Palisade Bio (NasdaqCM:PALI) FY Conference Transcript

Summary of Palisade Bio FY Conference Call Company Overview - Company: Palisade Bio (NasdaqCM:PALI) - History: Established approximately 16 years ago, with a significant transformation occurring in summer 2023 after a phase 2 study yielded disappointing results. The company pivoted to focus on a PDE4 inhibitor acquired from Giiant Pharma, which was originally developed in Merck labs in Montreal [4][5]. Core Product and Mechanism - Product: PALI-2108, a prodrug PDE4 inhibitor designed to mitigate common adverse effects associated with traditional PDE4 inhibitors, such as diarrhea, headache, and nausea [7][9]. - Mechanism: The prodrug formulation allows for gut-restricted action, releasing the active ingredient in the distal gut, thus avoiding upper gastrointestinal issues. It has a long half-life and is administered once daily, which is unique among PDE4 inhibitors [10][11][12]. Clinical Development - Phase 1A and 1B Studies: Completed with promising results, including a 63% improvement in modified Mayo score in a small open-label study of 5 ulcerative colitis (UC) patients [18]. - Phase II Plans: Enrollment for the Phase II UC study is expected to start in Q3 2026, with top-line results anticipated by the end of 2027. The study aims to include 50-70% bio-experienced patients [23][39]. Market Opportunity - Fibrostenosing Crohn's Disease (FSCD): Identified as a significant unmet need, with 75% of Crohn's patients requiring surgery for strictures. There are approximately 200,000 symptomatic patients in the U.S. alone [27]. - Potential for Broader Applications: The drug's mechanism may also be applicable to other inflammatory conditions, including COPD and IPF, due to its improved pharmacology and tolerability [43]. Financial Position - Funding: The company raised $138 million in a re-IPO, providing sufficient runway to conduct definitive studies in UC and Crohn's, with cash expected to last into 2029 [40]. Strategic Considerations - Corporate Development: The company is in early discussions with large pharmaceutical firms to raise awareness of its developments, preparing for potential partnerships as data becomes available [45]. Key Takeaways - Innovative Approach: PALI-2108's prodrug formulation represents a significant advancement in the treatment of inflammatory bowel diseases, aiming to improve patient tolerability and outcomes. - Strong Pipeline: The company is strategically positioned to address significant unmet needs in both UC and Crohn's disease, with plans for future studies and potential expansion into other therapeutic areas. - Robust Financial Backing: The recent funding provides a solid foundation for ongoing clinical trials and development efforts, enhancing the company's prospects for success in the competitive biotech landscape.