Kostaive and the timing thereof, the continued
clinical development of the rare disease programs, the planned completion of the European Phase 2 ARCT-810 Phase 2 study and availability
of interim data from the study, the likelihood and timing of a European Marketing Authorization application approval decision for Kostaive ,
the anticipated enrollment in the Phase 2 clinical program for ARCT-810, that preclinical or clinical data will be predictive of future
clinical results, the likelihood and timing of clinical study updates, the likelihood or timing of collection of accounts receivables
including expected future milestone and other payments from CSL, 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' most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions
to, the SEC, which are available on the SEC's website at www.sec.gov.
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.
logo and other trademarks of Arcturus appearing in this announcement, including LUNAR and STARR ,
are the property of Arcturus. All other trademarks, services marks, and trade names in this announcement are the property of their respective
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