PALI
Live News • Jun 30
FDA Clears IND Application for PALI-2108 as Palisade Bio Prepares Phase 2 Trial Palisade Bio announced that the FDA has cleared its Investigational New Drug application for PALI-2108, allowing the company to begin the ASCENTRA-UC global Phase 2 trial in ulcerative colitis with a planned enrollment of up to 204 patients and primary efficacy data targeted in the second half of 2027.
The IND clearance is a key regulatory milestone that supports continued progress of Palisade Bio’s inflammatory bowel disease portfolio, moving PALI-2108 from preclinical work into mid-stage human testing.
Palisade Bio’s stock last traded at US$2.23, with the share price down 10.8% year to date, so the market is coming into this trial phase after a period of weaker performance.
This update places greater emphasis on clinical execution risk, as the ASCENTRA-UC trial outcomes and timing will influence how investors evaluate Palisade Bio’s pipeline value and funding needs over the coming years. Announcement • Jun 30
Palisade Bio Receives FDA Clearance Of IND For PALI-2108 And Plans To Initiate Global Phase 2 ASCENTRA-UC Study In Ulcerative Colitis Palisade Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for PALI-2108, enabling initiation of the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis. The Company anticipates initiating patient enrollment in the second half of 2026, with primary efficacy results expected in the second half of 2027. ASCENTRA-UC is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in patients with moderately to severely active ulcerative colitis. The study is expected to enroll approximately 204 patients and evaluate two once-daily dose levels of PALI-2108, 15 mg and 30 mg, compared with placebo. The primary endpoint is clinical remission at Week 12, as measured by the modified Mayo Score. Key secondary endpoints include clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI). Following the 12-week induction period, eligible patients will continue into a 36-week maintenance phase designed to evaluate durability of response through Week 48. In parallel with ASCENTRA-UC, the Company continues to advance development plans for Crohn’s disease and currently expects to submit an IND application for ASCENTRA-CD in the second half of 2026. The Company believes the broad applicability of PALI-2108 across inflammatory bowel disease indications may provide opportunities to expand the program beyond ulcerative colitis. To support execution of ASCENTRA-UC, Palisade Bio has partnered with PSI, the leading global contract research organization (CRO) in IBD, to manage the execution of the program. PSI brings extensive experience delivering complex phase 2 and phase 3 international clinical trials in immunology and gastroenterology. PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the terminal ileum and colon. The Company believes this differentiated approach may enable localized gastrointestinal activity while maintaining a pharmacokinetic profile supportive of chronic administration. Positive Phase 1 clinical data previously reported by the Company demonstrated encouraging safety, tolerability, pharmacokinetic and pharmacodynamic results supporting continued clinical development. New Risk • Jun 25
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 6.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 35x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$91m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). 
