Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)

Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for the treatment of UC.

“We are thrilled to receive a No Objection Letter from Health Canada in response to our Clinical Trial Application. This achievement marks the most important milestone to date for our PALI-2108 development program. We continue to believe in the potential of PALI-2108 to be the first approved PDE4 inhibitor for UC and more importantly, provide a much-needed effective and safe solution for UC patients still experiencing significant medical need. Our team remains focused on continuing preparations for the initiation of our Phase 1 clinical trial which is on track to commence before year end,” commented J.D. Finley, Chief Executive Officer.

PALI-2108 is an orally administered PDE4 inhibitor prodrug which is locally bioactivated in the colon and is in development for patients affected by UC. The Phase 1 study will evaluate PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. As previously announced, the Company has established dose levels and trial design for PALI-2108 and plans to enroll approximately 90 patients across the SAD, FE, MAD and UC cohorts.

“Patients are actively seeking new and more effective treatment options for their ulcerative colitis. Currently, existing therapies achieve complete remission in fewer than a quarter of patients, and many of the most effective treatments involve injections or carry black box warnings due to serious side effects. A safe and effective oral medication for UC would be highly desirable for the majority of patients,” said Florian Rieder, MD, a member of the Palisade Bio Clinical Advisory Board and Associate Staff in the Department of Gastroenterology, Hepatology, and Nutrition, as well as an Investigator in the Department of Pathobiology at the Cleveland Clinic.

The primary objective of the study will be to assess the safety and tolerability of single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses of PALI-2108. Secondary objectives include determining the plasma, urinary, and fecal (MAD healthy subjects and UC patients only) pharmacokinetics (PK) of PALI-2108 and its metabolites following PALI-2108 single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses, as well as the effect of food on the PK of PALI-2108 and its metabolites following a single oral dose in healthy subjects. Exploratory objectives will include PDE4-related pharmacodynamic (PD) biomarkers, concentrations of the active form of PALI-2108, high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), colonic tissue Absolute Lymphocyte Count (ALC), Modified Mayo score, as well as colonic histological changes in UC patients following repeated PALI-2108 oral doses.

Preparations for the clinical study remain ongoing and the Company is on track commence site initiation and enrollment for the study before year end.

About Palisade Bio

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

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