Seasoned Pharmaceutical leader bringing over 24 years of experience in clinical development across autoimmune, metabolic, cardiovascular, and gastrointestinal indications Company remains focused on advancing PALI-2108 in ulcerative colitis and fibrostenotic Crohn’s disease, with Phase 2 IND submission planned for H1 2026 Carlsbad, CA, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies fo ...

Core Insights - Palisade Bio has developed PALI-2108, a first-in-class PDE4 inhibitor specifically targeting the terminal ileum and colon for treating fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC) to meet significant unmet medical needs [1][4] Intellectual Property - The Canadian Intellectual Property Office has granted patent number 3,174,137 for PALI-2108, providing composition-of-matter protection until May 28, 2041 [2] - The patent covers the unique design of PALI-2108, which includes a galactose-derived sugar moiety that minimizes absorption until activated by colonic bacteria [2] Clinical Development - Palisade Bio is advancing PALI-2108 in a Phase 1b study for FSCD, with patient dosing expected to start in the second half of 2025 and topline data anticipated in the first quarter of 2026 [3] - Results from the Phase 1b study, along with data from completed Phase 1a/1b trials in UC, will support a planned Phase 2 IND submission to the FDA in the first half of 2026 [3] Product Overview - PALI-2108 is an orally administered prodrug designed for gut-restricted delivery, achieving high local tissue concentrations while minimizing systemic exposure [4] - The mechanism of action aims to maximize anti-inflammatory and anti-fibrotic effects while reducing common tolerability issues associated with systemic PDE4 inhibitors [4] Company Background - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [5]

Core Insights - Cogent Biosciences has secured a debt financing facility of up to $400 million to support its growth strategy, including the anticipated launch of bezuclastinib in 2026 [1][2] - The company is on track to report results from three pivotal trials in 2025, starting with the SUMMIT trial results in July [1][4] Financing Details - An initial tranche of $50 million was drawn at closing, with an additional $100 million available in 2025 based on successful data readouts from SUMMIT and PEAK trials [3] - A further $50 million can be accessed upon achieving early commercial success after the bezuclastinib launch, with the remaining $200 million available through mutual agreement [3] Clinical Trials - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study focused on patients with NonAdvSM, with results expected in July 2025 [4] - The APEX trial, an open-label study in patients with AdvSM, is set to release results in the second half of 2025, while the PEAK trial results are expected before the end of 2025 [4] Company Overview - Cogent Biosciences specializes in developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6] - The company is also advancing a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6]