Arcturus Therapeutics Holdings Inc Dossier
Qualitative Analysis
Business overview
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a late-stage clinical messenger RNA (mRNA) medicines and vaccines company founded in 2013 and headquartered in San Diego, California. The company is focused on developing liver and respiratory rare disease therapeutics alongside infectious disease vaccines. Its proprietary enabling technologies include the LUNAR® lipid-mediated delivery system, STARR® self-amplifying mRNA (sa-mRNA) technology, and in-house mRNA drug substance and drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the world's first approved self-amplifying mRNA COVID-19 vaccine. The company maintains a global collaboration with CSL Seqirus, a pandemic flu partnership with the U.S. BARDA, and a manufacturing joint venture in Japan called ARCALIS. Its internal therapeutic pipeline is highlighted by ARCT-032 (LUNAR-CF) for cystic fibrosis and ARCT-810 (LUNAR-OTC) for ornithine transcarbamylase deficiency, both of which are in Phase 2 clinical development.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Arcturus is strategically refocusing its resources and clinical development efforts away from infectious disease vaccine development and toward its high-value rare disease clinical pipeline, specifically ARCT-032 for cystic fibrosis and ARCT-810 for ornithine transcarbamylase (OTC) deficiency.
Expected impact: Extends the company's cash runway beyond Q2 2028 and concentrates capital on proprietary therapeutic assets with high unmet medical needs.
Advancing ARCT-032, an inhaled mRNA therapeutic candidate for cystic fibrosis, into a 12-week open-label Phase 2 clinical study to monitor safety, tolerability, and early clinical benefits (such as lung function improvements and mucus reduction).
Expected impact: Demonstrate the safety and efficacy of repeat-dose inhaled mRNA therapeutics, establishing a clinical proof of concept.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Global collaboration for the development and commercialization of self-amplifying mRNA vaccines, including KOSTAIVE for COVID-19 and pandemic/seasonal influenza candidates.
Terms: Included a $200 million upfront payment, with eligibility for over $1.3 billion in development milestones and $3.0 billion in sales milestones, plus net profit sharing. Note: Currently subject to arbitration over EU milestone payments.
Supports the development of ARCT-2304, a next-generation self-amplifying mRNA pandemic influenza vaccine candidate.
Terms: Fully funded contract with $25.8 million in remaining funding available as of March 31, 2026.