Arcturus Therapeutics Holdings Inc. Q4 FY2025 earnings call

Update on ARCT 032 phase two trial progressing with higher dose testing; ARCT 810 advancing toward pivotal development with type C regulatory meetings in first half of 2026; CoStave vaccine granted approval by UK MHRA; ARCT 2304 phase one study showed durable immune response; Financial position overview including revenue, expenses, and cash runway.

Annual and quarterly revenue decreased $70.3 million and $15.6 million respectively. Annual and quarterly R&D expenses decreased by $83.0 million and $19.3 million respectively. Annual G&A expenses decreased by $6.7 million, while quarterly G&A expenses increased by $1.6 million. Cash, cash equivalents and restricted cash were $232.8 million as of Dec 31, 2025, with cash runway extended into Q2 2028.

Plan to initiate dosing for ARCT 032 Phase 2 12-week study in first half of 2026; Type C regulatory meetings for ARCT 810 in first half of 2026 to clarify clinical development strategy; Expect general and administrative expenses to continue decreasing over next 12 months.

Ongoing lawsuit against AbbVie and Capstan Therapeutics filed on September 23rd, 2025.

Q: Yasmeen Rahimi asks about optimizations in 12-week Phase II study and working with CF Foundation; A: Alan explains differences in study design including stable baseline, LCI, 12-week period, and quality of life measures, and mentions close collaboration with CF Foundation.

Q: Pete Stavropoulos asks about LCI test, OTC program biomarker reception; A: Alan explains LCI's sensitivity and reproducibility, and says they're actively engaged in Type C meetings for OTC program.

Q: Evan Wang asks about dosing in CF program and enrollment split; A: Joe says they're initiating fourth cohort at 10 mg with early efficacy at 10 mg, and Alan mentions expanding enrollment in other countries for higher preponderance of null CF mutants.

Q: Lily Songo asks about dosing in CF program and OTC program regulatory path; A: Joe says they have flexibility to increase dosing, and Alan says OTC program likely has bifurcated regulatory path for pediatric and adult populations.

Q: Yanan Zhu asks about stable baseline in CF program and OTC program regulatory alignment; A: Alan explains importance of stable baseline in CF study, and says they're seeking clarity in Type C meetings for OTC program.

Q: Miles Minter asks about dose selection in CF program; A: Joe says 10 mg showed early signs, and they have flexibility to increase dose if needed.

Q: Adam Walsh asks about CF study exposure time and OTC program clinical data; A: Joe explains longer exposure time in 12-week study, and says OTC program data will be provided after Type C meetings.

Q: Whitney Ejem asks about efficacy data in CF program and dosing optionality; A: Joe says they're focused on fourth cohort, and they have flexibility to dose up.

Q: Juwan Kim asks about LCI data in CF program and FDA review; A: Alan says LCI was assessed in early studies, and they'll align with CF Foundation's natural history study.

Q: Tom Schrader asks about mucus plug data in CF program and vaccine safety; A: Joe says some subjects showed reduction in mucus plugs, and vaccine safety is similar to other technologies.

Q: Yale Jen asks about stable baseline screening in CF program and OTC program trial plan; A: Alan says they're looking for stable baseline, and OTC program trial plan will be clarified after Type C meetings.

Q: Last question about CSL and CoastAid; A: Refers to CSL's public statements.