Palisade Bio, Inc. - PALI STOCK NEWS

Palisade Bio (NASDAQ: PALI) has successfully completed all five Single Ascending Dose (SAD) cohorts and advanced to Multiple Ascending Dose (MAD) cohorts in its Phase 1a/b study of PALI-2108 for Ulcerative Colitis treatment. The SAD study, testing doses from 15mg to 450mg, demonstrated favorable safety and tolerability with no serious adverse events or treatment-related laboratory abnormalities.

The preliminary pharmacokinetic analysis showed PALI-2108's delayed-release and extended-release characteristics, providing sustained, dose-dependent drug exposure with high local concentrations in the colon. Only mild treatment-emergent adverse events were observed at the highest dose of 450mg.

The ongoing MAD portion will assess repeat dosing and further evaluate safety and pharmacokinetics in both healthy volunteers and UC patients. The company remains on track to report topline data in the first half of 2025.

Palisade Bio (NASDAQ: PALI), a clinical-stage biopharmaceutical company focused on developing therapeutics for autoimmune, inflammatory, and fibrotic diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company has issued stock options to a new employee as part of its 2021 Inducement Plan.

The grant consists of options to purchase 2,600 shares of common stock, issued on January 3, 2025, with an exercise price matching the closing price on the grant date. The options will vest quarterly over a three-year period, subject to continued employment with the company.

Palisade Bio (NASDAQ: PALI) has appointed Dr. Brian G. Feagan to its Clinical Advisory Board. Dr. Feagan brings over 30 years of experience in gastroenterology and has served as Principal Investigator in more than 140 multi-center randomized controlled trials for Crohn's disease and ulcerative colitis. He currently serves as a Professor of Medicine at the Schulich School of Medicine & Dentistry and is the Senior Scientific Director of Alimentiv, Inc.

His expertise will support the development of PALI-2108, the company's treatment candidate for ulcerative colitis. Dr. Feagan highlighted PALI-2108's potential advantages, particularly its localized bioactivation approach, which could address tolerability issues associated with systemic distribution of similar therapeutics.

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.