PALISADE BIO, INC.

PALI Biopharma Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation, once-daily, oral phosphodiesterase-4 ("PDE4") inhibitor prodrugs. These prodrugs are designed for targeted delivery to the terminal ileum and colon. The company's primary clinical product candidate, PALI-2108, is under development to treat patients with inflammatory bowel disease ("IBD"), specifically ulcerative colitis ("UC") and Crohn's disease ("CD"). PALI Biopharma's strategy involves advancing its lead candidate, PALI-2108, towards a Phase 2 clinical study in UC. This study is designed to assess clinical remission response and pharmacodynamic biomarkers over 12 weeks, with an extension phase to evaluate maintenance of remission. The company is also completing early studies in FSCD to further characterize PALI-2108's safety, pharmacology, and potential therapeutic benefits across IBD indications. They leverage their drug development platform infrastructure to identify product candidates targeting inflammatory and fibrotic diseases. Additionally, PALI Biopharma pursues strategic partnerships to expand programs and maximize the worldwide potential of its product candidates and platform, and engages in in-licensing/acquisitions or out-licensing/sales of product candidates. The company is currently advancing clinical trials of PALI-2108 for IBD, including UC and CD. PALI Biopharma employs a precision medicine approach, developing a biomarker-based patient selection method. This approach uses clinical and multiomics data from large patient populations to identify PDE4-related biomarkers correlated with IBD and its severity, which are modified by local PDE4-inhibitor therapy in the colon.