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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:证券上市注册声明(修正)

美股sec公告 ·  01/22 00:00
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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.
临床阶段的生物制药公司Panbela Therapeutics, Inc. 宣布启动一项治疗胰腺癌的新临床试验。该试验被称为ASPIRE,是一项随机双盲安慰剂对照试验,与吉西他滨和nab-紫杉醇联合使用,这是一种标准胰腺癌治疗方案。该试验将在全球范围内的美国、欧洲和亚太地区约93个地点进行。ASPIRE试验于2022年初开始,预计所有国家和地点都将在2024年初开放。该研究将招收600名受试者,预计需要36个月才能完成入组,中期分析将于2024年中期公布。独立数据安全监督委员会(DSMB)已经举行了两次会议,两次会议都没有产生任何安全问题,试验继续进行,没有进行任何修改。Panbela The...展开全部
临床阶段的生物制药公司Panbela Therapeutics, Inc. 宣布启动一项治疗胰腺癌的新临床试验。该试验被称为ASPIRE,是一项随机双盲安慰剂对照试验,与吉西他滨和nab-紫杉醇联合使用,这是一种标准胰腺癌治疗方案。该试验将在全球范围内的美国、欧洲和亚太地区约93个地点进行。ASPIRE试验于2022年初开始,预计所有国家和地点都将在2024年初开放。该研究将招收600名受试者,预计需要36个月才能完成入组,中期分析将于2024年中期公布。独立数据安全监督委员会(DSMB)已经举行了两次会议,两次会议都没有产生任何安全问题,试验继续进行,没有进行任何修改。Panbela Therapeutics还参与了针对各种适应症的其他临床试验和临床前研究,包括家族性腺瘤性息肉病(FAP)和卵巢癌。该公司面临财务挑战,截至2023年9月30日的九个月净亏损为1,880万美元,经营活动产生的现金流为负数。Panbela通过公开发行和出售普通股筹集资金以支持其运营。该公司未来的成功取决于获得额外的融资、成功的临床试验、监管部门的批准以及推销和销售其候选产品的能力。
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