Arcturus Therapeutics Holdings Inc (ARCT) Q1 2025 Earnings Call Highlights: Strategic Focus and ...
Revenue: $29.4 million for Q1 2025, down from $38 million in Q1 2024.
Research and Development Expenses: $34.9 million for Q1 2025, down from $53.6 million in Q1 2024.
General and Administrative Expenses: $11.3 million for Q1 2025, down from $14.9 million in Q1 2024.
Net Loss: Approximately $14.1 million or $0.52 per diluted share for Q1 2025.
Cash and Cash Equivalents: $273.8 million as of March 31, 2025, down from $293.9 million as of December 31, 2024.
Cash Runway: Extended to Q1 2028.
Warning! GuruFocus has detected 4 Warning Signs with ARCT.
Release Date: May 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) is advancing its mRNA therapeutics pipeline with significant progress in clinical trials for cystic fibrosis (ARCT-032) and ornithine transcarbamylase deficiency (ARCT-810).
The company received EU approval for its self-amplifying mRNA COVID-19 vaccine, KOSTAIVE, and an initial milestone payment from its global vaccine partner, CSL.
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) has extended its cash runway until the first quarter of 2028, allowing it to focus on its critical CF and OTC programs.
The company has received US FDA fast track designation for its SA mRNA vaccine candidate for pandemic influenza A (H5N1), ARCT-2304.
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) is in a strong financial position with cash and cash equivalents of $273.8 million as of March 31, 2025.
Revenues for the first quarter of 2025 decreased to $29.4 million from $38 million in the same period of 2024, primarily due to lower development milestone revenues.
Research and development expenses decreased to $34.9 million from $53.6 million in the comparable period last year, reflecting lower manufacturing costs but also indicating reduced activity in some areas.
The company reported a net loss of approximately $14.1 million for the first quarter of 2025, highlighting ongoing financial challenges.
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) has made the decision to focus its research and development expenditures exclusively on its CF and OTC programs, potentially limiting diversification.
There are no anticipated milestone payments from the UK or US filings for KOSTAIVE until 2028, which may impact short-term financial expectations.
Q: Could you provide more details on the changes made to extend the cash runway and potential incoming cash flows? A: Andrew Sassine, CFO, explained that the decision to focus on the two most critical programs, CF and OTC, involved cost reductions, including eliminating early development R&D programs and consolidating facilities. This strategic focus, along with conservative cash burn guidance, contributed to extending the cash runway to 2028.
Q: Regarding the KOSTAIVE vaccine, what are the potential milestones related to UK and US approvals? A: Joseph Payne, CEO, stated there are no milestones associated with UK or US approvals. However, there is a milestone for the first US revenues from KOSTAIVE, anticipated around 2028, assuming approval in 2026.
Q: What is the expected size and success criteria for the ARCT-032 interim readout? A: Joseph Payne, CEO, mentioned the interim data will likely involve 6 to 9 subjects from two cohorts. Success criteria include achieving reasonable safety and tolerability over 28 daily administrations and a 3% improvement in FEV (lung function), which would justify advancing the program.
Q: How does ARCT-032 differ from competitor mRNA programs for cystic fibrosis? A: Joseph Payne, CEO, highlighted that ARCT-032 uses Arcturus's proprietary LUNAR lipid nanoparticle delivery technology and highly purified mRNA, which may enhance safety and tolerability compared to competitors.
Q: Are there any plans for an accelerated approval pathway for ARCT-032? A: Joseph Payne, CEO, indicated that if the phase 2 data is excellent, discussions with regulators about accelerating the approval pathway would be warranted, especially given the significant unmet medical need in cystic fibrosis.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
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