Arcturus Therapeutics ((ARCT)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Arcturus Therapeutics’ recent earnings call painted a picture of mixed sentiments, with notable advancements in clinical trials and strategic partnerships. However, these positives were overshadowed by significant financial challenges, including a decline in revenue and an increased net loss. The indefinite delay in the Costave BLA filing emerged as a major hurdle for the company’s commercial prospects in the US market.
ARCT032 Phase II Clinical Trial Progress
Interim data from the Phase II clinical trial of ARCT032 for cystic fibrosis indicated that the treatment was generally safe and well tolerated. A protocol pre-specified analysis using AI technology revealed reductions in mucus burden in four out of six participants in the second cohort, showcasing promising progress in the development of this therapeutic candidate.
ARCT810 Program Advancements
The ARCT810 program, aimed at treating ornithine transcarbamylase deficiency, reported positive interim Phase II data. The company plans to hold regulatory meetings in 2026 to discuss pivotal trial strategies, underscoring its commitment to advancing this therapeutic candidate.
Partnership with Meiji Seika Pharma
Arcturus announced the launch of the two-dose vial of Costave, updated for the JN1 variant XE in Japan. This marks the first distribution of this presentation in the country, highlighting the company’s strategic partnership with Meiji Seika Pharma.
Financial Position and Cost Reductions
Despite financial challenges, Arcturus reported a strong financial position with a cash runway extended into 2028. This is attributed to planned cost reductions and a strategic focus on key therapeutic programs, providing a buffer against current revenue declines.
Revenue Decline
The company experienced a significant revenue decline, with a decrease of $24.5 million and $54.7 million year-over-year for the three and nine months ended September 30, 2025, respectively. This decline was primarily due to reduced revenues from the CSL collaboration.
Indefinite Delay in Costave BLA Filing
A major setback for Arcturus is the indefinite delay in the BLA filing for Costave, caused by sudden regulatory changes by the FDA. This delay impacts the company’s commercial visibility and potential market expansion in the United States.
Increased Net Loss
Arcturus reported an increased net loss of approximately $13.5 million for the three months ended September 30, 2025, compared to $6.9 million in the same period in 2024. This increase in net loss reflects the financial challenges faced by the company.
Forward-Looking Guidance
Looking ahead, Arcturus provided guidance on several key areas. The ARCT032 program for cystic fibrosis is progressing, with plans to assess a 15 mg dose in a third cohort and start a twelve-week study in 2026. For the ARCT810 program, regulatory meetings are planned for 2026 to discuss pivotal trial strategies. The Costave COVID-19 vaccine program in Japan has seen updated approvals, but the BLA filing in the U.S. remains delayed indefinitely. Financially, the company aims to extend its cash runway into 2028 through planned cost reductions.
In summary, Arcturus Therapeutics’ earnings call highlighted a blend of clinical progress and strategic partnerships, tempered by financial hurdles and regulatory delays. While the company faces challenges, its focus on advancing therapeutic programs and strategic cost management provides a path forward.