{"success":true,"data":{"pressRelease":{"id":"166348","rtpr_id":"nGNX6Hg5Lm-20261012","ticker":"PALI","exchange":"NASDAQ","all_tickers":["PALI"],"title":"Palisade Bio Presents New Clinical, Pharmacokinetic, Pharmacodynamic and Mechanistic Data Strengthening the Phase 2 Rationale for PALI-2108 in Ulcerative Colitis and Crohn’s Disease at ACG 2026","author":"Globe Newswire","published_at":"2026-10-12T12:05:00.122Z","article_body":"Five presentations connect targeted intestinal exposure and sustained systemic\ndrug exposure with PDE4 target engagement and early clinical activity,\nsupporting ongoing Phase 2 development\n\nTwo presentations selected for ACG Presidential Poster Awards, a distinction\nreceived by approximately 5% of accepted abstracts\n\nMicrobiome and transcriptomic analyses support the delivery platform and a\npotential precision medicine approach\n\nDenver, CO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq:\nPALI) (“Palisade” or the “Company”), a clinical-stage\nbiopharmaceutical company developing next-generation oral therapies for\nimmune-mediated diseases, today announced clinical and translational findings\nfeatured in five poster presentations at the American College of\nGastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee.\nThe findings strengthen the scientific rationale for the Company’s ongoing\nPhase 2 development of PALI-2108, its investigational oral, locally activated\nPDE4 inhibitor prodrug, in ulcerative colitis (UC) and Crohn’s disease (CD).\n\n“These findings connect the key elements of our development strategy:\ndelivering active drug to diseased intestinal tissue, engaging PDE4, and\nobserving early clinical activity alongside reductions in inflammation,”\nsaid Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade\nBio. “The tissue analyses strengthen the mechanistic foundation for the\nclinical signals observed in UC and fibrostenotic Crohn’s disease, while our\nmicrobiome and biomarker work supports the delivery platform and a potential\npath toward more informed patient selection. As we advance our Phase 2\nprograms, the two Presidential Poster Awards are meaningful recognition of the\nwork of our investigators and collaborators.”\n\nUlcerative Colitis Findings Link Target Engagement to Early Clinical and\nHistologic Improvement\n\nPoster P3504 — ACG Presidential Poster Award: “The Microbiome-Activated\nPhosphodiesterase (PDE)-4 Inhibitor, PALI-2108 Leads to Rapid Clinical and\nHistologic Improvement in Moderate-to-Severe Ulcerative Colitis: A Phase1a/1b\nStudy”\n\nFive patients with moderate-to-severe UC received open-label PALI-2108 for\nseven days, including a five-day titration to 30 mg twice daily. Findings\nincluded:\n* Early clinical activity: All five patients achieved clinical response and\ntwo achieved clinical remission. The poster reported a 62.8% mean reduction in\nmodified Mayo score, alongside improvements in the Nancy, Robarts, and Geboes\nhistologic indices.\n\n\n* Evidence of target engagement: Colonic tissue cAMP increased in four of five\npatients, and PDE4B expression decreased in all five. Fecal calprotectin\ndecreased in four of five patients.\n\n\n* Tissue evidence of reduced inflammation: PathAI-enabled quantitative digital\npathology identified reductions in tissue lymphocytes and other\ninflammatory-cell populations, together with structural changes consistent\nwith early mucosal improvement, including increased normal epithelium and\ngoblet cell mucin and reduced ulceration.\nThese findings provide clinical and mechanistic support for the ongoing Phase\n2 ASCENTRA-UC study, which is designed to evaluate once-daily PALI-2108 at 15\nmg and 30 mg versus placebo in approximately 204 patients. Steady-state\npharmacokinetic data from healthy volunteers receiving 15 mg, 30 mg and 45 mg\nonce daily demonstrated sustained exposure to PALI-0008, the active metabolite\nof PALI-2108, providing additional pharmacologic support for dose selection in\nthe Phase 2 program.\n\nCrohn’s Disease Findings Show Early Endoscopic Activity and Changes in\nTissue Remodeling Biomarkers\n\nPoster P3611: “Gut-Targeted Inhibition of Phosphodiesterase 4 with PALI-2108\nDemonstrates Early Endoscopic and Biomarker Improvements in Fibrostenotic\nCrohn’s Disease: Results from a Phase 1b Study”\n\nFive adults with symptomatic ileal fibrostenotic Crohn’s disease (FSCD)\nreceived open-label PALI-2108 once daily with food for 14 days, including a\n10-day titration to target doses of 20, 25, or 30 mg. Four of five patients\nwere receiving concomitant biologic therapy. Findings included:\n* Favorable short-term tolerability: All reported adverse events were mild,\nwith no serious adverse events or treatment discontinuations. No nausea,\nvomiting, or diarrhea were reported.\n\n\n* Early endoscopic activity: A 47.5% mean reduction in the Simple Endoscopic\nScore for Crohn’s Disease (SES-CD), with two of five patients achieving\nendoscopic response and two of five achieving endoscopic remission after 14\ndays.\n\n\n* Evidence of local pharmacologic activity: Increased ileal tissue cAMP and\nreduced fecal calprotectin were accompanied by reductions in inflammatory-cell\ndensities in paired intestinal biopsies.\n\n\n* Exploratory tissue-remodeling signals: Plasma biomarker changes were\nconsistent with increased collagen degradation and changes in markers\nassociated with macrophage activation. These findings support further\nevaluation of potential effects on extracellular matrix remodeling; they do\nnot establish reversal of intestinal fibrosis or strictures.\nThe findings support continued evaluation in the Company’s Phase 2 Crohn’s\ndisease program. The UC and FSCD patient cohorts were small, short-duration,\nopen-label studies without placebo control; their clinical and translational\nfindings require confirmation in larger studies.\n\nIntestinal Exposure and Sustained Pharmacokinetics Support Once-Daily\nDevelopment\n\nPoster P3413 — ACG Presidential Poster Award: “PALI-2108, a\nNext-Generation Oral PDE4 Inhibitor Prodrug, Demonstrates Localized\nIleocolonic Exposure with Favorable Tolerability in IBD”\n\nAnalyses across the Phase 1a/b program support the pharmacologic rationale for\ntargeted intestinal delivery and once-daily dosing:\n* Targeted intestinal exposure: Concentrations of PALI-0008, the active\nmetabolite of PALI-2108, in sampled ileal and colonic tissue were\napproximately sevenfold higher than peak plasma concentrations in the\nevaluated FSCD cohort.\n\n\n* Sustained exposure: At 30 mg once daily, the poster reported PALI-0008\nplasma exposure above the estimated PDE4 IC90 over 24 hours, supporting\ncontinued once-daily development.\n\n\n* Exploratory pharmacokinetic comparisons: The pooled 30 mg once-daily cohort\nshowed lower trough-concentration variability than published apremilast and\nmufemilast datasets, alongside comparisons of daily exposure normalized to\nPDE4 inhibitory potency. These comparisons were based on small cohorts and\ndiffering study populations and conditions and do not establish comparative\nclinical efficacy or safety.\nMicrobiome Findings Support Prodrug Activation Without Significant Short-Term\nDiversity Changes\n\nPoster P3412: “Microbiome Beta-Glucuronidase Activity Does Not Limit\nBioconversion or Pharmacokinetic Consistency of the Colon-Targeted PDE4\nProdrug PALI-2108 in Ulcerative Colitis”\n\nBecause PALI-2108 relies on the gut microbiome for activation, the analysis\nexamined whether differences in microbiome composition could affect its\nconversion to PALI-0008, the active drug. Findings included:\n* Evidence of microbiome activation: PALI-2108 was converted to PALI-0008 in\nboth healthy volunteers and patients with UC, supporting microbiome-mediated\nactivation in the evaluated cohorts.\n\n\n* Comparability of functional features: Beta-glucuronidase-associated\nfunctional features were comparable between evaluated healthy volunteers and\npatients with UC and remained stable over seven days of treatment.\n\n\n* Consistency in microbiome diversity: No statistically significant changes in\nmeasured alpha or beta microbiome diversity were detected in patients with UC\nover seven days. These short-term findings support further evaluation of the\nplatform’s compatibility with the intestinal microbiome.\nExploratory Transcriptomic Research Supports a Potential Precision Medicine\nApproach\n\nPoster P3505: “Development of Mucosal Transcriptomic Signatures to Predict\nResponse to the Microbiome-Activated Phosphodiesterase (PDE)-4 Inhibitor\nPALI-2108 in Ulcerative Colitis”\n\nAn analysis integrating approximately 3,000 transcriptomic samples from more\nthan 15 studies combined UC disease biology with PDE4/cAMP pathway activity to\ndevelop candidate treatment-response signatures. Findings included:\n* Potential for patient stratification: Exploratory signatures showed\npreliminary discrimination between responder and non-responder phenotypes,\nsupporting further evaluation of a mechanistically informed approach to\npatient stratification.\n\n\n* Integration of inflammatory signaling into framework: The framework\nintegrated inflammatory signaling and PDE4-associated pathways, with\nadditional analyses of fibrosis-related transcriptional activity.\n\n\n* Potential treatment-response biomarker: The findings support continued\nprospective validation of a potential treatment-response biomarker; the\nsignatures are not established clinical tools for selecting patients for\nPALI-2108 treatment.\nAbout the ACG Presidential Poster Awards\n\nPosters P3413 and P3504 were selected for ACG Presidential Poster Awards.\nRecipients are selected by the ACG Abstract Selection Committee based on\nscores and scientific merit. Approximately 5% of accepted abstracts receive\nthe distinction each year.\n\nAbout PALI-2108\n\nPALI-2108 is an investigational oral, locally activated PDE4 inhibitor prodrug\ndesigned for targeted bioactivation in the terminal ileum and colon and being\ndeveloped for once-daily dosing. Its active metabolite, PALI-0008, inhibits\nPDE4, increasing intracellular cAMP to modulate inflammatory signaling. Phase\n1 studies in healthy volunteers and patients with UC or FSCD have provided\nevidence of intestinal exposure, target engagement, favorable short-term\ntolerability, and early clinical activity, supporting continued Phase 2\ndevelopment. PALI-2108 has not been approved for any indication.\n\nAbout Palisade Bio\n\nPalisade Bio is a clinical-stage biopharmaceutical company developing\nnext-generation oral therapies for immune-mediated diseases. Its lead program,\nPALI-2108, is advancing in inflammatory bowel disease, with Phase 2 studies in\nulcerative colitis and Crohn’s disease. For more information, please visit\nwww.palisadebio.com.\n\nForward Looking Statements\n\nAny statements contained in this communication that are not statements of\nhistorical fact may be deemed to be forward-looking statements for purposes of\nthe safe harbor provisions of the Private Securities Litigation Reform Act of\n1995. Forward-looking statements include but are not limited to: implied or\nexpress statements regarding the pharmacological properties, safety,\ntolerability, clinical response and efficacy, and therapeutic potential of\nPALI-2108, dosing levels and timing of key PALI-2108 development milestones\nsuch as regulatory submissions and approvals, trial enrollments and\ncommencements and efficacy readouts, and the Company’s expected cash runway.\nThese forward-looking statements are based on the Company’s current\nexpectations. Forward-looking statements involve risks and uncertainties.\nImportant factors that could cause actual results to differ materially from\nthose reflected in the Company’s forward-looking statements include, among\nothers, the timing of enrollment, commencement and completion of the\nCompany’s clinical trials; the Company’s reliance on PALI-2108, and its\nearly stage of clinical development; the risk that prior results, such as\nsignals of safety, clinical response and efficacy, dosing, durability of\neffect or pharmacological properties, observed from preclinical or clinical\ntrials (such as our Phase 1b findings) with a limited number of patients, will\nnot be replicated or will not continue in ongoing or future studies or\nclinical trials involving the Company’s product candidates in clinical\ntrials focused on the same or different indications; and other factors that\nare described in the “Risk Factors” and “Management’s Discussion and\nAnalysis of Financial Condition and Results of Operations” sections of the\nCompany’s Annual Report on Form 10-K for the fiscal year ended December 31,\n2025, filed with the Securities and Exchange Commission (“SEC”) on March\n20, 2026, and the Quarterly Reports on Form 10-Q or other SEC filings that are\nfiled thereafter. Investors are cautioned not to put undue reliance on these\nforward-looking statements. These forward-looking statements speak only as of\nthe date hereof, and the Company expressly disclaims any obligation or\nundertaking to release publicly any updates or revisions to any\nforward-looking statements contained herein to reflect any change in the\nCompany’s expectations with regard thereto or any change in events,\nconditions or circumstances on which any such statements are based, except as\nrequired by law.\n\nInvestor Relations Contact\nJTC Team, LLC\nJenene Thomas\n908-824-0775\nPALI@jtcir.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0beaede8-1c7c-4f77-84a7-b1efd54c343c)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6Hg5Lm-20261012","title":"Palisade Bio Presents New Clinical, Pharmacokinetic, Pharmacodynamic and Mechanistic Data Strengthening the Phase 2 Rationale for PALI-2108 in Ulcerative Colitis and Crohn’s Disease at ACG 2026","author":"Globe Newswire","ticker":"PALI","created":"2026-10-12T12:05:00.122Z","tickers":["PALI"],"exchange":"NASDAQ","article_body":"Five presentations connect targeted intestinal exposure and sustained systemic\ndrug exposure with PDE4 target engagement and early clinical activity,\nsupporting ongoing Phase 2 development\n\nTwo presentations selected for ACG Presidential Poster Awards, a distinction\nreceived by approximately 5% of accepted abstracts\n\nMicrobiome and transcriptomic analyses support the delivery platform and a\npotential precision medicine approach\n\nDenver, CO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq:\nPALI) (“Palisade” or the “Company”), a clinical-stage\nbiopharmaceutical company developing next-generation oral therapies for\nimmune-mediated diseases, today announced clinical and translational findings\nfeatured in five poster presentations at the American College of\nGastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee.\nThe findings strengthen the scientific rationale for the Company’s ongoing\nPhase 2 development of PALI-2108, its investigational oral, locally activated\nPDE4 inhibitor prodrug, in ulcerative colitis (UC) and Crohn’s disease (CD).\n\n“These findings connect the key elements of our development strategy:\ndelivering active drug to diseased intestinal tissue, engaging PDE4, and\nobserving early clinical activity alongside reductions in inflammation,”\nsaid Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade\nBio. “The tissue analyses strengthen the mechanistic foundation for the\nclinical signals observed in UC and fibrostenotic Crohn’s disease, while our\nmicrobiome and biomarker work supports the delivery platform and a potential\npath toward more informed patient selection. As we advance our Phase 2\nprograms, the two Presidential Poster Awards are meaningful recognition of the\nwork of our investigators and collaborators.”\n\nUlcerative Colitis Findings Link Target Engagement to Early Clinical and\nHistologic Improvement\n\nPoster P3504 — ACG Presidential Poster Award: “The Microbiome-Activated\nPhosphodiesterase (PDE)-4 Inhibitor, PALI-2108 Leads to Rapid Clinical and\nHistologic Improvement in Moderate-to-Severe Ulcerative Colitis: A Phase1a/1b\nStudy”\n\nFive patients with moderate-to-severe UC received open-label PALI-2108 for\nseven days, including a five-day titration to 30 mg twice daily. Findings\nincluded:\n* Early clinical activity: All five patients achieved clinical response and\ntwo achieved clinical remission. The poster reported a 62.8% mean reduction in\nmodified Mayo score, alongside improvements in the Nancy, Robarts, and Geboes\nhistologic indices.\n\n\n* Evidence of target engagement: Colonic tissue cAMP increased in four of five\npatients, and PDE4B expression decreased in all five. Fecal calprotectin\ndecreased in four of five patients.\n\n\n* Tissue evidence of reduced inflammation: PathAI-enabled quantitative digital\npathology identified reductions in tissue lymphocytes and other\ninflammatory-cell populations, together with structural changes consistent\nwith early mucosal improvement, including increased normal epithelium and\ngoblet cell mucin and reduced ulceration.\nThese findings provide clinical and mechanistic support for the ongoing Phase\n2 ASCENTRA-UC study, which is designed to evaluate once-daily PALI-2108 at 15\nmg and 30 mg versus placebo in approximately 204 patients. Steady-state\npharmacokinetic data from healthy volunteers receiving 15 mg, 30 mg and 45 mg\nonce daily demonstrated sustained exposure to PALI-0008, the active metabolite\nof PALI-2108, providing additional pharmacologic support for dose selection in\nthe Phase 2 program.\n\nCrohn’s Disease Findings Show Early Endoscopic Activity and Changes in\nTissue Remodeling Biomarkers\n\nPoster P3611: “Gut-Targeted Inhibition of Phosphodiesterase 4 with PALI-2108\nDemonstrates Early Endoscopic and Biomarker Improvements in Fibrostenotic\nCrohn’s Disease: Results from a Phase 1b Study”\n\nFive adults with symptomatic ileal fibrostenotic Crohn’s disease (FSCD)\nreceived open-label PALI-2108 once daily with food for 14 days, including a\n10-day titration to target doses of 20, 25, or 30 mg. Four of five patients\nwere receiving concomitant biologic therapy. Findings included:\n* Favorable short-term tolerability: All reported adverse events were mild,\nwith no serious adverse events or treatment discontinuations. No nausea,\nvomiting, or diarrhea were reported.\n\n\n* Early endoscopic activity: A 47.5% mean reduction in the Simple Endoscopic\nScore for Crohn’s Disease (SES-CD), with two of five patients achieving\nendoscopic response and two of five achieving endoscopic remission after 14\ndays.\n\n\n* Evidence of local pharmacologic activity: Increased ileal tissue cAMP and\nreduced fecal calprotectin were accompanied by reductions in inflammatory-cell\ndensities in paired intestinal biopsies.\n\n\n* Exploratory tissue-remodeling signals: Plasma biomarker changes were\nconsistent with increased collagen degradation and changes in markers\nassociated with macrophage activation. These findings support further\nevaluation of potential effects on extracellular matrix remodeling; they do\nnot establish reversal of intestinal fibrosis or strictures.\nThe findings support continued evaluation in the Company’s Phase 2 Crohn’s\ndisease program. The UC and FSCD patient cohorts were small, short-duration,\nopen-label studies without placebo control; their clinical and translational\nfindings require confirmation in larger studies.\n\nIntestinal Exposure and Sustained Pharmacokinetics Support Once-Daily\nDevelopment\n\nPoster P3413 — ACG Presidential Poster Award: “PALI-2108, a\nNext-Generation Oral PDE4 Inhibitor Prodrug, Demonstrates Localized\nIleocolonic Exposure with Favorable Tolerability in IBD”\n\nAnalyses across the Phase 1a/b program support the pharmacologic rationale for\ntargeted intestinal delivery and once-daily dosing:\n* Targeted intestinal exposure: Concentrations of PALI-0008, the active\nmetabolite of PALI-2108, in sampled ileal and colonic tissue were\napproximately sevenfold higher than peak plasma concentrations in the\nevaluated FSCD cohort.\n\n\n* Sustained exposure: At 30 mg once daily, the poster reported PALI-0008\nplasma exposure above the estimated PDE4 IC90 over 24 hours, supporting\ncontinued once-daily development.\n\n\n* Exploratory pharmacokinetic comparisons: The pooled 30 mg once-daily cohort\nshowed lower trough-concentration variability than published apremilast and\nmufemilast datasets, alongside comparisons of daily exposure normalized to\nPDE4 inhibitory potency. These comparisons were based on small cohorts and\ndiffering study populations and conditions and do not establish comparative\nclinical efficacy or safety.\nMicrobiome Findings Support Prodrug Activation Without Significant Short-Term\nDiversity Changes\n\nPoster P3412: “Microbiome Beta-Glucuronidase Activity Does Not Limit\nBioconversion or Pharmacokinetic Consistency of the Colon-Targeted PDE4\nProdrug PALI-2108 in Ulcerative Colitis”\n\nBecause PALI-2108 relies on the gut microbiome for activation, the analysis\nexamined whether differences in microbiome composition could affect its\nconversion to PALI-0008, the active drug. Findings included:\n* Evidence of microbiome activation: PALI-2108 was converted to PALI-0008 in\nboth healthy volunteers and patients with UC, supporting microbiome-mediated\nactivation in the evaluated cohorts.\n\n\n* Comparability of functional features: Beta-glucuronidase-associated\nfunctional features were comparable between evaluated healthy volunteers and\npatients with UC and remained stable over seven days of treatment.\n\n\n* Consistency in microbiome diversity: No statistically significant changes in\nmeasured alpha or beta microbiome diversity were detected in patients with UC\nover seven days. These short-term findings support further evaluation of the\nplatform’s compatibility with the intestinal microbiome.\nExploratory Transcriptomic Research Supports a Potential Precision Medicine\nApproach\n\nPoster P3505: “Development of Mucosal Transcriptomic Signatures to Predict\nResponse to the Microbiome-Activated Phosphodiesterase (PDE)-4 Inhibitor\nPALI-2108 in Ulcerative Colitis”\n\nAn analysis integrating approximately 3,000 transcriptomic samples from more\nthan 15 studies combined UC disease biology with PDE4/cAMP pathway activity to\ndevelop candidate treatment-response signatures. Findings included:\n* Potential for patient stratification: Exploratory signatures showed\npreliminary discrimination between responder and non-responder phenotypes,\nsupporting further evaluation of a mechanistically informed approach to\npatient stratification.\n\n\n* Integration of inflammatory signaling into framework: The framework\nintegrated inflammatory signaling and PDE4-associated pathways, with\nadditional analyses of fibrosis-related transcriptional activity.\n\n\n* Potential treatment-response biomarker: The findings support continued\nprospective validation of a potential treatment-response biomarker; the\nsignatures are not established clinical tools for selecting patients for\nPALI-2108 treatment.\nAbout the ACG Presidential Poster Awards\n\nPosters P3413 and P3504 were selected for ACG Presidential Poster Awards.\nRecipients are selected by the ACG Abstract Selection Committee based on\nscores and scientific merit. Approximately 5% of accepted abstracts receive\nthe distinction each year.\n\nAbout PALI-2108\n\nPALI-2108 is an investigational oral, locally activated PDE4 inhibitor prodrug\ndesigned for targeted bioactivation in the terminal ileum and colon and being\ndeveloped for once-daily dosing. Its active metabolite, PALI-0008, inhibits\nPDE4, increasing intracellular cAMP to modulate inflammatory signaling. Phase\n1 studies in healthy volunteers and patients with UC or FSCD have provided\nevidence of intestinal exposure, target engagement, favorable short-term\ntolerability, and early clinical activity, supporting continued Phase 2\ndevelopment. PALI-2108 has not been approved for any indication.\n\nAbout Palisade Bio\n\nPalisade Bio is a clinical-stage biopharmaceutical company developing\nnext-generation oral therapies for immune-mediated diseases. Its lead program,\nPALI-2108, is advancing in inflammatory bowel disease, with Phase 2 studies in\nulcerative colitis and Crohn’s disease. For more information, please visit\nwww.palisadebio.com.\n\nForward Looking Statements\n\nAny statements contained in this communication that are not statements of\nhistorical fact may be deemed to be forward-looking statements for purposes of\nthe safe harbor provisions of the Private Securities Litigation Reform Act of\n1995. Forward-looking statements include but are not limited to: implied or\nexpress statements regarding the pharmacological properties, safety,\ntolerability, clinical response and efficacy, and therapeutic potential of\nPALI-2108, dosing levels and timing of key PALI-2108 development milestones\nsuch as regulatory submissions and approvals, trial enrollments and\ncommencements and efficacy readouts, and the Company’s expected cash runway.\nThese forward-looking statements are based on the Company’s current\nexpectations. Forward-looking statements involve risks and uncertainties.\nImportant factors that could cause actual results to differ materially from\nthose reflected in the Company’s forward-looking statements include, among\nothers, the timing of enrollment, commencement and completion of the\nCompany’s clinical trials; the Company’s reliance on PALI-2108, and its\nearly stage of clinical development; the risk that prior results, such as\nsignals of safety, clinical response and efficacy, dosing, durability of\neffect or pharmacological properties, observed from preclinical or clinical\ntrials (such as our Phase 1b findings) with a limited number of patients, will\nnot be replicated or will not continue in ongoing or future studies or\nclinical trials involving the Company’s product candidates in clinical\ntrials focused on the same or different indications; and other factors that\nare described in the “Risk Factors” and “Management’s Discussion and\nAnalysis of Financial Condition and Results of Operations” sections of the\nCompany’s Annual Report on Form 10-K for the fiscal year ended December 31,\n2025, filed with the Securities and Exchange Commission (“SEC”) on March\n20, 2026, and the Quarterly Reports on Form 10-Q or other SEC filings that are\nfiled thereafter. Investors are cautioned not to put undue reliance on these\nforward-looking statements. These forward-looking statements speak only as of\nthe date hereof, and the Company expressly disclaims any obligation or\nundertaking to release publicly any updates or revisions to any\nforward-looking statements contained herein to reflect any change in the\nCompany’s expectations with regard thereto or any change in events,\nconditions or circumstances on which any such statements are based, except as\nrequired by law.\n\nInvestor Relations Contact\nJTC Team, LLC\nJenene Thomas\n908-824-0775\nPALI@jtcir.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0beaede8-1c7c-4f77-84a7-b1efd54c343c)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-12T12:05:00.171280763Z","server_sent_at_ms":1791806700171},"received_at":"2026-10-12T12:05:00.337Z","source_url":null},"analysis":{"id":"154708","press_release_id":"166348","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Early data from only five patients per cohort, open-label without placebo control; signals may not replicate in Phase 2"],"eventType":"clinical_trial","narrative":"Palisade Bio presented five posters at ACG 2026 supporting the Phase 2 rationale for PALI-2108, its gut-activated PDE4 inhibitor prodrug, in ulcerative colitis and Crohn's disease.\n\nPhase 1a/1b data showed early activity — all five UC patients achieved clinical response with a 62.8% mean reduction in modified Mayo score, and fibrostenotic Crohn's patients showed a 47.5% mean SES-CD reduction after 14 days — with no serious adverse events.\n\nTwo posters received ACG Presidential Poster Awards, a distinction given to roughly 5% of accepted abstracts. The Phase 2 ASCENTRA-UC study will test 15 mg and 30 mg once-daily doses versus placebo in approximately 204 patients.\n\nThe company cautions these were small, short-duration, open-label studies without placebo control; results require confirmation in larger trials.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Congressional poster validation of PALI-2108 mechanism ahead of Phase 2 UC and Crohn's readouts — positive but early-stage signal."},"keyFigures":{"drugName":"PALI-2108","phaseOfTrial":"Phase 2","customDimensions":{"ses_cd_reduction":"47.5%","mayo_score_reduction":"62.8%","phase2_uc_trial_size":204,"transcriptomic_samples":"approximately 3,000","tissue_vs_plasma_exposure":"~sevenfold higher","presidential_poster_awards":2}},"quotedText":"These findings connect the key elements of our development strategy: delivering active drug to diseased intestinal tissue, engaging PDE4, and observing early clinical activity alongside reductions in inflammation","namedEntities":{"people":[{"name":"Mitch Jones, M.D., Ph.D.","role":"President and Chief Medical Officer"},{"name":"Jenene Thomas","role":"Investor Relations contact, JTC Team"}],"products":["PALI-2108","PALI-0008","ASCENTRA-UC"],"companies":[{"name":"Palisade Bio, Inc.","ticker":"PALI","relationship":"filer"},{"name":"JTC Team, LLC","relationship":"investor relations"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Scientific congress data presentations supporting the ongoing Phase 2 program; early open-label signals are encouraging but small, unblinded, and not confirmatory. No binary event or new trial result."},"tickerRelevance":{"others":[],"primary":"PALI"},"globalImportance":22,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"congress data presentations, no new trial readout","retailFavoriteBoost":"small biotech with clinical catalysts"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Palisade Bio presented five posters at ACG 2026 supporting the Phase 2 rationale for PALI-2108, its gut-activated PDE4 inhibitor prodrug, in ulcerative colitis and Crohn's disease.\n\nPhase 1a/1b data showed early activity — all five UC patients achieved clinical response with a 62.8% mean reduction in modified Mayo score, and fibrostenotic Crohn's patients showed a 47.5% mean SES-CD reduction after 14 days — with no serious adverse events.\n\nTwo posters received ACG Presidential Poster Awards, a distinction given to roughly 5% of accepted abstracts. The Phase 2 ASCENTRA-UC study will test 15 mg and 30 mg once-daily doses versus placebo in approximately 204 patients.\n\nThe company cautions these were small, short-duration, open-label studies without placebo control; results require confirmation in larger trials.","key_figures":{"drugName":"PALI-2108","phaseOfTrial":"Phase 2","customDimensions":{"ses_cd_reduction":"47.5%","mayo_score_reduction":"62.8%","phase2_uc_trial_size":204,"transcriptomic_samples":"approximately 3,000","tissue_vs_plasma_exposure":"~sevenfold higher","presidential_poster_awards":2}},"named_entities":{"people":[{"name":"Mitch Jones, M.D., Ph.D.","role":"President and Chief Medical Officer"},{"name":"Jenene Thomas","role":"Investor Relations contact, JTC Team"}],"products":["PALI-2108","PALI-0008","ASCENTRA-UC"],"companies":[{"name":"Palisade Bio, Inc.","ticker":"PALI","relationship":"filer"},{"name":"JTC Team, LLC","relationship":"investor relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-12T12:05:06.473Z","global_importance":22,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"congress data presentations, no new trial readout","retailFavoriteBoost":"small biotech with clinical catalysts"}},"durationMs":6097,"modelName":"glm-5.3-flashx"}}