Full Press Release Details
Therapeutics Announces Third Quarter 2025 Financial Update and Pipeline Progress
Encouraging CF interim Phase 2 data support
continued and expanded trial design
12-week safety and preliminary efficacy study
in up to 20 CF participants planned to start H1 2026
Additional cost reductions planned in fourth
quarter to extend cash runway
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)-Nov 10, 2025-- Arcturus
Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a commercial messenger RNA medicines
company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced
its financial results for the third quarter ended September 30, 2025, and provided corporate updates.
"We were pleased to share the initial findings
of ARCT-032 clinical activity with the CF community last month at the NACFC," said Joseph Payne, President & CEO of Arcturus
Therapeutics. "Conversations at NACFC with CF patients, physicians, investigators and global experts reinforced our commitment to
advance ARCT-032 further into development. We look forward to initiating a 12-week safety and preliminary efficacy study in first half
of 2026. Our team is also working diligently to achieve alignment with regulatory agencies regarding pivotal studies of ARCT-810 in adults
and young children with OTC deficiency."
"The observed mucus plug reduction after
28 days of treatment with ARCT-032 in people with Class I CF is encouraging," said Denis Hadjiliadis, MD, MMHS, FRCP(C), Professor
and Cystic Fibrosis Program Director, Perelman School of Medicine, University of Pennsylvania. "Clearance of mucus suggests that
treatment with ARCT-032 is acting on the thick mucus defect which is fundamental in CF; more extended treatment with ARCT-032 could provide
further reduction in mucus burden leading to more meaningful benefits, including lung function and structural lung defect improvement. These
changes could ultimately lead to reduction in exacerbations and change the clinical course of this progressive disease."
"The sudden changes in regulatory requirements
by the FDA for COVID-19 vaccines have delayed the U.S. BLA filing for KOSTAIVE indefinitely. We have decided to reduce additional
expenses to extend the runway for the CF and OTC deficiency programs," said Andy Sassine, CFO of Arcturus Therapeutics. "We
anticipate continued support from CSL to commercialize KOSTAIVE in Asia and Europe and will provide more details on our year end call."
Corporate Highlights
| o | Protocol prespecified analyses of high-resolution computed tomography (HRCT) lung scans using FDA 501(k)-cleared AI technology revealed reductions in mucus burden in four of the six Class I CF participants. | |
| o | The ongoing third cohort is enrolling up to six subjects to assess the safety and tolerability of the 15 mg dose daily over 28 days and the impact on the efficacy endpoints. |
| o | These new data further validate Arcturus' STARR sa-mRNA vaccine platform. | |
| o | This work was funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00007. The contract and federal funding are not an endorsement of the study results, product, or company. |
Financial Results for the three months ended September 30,
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. Revenue for the three and nine months ended September 30, 2025,
was $17.2 million and $74.8 million, respectively, representing decreases of $24.5 million and $54.7 million compared to the same periods
in 2024. These declines were primarily driven by reduced revenue from the CSL collaboration, reflecting lower supply agreement activity
and lower amortization of the upfront payment as KOSTAIVE progresses toward commercialization.
Total operating expenses for the three months
ended September 30, 2025, were $33.7 million compared with $52.4 million for the three months ended September 30, 2024. Total operating
expenses for the nine months ended September 30, 2025, were $119.8 million compared with $191.8 million for the nine months ended September
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 $23.3 million for the three months ended September 30, 2025, compared with
$39.1 million for the three months ended September 30, 2024. The decrease was primarily driven by lower manufacturing costs for the LUNAR-COVID,
LUNAR-FLU, and LUNAR-CF programs, as well as reduced clinical trial expenses for LUNAR-COVID and LUNAR-CF. Lower payroll and employee
benefits further contributed to the decrease.
Research and development expenses were $87.7 million
for the nine months ended September 30, 2025, compared with $151.4 million for the nine months ended September 30, 2024. The decrease
was primarily driven by lower manufacturing and clinical costs related to the LUNAR-COVID program, reflecting the program's transition
from a development program to the commercial phase. Additional decreases were attributable to lower manufacturing costs for the LUNAR-CF
and LUNAR-FLU programs. These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program. Payroll and
benefits expenses also decreased, primarily due to lower stock-based compensation expense.
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 $10.4 million
and $32.1 million for the three and nine months ended September 30, 2025, respectively, compared with $13.3 million and $40.4 million
in the comparable periods last year. The decreases in both periods were primarily due to reduced share-based compensation expense as well
as reduced payroll and benefits. We expect general and administrative expenses to continue to decrease slightly during the next twelve
months driven by lower share-based compensation costs.
For the three months ended September 30, 2025,
Arcturus reported a net loss of approximately $13.5 million, or ($0.49) per diluted share, compared with a net loss of $6.9 million, or
($0.26) per diluted share in the three months ended September 30, 2024. For the nine months ended September 30, 2025, Arcturus reported
a net loss of approximately $36.7 million, or ($1.35) per diluted share, compared with a net loss of $50.9 million, or ($1.89) per diluted
share in the nine months ended September 30, 2024.
Cash Position and Balance Sheet:
Cash, cash equivalents
and restricted cash were $237.3 million as of September 30, 2025, compared to $293.9million on December 31, 2024. Based on the additional
planned cost reduction in Q4 2025 and the delay in Phase 3 CF clinical trial commencement until 2027, the cash runway remains extended
Earnings Call: Monday, November 10, 2025 @ 4:30 p.m. 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 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 X (formerly
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 clinical data,
including interim data, will be predictive of future clinical results, the likelihood that observed mucus plug reduction is predictive
of future and future reduction and will lead to lung function or structural lung defect improvements, the plans to enroll subjects in
the third cohort of the Phase 2 clinical trial of ARCT-032, the likelihood and timing for initiation, and size and scope, of a planned
12-week safety and preliminary efficacy study for ARCT-032, plans to advance ARCT-032 further into development, the likelihood and timing
for achieving alignment with regulatory agencies on pivotal studies for ARCT-810, the likelihood of success of any collaboration including
the anticipated continued support from CSL to commercialize KOSTAIVE, the continued determination that ARCT-032 is generally safe and
well tolerated, the likelihood of further development of a self-amplifying mRNA pandemic influenza vaccine candidate, the likelihood that
preclinical or clinical data will be predictive of future clinical results, the likelihood that general and administrative expenses will