PALI PALISADE BIO INC

Palisade Bio Strengthens Clinical Leadership Team with Appointment of James Izanec, MD, AGAF as Vice President, Clinical Development

Palisade Bio Strengthens Clinical Leadership Team with Appointment of James Izanec, MD, AGAF as Vice President, Clinical Development

Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease

Carlsbad, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients with inflammatory and fibrotic diseases, today announced the appointment of James Izanec, MD, AGAF as Vice President, Clinical Development.



Dr. Izanec is a physician–scientist with over two decades of clinical and drug development leadership spanning immunology, neuroscience, and gastroenterology. He brings extensive experience directing registrational Phase 2 and Phase 3 programs, shaping asset-level development strategies, and guiding cross‑functional execution at leading pharmaceutical organizations including Bristol Myers Squibb and Janssen.

Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, commented, “We are thrilled to welcome Dr. Izanec to Palisade. His leadership of major late‑stage global programs, combined with his deep expertise in gastroenterology and immunology, brings the operational rigor and scientific depth needed as PALI‑2108 advances toward key milestones. His experience running complex, multinational Phase 3 programs spanning Crohn’s disease, ulcerative colitis, multiple sclerosis, Sjögren’s syndrome, and pediatric indications positions him to make an immediate and meaningful impact on our development strategy and execution.”

Prior to joining Palisade Bio, Dr. Izanec served as Senior Medical Director and Clinical Development Lead at Bristol Myers Squibb, where he led global Phase 2/3 development programs across autoimmune and neurological diseases. His responsibilities included oversight of a 1,200‑patient Phase 3 Crohn’s program, leadership of pediatric development programs in Crohn’s disease, ulcerative colitis, and multiple sclerosis, and strategic ownership for the clinical development plans of ozanimod and deucravacitinib.



Previously, he served as Medical Director at Janssen, where he led global Phase 3 and Phase 4 studies in gastroenterology and immunology, contributed to lifecycle and label‑expansion programs for ustekinumab and infliximab, and helped support the successful launch of Stelara in ulcerative colitis, the largest franchise within Johnson & Johnson.

Earlier in his career, Dr. Izanec spent a decade as a practicing gastroenterologist and hepatologist, serving as principal investigator for more than 50 clinical trials across inflammatory bowel disease, hepatology, functional GI disorders, and motility disorders. He has authored more than 100 peer‑reviewed publications and abstracts and has been a frequent invited speaker at global medical congresses including DDW, ECCO, ACG, and UEGW.

Dr. Izanec received his medical degree from Weill Cornell Medical College, completed his internal medicine residency at Temple University Hospital, and his gastroenterology fellowship at Drexel University College of Medicine. He is a Fellow of the American Gastroenterological Association and graduated magna cum laude from Cornell University.

About Palisade Bio

Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”) is a clinical-stage biopharmaceutical company advancing a next generation of, once daily, oral PDE4 inhibitor prodrugs designed to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases. Through its differentiated prodrug platform and precision pharmacology strategy, Palisade Bio is committed to transforming proven PDE4 biology into better, safer oral therapies for patients living with chronic inflammatory and fibrotic diseases.

The Company’s lead program, PALI-2108, is a locally-bioactivated PDE4 inhibitor prodrug being developed for moderate-to-severe Ulcerative Colitis (UC) and Fibrostenotic Crohn’s Disease (FSCD), two diseases with limited non-immunosuppressive therapy options. In a recently reported Phase 1b trial, PALI-2108 achieved a 100% clinical response in the UC cohort, with no serious adverse events, favorable tolerability and pharmacokinetics consistent with sustained localized activation, low systemic exposure, and controlled release within the GI tract.

Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission, response and pharmacodynamic biomarkers over 12 weeks, with an extension phase assessing maintenance of remission. In addition, the Company is preparing to initiate studies in FSCD to further characterize PALI-2108’s safety, pharmacology and therapeutic benefit across inflammatory bowel disease indications. For more information, please go to .

Forward Looking Statements

Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include but are not limited to: statements regarding the timing and results of clinical trials, the potential mechanisms of action and therapeutic benefits of PALI-2108, and plans for regulatory submissions. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the risk that prior results, such as signals of safety, activity, dosing or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.



Investor Relations Contact

JTC Team, LLC

Jenene Thomas

908-824-0775

Source: Palisade Bio



EN
02/12/2025

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