The following is a summary of the Iterum Therapeutics Plc (ITRM) Q4 2023 Earnings Call Transcript:
Financial Performance:
Iterum Therapeutics reported total operating expenses of $11.4 million in Q4 2023 and $47.5 million for the full year 2023.
The cost of R&D accounted for a significant amount of these expenses, with $9.7 million spent in Q4 2023, and $40 million across the year due to the REASSURE trial costs.
G&A costs in Q4 2023 were down from Q4 2022, with a reported $1.7 million, due to lower legal fees and insurance costs.
The company stated a net loss of $12.4 million for Q4 2023 and $38.4 million for the full year.
Accrued assets consist of $23.9 million in cash and short-term investments, providing a runway till 2025.
Business Progress:
The company completed enrollment for its REASSURE clinical trial involving oral sulopenem, a proposed treatment for urinary tract infections.
The REASSURE trial supported the efficacy of oral sulopenem, demonstrating its superiority over Augmentin, as well as a good safety profile.
Iterum is proactively seeking long-term product protection by preparing patent applications for sulopenem in various jurisdictions.
The company is projected to resubmit its NDA to the FDA in the first half of Q2 2024, with a potential FDA decision expected in H1 of Q4 2024.
A strategic process has been initiated for the licensing or sale of sulopenem rights.
More details: Iterum Therapeutics IR
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