Arcturus Therapeutics Holdings Inc. Q1 FY2025 earnings call

• Joe Payne provided updates on the mRNA therapeutics pipeline, including ARCT-032 (CF Phase 2 study ongoing, expects Phase 2 interim data mid-2025) and ARCT-810 (Phase 2 OTC study ongoing, expects Phase 2 interim data Q2 2025 or this quarter). - Discussed partnered COVID-19 vaccine program, EU approval of KOSTAIVE, anticipates MAA filing in UK Q2 2025 and US BLA filing Q3 2025. - Andy Sassine reported financial results, extended cash runway until Q1 2028 by focusing resources on CF and OTC programs, noted revenue decrease due to KOSTAIVE commercialization, R&D and G&A expense decreases, and strong financial position with cash runway to achieve milestones.

Over the three months ended March 31, 2025, revenues were $29.4 million compared to $38 million in the same period of 2024. Research and development expenses were $34.9 million for the three months ended March 31, 2025, compared to $53.6 million in a comparable period last year. General and administrative expenses were $11.3 million for the three months ended 2025, compared to $14.9 million in a comparable period last year. For the three months ended March 31, 2025, Arcturus reported a net loss of approximately $14.1 million or $0.52 per diluted share. Cash and cash equivalents and restricted cash were $273.8 million as of March 31, 2025, down from $293.9 million on December 31, 2024.

• Cash runway extended to Q1 2028 due to resource reallocation to CF and OTC programs. - Anticipates MAA filing for KOSTAIVE in UK in Q2 2025. - Anticipates US BLA filing for KOSTAIVE in Q3 2025. - General and administrative expenses expected to decrease over next 12 months due to lower share-based compensation and COVID program transition expenses.

• Uncertainties related to regulatory processes for therapeutic programs. - Market conditions impacting resource allocation and financial performance. - Risks associated with forward-looking statements not materializing as expected.

Q: Could you provide more color on changes to extend cash runway and potential incoming cash flows?

A: It was a prudent decision to focus on CF and OTC programs, including cost reductions like early R&D program elimination and facility consolidation; guidance originally conservative.

Q: How to think about milestones related to UK and US KOSTAIVE approval?

A: No milestones associated with approval; milestone on first US commercial sales not included in guidance as not anticipating commercial sales until 2028.

Q: About CF interim readout, size of data set, bar for success, and patient population?

A: Interim data from two cohorts expected to be 6-9 subjects; bar includes safety/tolerability and FEV improvement of 3%; half Class 1 and half non-Class 1, all non-modulator responders.

Q: Difference of ARCT-032 vs competitor mRNA programs?

A: Differentiated by LUNAR lipid nanoparticle delivery technology and mRNA purification IP; Phase 2 study has 12 subjects, data from two dose levels to be shared midyear.

Q: Accelerated approval pathway for ARCT-032 and glutamine biomarker in OTC?

A: If Phase 2 data excellent, would discuss with regulators for acceleration; in OTC, glutamine is biomarker as elevated in urea cycle disorders, aim to restore to normal levels.