Iterum Therapeutics plc SEC 10-Q Report

Iterum Therapeutics plc, a pharmaceutical company focused on developing treatments for infections caused by multi-drug resistant pathogens, has released its Form 10-Q report for the third quarter. The report highlights significant financial improvements and key business developments, including the launch of a new product and strategic operational initiatives.

Financial Highlights

• Net Loss: $(4.9) million, reflecting a decrease from $(7.1) million in the prior year period, indicating a reduction in losses.
• Net Loss Per Share – Basic and Diluted: $(0.14), compared to $(0.46) in the prior year period, showing an improvement in per-share loss.
• Operating Loss: $(3.7) million, down from $(6.2) million in the prior year period, suggesting improved operational efficiency.
• Total Operating Expenses: $(3.7) million, a decrease from $(6.2) million in the prior year period, primarily due to reduced research and development expenses.

Business Highlights

• New Product Launch: Iterum Therapeutics launched ORLYNVAH™, the first oral branded penem available in the United States, following FDA approval in October 2024. This product is aimed at treating uncomplicated urinary tract infections in adult women with limited or no alternative oral antibacterial treatment options.
• Production Launch: The company began capitalizing inventory costs and commenced production of ORLYNVAH™ in February 2025, following FDA approval in October 2024.
• Future Outlook: Iterum Therapeutics is preparing for the potential commercialization of ORLYNVAH™ in the United States, either with a commercial partner or independently with a targeted sales force. The company is also exploring strategic transactions to sell, license, or otherwise dispose of its rights to sulopenem.
• Operational Strategy: The company is focused on maximizing the commercial potential of ORLYNVAH™ and is concurrently evaluating strategic alternatives, including licensing or selling its sulopenem program, to maximize value for stakeholders.
• Geographical Performance: The company operates primarily in the U.S. and Ireland, with long-lived assets distributed between these regions. The focus remains on the U.S. market for the commercialization of ORLYNVAH™.
• Research and Development Focus: Iterum Therapeutics continues to invest in the development of its sulopenem program, including both oral and intravenous formulations, to address antibacterial resistance.

SEC Filing: Iterum Therapeutics plc [ ITRM ] - 10-Q - May. 13, 2025