Arcturus Therapeutics Reports Third Quarter 2025 Financial Results and Provides Key Corporate Updates
Arcturus Therapeutics Holdings Inc. (“Arcturus” or the “Company”) (Nasdaq: ARCT), a commercial-stage messenger RNA (mRNA) medicines company dedicated to developing innovative treatments for liver and respiratory rare diseases as well as infectious disease vaccines, today announced its financial results for the third quarter ended September 30, 2025. The Company also shared major corporate updates, including advancements in its cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs, as well as progress across its infectious disease vaccine portfolio.
CEO Commentary and Strategic Vision
“We were very pleased to share the initial findings of ARCT-032’s clinical activity with the cystic fibrosis community last month at the North American Cystic Fibrosis Conference (NACFC),” said Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics. “Conversations with patients, physicians, investigators, and global CF experts reinforced our Therapeutics commitment to move ARCT-032 further along the development pathway. We are now preparing to initiate a 12-week safety and preliminary efficacy study in the first half of 2026.”
Payne added, “In parallel, our team is also focused on achieving alignment with regulatory agencies regarding pivotal studies for ARCT-810, our investigational therapy for OTC deficiency, in both adults and pediatric populations. These programs continue to demonstrate strong scientific rationale, encouraging data, and potential to make a meaningful impact in the lives of patients suffering from rare and serious diseases.”
Clinical and Scientific Updates
Encouraging Findings for ARCT-032 in Cystic Fibrosis
Dr. Denis Hadjiliadis, Professor and Director of the Cystic Fibrosis Program at the Perelman School of Medicine, University of Pennsylvania, shared insights on the ongoing ARCT-032 study results. “The observed mucus plug reduction after 28 days of treatment with ARCT-032 in people with Class I cystic fibrosis is encouraging,” Dr. Hadjiliadis stated. “These findings suggest that ARCT-032 may directly target the thick mucus defect that lies at the core of cystic fibrosis pathology. More extended treatment could potentially yield greater reductions in mucus burden, improving lung function, alleviating structural lung damage, and ultimately reducing disease exacerbations. This could represent a meaningful step forward in altering the long-term clinical course of CF.”
Financial Leadership Commentary
Andy Sassine, Chief Financial Officer of Arcturus Therapeutics, commented on the company’s financial position and strategic adjustments. “The sudden changes in regulatory requirements by the FDA for COVID-19 vaccines have delayed the U.S. Biologics Therapeutics License Application (BLA) filing for KOSTAIVE® indefinitely. In light of this, we are taking proactive steps to reduce additional expenditures and extend our operational runway to support the advancement of our CF and OTC deficiency programs,” said Sassine.
“Despite the delay in the U.S. market, we continue to anticipate strong support from our partner, CSL, to commercialize KOSTAIVE in Asia and Europe. We expect continued momentum in those regions and plan to provide further updates during our year-end earnings call.”
Recent Corporate and Development Highlights
ARCT-810 for OTC Deficiency
Arcturus continues to advance ARCT-810, its investigational therapy designed to address ornithine transcarbamylase deficiency, a rare inherited metabolic disorder. The Company remains on track to achieve regulatory alignment with agencies in the Therapeutics first half of 2026 regarding pivotal trial strategies for both adult and pediatric populations. This milestone will mark a significant step toward enabling late-stage clinical development and potential future regulatory submissions.
ARCT-032 in Cystic Fibrosis
In October 2025, Arcturus announced interim results from its ongoing Phase 2 clinical trial evaluating ARCT-032, an inhaled mRNA therapeutic designed for individuals with Class I cystic fibrosis mutations. Key findings include:
- Safety and Tolerability:
Daily administration of inhaled 10 mg doses of ARCT-032 over 28 days in six adult participants with Class I CF mutations was generally safe and well-tolerated, with no dose-limiting toxicities observed. - Efficacy and Imaging Results:
Advanced imaging analysis using FDA 510(k)-cleared artificial intelligence (AI) technology on high-resolution computed tomography (HRCT) lung scans demonstrated reductions in mucus burden in four of the six participants after treatment. - Dose Escalation and Next Steps:
The ongoing third cohort is Therapeutics enrolling up to six additional participants to assess the safety and tolerability of a higher 15 mg daily dose over 28 days, as well as to evaluate its impact on efficacy endpoints. - Upcoming Studies:
Based on promising safety and imaging data, Arcturus plans to initiate a 12-week safety and preliminary efficacy study involving up to 20 participants in the first half of 2026. This extended study is expected to further explore potential improvements in pulmonary function and mucus clearance.
KOSTAIVE® Commercial Updates
Meiji Seika Pharma, Arcturus’ regional partner, launched a two-dose vial formulation of KOSTAIVE updated for the JN.1 variant XEC in Japan. The product received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in August 2025 Therapeutics and was subsequently commercialized under Meiji’s leadership. The updated formulation demonstrates Arcturus’ commitment to rapidly adapting its sa-mRNA technology to emerging viral variants.
Peer-Reviewed Publication for ARCT-2303 COVID-19 Vaccine
In August 2025, Arcturus published results from its Phase 3 clinical trial evaluating ARCT-2303, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, in eClinicalMedicine. The study investigated the immunogenicity and safety of ARCT-2303 both as a standalone vaccine and in co-administration with a licensed seasonal influenza vaccine.
Results demonstrated that:
- ARCT-2303 elicited a robust immune response against the SARS-CoV-2 variant targeted by the vaccine.
- Co-administration with influenza vaccines had no negative impact on the immunogenicity or safety of either vaccine.
- The data validated the versatility and scalability of Arcturus’ proprietary STARR® sa-mRNA platform, which enables efficient and durable immune responses.
Advancements in Pandemic Influenza Vaccine (ARCT-2304)
The Company also shared findings from its Phase 1 study (NCT06602531) of ARCT-2304, an sa-mRNA vaccine candidate designed to combat Therapeutics Pandemic Influenza A Virus (H5N1). Conducted in 132 younger adults (ages 18–59) and 80 older adults (ages 60–80), the study aimed to evaluate safety, tolerability, and immune response across three dose levels (1.5 µg, 5 µg, and 12 µg).
Key takeaways included:
- Strong Immune Activation:
ARCT-2304 induced a robust humoral immune response after a single dose across all dose levels, with a second dose further enhancing antibody responses. - Comparable to Licensed Vaccines:
Immune responses at the tested doses were similar to or greater than those observed with the MF59-adjuvanted pandemic influenza vaccine. - Excellent Safety Profile:
The vaccine was well-tolerated in both age groups, with no significant safety concerns identified.
The Phase 1 results strongly support the continued development of ARCT-2304 and further validate Arcturus’ sa-mRNA vaccine platform as a potential cornerstone in global pandemic preparedness. The program was funded in part by the U.S. Therapeutics Therapeutics Department of Health and Human Services (HHS), specifically the Administration for Strategic Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50122C00007. Arcturus emphasized that federal funding does not constitute endorsement of the study results, product, or company.
Financial Results for the Third Quarter Ended September 30, 2025
Revenues
Arcturus generates revenue through license fees, technology transfer payments, consulting, and collaborative research and development arrangements with pharmaceutical and biotechnology partners.
For the three months ended September 30, 2025, total revenue was $17.2 million, compared to $41.7 million during the same period in 2024 — a decrease of $24.5 million. For the nine months ended September 30, 2025, revenue totaled $74.8 million, representing a $54.7 million decrease from the prior-year period.
The decline was primarily attributed to lower revenue recognition from the CSL collaboration, reflecting reduced supply agreement activity and a lower amortization rate of upfront payments as KOSTAIVE® moved closer to full-scale commercialization.
Operating Expenses
Total operating expenses for the third quarter of 2025 were $33.7 million, down significantly from $52.4 million in the same quarter of 2024. For Therapeutics Therapeutics the nine months ended September 30, 2025, total operating expenses were $119.8 million, compared with $191.8 million in the corresponding period of 2024. The reduction primarily reflects focused cost management and completion of several large-scale manufacturing activities associated with earlier vaccine programs.
Research and Development (R&D) Expenses
R&D expenses comprise external manufacturing costs, in vivo research, clinical trials, regulatory consulting, and personnel costs.
For Q3 2025, R&D expenses totaled $23.3 million, compared with $39.1 million in Q3 2024 — a substantial reduction. For the nine months ended September 30, 2025, R&D expenses were $87.7 million, down from $151.4 million a year earlier.
This decrease was driven primarily by lower manufacturing and clinical costs related to the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF programs as these transitioned from intensive development toward commercial readiness. Decreases in payroll and benefits, Therapeutics including reduced stock-based compensation, also contributed to lower expenditures. However, the Company noted partially offsetting increases tied to Phase 2 clinical trial costs for the LUNAR-CF program.
General and Administrative (G&A) Expenses
G&A expenses for the third quarter of 2025 were $10.4 million, compared with $13.3 million for the same period in 2024. For the nine months ended September 30, 2025, G&A expenses totaled $32.1 million, down from $40.4 million last year.
These reductions reflect continued efforts to streamline operations, including lower share-based compensation, payroll savings, and reduced professional service fees. The Company anticipates G&A expenses will continue to decline modestly over the next 12 months as part of its disciplined cost-control strategy.
Looking ahead to 2026, Arcturus plans to maintain a strategic focus on advancing its CF (ARCT-032) and OTC deficiency (ARCT-810) programs toward pivotal studies. The Company also intends to strengthen collaborations and seek additional funding opportunities to accelerate late-stage clinical trials and broaden global access to its self-amplifying mRNA technology.
CEO Joseph Payne concluded, “We remain deeply committed to our mission — delivering transformative mRNA medicines to patients in need. Our progress in cystic fibrosis, OTC deficiency, and next-generation vaccine programs underscores the versatility and promise of our STARR® platform. As we move into 2026, Arcturus is well-positioned scientifically and financially to continue making meaningful strides in rare disease and infectious disease therapeutics.”
About Arcturus Therapeutics
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global leader in the development of innovative messenger RNA (mRNA) medicines and vaccines. Utilizing its proprietary LUNAR® delivery system and STARR® self-amplifying mRNA technology, Arcturus is advancing a diverse pipeline addressing rare genetic diseases, respiratory disorders, and infectious diseases. The Company’s mission is to pioneer new modalities of treatment that are safe, scalable, and capable of transforming the standard of care across multiple therapeutic areas.
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