Appointment strengthens Phase 2 development strategy for PALI-2108 in ulcerative colitis and fibrostenotic Crohn’s disease; Phase 2 ulcerative colitis IND submission planned for first half of 2026

Carlsbad, CA, Feb. 17, 2026 (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 engineered for targeted delivery to the terminal ileum and colon, today announced the appointment of Bram Verstockt, MD, PhD, to its Clinical Advisory Board (CAB).

Dr. Verstockt is an internationally recognized expert in inflammatory bowel disease (IBD) and a leader in precision medicine and advanced, non-invasive disease assessment. His appointment further enhances Palisade’s clinical and translational expertise as the Company prepares to advance PALI-2108 into Phase 2 development in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD).

“As we transition into Phase 2 development, optimizing patient selection, endpoint strategy, and disease monitoring will be central to demonstrating meaningful clinical benefit,” said Mitch Jones, MD, PhD, President and Chief Medical Officer of Palisade Bio. “Dr. Verstockt is a global leader in precision medicine and non-invasive assessment in IBD. His expertise in advanced imaging, biomarker integration, and multi-omics research will be highly valuable as we design studies intended to efficiently demonstrate durable efficacy and disease modification in both UC and FSCD.”

About Bra m Verstockt, MD, PhD

Dr. Verstockt is an IBD staff physician and professor in the Department of Gastroenterology and Hepatology at University Hospitals Leuven and KU Leuven, Belgium. His clinical and translational research centers on precision medicine in IBD, with a focus on disease heterogeneity, biomarker development, and non-invasive disease monitoring techniques, including intestinal ultrasound and advanced radiologic modalities.

He has played a leading role in international collaborations applying multi-omics, proteomics, and organoid-based platforms to better characterize treatment response and disease behavior in IBD. Dr. Verstockt is also a co-founder of the COLLIBRI proteomics consortium, which advances biomarker discovery and translational research across inflammatory diseases.

“Precision stratification and objective, non-invasive disease assessment are increasingly critical in IBD drug development,” said Dr. Verstockt. “PALI-2108 represents a differentiated oral approach targeting inflammatory pathways in the ileum and colon. I look forward to supporting the integration of advanced imaging and biomarker-driven strategies into its Phase 2 development program.”

Palisade plans to submit an Investigational New Drug (IND) application for a Phase 2 study of PALI-2108 in UC in the first half of 2026, with parallel development planning underway in FSCD.

About PALI-2108

PALI-2108 is a once-daily, oral prodrug designed for targeted delivery of PDE4 inhibition to the terminal ileum and colon through local bacterial bioactivation. The prodrug is pharmacologically inactive until it reaches the lower intestine, where bacterial enzymes convert it into the active PDE4 inhibitor at sites of inflammation and fibrosis. This targeted activation strategy prevents absorption in the upper gut, enables sustained local exposure with controlled systemic distribution, and is engineered to reduce peak plasma levels, thereby improving the overall therapeutic index and reducing tolerability limitations such as diarrhea, nausea and headache that have constrained systemic PDE4 inhibitors.

About Palisade Bio

Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”) is a clinical-stage biopharmaceutical company advancing a next generation 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 once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the ileum and colon, initiating targeted PDE4 inhibition at sites of disease while enabling systemic distribution of the active drug. 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 localized activation in the lower intestine, 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 completing early studies in FSCD to further characterize PALI-2108’s safety, pharmacology and and potential therapeutic benefit across inflammatory bowel disease indications. For more information, please go to www.palisadebio.com .

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
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