BerGenBio

Investor Presentation • Aug 21, 2018

BerGenBio ASA (OSE:BGBIO) Results Second Quarter 2018

21 August 2018 Richard Godfrey, CEO Rune Skeie, CFO

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.

Agenda

• 1.Introduction and Q2 2018 highlights
• 2.Advanced Lung Cancer (NSCLC): First efficacy endpoint met in phase II trial combining with KEYTRUDA
• 3.Advanced leukaemia (R/R AML/MDS): Monotherapy efficacy in a hard to treat patient population
• 4.Pipeline update
• 5.Finance report
• 6.Outlook
• 7.Q&A

Introduction & Q2 highlights

Corporate Snapshot

Focussed on AXL

Leaders in developing selective AXL inhibitors: innovative drugs for aggressive diseases, including immune evasive, drug resistant and metastatic 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

Bemcentinib*: First-in-class highly selective oral AXL inhibitor

Cash runway through to 2020

Developed as potential cornerstone of cancer therapy: NSCLC, TNBC, AML/MDS, melanoma

Included in the OSEBX index from 1st

Well funded

June 2018

Experienced Team

35 staff

Headquarters and research

in Bergen, Norway

Clinical Trial Management in Oxford, UK

Proof of Concept Phase 2 data with bemcentinib

Phase 1 clinical trial with AXL antibody & AXL ADC (partnered)

Pipeline with significant

milestones in 2018/19

Q2 2018 results

Encouraging clinical data emerging from several Phase II trials with bemcentinib

Advanced Lung Cancer (NSCLC): First efficacy endpoint met in combination with KEYTRUDA

• 9First stage fully recruited and efficacy threshold to trigger start of second stage surpassed
• 9Encouraging results observed in PD-L1 negative patients (interim data presented at ASCO)

Advanced leukaemia (R/R AML/MDS): Monotherapy efficacy in a hard to treat patient population

• 9Superior response rates observed in biomarker subgroup analysis, presented at ASCO and EHA
• 9Evidence of immune activation following bemcentinib monotherapy

Advanced Triple Negative Breast Cancer (TNBC): Negative for AXL & PD-L1, efficacy endpoint not met

Biomarker programme: Correlation reported with patient benefit

• 9Tissue: AXL IHC method reported encouraging correlation data
• 9Blood-based biomarkers: Low plasma soluble AXL predicts patient benefit in R/R AML/MDS

Pipeline development: AXL antibody preparing for phase 1 clinical trial

Corporate: Cash position NOK441m

Bemcentinib: selectively inhibits AXL kinase, this prevents immune evasion, restores sensitivity to chemo therapy and blocks spread.

Pipeline of innovative AXL inhibitors

			P l i i l r e c n c a	P h I a s e	P h I I a s e	P h I I I a s e	S t t a s u
B i i t e m c e n n	b – A X L k i n a	i h i b i t s e n o r
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	La ter l ine	P h I / I I do tax l co bo ce e m	iou ly d a dva tre te p rev s a	d N S C L C nce			ing o ng o
T N B C	d l 2n ine me tas ta t ic	P h I I K E Y T R U D A c bo om	tas ta t ic o loc l ly me r a a	dva d tr ip le n t ive bre nce eg a	t c as an ce r	( 1 )	st e S 1 r i d, 1 f f ic t t a g e e c ru e a cy d in t t t e n p o no me
Me lan om a	t & d l 1s 2n ine	P h I I ra dom ise d c bo i t h n om w / S K E Y T R U D A o T A F I N L A R M E K I N I T r	ly d iag d u new no se nre	ta b le lan sec me om a			ing o ng o
A M L / M D S	t & d l 1s 2n ine	P h I I m t her d c bo i t h on o ap y an om w low dos hem e c o	A M L o iou ly tre r p rev s a	te d M D S u f i t for in ten ive n s	he c mo		Pa A i d / io R R; t t r re c ru e su p e r r Pa t B ing r o ng o
A t i b d n o p r y	o g r a m m e s
B G B 1 4 9	log on co y		An t i- A X L m A b				P ha 1 Y E 1 8 s e
B G B 6 0 1	tas ta t ic c me	an cer	A D C			( ) 2	Ou l ic d t- e ns e
C i o m p a n o n	D i t i a g n o s c s	P i l i p e n e	B i k D i o m a r e r s c o v e	B i k r y o m a r	f V i i t i e r e r c a o n	V l i d t i a a o n
t iss & b loo d ue						C la t io i t h e f f ic t d o rre n w a cy re p o r e
			G B B i e r e n o s p o n	d t d I s o r e s u y n	i t t v e s g a o r s p o n s o r	d d t e s u y

(1): Clinical trial collaboration, no preferential rights (2): out licensed

AXL inhibition as cornerstone for cancer therapy: bemcentinib proof-of-concept Phase II clinical trials

H2 2018 News flow

Sep 2018: World Conference of Lung Cancer (WCLC) Update on BerGenBio lung cancer trials

Oct 2018: European Society for Medical Oncology meeting (ESMO) Biomarker update

Dec 2018: BGB149 Phase I clinical trial (anticipated)

Nov 2018: Society for Immunotherapy of Cancer (SITC) meeting (anticipated)

Dec 2018: American Society for Hematology (ASH) meeting (anticipated)

Advanced Lung Cancer (NSCLC)

Lung Cancer

12

The largest cancer killer globally

• ¾> 1.8 million new cases/yr worldwide1
• ¾> 1.5 million lung cancer deaths/yr worldwide1

85% cases are non-small cell lung cancer (NSCLC), mostly:

• ¾Adenocarcinoma (40% of all lung cancers)3
• ¾Squamous cell carcinoma (25-30% of all lung cancers)3

Drug therapy is the only option for most patients, with little benefit:

• ¾> 50% of cases detected late and can thus not be treated with surgery alone2
• ¾5 year survival < 5% for cases detected late2

Large growing market driven by targeted therapies & immuneoncology

• ¾> \$35bn global lung cancer market (in 2023)4
• ¾NSCLC has 80% share (of total lung cancer market )4

Potential for bemcentinib to become a cornerstone therapy for lung cancer (NSCLC)

• • Lung cancer is the most frequent cause of cancer-related death in developed countries

• • Strategy to position bemcentinib as the cornerstone of treatment for NSCLC by combining with standard of care therapies

• 9Combination with Chemo drugs

• 9Combination with Targeted drugs
• 9Combination with KEYTRUDA

The development of immune checkpoint inhibitors in NSCLC: KEYTRUDA emerged as the SOC for PD-L1 positive NSCLC

(1) KEYNOTE-001: Garon et al, NEJM (2015); previously treated NSCLC patients (2) KEYNOTE-024: Reck NEJM (2016) (3) KEYNOTE-010: Herbst Lancet (2016) * randomised control with SOC chemo and ** PD-L1 expression given as tumor proportion score; reference: Garon NEJM (2016), Patient disposition: Fugure S4; response according to biomarker status (previously treated patients only):Table S7

Strategy to develop bemcentinib in combination with KEYTRUDA in NSCLC patients, with the objective to enlarge the addressable patient population and offer a chemo free combination option

BGBC008 interim data reported at ASCO 2018

Encouraging interim efficacy data

• 9 8 out of 15 patients reported tumour shrinkage by radiographic evaluation (ASCO)
• 9 4 PRs (RECIST v1.1; June 26th announcement)
• 9 Durable responses, many patients remain on study.

Results particularly promising in PD-L1 negative patients

9 Encouraging efficacy in 7 PD-L1 negative patients (ASCO):

¾ 2 PRs (2/7 = 29%) ¾4 SDs (4/7 = 57%)

¾1 PD (1/7 = 14%)

Data subject to ongoing analysis

Comprehensive analysis of stage 1 will be presented at future medical congresses

Increasing the number of cancer patients who respond to KEYTRUDA without combining with chemo is a major opportunity

Ca 40%1 of patients are PDL-1 negative

PDL-1 negative patients do not benefit from KEYTRUDA monotherapy

Opportunity to increase addressable market by adding bemcentinib

Data subject to ongoing analysis. Comprehensive analysis of stage 1 will be presented at future medical congresses

Advanced leukaemia (R/R AML/MDS): Monotherapy efficacy in a hard to treat patient population

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

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BerGenBio

Evaluation of bemcentinib as a single agent and in combination with SOC low dose chemotherapy (LDCT) in relapsed/refractory (R/R) AML or MDS patients

BGBC003: all comer, R/R AML or high-risk MDS patients unfit for intensive chemotherapy

Bemcentinib +/- LDCT

Sub-group analysis: Efficacy according to plasma soluble AXL (sAXL; and others)

Strategy for randomised and pivotal trials

Programme key points

• 9 4 arm study:
• ¾MDS – 2L monotherapy
• ¾ AML
  • •2L monotherapy
  • •1L/2L combo with azacitidine
  • •1L/2L combo with decitabine
• 9Monotherapy efficacy demonstrated
• 9 Predictive biomarker candidate identified: sAXL, measured in blood (non-invasive liquid biopsy)
• 9 Immune activation observed following bemcentinib monotherapy

ASCO: Strong efficacy seen in AML patients with low plasma soluble AXL (sAXL)

ASCO: Strong efficacy seen in MDS patients with low plasma soluble AXL (sAXL)

ASCO: Superior efficacy in patients with low sAXL

ORR in R/R AML & MDS patients Bemcentinib compared to another experimental drug

Soluble AXL biomarker (sAXL): measured in blood (non-invasive liquid biopsy)

Venetoclax: oral BCL-2 inhibitor approved for CLL. Received recent attention for encouraging monotherapy efficacy in R/R AML unfit for intensive. Breakthrough designation for 1L AML in combo with LDCT; not approved in R/R AML

23

AXL inhibition as cornerstone for cancer therapy: bemcentinib proof-of-concept Phase II clinical trials

Pipeline update: Translating leadership in understanding AXL biology into a diversified portfolio of novel AXL inhibitors

BGB149: AXL function blocking antibody drug

• ü First in class anti AXL monoclonal antibody
• ü Phase I clinical trial anticipated YE'18
• ü Wholly owned asset
• ü Board and long IP coverage
• ü Potent molecule and differentiated clinical position

BGB601 (ADCT-601): AXL Antibody Drug Conjugate

AXL antibody Drug Conjugate (ADC)

Targeted killing of AXL expressing tumour cells

Outlicensed to ADC Therapeutics (Switzerland)

Begin of clinical trial will trigger milestone payment by ADCT to BerGenBio

AACR (April '18)1:

Preclinical data on safety, tolerability and in vivo antitumour activity demonstrated (renal, breast, pancreatic), supports anticipated clinical development

Financial review: Cash position strengthened

Rune SkeieCFO

Operating profit (loss)

• Q1'18 increase in operating loss associated with increased social security tax provision (no cash effect) related to share price and share option scheme (NOK 8,4 million)

Operating expenses Q2 2018

• •Effective organisation
• • 77,3% (YTD 71,2%) of operating expenses in Q2 2018 attributable to R&D activities

•Private placement completed in April 2018 - gross fund raise NOK 187,5 million

Cash position

• •Gross fund raise NOK 187,5 million completed in April – strengthening cash position
• •Shareholder base broadened with addition of US-based specialist healthcare funds
• Cash position gives runway to deliver key clinical read outs on ongoing clinical studies
• •Cash runway into 2020 based on current burn rate

Summary & Outlook: A number of significant milestones expected in H2 2018 and 2019

Richard Godfrey

CEO

Significant milestones expected in 2018 & 2019

Significant milestones expected in H2 2018

Bemcentinib

NSCLC KEYTRUDA combo: presentation of completed stage 1 data and initiate stage 2

BGB149

AXL antibody BGB149: begin phase I clinical trial

Focused on developing innovative drugs for aggressive diseases

Selective AXL inhibitors: a novel cornerstone approach to target immune evasive, drug resistant and metastatic cancers

Promising interim clinical data from broad phase II programme with bemcentinib, selective AXL inhibitor Interim data from ongoing phase II trials supporting proof of concept for bemcentinib to become a cornerstone of cancer therapy

Positioned to deliver significant value inflection points over the next 18 months

• •Key read-outs from phase II trial PoC programme with bemcentinib in NSCLC, AML/MDS and melanoma
• •Start first in man phase I clinical trial with BGB149, anti AXL antibody
• •Start randomised phase II programme with bemcentinib in target indications

Anticipated cash runway into 2020 based on current burn rate

Included in the OSEBX index from 1st June 2018

Thank you for your attention

Appendix

Condensed consolidated statement of profit and loss and other comprehensive income

( N O K 1 0 0 0 ) Un d i te d au	No te	Q 2 2 0 1 8	Q 2 2 0 1 7	Y T D 2 0 1 8	Y T D 2 0 1 7	Fu l l y ea r 2 0 1 7
Re ve nu e		0	0	0	0	0
Ex p en se s
Em loy be f i t e p ee ne xp en se s	3	6 3 0 0	5 8 9 5	2 1 9 7 2	1 2 1 8 9	2 8 8 2 7
De ia t ion p rec		5 4	5 1	1 0 8	1 0 1	1 9 3
O t he t ing r o p era ex p en se s	6	4 4 3 7 8	2 7 8 9 9	8 3 4 3 3	8 7 3 4 5	1 5 4 6 8 6
To ta l o t ing p er a ex p en se s		0 3 2 5 7	3 3 8 4 6	1 0 1 3 5 5	9 9 6 3 5	1 8 3 0 7 7
Op ing f i t t er a p ro		0 3 2 -5 7	3 3 8 4 6 -	1 0 1 3 5 5 -	-9 9 6 3 5	-1 8 3 0 7 7
F ina inc nc e om e		1 6 2 2	5 4 1	2 6 6 8	1 6 6 0	4 1 6 8
F ina nc e e xp en se		1 2 8	7 7 8	1 7 2	1 1 7 3	2 6 6 8
F ina ia l i tem t nc s, ne		1 4 9 5	2 3 6 -	2 4 9 6	4 8 7	1 5 0 0
f for Pr i t be tax o e		-4 9 2 3 8	3 4 0 8 2 -	1 0 3 0 1 7 -	-9 9 1 4 8	-1 8 2 2 0 7
Inc tax om e ex p en se		0	0	0	0	0
Pr f i t a f ter tax o		-4 9 2 3 8	3 4 0 8 2 -	1 0 3 0 1 7 -	-9 9 1 4 8	-1 8 2 2 0 7
O t he he ive inc r c om p re ns om e I tem h ic h w i l l n t be las i f ie d o f i t a d s w o re c s ve r p ro n los s
Ac ia l g ins d los de f ine d be f i tua t r a an se s o n ne ion lan p en s p s		0	0	0	0	0
To ta l c he ive inc for t he io d om p re ns om e p er		4 9 2 3 8 -	3 4 0 8 2 -	1 0 3 0 1 7 -	-9 9 1 4 8	-1 8 2 2 0 7
Ea ing ha rn s p er s re :
Ba ic a d d i lu te d p ha s n er s re -	7	-0, 9 2	-0, 7 0	-1, 9 9	-2, 4 1	-4, 0 1

37View Q2 2018 report for notes: http://www.bergenbio.com/investors/reports/quarterly-reports/

Condensed consolidated statement of financial position

	No te	3 0 J U N 2 0 1 8	3 0 J U N 2 0 1 7	3 1 D E C 2 0 1 7
( O ) N K 1 0 0 0 Un d i te d au
A S S E T S
No t a ts n-c urr en ss e
Pro lan d e ip ty, t a t p er p n q u me n		1 8 5	4 6 7	5 5 7
To l n ta t a ts on -cu rre n ss e		5 1 8	4 6 7	5 5 7
Cu t a ts rre n ss e
O he t t a ts r c urr en sse	8 5,	1 4 1 3 5	1 6 2 5 5	1 3 4 3 0
Ca h a d c h e iva len ts s n as q u		4 4 1 2 6 3	4 4 0 3 0 0	3 0 3 0 7 5
To l c ta t a ts urr en ss e		4 3 9 8 5 5	4 6 8 2 5 5	3 8 3 8 0 7
T O T A A S S E T S L		4 9 1 5 5 7	4 3 1 9 5 7	3 8 4 3 3 6
E Q U I T Y A N D L I A B I L I T I E S
Eq i ty u
Pa i d in i l ta ca p
S ha i l ta re ca p	9	4 1 5 7	4 9 4 7	4 9 9 2
S ha ium re p rem	9	3 9 8 2 1 5	4 0 6 3 0 1	3 2 0 1 8 5
O he i d in i l t ta r p a ca p	4, 9	2 0 6 8 7	1 8 9 6 9	2 0 3 4 0
To l p i d in i l ta ta a ca p		4 2 4 6 8 7	4 3 0 2 4 5	3 0 3 0 5 5
To l e i ta ty q u		4 2 4 6 8 7	4 3 0 2 4 5	3 0 3 0 5 5
No l ia b i l i ies t t n-c urr en
Pe ion l ia b i l i ty ns	1 0	0	0	0
To ta l n t l ia b i l i t ies on -cu rre n		0	0	0
Cu l ia b i l i ies t t rre n
Ac b le ts co un p ay a		1 6 6 4 6	1 0 8 2 6	2 1 5 7 5
O he l ia b i l i ies t t t r c urr en		4 4 3 5	1 2 6 0 5	9 3 9 1
Pro is ion v s		9 1 0 5	3 6 4 3	3 0 2 0
To l c l ia b i l i ies ta t t urr en		3 1 2 3 8	2 0 4 7 7	3 3 9 8 6
To ta l l ia b i l i t ies		3 1 2 3 8	2 0 4 7 7	3 3 9 8 6
T O T A E Q U I T Y A N D I A B I I T I E S L L L		4 9 1 5 5 7	4 3 1 9 5 7	3 8 4 3 3 6

View Q2 2018 report for notes: http://www.bergenbio.com/investors/reports/quarterly-reports/

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited	Note	YTD 2018	YTD 2017
Cash flow from operating activities
Loss before tax		$-103017$	-99 148
Non-cash adjustments to reconcile loss before tax to net cash flows
Depreciation of property, plant and equipment		108	101
Calculated interest element on convertible loan		0	0
Share-based payment expense	3, 4	347	944
Movement in provisions and pensions		6 1 3 0	$-1200$
Working capital adjustments:
Decrease in trade and other receivables and prepayments		$-705$	-4 250
Increase in trade and other payables		$-8878$	7 008
Net cash flow from operating activities		$-106015$	-96 545
Cash flows from investing activities
Purchase of property, plant and equipment		$-70$	-159
Net cash flow used in investing activities		-70	-159
Cash flows from financing activities
Proceeds from issue of share capital	9	176 998	375 020
Paid in, not registered capital increase	9	0	159
Net cash flow from financing activities		176 998	375 179
Net increase/(decrease) in cash and cash equvivalents		70914	278 475
Cash and cash equivalents at beginning of period		370 350	161 825
Cash and cash equivalents at end of period		441 263	440 300

View Q2 2018 report for notes: http://www.bergenbio.com/investors/reports/quarterly-reports/

Clinical trial update bemcentinib