Arcturus Therapeutics Q4 2024: Discrepancies in Cystic Fibrosis Trials and Enrollment Expectations

These are the key contradictions discussed in Arcturus Therapeutics' latest 2024Q4 earnings call, specifically including: CF Study Enrollment Progress and ARCT-032's Clinical Trial Plans, CF Trial Enrollment and Feasibility, CF Program Enrollment and Biomarker Expectations, and OTC Program Timeline and Targets:



Vaccine Program Milestones:
- Arcturus Therapeutics reported receiving European Commission approval for KOSTAIVE, the world's first approved self-amplifying mRNA COVID-19 vaccine.
- This approval is based on positive clinical data demonstrating KOSTAIVE's efficacy and safety against COVID-19 and higher immunogenicity results compared to conventional mRNA vaccines.
- The approval is valid in all 27 European Union member states and 3 additional European economic area countries.

Financial Performance and Revenue Trends:
- For the year ended December 31, 2024, Arcturus reported revenues of $152.3 million, a decrease of $14.5 million from the previous year.
- The decrease was primarily due to lower milestone achievements from the CSL agreement, offset by increased BARDA revenue due to pandemic flu program progress.
- For the quarter ended December 31, 2024, revenues were $22.8 million, a decrease of $8.1 million from the previous year, attributed to lower milestones from the CSL agreement.

Research and Development Expenses:
- Total research and development expenses for the year ended December 31, 2024, were $195.2 million, an increase from $192.1 million the previous year.
- The increase was primarily driven by higher clinical trial costs associated with OTC and CF programs and the COVID-19 and LUNAR-FLU programs in collaboration with CSL.

Interim Clinical Trial Data Expectations:
- Arcturus anticipates providing interim data from their CF participants who completed dosing in the ARCT-032 Phase II study by the end of Q2 2025.
- This data will likely include multiple subjects at multiple dose levels, with an FEV lung function improvement of 3% considered significant for advancing the program further.