Iterum Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results

Core Insights - Iterum Therapeutics has received FDA approval for ORLYNVAH, a novel oral penem antibiotic for uncomplicated urinary tract infections (uUTIs), marking a significant milestone as it is the first branded uUTI product in the U.S. market in over 25 years [3][9][16] - The company has extended its cash runway, expecting its cash and cash equivalents to fund operations into the second half of 2025, bolstered by recent fundraising efforts [5][11] - Iterum is actively pursuing strategic partnerships while preparing for the commercialization of ORLYNVAH to address unmet medical needs in treating uUTIs [3][9] Financial Performance - As of December 31, 2024, Iterum reported cash and cash equivalents of $24.1 million, with expectations to sustain operations through the second half of 2025 [5][23] - Research and development (R&D) expenses decreased to $10.5 million for the full year 2024 from $40.0 million in 2023, primarily due to reduced clinical trial costs [7] - General and administrative (G&A) expenses increased to $8.0 million in 2024 from $7.5 million in 2023, attributed to higher legal fees and consultant costs [8] Losses and Adjustments - The net loss for the fourth quarter and full year 2024 was $6.6 million and $24.8 million, respectively, showing improvement compared to losses of $12.4 million and $38.4 million in the same periods of 2023 [11][21] - Non-GAAP net loss for the fourth quarter and full year 2024 was $3.4 million and $17.9 million, respectively, compared to $10.7 million and $43.8 million in 2023 [11][21] - Adjustments to the fair value of derivatives for the fourth quarter and full year 2024 were $2.0 million and $3.3 million, respectively, reflecting changes in the fair value of Royalty-Linked Notes following FDA approval [10] Strategic Developments - Iterum has expanded its patent estate with a Notice of Allowance for an Australian patent covering the use of sulopenem etzadroxil in treating uUTIs, set to expire in June 2039 [9] - The company has repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025, enhancing its financial position [9] - Iterum is focused on pre-commercialization activities for ORLYNVAH, aiming to ensure timely availability for patients [3][9]