Palisade Bio (PALI) Virtual Investor Pitch Conference summary

Company overview and market opportunity

• Focus on early-stage drugs for immunology and inflammatory diseases, especially with fibrotic components.

• Lead program is a PDE4 inhibitor targeting ulcerative colitis (UC) and Crohn's disease, with a primary focus on UC.

• Inflammatory bowel disease represents a multi-billion-dollar market with significant acquisition activity.

• Total addressable market estimated at 8 million patients worldwide.

• CEO has personal motivation due to family experience with UC, emphasizing the need for better therapies.

Drug development and differentiation

• Lead drug PALI-2108 is in late preclinical stage, with human phase I studies planned to start within months.

• Pro-drug formulation enables delayed release in the lower intestine or colon, aiming to minimize systemic side effects.

• Animal studies validate local delivery and reduced adverse effects compared to other PDE4 inhibitors.

• Precision medicine approach uses biomarker analysis to identify likely responders and improve remission rates.

• Current therapies have sub-20% remission rates; PALI-2108 aims for rates above 30%.

Clinical and regulatory strategy

• Preclinical studies are concluding, with CTA filing planned in the next couple of months.

• Phase I-A trial to begin in Canada by year-end, with top-line data expected in the first half of next year.

• Phase I-B/II-A trial planned for the US, with ongoing discussions with the FDA and a pre-IND meeting scheduled this year.

• First-in-human trial will include a precision medicine component, selecting top responders based on biomarkers.

• Scientific advisory board is highly active, advising on trial design and development.