Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) is a clinical-stage biopharmaceutical company that discovers and develops mRNA medicines using its proprietary LUNAR lipid-mediated delivery platform. Revenue comes from collaboration and licensing agreements with pharmaceutical partners, recognized on a cost-incurred basis against defined performance obligations, rather than from commercial product sales. The company's pipeline includes ARCT-032 for cystic fibrosis (CF), which completed Phase 2 multiple ascending dose dosing as of October 2025, a COVID-19 program that transitioned to commercial phase as of FY2025, and LUNAR-FLU partnered with CSL Seqirus. The LUNAR delivery system relies on a proprietary library of more than 300 ATX lipid nanoparticle formulations developed across seven generations. Research and development expenses were $112.2 million for the year ended December 31, 2025, down from $195.2 million for the year ended December 31, 2024. The company carries an accumulated deficit and has not reached profitability, funding operations through equity issuances and partner payments.
LUNAR lipid nanoparticle delivery platform using proprietary ATX lipids (300+ compounds across seven generations). Clinical programs: ARCT-032 (CF, Phase 2 as of October 2025, Orphan Drug Designation); LUNAR-COVID (transitioned to commercial phase as of FY2025); LUNAR-FLU (partnered with CSL Seqirus, early-stage/Phase 1); LUNAR-OTC (clinical stage, reduced activity FY2025).
Collaboration and licensing revenue recognized under cost-to-cost percentage-of-completion method against partner-funded performance obligations. No commercial product revenue reported as of FY2025 outside the LUNAR-COVID transition to commercial phase.
Pharmaceutical and biotech partners (including CSL Seqirus for LUNAR-FLU). End markets include infectious disease vaccines and rare genetic disease (cystic fibrosis with Class I CFTR mutations, urea cycle disorder via LUNAR-OTC). Patient population for ARCT-032 targets CF adults who do not benefit from CFTR modulators.
Filing does not specify geographic revenue breakdown. Clinical studies reference enrollment of CF adults without specifying country distribution.
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