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

SEC announcement ·  Jan 22 13:00
Summary by Futu AI
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.

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