Arcturus Announces Launch of 12-Week Cystic Fibrosis Study in 2026, Facing Cost Management and KOSTAIVE BLA Delays
Management Insights: CEO Joseph Payne reported positive interim Phase II data for ARCT-032, an mRNA therapeutic for cystic fibrosis, and ARCT-810 for OTC deficiency, while also noting the indefinite delay of the KOSTAIVE COVID-19 vaccine's US BLA filing due to regulatory changes.
Financial Performance: CFO Andrew Sassine highlighted a significant revenue decline for Q3 2025, with total revenues of $17.2 million, and a net loss of approximately $13.5 million, while emphasizing the company's strong financial position with a cash runway extended into 2028.
Future Outlook: The company plans to initiate a 12-week study for ARCT-032 in the first half of 2026 and is preparing for regulatory meetings regarding pivotal trials for both CF and OTC programs, focusing on safety and efficacy data.
Risks and Concerns: Management acknowledged challenges due to sudden FDA regulatory changes affecting KOSTAIVE, alongside the need for further regulatory alignment for both therapeutic programs, while maintaining a focus on cost control and resource allocation.
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Arcturus to Present mRNA Technologies at J.P. Morgan Healthcare Conference
- Leadership Presentation: Arcturus Therapeutics CEO Joseph Payne will present at the J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco, showcasing the company's latest advancements in mRNA therapeutics, which is expected to attract investor and industry attention.
- Technological Innovation: Arcturus developed KOSTAIVE®, the world's first approved self-amplifying mRNA COVID vaccine, demonstrating its leading position in vaccine development and potentially laying the groundwork for future market expansion.
- Global Collaboration: The company's global collaboration with CSL Seqirus and U.S. BARDA focuses on pandemic flu vaccine development, indicating Arcturus's strategic positioning in addressing public health crises, which may enhance its market competitiveness.
- Diverse Pipeline: Arcturus's pipeline includes RNA therapeutic candidates targeting cystic fibrosis and ornithine transcarbamylase deficiency, showcasing its potential in rare disease treatment, which could provide new revenue streams for the company.
Arcturus Announces Launch of 12-Week Cystic Fibrosis Study in 2026, Facing Cost Management and KOSTAIVE BLA Delays
Management Insights: CEO Joseph Payne reported positive interim Phase II data for ARCT-032, an mRNA therapeutic for cystic fibrosis, and ARCT-810 for OTC deficiency, while also noting the indefinite delay of the KOSTAIVE COVID-19 vaccine's US BLA filing due to regulatory changes.
Financial Performance: CFO Andrew Sassine highlighted a significant revenue decline for Q3 2025, with total revenues of $17.2 million, and a net loss of approximately $13.5 million, while emphasizing the company's strong financial position with a cash runway extended into 2028.
Future Outlook: The company plans to initiate a 12-week study for ARCT-032 in the first half of 2026 and is preparing for regulatory meetings regarding pivotal trials for both CF and OTC programs, focusing on safety and efficacy data.
Risks and Concerns: Management acknowledged challenges due to sudden FDA regulatory changes affecting KOSTAIVE, alongside the need for further regulatory alignment for both therapeutic programs, while maintaining a focus on cost control and resource allocation.
