Iterum Therapeutics(US:ITRM)2022-11-10 16:42Financial Data and Key Metrics Changes - Total operating expenses for Q3 2022 were $7 million, up from $4.9 million in Q3 2021, and year-to-date expenses were $22.4 million compared to $17.7 million in 2021 [14] - Research and development (R&D) costs increased to $4.4 million in Q3 2022 from $1.8 million in Q3 2021, primarily due to the initiation of the REASSURE trial [14] - The net loss on a U.S. GAAP basis was $29.1 million for Q3 2022, compared to a net loss of $39.3 million year-to-date [16] - Non-GAAP net loss was $5.3 million for Q3 2022, compared to $3.7 million in Q3 2021, reflecting higher R&D expenses [17] Business Line Data and Key Metrics Changes - The REASSURE trial for uncomplicated urinary tract infections has begun enrollment, with approximately 1,966 patients expected to be enrolled [6][8] - R&D costs year-to-date were $11.8 million in 2022 versus $7 million in 2021, driven by costs associated with the REASSURE trial [15] Market Data and Key Metrics Changes - There are approximately 33 million uncomplicated urinary tract infections in the U.S. annually, with about 30% caused by quinolone non-susceptible organisms [9] - The need for new oral antibiotics remains high due to 1% of infections being caused by pathogens resistant to all commonly available oral antibiotics [9] Company Strategy and Development Direction - The company is focused on resubmitting the NDA for oral sulopenem in the second half of 2024, contingent on the success of the REASSURE trial [12][17] - A U.S. patent for the bilayer tablet of oral sulopenem has been granted, extending patent protection until at least 2039, which is crucial for the long-term commercial value [10][25] - The company is exploring new areas of unmet medical need for sulopenem and plans to discuss potential new indications with the FDA in the first half of 2023 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash position of $64 million as of September 30, 2022, which is expected to fund operations into 2024 [12][17] - The company remains optimistic about the potential of oral sulopenem to treat multidrug-resistant infections and is looking forward to completing ongoing clinical work [31] Other Important Information - The company regained compliance with NASDAQ's bid price rule through a 1-for-15 reverse share split in August 2022 [12] - As of September 30, 2022, there were approximately 12.2 million ordinary shares outstanding [18] Q&A Session Summary Question: About the powering of the study and patent details - The study is powered based on assumptions including a point estimate for sulopenem and Augmentin at 90%, with an interim analysis planned at 50% enrollment [23] - The new patent is a composition of matter patent for the bilayer tablet, not merely a formulation patent [24][25] Question: Clarification on cash runway and class action lawsuit - The company has sufficient cash to get through the top line data readout, but specific timing is uncertain due to enrollment [27] - There is no new information regarding the class action lawsuit, with a conference scheduled for December 7 [27]