Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — SAGES 2022
24 slides from Palisade Bio's conference presentation, Mar 16, 2022
Slide 1: Restoring Intestinal Barrier Health
Restoring Intestinal Barrier Health SAGES 2022 Presentation | March 16, 2022 PALI (NASDAQ) | palisadebio.com
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding our research and clinical development plans, hypothesis leading to adhesion formatio
Slide 3: Highlights and Implications from Pooled-Study Analysis
Highlights and Implications from Pooled-Study Analysis: LB1148 Has Potential to Impact Adhesion Prevention Overview LB1148 reduced the incidence of adhesions by 72% LB1148 reduced the mean extent and severity of adhesions by 92% By reducing adhesion formation, LB1148 potentially addresses a burdenso
Slide 4: Post-surgical Adhesions Develop in Approximately 93% of Abdominal Procedures
The bowel normally has smooth surfaces that easily slide in the abdomen Adhesions are scar tissues that form during the healing process, binding tissues and organs that are not normally connected HYPOTHESIS: Proteases, released as a result of bowel manipulation during surgeries, lead to adhesion for
Slide 5: Post-Surgical Intraabdominal Adhesions
Adhesions can form almost anywhere in the abdomen Most often they are formed: between the intestines and the abdominal wall, or within the intestines where they bend and loop Adhesions have varied appearances as: thin sheets of tissue similar to cellophane, or thick, large bands that engulf the inte
Slide 6: Unmet Need – Reducing Post-surgical Adhesions
Unmet Need – Reducing Post-surgical Adhesions Adhesions are a widespread and potentially severe problem after surgery: Up to 93% of abdominal procedures result in post-surgical adhesions #1 cause of secondary female infertility #1 cause of bowel obstruction (up to 75%) 10th most frequent cause of em
Slide 7: Barrier Film Medical Devices for Adhesion Prevention
Limitations: Only product approved for abdominal surgery Only approved for use with laparotomy Seprafilm is not designed for laparoscopies Only reduces adhesions between the abdominal wall and the underlying viscera Disrupts surgical process and extends duration of anesthetics Barrier Film Medical D
Slide 8: FDA Approved ADEPT Hydroflotation Medical Device for Pelvic Surgery
FDA Approved ADEPT Hydroflotation Medical Device for Prevention in Pelvic Surgery with a Less Than 10% Reduction in Adhesions Success ADEPT is peritoneal fluid used to reduce tissue apposition during surgery, thereby providing a barrier to adhesion formation ADEPT is believed to perform its function
Slide 9: Postoperative Complications are Driven by Proteolytic Activity
Postoperative Complications are Driven by Proteolytic Activity Injury (surgery or hypoperfusion) Compromised mucosal barrier Healthy intestine Protease leak and translocation ↑ Proteolytic activity ↑ Tissue damage/permeability ↑ Autodigestion ↑ Microbiome imbalance/pathology ↑ Pathologic cell signal
Slide 10: LB1148 – In Development to Reduce Post-Surgical Adhesions
Novel oral formulation comprised of FDA-approved components Broad-spectrum serine protease inhibitor (tranexamic acid) Plan to utilize 505(b)(2) pathway for approval Fast-track designation for reducing surgical adhesions Issued patents on drug product Patient takes drug at home prior to being hospit
Slide 11: Illustrative Patient Journey: GI Surgery with LB1148 Administration
Illustrative Patient Journey: GI Surgery with LB1148 Administration 1 Pre-op physical in clinic; Physician writes prescription Bowel prep Anti-nausea Antibiotics LB1148 Covered by pharmacy benefit 2 Prescription filled at pharmacy 3 Preoperative medications taken at home LB1148 4 In-patient surgery
Slide 12: LB1148 Reduced Adhesions by 63% in an Animal Model of Bowel Resection
LB1148 Reduced Adhesions by 63% in an Animal Model of Bowel Resection with Anastomosis LB1148 dramatically reduces the number of post-surgical adhesions Source: LBS-NC-IL-ADH-0003 DOF Reduced various types of adhesions: bowel to bowel, bowel to abdominal wall, bowel to viscera 63% Reduction p<0.001
Slide 13: LB1148 Reduced Adhesions by 78% in an Animal Model of Abdominal Surgery
LB1148 reduced the severity of post-surgical adhesions by 62% LB1148 Reduced Adhesions by 78% in an Animal Model of Abdominal Surgery Without an Enterotomy (Intestinal Incision) Animals receiving LB1148 before surgery had 78% fewer adhesions Source: LBS-NC-ADH-002 DOF Reduced various types of adhesi
Slide 14: Completed Phase GI Surgery Clinical Study
Completed Phase 1 GI Surgery Clinical Study Open label, investigator-sponsored, single-arm study of LB1148 in subjects undergoing elective GI surgery Patients take 700 mL of LB1148 as a split dose prior to surgery Study Design 11 subjects Single site in Los Angeles, CA A total of three subjects had
Slide 15: GI Surgery (PROFILE-CN) Phase 2 Clinical Study – Partnered Study
GI Surgery (PROFILE-CN) Phase 2 Clinical Study – Partnered Study GI Surgery Randomized, double-blind, placebo-controlled, multi-site Phase 2 trial Evaluate LB1148 for return of GI function and adhesions in subjects undergoing elective bowel resection with a laparotomy or minimally invasive approach
Slide 16: GI Surgery (PROFILE-CN) Phase Study: Safe and Well Tolerated
GI Surgery (PROFILE-CN) Phase 2 Study: Safe and Well Tolerated LB1148 was well tolerated Drug-related adverse events LB1148 = 10.9% Placebo = 4.8% The most common drug-related AEs were GI disorders LB1148 4.7% Placebo 3.2% No drug-related serious adverse events occurred in the trial Source LBS-POI-2
Slide 17: Key Demographics on Adhesion Data
Key Demographics on Adhesion Data LB1148 Placebo Patients Enrolled 8 9 Male/Female 4 / 4 7 / 2 Median Age (range) 57.5 (40-85) 59 (47-72) Reason for Bowel Resection Colorectal Cancer 8 9 Surgical Approach Laparotomy 2 0 Minimally invasive 6 9
Slide 18: Scoring System to Quantify Adhesions Extent and Severity
Scoring System to Quantify Adhesions Extent and Severity Coccolini et al., 2013 Adhesion Severity Score 0 = no adhesions 1 = filmy thickness, avascular 2 = moderate thickness, limited vascularity 3 = dense thickness, vascularized Adhesion Assessment Procedure: For each abdominal region, the score of
Slide 19: LB1148 Demonstrated a 72% Reduction in Adhesions
LB1148 Demonstrated a 72% Reduction in Adhesions 1Compared to placebo 2Fisher’s exact test 3Ouaïsi 2011 The results from the pooled analysis showed that 8/9 (89%) of subjects in the placebo had one or more adhesions Mirrors published incidence of post-surgical adhesion rate of up to 93% For subjects
Slide 20: LB1148 Reduced the Adhesions Extent and Severity Score by 93%
Placebo subjects' extent and severity adhesion score was 14.3 (±9.19 SEM) LB1148 treated subjects' extent and severity adhesion score was 1.0 (±0.672 SEM) 93% reduction compared to placebo LB1148 Reduced the Adhesions Extent and Severity Score by 93%
Slide 21: Key Findings
Key Findings: LB1148 reduced the relative risk of adhesions by 72% LB1148 reduced the extent and severity of adhesions by 93% The incidence of adhesions in the placebo group was within the expected published incidence Placebo-treated subjects - laparoscopic procedures: 100% LB1148-treated subjects -
Slide 22: Principal Investigator's Experience with Using LB1148 for GI Surgery Patients
Ronald Hurst, MD Chief Department of Surgery Principle Investigator’s Experience with Using LB1148 for GI Surgery Patients Would you comment on adhesion pathology in your patient population and practice? Do you consider adhesions an unmet medical need? Was LB1148 easy to use in your Scope of Practic
Slide 23: Next Steps for Clinical Studies of LB1148
Ongoing phase 2 clinical study in the US that will capture additional data on adhesions prevention with LB11481 Expected completion of subject enrollment of that study in H2 2022 Transitioning LB1148 for Phase 3 to accelerate the return of bowel function Next Steps for Clinical Studies of LB1148 1 N
Slide 24: Contact Details
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com