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Invivyd | 8-K: Invivyd Reports Third Quarter 2024 Financial Results and Recent Business Highlights

Invivyd | 8-K: Invivyd Reports Third Quarter 2024 Financial Results and Recent Business Highlights

Invivyd | 8-K:Invivyd公佈2024年第三季度財務業績和近期業務亮點
美股SEC公告 ·  2024/11/14 20:21

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Invivyd reported Q3 2024 PEMGARDA net product revenue of $9.3 million, up from $2.3 million in Q2. The company ended the quarter with $106.9 million in cash and expects to maintain at least $65 million by year-end. Management targets profitability in first half of 2025, supported by anticipated revenue growth and operational improvements.The FDA has updated PEMGARDA's Fact Sheet to reflect validated neutralization data against current variants including KP.3, KP.3.1.1 and LB.1. This aligns with exploratory clinical efficacy data from the CANOPY Phase 3 trial showing 84% relative risk reduction from symptomatic COVID-19 versus placebo through month 6 in immunocompetent participants.R&D expenses increased to $57.9 million in Q3 2024 from $30.2 million year-over-year, primarily due to higher manufacturing costs for VYD2311. The company began dosing its first-in-human trial for VYD2311 in August 2024, with preliminary data expected in late Q4. Net loss was $60.7 million or $0.51 per share, compared to $39.4 million or $0.36 per share in Q3 2023.
Invivyd reported Q3 2024 PEMGARDA net product revenue of $9.3 million, up from $2.3 million in Q2. The company ended the quarter with $106.9 million in cash and expects to maintain at least $65 million by year-end. Management targets profitability in first half of 2025, supported by anticipated revenue growth and operational improvements.The FDA has updated PEMGARDA's Fact Sheet to reflect validated neutralization data against current variants including KP.3, KP.3.1.1 and LB.1. This aligns with exploratory clinical efficacy data from the CANOPY Phase 3 trial showing 84% relative risk reduction from symptomatic COVID-19 versus placebo through month 6 in immunocompetent participants.R&D expenses increased to $57.9 million in Q3 2024 from $30.2 million year-over-year, primarily due to higher manufacturing costs for VYD2311. The company began dosing its first-in-human trial for VYD2311 in August 2024, with preliminary data expected in late Q4. Net loss was $60.7 million or $0.51 per share, compared to $39.4 million or $0.36 per share in Q3 2023.
Invivyd報告2024年第三季度PEMGARDA淨產品營業收入爲930萬美元,高於第二季度的230萬美元。公司在季度末現金餘額爲10690萬美元,並預計年末至少維持6500萬美元。管理層的目標是在2025年上半年實現盈利,這得益於預期的營業收入增長和運營改進。FDA已更新PEMGARDA的事實表,以反映針對當前變種(包括KP.3、KP.3.1.1和Lb.1)的驗證中和數據。這與CANOPY 3期試驗的探索性臨牀療效數據一致,顯示免疫功能正常的參與者在第6個月與安慰劑相比,症狀性COVID-19的相對風險降低了84%.研發費用從去年同期的3020萬美元增加至2024年第三季度的5790萬美元,主要由於VYD2311的製造成本上升。公司於2024年8月開始對VYD2311進行首次人體試驗的給藥,預計在第四季度末獲得初步數據。淨虧損爲6070萬美元,每股虧損0.51美元,較2023年第三季度的3940萬美元或每股0.36美元有所增加。
Invivyd報告2024年第三季度PEMGARDA淨產品營業收入爲930萬美元,高於第二季度的230萬美元。公司在季度末現金餘額爲10690萬美元,並預計年末至少維持6500萬美元。管理層的目標是在2025年上半年實現盈利,這得益於預期的營業收入增長和運營改進。FDA已更新PEMGARDA的事實表,以反映針對當前變種(包括KP.3、KP.3.1.1和Lb.1)的驗證中和數據。這與CANOPY 3期試驗的探索性臨牀療效數據一致,顯示免疫功能正常的參與者在第6個月與安慰劑相比,症狀性COVID-19的相對風險降低了84%.研發費用從去年同期的3020萬美元增加至2024年第三季度的5790萬美元,主要由於VYD2311的製造成本上升。公司於2024年8月開始對VYD2311進行首次人體試驗的給藥,預計在第四季度末獲得初步數據。淨虧損爲6070萬美元,每股虧損0.51美元,較2023年第三季度的3940萬美元或每股0.36美元有所增加。
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