Palisade Bio (PALI) investor relations material

Key milestones and catalysts

• Phase 1b cohort in fibrostenotic Crohn's disease to read out in early Q1 2025, with 6–12 patients.

• IND filing for a definitive UC study planned for mid-2025, with final top-line readout expected by end of 2027.

• Safety and toxicology data readouts expected in Q1 2025, supporting IND readiness.

• Phase II UC study designed as a definitive, potentially registrational trial with 65 patients per arm and a 52-week blinded maintenance extension.

• Recent $138 million fundraising ensures funding for Phase II studies in both UC and FSCD, with at least 1.5 years of runway post-study.

Scientific and clinical insights

• Lead asset is a once-daily, oral prodrug PDE4 inhibitor targeting the terminal ileum and colon, activated by gut bacteria.

• Demonstrated 100% clinical response and 40% clinical remission in a small UC cohort after one week, with rapid biomarker improvements.

• Drug is 20 times more potent than Apremilast and designed to minimize adverse events by limiting upper gut absorption and Cmax.

• Safety and tolerability are key differentiators versus other oral therapies, such as JAK inhibitors and S1Ps, which have black box warnings.

• Mechanistically, the drug is both anti-inflammatory and antifibrotic, addressing high unmet needs in fibrostenotic Crohn's disease.

Study design and future plans

• Phase II UC study will not use adaptive dose selection; all patients will be randomized to high, low, or placebo arms.

• Key secondary endpoints include safety, tolerability, and efficacy across patient subgroups, including biologic-experienced and naive.

• Phase 1b in fibrostenotic Crohn's will assess safety, PK/PD, histology, endoscopy, and ultrasound measures in symptomatic patients with ileal lesions.

• Data from the Crohn's study will inform dosing for future UC studies.

• Accelerated approval pathway for fibrostenotic Crohn's may use surrogate biomarkers and imaging endpoints, with post-marketing commitments.