Arcturus Therapeutics: Earnings Call Highlights Progress and Challenges

Arcturus Therapeutics ((ARCT)) has held its Q1 earnings call. Read on for the main highlights of the call.

In the recent earnings call, Arcturus Therapeutics presented a balanced outlook, highlighting significant progress in its mRNA therapeutics pipeline. The company has strategically extended its cash runway and reduced expenses, although it faces financial challenges due to a decline in revenue and a net loss. A notable achievement was the EU approval of the KOSTAIVE vaccine, despite conservative expectations for U.S. milestones.

Pipeline Advancements

Arcturus Therapeutics is making strides in its mRNA therapeutics pipeline, particularly with ARCT-032 for cystic fibrosis and ARCT-810 for OTC deficiency. Both are in Phase 2 studies, which have shown no safety or tolerability issues, indicating promising potential for these treatments.

Strategic Focus and Financial Stability

The company has strategically concentrated its resources on mRNA therapeutics, which has allowed it to extend its cash runway until the first quarter of 2028. This decision comes in response to a challenging market environment, showcasing Arcturus’s commitment to maintaining financial stability.

EU Approval of KOSTAIVE Vaccine

Arcturus achieved a significant milestone with the EU approval of its self-amplifying mRNA COVID-19 vaccine, KOSTAIVE. This approval also led to an initial milestone payment from CSL, marking a critical step in the company’s vaccine development efforts.

FDA Fast Track Designation

The company’s sa-mRNA vaccine candidate for Pandemic Influenza A (H5N1), ARCT-2304, received FDA Fast Track designation. This designation could expedite the development and review process, potentially bringing the vaccine to market more quickly.

Reduction in Operating Expenses

Arcturus successfully reduced its operating expenses, with research and development costs decreasing by $18.7 million and general and administrative expenses by $3.6 million year-over-year. This reduction is part of the company’s strategy to focus on its core mRNA programs.

Revenue Decline

The company reported a revenue decline for the first quarter of 2025, with revenues dropping to $29.4 million from $38 million in the same period of 2024. This decrease was primarily due to lower development milestone revenues.

Net Loss

Arcturus reported a net loss of approximately $14.1 million for the first quarter of 2025. This financial challenge highlights the need for continued strategic focus and cost management.

Reduced Guidance on Upcoming Milestones

The company has adopted a conservative outlook, not expecting a milestone payment from U.S. KOSTAIVE approval until 2028. This reflects a cautious approach to future financial planning.

Forward-Looking Guidance

Arcturus Therapeutics provided forward-looking guidance, emphasizing its focus on the mRNA therapeutics pipeline. The company expects to complete enrollment for ARCT-032 by year-end, with interim data anticipated by mid-2025. For ARCT-810, interim Phase 2 data is expected in Q2 2025. Financially, the company aims to maintain its extended cash runway until Q1 2028, with anticipated filings for KOSTAIVE in the UK and US later in 2025.

In summary, Arcturus Therapeutics’ earnings call presented a balanced outlook, with significant advancements in its mRNA therapeutics pipeline and strategic focus on financial stability. While the company faces challenges with revenue decline and net loss, the EU approval of the KOSTAIVE vaccine and strategic cost reductions are positive steps forward. The company’s forward-looking guidance highlights its commitment to advancing its pipeline and maintaining financial health.