Earnings release
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Palisade Bio Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of PALI - 2108 Into Phase 2 Development Advancing a potentially best - in - class once - daily oral , locally - activated PDE4 inhibitor prodrug specifically engineered for the treatment of inflammatory bowel disease ( IBD ) Enrollment of first patient for Phase 2 ASCENTRA - UC trial of PALI - 2108 expected in the second half of 2026 ; primary efficacy results expected in the second half of 2027 IND for Phase 2 ASCENTRA - CD trial of PALI - 2108 for the treatment of Crohn's disease expected in the second half of 2026 Strong balance sheet expected to support execution through key Phase 2 clinical readouts Denver , CO , Aug. 10 , 2026 ( GLOBE NEWSWIRE ) -- Palisade Bio , Inc. ( Nasdaq : PALI ) ( " Palisade Bio " or the " Company " ) , a clinical - stage biopharmaceutical company developing next - generation prodrugs for patients living with inflammatory and fibrotic diseases , today reported financial results for the second quarter ended June 30 , 2026 , and provided a business update . During the quarter , the Company completed key regulatory and operational activities supporting the planned commencement of the Phase 2 ASCENTRA - UC trial of PALI - 2108 in the second half of 2026 . Palisade Bio is advancing PALI - 2108 into Phase 2 development for ulcerative colitis ( UC ) and Crohn's disease ( CD ) , supported by encouraging results from its completed Phase 1 clinical trial . Key Takeaways from the Phase 1 Clinical Trial • Across the Phase 1 clinical trial , PALI - 2108 demonstrated favorable safety and tolerability , sustained exposure of the active metabolite above the IC90 threshold , targeted distribution in the ileum and colon , and pharmacodynamic ( PD ) activity across key inflammatory and fibrotic pathways . • The Phase 1 clinical trial included five patients with UC and five patients with fibrostenotic Crohn's disease ( FSCD ) . • In the UC cohort , 5 out of 5 patients achieved clinical response and 2 out of 5 achieved clinical remission based on Modified Mayo Score . • In the FSCD cohort , PALI - 2108 reduced mean SES - CD score by approximately 47.5 % ( a 3.8 - point improvement ) , with 2 out of 5 patients achieving both endoscopic response and remission based on SES - CD . Together , these findings provide a strong foundation for the planned commencement of the Phase 2 ASCENTRA - UC trial in the second half of 2026. The Company also intends to submit an investigational new drug ( IND ) application to the U.S. Food and Drug Administration ( FDA ) for the Phase 2 ASCENTRA - CD trial of PALI - 2108 in the second half of 2026 . " The second quarter marked a decisive transition for Palisade Bio as we completed the regulatory and operational work required to advance PALI - 2108 into Phase 2 development , " said JD Finley , Chief Executive Officer of Palisade Bio . " With FDA clearance of our IND , encouraging Phase 1 results and a strong financial position , we expect to commence the Phase 2 ASCENTRA - UC trial in the second half of 2026. PALI - 2108 was engineered for targeted activation within the gastrointestinal tract , with the goal of delivering sustained PDE4 inhibition while improving tolerability and convenience . We believe the ASCENTRA - UC Phase 2 trial represents a significant opportunity to demonstrate that differentiated profile in a larger patient population and establish PALI - 2108 as a potentially best - in - class , once - daily oral therapy for IBD . " Recent Highlights