Edesa Biotech, Inc. · NASDAQ:EDSA
Edesa Biotech — Investor Presentation (October 2020)
28 slides from Edesa Biotech's investor presentation, October 2020
Slide 1: Corporate Presentation
Corporate Presentation Edesa Biotech, Inc. Nasdaq: EDSA October 2020
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such a
Slide 3: Advancing Clinical-Stage Drug Candidates
Advancing Clinical-Stage Drug Candidates Focus on Immune Modulation Therapies and Inflammatory Diseases Exploring new ways to treat diseases, including alternatives to topical steroids Novel anti-inflammatory technology Topical sPLA2 inhibitor with demonstrated efficacy in two previous clinical st
Slide 4: Edesa Development Pipeline
Edesa Development Pipeline Advancing and Expanding Our Growth Opportunities Drug Candidates Indications Pre-Clinical Phase 1 Phase 2 Phase 3 Allergic Contact EB01 sPLA2 Inhibitor Enrollment Continuing Dermatitis EB02 sPLA2 Inhibitor Hemorrhoids CTA Approved EB04 Not Disclosed Anal Fissures Growth Op
Slide 5: Edesa Monoclonal Antibodies
Edesa Monoclonal Antibodies Compelling Data for Use in COVID19 & Beyond Potential to reduce the number of ICU patients, intubation procedures and death Compelling evidence of activity in acute lung injury Favorable human safety data (>120 subjects) Ability to quickly move into the clinic A
Slide 6: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) Leading Cause of Death in COVID-19 Patients A life-threatening form of respiratory failure Exaggerated immune response Inflammation and injury to the lungs Edema that deprives the body of oxygen Other causes Sepsis, bacterial and viral infection
Slide 7: Toll-like Receptor 4 (TLR4)
Toll-like Receptor 4 (TLR4) A Key Component of Innate Immune Response Key receptor as part of the innate immune response, discovered in 1997. A Nobel prize was awarded in 2011 Tissue Damage PAMPs DAMPs TLR4 is activated both by pathogen-associated molecular patterns (PAMPs) such as LPS, and dama
Slide 8: Evidence of Activity in Humans
Evidence of Activity in Humans EB05 Inhibited “Cytokine Storm” after In Vivo LPS Challenge IL-6 Serum Concentration (pg/mL) TNF-α Serum Concentration (pg/mL) CXCL10 Serum Concentration (pg/mL) 250 1200 9000 8000 1000 200 7000 CXCL10 (pg/ml) TNFα (pg/ml) 800 6000 150 IL6 (pg/ml) 5000 600 100 4000 400
Slide 9: Evidence of Activity in Humans
Evidence of Activity in Humans EB05 Lowered Fever and Stabilized Vital Signs after In Vivo LPS Challenge Mean Change from Baseline of Temperature Mean Change from Baseline of Heart Rate 30 1.6 25 Change from Baseline (HR bpm) Change from Baseline (Degrees C) 1.4 20 1.2 1 15 0.8 10 0.6 5 0.4 0 0 1 2
Slide 10: Overview of Clinical Trial Design
Overview of Clinical Trial Design A Phase 2/3 Adaptive Design to Study Prevention and Treatment of ARDS Efficacy of EB05 mAb in COVID-19 Patients Sequential adaptive design with interim analysis EB05 (15mg/Kg) + SOC Targeting COVID-19 patients at greatest Phase 2 risk of progressing to ARDS N =
Slide 11: Allergic Contact Dermatitis
Allergic Contact Dermatitis Disease State and current Treatments Allergic Contact Dermatitis (ACD) is a Type IV hypersensitivity reaction Current Limited Treatment Approaches for ACD Safety Issues Often Result in Discontinuation of Treatment Immune system sensitized with initial contact with aller
Slide 12: Contact Dermatitis
Contact Dermatitis One of the most prevalent skin conditions in U.S. Claims-Based Prevalence of Skin Disease in the US 9.0% Contact dermatitis is a leading 8.0% occupational illness affecting 13.2 7.0% million people in U.S. at a cost of up to 6.0% ~$2 billion annually 5.0% 4.0% ACD represents a
Slide 13: Occupational Contact Dermatitis
Occupational Contact Dermatitis Adversely Impacts Both Employers and Employees Loss of Productivity Industry Substances Physical and emotional distress Agriculture Daffodils, tulips, carrots, parsnips, parsley, celery Multiple physician visits Prolonged sick leaves Chemical Adhesives, paints
Slide 14: Novel Approaches to Chronic Conditions
Novel Approaches to Chronic Conditions Treating Inflammation without the Safety Concerns of Current Therapies Inhibiting the Inflammation Cascade sPLA2 inhibitors are designed to inhibit the inflammatory process at its inception Exerts its anti-inflammatory activity upstream of currently appro
Slide 15: EB01 Efficacy in Humans Established
EB01 Efficacy in Humans Established Phase 2 Study Demonstrated Efficacy & Safety in ACD Patients Mean Percent Improvement from Baseline in Total CDSI Score Phase 2 Efficacy Study of EB01 60 55.73% For the treatment of allergic contact dermatitis — 30 Patients Bilateral Design — 50 48.62% Efficacy:
Slide 16: Phase 2 Efficacy Study – Breakdown by Component
Phase 2 Efficacy Study – Breakdown by Component EB01 Addressed All Aspects of CDSI Composite Score Percent Reduction in Symptoms from Baseline to Day 21* P Value = <0.001 81% P Value = <0.001 62% P Value = <0.001 P Value = <0.001 P Value = <0.001 48% 47% 46% 45% 25% 20% 20% 15% Scaling Redness Pruri
Slide 17: EB01 Market Survey
EB01 Market Survey Physicians Most Impressed with Non-Steroidal Method of Action Physician-Perceived Strengths of EB01 Key opinion leaders expressed a high desire for additional treatment options for ACD Novel anti-inflammatory product (MoA) 41% Especially for lesions are located on face Safety
Slide 18: EB01 Phase 2b Study Plan
EB01 Phase 2b Study Plan Adaptive Design up to 166 Patients Patients with ACD EB01 2.0% (n=23) Primary Efficacy Endpoint Part A Mean Percent Change from Baseline in N=~46 Subjects Randomized (1:1) Vehicle (n=23) Contact Dermatitis Severity Index (CDSI) at Day 29 Protocol EB01 evaluated a randomize
Slide 19: Hemorrhoids Disease (HD)
Hemorrhoids Disease (HD) Extension of sPLA2 Anti-Inflammatory Tech Treatments of Internal Hemorrhoids2 Based on their Severity and Degree of Prolapse 12.5 million adults affected in U.S.1 Grade 1 Grade 2 Grade 3 Grade 4 Complicated By 50 years old, ~50% have experienced symptomatic hemorrhoids D
Slide 20: EB02 Program
EB02 Program Targeting clinical relief of itching, pain and thrombosis of HD Multifactorial etiology of HD Inflammation involving the vascular wall and surrounding connective tissue Hyper-perfusion of hemorrhoid plexus Prolapse Hemorrhoidal tissue contains Inflammatory cells and Newly
Slide 21: EB02 Proof of Concept Phase 2a Study Plan
EB02 Proof of Concept Phase 2a Study Plan Efficacy of EB02 Cream in Subjects with Protocol Grade I, II or III Internal Hemorrhoids EB02 will be evaluated in a randomized, double-blind, vehicle- controlled, two stage design. Patients with HD EB02 2.0% (n=24) Stage 1 Patients will be treated for 1
Slide 22: Upcoming Milestones and Strategic Objectives
Upcoming Milestones and Strategic Objectives Strategic Transaction and Capitalization Phase 2/3 Covid-19 study Reverse acquisition CTA approval Nasdaq listing IND filed Capital raise Jan 2020 IND Approval of EB05 Initiate patient enrollment (EB05) Advance lead product candidate (
Slide 23: Cash Position
Cash Position Historical Overview and Future Outlook Balance sheet Selected Financials As of June 30, 2020 Working capital focused on clinical programs Cash & Cash Equiv. $5.64 M* No long-term debt Total Assets $8.92 M Working Capital $5.24 M Flexibility Use of CROs and CMOs Debt $0.00 M
Slide 24: Capitalization Table
Capitalization Table As of September 28, 2020 Common Shares and Weighted Average Description Common Share Exercise Price Equivalents Common Shares 9,608,869 1 A-1 Convertible Preferred Shares $2.26 1,106,000 Options Outstanding2 $3.17 667,227 Warrants $4.92 998,971 Fully Diluted Shares 12,381,067 1
Slide 25: Current Holders of Common Shares
Current Holders of Common Shares Simplified Beneficial Ownership Table as of September 2020 Percent Shares Percent Holders Shares Share Options Warrant Shares Outstanding Fully Diluted Early Series Financing from Life Science Directors and Officers Specialists Par Nijhawan 3,257,157 33.9% 49,110 11,
Slide 26: Experienced Leadership Team
Experienced Leadership Team Pharmaceutical Pipelines, Corporate Development & Strategic Transactions Senior Management Team Edesa Board of Directors Par Nijhawan, MD, FRCPC, AGAF • Board-certified gastroenterologist and Sean MacDonald CEO and Board Director hepatologist • Successful track record of
Slide 27: Edesa Biotech Highlights
Edesa Biotech Highlights Novel technologies Working capital flexibility Inflammation inhibitor: positive evidence from two previous clinical Active calendar of clinical and studies corporate milestones TLR4 and CXCL10 antagonists Phase 2b study of EB01 Targeting patient populations wit
Slide 28: Company Contacts
Company Contacts Par Nijhawan Chief Executive Officer Michael Brooks President Gary Koppenjan Investor Relations Edesa Biotech, Inc. 100 Spy Court Markham, Ontario L3R 5H6 +1 (289) 800-9600 [email protected] www.EdesaBiotech.com