Celcuity Inc. (CELC) Q2 2024 Earnings Call Transcript Summary
Celcuity Inc. (CELC) Q2 2024 Earnings Call Transcript Summary
The following is a summary of the Celcuity Inc. (CELC) Q2 2024 Earnings Call Transcript:
以下是Celcuity（愛文思控股）Q2 2024業績會交流摘要：
Financial Performance:
金融業績：
For Q2 2024, Celcuity reported a net loss of $23.7 million or $0.62 per share, compared from a net loss of $14.6 million or $0.66 per share in Q2 2023.
Non-GAAP adjusted net loss was $22.2 million or $0.58 per share for Q2 2024, compared to a non-GAAP adjusted net loss of $11.1 million or $0.51 per share in Q2 2023.
The company raised $129 million from equity and debt offerings to strengthen their balance sheet.
2024年Q2，Celcuity報告淨損失2370萬美元或每股0.62美元，相比之下，2023年Q2淨損失爲1460萬美元或每股0.66美元。
2024年Q2，非GAAP調整後的淨損失爲2220萬美元或每股0.58美元，相比之下，2023年Q2非GAAP調整後的淨損失爲1110萬美元或每股0.51美元。
該公司通過股權和債務融資籌集了12900萬美元，以增強其資產負債表。
Business Progress:
業務進展：
Celcuity has advanced the clinical development of gedatolisib with ongoing enrollment in key trials such as VIKTORIA-1 for advanced breast cancer and a trial for metastatic castration resistant prostate cancer.
Plans are in place for launching VIKTORIA-2 to evaluate gedatolisib as a first-line treatment for patients with HR+/HER2- advanced breast cancer.
Non-clinical research on gedatolisib was published, demonstrating its efficacy compared to single-node PI3K inhibitors in various cancer models.
Celcuity正在推進gedatolisib的臨床開發，正在關鍵試驗如面向晚期乳腺癌的VIKTORIA-1試驗和轉移性去勢抵抗型前列腺癌的試驗中進行招募。
已制定計劃，計劃啓動VIKTORIA-2試驗，評估gedatolisib作爲HR+/HER2-晚期乳腺癌患者的一線治療方案。
發表了gedatolisib的非臨床研究，證明其在各種癌症模型中與單節點PI0.3萬抑制劑相比的療效。
Opportunities:
機會：
Celcuity expects to enroll about 638 subjects in the VIKTORIA-2 study, aimed at addressing the significant market of endocrine therapy resistant advanced breast cancer patients estimated at 15,000 to 20,000 annually in the US alone, potentially increasing the addressable market size for gedatolisib by up to $3 billion.
Celcuity預計在VIKTORIA-2研究中招募約638名受試者，以解決每年僅在美國被估計爲15000至20000名、患有內分泌治療耐藥型晚期乳腺癌的患者的重要市場問題，可能將gedatolisib的可尋址市場規模增加至30億美元。
Risks:
風險：
Projected shifts in the proportion of PIK3CA wild-type versus mutated patients in ongoing trials might impact the timing and outcomes of primary analysis events anticipated in late Q4 2024 to Q1 2025.
正在進行的試驗中，PIK3CA野生型與突變型患者的比例預計發生變化，這可能會影響預計在2024年Q4末至2025年Q1期間預期的主要分析事件的時間和結果。
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譯文內容由第三人軟體翻譯。