Arcturus Therapeutics (ARCT) Q2 2024 earnings summary

Executive summary

• Kostaive®, the self-amplifying mRNA COVID-19 vaccine, is on track for commercial launch in Japan in Q4 2024, with regulatory milestones progressing and EMA review ongoing; it received approval in Japan in November 2023, marking the world's first sa-mRNA product approval.

• Pivotal phase III data for Kostaive® showed strong efficacy and safety, with 100% efficacy against severe COVID-19 in healthy adults and over 90% in at-risk populations; data published in Nature Communications.

• The pipeline includes bivalent and variant-specific COVID-19 vaccines, a quadrivalent flu vaccine, an H5N1 pandemic flu candidate, and programs for cystic fibrosis (ARCT-032) and OTC deficiency (ARCT-810), both advancing to phase II with encouraging safety data.

• Strategic partnerships with CSL, Meiji, and Ultragenyx support a robust pipeline and global commercialization, with significant revenue and milestone payments achieved.

• Appointment of Dr. Moncef Slaoui as independent director to support innovation and commercialization.

Financial highlights

• Q2 2024 revenue was $49.9 million, up $39.4 million year-over-year, mainly due to CSL agreement milestones and BARDA pandemic flu program progress.

• Operating expenses for Q2 2024 were $71 million, up from $65.9 million in Q2 2023, driven by higher R&D and manufacturing costs.

• Net loss for Q2 2024 was $17.2 million ($0.64 per diluted share), a significant improvement from $52.6 million ($1.98 per share) in Q2 2023.

• Cash, cash equivalents, and restricted cash totaled $317.2 million as of June 30, 2024.

• Achieved $437.1 million in upfront and milestone payments from CSL as of June 30, 2024.

Outlook and guidance

• Cash runway expected to extend through Q1 2027, supporting ongoing vaccine and therapeutic development.

• Anticipated commercial launch of Kostaive® in Japan in Q4 2024, with EMA decision pending and potential for significant milestone and revenue recognition.

• Interim Phase 2 data for ARCT-810 expected in H2 2024; Phase 2 initiation for ARCT-032 in cystic fibrosis anticipated in H2 2024.

• Future milestone payments expected from CSL for COVID, flu, and additional vaccine programs.

• Phase 1 H5N1 pandemic flu study to begin in Q4, funded by BARDA.