Iterum Therapeutics(ITRM) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2022 were $7.9 million, up from $6.8 million in Q4 2021, and full-year expenses were $30.4 million compared to $24.5 million in 2021 [13] - R&D expenses increased to $5.8 million in Q4 2022 from $3.7 million in Q4 2021, and full-year R&D costs rose to $17.6 million from $10.7 million in 2021 [13] - The net loss on a U.S. GAAP basis was $5.1 million for Q4 2022 and $44.4 million for the full year, impacted by a non-cash charge of $17.4 million related to share option cancellations [14] Business Line Data and Key Metrics Changes - General and administrative (G&A) costs were $2.1 million for Q4 2022, down from $3.1 million in Q4 2021, and full-year G&A costs were $12.8 million, lower than $13.8 million in 2021 [35] Market Data and Key Metrics Changes - The market for uncomplicated urinary tract infections (uUTI) treatment is significant, with approximately 33 million prescriptions annually in the U.S., highlighting the need for new oral treatments due to safety and efficacy challenges of existing options [30] Company Strategy and Development Direction - The company is focused on the clinical development of oral sulopenem, with a new Phase 3 clinical trial (REASSURE) currently enrolling patients, expected to complete enrollment in the first half of 2024 [8][9] - The company has received two U.S. patents for oral sulopenem, providing protection until 2039, which supports its market strategy [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the value of oral sulopenem to address multi-drug resistant infections and emphasized the importance of completing ongoing clinical work [24] - The company anticipates resubmitting its NDA to the FDA in the second half of 2024 if the REASSURE trial is successful [15] Other Important Information - As of December 31, 2022, the company had cash, cash equivalents, and short-term investments of $60.8 million, expected to fund operations until mid-2024 [15][32] - The company has pending patent applications in various international markets, indicating a broader strategy for global market entry [31] Q&A Session Summary Question: How many patients have been enrolled in the REASSURE trial? - Management did not disclose specific enrollment numbers but indicated that the study is progressing well with a significant number of sites open [39] Question: What type of data can be expected from the interim analysis of the REASSURE trial? - The interim analysis will assess patient size and ensure the trial maintains its statistical power, but no specific efficacy data will be revealed at that stage [21] Question: Will the cash runway extend to include top-line data readout from REASSURE? - Yes, the company expects to fund operations through to the data readout, which is anticipated shortly after enrollment completion [22]