Immunovia Ab · OMXSTO:IMMNOV
Immunovia Ab — Investor Presentation (May 2020)
47 slides from Immunovia Ab's investor presentation, May 25, 2020
Slide 1: Immunovia Corporate Presentation
Immunovia Corporate Presentation May 2020 Mats Grahn, CEO
Slide 2: Forward Looking Statements
Forward Looking Statements IMPORTANT: The following applies to this document, the oral presentation of the information in this document by Immunovia AB (publ) (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows the oral presentation (collectively,
Slide 3: Agenda
01 Investment Highlights & Company Overview Unmet Need For Accurate Early Detection of 02 Pancreatic Cancer 03 IMMray™ Technology Platform Agenda 04 The Road To Market 05 IMMray™ PanCan-d Prospective Studies 06 Pipeline Projects 07 Summary 3
Slide 4: Investment Highlights & Company Overview
Investment Highlights & Company Overview 4
Slide 5: Investment Highlights
Investment Highlights First Mover Advantage With IMMrayTM PanCan–d IMMray™ Platform Technology Proprietary Blood-Based Biomarker Platform Significant Unmet Medical Need For Initial Addressable Market Size (EU/US) ~$4.4 Bn (USD) Early Detection Of Pancreatic Cancer First-To-Market Opportunity Expecte
Slide 6: Immunovia At A Glance
Immunovia At A Glance Company Background o Founded In 2007 At Lund University And CREATE Health In Lund, Sweden o IP-Rights For IMMray™ Platform Tests Transferred To Immunovia AB o HQ & Production Facility In Lund, Sweden o Immunovia Dx Laboratories in Lund, Sweden & Marlborough, Massachusetts, USA
Slide 7: Immunovia’s Pipeline Projects
Immunovia’s Pipeline Projects Leveraging IMMrayTM Discovery / Commercial Verification & Indication Optimization Commercial Early Dev. Test Model Validation Pancreatic Q4 2020 Cancer Lung Cancer Rheumatoid Arthritis 7
Slide 8: Experienced Leadership
Experienced Leadership Immunovia’s Management Team MICHAEL PETTIGREW MATS GRAHN ROLF EHRNSTRÖM SVP Sales NA CEO, MSc CSO, MSc • VP Sales Americas Thermo • CVP Marketing at Dako. • CSO & CVP R&D Dako. Fisher Scientific • VP Marketing at, GE • CSO Gyros, Amersham, • VP Corp Development Healthcare, Ame
Slide 9: Unmet Need For Accurate Early Detection of Pancreatic Cancer
Unmet Need For Accurate Early Detection of Pancreatic Cancer 9
Slide 10: Significant Unmet Medical Need
Significant Unmet Medical Need Early Detection Of Pancreatic Cancer ~50% Five Year Survival <5% Early Diagnosis In Pancreatic Cancer Is The Only Hope Today >80% Late Diagnosis 4.6 Months Median Survival Someone Diagnosed With Pancreatic Cancer In Europe 10
Slide 11: The Data: Pancreatic Cancer By The Numbers
The Data: Pancreatic Cancer By The Numbers Estimated Deaths By Cancer Type in the USA (2019) (Both Sexes Combined) Lung and bronchus 142,670 3rd Most Common Cancer 3rd By Mortality Colorectum 51,020 More Deaths Than From Pancreas 45,750 Breast Cancer (2019) Source: American Cancer Society Breast 42,
Slide 12: Current Technologies For Pancreatic Cancer
Current Technologies For Pancreatic Cancer Detection and Diagnosis 12
Slide 13: The Advantage Of Early Diagnosis Of Cancer
The Advantage Of Early Diagnosis Of Cancer IMMray™ vs. ctDNA IMMrayTM ctDNA 13
Slide 14: Pancreatic Cancer: High Risk Groups
Pancreatic Cancer: 3 High Risk Groups Hereditary Early NOD Familial symptoms •Familiar autosomal ≥ 2 •Depression •New onset diabetes type close fam members II after 50 years of age •Indigestion/Nausea •Familiar non-autosomal ≥ •Jaundice 3 close fam members •8-10 times increased risk •Mid back pain •
Slide 15: IMMray Targets A Large Growing Market
IMMray™ Targets A Large Growing Market Initial Addressable Market in EU/US: ~$4.4bn (USD) Pancreatic Cancer Risk Groups $3,600M $600M $240M • 200,000 patients • 1 million new patients / year • >3 million new patients / year • 2 tests / year • 1 test / patient • 1 test / year in 2 years • 600 USD / t
Slide 16: IMMray Technology Platform
IMMrayTM Technology Platform 16
Slide 17: The IMMray Platform
The IMMrayTM Platform Measuring The Immune System’s Response To Disease In A Single Drop Of Blood 17
Slide 18: IMMray Platform
IMMray™ Platform Patient Sample Testing In The Lab 18
Slide 19: Discovery and Development Studies
Discovery and Development Studies IMMray™ PanCan-d 19
Slide 20: The Optimization Study
The Optimization Study IMMray™ PanCan-d Pancreatic Cancer All controls Symptomatic PDAC Stage I-IV VS Diabetes Healthy 20
Slide 21: Patients With Concerning Symptoms
Patients With Concerning Symptoms The Criteria Concerning Symptoms Correct Diagnosis Examples • Abdominal pain • Pancreatitis, acute or • Change in bowel chronic habits • Liver disease • Jaundice • Biliary duct diseases • Weight loss • Gallstone disease • Reflux Pancreatic • Reflux/gastritis • Bloat
Slide 22: Excellent Optimization Study Results
Excellent Optimization Study Results IMMray™ PanCan-d Healthy vs PDAC Symptomatic vs PDAC Diabetes vs PDAC Results Combining IMMrayTM PanCan-d And CA19-9 22
Slide 23: Excellent Optimization Study Results
Excellent Optimization Study Results Early Diagnosis vs All Controls Results Results Combining IMMrayTM PanCan-d And CA19-9 Controls vs PDAC Stage I and II 23
Slide 24: Commercial Test Model Study
Commercial Test Model Study IMMray™ PanCan-d o Completed according to plan o Confirmed results from optimization study with accuracies ~95% For diagnosing pancreatic cancer vs all controls o 1,113 samples from 8 hospitals in US and EU, show IMMray™ PanCan-d robustness o Patenting registration ongoin
Slide 25: The Road To Market
The Road To Market 25
Slide 26: Road to Sales Start Q4 2020
Road to Sales Start Q4 2020 IMMray™ PanCan-d We Are Here IMMrayTM PanCan-d IMMrayTM PanCan-d IMMray PanCan-d Verification study Validation study Launch discovery and optimization study commercial test development studies model study • Defined candidate • Optimize • Test the • Locked signature • Lock
Slide 27: Sales Start Target Q4 2020
Sales Start Target Q4 2020 COVID-19 Related Delay & Updated Timeline Due to the lock down and the Emergency Order in Massachusetts from March, 23, 2020, to May, 25, 2020, Immunovia has revised the company’s timeline and sales start date for IMMray™ PanCan-d. Revised Target Verification Study Q3 2020
Slide 28: Remaining Steps to Launch
Remaining Steps to Launch IMMrayTM PanCan-d Remains First-to-Market Diagnostic for Early detection of Pancreatic Cancer Subset of studies need to be performed in US Commercialization laboratory for Product launch CLIA/CAP accreditation Validation Study Locked signature and algorithms on blinded samp
Slide 29: Leveraging The Largest KOL Network
Leveraging The Largest KOL Network IMMrayTM PanCan-d Main Programs Target Key Customers Reimbursement - Reference labs (EU/US) - Guidance Experts - Cancer Centre Clinicians - Health Economic Studies - Private/Public Centre - Private/Public Insurance Clinicians Key Opinion Leader Program Communicatio
Slide 30: Positioning IMMray PanCan-d
Positioning IMMray™ PanCan-d Focused Targeting of Sales and Marketing Asymptomatic Early symptoms Symptoms and Pancreatic cancer positive imaging recurrence Hospital Pancreatic Cancer Clinics Primary care evaluation HPB / Gastro clinic HPB / Gastro Familiar / Familiar / hereditary hereditary Disease
Slide 31: Commercial Launch Preparations
Commercial Launch Preparations Pre-launch Activities Digital Plans Sales Preparation Refocused To Online and and Activities Increased Launch Preparation Activities Maintained Clinical Conferences and Patient Organization meetings cancelled or postponed due to COVID-19 31
Slide 32: Virtual/Digital Launch Plan – Key Activities
Virtual/Digital Launch Plan – 6 Key Activities IMMray™ PanCan-d Patient Org Events: Virtual walks and digital patient organization events Virtual Road Tour: “Launch and Live Stream Digital learn” Launch Event: live streaming presentations and presentations for KOL speakers gastro/pancreatic IMMray™
Slide 33: Launch Priorities for IMMray PanCan-d
Launch Priorities for IMMray™ PanCan-d Countries with prospective site centers, PanFAM, PanSYM, PanDIA, FPC screening programs, diagnostic/GI centers and private health systems Priority Order: 1. USA 1. Sweden/Nordic 2. UK 2. Spain / Italy 2. Canada 3. DACH 3. Benelux 4. France 33
Slide 34: Commercialization Strategy in Place
Commercialization Strategy in Place Sales Force Focused On Gastro Centers In Prio Countries 1 Targets And Patient Flow Mapped 2 Marketing /Communication Planned For: • Online/Digital Marketing and Selling Tools and Channels 3 • All Relevant Pancreatic Cancer Events And Conferences • Patient Organiza
Slide 35: IMMray PanCan-d Logistics In Place
IMMray™ PanCan-d Logistics In Place Clinician And Patient Convenience Enable Market Penetration Test document Test ordered Test initiated Blood collected Sample Shipped Tested/Reported Test requisition and Signed Test Customer Support Phlebotomy is Serum is shipped Testing performed supporting mater
Slide 36: Strong Patient Organization Collaboration
Strong Patient Organization Collaboration Example: Pancreatic Cancer Awareness Walks 24,000 Participants In 2018 37,500 Participants In 2019 Digital Meetings In 2020 36
Slide 37: IMMray PanCan-d Prospective Studies
IMMray™ PanCan-d Prospective Studies 37
Slide 38: Prospective Studies
Prospective Studies Impacted By COVID-19 • All sites involved in the three ongoing prospective pancreatic cancer studies are following their respective national recommendations and regulations for health and safety and, thus, many have therefore in general stopped clinical trial activities, includin
Slide 39: IMMray PanCan-d
IMMray PanCan-d +10,000 subjects in three major risk groups for PDAC PanSYM-1 PanFAM-1 PanDIA-1 • Non-specific But • Asymptomatic • New Onset Diabetes Concerning Symptoms Familiar/Hereditary Type II After The Age Of 50 • University College of • 25 Pancreatic Diseases London In Collaboration Referenc
Slide 40: Three Prospective Studies
Three Prospective Studies 10,000 Subjects via KOL Network 40
Slide 41: Pipeline Projects
Pipeline Projects” f -
Slide 42: Process Overview for Pipeline Projects
Process Overview for Pipeline Projects Initial Study Results to Market Discovery Studies Development Studies to Market Introduction Commercialization Product launch Validation Study Locked signature and algorithms on blinded samples 05 Verification Study KOL Network & Fresh 08 Locked signature and a
Slide 43: Lung Cancer
Lung Cancer Pharma Study 1: Completed. Lung cancer stage I-IV vs healthy Study 2: Ongoing. Lung cancer stage I-IV healthy and symptomatic controls • Building KOL network 1. Early Diagnosis Current healthcare status • Symptoms of lung cancer often occur at an advanced, non-curable stage • Screeni
Slide 44: Rheumatoid Arthritis
Rheumatoid Arthritis IMMray™ RA-d Target Clinical Use: Early RA - PRIMARY CARE Developing RA Established RA - REUMATOLOGITS Patients with pain and unclear early symptoms Patients with pain and clear clinical symptoms EULAR recommendation for early RA Referral to specialist ACR criteria and scoring C
Slide 45: Summary
Summary 45
Slide 46: Summary
Summary Focused on IMMrayTM PanCan-d Sales Start in Q4 2020 Excellent Results for Optimized IMMrayTM PanCan-d Across All Target Groups First To Market Solution For Early Detection Of Pancreatic Cancer – Addressable Market Opportunity of ~$4.4 Billion (USD) PanFAM-1, PanSYM-1, PanDIA-1 : Largest, >10
Slide 47: Thank you!
Julie Silber Director of Investor Relations Immunovia AB Mobile: +46(0)79 3486277 julie. silber@immunovia.com www.immunovia.com