ARCT

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.

Investigation Announcement: Edelson Lechtzin LLP is investigating Arcturus Therapeutics for potential violations of federal securities laws due to allegations of misleading business information provided to investors.

Stock Impact: Following the release of disappointing Phase 2 trial results for its inhaled mRNA therapy ARCT-032, Arcturus's stock plummeted by over 50%, closing at $11.54 per share.

Company Overview: Arcturus Therapeutics focuses on developing mRNA vaccines and therapies, highlighting its role in the biotechnology sector.

Legal Representation: Investors affected by the stock drop or with relevant non-public information are encouraged to contact Edelson Lechtzin LLP for potential legal assistance.