Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Investor Presentation (May 2022)
46 slides from Palisade Bio's investor presentation, May 3, 2022
Slide 1: Restoring Intestinal Barrier Health
Restoring Intestinal Barrier Health Corporate Presentation | May 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: 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: LB1148 Overview: Pipeline in a Product – Multiple Indications
LB1148 Overview: Pipeline in a Product – Multiple Indications LB1148 Program Pre-Clinical Phase 1 Phase 2 Phase 3 Next Milestone Postoperative return of bowel function Phase 3 “Study May Proceed” letter Study initiation Q2 2022* FPI 2H 2022* CV program to follow GI study Prevention of post-surgical
Slide 5: Lead Drug: LB1148
Lead Drug: LB1148
Slide 6: 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 trial design and regulatory reviews;
Slide 7: 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 8: 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 9: 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 10: 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 11: 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 12: 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 13: Accelerating Return of Bowel Function
Accelerating Return of Bowel Function
Slide 14: GI Surgery (PROFILE) Phase 2 – 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 15: 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 16: Key Findings: LB1148 Accelerates Return of GI Function
Key Findings: LB1148 Accelerates Return of GI Function 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 LOS vs.
Slide 17: Global Phase 3 GI Surgery Study Design
Global Phase 3 GI Surgery Study Design GI Surgery Randomized, double-blind, placebo-controlled, multi-site Phase 3 trial of 600 patients Evaluate LB1148 for return of GI function (GI2) in subjects undergoing elective bowel resection with a laparotomy or minimally invasive approach. Study Design Prim
Slide 18: Preventing Post-surgical Adhesions
Preventing Post-surgical Adhesions
Slide 19: LB1148 Reduced Adhesions by 63% in an Animal Model
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 20: 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 21: Results from the Pooled Analysis: LB1148 Reduced Adhesions by 72%
Results from the Pooled Analysis: Demonstrates LB1148 Reduced Adhesions by 72% 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
Slide 22: Pooled Analysis: LB1148 Reduced Adhesions Extent and Severity Score by 93%
Results from the Pooled Analysis: 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
Slide 23: GI Surgery (PROFILE—US) Phase 2 (amended)
GI Surgery (PROFILE—US) Phase 2 (amended) GI Surgery Randomized, double-blind, placebo-controlled, multi-site Phase 2 trial Evaluate LB1148 to reduce the formation of post-surgical intraabdominal adhesions and accelerate the return of GI function in subjects undergoing elective bowel resection with
Slide 24: LB1148 Commercial Opportunity
LB1148 Commercial Opportunity
Slide 25: 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 26: 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 27: Next Steps for Clinical Studies of LB1148
Complete enrollment in phase 2 clinical study in the US that will capture additional data on adhesions prevention with LB11481 Expected in H2 2022 Initiate Phase 3 study for LB1148 to accelerate the return of bowel function Next Steps for Clinical Studies of LB1148 1 NCT02836470
Slide 28: 5800 Armada Dr, Suite Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com
Slide 29: Appendix Slides
Appendix Slides
Slide 30: 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 31: 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 32: Cardiovascular Surgery (Hypoperfusion Injury)
Cardiovascular Surgery (Hypoperfusion Injury)
Slide 33: 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 34: 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 35: GI Surgery: Return of Bowel Function (Physical Injury)
GI Surgery: Return of Bowel Function (Physical Injury)
Slide 36: 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 37: 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 38: GI Surgery Study Results: 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 39: GI Surgery (PROFILE) Phase 2 – 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 40: 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 41: GI Surgery: Reduction of Adhesions (Physical Injury)
GI Surgery: Reduction of Adhesions (Physical Injury)
Slide 42: 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 43: 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 44: Corporate Capitalization
Corporate Capitalization
Slide 45: Palisade Bio, Inc. Cap Table
Palisade Bio, Inc. Cap Table 110,938 warrants with a current exercise price of $1.10 are subject to anti-dilution protection. No price-based ratchets or resets are associated with any of the other outstanding preferred shares or warrants. Capitalization Common Stock Equivalents Common Stock 18,233,4
Slide 46: 5800 Armada Dr, Suite Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com