Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Investor Presentation (October 2021)
39 slides from Palisade Bio's investor presentation, Oct 28, 2021
Slide 1: Restoring Intestinal Barrier Health Corporate Presentation
Exhibit 99.1 Restoring Intestinal Barrier Health Corporate Presentation | October 2021 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 Scientific Platform Palisade Bio develops drugs to treat diseases caused by Technology digestive-enzyme leak producing inflammation and tissue damage LB1148 is an oral liquid protease inhibitor administered at home as a bowel prep
Slide 4: Lead Drug: LB1148
Lead Drug: LB1148 4
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 LB1148 can be taken at home prior to hospitalization; ideal Large Commercial Opportunity reimbursement scenario for commercializing a very large surgical market (20% of the market could lead to over $1.5
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 Major Surgeries • Patients generally do not leave hospital until they have a bowel movement • Lack of GI recovery: Gastrointestinal – Causes pain and bloati
Slide 7: Unmet Need – Reducing Post-surgical Adhesions
Unmet Need – Reducing Post-surgical Adhesions Adhesion 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%) Non-Adhesion Adhesion th
Slide 8: Only Single Competitor for Each Indication, Yet Precedent Pathway for FDA Approval
Only Single Competitor for Each Indication, Yet Competitors Demonstrate Precedent Pathway for FDA Approval Return of Bowel Function Post-surgical Adhesions • Limitations: • Limitations: – In-patient hospital administration only – Only product approved for abdominal surgery – Short-term use only – On
Slide 9: Postoperative Complications are Driven by Proteolytic Activity
Postoperative Complications are Driven by Proteolytic Activity Cascade of disease mechanisms Injury Protease leak (surgery or ↑ Proteolytic activity and translocation hypoperfusion) ↑ Tissue damage/permeability ↑ Autodigestion ↑ Microbiome imbalance/pathology ↑ Pathologic cell signaling activity ↑ I
Slide 10: LB1148 Prevents Intestinal Damage: Rapidly Reseals the Barrier
LB1148 Prevents Intestinal Damage: Rapidly Reseals the Barrier Hypoperfusion Injury Hypoperfusion Injury 100 75 50 Control – TXA LB1148 25 • Continuous epithelial • Permeable epithelial 0 barrier barrier Control Sham LB1148 • Intact villi structure • Loss of villi tissue Oral TXA • Robust basal memb
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 GI Surgery Postoperative return of bowel LB1148* Neonatal cardiac function Oral broad-spectrum surgery protease inhibitor* Prevention of post-surgical abdominal adhesions
Slide 12: Restoring Bowel Function
Restoring Bowel Function 12
Slide 13: GI Surgery Phase 2: Significantly Accelerated Return of GI Function
GI Surgery Phase 2: Significantly Accelerated Return of GI Function th Median 75 Percentile • P=0.0008 • Hazard ratio=1.8 1.5 day improvement 1.1 day improvement 13 LBS-POI-201 CSR
Slide 14: LB1148 Accelerates Return of GI Function – Phase 3 Ready
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 GI
Slide 15: Preventing Post-surgical Adhesions
Preventing Post-surgical Adhesions 15
Slide 16: GI Surgery Study Results: Zero Adhesions in Three Surgery Patients
GI Surgery Study Results: Zero Adhesions in Three Surgery Patients nd • 3 of 11 patients required a 2 surgery unrelated to adhesions – Opportunity to visualize and measure adhesions nd • For the three patients with a 2 surgery: • extent – No adhesions • severity – No evidence of inflammation Princip
Slide 17: LB1148 Commercial Opportunity
LB1148 Commercial Opportunity 17
Slide 18: Illustrative Patient Journey: GI Surgery with LB1148
Illustrative Patient Journey: GI Surgery with LB1148 Administration Drug is taken at home: • Reimbursed by patient’s q Bowel prep pharmacy benefit (no q Anti-nausea q Antibiotics cost to hospital) Pharmacy q LB1148 Physician’s Office • Doesn’t disrupt the Prescription filled 2 Pre-op physical in cli
Slide 19: LB1148 Has Large Global Market Opportunity
LB1148 Has Large Global Market Opportunity US Market Partnered 1.1 million open heart surgeries China: w/ Newsoara 5.7 million abdominal surgeries EU and ROW Opportunities 20-40% market penetration could translate to Potential to partner with US rights or >$2B revenue independently M&A – Shows Value
Slide 20: 5800 Armada Dr, Suite Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com 20
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com 20
Slide 21: Appendix Slides
Appendix Slides 21
Slide 22: LB1148 - Expeditious Regulatory Pathway; Limited Competition
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 surg
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 functi
Slide 24: LB1148 Program Overview Pipeline in a Product
LB1148 Program Overview Pipeline in a Product – Multiple Indications Accelerate Return of Reduce Post-surgical Postoperative GI Function Adhesions Abdominal Surgery Cardiovascular Gastrointestinal Surgery Surgery 24
Slide 25: Cardiovascular Surgery (Hypoperfusion Injury)
Cardiovascular Surgery (Hypoperfusion Injury) 25
Slide 26: CV Surgery Completed Phase 2: Study Design
CV Surgery Completed Phase 2: Study Design Screening Period CV Surgery Postoperative / Discharge Follow-up Day -42 to -1 Day 0* Day 1-14 Day 30 LB1148 Placebo Cardiovascular Surgery Scope & Timelines Study Design Primary Endpoint: Secondary Endpoints: • 120 patients undergoing • Open-heart CV surger
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 •
Slide 28: GI Surgery: Return of Bowel Function (Physical Injury)
GI Surgery: Return of Bowel Function (Physical Injury) 28
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 Screening Period GI Surgery Postoperative / Discharge Follow-up Adhesion Assessment Day -42 to -1 Day 0 Day 1-14 Day 30 Second Surgery LB1148 Study drug given as a split dose GI Surg
Slide 30: GI Surgery Study Results: 48% Faster than Historical Control
GI Surgery Study Results: 48% Faster than Historical Control GI Surgery 2.3-days earlier first bowel movement 48% better than historical control Data highlights: • 48% improvement in return of bowel function – Approvable endpoint • No LB1148-related AEs Placebo (Entereg Study 314) Source: Ludwig K,
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 1.3-day improvement in LOS 20% reduction p = 0.03 Patient’s actual length of stay (LOS) was compared to expected LOS as determined from their billing code at time of admission (GMLOS) 31 Time
Slide 32: GI Surgery (PROFILE) Phase 2 – Partnered Study
GI Surgery (PROFILE) Phase 2 – Partnered Study Screening Period GI Surgery Postoperative / Discharge Follow-up Adhesion Assessment Day -42 to -1 Day 0 Day 1-14 Day 30 Up to 7 months after initial surgery LB1148 Placebo Study drug given as a split dose GI Surgery 2-6 hours prior to surgery 6-10 hours
Slide 33: GI Surgery Phase 2: Significantly Accelerated Return of GI Function
GI Surgery Phase 2: Significantly Accelerated Return of GI Function th Median 75 Percentile • P=0.0008 • Hazard ratio=1.8 1.5 day improvement 1.1 day improvement Data Repeated from Body of Presentation 33 LBS-POI-201 CSR
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 34
Slide 35: GI Surgery: Reduction of Adhesions (Physical Injury)
GI Surgery: Reduction of Adhesions (Physical Injury) 35
Slide 36: Unmet Need - Post-surgical Adhesions Develop in up to 93% of Abdominal Procedures
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
Slide 37: LB1148 Reduces Adhesions by 63% in Animal Studies
LB1148 Reduces Adhesions by 63% in Animal Studies Animals receiving LB1148 before LB1148 dramatically reduces the surgery had 63% fewer adhesions number of post-surgical adhesions Reduced all types of adhesions: bowel to bowel, bowel to abdominal wall, bowel to viscera, etc. 37 Source: LBS-NC-IL-ADH
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 FDA approved ADEPT based on only 10% of patients achieving “success” (defined as a decrease ≥ 3 sites with adhesions) 38 Source: Adept (4% icodextrin) Package Insert; March 2006 www.accessdata.fda.gov/cdrh_docs/pdf5/P050011
Slide 39: 5800 Armada Dr, Suite Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com 39
5800 Armada Dr, Suite 210 Carlsbad, CA 92008 858-704-4900 IR@palisadebio.com PALI (Nasdaq) www.palisadebio.com 39