Edesa Biotech, Inc. · NASDAQ:EDSA
Edesa Biotech — Investor Presentation (May 2024)
41 slides from Edesa Biotech's investor presentation, May 2024
Slide 1: Corporate Presentation
f 3B Wey | Edesa Biotech Corporate Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains 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 as "
Slide 3: Edesa Highlights
Edesa Highlights Advancing First-in-Class Therapeutics for Immuno-Inflammatory Diseases First-in-Class Targets C-X-C motif chemokine ligand 10 (CXCL10) Secretory phospholipase A2 (sPLA2) Toll-like Receptor 4 (TLR4) Clinical Stage Pipeline and Data EB06: Phase 2 CTA in vitiligo approved, and IND bein
Slide 4: First-in-Class Development Pipeline
First-in-Class Development Pipeline Advancing First-in-Class Therapeutics for Immuno-Inflammatory Conditions Franchise Asset Program Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Status Comments Ph3 funding from the Anti-TLR4 EB05 ARDS - Covid-19 Enrolling Canadian Govt; Fast (mAb) Paridiprubart T
Slide 5: Large Addressable Market Opportunities
Large Addressable Market Opportunities Across Chronic and Acute, High-Cost Critical Care Total Addressable Markets* Few FDA approved therapies and $6.0B significant share of voice $15B Annually $5.0B $5.2B $4.7B Attractive health economics proposition $4.0B $3.9B Accessible with focused commercial $
Slide 6: Milestone-Rich Clinical Calendar
Milestone-Rich Clinical Calendar 12 to 24 months Next 6 months EB01 Partnering for Phase 3 2022 - 2023 EB05 & regulatory meetings Ph 2 IND for 2021 EB05 pulmonary fibrosis EB05 C$23m govt. funding Enrollment and data1 Vitiligo 2020 SIF Grant C$14m Subject to Timing of Launch EB05 Phase 2 IND in US E
Slide 7: EB05 Paridiprubart for ARDS
EBO5 Paridiprubart for ARDS 3 Edesa Biotech
Slide 8: Paridiprubart – Anti-Toll-like Receptor (TLR4) Antibody
Paridiprubart – Anti-Toll-like Receptor 4 (TLR4) Antibody First-in-Class mAb that Specifically Blocks TLR4 Signalling 1 Paridiprubart interferes with TLR4 dimerization in a ligand independent manner Drug Profile NFκB AP-1 IRF3 A humanized IgG1k monoclonal antibody Binds to TLR4 with high affinity IL
Slide 9: ARDS Treatment Paradigm
ARDS Treatment Paradigm Current Options Available Rely Primarily on Supportive Care and a Small Number of Drugs DIAGNOSIS The Berlin definition is the gold standard Based on chest imaging and oxygenation levels Oxygenation is used to classify patients as mild, moderate or severe 40% TREATMENT Mortal
Slide 10: A Significant Burden and Market Opportunity
A Significant Burden and Market Opportunity Total Addressable Market Disease Burden 600,000 7 to 21 days $100K+ Estimated ARDS-Related of ICU stay for surviving average cost per patient ICU Admissions/Year $5.2B ARDS patients1 in the US2 v v ARDS across the 7 major markets (US, UK, Germany, France,
Slide 11: EB05 – Phase 2 Clinical Efficacy
EB05 – Phase 2 Clinical Efficacy Signal-Finding Component; Wide Population and Variety of Endpoints Efficacy of EB05 in Subjects Phase 2 population Hospitalized with Covid-19 Infection 315 Hospitalized Covid-19 patients WHO Severity scale from level 4 to level 7 EB05 (15mg/kg) + SOC Phase 2 Identify
Slide 12: Phase 2 Clinical Efficacy Demonstrated
Phase 2 Clinical Efficacy Demonstrated Statistically Significant Mortality Trend in Critical Patients Profound Efficacy Signal for Mortality Reduction Phase 2 – Preemptively unblinded by independent data (28-Day Mortality Rate; n=33, p=0.04) safety monitoring board (DSMB) • Strong efficacy signal fo
Slide 13: U.S./Canada Phase 3 Clinical Study
U.S./Canada Phase 3 Clinical Study ARDS Patients Hospitalized with Covid-19 Infection Status Recruiting Primary Endpoint 28-Day Mortality Key Secondary Endpoints Ventilation Free Days 60-Day Mortality Target Population Adult subjects on invasive mechanical ventilation, both with and without addition
Slide 14: EB07 Paridiprubart for Pulmonary Fibrosis
EB07 Paridiprubart for Pulmonary Fibrosis
Slide 15: ILD and IPF – Treatment Paradigm
ILD and IPF – Treatment Paradigm Current Management Relies on Treatments that Slow Progression But Do Not Resolve/Reverse Fibrosis Pharmacological Tx Monitoring Antifibrotics (nintedanib and pirfenidone) Symptoms Diagnosis Based on IPF Non-Pharmacological Tx Pulmonary function Long-term oxygen thera
Slide 16: IPF Burden and Market Size
IPF Burden and Market Size A Significant Healthcare Burden and a Growing Market Opportunity Global IPF Market $4.50B 7.6 IPF prevalence per 100,000 (USA & EU) $4.00B $3.50B 9.4% CAGR $4.30B $3.00B Annual IPF-attributable medical cost to the $2B US Health system (excl. medication costs) $2.50B $2.00B
Slide 17: TLR4's Therapeutic Potential in Fibrotic Diseases
TLR4’s Therapeutic Potential in Fibrotic Diseases Summary of Preclinical Evidence TLR4 knock-out animal models display 1 attenuated fibrosis TLR4 antagonists lead to reduced fibrosis in 2 animal models TLR4 antagonists can reverse fibrosis in animal 3 models TLR4 agonists are predictors of disease 4
Slide 18: Leveraging Existing Work from the ARDS Program (EB05)
Leveraging Existing Work from the ARDS Program (EB05) Same Antibody as EB05 with a Significant Amount of Previous Preclinical, Clinical and Manufacturing Work Biological Activity in Favorable Safety Efficacy and Safety Manufacturing by Humans Established Profile Experience Leading Global CDMO Inhibi
Slide 19: Proposed U.S. Phase 2 Clinical Study
Proposed U.S. Phase 2 Clinical Study Patients with Idiopathic Pulmonary Fibrosis Status IND being prepared – 15mg/kg/4 weeks Anticipated Duration 24 Months - Enrollment & Data Primary Endpoint Absolute Change From Baseline in Forced Vital Capacity (FVC) at 52 weeks Key Secondary Endpoints Absolute C
Slide 20: EB06 - Vitiligo
EB06 - Vitiligo First-in-Class Anti-CXCL10 mAb
Slide 21: A Significant Unaddressed Market
A Significant Unaddressed Market Latent Market Comprised of Patients Waiting for Better Treatment Options Large Untapped Opportunity Large population but low proportion of patients seeking treatment due to lack of effective and safe treatments Diagnosed with 1.9M Vitiligo New therapies likely to dri
Slide 22: Vitiligo: A Life-Altering Autoimmune Disease
Vitiligo IFNγ-CXCL10-CXCR3 Chemokine Axis Play a Key Role in the A Life-Altering Autoimmune Disease Pathogenesis of Vitiligo High Prevalence – 1% Global Population 50% Onset Before Age 20; Must be Managed for Decades Associated with Type 1 Diabetes and Lupus, among others Severe Quality of Life Impa
Slide 23: Vitiligo Treatment Paradigm
Vitiligo Treatment Paradigm Limited Options with Topical Ruxolitinib as the Only Approved Product TREATMENT Topicals Significant Unmet Need Corticosteroids Calcineurin inhibitors Large unaddressed market due to lack of Ruxolitinib approved and effective options Only one approved drug with safety con
Slide 24: EB06 – Targeting the Chemokine CXCL10
EB06 – Targeting the Chemokine CXCL10 Monoclonal Antibody that Directly Binds CXCL10 with High Affinity and Blocks it from Binding to CXCR3 IFNγ CXCL10 EB06 Drug Profile CXCR3A CXCR3B A fully human IgG1k monoclonal antibody Binds specifically to CXCL10 with high Ca2+ flux MAPK Akt PKA affinity Seque
Slide 25: Targeting the IFNγ-CXCL10-CXCR3 Chemokine Axis
Targeting the IFNγ-CXCL10-CXCR3 Chemokine Axis EB06 is an anti-CXCL10 Monoclonal Antibody that Can Act on Different Stages of Vitiligo Non-Lesional (Innate) Lesional (Adaptive) EB06 inhibits: 1 CXCL10/CXC3B-mediated melanocyte apoptosis and antigen presentation 1 2 CXCL10/CXCR3A-mediated traffickin
Slide 26: CXCL10 Therapeutic Potential
CXCL10 Therapeutic Potential Therapeutically Targeting - Substantiated in Preclinical Studies IFNγ CXCL10 1 Melanocyte Apoptosis EB06 CXCL10/CXC3B mediates melanocyte apoptosis and activates anti-melanocytic CD8+ T-cells via CXCR3A 2 Knockout Mice CXCL10 -/- mice do not develop vitiligo CXCR3A CXCR3
Slide 27: EB06 Positioning – Target Product Profile
EB06 Positioning – Target Product Profile Addressing Unmet Needs in Vitiligo Topical JAK Inhibitors (e.g. Oral JAK Inhibitors Topical BET Inhibitors Biologics Ruxolitinib) (e.g. ritlecitinib, povorcitinib) (e.g. VYN201) (e.g. EB06, auremolimab) Treats lesional and non-lesional skin Viable for patien
Slide 28: Phase 2 Proof of Concept
Phase 2 Proof of Concept Moderate to Severe Non-Segmental (Generalized) Vitiligo Status CTA approved & IND being prepared Subjects Total of 153 evaluable patients randomized 1:1:1 (EB06, 10mg/kg: EB06, 20mg/kg: Placebo) across up to 25 study centers in US and Canada Treatment Period EB06 or placebo
Slide 29: EB06: Anti-CXCL10 Monoclonal Antibody
EB06: Anti-CXCL10 Monoclonal Antibody Summary and Next Steps Targeted Mechanism of Action 65 Subjects Dosed Biological Activity Phase 2 Ready Manufacturing Binds free and bound CXCL10 No Significant AEs Demonstrated CTA Approved Leading CDMO NEXT STEPS Readying IND for submission to FDA CRO identifi
Slide 30: Recent Transactions in Vitiligo Space
Recent Transactions in Vitiligo Space Incyte Announces Agreement To Acquire Medicxi-Backed Villaris Therapeutics And Auremolimab (VM6), An Anti-IL-15Rβ Monoclonal Antibody - Stage of Development When Acquired: Preclinical - Monoclonal Antibody $70 million, with potential for up to $1.36 billion in a
Slide 31: Daniluromer
Daniluromer First-in-Class sPLA2 Inhibitor Lead Indication: ACD Status: Topline Results Available
Slide 32: Daniluromer (EB01): Treating Chronic Inflammation
Daniluromer (EB01): Treating Chronic 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 approved NSAIDs •
Slide 33: Allergic Contact Dermatitis (ACD)
Allergic Contact Dermatitis (ACD) The Leading Occupational Health Issue Related to Dermatology ACD Represents a Significant Unmet Need 3,000+ 70% 0 Contact Unable to fully No Known ACD is a Type IV Hypersensitivity Reaction Allergens avoid allergen Labelled Drugs Immune system sensitized following i
Slide 34: Significant Number of Patients with Chronic ACD
Significant Number of Patients with Chronic ACD $4.7B Total Addressable Market Opportunity 7 major markets (US, UK, Germany, France, Spain, Italy, Japan) and Canada1 “ Physicians strongly desire additional treatment options, especially for hands and face2 “ACD…can make you quit your job.” 30M Patien
Slide 35: EB01 Market Positioning – Target Product Profile
EB01 Market Positioning - – Target Product Profile Edesa’s Cream is Being Developed to Address a Significant Unmet Need that Exists for Chronic ACD Patients Corticosteroids TCIs EB01 Viable for acute ACD patients Topical EB01 Cream Viable for chronic ACD patients Safe for long term use Positioned to
Slide 36: Confirmatory Phase 2B Design
Confirmatory Phase 2B Design Protocol 210 total subjects Moderate-to-severe chronic ACD Double blind, placebo-controlled protocol 28-day treatment with topical EB01 cream Dose-Ranging EB01 Cream 0.2% Determine the Lowest Efficacious Dose EB01 Cream 1.0% EB01 Cream 2.0% Multiple endpoints designed fo
Slide 37: Phase 2B Results – Composite CDSI and ISGA Scores
Phase 2B Results - – Composite CDSI and ISGA Scores 1.0% EB01 Met Primary Endpoint and a Key Secondary Endpoint with Statistical Significance Total CDSI Score* Total ISGA Score* Summary of Results Mean % Improvement from Baseline % Patients with a ≥2 Point Improvement from Baseline P Value = 0.027 P
Slide 38: Proposed Global Phase 3 Moderate to Severe Chronic ACD
Proposed Global Phase 3 Moderate to Severe Chronic ACD Two Replicate Pivotal Phase Studies Will Likely Be Required* Protocol ~500 total subjects Moderate-to-severe chronic ACD Double blind, placebo-controlled protocol 28-day treatment with topical EB01 cream Dose EB01 Cream 1.0% Primary Endpoint ISG
Slide 39: Clinical Summary
Clinical Summary First-in-Class Therapeutics for Immuno-Inflammatory Diseases EB05 (paridiprubart) Validated Phase 3 Program with Govt Funding EB01 (daniluromer) Phase 3 Ready w/ Partnering in Process EB06 – Vitiligo – Phase 2 Ready Significant Transactions in this Therapeutic Area and Pathway EB07
Slide 40: Experienced Leadership Team
Experienced Leadership Team Pharmaceutical Pipelines, Corporate Development & Strategic Transactions Executive Management Team Par Nijhawan, MD, FRCPC, AGAF Michael Brooks, PhD Stephen Lemieux, CPA CEO and Board Director President Chief Financial Officer Gary Koppenjan Blair Gordon, PhD VP, Corporat
Slide 41: www.EdesaBiotech.com
www.EdesaBiotech.com [email protected]