Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Investor Presentation (June 2021)
37 slides from Palisade Bio's investor presentation, Jun 1, 2021
Slide 1: Restoring Intestinal Barrier Health
Restoring Intestinal Barrier Health Corporate Presentation | May 2021 PALI (NASDAQ) | palisadebio.com
Slide 2: Forward Looking Statements
2 Forward Looking Statements This communication contains “forward - looking” statements, including, without limitation, statements related to the anticipated benefits of the transactions contemplated by Palisade Bio, Inc.’s (“Palisade”) recent merger, the private placement financing and the related
Slide 3: Merger Transaction Created Palisade Bio, Inc.
3 Merger Transaction Created Palisade Bio, Inc. (Nasdaq: PALI)
Slide 4: Leading BioSciences and Seneca Merged to Form Palisade Bio
4 Leading BioSciences and Seneca Merged to Form Palisade Bio • Nasdaq public listing allows for proper capitalization, liquidity, and strategic visibility – Reverse merger with Seneca provides the public listing under the ticker, PALI – Leading’s management team, expanded board, and top - tier scien
Slide 5: Accomplished Management Team Leading to Success
5 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 & S
Slide 6: Acute and Chronic Disorders Caused by GI Barrier Disruption
6 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 7: LB1148 Overview: Pipeline in a Product – Multiple Indications
7 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 8: LB1148 Program Overview
LB1148 Program Overview Pipeline in a Product – Multiple Indications 8 Accelerate Return of Postoperative GI Function Reduce Post - surgical Adhesions Cardiovascular Surgery Abdominal Surgery Gastrointestinal Surgery
Slide 9: Unmet Need – Postoperative GI Recovery After Surgery
9 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 10: Postoperative Complications Driven by Proteolytic Activity
10 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 signali
Slide 11: LB1148 Prevents Intestinal Damage: Rapidly Reseals the Barrier
11 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
Slide 12: LB1148 - Expeditious Regulatory Pathway; Limited Competition
12 • 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 13: Entereg: Only Drug Approved for Accelerating Return of GI Function
13 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 14: LB1148 Accelerates Return of GI Function – Phase Ready
14 LB1148 Accelerates Return of GI Function – Phase 3 Ready • Oral protease inhibitor addressing gut - barrier pathologies for two indications – Accelerate postoperative return of bowel function – Reduce post - surgical abdominal adhesions • Two completed clinical studies demonstrate statistically s
Slide 15: Cardiovascular Surgery (Hypoperfusion Injury)
Cardiovascular Surgery (Hypoperfusion Injury) 15
Slide 16: CV Surgery Completed Phase 2: Study Design
16 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 17: CV Surgery Phase 2: Significant Improvement in Bowel Function
17 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 18: LB1148 Compares Favorably to Entereg: 30% vs 16% Improvement
18 LB1148 Compares Favorably to Entereg: 30% vs 16% Improvement 16% Improvement Proportion achieving endpoint Hours after End of GI Surgery Proportion achieving endpoint Hours after End of CV Surgery 30% Improvement p<0.001 Source: Entereg FDA AdCom; Jan. 23, 2008 Entereg : Approved by FDA based on
Slide 19: Neonatal CV Surgery – Opportunity to Improve Development Status
19 Neonatal CV Surgery – Opportunity to Improve Development Status with Faster GI Recovery and Faster Return to Full Feedings • Unmet need for improving GI recovery after neonatal CV surgeries • Impaired GI function delays return to full feedings, which are a key criteria for ICU discharge – $400,00
Slide 20: LB1148 Planned Phase 3: Lead Indication in Pediatric Heart Surgery
20 • Estimated trial costs of <$10M – ~10 sites in the US • Estimated 1 year to enroll study • Homogeneity of patient population LB1148 Planned Phase 3: Lead Indication in Pediatric Heart Surgery • Attractive first indication • Enthusiastic investigators to participate in clinical studies • Strong p
Slide 21: Neonatal CV Surgery: Planned Phase 2/3 Study Design
21 Neonatal CV Surgery: Planned Phase 2/3 Study Design Screening Period CV Surgery Postoperative / Discharge LB1148 Day - 30 to - 1 Day 0 Day 1 - 60 Follow - up Day 90 Placebo • Neonatal infants undergoing elective on - pump open - heart surgery to correct congenital heart defects (emphasis on singl
Slide 22: Gastrointestinal Surgery (Physical Injury)
Gastrointestinal Surgery (Physical Injury) 22
Slide 23: Completed GI Surgery Study: Study, Indications, Data Readouts
23 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 S
Slide 24: GI Surgery Study Results: 48% Faster than Historical Control
24 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. 2
Slide 25: GI Surgery Study Results: Significant Improvement in Hospital Length of Stay
25 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 improve
Slide 26: Post-surgical Adhesions Develop in up to 93% of Abdominal Procedures
26 • 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 27: Post-surgical Adhesions Are Costly for Patients and Hospitals
27 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 28: LB1148 Reduces Adhesions by 63% in Animal Studies
28 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 29: GI Surgery Study Results: Zero Adhesions in 3 Patients
29 • 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 30: FDA Approved ADEPT with Only a 10% Reduction in Adhesions
30 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 31: GI Surgery (PROFILE) Phase 2 – Now Enrolling
31 GI Surgery (PROFILE) Phase 2 – Now Enrolling GI Surgery • Randomized, double - blind, placebo - controlled, multi - site Phase 2 Study • Evaluate LB1148 for return of GI function and adhesions in subjects undergoing elective bowel resection with a laparotomy or minimally invasive approach with pl
Slide 32: LB1148 Commercial Opportunity
LB1148 Commercial Opportunity 32
Slide 33: LB1148 Can Improve Patient Care While Reducing Costs
33 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 34: Illustrative Patient Journey: GI Surgery with LB1148 Administration
34 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 35: LB1148 Has Large Global Market Opportunity
35 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 36: Upcoming Potential Milestones
36 Upcoming Potential Milestones Close merger with Seneca Complete financing with Altium Initiate Phase 2/3 in neonatal cardiac surgeries Data from 1st 10 patients from Phase 2/3 in neonatal CV surgery Bowel function data from Phase 2 in GI surgery Adhesion data from Phase 2 in GI surgery
Slide 37: 5800 Armada Dr, Suite Carlsbad, CA 92008 - - 0 IR@palisadebio.com www.palisadebio.com 37
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858 - 704 - 4900 IR@palisadebio.com www.palisadebio.com 37