Iterum Therapeutics Reports Third Quarter 2024 Financial Results

Core Insights - Iterum Therapeutics has received FDA approval for ORLYNVAHTM, marking it as the only oral penem antibiotic available for uncomplicated urinary tract infections (uUTIs) in the U.S. in over 25 years, addressing a significant unmet need in the market due to antibiotic resistance [2][3] Company Developments - The approval of ORLYNVAHTM on October 25, 2024, allows Iterum to pursue strategic partnerships to enhance its market presence [2][3] - The company has submitted patent information for four U.S. patents for ORLYNVAHTM to be listed in the FDA's Orange Book, ensuring additional protection for its product [3] - Iterum has received a total of 10 years of marketing exclusivity under the GAIN Act, which includes an additional five years granted upon the approval of ORLYNVAHTM [3] Financial Performance - As of September 30, 2024, Iterum reported cash, cash equivalents, and short-term investments totaling $14.5 million, which is expected to fund operations into 2025 [4] - Research and development expenses for Q3 2024 were $3.1 million, a significant decrease from $14.9 million in Q3 2023, primarily due to reduced costs associated with the REASSURE trial [5] - General and administrative expenses remained stable at $1.8 million for Q3 2024 compared to the same period in 2023 [5] - The net loss for Q3 2024 was $6.1 million, compared to a net loss of $3.9 million in Q3 2023, while the non-GAAP net loss improved to $4.8 million from $15.7 million year-over-year [7] Market Context - ORLYNVAHTM is positioned to address the growing issue of antibiotic resistance, particularly in treating uUTIs caused by specific microorganisms, which include Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis [3][9] - The product's introduction is expected to fill a gap in the market for effective oral treatments for uUTIs, which have seen limited innovation over the past 25 years [2][3]