Q3 2025 Arcturus Therapeutics Holdings Inc Earnings Call Transcript
Key Points
- Arcturus Therapeutics Holdings Inc (ARCT) reported positive interim Phase 2 data for its ARCT-032 program, showing reductions in mucus burden in cystic fibrosis patients.
- The ARCT-810 program for ornithine transcarbamylase deficiency has shown positive interim Phase 2 data, with plans for regulatory meetings in 2026 to discuss pivotal trial strategies.
- The company's COVID-19 vaccine program, KOSTAIVE, has been launched in Japan with approval for a two-dose vial presentation.
- ARCT-2304, a next-gen vaccine candidate for pandemic A/H5N1 influenza virus, showed promising immune response data in Phase 1 trials.
- Arcturus Therapeutics Holdings Inc (ARCT) has a strong financial position with a cash runway extended into 2028, allowing for continued development of its therapeutic programs.
- The KOSTAIVE BLA filing has been delayed indefinitely due to regulatory changes by the FDA and uncertain commercial visibility in the United States.
- Revenues for the third quarter of 2025 decreased significantly compared to the same period in 2024, primarily due to reduced revenues from the CSL collaboration.
- Total operating expenses decreased, but the company still reported a net loss of approximately $13.5 million for the third quarter of 2025.
- The company faces challenges in establishing CT imaging as a surrogate endpoint for cystic fibrosis trials, as it is not yet considered a primary endpoint by the FDA.
- Enrollment pace for the cystic fibrosis program has been slow, with plans to expand globally to accelerate recruitment for future studies.
Good afternoon, everyone. Welcome to the Arcturus Therapeutics third-quarter 2025 earnings call. (Operator Instructions) Also, today's call is being recorded, (Operator Instructions)
Now, at this time, I'd like to turn things over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead, ma'am.
Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics' quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO; and Andy Sassine, our CFO. Dr. Pad Chivukula, CSO and COO, will join them for the Q&A session.
Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements
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