Palisade Bio Clears IND and Starts Phase 2 Ulcerative Colitis Trial
Cash and cash equivalents stood at $125.2 million as of June 30, 2026, which the company said is sufficient through Phase 2 readouts expected in the second half of 2027 and early 2028.
Palisade Bio, Inc. (PALI), a clinical-stage biopharmaceutical company developing prodrugs for inflammatory and fibrotic diseases, received FDA clearance of the investigational new drug application for PALI-2108 and said it expects to commence the Phase 2 ASCENTRA-UC trial in the second half of 2026.
That clearance completed the regulatory work the company had been preparing through the first quarter, when it had targeted a third-quarter 2026 start after an IND submission expected in the second quarter. Primary efficacy results from ASCENTRA-UC are expected in the second half of 2027.
Chief Executive Officer JD Finley said the quarter marked a decisive transition as the company finished the work required to move PALI-2108 into Phase 2. The company is advancing the once-daily oral, locally activated PDE4 inhibitor prodrug for ulcerative colitis and Crohn’s disease.
Phase 1 results, which support the Phase 2 plan, included five patients with ulcerative colitis and five with fibrostenotic Crohn’s disease. In the ulcerative colitis cohort, 5 of 5 patients achieved clinical response and 2 of 5 achieved clinical remission based on Modified Mayo Score. In the fibrostenotic Crohn’s disease cohort, PALI-2108 reduced the mean SES-CD score by approximately 47.5%, a 3.8-point improvement, with 2 of 5 patients achieving both endoscopic response and remission. The trial also showed favorable safety and tolerability, sustained exposure of the active metabolite above the IC90 threshold, targeted distribution in the ileum and colon, and pharmacodynamic activity across inflammatory and fibrotic pathways.
President and Chief Medical Officer Mitch Jones said Crohn’s disease is advancing in parallel with ASCENTRA-UC. The company intends to submit an IND for the Phase 2 ASCENTRA-CD trial in the second half of 2026, with trial commencement targeted for the first quarter of 2027 and a primary efficacy readout expected in early 2028. Those Crohn’s timelines matched the outlook given in the first-quarter update.
Research and development expenses were $7.4 million for the three months ended June 30, 2026, compared with $1.7 million a year earlier. The increase was primarily attributable to higher research and development employee-related expenses, including increased non-cash stock-based compensation, and higher PALI-2108 program expenses from increased clinical operations, chemistry, manufacturing and controls activities, and expanded preclinical and translational science supporting Phase 2 advancement. Sequentially, research and development expenses were $7.4 million versus $6.4 million in the three months ended March 31, 2026.
General and administrative expenses were $4.8 million for the three months ended June 30, 2026, compared with $1.2 million a year earlier, on higher employee-related costs, including stock-based compensation, and professional fees.
The company recognized $0.5 million of license revenue in the quarter from a milestone under a co-development and distribution agreement with Newsoara, a joint venture established by Biolead Medical Technology Limited. No license revenue was recognized in the year-ago quarter.
Net loss was $10.6 million, or $0.05 a share, for the three months ended June 30, 2026, compared with a net loss of $2.8 million, or $0.58 a share, a year earlier, as operating expenses rose and weighted-average shares increased.
Cash and cash equivalents were $125.2 million at June 30, 2026, down from $133.4 million at December 31, 2025. Existing cash resources are sufficient to fund operations through major clinical development milestones, including the anticipated primary efficacy readout from ASCENTRA-UC expected in the second half of 2027 and the planned primary efficacy readout from ASCENTRA-CD expected in early 2028.
The company also added biopharmaceutical industry veterans Robert Baltera and Jordan Zwick to the board and presented Phase 1 translational findings at Digestive Disease Week 2026, with additional PALI-2108 data slated for the American College of Gastroenterology 2026 Annual Scientific Meeting and United European Gastroenterology Week 2026.