Arcturus Therapeutics(US:ARCT)2024-05-09 01:04Financial Data and Key Metrics Changes - For Q1 2024, the company reported revenues of $38 million, an increase from $30.9 million in Q4 2023, driven by increased activities across all CSL programs, including Kostaive commercialization preparations [18] - Total operating expenses for Q1 2024 were $68.4 million, up from $49.1 million in Q4 2023, primarily due to increased R&D expenses [19] - The net loss for Q1 2024 was approximately $26.8 million, or $1 per diluted share, compared to a net loss of $11.7 million, or $0.44 per diluted share in Q4 2023 [20] - Cash, cash equivalents, and restricted cash were $345.3 million as of March 31, 2024, slightly down from $348.9 million on December 31, 2023 [20] Business Line Data and Key Metrics Changes - The Kostaive COVID-19 vaccine program is set to deliver 4 million doses to Japan in Q3 2024, with Meiji responsible for distribution [7][15] - The ARCT-2138 quadrivalent seasonal influenza program is progressing well, with 84 healthy young adults recruited for the Phase 1 study as of May 1, 2024 [10] - The ARCT-810 program for OTC deficiency has initiated a Phase 2 multiple ascending dose study in the UK and EU, following positive Phase 1 results [12] Market Data and Key Metrics Changes - The company filed a marketing authorization application for Kostaive with the European Medicines Agency, with an expected approval decision in Q3 2024 [10] - The Japanese government is subsidizing approximately 80% of the vaccine price, which is expected to be around $100 per dose [45] Company Strategy and Development Direction - The company is focused on commercializing Kostaive and expanding its global franchise, with a strategic emphasis on working with established CDMOs for manufacturing [16] - The company aims to become an asset-light and variable-cost operating entity, leveraging partnerships for manufacturing and distribution [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and resources to achieve near-term milestones for vaccine and therapeutic programs [21] - The anticipated delivery of Kostaive in Japan is expected to begin generating commercial sales in 2024 [21] Other Important Information - The company has engaged JPMorgan Investment Banking to help monetize its investment in ARCALIS, a joint venture in Japan [16] - The ARCALIS facility is expected to become a leading manufacturer of mRNA vaccines and therapeutics, with significant government funding received for its construction [17] Q&A Session Summary Question: Expectations for the number of OTC and CF patients for the July 1 update - Management indicated that the July 1 meeting will provide interim data for Phase 1b of the ARCT-032 program and some Phase 2 data for the OTC program, but it will be on a subset of patients [24] Question: Rationale for Meiji monetization of ARCALIS - Management stated that the decision to monetize ARCALIS was strategic, aiming to work with established CDMOs to support manufacturing efforts [26] Question: Expectations around Japan's order for Kostaive in 2025 - Management noted that ARCALIS is in the process of getting GMP batches approved for commercialization, which could lead to additional orders from Meiji [30] Question: Biomarkers for dose finding in the CF program - Management clarified that dosing has been guided by safety and tolerability measures, with no specific biomarker driving these decisions [47] Question: Pricing and government subsidies for Kostaive - Management confirmed that the local government will subsidize about 80% of the vaccine price, making it a strategic investment for public health [45]