Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2024 Earnings Call Transcript Summary
Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2024 Earnings Call Transcript Summary
R&D expenses for the quarter were $21.2 million, down from $30 million compared to the same period in 2023.The following is a summary of the Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2024 Earnings Call Transcript:
以下是Amylyx Pharmaceuticals, Inc. (AMLX) 2024年第三季度業績會交易摘要：
Financial Performance:
財務表現:
Ended Q3 with $234.4 million in cash and investments.
Net product revenues for the quarter were $400,000 with cost of sales reported at $800,000.
R&D expenses for the quarter were $21.2 million, down from $30 million compared to the same period in 2023.
Recorded $36.2 million of expense related to the acquisition of Avexitide.
Operating leverage expected with Q3 net loss at $72.7 million or $1.07 per share.
第三季度結束時現金和投資總額爲23440萬美元。
本季度淨產品收入爲40萬美元，銷售成本爲80萬美元。
本季度研發費用爲2120萬美元，較2023年同期的3000萬美元下降。
錄得與收購Avexitide相關的3620萬美元費用。
預計第三季度運營槓桿效應，淨虧損達到7270萬美元，每股1.07美元。
Business Progress:
業務進展：
Reported positive topline data from open-label Phase II HELIOS trial of AMX0035 showing improvements in pancreatic function.
Preparing to initiate a pivotal Phase III program in PBH in Q1 2025 with topline data expected in 2026.
Clearance received from Health Canada to start a Phase I trial of AMX0114 in ALS; plan to commence in the coming months.
ORION trial of AMX0035 in PSP is recruiting well with interim analysis expected mid next year.
公佈了AMX0035開放標籤第II期HELIOS試驗的陽性主要數據，顯示胰島功能改善。
準備在2025年第一季度啓動關鍵的第III期PBH項目，預計到2026年公佈主要數據。
獲得加拿大衛生部批准，開始AMX0114在ALS的第I期試驗；計劃在未來幾個月開始。
AMX0035在PSP的ORION試驗招募良好，預計明年中旬進行中期分析。
Opportunities:
機會：
Avexitide, with FDA breakthrough therapy and orphan drug designations, leading to Phase III development in PBH by Q1 2025.
Potential expansion of AMX0035 into progressive supranuclear palsy.
Avexitide獲得FDA突破性療法和孤兒藥品認定，有望在2025年第一季度開始PBH的第III期開發。
有可能將AMX0035擴展到進行性核上性麻痹。
Risks:
風險：
Clinical hold by the FDA on AMX0114, requiring lower dosing understanding and more information.
Gradual growth expected from AI services in neurodegenerative diseases.
FDA對AMX0114實施臨床暫停，需要降低劑量並提供更多信息。
預計人工智能服務在神經退行性疾病領域將逐漸增長。
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：如需更全面的詳情，請參閱投資人關係網站。本文僅供投資者參考，不作任何指引或建議。
譯文內容由第三人軟體翻譯。
