BerGenBio — Investor Presentation 2018

Feb 13, 2018

AXL inhibitors as cornerstone of combination cancer therapy

Q4 and Full Year Results 2017 presentation, 13 February 2018

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

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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 (Bemcentinib)

First-in-class highly selective small molecule AXL inhibitor

Broad phase II proof of concept clinical trials ongoing in NSCLC, TNBC, AML/MDS, melanoma.

Pipeline BGB324 (Bemcentinib) AXL antibody AXL ADC (partnered) Immunomodulatory small molecules

OSE:BGBIO

Raised NOK400m in IPO on OSE in April '17

NOK1.8bn market cap (Feb 12th 2018)

Corporate

35 staff

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

BGB324 is now called bemcentinib

Agenda

1. Highlights Q4 and FY 2017

• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 1. Outlook
• 1. Q&A

Highlights Full year 2017

IPO (NOK 400m) enabling broad and ambitious Phase II clinical development programmes

Clinical collaborations (2) with Merck & Co. (MSD) to combine bemcentinib with KEYTRUDA, its blockbuster anti-PD-1 immune-oncology drug

Clinical development plan designed to establish clinical proof-of-concept and bemcentinib's potential to become a cornerstone of cancer therapy across multiple indications

Six international Phase II trials underway (350 patients, 50 sites, 6 countries) with multiple read-outs expected during 2018

All project milestones met in 2017

Companion diagnostic development made good progress using blood and tumour biomarkers

Scientific data presented at numerous conferences and journals demonstrate bemcemntib is an IO drug

BGB149 anti-AXL antibody on track to enter clinical trials in H2 2018

UK subsidiary (Oxford) established for efficient management of clinical trial operations

Highlights Q4

Clinical efficacy data presented at ASH: 2nd Line R/R AML 19% ORR

Clinical efficacy data presented at World Conference on Lung Cancer

Two non-dilutive grants (ca NOK 40m) received to support clinical trials of bemcentinib

Robust cash position of NOK 370.3 million at the end of Q4 2017

Cash sufficient to deliver key read-outs from Phase II trials during 2018

Strong progress in 2017, achieving all milestones outlined at IPO and well-positioned to deliver key proof-of-concept read-outs from clinical development programme designed to position bemcentinib as a cornerstone of cancer therapy

Agenda

1. Highlights Q4 and FY 2017

2. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments

• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 1. Outlook
• 1. Q&A

Advancing a broad clinical development pipeline

*Investigator-sponsored trials

Bemcentinib is active through-out the complete cancer immunity cycle

Clinical PoC for bemcentinib's immunomodulatory activity: Immune activation reported in BGBC003 patients

T-cell-repertoire (TCR):

• Measures the number and size of Tcell clones in a patient tissue before and after treatment
• An increase in diversity over time indicates an immune activation

TCR diversification reported after bemcentinib monotherapy

Elderly (61 – 80 yrs) and immune compromised R/R AML & MDS patient population had their TCR measured before and after monotherapy treatment with bemcentinib

• ü 6 out of 9 patients showed increased TCR diversity in either their blood or bone marrow or both after treatment with bemcentinib monotherapy
• ü These results suggest that bemcentinib monotherapy may have immunomodulatory effect

Combination therapies to unlock the full potential and promise of novel therapies – example anti-PD-1 therapy

Lung cancer: Largest oncology indication by fatalities and driver for IO growth

Lung cancer fatalities outnumber colon, breast, pancreas and prostate combined ¹

Lung cancer is driver for anti-PD-1 therapies sales forecast

Pembrolizumab alone expected to reach \$10bn annual sales

AXL inhibition as cornerstone for cancer therapy Bemcentinib (BGB324) proof of concept Phase II clinical trials

Bemcentinib recently reported Proof of Concept Phase II data

Bemcentinib (BGB324) foundation therapy

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 3. Bemcentinib in Lung Cancer – compelling clinical data presented
• First stage of BGBC004 – reversal of erlotinib resistance – successfully completed (Jan '18)
• Early efficacy for combination of bemcentinib with docetaxel reported (Dec '17)
• 1. Other clinical trial data
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 1. Outlook
• 1. Q&A

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

Proof of Concept Phase II data

• ü Combination with Chemo drugs
• ü Combination with Targeted drugs
• ü Well-tolerated in combination with KEYTRUDA

BGBIL005 trial in NSCLC

Docetaxel is standard second line chemo in NSCLC patients without activating mutations or low PD-L1 expression and common last line treatment option. Docetaxel is not well tolerated by patients, response rates are very low and PFS short.

The BGBIL005 trial is designed to test the hypothesis whether AXL inhibition with bemcentinib can

§ Enhance responses to chemotherapy

when given in combination with docetaxel in previously treated NSCLC patients

Bemcentinib + docetaxel in NSCLC patients

Duration of treatment (days)

6 weeks time of first response evaluation

Docetaxel is main treatment option in NSCLC after chemo failure and as last line after failure of chemo, targeted and/or IO

Recent results in recurrent NSCLC (chemo failure) with docetaxel

	Study	Intervention	ORR
	CheckMate 057: Borghaei et al1 582 patients randomised Pt chemo failures	Nivolumab vs Docetaxel	19% 12%
Single agent	et al2 OAK trial: Marinis 850 patients randomised Pt chemo failures	Atezo vs Docetaxel	14% 14%
	KEYNOTE 0103 ≥ 1% PDL1	Pembro Docetaxel	19% 9%
	BGBIL005	Bemcentinib + docetaxel	33%
	Levvy et al4 95 patients randomised	Docetaxel + PX-866 (PI3K inhibitor) vs Docetaxel alone	6% 0%
Combination	et al5 Ramlau 913 patients randomised	Docetaxel + Aflibercept (anti-VEGF) vs Docetaxel alone	23% 9%

BGBC004 trial in NSCLC

NSCLC patients tend to initially respond well to targeted therapies but virtually all develop resistance in less than 1 year.

The BGBC004 trial is designed to test the hypothesis whether AXL inhibition with bemcentinib can

• § Reverse and / or
• § Prevent resistance to EGFRm targeted therapies

when given in combination with erlotinib in EGFRm NSCLC patients who have either progressed on or have just started EGFRm targeted therapy

BGBC004: Proof-of-concept Phase II trial in NSCLC of bemcentinib with TARCEVA (erlotinib)

BGBC004 Phase II – NSCLC EGFR-mutation driven

Designed to evaluate the potential of bemcentinib to reverse and prevent acquired resistance to EGFR targeted therapy: Reversal setting (Arm B) successfully completed proof of concept stage

23 * FLAURA trial comparator arm, SoC erlotinib or gefitinib

Arm B, resistance reversal Proof-of-concept Phase II patient data

Clinical Efficacy

• § 33% disease control à Reverse resistance to erlotinib
• § 2 pts ongoing beyond 4 months

Arm B patient population

• § Progressed on 1st line approved EGFR TKI therapy (erlotinib, afatinib, gefitinib)
• § Median 3 lines prior therapy
• § T790M negative

Clinical benefit

• § 2 SD > 4 cycles
• § 3 SD at 6 wks
• 24 Source: Byers et al World Conference on Lung Cancer

Status January 2018

Clinical trial regulatory update

• BerGenBio received all the required approvals from the US Food & Drug Administration (FDA) and from the ethics committees at the participating US hospitals prior to starting this study.
• In November 2017, BerGenBio informed that the Company is in discussions with the Regional Ethics Committee (REK) in Bergen and the Norwegian Board of Health regarding the BGBC004 study.

BGBC008 trial in NSCLC

KEYTRUDA monotherapy showed 18% response rate in previously treated NSCLC patients. PD-L1 negative patients remain particularly challenging.

The BGBC008 trial is designed to test the hypothesis whether AXL inhibition with bemcentinib can

§ Enhance responses to immunotherapy

when given in combination with pembrolizumab in previously treated, immunotherapy-naïve NSCLC patients.

Clinical collaboration with Merck & Co. (MSD)

BGBC008: Phase II trial in NSCLC of bemcentinib in combination with KEYTRUDA

Patient recruitment on track

BGBC008 Phase 2 – NSCLC Adenocarcinoma of the lung

Previously treated, unresectable adenocarcinoma of the lung

up to 48 pts any PD-L1 expression any AXL expression no prior IO

Simon two stage (interim after 22 pts)

Single arm

BGB324 200mg/d Keytruda 200mg/3w

Safety, DoR, TtP, OS at 12 mo, response by biomarker expression

ORR

Expected readout

Initial read-out expected 2H 2018

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 4. Other clinical trial data
• Encouraging safety reported for combination of bemcentinib & Keytruda (Oct '17 & Jan '18)
• Encouraging efficacy reported for bemcentinib monotherapy in R/R AML & MDS (Dec '17)
• Immune activation reported in R/R AML & MDS (Dec '17 & Jan '18)
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 1. Outlook
• 1. Q&A

BGBC007 trial in TNBC

KEYTRUDA monotherapy showed 4% response rate in previously treated TNBC patients.

The BGBC007 trial is designed to test the hypothesis whether AXL inhibition with bemcentinib can

§ Enhance responses to immunotherapy

when given in combination with pembrolizumab in previously treated, immunotherapy-naïve TNBC patients.

Clinical collaboration with Merck & Co. (MSD)

BGBC007: Phase II trial in TNBC of bemcentinib in combination with KEYTRUDA

Patient recruitment on track

BGBC007 Phase 2 – TNBC

Previously treated, unresectable or metastatic TNBC

up to 56 pts any PD-L1 expression any AXL expression no prior IO

Simon two stage (interim after 22 pts)

Single arm

BGB324 200mg/d Keytruda 200mg/3w

Safety, DoR, TtP, OS at 12 mo, response by biomarker expression

ORR

Initial read-out expected 2H 2018

Expected readout

ASCO-SITC Clinical IO Symposium 2018: Bemcentinib + KEYTRUDA well tolerated

• Serious adverse event profile across three combination trials with bemcentinib/pembrolizumab presented at ASCO-SITC Clinical Immuno-Oncology Symposium (Jan 2018)
• Data available for n = 34 pts across TNBC, NSCLC and melanoma

• Rash & pyrexia most commonly observed

• üBemcentinib/ pembrolizumab combination is well tolerated across three cancer indications

• üSerious adverse event profile similar to that reported for pembrolizumab alone

BGBC003 trial in AML/MDS

AML and high-risk MDS patients unfit for high intensity chemotherapy remain a very challenging patient population with no treatment options when driver mutations are absent

The BGBC003 trial is designed to test the hypothesis whether AXL inhibition with bemcentinib can

• § Elicit single agent effect and / or
• § Enhance responses to chemotherapy

when given as a single agent in relapsed / refractory AML and high risk MDS or in combination with azacitidine or decitabine in treatment naïve AML patients

Superior 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

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

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

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

34 (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

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 5. Companion Diagnostic development
• Predictive biomarker candidates identified – soluble and cellular (Dec '17)
• AXL IHC established and rolled out for BGBC007 and BGBC008 (Jan '18)
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 1. Outlook
• 1. Q&A

Companion diagnostic for personalised medicine

High AXL expression correlates to poor prognosis

Low AXL expression1

High AXL expression1

Benefits of CDx

• Selecting patients most likely to benefit from treatment
• Improving probability of approval
• Increase reimbursement rates

Parallel CDx development becoming standard practice

Tumour markers

PD-L1, total & phospho AXL	Tumour mutational burden
mRNA	Microsatellite
expression	instability

Tumour immune infiltrate

PD-L1, PD-1, CTLA-4, CD8 and CD45RO expression phenotypes

Circulation

Cell mediated immune system and other cell types

Circulating factors

• Soluble AXL &
• Cytokines

Circulation

BerGenBio AML blood-based biomarkers predict patients benefitting from bemcentinib therapy

BerGenBio AXL immunohistochemistry (IHC) assay developed and validated

AXL expression in tumour adjacent alveolar macrophages

AXL can be detected in patient tumour and immune cells IHC assays:

Shown are squamous cell carcinoma FFPE patient samples stained for AXL (brown) as per BerGenBio's proprietary AXL IHC assay

• ü Widely used diagnostic method Methods Establishment of a validated, automated immunohistochemistry (IHC) assay for the detection of AXL in human formalin-fixed paraffin-embedded
• ü Standard for PD-1 directed and other targeted therapies IHC was implemented on the Discovery XT staining platform (Roche Diagnostics/Ventana Medical Systems) using a rabbit monoclonal anti-AXL antibody. FFPE tissue samples and FFPE TMAs were sliced was verified for linerity and precision using a semi-quantitative H-score performed by a pathologist.
• ü Provide spatial information carcinoma of the lung and squamous cell carcinoma, respectively, were pathologist scored for presence of AXL expression on either tumour tissue or tumour infiltrating immune cells.

Bemcentinib clinical development strategy: AXL inhibition as cornerstone for cancer therapy

Bemcentinib (BGB324) clinical development strategy: AXL inhibition as cornerstone for cancer therapy

Bemcentinib (BGB324) clinical development strategy: AXL inhibition as cornerstone for cancer therapy

Bemcentinib (BGB324) clinical development strategy: AXL inhibition as cornerstone for cancer therapy

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

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 1. Companion Diagnostic development

6. BGB149 – solid progress towards starting clinical trials

• 1. Finance report
• 1. Outlook
• 1. Q&A

BGB149: AXL function blocking antibody programme

Series of AXL functionally blocking antibodies – lead and back-ups

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

Patent position on CDR sequences

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

Development timeline – FiM 2H 2018

Milestone		'15			2016								2017												2018								2019
	Q 3	Q 4	Q 1	Q 2	Q 3	Q 4		Q1			Q2			Q3			Q4			Q1			Q2			Q3			Q4		Q 1	Q 2	Q 3	Q 4
							J	F	M	A	M	J	J	A	S	O	N	D	J	F	M	A	M	J	J	A	S	O	N	D
Feasibility in vivo				POC in vivo
Humanization						Development candidate
Cell line development
Process (USP/ DSP) develop
MCB
Non-GMP run
Pre-clinical Tox studies
cGMP Batch
IMPD/CTA submission																																FTIM
Phase I (single dose) study

• ü Clinical candidate selected
• ü Scale-up successfully completed
• ü Toxicology studies on track for first in human trials in H2 2018

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials

7. Finance report

• 1. Outlook
• 1. Q&A

Key financials

• OPEX sequentially increased as recruitment to our clinical studies is ramping up which triggers milestone payments

• Net cash flow is NOK 18.8 million below operating loss due to non dilutive cash grants and favourable working capital development

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

Agenda

• 1. Highlights Q4 and FY 2017
• 1. Bemcentinib's aspiring leadership position as the future cornerstone of cancer combination treatments
• 1. Bemcentinib in Lung Cancer compelling clinical data presented
• 1. Other clinical trial data
• 1. Companion Diagnostic development
• 1. BGB149 solid progress towards starting clinical trials
• 1. Finance report
• 8. Outlook
• 1. Q&A

Milestones 2017 & 2018

Significant value drivers expected over the next 12 months:

üInterim clinical data from 6 ph II trials H1'18

üFinal readout from 4 phase 2 trials in H2

üInitiation of AXL antibody BGB149 clinical trials in H2

BGBIO Investment case

Bemcentinib, potential first-in-class, selective AXL inhibitor for multiple cancers with addressable market in excess of \$20bn

Axl mechanism now widely accepted by Pharma industry as a 'hot' target of great interest

Promising preliminary Phase II proof-of-concept data for bemcentinib already reported – additional data anticipated June 2018

Clear strategy to develop and commercialise assets

• Deliver key clinical data from ongoing Phase II studies, develop CDx in parallel, and advance pipeline candidates
• High value, first-in-class drug candidates are attractive targets for strategic partnering and M&A
• Select go-to market possibilities in enriched patient populations

Well funded & experienced organisation to deliver milestones that create shareholder value

Thank you.

For further information please visit www.bergenbio.com

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

Appendix

Condensed consolidated statement of profit and loss and other comprehensive income

(NOK 1000) Unaudited	Note	Q4 2017	Q4 2016	FY 2017	FY 2016
Revenue		-	-	-	-
Cost
Employee benefit expenses	3	10 302	6 242	28 827	20 561
Depreciation		41	58	193	207
Other operating expenses	6	37 168	21 734	154 687	110 802
Total operating expenses		47 511	28 034	183 708	131 570
Operating profit		-47 511	-28 034	-183 708	-131 570
Finance income		912	801	4 168	3 031
Finance expense		1 035	667	2 668	1 260
Financial items, net		- 122	134	1 500	1 771
Profit before tax		-47 633	-27 900	-182 208	-129 799
Income tax expense			-	-	-
Profit after tax		-47 633	-27 900	-182 208	-129 799
Other comprehensive income
Items which will not be reclassified over profit and loss
Actuarial gains and losses on defined benefit pension plans		-	-1 089	-	-1 089
Total comprehensive income for the period		-47 633	-28 989	-182 208	-130 888
Earnings per share:
- Basic and diluted per share	7	-0. 96	-82. 81	-4. 01	-419. 68

54 View Q4 and FY 2017 report for notes: http://www.bergenbio.com/investors/reports/quarterly-reports/

Condensed consolidated statement of financial position

(NOK 1000) Unaudited	Note	31 Dec 2017	31 Dec 2016
ASSETS
Non-current assets
Property, plant and equipment		557	410
Total non-current assets		557	410
Current assets
Other current assets	8	13 430	12 302
Cash and cash equivalents		370 350	161 825
Total current assets		383 780	174 126
TOTAL ASSETS		384 336	174 536
EQUITY AND LIABILITIES
Equity
Paid in capital
Share capital	9	4 992	3 369
Share premium	9	325 018	131 875
Other paid in capital	4, 9	20 340	18 026
Paid in, not registered capital raise	9		-
Total paid in capital		350 350	153 270
Total equity		350 350	153 270
Non-current liabilities
Pension liability	10	-	-
Total non-current liabilities		0	0
Current liabilities
Accounts payable		21 575	10 703
Other current liabilities		9 391	5 721
Provisions		3 020	4 843
Total current liabilities		33 986	21 266
Total liabilities		33 986	21 266
TOTAL EQUITY AND LIABILITIES		384 336	174 536

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited	Note	FY 2017	FY 2016
Cash flow from operating activities
Loss before tax		-182 208	-129 799
Non-cash adjustments to reconcile loss before tax to net cash flows
Depreciation of property, plant and equipment		193	207
Calculated interest element on convertible loan		-	19
Share-based payment expense	3, 4	2 314	5 702
Movement in provisions and pensions		-1 823	-2 099
Working capital adjustments:
Decrease in trade and other receivables and prepayments		-1 128	-4 263
Increase in trade and other payables		14 543	5 919
Net cash flow from operating activities		-168 109	-124 314
Cash flows from investing activities
Purchase of property, plant and equipment		- 340	- 255
Net cash flow used in investing activities		- 340	- 255
Cash flows from financing activities
Proceeds from issue of share capital	9	376 974	212 220
Paid in, not registered capital increase	9	-	-
Proceeds from borrowings, convertible loan		-	-1 307
Conversion of loan by issue of share capital		-	1 489
Net cash flow from financing activities		376 974	212 402
Net increase/(decrease) in cash and cash equvivalents		208 525	87 832
Cash and cash equivalents at beginning of period		161 825	73 993
Cash and cash equivalents at end of period		370 350	161 825