Palisade Bio (PALI) Morgan Stanley 24th Annual Global Healthcare Conference summary

Program and pipeline overview

• PALI-2108, a gut-targeted oral PDE4 inhibitor prodrug, was acquired in preclinical stage and has completed phase I; phase II trials in ulcerative colitis (UC) and Crohn's are commencing in parallel.

• The molecule is engineered to minimize adverse events typical of PDE4 inhibitors by local activation in the gut.

• Strategic focus shifted from niche fibrostenotic Crohn's to broader UC and Crohn's indications based on investor mandate and regulatory feedback.

• Both UC and Crohn's phase II studies are funded and expected to conclude by end of next year, with additional cash runway available.

Clinical trial design and data

• The UC phase II trial is a quadruple-blinded, 12-week induction study with three arms, followed by a double-blinded maintenance phase up to 48 weeks.

• The trial is powered to detect a 20% difference between treatment and placebo with 90% power, and 17.5% with 80% power.

• Phase I data showed strong biomarker and endoscopic improvements, with 100% response and 40% remission in UC, and 40% response/remission in Crohn's.

• PALI-2108 achieves high tissue drug concentrations and once-daily dosing, differentiating it from other PDE4s that require twice-daily dosing and have more tolerability issues.

• The Crohn's phase II IND is expected to be cleared in the second half of the year, with first patient dosing targeted for Q1 2027.

Competitive landscape and differentiation

• The IBD treatment landscape remains crowded but unsatisfactory, with unmet needs in both UC and Crohn's.

• PALI-2108's oral, locally activated profile and improved tolerability position it as a potential monotherapy and future backbone for combination regimens.

• The drug is seen as competitive with emerging therapies like icatibant and obefazimod, and as a strong candidate among oral small molecules.