• Findings demonstrate that the microbiome and enzymes are sufficient in mouse, dog, and Normal Healthy Volunteers (NHV) and Ulcerative Colitis (UC) patients
• Company advancing toward commencement of Phase 1 human clinical study of PALI-2108 for the treatment of UC before year end

Carlsbad, CA, July 29, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc.(Nasdaq: PALI) (the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the successful completion of a microbiome study demonstrating that beta-glucuronidase is present at similar levels among dog, mouse, and human microbiota as well as within healthy humans and those with Crohn’s disease (CD) and ulcerative colitis (UC).

“We are pleased to bolster our growing body of data for PALI-2108. The study completed by CosmosID, which uses direct identification of beta-glucuronidase by multiple databases, indicates that the presence of this enzyme is not significantly different among the species or between healthy and disease human cohorts. This allows the prodrug to break down in the areas of the GI tract where we are trying to deliver the active drug and confirms our previous findings of adequate bioactivation of PALI-2108 in NHV and UC patients’ stool,” commented Dr. Mitch Jones, CMO of Palisade Bio.

Publicly available data for dog, mouse, and human whole genome metagenomic sequencing was obtained from the NCBI Sequence Read Archive (https://www.ncbi.nlm.nih.gov/sra). These samples were found by searching for metagenomic data for the specific host species and further filtered for Illumina paired-end whole genome sequencing (WGS) data.

These data samples were subsampled to 6 million reads each to allow for accurate functional pathway and gene identification while keeping the maximum number of samples for comparison. After subsampling, the samples were uploaded to the CosmosID-HUB (app.cosmosid.com) for functional identification of genes, enzymes, and pathways utilizing the MetaCyc, Gene Ontology, and Enzyme Commission databases.

Findings from the study demonstrated that although there are overall significant differences by species among the functional data as a whole, beta-glucuronidase-specific functions are not significant. The superpathway of beta D-glucuronoside degradation does show significant differences by species, but this pathway does not directly identify the enzyme beta-glucuronidase. Beta-D-glucuronoside is the substrate for beta-glucuronidase (MetaCyc pathway), which may imply that the enzyme is present. However, direct identification of beta-glucuronidase by both EC and GO databases indicate that the presence of this enzyme is not significantly different among the species or between healthy and disease human cohorts.

Palisade continues to advance PALI-2108 for the treatment of moderate-to-severe UC toward a Phase 1 clinical study, expected to be initiated before the end of 2024. The Company’s PALI-1908 candidate is a microbiota-activated PDE4 inhibitor prodrug that leverages the advancements made with PALI-2108 and is being developed for the treatment of fibro stenotic Crohn’s Disease.

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

This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024 and May 13, 2024, respectively. 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.

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