Latest news with #PalisadeBio
Yahoo
11-08-2025
- Business
- Yahoo
Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108
PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs) Extended half-life and local bioactivation support convenient once-daily dosing in ulcerative colitis (UC) and fibrostenotic Crohn's disease (FSCD) Colon tissue drug levels exceeded target thresholds 36 hours post-dose in completed Phase 1a MAD cohort Company advancing toward IND submission for Phase 2 study in H1 2026 Carlsbad, CA, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ('Palisade', 'Palisade Bio', or the 'Company'), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced compelling new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor, including positive topline results from its Phase 1b open-label cohort in patients with moderate-to-severe UC and colon tissue pharmacokinetic (PK) data from the Phase 1a multiple ascending dose (MAD) cohort. 'These results represent a significant milestone for PALI-2108,' said JD Finley, Chief Executive Officer of Palisade Bio. 'The early clinical activity, targeted delivery, dose flexibility, the potential for once-daily oral dosing and its favorable safety profile positions PALI-2108 as a potentially best-in-class oral therapy for patients with UC.' Dr. Mitchell Jones, Chief Medical Officer added, 'What is most compelling about the Phase 1b data is the remarkable consistency across all layers of assessment. The clinical response rate of 100% was tightly aligned with robust histologic improvements and a marked reduction in tissue lymphocytes—reflecting immunologic resolution. These effects were mechanistically supported by increased tissue cAMP levels and decreased PDE4B expression, confirming potent local target engagement. Additionally, RNA sequencing demonstrated coordinated downregulation across our inflammatory biomarker panel, fibrotic markers, PDE4 effector genes, and our companion diagnostic biomarker score, reinforcing both the breadth of pharmacodynamic activity and the precision medicine potential of PALI-2108.' Phase 1b UC Cohort: 100% Clinical Response with Strong Biomarker and Histology Improvements The 7-day, open-label Phase 1b study enrolled five patients with moderate-to-severe UC, receiving titrated BID dosing of PALI-2108 (30 mg BID). Key highlights include: Achieved 100% (5/5) clinical response (≥30% or ≥3-point reduction in modified Mayo score with rectal bleeding subscore ≤1) Mean reduction of 62.8% in modified Mayo score (−4.0 point absolute change) One patient achieved clinical remission Fecal calprotectin decreased in 4/5 patients (mean 70%) Plasma hsCRP decreased by 15% Showed histologic improvement across multiple indices: Nancy Index: 58% Robarts Histopathology Index: 56% Geboes Score: 36% Mechanistically, colon tissue analyses confirmed PDE4 inhibition and immunomodulation: Tissue cAMP increased in 4/5 patients Tissue lymphocytes decreased by an average of 40% PDE4B expression decreased by an average of 51% RNAseq data confirmed downregulation of inflammatory, fibrotic, and CDx biomarkers from baseline to end-of-study Importantly, PALI-2108 was well tolerated, with >95% of treatment-emergent adverse events (TEAEs) rated mild and transient (e.g., headache, nausea), and no SAEs, SUSARs (suspected unexpected adverse reactions), or discontinuations. Phase 1a MAD Cohort: Colon Tissue Drug Concentrations Confirm Extended Exposure and Once-Daily Dosing In parallel, Palisade Bio completed a comprehensive Phase 1a study in 84 healthy volunteers across SAD, MAD, and food-effect cohorts. Key results include: The PDE4 inhibitor active metabolite (PALI-0008) remained detectable in colon tissue ≥36 hours post-dose, maintaining levels near or above IC90 Steady-state trough concentrations exceeded IC90 with minimal accumulation Half-life of PALI-0008 exceeded that of any known PDE4 inhibitor, supporting sustained local activity PK modeling supports a once-daily dose regimen of 30 mg for both UC and FSCD Food reduced systemic exposure (~42% ↓ Cmax, ~20% ↓ AUC) but improved tolerability No SAEs or dose-limiting toxicities reported; >95% of TEAEs were mild and self-limited Based on these findings, Palisade Bio plans to complete a Phase 1b study in patients with fibrostenotic Crohn's disease by the second half of 2025. The Company's previously completed Phase 1a and 1b studies in ulcerative colitis, along with the upcoming FSCD study, will form the foundation for submitting a Phase 2 Investigational New Drug (IND) application and clinical protocols to the U.S. Food and Drug Administration (FDA) in the first half of 2026. For more information about the Phase 1a/b clinical study, visit and reference identifier NCT06663605. About PALI-2108 PALI-2108 is an orally administered prodrug engineered to deliver PDE4 inhibition selectively to the distal ileum and colon. The compound leverages a microbiome-activated mechanism to achieve regional bioactivation, minimize systemic exposure, and optimize mucosal tissue concentration. This localized approach reduces class-associated side effects while preserving anti-inflammatory and anti-fibrotic activity—a unique and clinically validated therapeutic strategy. About Palisade Bio Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to Forward Looking Statements Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to: statements regarding the safety and tolerability, PK and drug release characteristics, potential clinical efficacy and dosing requirements of PALI-2108 based on the Company's preclinical studies and data from its Phase 1a/b clinical study; indications and anticipated benefits of PALI-2108, including the potential of PALI-2108 to be a first-in-class and best-in-class therapy; and the expected timing of the Company's planned Phase 2 clinical studies. These forward-looking statements are based on the Company's current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company's forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company's clinical trials; the Company's reliance on PALI-2108, and its early stage of clinical development; the risk that prior results, such as signals of safety, activity, dosing or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company's product candidates in clinical trials focused on the same or different indications; the Company's ability to secure additional financing to fund future operations and development of its product candidates; and other factors that are described in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 24, 2025, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Investor Relations Contact JTC Team, LLCJenene Thomas908-824-0775PALI@
Yahoo
24-07-2025
- Business
- Yahoo
Palisade Bio Announces Exercise of Previously Issued Warrants for $3.9 Million
Carlsbad, CA, July 23, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ('Palisade' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced an agreement between the Company and several accredited investors to exercise certain existing warrants (the 'Existing Warrants') to purchase up to an aggregate of 4,318,905 shares of common stock. The Existing Warrants had adjusted exercise prices of $1.40 and were issued by the Company on May 10, 2022; February 1, 2024; May 6, 2024; and December 13, 2024, with each exercise occurring at a reduced exercise price of $0.9047 per share. Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for this transaction. The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to registration statements which were filed and declared effective by the Securities and Exchange Commission (the 'SEC'). The gross proceeds to the Company from the exercise of the Existing Warrants are expected to be approximately $3.9 million prior to deducting placement agent fees and estimated offering expenses. In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holders will receive new unregistered warrants (the 'Replacement Warrants') to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the '1933 Act'). The Replacement Warrants will be exercisable, beginning on the effective date of stockholder approval, into an aggregate of up to 8,637,810 shares of common stock, at an exercise price of $0.9047 per share, and a term of exercise equal to five years from the date of shareholder approval. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The Replacement Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the Replacement Warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. About Palisade Bio Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to Forward Looking Statements This communication contains 'forward-looking' statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: statements regarding the intended use of proceeds, the expected gross proceeds from the offering and the expected closing of the offering. These forward-looking statements are based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company's forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company's clinical trials, the timing and success of preclinical studies and clinical trials conducted by the Company, the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company's product candidates in clinical trials focused on the same or different indications; and the Company's ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 24, 2025, as well as the Company's Quarterly Report on Form 10-Q, for the three-month period ended March 31, 2025, filed with the SEC on May 12, 2025. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Investor Relations Contact JTC Team, LLCJenene Thomas 908-824-0775PALI@
Globe and Mail
22-07-2025
- Business
- Globe and Mail
Palisade Bio Participates in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference
– Video webcast now available on-demand Carlsbad, CA, July 22, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ('Palisade', 'Palisade Bio', or the 'Company'), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced JD Finley Chief Executive Officer of Palisade Bio, participated in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference. As part of the event, Mr. Finley dove deeper into his dedication to the Company, how he got to where he is today and provided insight into why he is so passionate about the Company's programs in development. The on-demand video webcast is now available on as well as the Events page under the Investors section of the Company's website ( About Palisade Bio Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to
Yahoo
22-07-2025
- Business
- Yahoo
Palisade Bio Participates in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference
– Video webcast now available on-demand Carlsbad, CA, July 22, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ('Palisade', 'Palisade Bio', or the 'Company'), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced JD Finley Chief Executive Officer of Palisade Bio, participated in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference. As part of the event, Mr. Finley dove deeper into his dedication to the Company, how he got to where he is today and provided insight into why he is so passionate about the Company's programs in development. The on-demand video webcast is now available on as well as the Events page under the Investors section of the Company's website ( About Palisade Bio Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to Investor Relations Contact JTC Team, LLCJenene Thomas908-824-0775PALI@ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
12-03-2025
- Health
- Yahoo
Palisade Bio Announces Two Abstracts Selected to be Showcased as Poster of Distinction and Poster Presentation at Leading GI Forum, Digestive Disease Week (DDW) 2025
PALI-2108, a Colon-Specific PDE4 Inhibitor Prodrug, Abstract was Rated in the Top 10% of all AGA Abstracts Selected for Poster Presentation at DDW Carlsbad, CA, March 12, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ('Palisade', 'Palisade Bio', or the 'Company'), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it has been selected to present data from its lead program PALI-2108 for the treatment of ulcerative colitis at Digestive Disease Week® (DDW) 2025 being held May 3–6, in San Diego, California. Participation details are as follows: Poster PresentationSession Title: Transcriptional, Epigenetic and Genetic Regulation of GI Function and Disease Session Date & Time: May 4, 2025 from 12:30 PM to 1:30 PM PDTTitle: A BIOINFORMATIC APPROACH TO PALI-2108 TREATMENT IN ULCERATIVE COLITIS REVEALS THE POTENTIAL FOR ANTI-FIBROTIC EFFICACY WITH LOCAL PDE4 INHIBITION IN INTESTINAL FIBROSIS DDW Poster of Distinction – Poster PresentationSession Title: In Vivo Models of Gastrointestinal Disorders Session Date & Time: May 5, 2025 from 12:30 PM to 1:30 PM PDTTitle: PALI-2108, A COLON-SPECIFIC PDE4 INHIBITOR PRODRUG, IS BIOACTIVATED IN THE COLON AND REDUCES COLON TISSUE PDE4B IN A DOSE-DEPENDENT MANNER, INCREASING C-AMP AND SUPPRESSING TNF-Α IN A MOUSE MODEL OF COLITIS Digestive Disease Week is a leading forum for experts in the field of gastroenterology bringing together clinicians, researchers, and pharmaceutical leaders to discuss the latest advancements in treating digestive diseases. For more information about Digestive Disease Week please visit the conference website. About Palisade Bio Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to Forward Looking Statements Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the safety and tolerability, PK and drug release characteristics of PALI-2108 based on the Company's preclinical studies and preliminary data from the Company's Phase 1b/2a clinical study, indications and anticipated benefits of PALI-2108 and the expected timing of the release of topline data from the Phase 1b/2a clinical study. These forward-looking statements are based on the Company's current expectations. Forward-looking statements involve risks and uncertainties. The Company's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company is heavily dependent on the success of PALI-2108, which is in the early stages of clinical development and may not successfully progress through clinical development or receive regulatory approval; preliminary clinical study results or the results from earlier preclinical studies may not be predictive of final or future results and unexpected adverse side effects or inadequate efficacy of PALI-2108 may limit its development, regulatory approval and/or commercialization; the Company needs to raise significant additional funds to support its operations and the continued development of PALI-2108; the timing and outcome of the Company's current and anticipated clinical studies related to its product candidates; indications of use and estimates about the size and growth potential of the markets for the Company's product candidates, and its ability to serve those markets, including any potential revenue generated; the Company's ability to maintain the Nasdaq listing of its securities; the Company's ability to compete effectively in a competitive industry; the Company's ability to identify and qualify manufacturers to provide API and manufacture drug product; the Company's ability to enter into commercial supply agreements; the Company's ability to attract and retain key scientific or management personnel; the accuracy of the Company's estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and the impact of any global event on the Company's business, and operations, and supply. Additional risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission ('SEC') on March 26, 2024, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Investor Relations Contact JTC Team, LLCJenene Thomas908-824-0775PALI@
