PALI-2108 is the first and only PDE4 inhibitor in development targeting
the terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs

Ongoing development of PALI-2108 across FSCD and UC, with Phase 2 IND submission planned for H1 2026

 Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral PDE4 inhibitor prodrugs designed for targeted delivery to the terminal ileum and colon, announced that the Japan Patent Office (JPO) has granted a key patent covering PALI-2108, the Company’s lead, gut-microbiota-activated PDE4 B/D inhibitor being advanced for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).

The patent, titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug,” provides composition-of-matter protection for PALI-2108 in Japan. The base patent term extends into 2041 and is eligible for patent term extension based on regulatory review timelines. This issuance expands Palisade Bio’s growing global intellectual property estate supporting PALI-2108 and its broader platform of locally activated PDE4 inhibitor prodrugs.

“Securing this Japanese patent for PALI-2108 is an important milestone as we continue to strengthen the IP foundation for our IBD portfolio,” said J.D. Finley, Chief Executive Officer of Palisade Bio. “Japan represents one of the world’s largest and most commercially significant markets for inflammatory bowel disease, and patients with UC and FSCD continue to face limited targeted treatment options. This patent not only reinforces the global reach of our technology but also supports the long-term opportunity of PALI-2108 as a differentiated, locally-acting therapy. We believe PALI-2108 has the potential to meaningfully improve outcomes for IBD patients in Japan and worldwide.”

PALI-2108 has recently completed a Phase 1a SAD/MAD and FE, followed by a Phase 1b cohort study in UC and is currently being evaluated in an ongoing Phase 1b cohort study in FSCD. Data from these studies are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.