Palisade Bio (PALI) investor relations material

Corporate highlights and mission

• Advancing once-daily, oral PDE4 inhibitor prodrugs for inflammatory and fibrotic diseases, targeting the multi-billion-dollar IBD market.

• Lead asset PALI-2108 is the only oral PDE4 inhibitor prodrug in development for ulcerative colitis (UC) and Crohn's disease (CD), with positive Phase 1a/b data supporting safety and local bioactivation.

• Raised $138 million from institutional healthcare investors, providing funding through major development milestones.

• Developing a precision medicine CDx test to identify UC patient responders to PDE4 inhibitors.

Product differentiation and mechanism

• PALI-2108 is a potent, gut-activated PDE4 inhibitor prodrug with 10–20x potency over other PDE4 inhibitors, targeting the terminal ileum and colon.

• Localized bioactivation in the GI tract minimizes systemic exposure and reduces risk of GI and CNS adverse events.

• Dual anti-inflammatory and anti-fibrotic mechanism, with improved tolerability and potential for combination therapies.

• Extended-release PK supports once-daily dosing, with high local tissue drug levels and delayed systemic exposure.

Clinical development and results

• Phase 1a/b studies in UC and FSCD (fibrostenosing Crohn's disease) showed exceptional safety, no serious adverse events, and robust PK/PD supporting mucosal targeting.

• In UC, 100% clinical response and 40% clinical remission after 7 days of 30mg BID dosing; significant improvements in histology and biomarkers.

• In FSCD, once-daily dosing was well tolerated, with 40% achieving endoscopic response and remission; tissue drug levels exceeded IC90, and strong correlation between CAMP increase and inflammation reduction.

• Phase 2 studies in UC and CD planned to start in 2026, with key efficacy and safety endpoints.