BerGenBio

Earnings Release • Feb 12, 2019

BerGenBio ASA (OSE: BGBIO) Results Fourth Quarter & FY 2018

12th February 2018 Richard Godfrey , CEO Rune Skeie, CFO

Disclaimer

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Introduction & recent highlights

BGBIO – Investment Highlights

Ph2 data in AML & NSCLC with selective AXL inhibitor bemcentinib

Monotherapy and combinations with immune-, targeted and chemotherapies

Biomarker correlation across programme, parallel CDx development

AXL positive patients: 43% ORR in R/R AML/MDS (monotherapy) 40% ORR in 2L NSCLC (KEYTRUDA combo)

Late stage clinical trials to start H2'19

Resourced to deliver significant milestones

Clinical trial collaborations with Merck and leading academic centres

AXL antibody out licensed to ADC Therapeutics SA

38 staff at two locations: HQ & R&D in Bergen, Norway; Clinical Development in Oxford, UK

Cash NOK360m

Agenda

• 1. Introduction and recent highlights
• 2. Bemcentinib: First-in-class highly selective AXL inhibitor in Phase II
• 3. Clinical Development Opportunities
• 4. BGB149 – Anti AXL monoclonal antibody in Phase I
• 5. Finance
• 6. Outlook

Q4 2018 Highlights

Bemcentinib monotherapy & combo in AML/MDS (BGBC003): PoC monotherapy data reported at ASH, combination studies ongoing

Bemcentinib + KEYTRUDA® in NSCLC (BGBC008): Selected as late-breaking abstract for SITC – PoC phase II data (stage 1)

Bemcentinib biomarker programme: Selected for poster discussion at ESMO

Strengthened clinical development team

Post-period updates: BGB149 (AXL antibody) and ADCT-601 (partnered AXL ADC): start phase I trial

Increasing profile and recognition of bemcentinib at international clinical congresses in 2018

Key data presented in Q4 supports future strategy for late-stage clinical development of bemcentinib in AML/MDS and NSCLC

ASCO-SITC: Clinical Immuno-Oncology symposium, San Francisco ASCO: American Society of Clinical Oncology, Chicago WCLC: World Conference of Lung Cancer, Toronto ESMO: European Society of Medical Oncology, Munich

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AACR: American Association for Cancer Research, Chicago EHA: European Hematology Association, Stockholm SITC: Society for Immunotherapy of Cancer, DC ASH: American Society for Hematology, San Diego

AXL drives aggressive cancer

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

Drives tumour cell plasticity: non-genetic resistance mechanism

Key suppressor of innate immune response

AXL drives features of aggressive cancer:

• Acquired therapy resistance
• Immune escape
• Metastasis

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

Three AXL-targeting drug candidates in clinical development

Clinical development programmes of AXL inhibitors

> 350 patients at 50 sites across Europe and USA

		Preclinical	Phase I	Phase II	Phase III	Status
	Selective AXL kinase inhibitors
	Bemcentinib: selective oral small molecule AXL inhibitor
	NSCLC + KEYTRUDA (2L, IO naïve)	previously treated advanced adenocarcinoma of the lung			(1)	Stage 1 complete, 40% ORR in AXL+; stage 2 ongoing
	NSCLC + TARCEVA (1L & 2L)	advanced NSCLC with activating mutation of EGFR				Fully recruited, 1st efficacy endpoint met
	NSCLC + docetaxel (later line) (2)	previously treated advanced NSCLC				ILS, ongoing – latest update WCLC 2018
	AML single agent + low dose chemo (1L & 2L)	AML or previously treated MDS unfit for intensive chemo			Mono: 43% ORR in AXL+ R/R AML/MDS; decitabine combo completed recruitment
	ILS programme in additional oncology indications (2)	Melanoma, mesothelioma, pancreatic, glioblastoma, MDS				Portfolio of ILS, ongoing & in set-up
	Fibrosis – preclinical	IPF, NASH				Pre-clinical work published throughout 2018
	BGB149: anti-AXL mAb
	Healthy volunteers – phase 1a dose escalation	Healthy volunteer SAD
	BGB601: AXL ADC outlicensed
	Metastatic cancers	First-in-man solid tumours	Out-licensed	to
	Companion Diagnostics Pipeline	Biomarker Discovery		Biomarker Verification	Validation
Tissue AXL Soluble AXL Additional soluble markers		targeted and immunotherapy	Correlation with benefit from monotherapy, combo with			Correlation with efficacy reported

Summary of Phase II PoC data with bemcentinib (Focus on NSCLC & leukaemia)

Associate Professor Dr David Gerber, UTSW Dallas, TC, lead PI BGBIL005

Bemcentinib PoC data summary: Monotherapy and combinations

Bemcentinib: once-a-day AXL inhibitor

Highly selective, orally bioavailable small molecule, administered once a day, in phase II clinical trials

Blocks AXL signalling, reverses aggressive tumour traits & counteracts immune escape

Clinical PoC in AML and NSCLC as a monotherapy and in combination

Correlation of clinical efficacy with AXL biomarkers observed

Excellent clinical safety profile

Randomised, late stage clinical trials planned to start in H2 2019

Ref. BGBC003 / NCT02488408

Acute Myeloid Leukaemia (AML) & Myelodysplastic Syndrome (MDS)

Bemcentinib is being evaluated as a monotherapy and in combination with standard of care to treat AML and high-risk MDS

43% ORR in AXL +ve R/R AML and MDS patients chemo combos in 1L ongoing

MDS & AML: Disease characteristics

New strategies to treat older & relapsed/ refractory patients is an urgent, unmet need

Myelodysplastic syndromes (MDS)

(pre-leukaemia or smoldering leukaemia)

Occurs when the blood-forming cells in the bone marrow (the soft inner part of certain bones, where new blood cells are made), become abnormal. This leads to low numbers of one or more types of blood cells.

~ 40,000 new cases per year (U.S. only)3

Most diagnoses made in 70s or 80s1

MDS 40% risk of developing into AML.4

Acute Myeloid Leukaemia (AML)

Cancer of the myeloid line of blood cells, characterized by rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cells

~ 20,000 new cases

diagnosed and >10,000 deaths (2018, U.S.)2

Most common type of acute leukaemia in adults1

AML & MDS – difficult to treat malignancies, predominantly elderly frail patient population.

AML & MDS – difficult to treat malignancies, predominantly elderly frail patient population.

Phase II trial in AML/high risk MDS: monotherapy and combination with LDCT*

Summary results slide and next steps

Status Jan '19

Summary results Next steps

• Monotherapy cohort complete
• 43% ORR in AXL positive patients
• Excellent safety

• Evidence of immune activation

• Chemo combinations ongoing Ø Top line data Q1'19

• Comprehensive analysis anticipated at ASCO/EHA '19

Monotherapy shows promising efficacy in comparison to approved & emerging regimens

	Regimen	0,0 % 10,0 %	Overall response 20,0 %	30,0 % 40,0 %	50,0 %	Patient population	Mechanism of action	Administration	Source
	Bemcentinib (Phase II)			42,8 %		low soluble AXL	selective AXL inhibitor	oral, once-daily	Loges et al, ASH 2018
	Enasidenib (APPROVED)			40,3 %		IDH2 mutation	IDH2 inhibitor	oral, once-daily	FDA label, prescribing info
Approved, limited pt	Ivosidenib (APPROVED)			41,6 %		IDH1 mutation	IDH1 inhibitor	oral, once-daily	FDA label, prescribing info
populations only	Gilteritinib (APPROVED)		21,0 %			FLT3 mutation	FLT3/AXL inhibitor	oral, once-daily	FDA label, prescribing info
	Gemtuzumab ozogamicin (APPROVED)		26,0 %			CD33-positive (reported CR only)	CD33-directed antibody drug conjugate	injection, days 1, 4 and 7	FDA label, prescribing info
Emerging	Quizartinib (Phase III)	48,0 % 19,0 %	FLT3-ITD-positive	FLT3-ITD inhibitor	oral, once-daily	Cortes J, et al; ASH 2018, Blood
therapies in R/R AML	Venetoclax (Phase II)					any r/r AML	BCL-2 inhibitor	oral, once-daily	Konopleva M, et al: Cancer Discov 6:1106- 1117, 2016
presented at ASH	IMGN632 (Phase I)			33,0 %		CD123-positive	CD123-targeting antibody drug conjugate	IV infusion, once every 3 weeks	Daver N, et al; ASH 2018, Blood
	IMGN779 (Phase I)	6,9 %				CD33-positive; ≥20% of blasts expressing CD33 by flow cytometry	next-generation anti-CD33 antibody drug-conjugate (ADC)	IV infusion, Q2W or QW; premediation with steroids	Cortes J, et al; ASH 2018, Blood
	AMG 330 (Phase I)	11,4 %				any r/r AML	anti-CD33 bispecific T-cell engager (BiTE)	IV infusion, 14- or 28-day duration; pretreatment with corticosteroids	Ravandi et al, ASH 2018, Blood
	XmAb14045 / SQZ622 (Phase I)		23,1 %			any r/r AML	CD123-/CD3-targeting bispecific antibody	IV intermittent infusion, weekly in 28 day cycles	Ravandi et al, ASH 2018, Blood
	Flotetuzumab (Phase I/II)		22,0 %			any r/r AML	CD123-/CD3-targeting bispecific DART molecule	IV continuous infusion, 7- day/week	Uy,G, et al; ASH 2018, Blood
	CYAD-01 (Phase I)			42,0 %		any r/r AML	NKG2D CAR-T therapy	IV infusion, frequency unclear	Sallman et al, ASH 2018, Blood

Ref. BGBC008 / NCT03184571

Bemcentinib in combination with KEYTRUDA in 2L NSCLC

The BGBC008 trial is designed to test whether AXL inhibition can enhance responses to immunotherapy (KEYTRUDA monotherapy showed 8% response rate* in previously treated PD-L1 negative NSCLC), summary of responses:

27% ORR in PD-L1 –ve patients 40% ORR in AXL+ve patients

Clinical collaboration with Merck & Co. (MSD)

* Garon, N Engl J Med 2015: Includes any PD-L1 expression

NSCLC causes more cancer related deaths than breast, colon, pancreas and prostate combined

The largest cancer killer, most patients depend on drug therapy

• Ø 2.09 million new cases of lung cancer diagnosed/yr worldwide, making up 11.6% of all cancer cases1
• Ø 1.76 million lung cancer deaths/yr worldwide1
• Ø In the U.S, 5-year survival rate is approximately 18.6%, and 4.7% in patients with distant metastases2

Non-small cell lung cancer is the most common type of lung cancer, making up 80-85% of lung cancers

Rapidly emerging SoC creates opportunities for novel effective, chemo free regimens

Phase II 2L NSCLC study of bemcentinib with KEYTRUDA

Key objectives

• Evaluate safety of the combination and response to treatment with the combination
• Characterise patients by PD-L1 and AXL status
• Evaluate efficacy of patients by biomarker status, and assess predictive qualities of biomarkers
• Assess survival measures in patients by biomarker status

Response per biomarker expression

Analysis of biomarker expression in the BGBC008 trial revealed:

• ü Appr. half of patients were AXL positive (10 out of 21 analysed for AXL)
• ü The vast majority of patients did not express high levels of PD-L1, the biomarker for KEYTRUDA monotherapy efficacy

Promising efficacy in comparison to approved monotherapy and emerging combinations*

	Overall Response Rate
Regimen		0%	10%	20%	30%	40%	PFS	Patient details / Biomarker	Mechanism of action	Administration	Source
	Bemcentinib + pembrolizumab (Phase II)	n=10			40%		5.9 mo	AXL positive, any PD-L1 (TPS 0- 49% in 70%)	selective AXL inhibitor	oral, once daily	Krebs, M, et al; SITC 2018
mono	Pembrolizumb (APPROVED)	n=344	18%				3.9 mo	PD-L1 positive (TPS>1%)	PD-1 inhibitor	IV infusion, once every 3 weeks	FDA label, prescribing info
	Atezolizumab (APPROVED)	n=425	14%					2.8 mo any PD-L1 (55% PD-L1 positive)	PD-L1 inhibitor	IV infusion, once every 3 weeks	FDA label, prescribing info
	Nivolumab (APPROVED)	n=135	20%				3.5 mo	any PD-L1 (53% PD-L1 positive), squamous	PD-1 inhibitor	IV infusion, once every 2 weeks	FDA label, prescribing info
	Nivolumab (APPROVED)	n=292	19%				2.3 mo	any PD-L1 (54% PD-L1 positive), non-squamous	PD-1 inhibitor	IV infusion, once every 2 weeks	FDA label, prescribing info
combo	Epacadostat + pembrolizumab (Phase I/II)	n=70		29%			4.0 mo	prior treatment w/ CT; IO naive; responses regardless of PD-L1 (no details provided)	selective inhibitor of IDO1 enzyme	oral, twice daily	Villaruz, L, et al; WCLC 2018 abstract
	HBI-8000 + nivolumab (Phase Ib/II)	n=8			38%		not yet available	includes CPI-naïve and – experienced patients	HDAC class I & IIb inhibitor	oral, twice weekly	Khushalani, N, et al; SITC 2018
	TSR-042 (Phase I)	n=32		25%			not yet available	PD-L1 low (TPS 0-49%)	PD-1 inhibitor	IV infusion, once every 3 weeks	Perez, D, et al; SITC 2018
	TSR-022 + TSR-042 (Phase I)	n=31	13%				not yet available	patients include IO-naive and - experienced; all responses in PD-L1 positive (TPS>1%)	anti-TIM-3 antibody + anti-PD-1, respectively	IV infusion, once every 3 weeks	Davar, D, et al; SITC 2018
	Ramucirumab + pembrolizumab (Phase Ia/b)	n=11	18%				9.7 mo	PD-L1 negative (TPS<1%)	anti-VEGFR2	IV infusion, once every 3 weeks	Herbst, R, et al; ASCOPubs 2018, JCO

27 *emerging therapies presented at SITC, similar patient populations

The majority of NSCLC patients are eligible for CPIs, but only few respond: novel combination agents will drive CPI differentiation & multi-billion market opportunity

*seer.com – US only, incidence is 230,000; 70% diagnosed at late stage; 85% NSCLC ** EGFR mutations or ALK rearrangements, (1) Garon Iet al (2015) KEYNOTE 001 study (2) Company estimate based on Q3 2018 worldwide revenues for Opdivo, Keytruda and Tecentriq; half are expected to be in lung cancer

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Summary results and next steps

Status Jan '19

Summary results Next steps

• 1st efficacy endpoint met
• 40% ORR and 6m PFS in AXL positive patients

• 27% ORR in PD-L1 -ve patients

• Second stage ongoing

• H1 '19
• Ø Top line OS for stage 1
• Ø Preliminary ORR per biomarker stage 2
• H2 '19
• Ø Final efficacy & biomarkers stage 1 + 2
• Ø PFS

Clinical development opportunities for bemcentinib

Clinical Development opportunities for bemcentinib

Data generated provides strong rationale for late stage clinical trials to start in 2019*

BGB149 – a monoclonal anti-AXL antibody

Ref. BGB149-101 / NCT03795142

BGB149: Anti-AXL monoclonal antibody Phase I clinical trial initiated January 2019

Functionally blocking humanised monoclonal antibody

Binds human AXL, blocks AXL signalling

High affinity (KD: 500pM), Anti-tumour efficacy demonstrated in vivo

Robust manufacturing process established, 18 months stability

First-in-human healthy volunteer Phase I study initiated

• Up to 36 subjects
• Safety, PK/PD

First-in-patient trial expected in H2 2019

ADCT-601 – AXL ADC

Out-licensed to ADC Therapeutics (ADCT)

BGB601/ADCT-601: Anti-AXL ADC Phase 1 in solid tumours started January 2019

Antibody Drug Conjugate (ADC)

Targets human tumour AXL, induces cell death when internalised

Potent and specific anti-tumour activity demonstrated preclinically1

First-in-human Phase I study initiated in Jan 2019

• Solid tumours
• Up to 75 patients
• Safety, PK/PD, preliminary efficacy

Based on anti-AXL antibody BGB601 licensed from BerGenBio

Near term goals and news flow

Anticipated clinical data readouts and operational milestones for 2019

* expected

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ASCO-SITC: Clinical Immuno-Oncology symposium, San Francisco ASCO: American Society of Clinical Oncology, Chicago WCLC: World Conference of Lung Cancer, Toronto ESMO: European Society of Medical Oncology, Munich

AACR: American Association for Cancer Research, Chicago EHA: European Hematology Association, Stockholm SITC: Society for Immunotherapy of Cancer, DC ASH: American Society for Hematology, San Diego

Upcoming company news flow and value creating catalysts

Strategic priority		Goals
Late stage clinical trials with bemcentinib	H2 2018 H2 2018 H1 2019 H2 2019 H2 2020	Clinical PoC monotherapy AML Clinical PoC combo in NSCLC Clinical PoC combo in AML Start late stage clinical programme Interim read-out late stage clinical programme	✓ ✓
Develop Companion Diagnostics	H2 2018 H2 2020 H2 2021	Identify candidates that correlate with efficacy Validate candidates in late stage clinical programme Clinical assay developed	✓
BGB149 anti-AXL antibody programme	H2 2018 H2 2019 H2 2020	Initiate first-in-man phase I trial Initiate first-in-patient phase Ib trial Interim readout	✓
Maximise value for bemcentinib	H1 2019	Initiate pipeline opportunities for bemcentinib via ISTs	✓

Financial review: Good financial position and cost control

Rune Skeie CFO

Key financial figures

(NOK million)	Q4 2018	Q4 2017	FY 2018	FY 2017
Operating revenues	2.3	0	2.3	0
Operating expenses	53.2	47.5	196.9	183.7
Operating profit (loss)	-50.9	-47.5	-194.5	-183.7
Profit (loss) after tax	-51.1	-47.6	-191.7	-182.2
Q4 Q1 Basic and diluted earnings 2017 2018		Q2 2018	Q3 2018	Q4 2018
(loss) per share (NOK)	-0.93	-0.96	-3.60	-4.01
Net cash flow in the period	-37.8	-28.8	-9.9	208.5
Cash position end of period	360.4	370.3	360.4	370.3

Operating profit (loss) million NOK

Operating expenses Q4 2018

• Effective organisation

• 78.1% (YTD 73.8%) of operating expenses in Q4 2018 attributable to Research &

• Q4 18 operating loss reflecting level of research and development activities in the quarter

• Revenue NOK 2.3 million, licence revenue triggered by pre-clinical milestone (ADCT-601)
• Stage 2 of NSCLC combination with Keytruda re-opened in Q4 18 and ongoing (mandatory safety review in Q3 18)

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Cash flow and cash position

• Private placement Q2,18 strengthened cash position - gross funds raised NOK 187.5m

• Quarterly cash burn average 2018 at NOK 46.7 million

• Cash position gives runway to deliver key clinical read outs from ongoing clinical studies
• Cash runway into 2020 based on current burn rate

Full year 2018 highlights

Strong Phase II PoC clinical data readouts with bemcentinib: All operational milestones met with data presented at international clinical congresses

Data paving the way to late stage clinical trial programme in 2019: Targeting monotherapy and combination opportunities in AML/MDS and NSCLC

Pipeline opportunities pursued to complement key internal programmes: Investigator-led studies broaden oncology applications; rationale in fibrosis

Bemcentinib biomarker programme progressed: Efficacy correlation with AXL reported in clinical trials