Immunovia Investor Day · Immunovia Investor Day Agenda Introduction Julie Silber Director of...

Immunovia Investor DayLund, SwedenJune 30, 2020

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Forward Looking Statements

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Immunovia Investor Day Agenda

IntroductionJulie Silber Director of Investor Relations

Carl Borrebaeck Founder & Chairman of the Board

The Market & IMMray™ Platform Mats Grahn Chief Executive Officer

Road To MarketOur Strategy

Laura Chirica Chief Commercial Officer

Building Sales CLIA/CAP

Michael Pettigrew Senior VP Sales North America

Thomas King, M.D. Medical Director

Conclusion Mats Grahn Chief Executive Officer

Q&A

Mats Grahn Chief Executive Officer

4

Founder & Chairman of the Board

Carl BorrebaeckCEO

Mats Grahn

Welcome & Introduction

5

CEO

IMMrayTM Platform and Market Overview

Mats Grahn

6

Early Detection Of Pancreatic Cancer

Significant Unmet Medical Need

4.6 Months Median SurvivalSomeone Diagnosed With Pancreatic

Cancer In Europe

Today >80% Late Diagnosis Early Diagnosis In Pancreatic Cancer Is The Only Hope

~50% <5% Five Year Survival

7

3 High Risk Groups

Pancreatic Cancer

• Familial autosomal ≥ 2 close fam members

• Familiar non-autosomal ≥ 3 close fam members

• BRCA1/2 Hereditary• FAMMM p16, CDKN2A• Peutz Jeghers• Lynch Syndrome• Hereditary pancreatitis• 2-132 risk of developing

pancreatic cancer

• Depression• Indigestion/Nausea• Jaundice• Mid back pain• Upper abdominal pain• Pain on eating• Fatigue• Unexplained weight loss• Diabetes

• New onset diabetes type II after 50 years of age

• 8-10 times increased risk of developing pancreatic cancer 1-3 year after diagnosis

Early symptoms

Hereditary Familial NOD

8

Initial Addressable Market in EU/US: ~$4.4bn (USD)

IMMray™ Targets A Large Growing Market

Hereditary Early symptoms New Onset Diabetes over 50years of age

• 200,000 patients• 2 tests / year• 600 USD / test

• >3 million new patients / year• 1 test / year in 2 years• 600 USD / test

• 1 million new patients / year• 1 test / patient• 600 USD / test

Pancreatic Cancer Risk Groups

$240M$600M

$3,600M

9

Patient Sample Testing In The Lab

IMMray™ Platform

10

Patent Summary

Pancreatic Cancer Patent Portfolio

PDAC-I filed 25 Mar 2008

PDAC-II

PDAC-III

PDAC-IV

PDAC-V

PDAC-VIfiled 5 Mar 2012

filed 11 Nov 2014

filed 22 Sep 2016

PDAC-VII

filed 10 May 2017

filed 31 Jan 2018

will be filed early July 2020

11

Lund, Sweden

State-of-the-Art Production Facility

12

Immunovias vision is to dominate the pancreatic cancer diagnostics market

Summary

• First to a 4 BUSD Market• Fully Funded Commercial Rollout • Target a Long Term 30% Market Share

13

Chief Commercial Officer

Road to Market

Laura Chirica

14

Immunovia Chief Commercial Officer

Laura Chirica, PhD

Career Highlights:• Global Monoclonal Antibody Purification Program Manager,

BioProcess, GE Healthcare, Uppsala, Sweden• Talent Management mentee for future great leaders, GE Mentorship

Program• Global Marketing Director Agilent Technologies (“Dako”),

Copenhagen, Denmark

• Purification Technologies Director Sartorius, Göttingen, Germany • VP Wieslab Laboratory Services (private lab) Malmö, Sweden• VP Sales and Marketing Svar Sciences (“Euro Diagnostica”), Sweden• 5 years in Immunovia

+20 years experience in developing and leading successful global

commercial strategies with large marketing, sales, application

support and customer support teams from Europe, US and Asia

BSc in Biotechnology, MSc in Biochemistry and PhD in Biochemistry, Sweden.

15

Timeline

IMMrayTM PanCan–d Road to Market

2016 - 2019 2020-2022 2023-

RETROSPECTIVE /OPTIMIZATION/VALIDATION SELF PAY-SALES

PROSPECTIVE STUDIES REIMBURSED SALES

CONFIRMATORY MARKET EXPANSION STUDIES

IMMray™ PanCan-d Q4 2020

ACCREDITATIONS

16

Main programs

Road to market IMMray™ PanCan-d

Key Opinion Leader

Program

Clinical Studies Program

Target Key Customers in priority geographies

- Reference labs (EU/US)- Cancer Centre Clinicians- Private/Public Centre

Clinicians

Build sales org

Reimbursement

- Guidance Experts- Health Economic Studies- Private/Public Insurance

Marketing &Communication

- Press - Home page- Media- Social media- Events (EU/US)

Patient Organizations

Immunovia Dx Laboratories

17

Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement






18

Over 30 KOLs worldwide, including:

World’s Largest Key Opinion Leader Network US and Europe

Prof. Steve Pereira, London, UK

Prof. Bill Greenhal, Liverpool, UK

Prof. Eithne Costello, Liverpool, UK

Prof. Alfredo Carrato, Madrid, Spain

Prof. J. E. Domínguez Muñoz, Santiago de Compostela, Spain

Prof. Robert Grützmann, Erlangen, Germany

Prof. Mattias Löhr, Stockholm, Sweden

Dr. Svein Olav Bratlie, Gothenburg, Sweden

Dr. Diane Simeone, New York, USA

Prof. Margaret Tempero, San Francisco, USA

Dr. Randall Brand, Pittsburgh, USA

Dr. James Moser, Boston, USA

Dr. James Farrell, Yale New Haven, USA

Dr. George Zogopoulos, Montreal, Canada

Assoc. Prof. Aimee Lucas, New York, USA

Dr. Giles Whalen, Boston, USA

Dr. Bryson Katona, Philadelphia, USA

Dr. Brett Shepard, Oregon, USA

North America Europe

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Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement


Marketing&Communication




20

Positioning IMMray™ PanCan-d and Supporting Clinical Studies

AsymptomaticHospital Pancreatic Cancer Clinics

Early symptoms

Primary care evaluation

Symptoms and positive imaging

HPB / Gastro clinic

Pancreatic cancer recurrence

HPB / Gastro

PanFAM-1 PanSYM-1 To be addressed

PanDIA-1

Frontline diagnostics / Adjunct diagnostics Disease recurrence monitoring tests

Familial / hereditary

individuals inscreening programs

Familial / hereditary individuals

NOT inscreening

Disease progression

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>10,000 subjects in three major risk groups for pancreatic cancer

3 Prospective Studies

Umeå University HospitalUmeå, Sweden

Healthcare Regional UppsalaUppsala, Sweden

Karolinska InstituteStockholm, Sweden

Linköping University HospitalLinköping, Sweden

Sahlgrenska University HospitalGothenburg, Sweden

Healthcare Region SkåneSkåne, Sweden

Danish Center for Strategic Research Into Typee 2 Diabetes (DD2) – Letter of Intent Copenhagen, Denmark

University of LiverpoolLiverpool, UK

University College London HospitalLondon, UKUniversity Hospital

Santiago De Compostela, Spain

Ramon y Cajal Institute for Health Research (IRYCIS)

Madrid, Spain

Clínica Universidad de Navarra (CUN)

Navarra, SpainCatalan Institute of Oncology (ICO Hospitalet)Bellvitge Biomedical Research Institute

Barcelona, Spain

Research Institute of the McGill University Health Center (RI-MUHC)Montreal, Canada

Massachusetts General Hospital

Boston, MAUniversity of Massachusetts Boston, MA

Yale University Boston Boston, MA

Beth Israel Deaconess Medical Center (BIDMC

Boston, MA

Columbia University

New York, NYMount Sinai

New York, NY

NYU School of Medicine

New York, NYThe Trustees of the University of PENN

Philadelphia, PA

University of Pittsburg Medical Center

Pittsburg, PA

University of Chicago Medical Center

Chicago, IL

OHSU Knight Cancer Institute Portland

Portland, OR

Stanford UniversityPalo Alto, CA

UCLA Health MedicalLos Angeles, CA

Immunovia leads clinical validation studies with > 10,000 subjects recruited at 27 sites from Europe and the USA covering the three highest risk groups for pancreatic cancer

Study High Risk Group No. of Subjects

Non-specific but concerning symptoms >2,000

Asymptomatic familiar/hereditary >2,000

New onset diabetes type II after the age of 50 6,000

Total >10,000

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Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement






23

Timeline

Road to Reimbursement

2020-2022 2023-

SELF PAY-SALES

PROSPECTIVE STUDIES

REIMBURSED SALES

CONFIRMATORY MARKET EXPANSION STUDIES FOR COUNTRY SPECIFIC REIMBURSEMENT


PAYER ENGAGEMENT CONTINUES WITH INTERIM PROSPECTIVE RESULTS

Interim read out

Final read out

PAYER INTERACTION

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Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement






25

Global Collaboration With PancreaticCancer Patient Organizations

Canada: Pancreatic Cancer Canada

US:Lustgarten FoundationThe Pancreatic Cancer Action Network (PanCAN)The World Pancreatic Cancer CoalitionThe Ron Foley FoundationThe Griffith Family FoundationThe MA Pancreatic Cancer AllianceThe Marino/Connolly FoundationPurple Iris FoundationKenner Family Research FundFORCE (Facing Our Risk of Cancer Empowered)Families Fighting Pancreatic Cancer

Sweden: PalemaNätverket mot cancer

Norway:Pancreaskreft Nettverk

Denmark:Pancreasnetværket

Germany:TEB e. V. SelbsthilfeAdP, der Arbeitskreis der Pankreatektomierten e. V.UK:Pancreatic Cancer Action UKPCUK - Pancreatic Cancer UKCancer Research UK (CRUK)Pancreatic Cancer Research Fund (PCRF)MacMillan Cancer Support

Spain:ACANPANGEPAC

Japan:PanCAN Japan

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Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement


Marketing & Communication




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Primary Message

IMMray™ PanCan-d test takes a snapshot of an individual’s immune

response in the early stages of pancreatic cancer when resection of

tumour and treatment is possible. 5-year survival rate 5-9%

When PDAC diagnosed in resectablestages

Today 80% PDAC diagnosed in late stages

5-year survival rate upto 50%

Early Diagnosis Saves Lives

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IMMray™ PanCan-d

Early Detection Targets

Symptomatic patients Gastroenterologist

Patients

Asymptomatic familial

surveillance

New onset diabetes, 50+ years

GP / PCP

CT Scan CT positive

EUS

MRI

CT positiveMRI / EUS positive


CT positiveMRI positive

EUS negative

CT positiveMRI negative EUS negative

Follow up

Follow up

Surgeon

Further investigation

Emergency

Genetic Counselor

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Reaching PDAC risk groups and clinicians

IMMray™ PanCan-d Virtual / Digital Launch Plan

IMMray™ PanCan-d

Virtual/Digital Launch

Events

Launch and Learn

Online Channels

Communication

Advertising Online Launch

Campaign

Sales Tools

Livestream Launch Day

Event

1

2

3

4

5

6

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“Around The World For Awareness Of Pancreatic Cancer”

Virtual Walk Events

Main Goal‘Walking Together Around The World’ Will Bring Together Risk Group Individuals, Patients And Their Families To

Raise Awareness Of Pancreatic Cancer and IMMray™ PanCan-d Launch In Q4 2020

Secondary Goals• Cover together 40 075 km from 19 July

2020 to • 19 November 2020- World Pancreatic

Cancer Day • Boost our online presence for the launch• Provide the details to order IMMray™

PanCan-d

1

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Virtual Events

Examples: • European Pancreatic Club gone digital: 2 July 2020,

Immunovia E-Symposium presentation about latest results and Q4 2020 launch

• Pri-Med Virtual Industry Theatres for primary care doctors, USA• Sept and Dec, Immunovia organizing workshops

• Patient organizations virtual walks support from Immunovia

Main GoalTo Present The Results Of The Final Validation Studies For Clinicians

To Make Them Aware About The Availability Of The Test

1

32

Virtual Launch and Learn

Concept:• KOL presentations• Recorded content, Q&A

live• Start Q3 and continue for

12-18 months

Main GoalTo create sales leads at targeted priority hospitals

2

33

Digital Communication

Communication Tool Target Audience

Podcasts/Interviews Gastro Clinicians, Surgeons, Primary Care Doctors, Genetic Counsellors, Patients And Their Families

Online TV And Radio Patients And Their Families

Online Advertising In Relevant Journals Gastro Clinicians, Surgeons, Primary Care Doctors, Genetic Counsellors

Main GoalTo Create Awareness About The Availability Of IMMray™ PanCan-d

3

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Awareness of launch Q4 2020

Advertising Campaign

Concept• What does early detection mean for

you?• Start Sept until launch in US and

Europe• In collaboration with patients, their

families and clinicians• Distributed via all online channels

Main GoalTo create awareness about the availability of IMMray PanCan-d for all target groups

4

35

Digital Sales Tools

Concept:• Virtual sales training• Virtual selling educational

program

• Virtual sales tools• E- Marketing collaterals • Customer engagement

tracking

Main GoalTo educate sales team with digital tools and how to use digital tools

5

36

Live Stream Digital Launch Event

Launch Day

Concept:• Launch E-conference on the launch

date, in Q4 2020,• Talks and interviews from:

• Survivors/patient orgrepresentative

• KOLs• Immunovia

Main GoalTo create awareness about the availability of IMMray PanCan-d for all target groups

6

37

Main programs

Road to Market IMMray™ PanCan-d

Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement






38

IMMray™ PanCan-d

Launch and Commercialization Countries

Countries with prospective site centers, PanFAM, PanSYM, PanDIA, familial pancreatic screening programs, diagnostic/GI centers and private health systems

1st Wave US Commercialization2nd Wave Europe Commercialization

Sweden/NordicUKSpain / ItalyDACHBeneluxFranceCanada

39

Main programs


Key Opinion Leader

Program


Target Key Customers in priority geographies- Reference labs (EU/US)- Cancer Centre Clinicians- Private/Public Centre

Clinicians

Build sales orgMike Pettigrew

Reimbursement


Marketing&Communication




40

Senior VP Sales North America

Road to Market

Michael Pettigrew

Sales Strategy

41

Immunovia Senior Vice President Sales

Michael Pettigrew

Career Highlights• Management of over 500 M USD Revenue per year• Management of over 300 Sales and Support Personnel• Commercialization of AKTA platform of Chromatography Systems• Commercialization of MegaBACE DNA Sequencer

• Acquisition of Microarray platform from Motorola Corp• Divestment of ESA Biosciences from Magellan Corp• Integration of multiple companies, individuals and technologies in multiple

organizations• Responsible for significant revenue and resource growth in multiple organizations

Mr. Pettigrew brings over 30 years of experience and has focused his extensive global expertise in the management of marketing & sales, business and

strategic account development, licensing, mergers & acquisition, and commercial technology platform

development. Has held positions at Thermo Fisher Scientific, Magellan Biosciences, at GE Healthcare (Vice

President, Sales), Amersham (Vice President, Genomics), and Pharmacia (Director of Marketing,

North America).

42

Sales Focus by Clinical Specialty

Symptomatic patients Gastroenterologist

Patients

Asymptomatic familial

surveillance

New onset diabetes, 50+ years

GP / PCP

CT Scan CT positive

EUS

MRI



CT positiveMRI positive

EUS negative

CT positiveMRI negative EUS negative

Follow up

Follow up

Surgeon

Further investigation

Emergency

Genetic Counselor

43

Territory 1 • Gastroenterologists = 1458• 68 Multidisciplinary GI centers• Genetic Counselor = 154

Territory 2 • Gastroenterologists = 2698• 135 Multidisciplinary GI centers• Genetic Counselor = 160

Territory 4 • Gastroenterologist = 2159• 155 Multidisciplinary GI centers• Genetic Counselor = 99

Territory 3 • Gastroenterologist = 2069• 147 Multidisciplinary GI centers• Genetic Counselor= 226

1

2

3

4

By Geography

Sales Implementation Strategy

44

Sales Implementation By Pancreatic Cancer Center

National Pancreas Foundation Accredited Center

Pancreatic Cancer Center

45

Sales Implementation by Priority 1 Hospitals

Yale Center for Pancreatic Disease CTStamford Hospital CTHartford Hospital CTMiddlesex Hospital CT

Beth Israel Deaconess Medical Center MABrigham and Women’s Hospital / Dana Farber Cancer Inst MAMassachusetts General Hospital MALahey Hospital and Medical Center MA

Dartmouth-Hitchcock Medical Center NHUniversity of Vermont Medical Center VTMaine Medical Center MERI Hospital, The Miriam Hospital, Newport Hospital RI

1

46

Targeting Will Be Key

Target Customers Mass General Hospital

Focus on Following:• Pancreatic Specialists• Pancreatic Surgeons• Gastroenterologist• Clinical Geneticists

Populating CRM:• Hospitals• Clinical Target

customers

Endocrinology, Diabetes and Metabolism 31Family Medicine / General Practice 65Gastroenterology 11General Surgery 28Geriatric Medicine 9Hematology & Oncology 28Internal Medicine 164Pediatric Hematology & Oncology 2Total 338

Total Accessible Market (Massachusetts General Hospital)

47

Pancreatic Specialists Mass General

Approximately 30 Pancreatic Specialists • Focus for Sales• Educate all involved in these

practicesSource for additional Target CustomersReference Base

Disorders of The Biliary and Pancreas 1Endocrine Pancreas 1ERCP (Endoscopic Retrograde Cholangiopancreatography) 1Familial Pancreatic Cancer 1Liver and Pancreatic Disorders 1Liver, Biliary and Pancreatic Disease 2Organ Transplantation (Kidney, Liver, And Pancreas) 1Pancreas and Islet Transplant 2Pancreatic and Hepatobiliary 2Pancreatic Biliary Disorders 2Pancreatic Cancer 12Pancreatic Cystic Tumors 3Pancreatic Disease 4Pancreatic Neuroendocrine Tumors 1Pancreatic Transplant 1Pancreatitis (Acute and Chronic) 6Pancreatobiliary Surgery 2Primary Hepatic and Pancreatic Cancers 1

Total 44

Pancreatic Specialists (Massachusetts General Hospital)

48

Sales Organization

CustomerRelationshipManagement

System

FIELD SALES REPRESENTATIVES

INSIDE SALES SUPPORT

Next Steps

49

Based On Population PDAC Incidence Age Distribution

Sales Expansion Principles

1

2

3

46

57

10

8

9

11

Step 1

Step 3

Step 2

Step 1

Step 2

Step 1

Step 3

Step 3

Based on: PopulationPDAC incidenceAge distribution

Step 2

50

Medical Director

Road to Market

Dr. Thomas King

Insight From The Clinical Perspectives

51

Main programs


Key Opinion Leader

Program




Clinicians

Build sales org

Reimbursement


Communication




52

Immunovia US Laboratory Medical DirectorThomas King, MD, PhD

Career Highlights:Career Highlights:Director, MEDPACE HOLDINGS, INC. (MEDP, NASDAQ)Adjunct Associate Professor, RUTGERS, THE STATE UNIVERSITY OF NEW JERSEYMedical Director, IMMUNOVIAChief of Pathology and Laboratory Medicine, ST. VINCENT

HOSPITAL, Worcester, MA 2013-2017, Partner and Medical Director, UNIVERSITY PATHOLOGISTS, LLCAssociate Professor, BOSTON UNIVERSITY SCHOOL OF MEDICINESenior Director, MILLENNIUM PHARMACEUTICALSAssociate Professor of Pathology and Residency Program Director, BROWN UNIVERSITY SCHOOL OF MEDICINE

Board certified Pathologist with Ph.D. in Molecular Biology and extensive experience as a laboratory director in hospital, academic and corporate settings. MD and PhD, Washington University 1984 Fellow and Inspector, College of American Pathologists Established multiple Molecular Pathology Laboratories with Laboratory Developed Tests (LDTs)

53

Process for CLIA Registration and Accreditation (CAP)


Train Personnel and Verify or Validate Test Method• Document training and

competence• Verify FDA approved

tests• Validate non-FDA

approved tests (LDT’s)

Apply for MA State License

Accreditation by CAP

SalesStart

Fit Out Lab• Equipment• Personnel• Materials• Supplies

Develop & Approve Procedures/Methods• Use of Equipment• Performance of Lab

Tests (i.e. glucose, IMMray PanDAC)

54

Virtual Tour of Immunovia Dx Lab Marlborough USA and IMMray™ PanCan-d Test

55


Summary

• First to a 4 BUSD Market• Well Financed Commercial Rollout • Target a Long Term 30% Marketshare

Q & A

57

Development Studies to Market Introduction

Process Overview for Lung Cancer Program

Initial Discovery Study

KOL NetworkBuild network, get expert advice, complete study protocols and make agreements on sample delivery

Sample Delivery & Lab Work Once all the blood samples and clinical data have arrived, lab work is performed using IMMrayTM discovery arrays

Optimization Study (if needed)Optimize candidate commercial signature & algorithm; Full IMMrayTM array

CommercializationProduct launch

Commercial Test Model StudyThe candidate commercial signature and fine tune algorithm

Verification StudyLocked signature and algorithms on known samples

Validation StudyLocked signature and algorithms on blinded samples

08

04

01

02

03

06

07

AnalysisBioinformatic analysis of the study

Discovery Studies

KOL Network & Fresh Blood SamplesTo KOL Network to collect fresh blood samples that mirror the commercial environment

05

Q & A

59

Immunovia Virtual Walk

Let’s Walk, Together,

Around The Globe To Raise Awareness

For Pancreatic Cancer

Interested? Please send us an email at [email protected]

Registration opens 19 July 2020

http://immunovia.com

60


Summary

• First to a 4 BUSD Market• Well Financed Commercial Rollout • Target a Long Term 30% Market Share

Thank you!

Julie SilberDirector of Investor Relations

Immunovia ABMobile: +46(0)79 3486277

[email protected]

www.immunovia.com

http://immunovia.com

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Immunovia Investor Day · Immunovia Investor Day Agenda Introduction Julie Silber Director of...

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