Palisade Bio (PALI) investor relations material

Key program updates and clinical progress

• Lead drug is an oral PDE4 inhibitor prodrug, specifically designed for IBD, with dual anti-inflammatory and anti-fibrotic mechanisms.

• Phase I-A and I-B studies completed in ulcerative colitis and Crohn's disease, showing strong safety and efficacy signals, including 100% response and 40% remission in UC cohort.

• Phase II study in ulcerative colitis to begin soon, followed by a Crohn's disease study; both are well-funded after a $138 million raise.

• IND clearance for UC expected in H1 2026, with first patient dosing in H2 2026 and efficacy readout in H2 2027; Crohn's IND clearance expected H2 2024, with interim and primary readouts in H1 2028.

• Drug is differentiated by once-daily dosing, gut-restricted activation, and improved tolerability profile.

Scientific and competitive landscape

• Drug design leverages prodrug technology for targeted delivery and reduced systemic side effects, inspired by sulfasalazine's mechanism.

• Demonstrated robust pharmacokinetics and tissue targeting, with high drug levels in colon tissue and sustained IC90 levels.

• Compared favorably to other PDE4 inhibitors, including pan and isoform-selective competitors, with a focus on broad inhibition and local activation.

• Recent data from competitors like Mufemilast and AgomAb contextualized, highlighting the unique approach and efficacy of the current program.

• Plans to gather fibrotic biomarkers in Crohn's studies to support potential best-in-class positioning for fibrostenotic disease.

Financial and organizational highlights

• $138 million financing completed in October, providing runway through both phase II studies and an additional year.

• Clean cap table with minimal warrant overhang, no debt, and strong institutional backing.

• Recent recruitment of top biotech and pharma talent, as well as a world-class clinical advisory board with leading KOLs.

• Strategic shift to focus on broader Crohn's population based on regulatory feedback and market opportunity.

• Future Crohn's study planned as an open-label, moderate-to-severe cohort, targeting 50-60 patients.