Iterum Therapeutics(ITRM) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total operating expenses increased to $16.7 million in Q3 2023 from $7 million in Q3 2022, primarily driven by higher R&D expenses related to the REASSURE trial [38] - Net loss on a U.S. GAAP basis was $3.9 million for Q3 2023 compared to $29.1 million for the same period in 2022, while non-GAAP net loss was $15.7 million in Q3 2023 versus $5.3 million in Q3 2022, reflecting a $10.4 million increase due to higher R&D expenses [39] Business Line Data and Key Metrics Changes - R&D costs rose to $14.9 million in Q3 2023 from $4.4 million in Q3 2022, mainly due to costs associated with the REASSURE trial [69] Market Data and Key Metrics Changes - The market for uncomplicated urinary tract infections (uUTI) is substantial, with approximately 15 million to 17 million infections annually in the U.S. [23] Company Strategy and Development Direction - The company aims to bring the first new oral treatment for uncomplicated urinary tract infections to the U.S. market in over 20 years and is focused on efficiently raising capital to fund operations [15][18] - The timeline for key milestones has been accelerated by a quarter, with top line data expected in early Q1 2024 and potential NDA resubmission to the FDA in Q2 2024 [12][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the value of oral sulopenem for treating multidrug-resistant infections and looks forward to the upcoming top line data readout [54] - The company is exploring various financing strategies to ensure continued operations through 2024 and beyond, including potential partnerships and debt financing [50][52] Other Important Information - As of September 30, 2023, the company had cash and cash equivalents of $35.9 million, which is expected to fund operations into Q3 2024 [18][37] - The company has been granted new patents in Korea and Australia, enhancing its patent estate for oral sulopenem [36][63] Q&A Session Summary Question: When do you expect that oral sulopenem will be approved? - Approval is anticipated in Q4 2024, following a potential resubmission of the NDA in Q2 2024 [26][35] Question: How long can the company operate with its current cash on hand? - Current cash is sufficient to fund operations into Q3 2024, covering the top line data readout and NDA resubmission [37][49] Question: Can you discuss the long-term financing strategy of the company? - The company is evaluating various financing strategies, including share issuances and partnerships, to ensure sufficient capital for operations [50][52] Question: What actions are being taken for sulopenem in ex-U.S. markets? - The company plans to initiate discussions for ex-U.S. markets after obtaining data from the REASSURE trial [45]