Palisade Bio Doses First Patient in Phase 2b Ulcerative Colitis Trial

The Tip Desk · November 10, 2026 · 3 min read

Cash and cash equivalents were $113.6 million as of September 30, 2026, which the company said it believes will fund operations through Phase 2 readouts.

Palisade Bio, Inc. (PALI), a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases, dosed the first patient in its global Phase 2b ASCENTRA-UC trial of PALI-2108 on October 27, 2026, after its second-quarter update had said first-patient enrollment was expected in the second half of 2026.

The company activated 29 of 30 planned U.S. clinical sites. ASCENTRA-UC is expected to enroll approximately 204 patients with moderately to severely active ulcerative colitis and compare two once-daily oral doses of PALI-2108, 15 mg and 30 mg, with placebo. The primary endpoint is clinical remission at Week 12 by Modified Mayo Score. Topline results from the 12-week induction period are expected in the fourth quarter of 2027.

Chief Executive Officer JD Finley said the company’s focus is on driving enrollment and executing the study, and that it is expanding its global clinical footprint. Health Canada CTA clearance was received in September 2026 and regulatory clearance in the Republic of Georgia in October 2026, with additional submissions under review in Europe and other countries. The company said it is advancing toward approximately 115 total sites.

The FDA cleared the IND for the Phase 2a ASCENTRA-CD Crohn’s disease trial on September 22, 2026, after the second-quarter release had said that IND was expected in the second half of 2026. ASCENTRA-CD is a multicenter, open-label, single-arm study expected to enroll about 60 adults with moderate-to-severe Crohn’s disease at a target dose of 30 mg once daily. Enrollment is targeted for the first quarter of 2027, with the primary efficacy readout expected in the first quarter of 2028.

Research and development expenses were $10.6 million for the three months ended September 30, 2026, versus $1.4 million a year earlier. The company said the increase primarily reflects expenses associated with advancing PALI-2108 into Phase 2 clinical development, including clinical trial start-up activities, manufacturing and clinical supply, and supporting preclinical and translational research, as well as higher employee-related expenses, including increased non-cash stock-based compensation.

General and administrative expenses were $5.1 million for the three months ended September 30, 2026, versus $1.5 million a year earlier. The company said the year-over-year increase reflects expanded operating activities and higher employee-related expenses, including increased non-cash stock-based compensation.

Net loss was $14.6 million, or $0.07 a share, for the three months ended September 30, 2026, compared with a net loss of $2.9 million, or $0.38 a share, a year earlier.

Cash and cash equivalents stood at $113.6 million as of September 30, 2026, down from $133.4 million at December 31, 2025. The company said it believes that cash will fund operations through key Phase 2 clinical milestones, including the anticipated primary efficacy readouts from ASCENTRA-UC in the fourth quarter of 2027 and ASCENTRA-CD in the first quarter of 2028.

The company presented five posters at ACG 2026, including two selected for Presidential Poster Awards, and additional clinical and translational findings at UEG Week 2026, including endoscopic improvement within two weeks in an exploratory, open-label Phase 1b cohort of five patients with fibrostenotic Crohn’s disease. It said those findings support continued Phase 2 development of PALI-2108 in ulcerative colitis and Crohn’s disease.

PALI-2108 is an investigational, once-daily oral PDE4 inhibitor prodrug designed for localized bioactivation in the terminal ileum and colon. Its active metabolite, PALI-0008, inhibits PDE4 isoforms A, B and D. PALI-2108 has not been approved for any indication.