BerGenBio ASA (OSE:BGBIO) Results Third Quarter 2018

13 November 2018 Richard Godfrey, CEO Rune Skeie, CFO

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Agenda

1. Introduction and recent highlights
2. Advanced Lung Cancer (NSCLC):
Extended progression-free-survival in AXL positive patients on phase II trial with bemcentinib + KEYTRUDA (anti-PD-1 therapy)
Extended progression-free-survival in patients on phase II trial with bemcentinib + TARCEVA (anti-EGFR therapy)
Encouraging efficacy in combination with docetaxel
3. Investigator initiated trial programme will explore additional opportunities for bemcentinib
4. BGB149 anti-AXL antibody will enter first in human clinical trials in Dec 2018
5. Finance
6. Outlook

Introduction & recent 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

Developed as potential cornerstone of cancer therapy.

Well funded

Cash runway through to 2020

Included in the OSEBX index from 1st June 2018

Proof of Concept Phase 2 data with bemcentinib

Phase 1 clinical trial with AXL antibody

Experienced Team

38 staff

Headquarters and research in Bergen, Norway

Clinical Trial Management in Oxford, UK

Q3 2018 results

Efficacy reported in several Phase II trials with bemcentinib

Bemcentinib + KEYTRUDA 2L (BGBC008): Superior PFS & 40% response rate in AXL positive patients

ü Median PFS of 5.9 months reported in AXL positive patients vs 3.3 months in AXL negative (late-breaking abstract at SITC)
ü 40% ORR in AXL positive, predominantly PD-L1 negative/low patients (KEYTRUDA monotherapy effect is limited)
ü Stage 2 is actively recruiting and enrolling patients

Additional advanced NSCLC phII trials: Superior PFS in combo with TARCEVA

ü First line PFS prolonged by adding bemcentinib to TARCEVA, predictive biomarker candidate
ü Encouraging efficacy in combination with docetaxel in later line setting, overall well tolerated

Bemcentinib biomarker programme: Biomarker candidates identified across phase II trial programme

ü Strong correlation with tissue AXL status in NSCLC (bemcentinib + KEYTRUDA)
ü Strong correlation with soluble AXL status in AML/MDS (bemcentinib monotherapy)
ü Additional soluble markers identified across additional indications and drug combinations

Pipeline of innovative AXL inhibitors: AXL function blocking antibody BGB149 on track for FiH trials

ü IND filed, phase I trial to be initiated at the end of Q4

Cash position NOK398m, tight cost control. Cash to complete all ongoing clinical trials.

AXL receptor tyrosine kinase drives aggressive disease including therapy resistant, immune-evasive tumours

Drives tumour cell plasticity: non-genetic resistance mechanism

AXL drives features of aggressive cancer:

Acquired therapy resistance
Immune escape
metastasis

Key suppressor of innate immune response

AXL is an innate immune checkpoint:

M1 to M2 macrophage polarisation
Decreased antigen presentation by DCs
Immunosuppressive cytokine profile

very low expression under healthy physiological conditions (ko mouse phenotypically normal)

overexpressed in response to hypoxia, immune reaction, cellular stress / therapy

overexpression correlates with worse prognosis in most cancers

Phase II Proof of Concept data - Focus on NSCLC & leukaemia

Bemcentinib as cornerstone for cancer therapy: Phase II proof-of-concept development programme

Bemcentinib as a foundation therapy

Strong biomarker correlation

Approximately half of previously treated NSCLC patients had AXL positive disease

Plasma shed AXL (sAXL) levels are inversely correlated to receptor activity

(part A, n = 20 pts evaluable for sAXL status)

Additional predictive soluble and tissue markers identified & under investigation

Upcoming data & clinical milestones

Non-small Cell Lung Cancer (NSCLC)

Bemcentinib is being combined with the major therapy classes to treat advanced NSCLC

Lung Cancer: rapidly evolving standard of care… - but still lacking effective chemo free regimens

The largest cancer killer, most patients depend on drug therapy

Ø More than 1.76 million lung cancer deaths/yr worldwide1

NSCLC standard of care (SoC)

Rapidly emerging SoC creates opportunities for effective, chemo free second line combinations

Ø Most patients will start on Anti-PD-1 + chemo in first line
Ø Vacuum in second line, effective chemo free regimens needed

(Immuno)therapies are measured by their ability to prolong life

To help patients live longer, therapies need to both initially limit tumour growth and this benefit should be sustained over time

Ø ORR determines initial control of the tumour
Ø Patients with objective response and those with stable disease are equally likely to become long term survivors

Only the new immunotherapies lead to a lasting benefit: need to evaluate survival data

Ø Although initial responses are similar, only immunotherapy leads to improved survival
Ø Need for therapies that counteract resistance

BGBC008: Combination studies with KEYTRUDA

BGBC008 Phase 2 – Adenocarcinoma of the lung
Previously treated, unresectable	Simon two stage		Status Nov 2018
adenocarcinoma of the lung	Single arm	ORR	ü Stage 1: 24 patients dosed Ø 1st efficacy endpoint met
up to 48 pts any PD-L1 expression any AXL expression no prior IO	bemcentinib 200mg/d KEYTRUDA 200mg/3w		Ø 40% ORR in AXL positive patients Ø 27% ORR in PD-L1 negative patients Ø Ca. 6 months PFS in AXL positive patients ü Stage 2 open and actively recruiting

Biomarker analyses reveal predominantly PD-L1 low/negative patient population, half are AXL positive

In AXL positive patients, the bemcentinib + KEYTRUDA combination is better than KEYTRUDA monotherapy*

Median PFS in all AXL positive patients was 5.9 months: approximately 80% improvement over AXL negative disease (mPFS 3.3 months) Progression Free Survival: 5.9 months in AXL positive vs 3.3 in negative patients (ca 80% improvement)

Median PFS in AXL positive patients with negative to weak PD-L1 expression (TPS 0-49%) is 7.9 months (ongoing): benefit in AXL positive patients not driven by high PD-L1 expression Comparison of bemcentinib combination data (BGBC008) with selected anti-PD-1 monotherapy trial results

Trial	PD-L1 status		ORR (%)	PFS (months) Median (95% CI): 7.9 months, ongoing (3.0-NR), n =7
0.8	Mostly (75%	AXL+	40	5.9
without disease progression BGBC008	of patients) 0 – 49%	AXL-	9	3.3
0.6 Keynote	0 %		9	2.1
0011 0.4	1 – 49 %		14	2.3
% of patients on trial CheckMate 0572 0.2	0 – 100 %	reference values: pembrolizumab monotherapy mPFS ca 2.1 months in previously treated PD-L1 negative or weak positive patients	19	BGBC008 clinical study, stage 1: 2.3 bemcentinib + pembrolizumab mPFS: 7.9 months (ongoing) in previously treated AXL positive,

BGBC004: Phase Ib/II trial in NSCLC of bemcentinib with TARCEVA (erlotinib) ®

	Dose escalation & expansion (ongoing)			September 2018 Status
Stage IIIb or IV disease EGFR mutation positive	Phase Ib	Heavily pre-treated Arm A1: bemcentinib monotherapy Arm A2: Dose finding in combination	Safety & efficacy	Arm A1 - monotherapy: 25% CBR ü 2 SD including tumour shrinkage (19%) n=8 Arm A2– combination with erlotinib: 50% CBR ü 1 PR and 3 SD n=8. PR ongoing in excess of 2 years
	Phase II	Arm B: 2nd line Resistance reversal bemcentinib 200mg daily + erlotinib daily		Arm B – 2L / combo w/ erlotinib: 33% CBR ü First efficacy endpoint met 1 PR & 2 SD n=9
	Phase II	Arm C: 1st line Resistance prevention bemcentinib 200mg daily + erlotinib daily		Arm C – resistance prevention combo w/ erlotinib: ü PFS has surpassed that of erlotinib (TARCEVA) alone, currently 11.4 months and further maturing

Bemcentinib and TARCEVA combination extended PFS compared to TARCEVA monotherapy (historical data)

Progression Free Survival

Comparison of bemcentinib combination data (BGBC004) with TARCEVA alone

Trial	PFS (months)
BGBC004	11.4 (further maturing)
TARCEVA	10.41

BGBIL006: Phase Ib/II trial with bemcentinib and docetaxel in NSCLC

Sponsor Investigator: Dr David Gerber, UTSW Dallas

"It is important to remember that most patients with lung cancer will eventually be treated with chemotherapy and for most patients, the benefit from chemotherapy is suboptimal."

Patient 004

Majority of patients experience benefit, including PRs Includes patients with primary and acquired resistance to CPIs

Best % Change in Sum of Target Lesions

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

Company anticipates to update the market with proposed rPh2 strategy towards the end of 2018

	Targeted therapy	PD-1 blockade	Chemotherapy
	Bemcentinib	PoC phase II programme
bemcentinib single arm POC	BGBC004 Reverse (2L) and prevent resistance (1L) to EGFR targeted therapy (Tx)	BGBC008 Increase response rate - especially in PD-L1 negative	BGBIL005 Increase response rate
		Strategic considerations for randomised phase II programme based on phase II PoC
Bemcentinib ranodmised combos	1L • First line Tx +/- bemcentinib 2L • non-mutation driven resistance to Tx	1L • CT free combo (incl. PD-L1 neg) • Add to Pt CT 2L • Add to IO upon progression	2L • Combo with docetaxel in IO / Pt CT / Tx progressors

BerGenBio Investigator led programme: explore additional opportunities for bemcentinib

New Investigator Sponsored Trials in start up stage

Randomised phI/II in pancreatic cancer Phase II in mesothelioma

Randomised trial combining bemcentinib with nab-paclitaxel, gemcitabine and cisplatin chemotherapy combo in advanced pancreatic cancer

Sponsor: UT Southwestern, Dallas, TX, Dr Muhammad Beg

Supported by:

Phase II study combining bemcentinib with KEYTRUDA in malignant mesothelioma

AXL mAb – clinical trials start Dec 2018

BGB149: AXL function blocking antibody programme

AXL functionally blocking human antibody

Highly selective to human AXL High affinity (KD: 500pM)

robust, scaleable manufacturing process good titre and yield

Strong patent position on CDR sequences

Anti-tumour MoA and efficacy demonstrated (AML, NSCLC, pancreatic)

Robust GMP manufacturing process established and phase I first-in-man clinical studies starting in Q4 2018

Scale: current GMP manufacturing scale was 250L (bulk drug substance)
Cell banks: MCB & WCB characterised and laid down
Stability: current drug substance has 18 month stability at <-60 degrees C.
Toxicity: GLP toxicity reported no major concerns
CTA filed

Corporate update: Building the organisation – to prepare for the next stage

Leadership team strengthened with key appointments

• Mike Rogers HR Director

Ø 20 years strategic HR in biotech and biopharma, economist from Edinburgh University
Sonia Rodrigues PhD Director of Regulatory Affairs
Ø 10 years regulatory affairs with AbbVie, Takeda, Amgen, Merck Serono
Tone Bjaaland PhD Director of Clinical Operations
Ø 25 years clinical operations with Eisai, Takeda, Shire

Arbitration to Rigel Pharamaceuticals, Inc – in-license partner

Sep 13 2018: BerGenBio served Notice of Arbitration to Rigel pursuant to a License Agreement for bemcentinib made and entered into as of 29 June 2011
A dispute has arisen between the two companies with respect to the interpretation and application of certain provisions of the Agreement, particularly as they relate to the rights and obligations of the parties in the event of the licensing or sale of a Product(s) by BerGenBio and/or the sale of BerGenBio to a third party
Parties agreed to a binding arbitration to be completed within 180 days of commencement

Financial review: Good financial position and cost control

Rune Skeie CFO

Operating profit (loss)

Operating profit (loss) million NOK

Q3'18 decrease in operating loss associated with stage 1 of NSCLC study in combination with Keytruda meeting its clinical efficacy endpoint in Q2, requiring a 12 week safety review and therefore reduced spend in Q3. Stage 2 opened in Q4.
In addition increased cost reduction by grants:

Approval tax refund (Skatte funn) cost reduction in Q3´18 NOK 5.1 mill (Q3´17 NOK 2.3 mill) Other grants Q3´18 NOK 3.3 mill (Q3´17 NOK 0.5 mill)

Effective organisation
75.3% (YTD 72.3%) of operating expenses in Q3 2018 attributable to Research & Development activities

Cash flow and cash position

Private placement Q2,18 strengthened cash position - gross funds raised NOK 187.5m
Quarterly cash burn average at NOK 44.8m
Cash position gives runway to deliver key clinical read outs from 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

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 Ph II clinical data in NSCLC and Leukaemia

Selected for high profile presentations at global medical conferences

Significant milestones in the next 12 months

Additional 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