Palisade Bio (PALI) 25th Annual Needham Virtual Healthcare Conference summary

Key program updates and milestones

• Lead asset is a once-daily, oral PDE4 inhibitor prodrug, acquired via license 2.5 years ago, with preclinical and early clinical data completed in UC and Crohn's disease patients.

• IND clearance for phase II UC study expected in H1, with first dosing midyear and primary readout in H2 2027; Crohn's phase II to follow with interim readouts in 2027.

• Drug design leverages local gut activation and systemic absorption, aiming to improve tolerability and efficacy over prior PDE4 inhibitors.

• Phase I and Ib studies showed no significant PDE4-related adverse events at target doses, with robust PK/PD engagement and high tissue-to-plasma drug ratios.

• Company raised nearly $140 million following positive UC data, with cash runway projected to cover both phase II studies and an additional year.

Clinical data and mechanistic insights

• In UC, five-patient phase Ib showed 100% response and 40% clinical remission after one week, with significant biomarker improvements and no steroid use.

• Crohn's phase Ib in advanced, refractory patients demonstrated strong PK/PD effects, 40% endoscopic response/remission, and no PDE4-related adverse events.

• Drug achieves sixfold higher tissue-to-plasma concentration, supporting local efficacy and improved therapeutic index.

• Mechanism relies on microbiome enzyme activation in the gut, enabling targeted release in both ileum and colon, with systemic distribution to address extraintestinal symptoms.

• Titration will be used in phase II for safety, though future studies may explore fixed dosing due to favorable tolerability profile.

Strategic positioning and future plans

• Asset positioned as a potential monotherapy or combination therapy in IBD, with no observed drug-drug interactions in patients on background treatments.

• Aims to surpass current remission rates of existing IBD therapies, leveraging fast onset and precision medicine biomarker test for responder selection.

• Systemic distribution opens potential for expansion into other inflammatory and fibrotic diseases.

• Well-capitalized to execute on planned clinical milestones and further development.

• No major safety concerns observed to date; program is tracking as designed with high investor interest.