Capricor Therapeutics, Inc. (CAPR) Q3 2024 Earnings Call Transcript Summary
Capricor Therapeutics, Inc. (CAPR) Q3 2024 Earnings Call Transcript Summary
Capricor is on track to complete the submission of its BLA for deramiocel, a therapy for DMD cardiomyopathy, by the end of 2024, with FDA feedback expected by Q1 2025.The following is a summary of the Capricor Therapeutics, Inc. (CAPR) Q3 2024 Earnings Call Transcript:
以下是Capricor Therapeutics, Inc. (CAPR) 2024年第三區業績會的摘要：
Financial Performance:
財務表現:
Capricor reported Q3 2024 revenues of approximately $2.3 million, a decrease from $6.2 million in Q3 2023.
The net loss for Q3 2024 increased to approximately $12.6 million from $6.4 million in Q3 2023.
Capricor報告2024年第三區的營業收入約爲230萬，較2023年第三區的620萬有所下降。
2024年第三區的淨虧損增加至約1260萬，較2023年第三區的640萬有所上升。
Business Progress:
業務進展：
Capricor is on track to complete the submission of its BLA for deramiocel, a therapy for DMD cardiomyopathy, by the end of 2024, with FDA feedback expected by Q1 2025.
The company has expanded manufacturing capabilities, establishing a commercial manufacturing facility in San Diego to meet anticipated market demand.
Capricor正按計劃在2024年底之前完成deramiocel的BLA提交，這是一種用於DMD心肌病的療法，預計在2025年第一季度收到FDA的反饋。
該公司擴大了製造業-半導體能力，在聖地亞哥建立了一個商業製造設施，以滿足預期的市場需求。
Opportunities:
機會：
Capricor is preparing for potential commercial launch of deramiocel, targeting approximately 8,000 DMD patients in the U.S., and anticipates rapid adoption upon approval.
New market opportunities in Europe and Japan through partnerships with Nippon Shinyaku, including milestone payments totaling $1.5 billion, and revenue sharing.
Capricor正在爲deramiocel的潛在商業推出做準備，目標是在美國大約8,000名DMD患者，並預計在獲得批准後快速採用。
通過與日本新藥的合作，在歐洲和日本開拓新的市場機會，包括總計15億的里程碑付款和營業收入分享。
Risks:
風險：
The uncertainty of receiving FDA approval for deramiocel, with a planned advisory committee potentially affecting the approval process.
Manufacturing scale-up must align with market demands and regulatory expectations, posing risks to meeting projected timelines and market launch.
獲得FDA對deramiocel的批准存在不確定性，計劃中的諮詢委員會可能會影響批准過程。
製造業-半導體的規模擴大必須與市場需求和監管期望相一致，這對滿足預期時間表和市場推出構成風險。
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譯文內容由第三人軟體翻譯。
