Palisade Bio (PALI) investor relations material

Lead asset development and differentiation

• Lead asset is a PDE4 inhibitor (PALI-2108) for IBD, engineered as a prodrug for improved tolerability and local delivery.

• Asset was acquired after previous financing collapsed, and development continued through preclinical and phase I studies.

• Phase I and IB studies showed strong tolerability and biomarker improvements, including 100% response and 40% improvement in the modified Mayo Score in ulcerative colitis.

• Prodrug design aims to avoid GI side effects by local, slow release, differentiating it from drugs like Otezla and other PDE4 inhibitors.

• Drug targets multiple PDE4 isoforms, addressing patient variability in expression.

Clinical progress and future studies

• Completed phase I and IB studies in healthy volunteers, ulcerative colitis, and FSCD, with positive tolerability and efficacy signals.

• Regulatory uncertainty in fibrostenosing Crohn's disease led to a pivot toward open-label luminal Crohn's studies.

• Phase IIb (Acentra) study in ulcerative colitis is a three-arm, registration-like trial with 204 patients, targeting 17.5–20% difference over placebo.

• Study design includes 12-week induction and 48-week maintenance, with site activation underway and updates expected soon.

• Crohn's disease study approval and details to be announced, with potential interim data during the year.

Competitive landscape and positioning

• PDE4 inhibitors show promise for high remission rates when delivered locally; recent data from mufemilast and obefazimod inform expectations.

• Drug is positioned as a potent anti-inflammatory with early symptomatic improvement, aiming for efficacy similar to best-in-class competitors.

• Consistent drug exposure and local activation are expected to minimize side effects and maximize efficacy.

• Patient population for trials will be representative of moderate to severe UC, with a mix of bio-naive and advanced therapy-exposed patients.

• Combination therapy is a future focus, leveraging the drug's safety profile as a potential backbone for oral small molecule regimens.