Palisade Bio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses were $10.6 million for the three months ended September 30, 2026, compared to $1.4 million for the same period in 2025.
• General and administrative expenses were $5.1 million for the three months ended September 30, 2026, compared to $1.5 million for the same period in 2025.
• Net loss was $14.6 million ($0.07 per share) for the three months ended September 30, 2026, compared to a net loss of $2.9 million ($0.38 per share) for the same period in 2025.
• For the nine months ended September 30, 2026, net loss was $34.8 million ($0.16 per share), compared to $7.9 million ($1.38 per share) for the same period in 2025.
• Cash and cash equivalents totaled $113.6 million as of September 30, 2026, down from $133.4 million as of December 31, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $38.6 million, compared to $8.1 million for the same period in 2025.
• Net cash used in operating activities was $23.3 million for the nine months ended September 30, 2026, compared to $7.7 million for the same period in 2025.
• Net cash provided by financing activities was $3.5 million for the nine months ended September 30, 2026, compared to $3.1 million for the same period in 2025.
• Stock-based compensation expense was $14.1 million for the nine months ended September 30, 2026, compared to $0.2 million for the same period in 2025.
• Total liabilities were $6.1 million as of September 30, 2026, compared to $5.0 million as of December 31, 2025.
• Total stockholders' equity was $112.4 million as of September 30, 2026, compared to $129.4 million as of December 31, 2025.

Guidance and Future Outlook:

• Topline results from the ASCENTRA-UC Phase 2b trial are expected in the fourth quarter of 2027.
• Initiation of enrollment for the ASCENTRA-CD Phase 2a trial is targeted for the first quarter of 2027.
• Primary efficacy readout for the ASCENTRA-CD trial is expected in the first quarter of 2028.
• Management believes current cash and cash equivalents will fund operations through key Phase 2 clinical milestones, including the anticipated primary efficacy readouts from ASCENTRA-UC in Q4 2027 and ASCENTRA-CD in Q1 2028.

Business Segments and Product Lines:

• The first patient was dosed in the global Phase 2b ASCENTRA-UC trial on October 27, 2026.
• 29 of 30 planned U.S. clinical sites for ASCENTRA-UC have been activated, with global expansion targeting approximately 115 total sites.
• Health Canada CTA clearance was received in September 2026, and regulatory clearance was received in the Republic of Georgia in October 2026 for the ASCENTRA-UC trial.
• ASCENTRA-UC will enroll approximately 204 patients with moderately to severely active ulcerative colitis (UC) and evaluate 15 mg and 30 mg once-daily oral doses of PALI-2108 compared with placebo.
• The primary endpoint for ASCENTRA-UC is clinical remission at Week 12, measured by the Modified Mayo Score.
• The FDA cleared the IND application for PALI-2108 in Crohn's disease (CD) on September 22, 2026.
• ASCENTRA-CD is a multicenter, open-label, single-arm Phase 2a study expected to enroll approximately 60 adults with moderate-to-severe CD.
• ASCENTRA-CD will evaluate PALI-2108 at a target dose of 30 mg orally once daily, with the primary endpoint being endoscopic response at Week 12.
• Five posters were presented at ACG 2026, including two selected for Presidential Poster Awards, highlighting PALI-2108's clinical and mechanistic profile.
• Additional clinical and translational findings were presented at UEG Week 2026, including evidence of endoscopic improvement within two weeks in an exploratory Phase 1b cohort of five patients with fibrostenotic Crohn's disease.

Market and Competitive Landscape:

• PALI-2108 is an investigational, once-daily oral PDE4 inhibitor prodrug designed for localized bioactivation in the terminal ileum and colon.
• Its active metabolite, PALI-0008, potently inhibits PDE4 isoforms A, B, and D, increasing intracellular cAMP to modulate inflammatory signaling.
• Phase 1 studies have provided evidence of high intestinal exposure, measurable systemic exposure supportive of once-daily dosing, favorable short-term tolerability, and early clinical activity.
• The Company aims to establish PALI-2108 as a differentiated, once-daily oral treatment for patients living with inflammatory bowel disease (IBD).

Risks and Challenges:

• Risks include the timing of enrollment, commencement, and completion of clinical trials.
• The Company relies heavily on PALI-2108, which is in an early stage of clinical development.
• There is a risk that prior results observed from preclinical or limited clinical trials will not be replicated in ongoing or future studies.
• Safety or tolerability findings may emerge in larger, controlled studies.
• The Company may need additional capital to complete its clinical development programs.
• The Company relies on third parties, including contract research organizations, clinical sites, and contract manufacturers.
• Regulatory reviews of clinical trial applications outside the United States may face timing or outcome uncertainties.

Management Commentary and Tone:

• JD Finley, Chief Executive Officer, stated that the focus is on driving enrollment and executing the ASCENTRA-UC study to deliver topline results in Q4 2027, noting that nearly all planned U.S. sites are activated.
• Finley highlighted that the Company's strong financial position supports execution across both the UC and CD programs.
• Mitch Jones, M.D., Ph.D., President and Chief Medical Officer, emphasized the priority of maintaining enrollment momentum to deliver clinical data establishing PALI-2108's potential in ulcerative colitis.
• Jones noted the goal is to develop a treatment that, if approved, could offer patients an effective, well-tolerated, once-daily oral dosing option.

Other Key Points:

• The Company had $3.5 million in proceeds from the issuance of common stock and $155,000 in proceeds from the exercise of warrants during the nine months ended September 30, 2026.
• Total shares issued and outstanding increased from 159.4 million at December 31, 2025, to 174.4 million at September 30, 2026.
• The Company reported $500,000 in license revenue for the nine months ended September 30, 2026, with no license revenue reported for the three-month period.
• PALI-2108 has not been approved for any indication.
• The Company is a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases.