Palisade Bio, Inc. (PALI) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a c ...

Summary of Palisade Bio FY Conference Call Company Overview - **Company**: Palisade Bio (NasdaqCM:PALI) - **Industry**: Biotechnology, specifically focusing on treatments for inflammatory bowel disease (IBD) including ulcerative colitis (UC) and fibrostenotic Crohn's disease Key Milestones and Catalysts - Completion of a Phase 1B cohort in fibrostenotic Crohn's disease with results expected in early Q1 2026 [6] - Filing of an Investigational New Drug (IND) application for a definitive UC study, anticipated to start mid-year 2026 [6][7] - Final top-line readout for the UC study scheduled for the end of 2027 [7] Product Mechanism and Differentiation - **Product**: PALI-2108, a PDE4 inhibitor designed as a prodrug for optimized local delivery in the gut [9] - Unique formulation allows for once-daily dosing, targeting the terminal ileum and colon, which is not available with other PDE4 inhibitors [11] - The prodrug is activated by gut bacteria, minimizing systemic exposure and associated adverse effects [11][12] - Demonstrated 100% clinical response and 40% clinical remission in a small cohort of UC patients after one week of treatment [24] Clinical Data and Efficacy - Historical data shows a 31% clinical remission rate for Apremilast and a 57% rate for Mefenilast, while PALI-2108 showed a 100% clinical response in a five-patient cohort [14][15] - Significant biomarker improvements observed: 70% reduction in fecal calprotectin, 15% reduction in CRP, and a 70% increase in cyclic AMP after one week of treatment [15] - The drug is reported to be 20 times more potent than Apremilast, allowing for higher dosing without increased toxicity [17] Safety and Tolerability - Emphasis on safety and tolerability as key differentiators in the market, especially compared to JAK inhibitors and S1Ps which have safety warnings [22][37] - Ongoing studies aim to demonstrate safety and tolerability in symptomatic fibrostenotic Crohn's patients with ileal lesions [44] Future Development Plans - Phase 2 study design includes 195 patients with a focus on individual patient dosing adaptation after the first three weeks [30] - The study aims to establish safety, tolerability, and efficacy, with potential for accelerated approval based on surrogate biomarkers [49] - Current cash position is strong with $138 million raised, providing sufficient runway for Phase 2 studies in both UC and fibrostenotic Crohn's disease [50] Market Opportunity - High unmet medical need in fibrostenotic Crohn's disease with limited competition and no current approvals for anti-inflammatory, antifibrotic treatments [42][43] - The company is positioned uniquely as the only candidate targeting both anti-inflammatory and antifibrotic pathways in this indication [43] Conclusion - Palisade Bio is poised for significant developments in 2026 with promising clinical data, a strong financial position, and a unique product offering that addresses critical needs in the treatment of IBD [51]

Core Viewpoint - Palisade Bio, Inc. has appointed Dr. James Izanec as Vice President of Clinical Development, bringing extensive experience in leading global Phase 2/3 programs in immunology, neurology, and gastroenterology [1][3][4] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing next-generation, once-daily oral PDE4 inhibitor prodrugs for inflammatory and fibrotic diseases [8][10] - The lead program, PALI-2108, targets moderate-to-severe Ulcerative Colitis (UC) and Fibrostenotic Crohn's Disease (FSCD), with a recent Phase 1b trial showing a 100% clinical response in the UC cohort [10][11] Leadership and Experience - Dr. Izanec has over two decades of experience in clinical and drug development, having previously held senior roles at Bristol Myers Squibb and Janssen [3][4][5] - His background includes overseeing a 1,200-patient Phase 3 Crohn's program and leading pediatric development programs in related diseases [4][5] Clinical Development Strategy - The company is advancing PALI-2108 towards a Phase 2 clinical study in UC, focusing on clinical remission, response, and pharmacodynamic biomarkers over 12 weeks [11] - Plans are also in place to initiate studies in FSCD to further evaluate PALI-2108's safety and therapeutic benefits [11]

Group 1 - U.S. stock futures are higher, with Dow futures gaining around 50 points [1] - Tilray Brands Inc announced a one-for-10 reverse stock split, effective December 1 [1] - Tilray shares fell sharply by 15% to $0.88 in pre-market trading [2] Group 2 - Inventiva ADR fell 7.4% to $4.26 in pre-market trading after a previous gain [4] - Anglogold Ashanti PLC dipped 5.5% to $83.97 in pre-market trading after a gain of over 5% [4] - Lexicon Pharmaceuticals Inc fell 5% to $1.36 in pre-market trading [4] - SuperX AI Technology Ltd fell 3.9% to $26.00 in pre-market trading after a significant previous jump of 23% [4] - Palisade Bio Inc declined 3.6% to $2.15 in pre-market trading [4] - Gold Fields Ltd fell 3.4% to $41.76 in pre-market trading after a gain of 6% [4] - Abacus Global Management Inc fell 3.2% to $6.33 in pre-market trading after reporting better-than-expected third-quarter results and announcing a $10 million buyback [4]

Core Insights - Palisade Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation, once-daily oral PDE4 inhibitor prodrugs for inflammatory and fibrotic diseases [3][4] - The company will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, featuring CEO JD Finley and CMO Dr. Mitchell Jones [1][2] Company Overview - Palisade Bio is dedicated to improving pharmacology, tolerability, and convenience for patients suffering from chronic inflammatory and fibrotic diseases through its differentiated prodrug platform and precision pharmacology strategy [3] - The lead program, PALI-2108, is being developed for moderate-to-severe Ulcerative Colitis (UC) and Fibrostenotic Crohn's Disease (FSCD), addressing the need for non-immunosuppressive therapy options [4] Clinical Development - In a Phase 1b trial, PALI-2108 demonstrated a 100% clinical response in the UC cohort, with no serious adverse events and favorable tolerability [4] - The company is advancing towards a Phase 2 clinical study in UC to evaluate clinical remission, response, and pharmacodynamic biomarkers over 12 weeks, with plans for an extension phase [5] - Additionally, studies in FSCD are being prepared to further assess PALI-2108's safety, pharmacology, and therapeutic benefits across inflammatory bowel disease indications [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR WASHINGTON, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-33672 PALISADE BIO, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporati ...

A downtrend has been apparent in Palisade Bio, Inc. (PALI) lately. While the stock has lost 18.8% over the past week, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future ...

Core Viewpoint - Palisade Bio, Inc. (PALI) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for Palisade Bio reflects an improvement in the company's earnings outlook, which is expected to lead to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimate Revisions - Changes in a company's future earnings potential, as shown through earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to significant stock price movements based on their buying or selling activities [5]. Performance of Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The system maintains a balanced distribution of "buy" and "sell" ratings across over 4,000 stocks, ensuring that only the top 20% receive a "Strong Buy" or "Buy" rating [10][11]. Specifics on Palisade Bio - For the fiscal year ending December 2025, Palisade Bio is expected to earn -$1.33 per share, unchanged from the previous year, but analysts have raised their estimates by 4.7% over the past three months [9].

Core Insights - Palisade Bio has appointed Sharon Skare, PhD(c), as Vice President, Global Head of Clinical Operations, bringing over 24 years of experience in clinical development across various therapeutic areas [1][3][4] - The company is focused on advancing PALI-2108 for ulcerative colitis and fibrostenotic Crohn's disease, with a Phase 2 IND submission planned for the first half of 2026 [1][7] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases [8] - The company aims to transform the treatment landscape by utilizing a targeted approach with its novel therapeutics [8] Product Development - PALI-2108 is an orally administered prodrug designed for local delivery of phosphodiesterase-4 (PDE4) inhibition specifically to the terminal ileum and colon [5] - The prodrug is engineered to be gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is activated by bacterial enzymes [5][6] - A Phase 1a/1b study of PALI-2108 for ulcerative colitis has been completed with positive data, and a Phase 1b study for fibrostenotic Crohn's disease is currently underway [7] Leadership and Expertise - Sharon Skare has a strong background in global clinical development, having previously held senior positions at Abivax, Pfizer, and Arena Pharmaceuticals [3][4] - Her experience includes overseeing global Phase 3 and Phase 2 programs in ulcerative colitis and Crohn's disease, as well as leading clinical operations for Etrasimod, now approved as Velsipity™ [3][4]

Core Viewpoint - Purcell & Lefkowitz LLP is investigating Palisade Bio, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is being conducted on behalf of Palisade Bio's shareholders [1]. - Shareholders interested in more information about their rights and options can contact Purcell & Lefkowitz LLP [2]. - The law firm specializes in representing shareholders affected by securities fraud and breaches of fiduciary duty [3].