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].

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].

Core Insights - Palisade Bio has initiated a Phase 1b clinical study for PALI-2108, a first-in-class PDE4 inhibitor prodrug targeting fibrostenotic Crohn's disease (FSCD), with topline data expected in Q1 2026 [2][3][5] Group 1: Clinical Development - The Phase 1b study will enroll approximately 6 to 12 patients and aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 over a 14-day treatment period [3][4] - PALI-2108 is designed for targeted activation in the terminal ileum and colon, providing high local tissue exposure with minimal systemic absorption [3][6] - The study will also assess tissue-level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs) [4] Group 2: Future Plans - Data from the Phase 1b study, along with results from the Phase 1a/1b ulcerative colitis program, are expected to support Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026 [5] - The company aims to transform the treatment landscape for autoimmune, inflammatory, and fibrotic diseases through its targeted therapeutic approach [7]

Core Insights - Palisade Bio has developed PALI-2108, a first-in-class PDE4 inhibitor specifically targeting the terminal ileum and colon for treating fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC) to meet significant unmet medical needs [1][4] Intellectual Property - The Canadian Intellectual Property Office has granted patent number 3,174,137 for PALI-2108, providing composition-of-matter protection until May 28, 2041 [2] - The patent covers the unique design of PALI-2108, which includes a galactose-derived sugar moiety that minimizes absorption until activated by colonic bacteria [2] Clinical Development - Palisade Bio is advancing PALI-2108 in a Phase 1b study for FSCD, with patient dosing expected to start in the second half of 2025 and topline data anticipated in the first quarter of 2026 [3] - Results from the Phase 1b study, along with data from completed Phase 1a/1b trials in UC, will support a planned Phase 2 IND submission to the FDA in the first half of 2026 [3] Product Overview - PALI-2108 is an orally administered prodrug designed for gut-restricted delivery, achieving high local tissue concentrations while minimizing systemic exposure [4] - The mechanism of action aims to maximize anti-inflammatory and anti-fibrotic effects while reducing common tolerability issues associated with systemic PDE4 inhibitors [4] Company Background - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [5]

Key Points - Several biotech stocks experienced notable after-hours gains on October 9, driven by new data and corporate developments [1] Company Summaries Palisade Bio Inc. (PALI) - Shares traded at $2.26 in after-hours, reflecting a 7.62% gain from the prior close of $2.10, which was up 5% on the day [1] - The company cancelled its special meeting of stockholders due to lack of quorum, withdrawing all proposals from consideration [2] Healthcare Triangle Inc. (HCTI) - Shares traded at $2.88 in after-hours, up 4.35% from the regular session close of $2.76, which was down 17.86% [3] - The company signed a non-binding Letter of Intent to acquire Teyame.AI, projected to generate $34 million in revenue for fiscal year 2025 [4] Nutriband Inc. (NTRB) - Shares traded at $8.25 in after-hours, up 4.30% from the regular session close of $7.91, which was down 6.94% [5] - The company filed a provisional patent application with the USPTO to strengthen its intellectual property for its AVERSA abuse deterrent transdermal [5] Karyopharm Therapeutics Inc. (KPTI) - Shares traded at $6.08 in after-hours, up 4.46% from the regular session close of $5.82, which had declined 1.36% [6] - The company announced financing transactions expected to provide $100 million in financial flexibility, extending its cash runway into Q2 2026 [6] Editas Medicine Inc. (EDIT) - Shares traded at $4.22 in after-hours, up 3.43% from the regular session close of $4.08, which was down 1.69% [7] - The company presented new preclinical proof-of-concept data for its therapy EDIT-401, showing a 90% LDL-C reduction in non-human primates and mice [7] CG Oncology Inc. (CGON) - Shares traded at $45.40 in after-hours, up 2.11% from the regular session close of $44.46, which gained 9.21% [8] - No official news releases or filings were issued during the day [8]

Core Viewpoint - Palisade Bio, Inc. has decided to cancel its special meeting of stockholders originally scheduled for October 10, 2025, due to the lack of a required quorum [1][2]. Group 1: Special Meeting Details - The special meeting was previously adjourned to September 26, 2025, but was adjourned again without any business being conducted due to insufficient proxies to form a quorum [2]. - The company has not received the necessary proxies to constitute a quorum and has withdrawn the proposals set forth in the definitive proxy statement filed with the U.S. Securities and Exchange Commission on August 18, 2025 [2]. Group 2: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases [3]. - The company aims to transform the treatment landscape through a targeted approach with its novel therapeutics [3].