Core Insights - Palisade Bio Inc. (NASDAQ:PALI) has shown strong performance, with a 5.26% increase in stock price to $2.20, marking a four-day winning streak as investors anticipate clinical trial results for its treatment of fibrostenotic Crohn's disease (FSCD) [1][4] - The company plans to present topline results from its Phase 1b study of PALI-2108 in Q1 2026, with an Investigational New Drug submission expected in the first half of the following year [2] - The stock rally is partly attributed to window-dressing activities by institutional investors, who adjust their portfolios before reporting periods [3] Company Performance - Year-to-date, Palisade Bio Inc.'s shares have increased by 33.33% [4] - The company is focused on developing a next-generation oral PDE4 inhibitor prodrug aimed at treating inflammatory and fibrotic diseases [4]

Core Insights - Palisade Bio (PALI) is a clinical-stage biopharmaceutical company focused on developing PALI-2108, a prodrug candidate aimed at treating ulcerative colitis (UC) and fibrostenotic Crohn's disease (FSCD), both of which have significant unmet medical needs [1] Company Overview - PALI-2108 is being studied for two indications related to inflammatory bowel disease (IBD), specifically targeting ulcerative colitis and fibrostenotic Crohn's disease [1]

Core Insights - Palisade Bio (PALI) is a clinical-stage biopharmaceutical company focused on developing PALI-2108, a prodrug candidate aimed at treating ulcerative colitis (UC) and fibrostenotic Crohn's disease (FSCD), both of which have significant unmet medical needs [1] Company Overview - PALI-2108 is being studied for two indications related to inflammatory bowel disease (IBD), specifically targeting ulcerative colitis and fibrostenotic Crohn's disease [1] Market Opportunity - The conditions targeted by PALI-2108 represent significant unmet medical needs, indicating a potential market opportunity for the company [1]

Core Viewpoint - Palisade Bio, Inc. (PALI) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is effective for individual investors as it focuses on earnings estimate revisions, which are strongly correlated with near-term stock price movements [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Company Performance and Investor Sentiment - The upgrade for Palisade Bio reflects an improvement in its underlying business, suggesting that investor sentiment will likely push the stock price higher [5]. - Over the past three months, the Zacks Consensus Estimate for Palisade Bio has increased by 50.2%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Palisade Bio in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

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]

Financial Performance - The company reported a net loss of $2.868 million for the three months ended September 30, 2025, a decrease of 18% compared to a net loss of $3.487 million in the same period of 2024[144]. - Net loss for the nine months ended September 30, 2025, was $7.9 million, a reduction of 29% compared to a net loss of $11.1 million in 2024[151]. - The company expects to incur substantial operating losses for the foreseeable future and will require additional funding for future clinical activities[161]. - The company has incurred significant operating losses and negative cash flows since inception, with no significant revenues generated to date[176]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $2.922 million, down 19% from $3.593 million in the same period of 2024[144]. - General and administrative expenses increased by 5% to $1.528 million for the three months ended September 30, 2025, compared to $1.456 million in the same period of 2024[144]. - Research and development expenses decreased by approximately $0.7 million, or 35%, for the three months ended September 30, 2025, primarily due to a $1.1 million decrease in preclinical joint development expenses related to PALI-2108[145]. - General and administrative expenses decreased by approximately $0.4 million, or 10%, for the nine months ended September 30, 2025, compared to the same period in 2024[158]. - Total operating expenses for the nine months ended September 30, 2025, were $8.1 million, a decrease of 30% from $11.5 million in 2024[151]. Cash Flow and Financing - Cash used in operating activities was approximately $7.7 million for the nine months ended September 30, 2025, down from $9.8 million in 2024[169]. - Cash provided by financing activities for the nine months ended September 30, 2025, was approximately $3.1 million, primarily from net cash proceeds of approximately $3.5 million from the exercise of common stock warrants[172]. - The October 2025 Offering generated gross proceeds of approximately $138 million, which will fund operations through major clinical development milestones[162]. - The company has a cash and cash equivalents balance of $138 million from an underwritten public offering that closed on October 2, 2025, sufficient to fund operations through major clinical development milestones[176]. - Cash provided by financing activities for the nine months ended September 30, 2024, was approximately $5.4 million, attributed to net cash proceeds from common stock warrants and private placement financing[173]. Clinical Development - The company completed dosing of 89 subjects in the Phase 1 clinical study of PALI-2108, which included five Single Ascending Dose cohorts and four Multiple Ascending Dose cohorts[129]. - Positive results were announced from the Phase 1 clinical study, with all five patients in the UC cohort demonstrating rapid and consistent clinical activity[130]. - The exploratory Phase 1b cohort in FSCD is expected to be followed by Phase 2 clinical programs to assess PALI-2108's efficacy, safety, and tolerability[132]. - The company anticipates submitting an Investigational New Drug Application to the FDA in the first half of 2026 based on data from the exploratory Phase 1b cohort and Phase 1a/1b UC program[133]. - PALI-2108's Phase 1 clinical trial commenced in November 2024, with top-line results reported in Q2 and Q3 2025[147]. Milestones and Obligations - A development milestone payment of $235,000 is owed to Giiant upon the dosing of the first patient in a Phase 1b clinical trial of PALI-2108, which was achieved on October 16, 2025[174]. - The company will settle the milestone payment to Giiant in cash within 30 days of the milestone being met[174]. - The company recognized a non-cash loss of approximately $0.3 million in the nine months ended September 30, 2025, due to the fair value remeasurement of the contingent consideration liability[157]. Research and Development - Research and development expenses decreased by approximately $3.0 million, or 42%, for the nine months ended September 30, 2025, compared to the same period in 2024[152]. - Clinical trial-related expenses increased to approximately $2.4 million for the nine months ended September 30, 2025, compared to $0.4 million in 2024[156]. - The company has initiated the development of biomarker assays for PDE4-related biomarkers to improve patient selection for PALI-2108[124]. Accounting and Reporting - The company has not reported significant changes in critical accounting policies and estimates since the last Annual Report[178]. - The company is considered a smaller reporting company and is not required to provide certain market risk disclosures[180].

Core Viewpoint - Palisade Bio, Inc. (PALI) has shown a downtrend recently, losing 18.8% over the past week, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a minor difference between opening and closing prices, with a long lower wick, suggesting that the bears may be losing control and a potential trend reversal could occur [4][5]. - This pattern is significant when it appears at the bottom of a downtrend, signaling that buying interest is starting to emerge [5]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for PALI, which is a bullish indicator suggesting potential price appreciation in the near term [7]. - The consensus EPS estimate for the current year has increased by 20.1% over the last 30 days, indicating that analysts are optimistic about the company's earnings potential [8]. - PALI currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].