Palisade Bio, Inc. - PALI STOCK NEWS

Palisade Bio (NASDAQ: PALI) has closed its previously announced underwritten public offering, raising approximately $5 million in gross proceeds. The offering consists of 158,000 Class A Units (common stock + warrants) at $1.525 per unit and 3,120,688 Class B Units (prefunded warrants + warrants) at $1.5249 per unit. The Common Warrants have a $1.40 exercise price with a five-year term.

Ladenburg Thalmann & Co. acted as sole bookrunner, with a 45-day option to purchase additional shares/warrants. The company has repriced approximately one million previously issued warrants to $1.40 per share. Net proceeds will fund Phase 1 clinical trial of PALI-2108, pre-clinical studies, research and development, and working capital.

Palisade Bio (NASDAQ: PALI) has announced the pricing of an underwritten public offering expected to generate approximately $5 million in gross proceeds. The offering consists of 158,000 Class A Units (common stock plus warrants) at $1.525 per unit and 3,120,688 Class B Units (prefunded warrants plus warrants) at $1.5249 per unit. The Common Warrants will have an exercise price of $1.40 per share with a five-year term.

Ladenburg Thalmann & Co. Inc. is serving as the sole bookrunning manager. The offering is expected to close around December 13, 2024. The company plans to use the proceeds to fund their Phase 1 clinical trial of PALI-2108, pre-clinical studies, research and development, and working capital.

Palisade Bio (NASDAQ: PALI) announced preliminary results from its Phase 1 clinical study of PALI-2108 for treating moderate-to-severe Ulcerative Colitis. The first three single ascending dose (SAD) cohorts demonstrated promising safety results with no treatment-related adverse events. The study included 24 subjects (6:2 active to placebo ratio) at doses of 15mg, 50mg, and 150mg. Preliminary pharmacokinetic data showed delayed release of the PDE4 inhibitor active, suggesting successful colonic bioactivation. The company plans to proceed with a food effect crossover study, multiple ascending dose cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Palisade Bio announced preclinical results for PALI-2108, a novel local PDE4 inhibitor prodrug, showing promising effects in treating fibrostenotic Crohn's disease. Studies using the DSS colitis mouse model demonstrated that PALI-2108 modulated 187 genes involved in four main fibrotic pathways of IBD, with dose-dependent effects. The drug is designed for local activation in the ileum and colon, potentially offering enhanced safety compared to traditional systemic PDE4 inhibitors. The company is currently conducting a Phase 1 study with topline data expected in first half of 2025.

Palisade Bio (Nasdaq: PALI) announced its participation in the 8th Annual Antifibrotic Drug Development Summit in Boston, MA, from November 19-21, 2024. Chief Medical Officer Mitch Jones, MD, PhD, will present on fibrostenotic Crohn's Disease and local PDE4 inhibitor prodrug development on November 21 at 2:30 PM ET.

The presentation, titled 'Detailing Characteristics of Fibrostenotic Crohn's Disease Biology & the Potential of a Local PDE4 Inhibitor Prodrug to Minimize Off-Target Effects & Maximize Efficacy,' will be part of the session examining latest research in antifibrotic development. The AFDD Summit is a key forum bringing together experts in antifibrotic drug development.

Palisade Bio (Nasdaq: PALI) reported Q3 2024 financial results and key developments for PALI-2108, its lead program for treating moderate-to-severe Ulcerative Colitis (UC). The company has commenced enrollment and dosing in its Phase 1 clinical study. Notable achievements include presenting translational studies data at ACG's 2024 Annual Scientific Meeting, completing refined patient selection strategies with Strand Life Sciences, conducting a microbiome study confirming bacterial enzymes for local bioactivation, expanding intellectual property in Europe, and completing the first GMP batch of PALI-2108 drug substance.

Palisade Bio (NASDAQ: PALI) has initiated its Phase 1 clinical study of PALI-2108, dosing its first subject. The study evaluates an orally administered PDE4 inhibitor prodrug for treating moderate-to-severe Ulcerative Colitis (UC). The single-center, double-blind, placebo-controlled study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and UC patients. The study includes single ascending dose (SAD) cohorts, food effect evaluation, multiple ascending dose (MAD) cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Palisade Bio (NASDAQ: PALI) has presented positive data from two ex vivo translational studies of PALI-2108, their colon-specific PDE4 inhibitor prodrug for ulcerative colitis treatment. The studies demonstrated successful bioactivation in stool samples and significant TNFα inhibition in whole blood. PALI-2108 achieved a 90.1% conversion rate at 24 hours and showed 20-fold higher potency compared to apremilast. The drug's targeted activation in the colon aims to minimize systemic exposure and side effects. The company plans to initiate Phase 1 clinical trials before year-end, including studies with healthy volunteers and UC patients.

Palisade Bio (Nasdaq: PALI) has received a No Objection Letter from Health Canada for its Phase 1 clinical study of PALI-2108, an oral PDE4 inhibitor prodrug for treating Ulcerative Colitis (UC). The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. The trial design includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food effects (FE) cohorts, with approximately 90 patients planned for enrollment.

The primary objective is to assess safety and tolerability, with secondary objectives focusing on pharmacokinetics. Exploratory objectives include examining PDE4-related biomarkers and UC-specific markers. Palisade Bio aims to commence site initiation and enrollment before year-end. The company believes PALI-2108 could be the first approved PDE4 inhibitor for UC, addressing a significant medical need in a market expected to reach nearly $10 billion by 2028.