Trump announces trade deal with EU following months of negotiations
CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ: PALI), a clinical-stage biopharmaceutical company with a market capitalization of $3 million, today announced the successful completion of the Phase 1a trials for its drug PALI-2108, intended to treat Ulcerative Colitis (UC). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.24, indicating solid short-term financial stability. The trials, which included single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as a food effects crossover, reported no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs.
The Phase 1a trials, which are part of a larger Phase 1a/b study, have now finished enrollment and dosing. Preliminary findings suggest that PALI-2108 is well-tolerated, with the majority of TEAEs being mild. Only one participant withdrew from the highest 50 mg twice-daily dosage group. While the clinical progress is promising, InvestingPro analysis shows the stock has faced significant challenges, declining by about 87% over the past year. Analyst price targets range from $2 to $16, suggesting potential upside if the clinical development succeeds. The MAD cohorts, which ranged from 15 mg to 30 mg twice daily, also showed no SAEs or TEAEs related to laboratory values or EKGs, with one mild TEAE reported in the 30 mg group.
Palisade Bio's Chief Medical Officer, Dr. Mitch Jones, expressed confidence in the drug's potential, noting its high potency and excellent tolerability at therapeutic dose levels. The company is now progressing with the screening and dosing of the Phase 1b UC patient cohort, with one subject having completed this portion of the study. Palisade Bio anticipates reporting topline data from the Phase 1a study by the end of May 2025.
PALI-2108 is a new chemical entity targeting PDE4 B and D, which has shown promise in preclinical studies. The Phase 1a/b study's primary goal is to assess the safety, tolerability, and pharmacokinetics (PK) of PALI-2108 in healthy volunteers and UC patients. Biomarkers such as serum high sensitivity C-reactive protein and fecal calprotectin will be used to provide further insights into the drug's effects.
Palisade Bio aims to develop novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases. The company's forward-looking statements highlight its dependency on the success of PALI-2108, which is still in early clinical development and may face risks such as unexpected adverse side effects or inadequate efficacy that could limit its progress. Based on InvestingPro's Fair Value analysis, the stock appears undervalued, though investors should note the company's overall Financial Health Score of 1.87 (rated as "FAIR") and that analysts don't expect profitability this year. InvestingPro subscribers have access to 11 additional investment tips for PALI and comprehensive financial analysis tools.
This report is based on a press release statement and contains no endorsements of claims. The company's stock is listed on NASDAQ under the ticker PALI.
In other recent news, Palisade Bio, Inc. reported the completion of the Single Ascending Dose stage of its Phase 1a/b study for PALI-2108, a drug candidate aimed at treating Ulcerative Colitis. The data indicated that PALI-2108 was well-tolerated across doses ranging from 15 mg to 450 mg, with no serious adverse events reported. This study also suggested that the drug has delayed-release and extended-release properties, which are crucial for targeting the treatment effectively. Palisade Bio has also secured 1.39 million Canadian dollars in Scientific Research and Experimental Development tax credits from Canada, which will reimburse pre-clinical costs associated with PALI-2108, developed jointly with Giiant Pharma, Inc. The company is conducting a Phase 1a/b clinical study, which includes a patient cohort with ulcerative colitis, with topline data expected in the first half of 2025. Additionally, Palisade Bio is set to present data from its lead program, PALI-2108, at the Digestive Disease Week 2025, focusing on its potential anti-fibrotic efficacy and bioactivation in the colon. These developments highlight Palisade Bio's ongoing efforts to advance its clinical programs, though the company acknowledges the need for further funding and regulatory approvals. Investors are advised to consider the risks and uncertainties detailed in the company's SEC filings.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.