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Palisade Bio Inc. (NASDAQ: PALI) is a clinical-stage biopharmaceutical company dedicated to advancing the science of intestinal health through the development of innovative therapeutics. The company focuses on addressing critical unmet medical needs by protecting and enhancing the integrity of the intestinal barrier, a vital component of gastrointestinal health. Operating within the dynamic biotechnology and pharmaceutical industry, Palisade Bio is carving out a niche in the treatment of gastrointestinal disorders, particularly inflammatory bowel disease (IBD), which includes conditions such as ulcerative colitis (UC) and Crohn's disease (CD).
Core Business and Therapeutic Focus
At the heart of Palisade Bio’s mission is its commitment to improving patient outcomes through groundbreaking research and development (R&D). The company’s primary focus is its proprietary pipeline of therapeutics designed to address the root causes of intestinal barrier dysfunction. By targeting the mechanisms that compromise intestinal health, Palisade Bio aims to offer novel solutions that go beyond symptom management to deliver long-term benefits for patients.
Palisade Bio’s portfolio includes its lead candidate, PALI-2108, which is being developed for the treatment of IBD, with a particular focus on UC and CD. Additionally, the company is conducting research on PALI-1908, further demonstrating its commitment to innovation in gastrointestinal therapeutics. These investigational treatments are designed to address the critical need for effective, targeted therapies that improve intestinal barrier function, a key factor in the progression of many gastrointestinal disorders.
Industry Context and Competitive Landscape
Palisade Bio operates in a highly specialized segment of the biopharmaceutical industry, where the development of gastrointestinal therapies represents a significant growth opportunity. The company’s focus on intestinal barrier integrity sets it apart from competitors that often emphasize broader gastrointestinal treatments. By addressing the underlying causes of intestinal dysfunction, Palisade Bio aims to differentiate itself in a crowded and competitive market.
The pharmaceutical industry is characterized by rigorous regulatory standards, high R&D costs, and lengthy clinical trial processes. As a clinical-stage company, Palisade Bio faces these challenges while striving to demonstrate the safety and efficacy of its therapies. Success in this space requires not only scientific innovation but also strategic partnerships, effective clinical trial management, and eventual regulatory approval.
Business Model and Revenue Streams
As a clinical-stage company, Palisade Bio does not yet generate revenue from product sales. Instead, its business model relies on securing funding through equity financing, strategic partnerships, and potential licensing agreements. The company’s ability to attract investment is closely tied to the progress of its clinical trials and the promise of its therapeutic candidates. By focusing on a niche area with significant unmet medical needs, Palisade Bio aims to position itself as a valuable partner for larger pharmaceutical companies and healthcare organizations.
Significance and Potential Impact
Palisade Bio’s work has the potential to transform the treatment landscape for patients suffering from debilitating gastrointestinal disorders. By prioritizing the integrity of the intestinal barrier, the company addresses a critical aspect of gastrointestinal health that has been largely overlooked by traditional therapies. This focus not only enhances its scientific credibility but also underscores its commitment to delivering meaningful solutions for patients.
In summary, Palisade Bio Inc. represents a promising player in the biopharmaceutical industry, leveraging cutting-edge science to tackle complex gastrointestinal disorders. While the company is still in the clinical development phase, its innovative approach to intestinal health positions it as a potential leader in this specialized field. Through its dedication to research, patient-centered focus, and strategic positioning, Palisade Bio continues to advance its mission of improving lives through better gastrointestinal health.
Palisade Bio (Nasdaq: PALI) has reported promising data on PDE4B expression as a potential marker for patient stratification in Ulcerative Colitis (UC) treatment. The company's analysis, conducted in collaboration with Strand Life Sciences, revealed that 70% of adult colitis patients and 90% of pediatric colitis patients show PDE4B expression above a specific threshold. This finding could significantly improve patient selection for targeted therapies.
Palisade is advancing its lead program PALI-2108, an oral colon-specific PDE4 inhibitor prodrug for UC treatment. A Phase 1 clinical study is set to begin before year-end. Preclinical studies in a DSS-induced UC mouse model demonstrated PALI-2108's potential efficacy, showing reduced PDE4B expression, increased cAMP levels, and decreased inflammatory markers with increasing doses.
Palisade Bio (Nasdaq: PALI), a biopharmaceutical company focusing on autoimmune, inflammatory, and fibrotic diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee approved an option grant for 5,000 shares of common stock to Joerg Heyer, the new Head of Translational Science and Medicine, as a material inducement to employment.
The option, issued on August 16, 2024, has an exercise price of $3.94, matching the closing price of Palisade's common stock on the grant date. The option will vest quarterly over three years, contingent on Mr. Heyer's continued service to the company.
Palisade Bio (Nasdaq: PALI) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Progress towards Phase 1 clinical study of PALI-2108 for Ulcerative Colitis (UC) before year-end
2. Completed microbiome study and nonclinical IND/CTA-enabling studies
3. Expanded global IP portfolio with European patent grant
4. Completed first GMP batch of PALI-2108
5. Advanced collaboration with Strand Life Sciences on PDE4-related biomarkers
6. Received Canadian patent allowance for PALI-2108
Financial results: $11.4M cash on hand, sufficient through Q1 2025. Net loss of $4.1M, up from $3.4M in Q2 2023. R&D expenses increased 21% to $2.6M, while G&A expenses rose 11% to $1.6M.
Palisade Bio (Nasdaq: PALI) has announced progress in developing PALI-2108, its lead drug candidate for Ulcerative Colitis (UC). The company has determined the Maximum Recommended Starting Dose (MRSD) for human trials using comprehensive scaling approaches and modeling. Key findings from pharmacokinetic (PK) modeling and simulations indicate that dosing regimens with minimal accumulation are both safe and within the doses showing maximal efficacy in animal models. Palisade Bio has established dose levels and trial design for PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug. The upcoming Phase 1 clinical trial, set to commence before year-end, will evaluate safety, tolerability, and PK in healthy volunteers and UC patients, as well as pharmacodynamics in UC patients.
Palisade Bio (Nasdaq: PALI) has released a Virtual Investor 'What This Means' segment featuring Chief Medical Officer Mitchell Jones, MD, PhD. The segment focuses on the company's recent microbiome study that confirmed bacterial enzymes for local bioactivation of their lead product candidate, PALI-2108. This development is significant for Palisade Bio's planned Phase 1 human clinical study for the treatment of Ulcerative Colitis.
The company, which specializes in developing therapeutics for autoimmune, inflammatory, and fibrotic diseases, views this as an important step forward in their research. The Virtual Investor segment is now available online, providing investors and interested parties with insights into the implications of this study for Palisade Bio's future clinical trials and potential treatment options.
Palisade Bio (Nasdaq: PALI) has successfully completed a microbiome study for its lead product candidate, PALI-2108, aimed at treating Ulcerative Colitis (UC). The study confirmed that beta-glucuronidase, an enzyme important for the bioactivation of PALI-2108, is present at similar levels in mouse, dog, and human microbiota, including healthy humans and those with Crohn's disease and UC.
Key findings include:
- Beta-glucuronidase presence is not significantly different among species or between healthy and diseased human cohorts
- The study supports previous findings of adequate bioactivation of PALI-2108 in Normal Healthy Volunteers and UC patients' stool
- Palisade Bio is advancing towards a Phase 1 clinical study of PALI-2108 for UC treatment, expected to begin before the end of 2024
Palisade Bio (Nasdaq: PALI) announced that the European Patent Office has issued a decision to grant notice for patent number 4,157,853, titled 'Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.' This patent, expected to be issued on July 31, 2024, includes composition of matter claims for PALI-2108 and PALI-1908, providing coverage beyond 2042. PALI-2108 is being developed for moderate-to-severe Ulcerative Colitis, while PALI-1908 targets fibro stenotic Crohn's Disease.
The patent claims cover PALI-2108's proprietary composition, designed as an orally administered, colon-specific PDE4 inhibitor prodrug. Its unique galactose-derived sugar moiety allows for minimal absorption until cleaved by colonic bacteria, ensuring localized bioactivation. Palisade Bio plans to initiate a Phase 1 clinical study for PALI-2108 before the end of 2024.
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.
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