Celcuity Inc. (CELC) Q3 2024 Earnings Call Transcript Summary
Celcuity Inc. (CELC) Q3 2024 Earnings Call Transcript Summary
Research and development expenses increased to $27.6 million, primarily due to activities supporting ongoing clinical trials.The following is a summary of the Celcuity Inc. (CELC) Q3 2024 Earnings Call Transcript:
以下是celcuity Inc. (CELC) 2024年第三季度業績會議通話摘要：
Financial Performance:
財務表現：
Celcuity reported a net loss of $29.8 million, or $0.70 per share for Q3 2024, compared to a net loss of $18.4 million, or $0.83 per share for Q3 2023.
Non-GAAP adjusted net loss was $27.6 million, or $0.65 per share, compared to $17.3 million, or $0.78 per share, year over year.
Research and development expenses increased to $27.6 million, primarily due to activities supporting ongoing clinical trials.
Celcuity報告2024年第三季度淨虧損$2980萬，每股虧損$0.70，相比於2023年第三季度淨虧損$1840萬，每股虧損$0.83。
非通用會計準則調整後淨虧損爲$2760萬，每股虧損$0.65，與去年相比$1730萬，每股虧損$0.78。
研發費用增至$2760萬，主要是由於支持進行中臨床試驗的活動增加。
Business Progress:
業務進展：
The VIKTORIA-1 Phase III clinical trial evaluating gedatolisib in breast cancer is progressing with the PIK3CA wild-type cohort fully enrolled and the mutant cohort on track.
Plans are on track to enroll the first patient in the VIKTORIA-2 Phase III trial in Q2 2025, which evaluates gedatolisib in a first-line setting.
Phase Ib/II trial evaluating gedatolisib in metastatic castration-resistant prostate cancer is also ongoing, with expected preliminary data in Q2 2025.
VIKTORIA-1第三期乳腺癌評估gedatolisib的臨床試驗正在進行中，PIK3CA野生型群體已招滿，突變群體進展順利。
計劃按計劃在2025年第二季度招募VIKTORIA-2第三期試驗的第一名患者，該試驗評估gedatolisib在一線設置中的應用。
目前，正在進行一項評估gedatolisib在轉移性去勢抵抗性前列腺癌中的Ib/II期試驗，預計將於2025年第二季度公佈初步數據。
Opportunities:
機會：
Potential market expansion with gedatolisib, targeting a peak revenue opportunity exceeding $2 billion if FDA approvals are granted for both PIK3CA wild-type and mutant populations.
Potential to establish a new standard of care in breast cancer management with a triplet regimen including gedatolisib, addressing three interconnected signaling pathways.
Favorable feedback on gedatolisib's IV route of administration, which could offer advantages in market access and therapy adherence.
如果FDA批准PIK3CA野生型和突變型人群，gedatolisib有潛力拓展市場，目標營收機會超過20億美元。
使用包括gedatolisib在內的三聯療法有望在乳腺癌治療中確立新的標準，涉及到三個相互關聯的信號通路。
關於gedatolisib的靜脈給藥途徑獲得了良好的反饋，這可能在市場準入和治療依從性方面帶來優勢。
Risks:
風險：
Delay in reaching the primary analysis event threshold for the clinical trial cohorts could impact the timeline for drug approval and market entry.
臨床試驗隊列未達到主要分析事件門檻的延遲可能影響藥物批准和市場準入的時間表。
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。
