Palisade Bio Announces Granting of Japanese Patent Covering Composition of Matter for Lead Product Candidate, PALI-2108

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

Carlsbad, CA, Dec. 30, 2025 (GLOBE NEWSWIRE) -- 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, today 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.

About PALI-2108

PALI-2108 is an orally administered, prodrug engineered for local delivery of phosphodiesterase-4 (PDE4) inhibition to the terminal ileum and colon. The prodrug molecule is gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is cleaved by bacterial enzymes to release its active PDE4 inhibitor metabolite directly at the site of inflammation and fibrosis. This targeted and slow-release design prevents absorption through the upper gut, achieves sustained local exposure and a longer half-life that enables once-daily dosing, and is engineered to produce a blunted peak plasma concentration to improve the overall therapeutic index. Together, these properties are intended to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure and reducing class-related tolerability issues, such as nausea and headache, that have limited 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 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 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
908-824-0775
PALI@jtcir.com

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