Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has announced its first quarter 2024 financial results and provided corporate updates, highlighting progress in its vaccine and therapeutics pipeline. The company is advancing multiple mRNA programs, including Kostaive® for COVID-19, ARCT-032 for cystic fibrosis, and ARCT-810 for ornithine transcarbamylase (OTC) deficiency.
Kostaive Commercialization and Regulatory Milestones
Arcturus is on track for the commercial manufacture of Kostaive®, with the initial delivery of 4 million doses expected in Q3 2024. This milestone is supported by ongoing collaboration with CSL and Meiji Seika Pharma. The European Medicines Agency (EMA) is expected to provide an approval decision on the Marketing Authorization Application (MAA) for Kostaive® in Q3 2024.
Advancing mRNA Therapeutics for Rare Diseases
Significant clinical study data updates are anticipated on July 1st for ARCT-810 (LUNAR-OTC) and ARCT-032 (LUNAR-CF). ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis, is currently in a Phase 1b trial where each patient receives two inhaled administrations. ARCT-810, targeting OTC deficiency, has completed Phase 1 studies and is now in a Phase 2 multiple ascending dose study in adolescents and adults in the UK and EU. In the Phase 2 study, subjects are randomized to receive 6 doses of ARCT-810 or placebo every 14 days.
COVID-19 Vaccine Program
In March, Arcturus, along with partners CSL and Meiji, announced that ARCT-2301, its bivalent COVID-19 vaccine candidate, met the primary endpoint (non-inferiority) in a Phase 3 clinical study in Japan. The study involved 930 healthy adults and individuals with comorbidities who had previously received three to five doses of mRNA COVID-19 vaccines. The results showed that ARCT-2301 demonstrated non-inferiority and superiority criteria versus a licensed mRNA vaccine comparator.
Financial Overview
For the three months ended March 31, 2024, Arcturus reported revenues of $38.0 million, compared to $80.3 million for the same period in 2023. The decrease was primarily due to the timing of revenue recognition from the CSL agreement. Research and development expenses were $53.6 million, driven by the CSL and BARDA programs, as well as internal OTC and Cystic Fibrosis programs. The company reported a net loss of $26.8 million, or ($1.00) per diluted share. As of March 31, 2024, cash, cash equivalents, and restricted cash totaled $345.3 million, providing a cash runway extending to the first quarter of fiscal year 2027.
Pipeline Expansion
Arcturus is also progressing ARCT-2138 (LUNAR-FLU), a quadrivalent seasonal influenza vaccine, through its partner CSL. A Phase 1 dose-finding and immunogenicity study is ongoing, with 84 healthy young adults recruited as of May 1, 2024. Recruitment of older adults is also underway. Additionally, Arcturus has engaged JP Morgan to monetize its investment in ARCALIS JV in Japan.
