Arcturus Therapeutics (ARCT) Q2 2024 earnings summary

Executive summary

• Kostaive®, the self-amplifying mRNA COVID-19 vaccine, received approval in Japan in November 2023 and is on track for commercial launch in Q4, with EMA review ongoing and manufacturing milestones progressing as planned.

• 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; results published in Nature Communications.

• The pipeline includes bivalent and variant-specific COVID-19 vaccines, a quadrivalent flu vaccine, and mRNA therapeutics for cystic fibrosis (ARCT-032) and OTC deficiency (ARCT-810), with multiple clinical trials underway.

• IND submitted for ARCT-032 phase II; ARCT-810 phase II enrollment completed in Europe and expanded in the U.S. to include younger, more severe patients; interim data expected in H2 2024.

• Dr. Moncef Slaoui joined the board, bringing significant vaccine and pharma expertise.

Financial highlights

• Q2 2024 revenue was $49.9 million, up from $10.5 million in Q2 2023, 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, with a projected cash runway through Q1 2027.

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

Outlook and guidance

• Kostaive® commercial launch in Japan expected in Q4 2024, with potential for increased orders in the next fiscal year if initial sales are successful; EMA decision pending.

• Regulatory filings for variant and bivalent vaccines planned globally; phase II data for ARCT-032 and interim data for ARCT-810 expected later in 2024.

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

• Cash runway expected to support operations through Q1 2027.