Arcturus Therapeutics

What Arcturus Therapeutics does

Arcturus Therapeutics Holdings Inc. is a commercial-stage mRNA medicines company headquartered in San Diego, California, founded in 2013 (originally incorporated in Israel, redomiciled to Delaware in 2019) and publicly traded on NASDAQ under ticker ARCT. The company develops messenger RNA medicines and vaccines enabled by two proprietary technology platforms: LUNAR, a lipid-mediated delivery system that targets mRNA payloads to specific tissues including liver hepatocytes (via IV) and lung epithelium (via inhaled aerosol); and STARR, a self-amplifying mRNA (sa-mRNA) construct that enables cells to produce multiple copies of the encoded protein from a single mRNA molecule, allowing lower doses and longer duration of effect than conventional mRNA. The company's commercial product KOSTAIVE is the world's first approved self-amplifying mRNA COVID-19 vaccine, with marketing authorizations in the European Commission, the UK MHRA, and Japan. Its clinical pipeline includes ARCT-032 (inhaled mRNA therapy for cystic fibrosis, particularly Class I patients), ARCT-810 (IV mRNA therapy for Ornithine Transcarbamylase deficiency), ARCT-2138 (sa-mRNA seasonal influenza vaccine), and ARCT-2304 (sa-mRNA H5N1 pandemic influenza vaccine). The company maintains an intellectual property estate exceeding 500 patents and applications across the U.S., Europe, Japan, and China.

Arcturus generates revenue through three streams: collaboration revenue (upfront, milestone, and ongoing R&D funding from pharmaceutical partners, historically concentrated with CSL Seqirus); grant revenue (non-dilutive funding from government and disease foundations); and product sales (commercialized via distribution partners including CSL Seqirus globally and Meiji Seika Pharma in Japan). The CSL Seqirus collaboration — originally valued at approximately $4.3 billion and covering KOSTAIVE plus seasonal flu, pandemic flu, RSV, and EBV programs — was terminated by settlement in August 2026, with Arcturus regaining global rights and receiving a $12M cash payment plus release of $16M in R&D credit liabilities. The company is now repositioning its commercialization infrastructure and in July 2026 entered a strategic collaboration with Thermo Fisher Scientific for Phase 3 development and potential commercialization of ARCT-032, providing integrated manufacturing (PPD), clinical research, and commercial readiness with exclusive commercial manufacturing rights on approval. Manufacturing capacity is supplemented by ARCALIS, a Japanese joint venture building a GMP facility in Minamisoma City with $115M in grants from the Japanese government.

The company's customer base is primarily enterprise/government: pharmaceutical collaborators (CSL Seqirus, Meiji Seika Pharma), U.S. BARDA (a $63M award for pandemic influenza), the Cystic Fibrosis Foundation (cumulative ~$25M commitment), and contract manufacturing/development partners (Thermo Fisher). Pricing is not publicly disclosed and is determined through partnership deal economics rather than standard list pricing. The company had 101-250 employees as of the most recent reporting and operates additional San Diego facilities totaling over 24,700 square feet. Reported revenue has declined sharply from $205.7M (FY2022) to $138.4M (FY2024) to $67.2M (FY2025), with Q2 2026 quarterly revenue of just $2.96M following the wind-down of CSL collaboration economics; cash and equivalents stood at $232.8M as of March 2026 with management-guided runway extending into Q2 2028.

Name

Arcturus Therapeutics

Legal name

Arcturus Therapeutics Holdings Inc.

Website

http://arcturusrx.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

101–250 employees

Short description

Arcturus Therapeutics is a commercial-stage mRNA medicines company developing self-amplifying mRNA vaccines and therapeutics for rare diseases (cystic fibrosis, OTC deficiency) and infectious diseases, using proprietary LUNAR lipid delivery and STARR sa-mRNA platforms.

Ownership category

akta.pro rank

Product category

mRNA Therapeutics and Vaccines

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

mRNA Therapeutics (vaccines, protein replacement, immuno-oncology) (HLAAADAA)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Gene Therapy for Rare/Monogenic Diseases (HLAAACAE)

Keywords

• MRNA therapeutics
• Self-amplifying vaccines
• Lipid nanoparticle delivery
• Rare disease medicines
• Pandemic influenza vaccines

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Collaboration Revenue: Revenue from research and development collaborations with pharmaceutical partners including upfront payments, milestone payments, and ongoing collaborative research funding. Major partner CSL Seqirus contributed through the KOSTAIVE partnership, though collaboration revenue declined significantly in 2025-2026 as the partnership wound down.
2. Grant Revenue: Non-dilutive funding from government agencies for pandemic preparedness and vaccine development programs. Includes funding from BARDA (up to $63M for pandemic flu vaccine) and the Cystic Fibrosis Foundation (nearly $25M total commitment for CF program).
3. Product Sales: Revenue from commercialized products. KOSTAIVE (self-amplifying mRNA COVID-19 vaccine) received approvals in Europe, UK, and Japan. Commercialization through partners like CSL Seqirus globally and Meiji Seika Pharma in Japan.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Arcturus Therapeutics develops and commercializes mRNA-based medicines and vaccines for rare diseases and infectious diseases. Its portfolio includes the approved self-amplifying mRNA COVID-19 vaccine KOSTAIVE and clinical-stage therapies such as ARCT-032 for cystic fibrosis and ARCT-810 for Ornithine Transcarbamylase (OTC) deficiency, all enabled by proprietary LUNAR lipid delivery and STARR self-amplifying mRNA platforms. The company partners with global pharmaceutical companies (CSL Seqirus, Meiji Seika Pharma, Thermo Fisher Scientific) to commercialize its products and operates the ARCALIS manufacturing joint venture in Japan.

Product overview

Arcturus Therapeutics is a commercial mRNA medicines company that has developed a portfolio of RNA-based therapeutics and vaccines. The company's core offerings include KOSTAIVE, the world's first approved self-amplifying mRNA COVID-19 vaccine, and a pipeline of investigational mRNA therapies including ARCT-032 for cystic fibrosis and ARCT-810 for OTC deficiency. These products are enabled by two proprietary technology platforms: LUNAR lipid-mediated delivery (for targeted tissue delivery including lungs and liver) and STARR self-amplifying mRNA technology. Arcturus also operates ARCALIS, a Japanese manufacturing joint venture, and maintains global collaborations with CSL Seqirus for vaccine development.

Differentiator

Problem solved

Functional benefit

Brands

• KOSTAIVE: The world's first approved self-amplifying mRNA COVID-19 vaccine developed by Arcturus
• LUNAR
• STARR
• LunairCF
• LUNAR-OTC

Products and services

• KOSTAIVE KOSTAIVE is the world's first approved self-amplifying mRNA (sa-mRNA) COVID-19 vaccine. It uses Arcturus's STARR technology to enable the vaccine to self-replicate within cells, potentially requiring lower doses than traditional mRNA vaccines. Approved in Europe, Japan, UK, and other markets.
• ARCT-032 (LunairCF) ARCT-032 is an investigational inhaled mRNA therapy for cystic fibrosis that uses the LUNAR lipid-mediated delivery platform to deliver functional CFTR mRNA to lung cells. It has received Orphan Drug Designation from FDA and Orphan Medicinal Product Designation from EMA.
• ARCT-810 (LUNAR-OTC) ARCT-810 is an mRNA therapy for Ornithine Transcarbamylase (OTC) deficiency using LUNAR delivery to deliver OTC enzyme mRNA to liver cells. It has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from FDA and Orphan Medicinal Product Designation from EMA.
• ARCT-2138 ARCT-2138 is a self-amplifying mRNA seasonal influenza vaccine candidate encoding hemagglutinin and neuraminidase antigens from four WHO-recommended influenza strains. Phase 1 results demonstrated immunogenicity in both young and older adults.
• ARCT-2304 ARCT-2304 is a self-amplifying mRNA vaccine candidate for Pandemic Influenza A Virus H5N1. It received U.S. FDA Fast Track Designation and is supported by BARDA funding.
• ARCALIS Manufacturing Services ARCALIS is Arcturus's Japanese manufacturing joint venture focused on the manufacture of mRNA vaccines and therapeutics, supported by $115M in grants from the Japanese government to build a manufacturing facility in Minamisoma City.

Quantifiable outcome

• KOSTAIVE approved in Europe, UK, and Japan
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and regional.

• Thermo Fisher ScientificcoreImplementation/ SI/ Consulting Partner · 2 July 2026Strategic collaboration for Phase 3 development and potential commercialization of ARCT-032 for cystic fibrosis. Thermo Fisher provides integrated manufacturing, clinical research (PPD business), and commercial readiness services. Receives exclusive commercial manufacturing rights upon regulatory approval. Five-year Master Services Agreement with up to $40M clinical manufacturing and $40M CRO services.
• Meiji Seika PharmaregionalChannel Partner/ Reseller/ Distributor · 15 February 2025Filed NDA applications with Japan's PMDA for KOSTAIVE vaccine, including 2-dose lyophilized vaccine presentation and 2025-2026 season SARS-CoV-2 variant update.
• ARCALIS (Japanese Joint Venture)coreStrategic or Co-development Partner · 14 August 2023Manufacturing joint venture in Japan focused on manufacture of mRNA vaccines and therapeutics. Received $115M in grants from Japanese government to build GMP manufacturing facility in Minamisoma City.
• CSL SeqiruscoreStrategic or Co-development PartnerGlobal collaboration for innovative mRNA vaccines including KOSTAIVE (COVID-19), seasonal influenza, pandemic influenza, RSV, and EBV vaccine programs. Original deal valued at approximately $4.3 billion. Partnership terminated in August 2026 via settlement agreement; Arcturus regained global rights to KOSTAIVE and all associated vaccine programs. CSL paid $12M in cash and released $16M in R&D credit liabilities.

Scale indicators8 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Moderna: Moderna is a leading mRNA therapeutics and vaccines company with an approved COVID-19 vaccine (Spikevax) and a broad pipeline spanning infectious disease, oncology, and rare diseases. Directly competes with Arcturus across both mRNA platform technology and therapeutic/vaccine indications.
• BioNTech: BioNTech developed Comirnaty, the world's first approved mRNA COVID-19 vaccine (with Pfizer), and has expanded into oncology and infectious disease mRNA programs. A direct peer to Arcturus in self-amplifying and conventional mRNA vaccine/therapeutic platforms.
• CureVac: CureVac is a clinical-stage mRNA company developing prophylactic vaccines and molecular therapies using both conventional and optimized mRNA technology. Direct comparable in mRNA platform development, target indications (flu, COVID, oncology), and clinical stage.
• Translate Bio: Translate Bio (acquired by Sanofi in 2021) developed an mRNA platform for vaccines and protein-replacement therapeutics, including a CF program. Highly comparable to Arcturus in mRNA delivery technology and CF therapeutic focus.

Broad incumbents

• Pfizer: Pfizer commercializes Comirnaty (with BioNTech) and operates one of the largest vaccine and biopharmaceutical franchises globally. A broad incumbent whose mRNA efforts and existing respiratory/vaccine infrastructure directly overlap with Arcturus's KOSTAIVE and ARCT-2138 programs.
• Sanofi: Sanofi is a global vaccine leader (Fluzone, Beyfortus) and acquired Translate Bio to build an mRNA platform. Competes with Arcturus in seasonal/pandemic influenza and broader respiratory vaccine markets, and represents a potential strategic acquirer.
• CSL Limited: CSL (parent of CSL Seqirus) is a global vaccine and plasma-derived therapeutics leader and was Arcturus's anchor commercial partner before the August 2026 termination. Remains a relevant comparable for influenza/COVID vaccine commercialization dynamics and pandemic preparedness contracts.
• GSK: GSK is a global vaccine leader with established influenza, RSV, and pandemic preparedness franchises. A broad incumbent competing with Arcturus for government pandemic contracts and seasonal flu market share.

Emerging players

• Strand Therapeutics: Strand Therapeutics is an early-stage biotech developing self-amplifying mRNA therapeutics for oncology and other indications. Comparable emerging player focused on sa-mRNA platform technology similar to Arcturus's STARR.
• Ethris: Ethris is a clinical-stage company developing stabilized mRNA therapeutics delivered via inhaled formulations for respiratory diseases including cystic fibrosis. A direct emerging competitor in LUNAR-equivalent delivery and CF mRNA therapeutics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/arcturusrx
• YouTubeyoutube.com/channel/UCkdIWUjoFNm-IXHJLp7vVUg
• LinkedInlinkedin.com/company/arcturus-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A3 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Arcturus Therapeutics