Arcturus Therapeutics Holdings Inc. Q1 FY2026 earnings call

• CF program: 12-week phase two study for Class 1 CF began enrollment in Q1, ARCT032 shows good safety and tolerability, study monitors lung function measures. • Liver program: ARCT810 met with FDA for pediatric clinical development strategy, received clear regulatory direction, collecting additional data for end of phase two meeting. • Partner Meiji manufacturing CoStave for COVID vaccine. • Expanded executive leadership team with Dennis Mulroy as CFO and Dr. Alan Cohen as CMO.

Cash, cash equivalents, and restricted cash totaled $213.4 million on March 31, 2026, down from $232.8 million on December 31, 2025. Quarterly revenue decreased by $27.3 million due to reductions from CSL collaboration. R&D expenses decreased by $13.4 million mainly from lower manufacturing and clinical trial costs for lunar COVID, offset by higher costs for lunar OTC. General and administrative expenses decreased by $1.8 million due to reduced share-based compensation and headcount.

• CF program: Looking to collect clinical data during 12-week open-label Phase II study. • Liver program: Aim to align with FDA at end of phase two meeting in second half of 2026. • Cash runway extends beyond second quarter of 2028, remains in strong financial position to achieve near-term milestones.

Q: Regarding OTC deficiency, specific FDA feedback on glutamine and ureogenesis assay, and path forward in adult setting; on CF, patient enrollment progress and interim potential.

A: Alan addressed FDA feedback on biomarkers, Joe said CF enrollment cadence to be determined later.

Q: On OTC program, type of exploratory data needed and if pediatric study initiation required.

A: Alan said completing scheduled study data set and preparing for end of phase two meeting.

Q: On CF study without placebo, variability of FEV1 and LCI, and interpretation.

A: Alan talked about reproducibility of spirometry in CF patients and upcoming REACH study data.

Q: On competitor discontinuing inhaled CFTR mRNA trial, manifestations seen and enrollment discussions.

A: Joe said differences in technology, no seen manifestations, expanding enrollment outside US.

Q: On CF study intermediate decisions, REACH data, and combining with modulators.

A: Alan and Joe talked about study monitoring, REACH data relevance, and potential combination with modulators.

Q: On adult Type C meeting timing, pediatric vs adult segmentation for OTC, and interim disclosure for CF.

A: Joe said second Type C meeting near term, Alan talked about pediatric segmentation, Joe said later this year for CF interim disclosure.

Q: On preclinical data of lunar CF, mucus penetration, endosomal escape, cells reached.

A: Pat talked about preclinical data in various models.

Q: On OTC program resource allocation, pediatric vs adult paths, and EOP2 meeting outcome.

A: Alan talked about prioritization to pediatric program and expectations for EOP2 meeting.

Q: On pediatric OTC program, stopgap vs disease-modifying.

A: Alan said hope to forestall liver transplantation.

Q: On OTC program enrollment and HRCT scans, etc.

A: Alan talked about enrollment and HRCT scan frequency