Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — IPO Roadshow (July 2022)
34 slides from Palisade Bio's IPO roadshow presentation, Jul 25, 2022
Slide 1: July 2022 Corporate Presentation
July 2022 Corporate Presentation Free Writing Prospectus dated July 25, 2022 Filed Pursuant to Rule 433 of the Securities Act of 1933, as amended Registration Statement No. 333-265769
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, expected near-term Phase 2 and Phase 3
Slide 3: Free Writing Prospectus
Free Writing Prospectus This presentation highlights basic information about the Company and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in our Company. Except as
Slide 4: Risk Factors
Risk Factors Investing in our securities stock involves a high degree of risk. You should carefully consider the risks described below, as well as other information included in our Registration Statement on Form S-1 (File No. 333-265769), Annual Report on Form 10-K filed with the SEC on March 17, 20
Slide 5: Palisade Bio Investment Highlights
Palisade Bio Investment Highlights We develop therapeutics to improve patients’ lives by protecting intestinal integrity We leverage scientific knowledge and proprietary technology to address potential multi-billion-dollar opportunities1 Clear Precedent for Regulatory Strategy Plan to leverage 505(b
Slide 6: Clinical Development Pipeline Provides Opportunities Across Multiple High-Value Indications
Clinical Development Pipeline Provides Opportunities Across Multiple High-Value Indications Indication Pre-Clinical Phase 1 Phase 2 Phase 3 NDA Target Milestones Accelerating Return of Postoperative GI Function US/Global Phase 3 Study initiated June 2022 US/Global FPI 2H 2022 Newsoara to initiate Ph
Slide 7: Expected Upcoming Milestones
Expected Upcoming Milestones Phase 3 Accelerating Return of Postoperative Bowel Function: GI2 June 2022 Phase 3 Study Initiation 2H 2022 Phase 3 Study First Patient In Phase 2 Reducing Abdominal Adhesions Phase 2 Enrollment Completion 4Q 2022 Phase 2 Study Completion Phase 2 Topline Results 2H 2023
Slide 8: LB1148 Lead Program: Ongoing Phase 3 and Phase 2 Studies
LB1148 Lead Program: Ongoing Phase 3 and Phase 2 Studies Positive Data Showed Accelerated Time to Return of Postoperative Bowel Function and Reduced Post-Surgical Abdominal Adhesions Novel, Patent Protected Oral Formulation of FDA-Approved Tranexamic Acid Broad-spectrum serine protease inhibitor wit
Slide 9: LB1148 is Well Tolerated in Multiple Clinical Studies
LB1148 is Well Tolerated in Multiple Clinical Studies No drug related SAEs Incidence of AEs are low and similar between LB1148 and placebo Well tolerated in >175 patients dosed to date across 4 clinical studies1 Preferred Term LB1148 (N=64) n (%) Placebo (N=63) n (%) Fever 10 (15.6) 13 (20.6) Nausea
Slide 10: Post Operative Bowel Function is a Big Bottleneck
Post Operative Bowel Function is a Big Bottleneck Waiting for Bowel Function Post Surgery Can Result in Hospital Stays Up to 11.5 Days2 ~$2,700 Average Hospital Expenses Per Inpatient Day3 Patients Generally Do Not Leave Hospital Until Having a Bowel Movement Delayed Bowel Movement Causes Prolonged
Slide 11: Opportunity to Provide Significant Cost Savings to Hospitals
Opportunity to Provide Significant Cost Savings to Hospitals Hospitals are Often Reimbursed Flat Rate for Surgeries Based on Diagnosis Related Group (DRG) DRG Code1 Description Avg. LOS Avg. DRG Payment Hospital Cost/Day 329 Major Small and Large Bowel Procedures with MCC 14.4 $29,949 $2,080 330 Maj
Slide 12: Abdominal Adhesions are a Significant Medical Burden
Abdominal Adhesions are a Significant Medical Burden Alarming Adhesion Stats: J Chir Viscerale. 2012;149(2):114-126. doi:10.1016/j.jviscsurg.2011.11.006, Causes of female infertility, UpToDate 2020, Etter, K., et. Al.. Impact of postcolectomy adhesion-related complications on healthcare utilization.
Slide 13: LB1148: Protecting Intestinal Barrier Health
LB1148: Protecting Intestinal Barrier Health Mechanism of Action
Slide 14: Postoperative Complications are Driven by Proteolytic Activity Damaging Intestinal Tissues
Postoperative Complications are Driven by Proteolytic Activity Damaging Intestinal Tissues Healthy Intestine Compromised Mucosal Barrier Injury from surgery, manipulation, or reduced blood flow (hypoperfusion) triggers cascade of mechanisms resulting in protease leak and translocation Leads to Intes
Slide 15: LB1148 Protects Intestinal Barrier Health
LB1148 Protects Intestinal Barrier Health Broad-Spectrum Serine Protease Inhibitor Prevents Digestive Enzyme (Trypsin) Driven Tissue Injury Intestinal Barrier Breakdown Control-TXA Permeable epithelial barrier Extensive loss of villi tissue Basal membrane compromised Lymph vessel damage LB1148 Conti
Slide 16: LB1148: Accelerating Return of Bowel Function
LB1148: Accelerating Return of Bowel Function Development Path to Registration
Slide 17: Completed Positive Phase 2 GI Surgery Study
Completed Positive Phase 2 GI Surgery Study Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study 120 patients ∣ Six sites in China Adhesion Exploratory Endpoint Extent and severity of adhesions at the time of 2nd surgery Primary Endpoint Time to return of GI function: Toleration of food an
Slide 18: Completed Phase 2 GI Surgery Study: LB1148 Accelerated Return of GI Function
Completed Phase 2 GI Surgery Study LB1148 Accelerated Return of GI Function 1.1 Day Improvement Median 1.5 Day Improvement 75th Percentile Primary Endpoint, per protocol population, GI2: P=0.0008 | Hazard Ratio=1.89 | n=120 Median time from surgery to GI2 (Days) Q3 Time from surgery to G12 (Days) Q3
Slide 19: LB1148 Demonstrated Consistent Meaningful Results in Multiple Clinical Studies
LB1148 Demonstrated Consistent Meaningful Results in Multiple Clinical Studies Positive Results Give Confidence as LB1148 Commences Phase 3 Study n=11 n=120 n=120 Open-Label, Single Arm Randomized, Double-Blind, Placebo Controlled Randomized, Double-Blind, Placebo Controlled NA 28% Improvement (p<0.
Slide 20: Ongoing Phase 3 GI Surgery Study Mirrors Successful Phase 2 Study Design
Day 0 Ongoing Phase 3 GI Surgery Study Mirrors Successful Phase 2 Study Design Same Dosing, Same Endpoint, Same Patients as Positive Phase 2 Study That Demonstrated 1.1 Day Improvement in Return of Bowel Function GI Surgery Discharge Follow-up Randomized, Double-Blind, Placebo-Controlled, Multi-Site
Slide 21: Advancing Second Program Towards Potential FDA Approval
Advancing Second Program Towards Potential FDA Approval LB1148: Preventing Post-Surgical Adhesions
Slide 22: LB1148 Reduced Adhesion Formation by 63% in an Animal Model of GI Surgery
LB1148 Reduced Adhesion Formation by 63% in an Animal Model of GI Surgery Reduced Various Types of Adhesions when Taken Prior to Surgery: Bowel to Bowel | Bowel to Abdominal Wall | Bowel to Viscera Animals Receiving LB1148 Had Fewer Adhesions Vehicle Treated LB1148 Treated p<0.001 63% Reduction Dram
Slide 23: Quantifying Abdominal Adhesions
Quantifying Abdominal Adhesions: Performed Visually During 1st and 2nd Surgeries 1st Surgery Bowel Resection and Colostomy Bag Adhesion Extent Score 0 = no adhesion 1 = minimal (<1/3 of the site is covered) 2 = moderate (1/3 to 2/3 of the site is covered) 3 = extensive (>2/3 of the site is covered)
Slide 24: LB1148 Reduced Adhesion Formation in GI Surgery Patients
LB1148 Reduced Adhesion Formation in GI Surgery Patients 75% of LB1148 Treated Subjects Had Zero Adhesions During Follow-up Surgery Clinically Significant Reduction in Extent and Severity of Adhesions * Results from Pooled Data Analysis 1. Compared to placebo; 2. Fisher’s exact test ; 3. Ouaïsi 20
Slide 25: Ongoing Phase 2 GI Surgery Study for Prevention of Post-Surgical Abdominal Adhesions
Ongoing Phase 2 GI Surgery Study for Prevention of Post-Surgical Abdominal Adhesions Randomized, Double-Blind, Placebo-Controlled, Multi-Site Study Up to 200 patients ∣ ~70 patients with a planned adhesion evaluation ∣ ～17 sites in the U.S. Evaluate LB1148 to reduce the formation of post-surgical in
Slide 26: LB1148: Commercial Opportunity
LB1148: Commercial Opportunity Potential to Reduce Costs for Hospitals and Improve Outcomes
Slide 27: Currently FDA Approved Options Have Significant Limitations
Currently FDA Approved Options Have Significant Limitations Return of Bowel Function Post-Surgical Adhesions m-opioid receptor modulator In-patient hospital administration only Phase 3 results demonstrated a 0.7-day improvement in return of bowel function and 0.3-day improvement in hospital length o
Slide 28: Commercial Strategy Aligns with Hospital Protocols and Financial Goals
Commercial Strategy Aligns with Hospital Protocols and Financial Goals Does Not Interfere with Surgical Practice Patients Can Potentially Benefit from Both Acceleration of Return of GI Function and Prevention of Post-Surgical Adhesions Commercial Goal to Be Incorporated into Hospital Protocol Potent
Slide 29: Targeting Multi-Billion Dollar U.S. Market
Targeting Multi-Billion Dollar U.S. Market 20-40% market penetration could translate to >$2B annual revenue in U.S.2 5.6 million annual abdominal surgeries1 1.1 million annual open heart surgeries1 CDC/NCHS National Hospital Discharge Survey, 2010 6.7M patients from (CDC/NCHS National Hospital Disch
Slide 30: Corporate Overview
Corporate Overview
Slide 31: Financials and Cap Table
Financials and Cap Table Capitalization (as of March 31, 2022) Common Stock Equivalents Common Stock* 21,880,169 Series A Convertible Preferred (200,000 shares) 6,479 Warrants* (WAEP $2.74) 9,213,008 Options (WAEP $6.03) 2,456,455 Total Fully Diluted 33,556,111 As of March 31, 2022 Cash and Cash Equ
Slide 32: Robust IP Portfolio
Robust IP Portfolio Multiple Layers of Protection Through Early-2037 Issued US 9,314,442 (Composition) Issued US 9,775,821 (Composition) Issued US 11,123,317 (Composition) Issued US 9,504,736 (Composition) Issued US 11,202,768 (Treatment of Ileus and Adhesions) https://patents.google.com/patent/US95
Slide 33: We Are Working to Establish New Standards of Care
We Are Working to Establish New Standards of Care Rapidly Advancing Lead Asset in Global Phase 3 Program for Postoperative Return of Bowel Function Commercial Strategy Aligns with Hospitals Financial Goals US reimbursement system incentivizes hospitals to accelerate patient discharge and reduce read
Slide 34: Thank You! Investor Relations
NASDAQ: PALI | palisadebio.com = PALISADE BIO Protecting Intestinal Barrier Health Thank You! Investor Relations JTC Team 833.475.8247 pali@jtcir.com