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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 26 01:25
Summary by Futu AI
Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial referred to as ASPIRE. The trial is a randomized, double-blind, placebo-controlled study in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. 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 full enrollment expected by the first quarter of 2025 and interim data analysis based on overall survival anticipated by mid-2024. The Independent Data Safety Monitoring Board has met twice, with no safety concerns reported, allowing the trial to continue without modification. As of January 25, 2024, the trial had exceeded 50% enrollment. Panbela's financials reflect...Show More
Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial referred to as ASPIRE. The trial is a randomized, double-blind, placebo-controlled study in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. 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 full enrollment expected by the first quarter of 2025 and interim data analysis based on overall survival anticipated by mid-2024. The Independent Data Safety Monitoring Board has met twice, with no safety concerns reported, allowing the trial to continue without modification. As of January 25, 2024, the trial had exceeded 50% enrollment. Panbela's financials reflect a net loss of $18.8 million for the nine months ended September 30, 2023, and negative cash flows from operating activities of approximately $21.8 million for the same period. The company has raised capital through public offerings and the sale of common stock to fund its operations. Panbela's future success depends on additional financing, successful clinical trials, regulatory approvals, and the commercialization of its product candidates.

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