Palisade Bio (PALI) Virtual Investor "Top 5 for '25" summary

Product innovation and clinical progress

• PALI-2108, a potent PDE4 inhibitor prodrug, targets inflammation and fibrosis in ulcerative colitis and Crohn's disease, with a formulation that minimizes upper GI exposure and maximizes delivery to the colon.

• Oral delivery is preferred by patients and clinicians, addressing a market of nearly a million US ulcerative colitis patients, many of whom have limited treatment success and face poor safety profiles with current options.

• Over 70% of ulcerative colitis patients overexpress PDE4, supporting the drug's potential efficacy; Phase I SAD data show strong tolerability, no serious adverse events, and only mild effects at the highest dose.

• No EKG or serious safety concerns were observed; PK analysis confirms delayed and extended release, ensuring high local drug concentrations in the colon.

Market opportunity and strategic outlook

• The global ulcerative colitis market exceeds $7 billion and is projected to surpass $9 billion by 2028, with robust deal activity and high average deal values in the IBD space.

• Over 70 deals in the last five years averaged $1.2 billion, with preclinical assets receiving upfront payments over $100 million.

• PALI-1908, a second drug, uses the same PDE4 inhibitor with a different prodrug formulation for targeted release in the terminal ileum, addressing fibrosis in Crohn's disease.

• Early PK data suggest PALI-2108 may also be effective for fibrostenotic Crohn's, potentially reducing the need for a separate Crohn's drug and associated development costs.

• Further exploration of PALI-2108's use in Crohn's is planned, with updates expected in the coming months.