Palisade Bio (NasdaqCM:PALI) FY Conference March 02, 2026 03:10 PM ET Company ParticipantsJ.D. Finley - CEOMitch Jones - President and Chief Medical OfficerTara Bancroft - VP of Health CareTara BancroftHi, I'm Tara Bancroft. I'm one of the Senior Biotech Analysts at TD Cowen. I wanna thank you guys all for coming to TD Cowen's 46th Annual Healthcare Conference. Our next session is a presentation from Palisade Bio. From Palisade we have J.D. Finley, the CEO, and Mitch Jones, the CMO. Thank you guys both for ...

Palisade Bio (NasdaqCM:PALI) FY Conference March 02, 2026 03:10 PM ET Speaker2Hi, I'm Tara Bancroft. I'm one of the senior biotech analysts at TD Cowen. I wanna thank you guys all for coming to TD Cowen's forty-sixth Annual Healthcare Conference. Our next session is a presentation from Palisade Bio, and from Palisade, we have J.D. Finley, the CEO, and Mitchell Jones, the CMO. Thank you guys both for being here. It's a pleasure to have you. I will let you go ahead with your presentation. If there's time at t ...

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.