Full Press Release Details
Therapeutics Announces First Quarter 2025 Financial Update and Pipeline Progress
Prioritization of mRNA therapeutics pipeline
extends cash runway into 2028
ARCT-032 (CF) Phase 2 interim data from first
two cohorts expected in mid-2025
ARCT-032 (CF) Phase 2 expected to complete enrollment
ARCT-810 (OTC) Phase 2 interim data expected
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)-May 12, 2025-- Arcturus
Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a commercial 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 first quarter ended March 31, 2025, and provided corporate updates.
"We are delighted with enrollment in our
cystic fibrosis (CF) program, and the company is working diligently to provide meaningful Phase 2 interim data mid-year," said Joseph
Payne, President & CEO of Arcturus Therapeutics. "We are encouraged by the clinical progress of our CF and OTC programs, and
given the current market conditions, we made a strategic decision to streamline resources to focus on our mRNA therapeutics pipeline."
"I am happy to report we have received the
initial European Union (EU) approval milestone payment from our partnership with CSL," said Andy Sassine, Chief Financial Officer
of Arcturus. "I am also pleased to report that the cash runway now extends into 2028 with the re-allocation of resources to our
therapeutics pipeline."
Corporate Highlights
Financial Results for the three months
ended March 31, 2025
Revenues in conjunction with strategic
alliances and collaborations:
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 March 31, 2025, revenues were $29.4
million compared to $38.0 million in the same period in 2024. The decrease primarily reflects lower milestone revenues recognized
under the CSL collaboration agreement as KOSTAIVE transitions from a development program to the commercial phase.
Total operating expenses
for the three months ended March 31, 2025, were $46.2 million compared to $68.4 million for the three months
ended March 31, 2024.
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 $34.9 million for the three months
ended March 31, 2025, compared to $53.6 million in the comparable period last year. The decrease in research and development
expenses was primarily driven by lower manufacturing costs associated with the KOSTAIVE , LUNAR-FLU, and BARDA programs, partially
offset by increased clinical and manufacturing costs for the CF and OTC programs. Research and development expenses also declined sequentially
from the three months ended December 31, 2024, by approximately $8.9 million, and we anticipate additional quarterly declines in the second
half of fiscal year 2025.
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 $11.3 million for the three months ended March 31, 2025, compared to $14.9 million in the comparable period last year.
The decrease in general and administrative expenses was attributable to reduced share-based compensation costs. We expect general and
administrative expenses to decrease slightly during the next twelve months driven by lower share-based compensation costs and a reduction
in expenses related to the commercial transition of the COVID program to CSL.
For the three months
ended March 31, 2025, Arcturus reported a net loss of approximately $14.1 million, or ($0.52) per diluted share, compared to
a net loss of $26.8 million, or ($1.00) per diluted share in the three months ended March 31, 2024.
Cash Position and Balance Sheet:
Cash, cash equivalents
and restricted cash were $273.8 million as of March 31, 2025, and $293.9 million on December 31, 2024.
Based on the current pipeline and programs, the cash runway is expected to extend into 2028 with the re-allocation of resources to the
therapeutics programs.
Earnings Call: Monday, May 12, 2025 @ 4:30 PM ET
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial 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 500 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 of and timing for
providing interim data from the ARCT-032 Phase 2 CF study and the ARCT-810 Phase 2 OTC deficiency study, the timing for completion of
enrollment in the ARCT-032 (CF) Phase 2 study, the likelihood of obtaining additional milestone payments from CSL Seqirus, the continued
enrollment in the Phase 2 OTC deficiency study, the likelihood of and timing for interim Phase 1 study data for Pandemic Influenza A virus
H5N1, the completion of and timing for KOSTAIVE regulatory filings in the United States and United Kingdom, the likelihood
that general and administrative expenses will decrease, the likelihood that preclinical or clinical data will be predictive of future
clinical results, 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
Trademark Acknowledgements
The Arcturus logo and other trademarks of Arcturus appearing in this
announcement, including
KOSTAIVE , LUNAR , and STARR ,
are the property of Arcturus. All other trademarks, services
marks, and trade names in this announcement are the property of their
Arcturus Therapeutics
Public Relations & Investor Relations
VP, Head of IR/PR/Marketing