Earnings Call Summary | Iterum Therapeutics(ITRM.US) Q4 2023 Earnings Conference
Earnings Call Summary | Iterum Therapeutics(ITRM.US) Q4 2023 Earnings Conference
The following is a summary of the Iterum Therapeutics Plc (ITRM) Q4 2023 Earnings Call Transcript:
以下是Iterum Therapeutics Plc（ITRM）2023年第四季度業績電話會議記錄的摘要：
Financial Performance:
財務業績：
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.
Iterum Therapeutics報告稱，2023年第四季度的總運營支出爲1140萬美元，2023年全年總運營支出爲4,750萬美元。
研發成本佔這些支出的很大一部分，2023年第四季度的支出爲970萬美元，全年支出爲4000萬美元，這歸因於REASSURE的試用成本。
由於律師費和保險成本降低，2023年第四季度的併購成本較2022年第四季度有所下降，據報道爲170萬美元。
該公司表示，2023年第四季度淨虧損1,240萬美元，全年淨虧損3,840萬美元。
應計資產包括2390萬美元的現金和短期投資，爲2025年鋪平道路。
Business Progress:
業務進展：
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.
該公司完成了REASSURE臨床試驗的註冊，該試驗涉及口服舒洛培南，這是一種擬議的尿路感染治療方法。
REASSURE試驗支持了口服舒洛培南的功效，表明其優於奧格門汀的優越性以及良好的安全性。
Iterum正在通過在各個司法管轄區準備舒洛培南的專利申請，積極尋求長期的產品保護。
預計該公司將在2024年第二季度上半年向美國食品藥品管理局重新提交保密協議，預計美國食品藥品管理局可能在2024年第四季度第一季度做出決定。
已經啓動了許可或出售舒洛培南權利的戰略進程。
More details: Iterum Therapeutics IR
更多詳情： Iterum 療法 IR
Tips: For more comprehensive details, please refer to the IR website. The article is only for investors' reference without any guidance or recommendation suggestions.
提示：欲了解更多詳情，請訪問投資者關係網站。本文僅供投資者參考，不構成任何投資建議。
譯文內容由第三人軟體翻譯。