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Panbela Therapeutics | S-1/A: General form for registration of securities under the Securities Act of 1933 (Amendment)

Panbela Therapeutics | S-1/A:證券上市註冊聲明(修正)

SEC announcement ·  01/22 13:00
牛牛AI助理已提取核心訊息
Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial for the treatment of pancreatic cancer. The trial, referred to as ASPIRE, is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, standard pancreatic cancer treatment regimens. The trial will be conducted globally at approximately 93 sites in the United States, Europe, and Asia-Pacific. The ASPIRE trial commenced in early 2022, with all countries and sites expected to be open by early 2024. The study will enroll 600 subjects and is anticipated to take 36 months for complete enrollment with the interim analysis available in mid-2024. The Independent Data Safety Monitoring Board (DSMB) has met twice, with both meetings resulting in no safety...Show More
Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial for the treatment of pancreatic cancer. The trial, referred to as ASPIRE, is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, standard pancreatic cancer treatment regimens. The trial will be conducted globally at approximately 93 sites in the United States, Europe, and Asia-Pacific. The ASPIRE trial commenced in early 2022, with all countries and sites expected to be open by early 2024. The study will enroll 600 subjects and is anticipated to take 36 months for complete enrollment with the interim analysis available in mid-2024. The Independent Data Safety Monitoring Board (DSMB) has met twice, with both meetings resulting in no safety concerns and the trial continuing without modification. Panbela Therapeutics has also been involved in other clinical trials and preclinical studies for various indications, including familial adenomatous polyposis (FAP) and ovarian cancer. The company has faced financial challenges, with a net loss of $18.8 million for the nine months ended September 30, 2023, and negative cash flows from operating activities. Panbela has raised capital through public offerings and the sale of common stock to support its operations. The company's future success is dependent on obtaining additional financing, successful clinical trials, regulatory approvals, and the ability to market and sell its product candidates.
臨床階段的生物製藥公司Panbela Therapeutics, Inc. 宣佈啓動一項治療胰腺癌的新臨床試驗。該試驗被稱爲ASPIRE,是一項隨機雙盲安慰劑對照試驗,與吉西他濱和nab-紫杉醇聯合使用,這是一種標準胰腺癌治療方案。該試驗將在全球範圍內的美國、歐洲和亞太地區約93個地點進行。ASPIRE試驗於2022年初開始,預計所有國家和地點都將在2024年初開放。該研究將招收600名受試者,預計需要36個月才能完成入組,中期分析將於2024年中期公佈。獨立數據安全監督委員會(DSMB)已經舉行了兩次會議,兩次會議都沒有產生任何安全問題,試驗繼續進行,沒有進行任何修改。Panbela The...展開全部
臨床階段的生物製藥公司Panbela Therapeutics, Inc. 宣佈啓動一項治療胰腺癌的新臨床試驗。該試驗被稱爲ASPIRE,是一項隨機雙盲安慰劑對照試驗,與吉西他濱和nab-紫杉醇聯合使用,這是一種標準胰腺癌治療方案。該試驗將在全球範圍內的美國、歐洲和亞太地區約93個地點進行。ASPIRE試驗於2022年初開始,預計所有國家和地點都將在2024年初開放。該研究將招收600名受試者,預計需要36個月才能完成入組,中期分析將於2024年中期公佈。獨立數據安全監督委員會(DSMB)已經舉行了兩次會議,兩次會議都沒有產生任何安全問題,試驗繼續進行,沒有進行任何修改。Panbela Therapeutics還參與了針對各種適應症的其他臨床試驗和臨床前研究,包括家族性腺瘤性息肉病(FAP)和卵巢癌。該公司面臨財務挑戰,截至2023年9月30日的九個月淨虧損爲1,880萬美元,經營活動產生的現金流爲負數。Panbela通過公開發行和出售普通股籌集資金以支持其運營。該公司未來的成功取決於獲得額外的融資、成功的臨床試驗、監管部門的批准以及推銷和銷售其候選產品的能力。

譯文內容由第三人軟體翻譯。


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