aibioPalisade Bio reports second quarter 2026 results and Phase 2 plans for PALI-2108
Tickers PALI
The company reported a net loss of $10.6 million for the quarter and cash of $125.2 million at June 30, 2026. It expects to start the Phase 2 ASCENTRA-UC trial in the second half of 2026.
Key facts
- Company
- Palisade Bio, Inc. (NASDAQ: PALI)
- News type
- Company Updates
- Primary source
- Palisade Bio, Inc. 8-K (2026-08-10)
Palisade Bio, Inc. (Nasdaq: PALI) reported financial results for the quarter ended June 30, 2026, in an exhibit to an 8-K dated August 10, 2026. The company reported a net loss of $10.6 million, or $0.05 per share, for the quarter. It had cash and cash equivalents of $125.2 million at June 30, 2026. It said it expects to begin the Phase 2 ASCENTRA-UC trial of its lead candidate, PALI-2108, in the second half of 2026.
Phase 1 results
The Phase 1 trial enrolled five patients with ulcerative colitis (UC) and five patients with fibrostenotic Crohn's disease (FSCD). In the UC cohort, 5 out of 5 patients achieved clinical response, and 2 out of 5 achieved clinical remission based on the Modified Mayo Score. In the FSCD cohort, PALI-2108 reduced the mean SES-CD score by approximately 47.5%, a 3.8-point improvement. Two of the five FSCD patients achieved both endoscopic response and remission based on SES-CD.
These are very small groups: five patients in each cohort, with no p-values given, and the release does not say how much of the response seen in UC would have occurred on placebo. Phase 1 work is meant to test safety, and the Phase 2 trials have not started. The company described the Phase 1 results as showing favorable safety and tolerability, sustained exposure of the active metabolite above the IC90 threshold, and targeted distribution in the ileum and colon. It also reported pharmacodynamic activity across key inflammatory and fibrotic pathways.
The development timeline
The company said the FDA has cleared its Investigational New Drug application for PALI-2108. The Phase 2 ASCENTRA-UC trial is expected to enroll its first patient in the second half of 2026, with primary efficacy results expected in the second half of 2027.
For ASCENTRA-CD, the Phase 2 trial in Crohn's disease, the company expects to submit an IND in the second half of 2026. It targets the start of the trial in the first quarter of 2027, with a primary efficacy readout expected in early 2028.
The company also appointed Robert Baltera and Jordan Zwick to its board.
Financial results
Research and development expenses were $7.4 million for the three months ended June 30, 2026, compared with $1.7 million a year earlier. The company blamed higher employee-related expenses, including non-cash stock-based compensation, and PALI-2108 program costs.
General and administrative expenses were $4.8 million, compared with $1.2 million for the same quarter of 2025. The company attributed the increase mainly to employee-related expenses, including non-cash stock-based compensation, and professional fees.
The company recognized license revenue of $0.5 million in the quarter. The revenue relates to the achievement of a milestone under its co-development and distribution agreement with Newsoara, a joint venture established by Biolead Medical Technology Limited. No license revenue was recognized in the second quarter of 2025.
The company's financial data for the full years shows a net loss of $16.8 million for 2025, compared with $14.4 million for 2024. Cash used in operations was $10.8 million in 2025 and $12.2 million in 2024.
The company and its lead candidate
Palisade Bio is a clinical-stage biopharmaceutical company developing once-daily, oral phosphodiesterase-4 (PDE4) inhibitor prodrugs. PALI-2108 is designed for targeted delivery to the terminal ileum and colon. The company says this approach limits absorption in the upper gut and may reduce the tolerability problems that have limited systemic PDE4 inhibitors.
The company's Phase 1 study was a single-center, randomized, double-blinded, placebo-controlled trial focused on safety, tolerability and pharmacokinetics in healthy volunteers and UC patients.
What comes next
The company expects to begin the Phase 2 ASCENTRA-UC trial in the second half of 2026 and to submit the ASCENTRA-CD IND in the same period. Costs are rising fast, with research and development at $7.4 million against $1.7 million a year earlier. The company says its existing cash resources are sufficient to fund operations through the anticipated primary efficacy readout from ASCENTRA-UC in the second half of 2027, and the planned readout from ASCENTRA-CD in early 2028.