Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Investor Presentation (January 2022)
39 slides from Palisade Bio's investor presentation, Jan 11, 2022
Slide 1: Restoring Intestinal Barrier Health
Restoring Intestinal Barrier Health Corporate Presentation | January 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, strategy, regulatory matters, market si
Slide 3: Palisade Bio – Developing Targeted Inhibitors of Digestive Proteases
Palisade Bio – Developing Targeted Inhibitors of Digestive Proteases Palisade Bio develops drugs treating diseases caused by digestive-enzyme leak that produce inflammation and tissue damage Scientific Platform Technology LB1148 is an oral liquid protease inhibitor administered at home as a bowel pr
Slide 4: Lead Drug: LB1148
Lead Drug: LB1148
Slide 5: Lead Drug Candidate LB1148 – Highlights of Potential Path to Commercialize
Lead Drug Candidate LB1148 – Highlights of Potential Path to Commercialize for Surgery Patients Oral digestive enzyme inhibitor has demonstrated clinical benefit in multiple surgical studies Clinical Safety & Efficacy Prior approvals provide precedent pathway for pivotal trial design and regulatory
Slide 6: Unmet Need – The Time to Postoperative GI Recovery
Unmet Need – The Time to Postoperative GI Recovery Postoperative return of bowel function is often a limiting determinant of hospital discharge Patients generally do not leave hospital until they have a bowel movement Lack of GI recovery: Causes pain and bloating Causes major discomfort Extends hosp
Slide 7: 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 8: Only Single Competitor for Each Indication
Post-surgical Adhesions Limitations: Only product approved for abdominal surgery Only approved for laparotomy Cannot be used for laparoscopic surgeries, which comprise a growing percentage of the market Only reduces adhesions between the abdominal wall and the underlying viscera Disrupts surgical pr
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 Prevents Intestinal Damage; Rapidly Reseals the Barrier
LB1148 Prevents Intestinal Damage; Rapidly Reseals the Barrier Hypoperfusion Injury Hypoperfusion Injury Control – TXA LB1148 Permeable epithelial barrier Loss of villi tissue Basal membrane compromised Lymph vessel damage Continuous epithelial barrier Intact villi structure Robust basal membrane st
Slide 11: LB1148 Overview: Pipeline in a Product – Multiple Indications
LB1148 Overview: Pipeline in a Product – Multiple Indications Drug/Class Indication Research Pre-clinical Phase 1 Phase 2 Phase 3 LB1148* Oral broad-spectrum protease inhibitor* Postoperative return of bowel function GI Surgery Neonatal cardiac surgery Prevention of post-surgical abdominal adhesions
Slide 12: Accelerating Return of Bowel Function
Accelerating Return of Bowel Function
Slide 13: GI Surgery Phase 2: Significantly Accelerated Return of GI Function
GI Surgery Phase 2: Significantly Accelerated Return of GI Function LBS-POI-201 CSR P=0.0008 Hazard ratio=1.89 N=120 1.1 day improvement 1.5 day improvement Median 75th Percentile
Slide 14: LB1148 Accelerates Return of GI Function – Advancing to Phase 3
LB1148 Accelerates Return of GI Function – Advancing to Phase 3 Consistent statistically significant clinical efficacy in three completed clinical studies 48% improvement in time to return of bowel function after GI surgery in phase 1 (vs. placebo in Entereg study 314*) 1.3-day reduction in hospital
Slide 15: Preventing Post-surgical Adhesions
Preventing Post-surgical Adhesions
Slide 16: GI Surgery Study Results: Zero Adhesions in Three Surgery Patients
For the three patients with a second surgery: No adhesions No evidence of inflammation GI Surgery Study Results: Zero Adhesions in Three Surgery Patients Three of 11 patients required a second surgery unrelated to adhesions Opportunity to visualize and measure adhesions extent severity As a surgeon
Slide 17: LB1148 Commercial Opportunity
LB1148 Commercial Opportunity
Slide 18: 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 Likely covered by pharmacy benefit 2 Prescription filled at pharmacy 3 Preoperative medications taken at home LB1148 4 In-patient s
Slide 19: LB1148 Has Large Global Market Opportunity
LB1148 Has Large Global Market Opportunity US Market 1.1 million open heart surgeries 5.6 million abdominal surgeries 20-40% market penetration could translate to >$2B revenue Partnered China: w/ Newsoara EU and ROW Opportunities Potential to partner with US rights or independently USA Strategy Comm
Slide 20: Contact
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com
Slide 21: Appendix Slides
Appendix Slides
Slide 22: LB1148 - Expeditious Regulatory Pathway; Limited Competition
Novel oral formulation comprised of FDA-approved components Broad-spectrum serine protease inhibitor (tranexamic acid) Known safety profile Plan to utilize 505(b)(2) pathway for approval Fast-track designation for Reducing surgical adhesions Reducing postoperative GI dysfunction for pediatric patien
Slide 23: Entereg: Only Drug Approved for Accelerating Return of GI Function
Entereg: Only Drug Approved for Accelerating Return of GI Function Provides a precedent pathway to FDA approval Developed by GSK/Adolor/Cubist and now owned by Merck Indicated to improve post-op recovery of bowel function Phase 3 demonstrated*: 17-hour improvement in return of bowel function 7-hour
Slide 24: LB1148 Program Overview
LB1148 Program Overview Pipeline in a Product – Multiple Indications Accelerate Return of Postoperative GI Function Reduce Post-surgical Adhesions Cardiovascular Surgery Gastrointestinal Surgery Abdominal Surgery
Slide 25: Cardiovascular Surgery (Hypoperfusion Injury)
Cardiovascular Surgery (Hypoperfusion Injury)
Slide 26: CV Surgery Completed Phase 2: Study Design
CV Surgery Completed Phase 2: Study Design * Study Day 0 is the day of surgery. Screening Period CV Surgery Postoperative / Discharge LB1148 Day -42 to -1 Day 0* Day 1-14 Follow-up Day 30 Placebo Cardiovascular Surgery Open-heart CV surgery requiring cardio-pulmonary bypass Randomized, double-blind,
Slide 27: CV Surgery Phase 2: Significant Improvement in Bowel Function
CV Surgery Phase 2: Significant Improvement in Bowel Function Top-line data highlights 30% improvement in return of bowel function Highly statistically significant; p<0.001 Median time to bowel recovery: 31.7 hours on LB1148 vs. 45.0 hours on placebo Same endpoint will be used for Phase 3 1.0-day re
Slide 28: GI Surgery: Return of Bowel Function (Physical Injury)
GI Surgery: Return of Bowel Function (Physical Injury)
Slide 29: Completed GI Surgery Study: Study, Indications, Data Readouts
Completed GI Surgery Study: 1 Study, 2 Indications, 2 Data Readouts: Return of Bowel Function and Adhesion Prevention 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
Slide 30: GI Surgery Study Results: 48% Faster than Historical Control
GI Surgery Study Results: 48% Faster than Historical Control Data highlights: 48% improvement in return of bowel function Approvable endpoint No LB1148-related AEs 2.3-days earlier first bowel movement 48% better than historical control GI Surgery Source: Ludwig K, et. al.. Arch Surg. 2008 Nov;143(1
Slide 31: GI Surgery Study Results: Significant Improvement in Hospital Length of Stay
GI Surgery Study Results: Significant Improvement in Hospital Length of Stay Versus Expected LOS GI Surgery Time from Surgery to Discharge (Days) Patient’s actual length of stay (LOS) was compared to expected LOS as determined from their billing code at time of admission (GMLOS) 1.3-day improvement
Slide 32: GI Surgery (PROFILE) Phase – Partnered Study
GI Surgery (PROFILE) Phase 2 – 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 with planned stoma
Slide 33: GI Surgery Phase 2: Significantly Accelerated Return of GI Function
GI Surgery Phase 2: Significantly Accelerated Return of GI Function LBS-POI-201 CSR P=0.0008 Hazard ratio=1.8 1.1-day improvement 1.5-day improvement Median 75th Percentile Data Repeated from Body of Presentation
Slide 34: GI Surgery Phase 2: Safe and Well Tolerated
GI Surgery Phase 2: 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
Slide 35: GI Surgery: Reduction of Adhesions (Physical Injury)
GI Surgery: Reduction of Adhesions (Physical Injury)
Slide 36: Unmet Need - Post-surgical Adhesions Develop in up to 93% of Abdominal Procedures
Adhesions are scar tissue that forms during the healing process that bind tissues/organs that are not normally connected HYPOTHESIS: Proteases, released as a result of bowel manipulation during surgeries, lead to adhesion formation Bands of adhesions can constrict organs and tissues, causing organ s
Slide 37: LB1148 Reduces Adhesions by 63% in Animal Studies
LB1148 dramatically reduces the number of post-surgical adhesions LB1148 Reduces Adhesions by 63% in Animal Studies Animals receiving LB1148 before surgery had 63% fewer adhesions Source: LBS-NC-IL-ADH-0003 DOF Reduced all types of adhesions: bowel to bowel, bowel to abdominal wall, bowel to viscera
Slide 38: FDA Approved ADEPT for Pelvic Surgery with Only a 10% Reduction in Adhesions
FDA Approved ADEPT for Pelvic Surgery with Only a 10% Reduction in Adhesions Source: Adept (4% icodextrin) Package Insert; March 2006 www.accessdata.fda.gov/cdrh_docs/pdf5/P050011B.pdf FDA approved ADEPT based on only 10% of patients achieving “success” (defined as a decrease ≥ 3 sites with adhesion
Slide 39: Contact
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com