|

BerGenBioDeveloping first-in-class drugs to treat

aggressive cancer

DnB Hordaland På Børs

24th August 2017

Richard Godfrey, CEO

|

Disclaimer

2

Certain statements contained in this presentation constitute forward-looking statements. Forward-looking statements

are statements that are not historical facts and they can be identified by the use of forward-looking terminology,

including the words "anticipate", "believe", "intend", "estimate", "expect", "will", "may", "should" and words of similar

meaning. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that

could cause actual results or events to differ materially from those expressed or implied by the forward-looking

statements. Accordingly, no assurance is given that such forward-looking statements will prove to have been correct.

They speak only as at the date of the presentation and no representation or warranty, expressed or implied, is made

by BerGenBio ASA or its affiliates ("BerGenBio"), or by any of their respective members, directors, officers or

employees that any of these forward-looking statements or forecasts will come to pass or that any forecast result will

be achieved and you are cautioned not to place any undue influence on any forward-looking statement. BerGenBio is

making no representation or warranty, expressed or implied, as to the accuracy, reliability or completeness of this

presentation, and neither BerGenBio nor any of its directors, officers or employees will have any liability to you or any

other person resulting from the use of this presentation.

Copyright of all published material, including photographs, drawings and images in this presentation remain with

BerGenBio and relevant third parties, as appropriate. Consequently, no reproduction in any form of the presentation,

or parts thereof, is permitted without the prior written permission, and only with appropriate acknowledgements.

|

BerGenBio Introduction

3

Bergen, Norway

▪ Listed on Oslo Børs : ‘BGBIO’

▪ HQ and Administration

▪ Research

Oxford, UK

Clinical trial management

Drug discovery programs

BerGenBio “Scientific discovery is our revenue,

Data is our PROFIT”

|

We are part of a big market and we can`t do it allWhere does Biotech fit into the food chain ?

|

BerGenBio – First-in-class Axl inhibitors for multiple aggressive cancers

5

90% of cancer deaths result from tumors spreading,

becoming immune evasive and drug resistant

Axl is a key mediator of these traits in most cancers

BerGenBio is a world-leader in Axl biology

and is developing an exciting pipeline of Axl inhibitors

BGB324 initially addressing an annual market potential of

USD 11 Billion

|

Key events in BerGenBio history

6

INTRODUCTION TO BERGENBIO

• UiB Spin- out

• Seed funding

• Patents filed

M D Anderson

• Phase II

• NOK 212m

capital raise

• Grant NOK

15m

Meteva

AS

2008 - 2010 2011 2012 2013 2014 2015 2016

• NOK 54m

equity issue

• In license

BGB324

• Grant NOK

12m

• Preclinical

• Phase I

• NOK 37m

equity issue

• Wellcome

Trust

investment

• Phase Ib

• NOK 165m

equity issue

• Grants

NOK24m

• Out-License

ADC

program

• Orphan

designation

• Grant NOK

13m

• UK office

Oxford

Key Partners

2017

• IPO NOK400m

• Merck

collaboration

• IFU Grant

NOK 24m

|

84

90 9196

104107

148-178

20

40

60

80

100

120

140

160

180

2010 2011 2012 2013 2014 2015 2020E

US EU5 Japan Pharmerging Rest of World

Global cancer drugs sales forecasted to exceed USD ~150bn by 2020

7

MARKET POTENTIAL

Overall global oncology market development

1 Across the 7 major countries of the US, France, Germany, Italy, Spain, the UK and Japan

Source: IMS Institute, Global Oncology Trend Report: A Review of 2015 and Outlook to 2020, DCAT, GlobalData

USDb

Immuno-oncology market development1)

1.4

14

34

0

5

10

15

20

25

30

35

40

2014 2019E 2024E

”

The cost of oncology drugs will exceed $150

billion (…) especially immunotherapies –

will drive much of this growth”“

- IMS Institute, Global Oncology Trend Report

USDb

|

4

8 7 7

13

19

15

34

0

10

20

30

40

2014 2015 2016 2017 2018 2019 2020 2021+

Combination treatments are driving clinical benefit & commercial opportunity

8

MARKET POTENTIAL

Multiple examples of potentially high value partnerships;

trend particularly prominent within immune-oncology▪ Expected new combination regimen launches

Source: IMS Institute – Developments in Cancer Treatments, Market Dynamics, Patient Access and Value; Business Insights - The Cancer Market Outlook to 2016, Pfizer, AstraZeneca,

ChemistryWorld, BioPharma-Reporter

"Combination treatments are becoming the

treatment of choice" - Business Insights, The Cancer Market Outlook to 2016

Expected combination regimen

launches in oncology

“Breast and haematology

combos will predominate in

the early years”

“After 2018, combos targeting

solid tumours, especially lung

cancer and melanoma, will

increase dramatically”

✓Growth expected in indications targeted by BerGenBio

|

BerGenBio is a world-leader in Axl biology and aggressive cancer

9

Source: Gjerdrum, 2010

epithelial cell

tumour cell

mesenchymal tumour cell

fibroblast

immune cell

cancer drugs

Axl- Axl+

immune escape

EMT

hostile tumour microenvironment

metastasis

drug resistance

* Epithelial to Mesenchymal Transition drives cell invasiveness, survival, drug

resistance and immune evasion

|

High Axl expression correlates with poor overall survival in most cancers

10

▪ Strong Axl expression correlates with poor survival rate ▪ Companion diagnostic

1 Gjerdrum, 2010; 2 Ishikawa, 2012; 3 Ben-Battala, 2013; 4 Song, 2010

High Axl expression1

Low Axl expression1

Breast carcinoma1

Acute Myeloid Leukaemia3 Pancreatic ductal adenocarcinoma4

Overa

ll surv

ival (%

)

Time after diagnosis (years)

Lung adenocarcinoma (NSCLC)2

|

BGB324 – First-in-class, highly selective oral Axl inhibitor

11

Investigational Medicinal Product

Patients take medicines home, one-a-day dose

3yr shelf life

Cost effective treatment

▪ Drug substanceMode of Action

Highly selective and potent

Orally bioavailable

Well tolerated: suitable for long-term therapy

Suitable for combination with existing drugs

Licensed from Rigel Inc. 2011

|

Strategic rationale for target indicationsMajor unmet need, strong scientific basis, block buster potential (~USD11Bn)

12

1) SEER Program – National Cancer Institute (National Institute of Health) http://seer.cancer.gov/; 3) Cancer.net; 4) Figure for male and female breast cancer; 5) Excluding rectum; 6) Estimates by

Alacrita Consulting

Most common tumours express high Axl levels

Head &

neck

Thyroid

Lung

Breast

Pancreatic

Renal

cancer

Ovarian

Prostate

Colon

CML

AML

61,7603

56,870

222,500

255,1804

53,670

63,990

22,440

161,360

95,5205

8,950

21,380

New incidences

in 2017 (U.S.)1

Estimated annual global market opportunity per indication6

45% of

addressable

market

45% of

addressable

market

60% of

addressable

market

60% of

addressable

market

65% of

addressable

market

~0.6

~2.3

~4.7

~1.6

~2.0

~11

AML MDS NSCLCEGFR+ve

NSCLCfirst line

TNBC Total estimatedopportunity

USDbn

|

Antibody programs

BGB149 –

Oncology

BGB601 –

Metastatic cancer (Partnered)

Discovery Pipeline – small molecule inhibitors

BGB002 – Oncology

BGB003 – Oncology

Discovery Preclinical Phase I Phase II Phase III

BGB324 – Axl kinase inhibitor

AML / MDS

NSCLC

(mutation driven)

NSCLC

(adenocarcinoma)

TNBC

13

Phase Ib / II – Single agent / Combination

Phase Ib / II – Combination with TARCEVA® (erlotinib)

Phase II Combination with KEYTRUDA® (pembrolizumab)

Phase II Combination with KEYTRUDA® (pembrolizumab)

Anti-Axl mAb

ADC

Investigator-sponsored trials

NSCLC

Melanoma

Phase II BGB324 in combination with Docetaxel

Phase II BGB324 in combination with current standard therapies, incl. CPIs

13

Strategic pipeline will drive value creation

Broad Phase II clinical trial program

14

300Patients

>2 yrTreatment

duration

50hospitals

|

Rationale for BGB324 in Lung Cancer

15

Most patients are diagnosed at late stage (IV)

70% die within 12 months / 1% 5year survival

(1) As per ASCO guidelines 2017 (2) Wilson et al. Cancer Res (2014) (2) Wilson et al. Cancer Res (2014)

BGB324 enhances the effect of chemotherapy

in animal models

Vehicle (n=6)

BGB324 (n=6)

Docetaxel (n=6)

Docetaxel + BGB324 ( n = 8)

HeLa xenograft2

BGB324 + docetaxel is a potential new

treatment regime for patients in first and

second line setting

Lung Cancer treatment depends on the type of disease

No known causeKnown, actionable

driver mutation

PD-L1 expression

>50%

Targeted

therapyKEYTRUDA

Chemotherapy

progression progression

30%18%

|

NSCLC Phase Ib: BGB324 monotherapy – clear clinical benefit

16

Overview 1 year Progression Free Survival in 25% of patients

BL= Baseline measurement

SD= Stable Disease according to RECIST1-1

UNS= unscheduled scan on 19 Jan 2017 – patient confirmed as PD following in patient hospitalisation

Sex 57 year old

Female

EGFR mutation None

#of previous

treatments

Seven

Measurable disease

with multiple

metastases

Brain lung

bone and leg

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

310-104

310-107

312-101

312-102

310-105

310-108

311-103

311-106

191 195

208203

195 196

183

172163

155

100

120

140

160

180

200

220

BL C2 C4 C6 C8 C10 C13 C14 C16 US

Duration of treatment (weeks)

SDSD

SD

SD

SDSD

SDSD

BGB324

mono-

therapy

Su

m o

f ca

nce

r m

ea

su

rem

en

ts

▪ 1 year PFS in 25%

patients

- 1 minor response

- 1 stable disease

▪ Two patients treated for

approximately 12 months

▪ Very well tolerated, patients

discontinued due to disease

progression

▪ Recommended Phase II Dose

|

NSCLC Phase Ib: Combination with erlotinib – 50% clinical benefit rate

17

Overview > 4 months Progression Free Survival in 50% of patients

Source: Byers, EORTC Nov 2016

Tumor diameter

Sex 68 Female

EGFR mutation Exon 19 deletion

# of pre-treatments Two including

progression on a

previous EGFR

inhibitor

Multiple

metastases

Stage IV

Bone and lung

Current status Ongoing, C18

25% reduction in size from baseline

BGB324

+

erlotinib

Su

m o

f ca

nce

r m

ea

su

rem

en

ts

▪ 50% CBR

- 3 SD > 4 months

- 1 minor response

▪ One patient ongoing > 15 months

▪ Very well tolerated

▪ Recommended Phase II Dose

|

Investigator-sponsored study:

Phase I/II trial in NSCLC of BGB324 with docetaxel

Patients with previously treated

advanced non-small cell lung

cancer (NSCLC) – have

exhausted all treatment

options

Sponsor Investigator: Dr David Gerber, UTSW Dallas

‘’The vast majority of my lung cancer patients progress onto chemotherapy,

combining this with BGB324 may significantly improve the performance of the

chemo and could lead to meaningful disease modification in some patients.’’

18

Patient population

Overview

One patient on treatment for 13

cycles

1 partial response (Recist 1.1)

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36

Category 1

Category 2

Category 3

Weeks

BGB324

+

docetaxel

Durable Partial response observed

|19

Hugo, 2016

Non-Responding Responding

Strong rationale for combining BGB324 with checkpoint inhibitors

Increased expression

of immune checkpoint

ligands & weakened

immune synapse

promotes immune

evasion and

resistance to CPIs

Axl expression is

upregulated in

response to

hostile tumour

microenvironment

AXL up-regulation is the greatest

change in non-responders

AXL

Inhibiting Axl

prevents and

reverses EMT,

restoring visibility

to immune system

and re-sensitises

tumours to CPIs

Drives

epithelial-

mesenchymal

transition

(EMT)

STABLE TUMOUR

AGGRESSIVE TUMOUR

Checkpoint inhibitors do not work for

all patients in all cancers

+HIGH - LOW

AXL drives immune evasion

1 2 3 4

|

BGB324/KEYTRUDA Combination Trials

• NSCLC – Phase II multi-centre study in patients with previously treated unresectable adenocarcinoma of the lung

• TNBC – Phase II multi-centre study in patients with previously treated, locally advanced TNBC.

• Biomarker studies will be conducted in parallel to support the development of companion diagnostics

KEYTRUDATM (pembrolizumab)

KEYTRUDA is a therapeutic antibody that increases the ability

of the body’s immune system to detect and destroy tumor cells.

KEYTRUDA blocks the drug target PD-1 thereby activates T

lymphocytes (CTLs)

KEYTRUDA is approved in the US for the treatment of:

• first-line treatment of metastatic NSCLC - high PD-L1 expression

• metastatic NSCLC where the tumors express PD-L1

• unresectable or metastatic melanoma

• recurrent or metastatic head and neck squamous cell carcinoma

• Hodgkin’s lymphoma

Sales of KEYTRUDA were USD 1.4bn in 2016

strong scientific rationale for evaluating BGB324 with

KEYTRUDA

▪ complementary modes of action

BerGenBio is sponsoring two Phase II clinical trials

Data expected end of 2018

27

The ONLY clinical trials globally with KEYTRUDA

addressing the fundamental mechanism behind

tumour resistance to CPIs

BIG PHARMA VALIDATION

Clinical collaboration with Merck & Co. (MSD) to evaluate BGB324 in

combination with KEYTRUDA

|

Accelerated

Patients in

pivotal trial

Patients in

safety

assessment

Program

duration

(years)

Nivolumab (Hodgkin's Disease) 95 263 4

Venetoclax (CLL with 17p deletion) 106 240 5

Alectinib (ALK + NSCLC) 225 253 4

Traditional

Cabozantinib (RCC) 658 331 11

Elotuzumab (multiple myeloma) 646 318 7

Ramucirumab (gastric cancer) 355 568 8

Companion diagnostics reduce risk, add significant clinical

and regulatory advantage

21

Source: American Association for Cancer Research, Alacrita Consulting

Potential benefits from a successful companion diagnostic

Increased

probability

of clinical

trial

success

Increased

likelihood of

accelerated

approval

with

enriched

smaller

trials

63%

28%

55%

83%

8%

76%

46%

76%

94%

26%

Ph I - Ph II Ph II - Ph III Ph III - NDA/BLA NDA/BLA -Approval

Ph I - Approval

Without biomarkers With selection biomarkers

Companion diagnostics are used to select patients that are expected to benefit from a particular drug

o Significantly increases the likelihood of a positive

response

Allows for smaller and faster clinical trials

o Significant value added to NPV calculations

Targeted therapies with patient selection diagnostic more likely to achieve a premium price

Multiple CDx development programmes ongoing

|22

Source: Abstract presentation at ASH, 2016

Prototype Companion Diagnostic

Predictive biomarker allows selection of patients that respond

Responders

Non-

responders

Patient #1 Patient #2 Patient #3

Pre-drug 21 days Pre-drug 21 days Pre-drug 21 days

Stable disease

> 4months

Stable disease

> 4months

Complete

remission

Activated Axl (pAxl) down after 21 days

Less activated downstream signalling

proteins

pAxl positive patients show

objective clinical response, as

determined by pre-treatment screen

of bone marrow

Patient #4 Patient #5

Pre-drug 21 days Pre-drug 21 days

Progressive

disease

Progressive

disease

Activated Axl (pAxl) absent pre-drug

More activated downstream signalling

proteins

Patient #6

Pre-drug 21 days

Progressive disease

|

Parallel development of companion diagnostic

A high value product in its own

23

✓✓ ✓

Axl +ve cell line Axl -ve cell line

Immunohistochemistry assay for Axl expression

H-score validation during phase II

|

BGB324 – Set to become a highly attractive and valuable asset

24

Late stage, first-in-class assets will be highly sought after

AA: Accelerated approval; BT: Breakthrough designation; PRIME: Priority Medicine status in EU

BerGenBio retains full strategic flexibility

Broad clinical application –alone and in combination

Axl inhibition: a game-changing

mechanism

Clear commercial-

isation strategy

Companion diagnostic

Axl+ tumours

Convenient administration, straight-forward manufacturing

First-in-class molecule

AA/BT/PRIME status

Clear Phase III strategy

Compelling Phase II data

BGB324

(2018)

Progress BGB324 into registration trials

Clear go to market opportunities

First-in-class drug with broad clinical

application potentially triggering interest

from bigger pharma

|

Successful IPO and broadened shareholder base

25

IPO and listing on OSE ▪ Share facts *

Completed 7 April 2017, ticker BGBIO

Raised NOK 400 million in gross proceeds

New and existing investors participated (approximately

2,000 shareholders)

Currency NOK

Market Oslo (NOK)

ISIN code NO0010650013

Ticker code BGBIO

Industry Biotechnology

Market Capitalization NOK 1.1 bn

Number of Shares 49,757,200

Number of shareholders 1,954

57 %

18 %

15 %

7 % 3 %

Long Only Family office Retail

HNW Hedge fund

▪ Shareholding by investor type in IPO

|

Key financials Q2 and 1H 2017

26

(NOK million) Q2 ‘17 Q2 ‘16 YTD ‘17 YTD ‘16 FY ‘16

Operating revenues - - - - -

Operating expenses 33.8 66.5 99.6 87.2 131.6

Operating profit (loss) (33.8) (66.5) (99.6) (87.2) (131.6)

Profit (loss) after tax (34.1) (66.2) (99.1) (86.5) (129.8)

Basic and diluted

earnings (loss) per

share (NOK)

(0.70) (225.83) (2.41) (307.27) (419.68)

Cash position end of

period440.3 105.2 440.3 105.2 161.8

Cash positionOperating loss

Cash flow

Operating expenses in Q1 2017 impacted by NOK 27.8 million (USD 3.3 million) Phase II milestone payment to Rigel Pharmaceuticals

Inc, and Q2 2016 impacted by the first instalment of the Phase II milestone

Net proceeds from the IPO approximately NOK 375 million – received in April

(70)

(60)

(50)

(40)

(30)

(20)

(10)

-Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017

(100)

(50)

-

50

100

150

200

250

300

350

400

Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017

-

50

100

150

200

250

300

350

400

450

500

Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017

|

Funded to deliver high value milestones

27

2017 2018

Phase II

Companion

diagnostic Method validation validation and collection of reference data set

BGB324

AML and MDS – Single agent / Combination

NSCLC (mutation driven) – Combination with erlotinib

NSCLC (adenocarcinoma) – Combination with KEYTRUDA

TNBC – Combination with KEYTRUDA

Ongoing

Ongoing

Phase II Clinical Data

Validated CDx

BGB149 First-in-man trials

Phase I Clinical Data

Ongoing

Manufacture and IND enabling work

|

Initiation of potential

Phase III studies

Multiple value-creating milestones 2017 – 20191

28

2017 2018 2019

Initiation Interim data Clinical data Regulatory

H1 H2 H1

BGB149

Conference

Conferences

BGB324

Phase II Phase IIAML/MDS

erlotinib

combo

NSCLC

KEYTRUDA

combo

NSCLC

Phase II

KEYTRUDA

combo

TNBC

H1 H2

Phase II Phase II Phase II

Phase II Phase II

Phase IIPhase II

IND Phase I

ASCO

AACR

World

Lung

ASH

SABCS

ASCO

AACR

World

Lung

ASH

SABCS

ASCO

AACR

Phase I

1) Progression of ongoing and start-up of new clinical trials are subject to customary regulatory reviews and approvals

|

Key progress and future milestones

29

Lung cancer (NSCLC) study with BGB324 in combination with TARCEVA opened (first and second line cohorts)

IPO – NOK 400m to fund BGB324 Phase II clinical programme, Axl CDx and BGB149 into the clinic

Data presentations at AACR and ASCO

Investigator-sponsored Phase II trial opened, first NSCLC patients dosed with BGB324 in combination with docetaxel

Investigator-sponsored Phase II trial opened, first melanoma patients dosed with BGB324 in combination with

KEYTRUDA or targeted therapy

Phase II initiated in TNBC study with BGB324 in combination with KEYTRUDA

- Sites active and patient recruitment ongoing

Phase II initiated in NSCLC study with BGB324 in combination with KEYTRUDA

- First patient dosed2H 2017

Presentation of interim data from Phase II study of BGB324 in AML/MDS 2H 2017

Presentation of Interim data from Phase II study of BGB324 in EGFR+ NSCLC 2H 2017

Initiation of Phase I for BGB149 2H 2018

Phase II Clinical proof-of-concept data from BGB324 studies

2H 2018

- AML/MDS – single agent/combination

- NSCLC (EGFR+) – combination with TARCEVA

- NSCLC (adenocarcinoma) – combination with KEYTRUDA

- TNBC – combination with KEYTRUDA

✔

✔

✔

✔

✔

✔

|

Summary and outlook

30

Multiple Phase II programmes with BGB324 in significant cancer indications are open and recruiting

Clinical collaboration with Merck.

Recent IPO provides funding for clinical and pipeline development through high-value inflection points

Strong supportive shareholder base

First-in-class drugs targeting aggressive cancers with large unmet need

Universal mechanism of action confers broad clinical potential across many tumour types

$11bn addressable market from ongoing sponsored studies

Clear strategy to develop and commercialise assets

High value, first-in-class drug candidates are attractive targets for partnering and M&A

Go-to market possibilities in enriched patient populations

Strong news flow and multiple value driving inflection points though 2018

|

Thank you.

For further information please visit

www.bergenbio.com

Developing first-in-class drugs to treat

aggressive cancer

|

Glossary

32

AA Accelerated approval

ADC Antibody drug conjugate

ALK Alkaline phosphatase

AML Acute myeloid leukemia

BLA Biologic license application

BT Breakthrough therapy

CAB Clinical advisory board

CBR Clinical benefit rate

CDx Companion diagnostic

CLIA Clinical Laboratory Improvement Amendments

CLL Chronic lymphocytic leukemia

CPI Checkpoint inhibitor

CR Complete response

CTL Cytotoxic T-lymphocytes

ECG Electrocardiogram

EGFR Epidermal growth factor receptor

ELISA Enzyme-linked immunosorbent assay

EMT Epithelial-to-mesenchymal transition

EU5 France, Germany, Italy, Spain, United Kingdom

FDA US Food and Drug Administration

GLP Good Laboratory Practice

IHC Immunohistochemistry

mAb Monoclonal antibody

MDS Myeloid dysplastic syndrome

NDA New drug application

NSCLC Non-small cell lung cancer

pAxl Phosphorylated Axl (activated Axl)

PD Progressive disease

PR Partial response

RCC Renal carcinoma

RP2D Recommended Phase II Dose

RTK Receptor tyrosine kinase

TAM Tyro, Axl, Mer (family of kinases)

TNBC Triple negative breast cancer

sAxl Soluble Axl

SD Stable disease

SoC Standard of Care

QTcF QT inverval, a measure of time in the heart’s electrical cycle