Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Investor Presentation (September 2021)
30 slides from Palisade Bio's investor presentation, Sep 13, 2021
Slide 1: Restoring Intestinal Barrier Health
Restoring Intestinal Barrier Health Corporate Presentation | September 2021 PALI (NASDAQ) | palisadebio.com
Slide 2: Forward Looking Statements
2 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, mar
Slide 3: Acute and Chronic Disorders Caused by GI Barrier Disruption
3 Acute and Chronic Disorders Caused by GI Barrier Disruption Focused on pathologies caused by loss of GI epithelial barrier integrity and the consequences to human health GI Epithelial Barrier Biology Expertise in GI - specific protease - targeted therapeutics Integrated discovery and development p
Slide 4: Highlights of Potential Path to Commercialize Lead Drug LB1148 for Surgery Patients
4 Highlights of Potential Path to Commercialize Lead Drug LB1148 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; LB1148 progressing to pi
Slide 5: LB1148 Overview: Pipeline in a Product – Multiple Indications
5 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 Neonatal cardiac surgery GI surgery Prevention of post - surgical abdominal a
Slide 6: LB1148 Program Overview Pipeline in a Product – Multiple Indications
LB1148 Program Overview Pipeline in a Product – Multiple Indications 6 Accelerate Return of Postoperative GI Function Reduce Post - surgical Adhesions Cardiovascular Surgery Gastrointestinal Surgery Abdominal Surgery
Slide 7: Unmet Need – Postoperative GI Recovery After Surgery
7 Unmet Need – Postoperative GI Recovery After Surgery 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 • Causes major discomfort • Extends hospital stay • Increases medical costs
Slide 8: Postoperative Complications Driven by Proteolytic Activity
8 Postoperative Complications 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 signalin
Slide 9: LB1148 Prevents Intestinal Damage: Rapidly Reseals the Barrier
9 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 b
Slide 10: LB1148 - Expeditious Regulatory Pathway; Limited Competition
10 • 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 • Prevents damage to the intestine – Improves time to post - surgical bowel recovery • Issued pate
Slide 11: Entereg: Only Drug Approved for Accelerating Return of GI Function
11 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 bow
Slide 12: LB1148 Accelerates Return of GI Function – Phase Ready
12 LB1148 Accelerates Return of GI Function – Phase 3 Ready • Consistent statistically significant clinical efficacy in 3 completed clinical studies – 28% improvement in time to return of bowel function after GI surgery in phase 2 (p<0.001) – 48% improvement in time to return of bowel function after
Slide 13: Gastrointestinal Surgery (Physical Injury)
Gastrointestinal Surgery (Physical Injury) 13
Slide 14: GI Surgery (PROFILE) Phase 2 – Newsoara Study
14 GI Surgery (PROFILE) Phase 2 – Newsoara 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 p
Slide 15: GI Surgery Phase 2: Significantly Accelerated Return of GI Function
15 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 75 th Percentile
Slide 16: GI Surgery Phase 2: Safe and Well Tolerated
16 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 17: Post-surgical Adhesions Develop in up to 93% of Abdominal Procedures
17 • 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, causin
Slide 18: Post-surgical Adhesions Are Costly for Patients and Hospitals
18 Post - surgical Adhesions Are Costly for Patients and Hospitals Increased healthcare complications: • #1 cause of secondary female infertility • #1 cause of bowel obstruction (up to 75%) • 10 th most frequent cause of emergency surgery • 80% of emergency surgery deaths • 400,000 adhesiolysis surg
Slide 19: LB1148 Reduces Adhesions by 63% in Animal Studies
19 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
Slide 20: GI Surgery Study Results: Zero Adhesions in 3 Patients
20 • For the 3 patients with a 2 nd surgery: – No adhesions – No evidence of inflammation GI Surgery Study Results: Zero Adhesions in 3 Patients • 3/11 patients required a 2 nd surgery for complications unrelated to adhesions – Opportunity to measure two FDA approvable endpoints in same patient • bo
Slide 21: FDA Approved ADEPT with Only a 10% Reduction in Adhesions
21 FDA Approved ADEPT 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 adhesions)
Slide 22: Cardiovascular Surgery (Hypoperfusion Injury)
Cardiovascular Surgery (Hypoperfusion Injury) 22
Slide 23: CV Surgery Completed Phase 2: Study Design
23 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 • Randomiz
Slide 24: CV Surgery Phase 2: Significant Improvement in Bowel Function
24 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
Slide 25: LB1148 Commercial Opportunity
LB1148 Commercial Opportunity 25
Slide 26: LB1148 Can Improve Patient Care While Reducing Costs
26 LB1148 Can Improve Patient Care While Reducing Costs Oral Drug Taken at Home – No Impact on Surgical Procedure Reduce Healthcare Costs and Improve Margins Well - Characterized Safety Profile Potential to Improve Patient Outcomes Strong Value Proposition Across the Healthcare System with Key Benef
Slide 27: Illustrative Patient Journey: GI Surgery with LB1148 Administration
27 Illustrative Patient Journey: GI Surgery with LB1148 Administration At patient’s local pharmacy, likely covered by pharmacy benefit Prescription Filled at Pharmacy 2 1 - 2 weeks pre - op Preoperative Medications Taken at Home 3 In - Patient Surgery 5 First bowel movement Leads to discharge orders
Slide 28: LB1148 Has Large Global Market Opportunity
28 LB1148 Has Large Global Market Opportunity US Market 1.1 million open heart surgeries 5.7 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
Slide 29: Accomplished Management Team Leading to Success
29 Accomplished Management Team Leading to Success J.D. Finley Chief Financial Officer Mr. Finley has raised nearly $1 billion in capital for companies during his career. Mr. Finley’s experience includes roles of Tax Specialist, EVP, CFO, CEO, and President at companies including Deloitte Haskins &
Slide 30: 5800 Armada Dr, Suite Carlsbad, CA 92008 - - 0 IR@palisadebio.com www.palisadebio.com 30
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858 - 704 - 4900 IR@palisadebio.com www.palisadebio.com 30
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