Palisade Bio (PALI) Corporate presentation summary

Corporate highlights and strategy

• Focus on next-generation, once-daily, oral PDE4 inhibitor prodrugs for inflammatory and fibrotic diseases, targeting the large IBD market.

• Lead asset PALI-2108 is the only PDE4 inhibitor prodrug in development for terminal ileum and colon, aiming to treat ulcerative colitis (UC) and Crohn's disease (CD).

• Raised $138 million from institutional healthcare investors, with $133.4 million cash as of December 2025, supporting major development milestones.

• Precision medicine CDx test in development to identify UC patient responders to PDE4 inhibitors.

Product differentiation and mechanism

• PALI-2108 is a potent, selective PDE4 inhibitor prodrug with 10–20x potency over other PDE4 inhibitors, designed for local GI activation and minimal systemic exposure.

• Localized bioactivation in the colon via bacterial β-glucuronidase limits adverse events and enhances tolerability compared to systemic PDE4 inhibitors.

• Dual anti-inflammatory and anti-fibrotic mechanism, with tissue-restricted action in the ileum and colon.

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

Clinical development and results

• Positive Phase 1a/b data in UC and FSCD (fibrostenosing Crohn's disease) show safety, tolerability, and robust PK/PD supporting local bioactivation.

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

• In FSCD, 40% achieved endoscopic response and remission after 14 days of once-daily dosing; strong PK/PD correlation and improved inflammatory markers.

• Safety profile across studies shows no serious adverse events, minimal withdrawals, and mild, transient TEAEs.