Palisade Bio (NasdaqCM:PALI) FY Conference Transcript

Summary of Palisade Bio FY Conference Call Company Overview - Company: Palisade Bio (NasdaqCM:PALI) - Industry: Biotechnology, specifically focusing on treatments for inflammatory bowel disease (IBD) including ulcerative colitis (UC) and fibrostenotic Crohn's disease Key Milestones and Catalysts - Completion of a Phase 1B cohort in fibrostenotic Crohn's disease with results expected in early Q1 2026 [6] - Filing of an Investigational New Drug (IND) application for a definitive UC study, anticipated to start mid-year 2026 [6][7] - Final top-line readout for the UC study scheduled for the end of 2027 [7] Product Mechanism and Differentiation - Product: PALI-2108, a PDE4 inhibitor designed as a prodrug for optimized local delivery in the gut [9] - Unique formulation allows for once-daily dosing, targeting the terminal ileum and colon, which is not available with other PDE4 inhibitors [11] - The prodrug is activated by gut bacteria, minimizing systemic exposure and associated adverse effects [11][12] - Demonstrated 100% clinical response and 40% clinical remission in a small cohort of UC patients after one week of treatment [24] Clinical Data and Efficacy - Historical data shows a 31% clinical remission rate for Apremilast and a 57% rate for Mefenilast, while PALI-2108 showed a 100% clinical response in a five-patient cohort [14][15] - Significant biomarker improvements observed: 70% reduction in fecal calprotectin, 15% reduction in CRP, and a 70% increase in cyclic AMP after one week of treatment [15] - The drug is reported to be 20 times more potent than Apremilast, allowing for higher dosing without increased toxicity [17] Safety and Tolerability - Emphasis on safety and tolerability as key differentiators in the market, especially compared to JAK inhibitors and S1Ps which have safety warnings [22][37] - Ongoing studies aim to demonstrate safety and tolerability in symptomatic fibrostenotic Crohn's patients with ileal lesions [44] Future Development Plans - Phase 2 study design includes 195 patients with a focus on individual patient dosing adaptation after the first three weeks [30] - The study aims to establish safety, tolerability, and efficacy, with potential for accelerated approval based on surrogate biomarkers [49] - Current cash position is strong with $138 million raised, providing sufficient runway for Phase 2 studies in both UC and fibrostenotic Crohn's disease [50] Market Opportunity - High unmet medical need in fibrostenotic Crohn's disease with limited competition and no current approvals for anti-inflammatory, antifibrotic treatments [42][43] - The company is positioned uniquely as the only candidate targeting both anti-inflammatory and antifibrotic pathways in this indication [43] Conclusion - Palisade Bio is poised for significant developments in 2026 with promising clinical data, a strong financial position, and a unique product offering that addresses critical needs in the treatment of IBD [51]