Palisade Bio (PALI) investor relations material

Key product and clinical development updates

• Lead asset is PALI-2108, a PDE4 inhibitor prodrug targeting the ileum and colon for IBD indications, designed to minimize adverse events by local activation in the lower GI tract.

• Completed preclinical and phase I studies, including 84 healthy volunteers and five UC patients, with positive safety and efficacy signals; ongoing FSCD cohort to read out by end of month.

• IND for a 196-patient ulcerative colitis study planned for May, with patient dosing in early Q3 and data readout by end of 2027; FSCD IND clearance expected second half of this year.

• Precision medicine test developed to select likely responders; dual anti-inflammatory and anti-fibrotic mechanism differentiates from competitors.

• Upcoming milestones include UC study initiation mid-year, FSCD interim readouts, and primary efficacy data in Crohn's in first half of 2028.

Competitive landscape and differentiation

• Main competitor Agomab recently IPO'd, highlighting market interest in FSCD; few oral, once-daily options exist for Crohn's and UC.

• PDE4 inhibitors have proven efficacy in related indications; PALI-2108 is the only locally activated, once-daily oral prodrug in development for IBD.

• Other oral options (JAKs, S1Ps) have safety or efficacy limitations; PALI-2108 aims to offer improved tolerability and dual action.

• Clinical remission rates for current biologics are sub-20% at 12 weeks; PALI-2108 aims to surpass this benchmark.

Clinical data and safety profile

• Phase I-B in UC showed 100% response and 40% remission after one week, with significant biomarker improvements and no steroid use.

• Safety profile favorable: no serious adverse events, minimal CNS or GI toxicity at target doses, supported by PopPK modeling.

• High tolerability even at elevated doses; ongoing studies to further confirm safety and PK/PD in sicker populations.