Iterum Therapeutics Reports $24.77 Million Net Loss for 2024, FDA Approves ORLYNVAH™

Iterum Therapeutics plc, an Irish pharmaceutical company focused on antibacterial resistance, reported a net loss of $24.77 million for the year ended December 31, 2024, compared to a net loss of $38.37 million in 2023. The improvement in net loss was primarily driven by a decrease in research and development expenses, which fell from $39.99 million in 2023 to $10.46 million in 2024, largely due to the completion of the REASSURE clinical trial. General and administrative expenses increased slightly, from $7.48 million to $7.98 million. Cost of sales, which primarily reflects amortization of a regulatory milestone payment to Pfizer, totaled $254,000 in 2024. Other expenses, net, decreased significantly from $9.71 million in 2023 to $5.84 million in 2024, primarily due to a decrease in adjustments to the fair value of derivative liabilities.

A key development during the year was the October 25, 2024, FDA approval of ORLYNVAH™ for uncomplicated urinary tract infections in adult women with limited oral antibiotic treatment options. Following positive Phase 3 REASSURE trial data in January 2024, the company initiated a strategic process to sell, license, or dispose of its sulopenem rights to maximize stakeholder value. This process remains ongoing, and the company is also evaluating options for direct commercialization of ORLYNVAH™ in the United States, potentially with a targeted sales force. The company currently has nine full-time employees and utilizes consultants and contractors for various business functions.

The company's cash and cash equivalents totaled $24.1 million as of December 31, 2024. Subsequent to year-end, additional shares were sold under an at-the-market offering agreement, and debt was repaid. Despite these actions, the company acknowledges conditions raising substantial doubt about its ability to continue as a going concern for the next 12 months. The company's accumulated deficit as of December 31, 2024, was $486.1 million. Future funding requirements will depend on commercialization costs for ORLYNVAH™, potential development of sulopenem for additional indications, regulatory filings and approvals, and other factors.

Iterum Therapeutics' strategy going forward includes maximizing the commercial potential of ORLYNVAH™, considering regulatory strategies outside the United States, pursuing additional indications for its sulopenem program, and potentially building a portfolio of anti-infective products. The company is evaluating a potential submission of a Marketing Authorization Application to the European Medicines Agency. The company's financial performance is heavily reliant on the success of its sulopenem program and the commercialization of ORLYNVAH™. The company's 10-K filing details numerous risk factors, including those related to its financial position, product development and commercialization, dependence on third parties, intellectual property, regulatory approvals, and competition.

The company's financial statements, included in the 10-K filing, show a significant increase in cash and cash equivalents from $6.07 million at the end of 2023 to $24.13 million at the end of 2024, primarily due to proceeds from equity offerings and the exercise of warrants. The company's accumulated deficit increased from $461.3 million to $486.1 million during the year. The filing also includes detailed information on the company's accounting policies, including those related to the valuation of derivative liabilities and intangible assets. The company's independent registered public accounting firm, KPMG, issued an unqualified opinion on the financial statements, but identified the measurement of the Royalty-Linked Notes liability as a critical audit matter due to the subjective judgments involved in the valuation process.