Earnings Call Summary | Outlook Therapeutics(OTLK.US) Q2 2024 Earnings Conference
Earnings Call Summary | Outlook Therapeutics(OTLK.US) Q2 2024 Earnings Conference
The following is a summary of the Outlook Therapeutics, Inc. (OTLK) Q2 2024 Earnings Call Transcript:
以下是Outlook Therapeutics, Inc.（OTLK）2024年第二季度業績電話會議記錄摘要：
Financial Performance:
財務業績：
Outlook Therapeutics recently secured funding through a private placement, generating up to $172 million in gross proceeds.
Of this, $65 million came from the sale of common stock, while an additional $107 million will be available upon full cash exercise of the warrants.
This funding is expected to support the company's business through potential product approvals and commercial launches in Europe and the US, given full exercise of the warrants.
Outlook Therapeutics最近通過私募獲得了融資，總收益高達1.72億美元。
其中，6,500萬美元來自普通股的出售，另外1.07億美元將在認股權證全額現金行使後提供。
在認股權證得到充分行使的情況下，這筆資金預計將通過潛在的產品批准和在歐洲和美國的商業上市來支持公司的業務。
Business Progress:
業務進展：
The company received positive feedback from the CHMP and expects potential approval for ONS-5010 in Europe in Q2 2024, with a planned launch in Q1 2025.
In the US, Outlook is in active discussions with the FDA and has achieved an agreement on a Special Protocol Assessment for their 90-day non-inferiority study, NORSE EIGHT.
They aim to resubmit their Biologics License Application by the end of 2024, with potential US approval expected in 2025.
Outlook Therapeutics also continues its development towards pre-filled syringes and is working to establish its brand in Europe and the US.
The company is looking to maximize its global footprint by considering current locations or partner facilities in Europe for manufacturing and supply.
該公司收到了CHMP的積極反饋，並預計 ONS-5010 可能在2024年第二季度在歐洲獲得批准，並計劃於2025年第一季度推出。
在美國，Outlook正在與美國食品藥品管理局進行積極討論，並已就其爲期90天的非劣勢研究NORSE EIGHT的特殊協議評估達成協議。
他們的目標是在2024年底之前重新提交生物製劑許可申請，預計美國可能在2025年獲得批准。
Outlook Therapeutics還繼續開發預充式注射器，並正在努力在歐洲和美國建立其品牌。
該公司希望通過考慮在歐洲的現有地點或合作伙伴設施進行製造和供應，最大限度地擴大其全球足跡。
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。