Palisade Bio Completes Dosing in Phase 1a Portion of Ongoing Phase 1a/b Study of PALI-2108

Sustained positive preliminary data from all completed single ascending dose (SAD) cohorts, multiple ascending dose (MAD) cohorts, and food effects crossover, further supporting the safety and tolerability of PALI-2108

No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs observed to date

Screening for Phase 1b UC cohort ongoing; On track to report topline data in the first half of 2025

Carlsbad, CA, April 09, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade", "Palisade Bio", or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases, today announced the completion of enrollment and dosing in all five Phase 1a SAD cohorts, all four MAD cohorts, and the food effects crossover in the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

Preliminary results show no SAEs and no TEAEs related to laboratory values or EKGs to date. The majority of observed TEAEs were considered mild, with only a single withdrawal in the highest 50 mg twice-daily dosage (BID) MAD cohort. Several of the MAD cohorts, ranging from 15 mg BID to 30 mg BID, were completed within the expected therapeutic dose range, again showing no SAEs or TEAEs related to laboratory values or EKGs. The 15 mg BID cohort was completed with no TEAEs, while the titrated 30 mg BID cohort was completed with a single mild TEAE. Given PALI-2108's high potency towards PDE4 B and D compared to other PDE4 inhibitors in preclinical studies, these results underscore its excellent tolerability at comparable dose levels. Screening and dosing of the Phase 1b UC patient cohort are ongoing, with one subject having completed this portion of the study. The Company is on track to report topline data from the Phase 1a portion of the study by the end of May 2025.

"We continue to make significant progress in our Phase 1a/b study of PALI-2108. With the completion of the Phase 1a portion and our ongoing efforts in screening, enrollment, and dosing within the Phase 1b cohort of UC patients, we remain on track to report topline data in the first half of 2025. Preliminary results from both our SAD and MAD cohorts support our confidence that we are dosing at the target therapeutic levels without encountering significant adverse events. This further strengthens our belief that PALI-2108 has the potential to offer a much-needed treatment option for patients with UC. We remain focused on the successful execution of the trial and look forward to sharing full topline data in the near future," said Dr. Mitch Jones, Chief Medical Officer of Palisade.

The primary aim of this single-center Phase 1a/b study is to evaluate the safety, tolerability, and PK of PALI-2108 in healthy volunteers as well as to evaluate the safety, tolerability, PK and pharmacodynamics PD in patients with UC. Several PDE4 inhibitors have received market approval in both inflammatory and fibrotic disease; however, PALI-2108 represents a new chemical entity that has not been previously administered to humans. Biomarkers, including serum high sensitivity C-reactive protein (hsCRP), and fecal calprotectin (CalPro), along with colonic tissue histological assessments, will be employed to provide further insights into the drug's effects. The analysis of colon tissue will include the study drug and metabolite levels, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, Absolute Lymphocyte Count (ALC), and related PD biomarkers, which are crucial for understanding the drug's mechanism and efficacy.

For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

About Palisade Bio

Palisade Bio is a clinical-stage 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

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 safety and tolerability, PK and drug release characteristics of PALI-2108 based on the Company's preclinical studies and preliminary data from the Company's Phase 1b/2a clinical study, indications and anticipated benefits of PALI-2108 and the expected timing of the release of topline data from the Phase 1b/2a clinical study. These forward-looking statements are based on 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 is heavily dependent on the success of PALI-2108, which is in the early stages of clinical development and may not successfully progress through clinical development or receive regulatory approval; preliminary clinical study results or the results from earlier preclinical studies may not be predictive of final or future results and unexpected adverse side effects or inadequate efficacy of PALI-2108 may limit its development, regulatory approval and/or commercialization; the Company needs to raise significant additional funds to support its operations and the continued development of PALI-2108; the timing and outcome of the Company's current and anticipated clinical studies related to its product candidates; indications of use and estimates about the size and growth potential of the markets for the Company's product candidates, and its ability to serve those markets, including any potential revenue generated; the Company's ability to maintain the Nasdaq listing of its securities; the Company's ability to compete effectively in a competitive industry; the Company's ability to identify and qualify manufacturers to provide API and manufacture drug product; the Company's ability to enter into commercial supply agreements; the Company's ability to attract and retain key scientific or management personnel; the accuracy of the Company's estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and the impact of any global event on the Company's business, and operations, and supply. 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, filed with the Securities and Exchange Commission ("SEC") on March 26, 2024, 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.

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