Iterum Therapeutics(ITRM) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total operating expenses increased to $10.8 million in Q2 2023 from $8.1 million in Q2 2022 [19] - R&D costs rose significantly to $9 million in Q2 2023 from $4 million in Q2 2022, primarily due to costs associated with the REASSURE trial [20] - G&A costs decreased to $1.9 million in Q2 2023 from $4.1 million in Q2 2022, attributed to lower share-based compensation and reduced legal fees [21] - Net loss on a GAAP basis was $12.2 million in Q2 2023 compared to $6.7 million in Q2 2022; on a non-GAAP basis, the net loss was $10 million in Q2 2023 versus $5.7 million in Q2 2022 [22][23] Business Line Data and Key Metrics Changes - The REASSURE trial reached 50% enrollment with 983 patients, indicating strong progress in clinical development [8][10] Market Data and Key Metrics Changes - The company has a strong cash position with approximately $45 million as of June 30, 2023, expected to fund operations into Q3 2024 [13][23] Company Strategy and Development Direction - The company aims to resubmit the NDA for oral sulopenem in the second half of 2024, contingent on positive trial results [10][24] - The company is exploring various financing strategies to support ongoing operations and future development [14][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the REASSURE trial's progress and the potential to bring the first new oral penem to market [17][35] - The company is focused on satisfying U.S. regulatory requirements while considering opportunities for international submissions based on trial outcomes [30][34] Other Important Information - The company has been granted a patent in Japan for oral sulopenem, enhancing its intellectual property portfolio [11][12] Q&A Session Summary Question: When is the expected timing for the interim analysis of the REASSURE trial? - Management expects the data monitoring committee's recommendation in early Q4, following an eight-week period post-enrollment [29] Question: Will positive data from REASSURE fulfill requirements for other regulatory agencies? - The company is primarily focused on U.S. requirements but will evaluate opportunities for submissions in other regions based on the trial data [30][34]