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BerGenBio

Investor Presentation Dec 14, 2017

3555_rns_2017-12-14_c8f06c2e-7bda-411d-8777-fcce40db5c63.pdf

Investor Presentation

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First-in-class medicines to treat aggressive cancers

DNB Nordic Healthcare day 2017

14th December 2017 Richard Godfrey, CEO

Disclaimer

Certain statements contained in this presentation constitute forwardlooking 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 forwardlooking 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.

Corporate snapshot

Background

Leaders in developing therapeutics

that target AXL, a protein that makes cancers and their environment highly aggressive and which is associated with poorer outcomes across many cancers

Diversified pipeline, lead drug is tested in several indications of high unmet medical need and large market potential

Promising efficacy with sustained treatment benefit and confirmed favourable safety

Companion diagnostic supported by biomarker tests

BGB324

First-in-class highly selective small molecule AXL inhibitor

Broad phase II clinical programme in NSCLC, TNBC, AML/MDS, melanoma

Pipeline

BGB324

AXL antibody

AXL ADC (partnered)

Immunomodulatory small molecules

OSE:BGBIO

Raised NOK400m in IPO on OSE in April '17

NOK1,000m market cap (Dec13th 2017)

Corporate

35 staff

Headquarters and research in Bergen, Norway; Clinical Trial Management in Oxford, UK

BerGenBio is developing AXL inhibitor drugs to treat aggressive cancers

BGB324 Phase II clinical trials AXL inhibition as cornerstone for cancer therapy

Recent highlights from clinical studies:

  • BGBC003 Leukaemia
  • BGBC004 & BGBIL005 Lung cancer

BGBC003

Relapsed & refractory AML and high risk MDS

Relapsed/refractory AML & MDS – Blood cancer, difficult to treat malignancies, predominantly elderly frail patient population.

8

Clinical Trial data for R/R AML patients from ASH December 2017

BerGenBio
BGB324
19%
37 patients
all comers,
elderly R/R patients
et al1
Pratz
TAK-659
9%
31 patients
investigational FLT-3 and SYK inhibitor
et al4
Daver
FLX925
0%
51 patients
Dual FLT3 and CDK4/6
Single agent
Dawson et al6
GSK525762
11%
46 patients
BET inhibitor
et al5
DiNardo
Ivosidenib
(AG-120)
258 patients –
selected
mutant IDH1 (mIDH1) inhibitor
30%
for mlDH1 mutation
Goldberg et al2 24 patients
Venetoclax* + hypomethylating
agent (HMA) or low dose
28%
cytarabine
(LDAC)
Combination
Rausch et al3
27 patients
Venetoclax
+ HMA or LDAC
22%

*Venetoclax + LDAC received breakthrough designation in 1st line AML (July 2017)

9 (1) ASH 2017 abstract 2622 (2) ASH 2017 abstract 1353 (3) ASH 2017 abstract 1356 (4) ASH 2017 abstract 1343 (5) ASH 2017 abstract 725 (6) ASH 2017 abstract 1377

Superior early monotherapy efficacy with favourable safety in R/R AML & high risk MDS reported at ASH 2017

19% Response Rate (CRi + PR)

• 2 CRi

• 5 PRs

An additional 7 patients were stable > 4 months

Well tolerated

Correlation with predictive biomarker candidates

BerGenBio AML blood based biomarkers predict patients benefitting from BGB324 therapy

BGBC003: Phase II trial in AML and MDS – remains ongoing.

BGBC003 Phase II – AML/high risk MDS as monotherapy and in combination with decitabine or azacitidine

BGBC005

NSCLC patients, last line setting BGB324 + chemo (docetaxel)

BGB324 + docetaxel in NSCLC patients (last line setting)

NSCLC Patients Mostly diagnosed at late stage, 70% mortality within 1y

BGBIL005 – patient population

Heavily pre-treated patient population:

  • All failed at least 1 line of chemo
  • Most received prior immunotherapy without sustained benefit
  • Most patients are metastatic
  • No more treatment options remain

Best response (CT scan every 6 weeks)

BGBIL005, Patient case # 004: PR on BGB324 + docetaxel after failure on chemo and IO

Age,
ethnicity & sex
63 year old Caucasian female
Histologic diagnosis NSCLC
Stage IV
Sites Lung, lymph,
lung metastasis
Mutations None (EGFR wt, ALK negative)
Previous lines of
therapy
CARBOPLATIN/PACLITAXEL
CARBOPLATIN/PEMETREXED
PEMBROLIZUMAB
Current status Ongoing, C5

BGBIL005, Patient case # 006: PR on BGB324 + docetaxel after failure on chemo and IO

Age,
ethnicity & sex
53 year old Asian male
Histologic diagnosis NSCLC
Stage IV
Sites Lung, lymph, liver, brain
Mutations None (EGFR wt, ALK negative)
Previous lines of
therapy
CISPLATIN/PEMETREXED
CISPLATIN
VINORELBINE
NIVOLUMAB
Current status Ongoing, C5

BGBIL005, Patient case # 002: SD on BGB324 + docetaxel after failure on chemo and IO

Age,
ethnicity & sex
75 year old Caucasian
male
Histologic diagnosis NSCLC
Stage IV
Sites Lung, lymph
Mutations CAM5.2, MIB-1
Previous lines of
therapy
CARBOPLATIN/PACLITAXEL/BEVACIZUMAB
PEMETREXED
NIVOLUMAB
Current status Off study,
alive

BGBIL005, Patient case # 005: SD on BGB324 + docetaxel after failure on chemo and IO

Age,
ethnicity & sex
63 year old Hispanic
male
Histologic diagnosis NSCLC
Stage IV
Sites Lung
Mutations None (EGFR wt, ALK negative)
Previous lines of
therapy
NIVOLUMAB/IPILIMUMAB
NIVOLUMAB
CARBOPLATIN/PEMETREXED
Current status Off study,
alive

BGBIL005: Phase I/II trial in NSCLC, BGB324 with docetaxel – remains ongoing.

BGBIL005 Phase I/II – NSCLC (2nd line – progressed/treatment-refractory disease) – Investigator-sponsored study

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."

BGB324 is an AXL inhibitor to target aggressive cancers…

Aggressive cancers

Time after diagnosis (years)

Strong AXL expression correlates with poor survival rate Broad evidence of AXL linked with poor prognosis5

Astrocytic brain tumors Melanoma
Breast cancer Mesothelioma
Gallbladder cancer NSCLC
GI Pancreatic cancer

Colon cancer
Sarcomas

Esophageal
cancer

Ewing Sarcoma

Gastric cancer

Kaposis
sarcoma
Gynaecological
Liposarcoma

Ovarian cancer

Osteosarcoma

Uterine cancer
Skin SCC
HCC Thyroid cancer
HNC Urological
Haematological
Bladder cancer

AML

Prostate cancer

CLL

RCC

CML

BGB324: selective AXL inhibitor, restores sensitivity to immune cell attack and therapy, prevents spread

BGB324 targets immunosuppression and therapy resistance

Which cancers are we targeting

Most common tumours express high AXL levels

AXL low = Higher survival; AXL high = Poor survival

Low Axl expression2

High Axl expression2

Companion diagnostic in development to identify AXL positive patients

Advancing a broad clinical development pipeline

Targeting cancers with an addressable market of USD 11bn

Most common tumours express high AXL levels

And…it's a simple pill taken once a day

BGB324 ongoing clinical trials Reporting interim response & safety data on a regular basis

Milestones 2017 & 2018

Significant value drivers expected over the next 12 months:

üInterim clinical data from 6 ph2 trials H1'18

üFinal readout from 4 phase 2 trials in H2

üInitiation of AXL antibody BGB149 clinical trials in H2

Key financials

Key Figures (NOK million) Q3 2017 Q3 2016 YTD2017 YTD2016 FY 2016
Operating revenues
Operating expenses -
36.6
-
16.3
-
136.2
-
103.5
-
131.6
Operating profit (loss) -36.6 -16.3 -136.2 -103.5 -131.6
Profit (loss) after tax -35.4 -15.4 -134.6 -101.9 -129.8
Basic and diluted earnings
(loss) per share (NOK)
-0.71 -45.64 -3.06 -339.63 -419.68
Net cash flow in the period -41.1 82.1 237.3 113.2 87.8
Cash position end of period 399.2 187.2 399.2 187.2 161.8

• OPEX sequentially increased by 8% in Q317 over Q217 as recruitment to our clinical studies is ramping up

• Robust cash position gives runway to deliver key clinical read outs on our ongoing clinical studies.

Summary and outlook / Investment case

First-in-class AXL inhibitors for aggressive cancers with addressable market in excess of \$11bn

BGB324 in multiple Phase II programmes with interim data readout @ ASCO 2018

Well resourced & experienced organisation to deliver pipeline and milestones

Clear strategy to develop and commercialise assets

Thank you.

For further information please visit www.bergenbio.com

Developing first-in-class Axl inhibitors to treat aggressive cancer

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