Palisade Bio, Inc. - PALI STOCK NEWS

Palisade Bio announced the successful completion of the first GMP manufacturing batch of its drug substance PALI-2108, targeted for treating moderate-to-severe ulcerative colitis (UC).

The company partnered with Eurofins for process development and scale-up. The drug substance has been utilized in completed murine and non-murine GLP toxicology studies and will be used in an upcoming Phase 1 clinical study set to start before the end of the year.

Palisade Bio also completed manufacturing and testing of enteric-coated tablets of PALI-2108, ensuring reliable drug release profiles. In a DSS-induced UC mouse model, significant reductions in disease activity index and body weight loss were observed, indicating promising efficacy.

CEO J.D. Finley emphasized the importance of this milestone in advancing effective therapies for UC patients and expressed optimism about the upcoming clinical trial data.

Palisade Bio (Nasdaq: PALI) will participate in the Virtual Investor Closing Bell Series on Wednesday, June 26, 2024, at 4:00 PM ET. The event will feature J.D. Finley, CEO, and Dr. Mitch Jones, CMO, who will provide a corporate overview and business outlook. Investors can submit questions live during the session. The live webcast will be available on the Events page of Palisade Bio's website, with a replay accessible two hours after the event for 90 days.

Palisade Bio has provided an update on its strategic collaboration with Strand Life Sciences, focusing on advancing precision medicine for ulcerative colitis (UC). Through extensive analysis of transcriptomics datasets and clinical biomarkers, the collaboration has identified promising PDE4-related biomarkers associated with UC pathology. This progress paves the way for targeted therapeutic interventions.

Key areas of progress include the identification of candidate predictive biomarkers, the refinement of patient selection strategies based on these biomarkers and disease characteristics, and the integration of clinical biomarkers with disease activity measures to develop personalized UC therapies. Dr. Mitch Jones, CMO, and CEO JD Finley emphasized the commitment to innovation and the goal of becoming a leader in precision medicine for inflammatory and fibrotic diseases.

Palisade Bio announced a Notice of Allowance from the Canadian Intellectual Property Office for a patent covering their lead product candidate, PALI-2108. This patent protects the composition of PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug, under development for treating Ulcerative Colitis (UC). In preclinical studies, PALI-2108 demonstrated promising results, reducing disease activity and body weight loss in a UC mouse model. The company plans to commence a Phase 1 human clinical study of PALI-2108 by the end of 2024.

Palisade Bio (Nasdaq: PALI), a biopharmaceutical company, is set to present at the Virtual Investor Pitch Conference on June 17, 2024, at 12:00 PM ET. J.D. Finley, the CEO, will deliver an 'elevator pitch' and outline the company's forthcoming milestones. The event offers investors and interested parties the chance to submit live questions. A live video webcast will be available on the company's website, with a replay accessible for 90 days post-event.

Palisade Bio's lead product, PALI-2108, has shown promising preclinical results for treating Ulcerative Colitis (UC).

Presented at Digestive Disease Week 2024, data indicates that PALI-2108, an orally administered, colon-specific PDE4 inhibitor, is safe, effective, and well-tolerated in mouse models.

It achieved comparable efficacy to apremilast doses, which are intolerable for human use.

Furthermore, PALI-2108 demonstrated significant improvements in disease activity markers and prevented colon length reduction in a dose-dependent manner.

Notably, it exhibited a large therapeutic window and no systemic toxicity in dog models.

The company plans to commence Phase 1 human trials by year-end 2024.

Palisade Bio reported its financial results for Q1 2024 and provided a business update. The company remains on track to commence a Phase 1 clinical study of its lead product, PALI-2108, for treating Ulcerative Colitis (UC) by the end of the year. Financially, Palisade has $11.3 million in cash and recently raised $4 million, ensuring operations can continue until Q1 2025. Net loss increased to $3.5 million from $2.3 million in the same period last year, primarily due to a 78% rise in R&D expenses, driven by costs related to PALI-2108. Key milestones include completing tox studies and nonclinical activities by Q2 and Q3 2024, respectively, and submitting initial IND/CTA in Q3 2024. The company has also formed a strategic collaboration with Strand Life Sciences and has completed significant ex-vivo studies on PALI-2108.

Palisade Bio, Inc. announced the appointment of Margery Fischbein to its Board of Directors. Ms. Fischbein, a veteran in Wall Street and the biotech industry, brings expertise in corporate finance, business development, M&A, licensing, and strategic alliance transactions. Her appointment is expected to enhance Palisade Bio's strategy and pipeline of novel therapeutics, particularly in autoimmune, inflammatory, and fibrotic diseases.

Palisade Bio, Inc. (Nasdaq: PALI) closed a $4 million private placement with an institutional investor for 615,242 shares of common stock, intended for development of PALI-2108 and general corporate purposes. Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent. The company issued unregistered warrants for up to 922,863 shares of common stock with a term of seven years and an exercise price of $6.314 per share.