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BerGenBio

Quarterly Report Feb 11, 2020

3555_10-k_2020-02-11_9e655d90-77e4-4ab0-ba62-5131d8906ec2.pdf

Quarterly Report

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INTERIM REPORT FOURTH QUARTER AND FULL YEAR 2019

Table of Contents

Highlights for the fourth quarter and full year 2019

Key Financial Figures

Overview & Outlook

  • Financial review
  • Condensed consolidated statement of profit and loss and other comprehensive income
  • Condensed consolidated statement of financial position
  • Condensed consolidated statement of changes in equity
  • Condensed consolidated statement of cash flow

Selected notes to the interim consolidated financial statements

Medical and biological terms

Contacts

Richard Godfrey Chief Executive Officer of BerGenBio

"In the final quarter of 2019 we continued our focus on the clinical development of lead candidate bemcentinib through proof of concept trials in AML and NSCLC. During the period we were pleased to present further encouraging data at the prestigious Society for Immunotherapy of Cancer meeting in November. Bemcentinib was shown to meet the primary and secondary endpoints in the first cohort of a Phase II study in combination with Merck's anti PD-1 Checkpoint inhibitor Keytruda®. Responses were seen in predominantly PD-L1 negative/low patients, for whom checkpoint inhibitors would not usually be an effective course of treatment. And these patients that were Axl positive with the diagnostic test we are developing, saw more than threefold improvement in their progression free survival.

Further data from the second cohort of the combination trial in NSCLC patients with confirmed progression on prior immune checkpoint therapy, showed promising efficacy. Reversing resistance to immune checkpoint inhibitors in patients who have relapsed on immunotherapy is a highly desirable alternative to the second-line chemotherapy standard-of-care. We are very excited with these early results in this challenging setting and look forward to expanding the study to confirm these findings and

Additional NSCLC patients who have failed first-line chemocheckpoint inhibitor combination therapy are now being recruited into a third cohort of the trial.

reporting comprehensive translational insight.

In AML, Phase II trial data presented to the Annual American Society of Hematology showed bemcentinib in combination with low-dose cytarabine (LDAC) in elderly AML patients unfit for intensive therapy was well tolerated and showed promising efficacy. Treatment options for patients who have relapsed or are too ill to undergo intensive chemotherapy are very limited, so these encouraging results warrant further investigation. We look forward to providing further updates. In October BerGenBio received FDA approval of Fast Track Designation for bemcentinib for the treatment of elderly patients with AML whose disease has relapsed. We have ongoing phase 2 clinical trials in this indication and plan to seek regulatory advice from the FDA and European Medicines Agency (EMA) to determine the optimal regulatory path for bemcentinib in relapsed AML.

I am pleased with the continued progress we have made over the quarter and the year as a whole. BerGenBio is now well capitalised, having recently closed a private placement funding of NOK 219.9 million in January 2020, part of which is contingent on confirmation by the EGM on 20th February 2020. With the continuing trend of positive data coming through in both indications we remain well positioned to meet our strategic objectives in 2020."

Q4 2019 (including post-period end)

Bemcentinib met primary endpoint in first cohort of Phase II NSCLC study in combination with KEYTRUDA®

  • Primary endpoint, Overall Response Rate, was been met in predominantly PD-L1 negative/low patients
  • Secondary endpoint, median Progression Free Survival in AXL positive patients was 3 times greater than in Axl negative patients
  • Data was presented at Society for Immunotherapy of Cancer 34th Annual Meeting on 8 November 2019

Preliminary clinical data from Phase II combination trial of bemcentinib and LDAC in elderly AML patients at ASH 2019

  • Phase II trial data showed bemcentinib in combination with low-dose cytarabine (LDAC) in elderly AML patients unfit for intensive therapy is well tolerated and shows promising efficacy
  • Long duration of response (>9.9 mo, still maturing) with 43% complete response (CR/Cri) in 6 evaluable newly diagnosed patients receiving the bemcentinib-LDAC combination
  • Clinical benefit demonstrated in >2L relapsed and refractory AML patients with 1 CR/CRi and 3 SD out of 6 evaluable patients
  • Data presented in a poster presentation at the 61st Annual American Society of Hematology (ASH) Meeting, on 7-10 December in Orlando, Florida.

U.S. Food and Drug Administration (FDA) approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.

With this Fast Track designation, BGB is eligible for:

  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
  • Eligibility for Accelerated Approval and Priority Review

Private Placement completed January 2020 (post period), gross proceeds NOK 2019.9 million.

• NOK 98.5m received by 10 February, NOK 121.3m subject to EGM approval (expected 25 February).

Clinical trial updates were presented at several major cancer scientific congresses and consistently confirm that NSCLC and AML are the optimal target indications

Phase II development programme read-outs according to plan

  • AML bemcentinib + LDAC: readouts at American Society of Clinical Oncology (ASCO) and European Haematology Association (EHA)
  • NSCLC bemcentinib + KEYTRUDA: readouts at ASCO, World Conference on Lung Cancer (WCLC), European Society of Medical Oncology (ESMO), The Society for Immunotherapy of Cancer (SITC)

Proprietary composite AXL tumor-immune (cAXL) score developed to identify & diagnose patients that show durable benefit

Commenced Phase I trial tilvestamab (BGB149) in healthy volunteers

Continued to build out the organisation with strategic medical, clinical, operational and regulatory hires

Private placement completed in June, raising NOK 74.2m

Q4 2019 FINANCIAL

Key financial figures

(NOK million) Q4 2019 Q4 2018 FY 2019 FY 2018
Operating revenues 0,2 2,3 8,9 2,3
Operating expenses 59,3 53,2 213,3 196,9
Operating profit (-loss) -59,1 -50,9 -204,4 -194,5
Profit (-loss) after tax -57,6 -51,1 -199,3 -191,7
Basic and diluted earnings (loss) per
share (NOK) -0.94 -0.93 -3.43 -3.60
Net cash flow in the period -35,9 -37,8 -106,8 -9,9
Cash position end of period 253,6 360,4 253,6 360,4

Operating loss

Q4 2018

Q1 2019

Q2 2019

Q3 2019

Cash flow

Q4 2018

Q4 2019

Q1 2019

Q2 2019

Q3 2019

Q4 2019

Cash position

OVERVIEW &

Q4 Business Overview

BerGenBio maintained its clinical research focus on its lead drug candidate bemcentinib, a novel once-a-day, orally administered, highly selective AXL inhibitor. Bemcentinib is currently progressing through a broad Phase II clinical development programme as a monotherapy and in combination with existing standard of care medicines, including immuno-, targeted and chemotherapies.

Non-Small Cell Lung Cancer

  • In June BerGenBio presented updated data from its Phase II clinical trial combining bemcentinib with Merck's anti-PD-1 therapy KEYTRUDA in patients with advanced NSCLC at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO). In November data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting showed that bemcentinib had met the primary and secondary endpoints in the first of three cohorts enrolled
  • Data from the trial (BGBC008) suggests that bemcentinib has the potential to enhance patient responses and overall survival when treated in combination with a PD-1 inhibitor. Investigators were particularly encouraged by responses in patients with no or limited expression of PD-L1, who would not be expected to respond to anti-PD(L)1 drugs alone
  • Post-period initial data from Cohort B of the NSCLC trial showed initial responses amongst patients who have relapsed on immunotherapy alone, which represents a very significant and encouraging development which warrants further investigation
  • In late 2019, BerGenBio improved its ability to identify patients with durable clinical benefit, with a refined composite AXL tumour immune score, an important development for BerGenBio's AXL targeting clinical programs. BerGenBio has assessed data from the first of three cohorts evaluating the combination of bemcentinib/KEYTRUDA in previously treated lung cancer patients, with further data from additional cohorts anticipated in the coming months

• US Food and Drug Administration (FDA) approved Fast Track Designation for bemcentinib for the treatment of elderly patients with AML whose disease has relapsed. There are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need

Acute Myeloid Leukaemia

  • BerGenBio has ongoing Phase II trials in this indication and plans to seek regulatory advice from the FDA and European Medicines Agency (EMA) to determine the optimal regulatory path for bemcentinib in relapsed AML
  • Phase IIa clinical trial data has shown that bemcentinib in combination with low-intensity chemotherapy (LDAC) in elderly AML patients is well tolerated and efficacious
  • Earlier in 2019, preliminary data showed responses in 43% of evaluated patients, with complete responses in a substantially higher percentage of patients compared to previously observed/historical benchmarks in single-agent cytarabine. This trial has been expanded to include an additional 28 patients to verify this early proof of concept, data from this expanded trial will be available in the first half of 2020

Strategic Priorities

The Company remains well placed to deliver its stated strategic priorities, specifically:

  • Continuing to advance the bemcentinib clinical development programme towards late stage clinical trials in AML and NSCLC
  • Developing companion diagnostics to enrich future clinical trials and improve chances of regulatory success
  • Advancing the clinical development of our anti AXL monoclonal antibody tilvestamab (BGB149)
  • Securing additional pipeline opportunities for the Company's AXL inhibitors in oncology and non-oncology indications

Outlook

BerGenBio has a clear strategy to progress the development and commercialisation of bemcentinib, aimed at creating maximum value for shareholders, including potential partnering and go-to-market strategies in selected indications and territories.

The Company continues to deliver promising clinical outcomes and increasingly robust translational biomarker data from its bemcentinib development programme. The Board's view is that these encouraging results in AML and NSCLC have established increasing clinical proof-of concept and the Company is focused on meeting its operational, regulatory and clinical goals.

Recent announcements from emerging competitors reaffirm the Company's leadership position in developing Axl inhibitors, and has heightened industry awareness of their potential value.

Risks and Uncertainties

The Group operates in a highly competitive industry sector with many large players and may be subject to rapid and substantial technological change.

BerGenBio is currently in a development phase involving activities that entail exposure to various risks. BerGenBio's lead product candidate bemcentinib is currently in Phase II clinical trials. This is regarded as an early stage of development and the clinical studies may not prove to be successful. Timelines for completion of clinical studies are to some extent dependent on external factors outside the control of the Group, including resource capacity at clinical trial sites, competition for patients, etc.

The financial success of BerGenBio and / or its commercial partners requires obtaining marketing authorisation and securing an acceptable reimbursement price for its drugs. There can be no guarantee that the drugs will obtain the selling prices or reimbursement rates foreseen.

BerGenBio and / or its commercial partners will need approvals from the US Food & Drug Administration (FDA) to market its products in the US, and from the European Medicines Agency (EMA) to market its products in Europe, as well as equivalent regulatory authorities in other worldwide jurisdictions to commercialise in those regions. The future earnings are likely to be largely dependent on the timely marketing authorisation of bemcentinib for various indications.

Financial Risks

Interest rate risk

The Group holds cash and cash equivalents and does not have any borrowings. The Group's interest rate risk is therefore in the rate of return of its cash on hand. Bank deposits are exposed to market fluctuations in interest rates, which affect the financial income and the return on cash.

Exchange rate risk

The value of non-Norwegian currency denominated costs will be affected by changes in currency exchange rates or exchange control regulations. The Group undertakes various transactions in foreign currencies and is consequently exposed to fluctuations in exchange rates. The exposure arises largely from the clinical trials and research expenses. The Group is mainly exposed to fluctuations in euro (EUR), pounds sterling (GBP) and US dollar (USD). The Group has chosen not to hedge its operational costs as the Group's cash flow is denominated in several currencies that change depending on where clinical trials are run. In 2019 the risk management of foreign exchange have been changed by increasing the holding of bank deposit in EUR, GBP and USD depending on the need for such foreign exchange.

The foreign currency exposure is also mostly linked to trade payables with short payment terms. The Group might consider changing its current risk management of foreign exchange rate if it deems it appropriate.

Credit risk

Credit risk is the risk of counterparty's default in a financial asset, liability or customer contract, giving a financial loss. The Group's receivables are generally limited to receivables from public authorities by way of government grants. The credit risk generated from financial assets in the Group is limited since it is cash deposits. The Group places its cash in bank deposits in recognised financial institutions to limit its credit risk exposure.

The Group has not suffered any loss on receivables during 2019 and the Group considers its credit risk as low.

Liquidity risk

Liquidity is monitored on a continued basis by Group management. The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives. Management considers the Group's liquidity situation to be satisfactory. The Group secured equity funding of NOK 74 million gross in June 2019 and additional NOK 220 million in January 2020 where NOK 99 million is completed and received by date of this report and additional NOK 121 million subject to approval from an Extraordinary General Meeting to be held on 20 February 2020.

Non-financial risks

Technology risk

The Group's lead product candidate, bemcentinib (BGB324), is currently in Phase II clinical trials and the Group's clinical studies may not prove to be successful.

Competitive technology

The Group operates in a highly competitive industry sector with many large players and is subject to rapid and substantial technological change.

Market risks

The financial success of the Group requires obtaining marketing authorisation and achieving an acceptable reimbursement price for its drugs. There can be no guarantee that the Group's drugs will obtain the selling prices or reimbursement rates foreseen by the Group. The Group will need approvals from the US Food and Drug Administration (FDA) to market its products in the US, and from the European Medicines Agency (EMA) to market its products in Europe, as well as equivalent regulatory authorities in other worldwide jurisdictions to commercialise in those regions. The Group's future earnings are likely to be largely dependent on the timely marketing authorisation of bemcentinib for various indications.

FINANCIAL

Financial Results

(Figures in brackets = same period 2018 unless stated otherwise)

FINANCIAL REVIEW Revenue for the fourth quarter and the full year 2019 respectively amounted to NOK 0.2 million (NOK 2.3 million) and NOK 8.9 million (NOK 2.3 million). The revenue is clinical and preclinical milestone payments from ADCT.

Total operating expenses for the fourth quarter and the full year 2019 respectively amounted to NOK 59.3 million (NOK 53.2 million) and NOK 213.3 million (NOK 196.9 million).

Employee expenses in the fourth quarter were NOK 13.0 million (NOK 6.8 million) and NOK 35.7 million (NOK 38.0 million) for the full year 2019. The increase in Q4 2019 compared to 2018 is caused by increased provision for social and security tax on employee options. The decrease in the full year from 2018 to 2019 was mainly due to reduction in provisions for social security tax on employee options and increased cost reduction from grants (non dilutive funding).

Other operating expenses amounted to NOK 46.0 million (NOK 46.5 million) for the fourth quarter and NOK 176.8 million (NOK 158.7 million) for the full year 2019. Operating expenses are driven by the expansion of ongoing clinical trials and preparations for new clinical trials. The Company incurs costs when clinical trials meet specific milestones of progress.

As recruitment of patients to the clinical trials has progressed, costs have increased proportionately and in-line with management's forecasts.

The operating loss for the quarter came to NOK 59.1 million (NOK 50.9 million) and NOK 204.4 million (NOK 194.5 million) for the full year 2019, reflecting the level of activity related to the clinical trials BerGenBio is conducting.

Net financial items amounted to a gain of NOK 1.5 million (loss of NOK 0.2 million) for the fourth quarter and a gain of NOK 5.1 million (gain of NOK 2.8 million) for the full year 2019.

Losses after tax for the fourth quarter were NOK 57.6 million (NOK 51.1 million) and for the full year 2019 NOK 199.3 million (NOK 191.7 million).

Financial Position

Total assets at year end 2019 decreased to NOK 270.4 million (NOK 378.8 million at year end 2018), mainly due to the operational loss in the period and reflecting the private placement completed in June 2019 raising gross NOK 74.2 million.

Total liabilities were NOK 50.6 million at year end 2019 (NOK 41.5 million at year end 2018).

Total equity as of 31 December 2019 was NOK 219.8 million (NOK 337.3 million at year end 2018), corresponding to an equity ratio of 81.3% (89.0%).

Cash Flow

Net cash flow from operating activities was negative by NOK 35.9 in the fourth quarter and 184.1 million for the full year 2019 (negative by 37.6 in Q4 2018 and NOK 186.7 million for the full year 2018), mainly driven by the level of activity in the clinical trials.

Net cash flow for investing during the quarter and the full year 2019 was NOK 0.0 million (NOK 0.2 in Q4 2018 and NOK 0.2 million for the full year 2018).

Net cash flow from financing activities was NOK 0 million for the fourth quarter 2019 and 77.3 million for the full year 2019 (NOK 0 in Q4 2018 and NOK 177.0 million for the full year 2018).

Net cash flow in the quarter was negative with NOK 35.9 million. Cash and cash equivalents decreased to NOK 253.6 million (NOK 289.5 at end of Q3 2019 and NOK 360.4 million at year end 2018).

Bergen 10 February 2020 Board of Directors and CEO of BerGenBio ASA

Sveinung Hole, Chairman Pamela A. Trail

Stener Kvinnsland Grunde Eriksen

Debra Barker Richard Godfrey, CEO

Condensed consolidated statement of profit and loss and other comprehensive income

(NOK 1000) Unaudited Note Q4 2019 Q4 2018 FY 2019 FY 2018
Revenue 219 2,335 8,900 2 335
Expenses
Employee benefit expenses 3, 10 13,048 6,756 35,717 38,012
Depreciation 2 196 37 785 204
Other operating expenses 6 46,026 46,452 176,773 158,658
Total operating expenses 59,270 53,245 213,274 196,874
Operating profit -59,051 -50,910 -204,374 -194,539
Finance income 4,033 1,216 11,530 4,857
Finance expense 2,568 1,380 6,434 2,065
Financial items, net 1,465 -164 5,096 2,793
Profit before tax -57,586 -51,074 -199,278 -191,747
Income tax expense 0 0 0 0
Profit after tax -57,586 -51,074 -199,278 -191,747
Other comprehensive income
Items which will not be reclassified over profit and
loss
Actuarial gains and losses on defined benefit
pension plans
0 0 0 0
Total comprehensive income for the period -57,586 -51,074 -199 278 -191,747
Earnings per share:
- Basic and diluted per share 7 -0.94 -0.93 -3.43 -3.60

Condensed consolidated statement of financial position

(NOK 1000) Unaudited Note 31 DEC 2019 31 DEC 2018
ASSETS
Non-current assets
Property, plant and equipment 2 974 581
Total non-current assets 974 581
Other current assets 5, 8 15,818 17,831
Cash and cash equivalents 253,586 360,413
Total current assets 269,404 378,245
TOTAL ASSETS 270,378 378,826
EQUITY AND LIABILITIES
Equity
Paid in capital
Share capital 9 6,108 5,471
Share premium 9 187,786 309,791
Other paid in capital 4, 9 25,860 22,018
Total paid in capital 219,754 337,280
Total equity 219,754 337,280
Non-current liabilities
Long term debt 2 0 0
Total non-current liabilities 0 0
Current liabilities
Accounts payable 26,746 23,939
Other current liabilities 21,803 12,875
Provisions 2,074 4,732
Total current liabilities 50,624 41,546
Total liabilities 50,624 41,546
TOTAL EQUITY AND LIABILITIES 270,378 378,826

Condensed consolidated statement of changes in equity

(NOK 1000) Unaudited Note Share
capital
Share premium Other paid in capital Total equity
Balance at 1 January 2019 5 471 309,791 22,018 337,280
Loss for the period -199,278 -199,278
Other comprehensive income (loss) for the period,
net of income tax
0 0
Total comprehensive income for the period 0 -199,278 0 -199,278
3, 4 3,842 3,842
Recognition of share-based payments
Issue of ordinary shares 9 637 82,148 82,785
Paid in, not registed capital raise 9 0
Share issue costs -4,875 -4,875
Balance at 31 December 2019 6,108 187,786 25,860 219,754
(NOK 1000) Unaudited Note Share
capital
Share premium Other paid in capital Total equity
Balance at 1 January 2018 4,992 325,018 20,340 350,350
Loss for the period -191,747 -191,747
Other comprehensive income (loss) for the period,
net of income tax
0 0
Total comprehensive income for the period 0 -191,747 0 -191,747
Recognition of share-based payments 3, 4 1,678 1, 678
Issue of ordinary shares 9 479 190,047 190,525
Paid in, not registed capital raise 9 0
Share issue costs -13,527 -13,527
Balance at 31 December 2018 5,471 309,791 22,018 337,280

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited Note Q4 2019 Q4 2018 FY 2019 FY 2018
Cash flow from operating activities
Loss before tax -57,586 -51,074 -199,278 -191,747
Non-cash adjustments to reconcile loss before tax to net
cash flows
Depreciation of property, plant and equipment 196 37 785 204
Share-based payment expense 3, 4 888 622 3,842 1,678
Movement in provisions and pensions 1,651 -3,462 -2,658 1,712
Working capital adjustments:
Decrease in trade and other receivables and
prepayments
3,704 4,036 2,013 -4,401
Increase in trade and other payables 15,285 12,246 11,151 5,847
Net cash flow from operating activities -35,862 -37,595 -184,145 -186,706
Cash flows from investing activities
Purchase of property, plant and equipment 0 -159 0 -228
Net cash flow used in investing activities 0 -159 0 -228
Cash flows from financing activities
Proceeds from issue of share capital 9 0 0 77,910 176,998
Debt repayments -56 0 -593 0
Net cash flow from financing activities -56 0 77,317 176,998
Net increase/(decrease) in cash and cash equvivalents -35,918 -37,754 -106,828 -9 936
Cash and cash equivalents at beginning of period 289,503 398,166 360,413 370,350
Cash and cash equivalents at end of period 253,586 360,413 253 586 360 413

SELECTED NOTES TO THE INTERIM CONSOLIDATED FINANCIAL

Corporate information

BerGenBio ASA ("the Company") and its subsidiary (together "the Group") is a clinical stage biopharmaceutical company focused on developing novel medicines for aggressive diseases, including advanced, treatment-resistant cancers. BerGenBio ASA is a limited public liability company incorporated and domiciled in Norway. The address of the registered office is Jonas Lies vei 91, 5009 Bergen, Norway. The condensed interim financial information is unaudited. These interim financial statements cover the twelvemonths period ended 31 December 2019 and were approved for issue by the Board of Directors on 10 February 2020.

Basis for preparation and significant accounting policies

Basis for preparation and significant accounting policies

The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group's annual financial statements for the year ended 31 December 2018, except for the adoption of new standards and interpretations effective as of 1 January 2019.

The new and amended standards and interpretations from IFRS that were adopted by the EU with effect from 2019 did not have any significant impact on the reporting for Q4 2019.

The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.

IFRS 16 Leases

The company has implemented IFRS 16 Leases from 1.1.2019.

IFRS 16 replaces IAS 17, Leases and related interpretations. IFRS 16 from a lessee viewpoint eliminates the classification of leases as either operating leases or finance leases. Instead, all leases are treated in a similar way to finance leases under IAS 17. The standard is effective for accounting periods beginning on or after 1 January 2019 and adopted by the company from the same date.

IFRS 16 allows various adoption approaches. The company applies the modified retrospective approach under which all right-of-use assets (ROU assets) are measured at an amount equal to the lease liability at 1 January 2019. The lease liability in turn is calculated as the discounted present value of remaining lease payments under the leases. The cumulative effect of initially applying the standard as an adjustment to the opening balance on retained earnings is zero. Under this transition approach, the 2018 comparable numbers presented in the first quarter 2019 reporting are not restated as if IFRS 16 was applied in 2018. The presented amounts are calculated based on judgements and interpretations at the time of adopting the new standard.

The company has only lease agreements previously classified as operational leases. Under IFRS 16 these are treated as financial leases.

Implementing effect of adopting the new standard and effect on the income statement for the fourth quarter and full year of 2019 are shown in the tables below.

(NOK 1,000 Unaudited)
Effect on Statement of Financial Position 31.12.2018 IFRS 16 effect 1.1.2019
Non-current assets 581 1,178 1,759
Total assets 378,826 1,178 380,004
Long term debt 0 551 551
Current liabilities 41,546 627 42,173
Total liabilities 41,546 1,178 42,724
Total equity and liabilities 378,826 1,178 380,004
Q4 2019 FY 2019
Effect on Income Statement Q4 2019
excl IFRS
16
IFRS 16
effects
Q4 2019 YTD
excl IFRS
16
IFRS 16 effects YTD 2019
Total operation revenue 219 0 219 8,900 0 8,900
Depreciation 41 155 196 165 620 785
Other operating expenses 46,188 -162 46,026 177,421 -648 176,773
Total operation expenses 59,277 -7 59,270 213,302 -28 213,274
Operating profit -59,058 7 -59,051 -204,402 28 -204,374
Financial items, net 1,474 -10 1,465 5,151 -55 5,096
Profit before tax -57,584 -3 -57,586 -199,251 -
27
-199,278

Basis for consolidation

The consolidated financial statements comprise the financial statements of the Company and its subsidiary as of 31 December 2019. The subsidiary is BerGenBio Limited, located in Oxford in the United Kingdom and is 100% owned and controlled by the parent company BerGenBio ASA

Estimates and assumptions

Preparation of the accounts in accordance with IFRS requires the use of judgment, estimates and assumptions that have consequences for recognition in the balance sheet of assets and liabilities and recorded revenues and expenses. The use of estimates and assumptions are based on the best discretionary judgment of the Group's management. The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives.

Capital markets are used as a source of liquidity when this is appropriate and when conditions in these markets are acceptable. A private placement and capital increase of gross NOK 74 million was completed in June 2019, and thus the Board of Directors has reasonable expectation that the Group will maintain adequate resources to continue in operational existence for the foreseeable future. The interim financial statements are prepared under the going concern assumption.

In addition a private placement was placed in January 2020 raising total of NOK 219.9 million. At date of this report Tranche 1 of total 5,475,136 shares at NOK 18.00 have been issued at gross proceeds of NOK 98.6 million. Additional 6,740,182 shares have been placed at NOK 18.00 but share issue is subject to approval from an extraordinary general meeting to be held 20 February 2020.

Payroll and related expenses

Q4 2019 Q4 2018 FY 2019 FY 2018
Salaries 7,446 4,659 28,643 24,941
Social security tax 1,246 1,700 5,055 4,465
Pension expense 652 517 2,358 2,066
Bonus 3,033 2,199 3,033 2,199
Share option expense employees 888 622 3,842 1,678
Accrued social security tax on share
options
1,651 -3,462 -2,658 1,712
Other remuneration 178 865 740 2,327
Government grants 1) -2,047 -345 -5,297 -1,376
Total payroll and related expenses 13 048 6 756 35,717 38,012
Average number of full time equivalent 26 24

employees

1) See also note 5 for government grants

Members of management and Board of Directors participating in the option program

Option
holder
Number of
options
outstanding
Grant date Expiry date Exercise price
(NOK)
Richard Godfrey 150,000 3-Sep-13 3-Sep-21 10.62
75,000 13-Jun-13 13-Jun-21 10.62
120,000 11-Jun-14 11-Jun-22 11.15
275,000 22-May-15 22-May-23 16.01
100,000 1-Jan-16 1-Jan-24 24.00
122,484 23-May-18 23-May-26 45.70
50,000 31-Oct-18 31-Oct-26 28.50
236,800 17-Apr-19 17-Apr-27 25.00
James B Lorens 55,000 3-Sep-13 3-Sep-21 10.62
100,000 13-Jun-13 13-Jun-21 10.62
70,000 11-Jun-14 11-Jun-22 11.15
275,000 22-May-15 22-May-23 16.01
50,000 1-Jan-16 1-Jan-24 24.00
10,707 23-May-18 23-May-26 46.70
7,000 31-Oct-18 31-Oct-26 28.50
20,800 17-Apr-19 17-Apr-27 25,00
Rune Skeie 24,090 23-May-18 23-May-26 46.70
20,000 31-Oct-18 31-Oct-26 28.50
52,000 17-Apr-19 17-Apr-27 25,00
James Barnes 59,400 17-Apr-19 17-Apr-27 25.00
1,873,281

In the annual general meeting on the 22nd of March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was split into 100 shares with a nominal value of NOK 0.10. The overview above takes into account the share split.

Employee share option program

The Group has a Long Term Incentive Program for employees, an option scheme program. Each option gives the right to acquire one share in BerGenBio at exercise.

The Group has a share option program to ensure focus and align the Group's long term performance with shareholder values and interest. Most of the employees in the Group take part in the option program. The program also serves to retain and attract senior management.

The exercise price for options granted is set at the market price of the shares at the time of grant of the options. In general, for options granted after 2012 the options expire eight years after the date of grant.

Primarlily the options vest at the earlier of an IPO or annually in equal tranches over a three-year period following the date of grant.

The following equity incentive schemes were in place in the current year:

Number of
options
Grant date Expiry date Exercise
price
Granted in September 2010 225,000 Sep 2010 Dec 2017/2019 5,65
Granted in May 2011 175,000 May 2011 Dec 2017/2019 7,56
Granted in June 2012 285,000 Jun 2012 Dec 2017/2019 10,62
Granted in June 2012 225,000 Jun 2012 Jun 2020 10,62
Granted in June 2013 360,000 Jun 2013 Jun 2021 10,62
Granted in September 2013 400,000 Sep 2013 Sep 2021 10,62
Granted in June 2014 280,000 Jun 2014 Jun 2022 11,15
Granted in May 2015 650,000 May 2015 May 2023 16,01
Granted in September 2015 260,000 Sep 2015 Sep 2021 16,01
Granted in January 2016 400,000 Jan 2016 Jan 2024 24,00
Granted in February 2016 122,500 Feb 2016 Feb 2024 24,00
Granted in December 2017 50,000 Dec 2017 Dec 2025 22,00
Granted in May 385,027 May 2018 May 2026 46,70
Granted in October 2018 277,000 Oct 2018 Oct 2026 28,50
Granted in April 2019 784,629 April 2019 April 2027 25,00
Forfeited in 2015 -7,500 10,62
Forfeited in 2016 -50,000 16,01
Forfeited and cancelled in 2017 * -220,000 12,33
Exercised in 2017 -230,000 9,98
Exercised in 2018 -160,000 19,01
Forfeited in 2018 -245,513 26,27
Exercised in 2019 -870,000 9,89
Forfeited in 2019 -511,596 28,19
Cancelled in 2019 -15,000 24,00
Total 2,569,547

In the annual general meeting on the 22nd of March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was split into 100 shares with a nominal value of NOK 0.10. The overview above takes into account the share split.

For the twelve months ended 31 December
Total options 2019 2018
Number of
options
Weighted
average
exercise
price
Number of
options
Weighted
average
exercise
price
Balance at 1 January 3,181,514 18,20 2,925,000 14,20
Granted during the period 784,629 25,00 662,027 39,08
Exercised during the period -870,000 9,89 -160,000 19,01
Forfeited and cancelled -526,596 28,07 -245,513 26,27
Balance at 31 December 2,569,547 21,07 3,181,514 18,21

0 options were granted in the three months period ended 31 December 2019 and 277,000 options were granted in the three months period ended 31 December 2018.

Vested options For the twelve months ended 31 December
2019 2018
Options vested at 1 January 2,598,334 2,891,667
Exercised and forfeited in the period -1,396,596 -310,000
Vested in the period 500,243 16,667
Options vested at 31 December 1,701,981 2,598,334
Total outstanding number of options 2,569,547 3,181,514

The options are valued using the Black-Scholes model.

The risk free interest rates are based on rates from Norges Bank and Oslo Børs on the Grant Date (bonds and certificates) equal to the expected term of the option being valued. Where there is no exact match between the term of the interest rates and the term of the options, interpolation is used to estimate a comparable term.

The vesting period is the period during which the conditions to obtain the right to exercise must be satisfied. Most of the options vest dependent on certain conditions. The Group has estimated an expected vesting date and this date is used as basis for the expected lifetime. The Group expects the options to be exercised earlier than the expiry date. For Options granted earlier than 2014, the mean of the expected vesting date and expiry date has been used to calculate expected lifetime due to the lack of exercise pattern history for the Group and experience from other companies in combination with the relatively long lifetime of these options (up to 8 years).

For valuation purposes 43% expected future volatility has been applied. As the Group recently went public it has limited history of volatility in its share price, therefore the historical volatility of similar listed companies has been used as a benchmark for expected volatility.

For the twelve months period ending 31 December 2019 the value of the share options expensed through the profit or loss amounts to NOK 3.8 million (for the same period in 2018: NOK 1.7 million). In addition a provision for social security contributions on share options of NOK - 2.7 million (for the same period in 2018: NOK 1.7 million) is recognized based on the difference between the share price and exercise price on exercisable option as at the end of the period.

Government grants

Government grants have been recognised in the profit or loss as a reduction of related expense with the following amounts:

Q4 2019 Q4 2018 YTD 2019 YTD 2018
Employee benefit
expenses
2,047 345 5,297 1,376
Other operating expenses 4,743 3,958 20,727 18,847
Total 6,790 4,302 26,024 20 223

Grants receivable as at 31 December are detailed as follows:

31 Dec 2019 31 Dec 2018
Grants from Research Council, BIA 2,531 2,297
Grants from Innovation Norway 0 5,400
Grants from SkatteFunn 8,033 7,933
Grants R&D UK 2,637 0
Total grants receivable 13,202 15,630

BIA grants from the Research Council:

The Company currently has three grants from the Research Council, programs for user-managed innovation arena (BIA).

The first BIA grant ("Axl targeting therapeutics to treat fibrotic diseases") totals to NOK 12.0 million and covers the period from April 2015 to April 2019. The Group has recognised NOK 0.9 million in 2019 (2018: NOK 2.9 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

The second BIA grant ("Investigator-Initiated Trials for AXL driven cancers with high unmet clinical need") totals to NOK 15.1 million and covers the period from February 2017 to January 2021. The Group has recognised NOK 4.0 million in 2019 (2018: NOK 4.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

The third BIA grant ("AXL as a therapeutic target in fibrosis; biology and biomarkers") has been awarded from 2019 and amount up to NOK 10.7 million. The Group has recognised NOK 3.6 million in 2019 (2018: NOK 0.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

Innovation Norway:

BerGenBio has been awarded a NOK 24 million (USD2.85m) grant from Innovasjon Norge to support the clinical development of BGB324 in combination with Merck & Co.'s KEYTRUDA® (pembrolizumab) in patients with advanced lung cancer.

The grant from Innovasjon Norge is an Industrial Development Award (IFU). The IFU program is directed to Norwegian companies developing new products or services in collaboration with foreign companies. BerGenBio received NOK 7.2 million in Q4 2017 of this grant and further NOK 12 mililion in Q3 2019. The grant may be withdrawn under certain circumstances.The Group has recognised NOK 6.3 million in 2019 (2018: NOK 5.4 million) classified as cost reduction of other operating expenses.

SkatteFunn:

R&D projects have been approved for SkatteFunn (a Norwegian government R&D tax incentive program designed to stimulate R&D in Norwegian trade and industry) for the period from 2018 until the end of 2020. The Group has recognised NOK 8.0 million in 2019 (2018: NOK 7.9 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

R&D tax grants UK:

BerGenBio Limited, a 100% subsidary of BerGenBio ASA, has been granted R&D tax grants in UK for 2017 and 2018. R&D grants are approved retrospectively by application. Grants for 2017 and 2018 have been approved and received in 2019. Application for R&D grants are expected to be approved for 2019. The Group has in 2019 recognised NOK 3.2 classified as reduction of payroll and related expenses for the years 2017, 2018 and 2019.

Other operating expenses

For the twelve months ended 31 December
Q4 2019 Q4 2018 2019 2018
Program expenses, clinical trials and
research
38,037 37,829 14, 630 133,699
Office rent and expenses 836 375 2,087 1,950
Consultants R&D projects 7,349 3,481 21,225 10,290
Patent and licence expenses 845 1,012 3,810 3,289
Other operating expenses 3,701 7,714 28,748 28,278
Government grants -4,743 -3,958 -20,727 -18,847
Total 46,026 46,453 176,773 158,658

Earnings per share

For the twelve months ended 31 December 2019 2018 Loss for the period (NOK 1,000) -199,278 -191,747 Average number of outstanding shares during the year 58,030,714 53,284,520 Earnings (loss) per share - basic and diluted (NOK) -3.43 -3.60

Share options issued have a potential dilutive effect on earnings per share. No dilutive effect has been recognized as potential ordinary shares only shall be treated as dilutive if their conversion to ordinary shares would decrease earnings per share or increase loss per share from continuing operations. As the Group is currently loss-making an increase in the average number of shares would have anti-dilutive effects.

Other current assets

31 Dec 2019 31 Dec 2018
Government grants 13,202 15,630
Refundable VAT 1,996 1,356
Prepaid expenses 371 488
Other receivables 249 358
Total 15,818 17,831

Share capital and shareholder information

As of 31 December Number of
shares
Nominal value
(NOK)
Book value
(NOK)
Ordinary shares 2019 61,076,590 0.10 6,107,659,00
Ordinary shares 2018 54,711,446 0.10 5,471,144,60
Changes in the outstanding number of shares For the twelve months ended 31 December
2019 2018
Ordinary shares at 1 January 54,711,446 49,922,200
Issue of ordinary shares 6,365,144 4,789,246
Ordinary shares at 31 December 61,076,590 54,711,446

Ownership structure 31 12 2019

Shareholder Number of
shares
% share of
total shares
METEVA AS 16,458,750 26,9%
INVESTINOR AS 7,270,780 11,9%
VERDIPAPIRFONDET ALFRED BERG GAMBA 2,474,793 4,1%
SARSIA SEED AS 2,117,900 3,5%
VERDIPAPIRFONDET KLP AKSJENORGE 1,937,484 3,2%
KOMMUNAL LANDSPENSJONSKASSE 1,378,322 2,3%
VERDIPAPIRFONDET NORDEA KAPITAL 1,278,740 2,1%
VERDIPAPIRFONDET NORDEA AVKASTNING 1,228,174 2,0%
BERA AS 1,204,800 2,0%
SARSIA DEVELOPMENT AS 1,175,000 1,9%
MP PENSJON PK 1,045,555 1,7%
VERDIPAPIRFONDET NORDEA NORGE VERD 1,039,488 1,7%
VERDIPAPIRFONDET ALFRED BERG NORGE 921,160 1,5%
NORSK INNOVASJONSKAPITAL II AS 806,170 1,3%
ALTITUDE CAPITAL AS 715,000 1,2%
VERDIPAPIRFONDET ALFRED BERG AKTIV 639,296 1,0%
VERDIPAPIRFONDET NORDEA NORGE PLUS 623,060 1,0%
Morgan Stanley & Co. LLC NOM 535,000 0,9%
Skandinaviska Enskilda Banken AB NOM 500,000 0,8%
J.P. Morgan Bank Luxembourg S.A. NOM 482,541 0,8%
Top 20 shareholders 43,832,013 71,8%
Total other shareholders 17,244,577 28,2%
Total number of shares 61,076,590 100,0%

The Board of Directors has been granted a mandate from the general meeting held on 13 March 2019 to increase the share capital with up to NOK 548,514 by subscription of new shares. The power of attorney was granted for the purpose of issuance of new shares in accordance with the Company's share incentive program and is valid until the earlier of the annual general meeting in 2020 and 30 June 2020. In Q1 2019 there was issued 140,000 new shares under this proxy at a nominal value of NOK 14,000 and in Q2 2019 there was issued 190,000 new shares under this proxy at a nominal value of NOK 19,000. In Q3 2019 there was issued 540,000 new shares under this proxy at a nominal value of NOK 54,000. See note 4 for more information about the share incentive program and number of option granted.

The Board of Directors has been granted a mandate from the general meeting held on 13 March 2019 to increase the share capital with up to NOK 1,097,028 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2020 and 30 June 2020. In June 2019 there was issued 5,495,144 shares under this proxy at a nominal value of NOK 549,514.40.

29 January 2020 there was a private placement of 12,215,318 shares. Of this 5,475,136 shares at a nominal value of 547,513.60 have been issued under the proxy granted in the general meeting 13 March 2019 before date of this report. An additional 6,740,182 shares have been placed but issuance of these shares is subject to approval by the General Meeting to be held on 20 February 2020. In addition a subsequent offering of up to 1,500,000 shares has been proposed for approval at the Extraordinary General Meeting, to be held 20 February 2020, furthermore an updated prospectus will be published shortly thereafter.

Shares in the Group held by the management group

Position Employed since 31 Dec 2019 31 Dec 2018
Richard Godfrey 1) Chief Executive
Officer
January 2009 215,449 160,408
James Bradley Lorens Senior Scientific
Adviser
January 2009 280,039 250,000
Total shares held by management 495,488 410,408

1) Richard Godfrey holds 215,449 shares in the Company through Gnist Holding AS.

Shares in the Group held by members of the Board of Directors

Position Served since 31 Dec 2019 31 Dec 2018
Sveinung Hole 1) Chairman September 2010 107,394 0
Stener Kvinnsland Board Member February 2015 104,444 0
Total shares held by members of the Board of Directors 211,838 0

1) Sveinung Hole holds 104,444 shares in the Company through Svev AS, a wholly owned company of Sveinung Hole, and 2,950 shares directly.

Grunde Eirksen (board member) is CEO in Altitude Capital AS. Altitude Capital AS is holding 715,000 shares in BerGenBio ASA at 31 December 2019.

Pension

BerGenBio ASA is required to have an occupational pension scheme in accordance with the Norwegian law on required occupational pension ("lov om obligatorisk tjenestepensjon").

The Company has a pension scheme which complies with the Act on Mandatory company pensions.

Adenocarcinoma Cancerous tumour that can occur in several parts of the body and that forms in mucus-secreting glands throughout
the body. It can occur in many different places in the body and is most prevalent in the following cancer types; lung
cancer, prostate cancer, pancreatic cancer, oesophageal cancer and colorectal cancer. Adenocarcinomas are part
of the larger grouping of carcinomas.
ADCT601 BGB601 (ADCT-601) is an antibody drug conjugate (ADC) composed of a humanised IgG1 antibody against human
AXL that is linked to a cytotoxic. Being developed by ADC Therapeutics
AML Acute myeloid leukaemia.
Anti-AXL MAb Anti-AXL Monoclonal antibody. A monoclonal antibody that recognises AXL and binds to the AXL receptor blocking
its function.
Antibody Proteins produced by the B Lymphocytes of the immune system in response to foreign proteins called antigens.
Antibodies function as markers, biding to the antigen so that the antigen molecule can be recognized and destroyed.
ASCO American Society of Clinical Oncology
AXL Cell surface expressed receptor tyrosine kinase, being an essential mediator of the EMT programme. AXL is up
regulated in a variety of malignancies and and associated with immune evasion, acquired drug resistance and
correlates with poor clinical prognosis.
Anti-AXL MAb AXL Monoclonal antibody. A monoclonal antibody that recognises AXL and binds to the AXL receptor.
Anti-PD-1 Agent that is used to inhibit the PD-1 receptor
Bemcentinib BerGenBio's lead drug candidate; a highly selective inhibitor of AXL currently undergoing Phase Ib/II clinical trials in
a range of aggressive cancers.
Biomarkers A measurable indicator of some biological state or condition. More specifically, a biomarker indicates a change in
expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of
the disease to a given treatment.
Checkpoint inhibitors The immune system depends on multiple checkpoint to avoid overactivation of the immune system on healthy cells.
Tumour cells often take advantage of these checkpoints to escape detection by the immune system. Checkpoint
inhibitors, inhibit these checkpoints by "releasing the brakes" on the immune system to enhance an anti-tumour T
cell response.
Clinical Research The research phases involving human subjects.
Clinical Trials Clinical Trials are conducted with human subjects to allow safety and efficiency data to be collected for health
inventions (e.g., drugs, devices, therapy protocols). There trials can only take place once satisfactory information
has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is
granted in the country where the trial is taking place.
CR Complete response
CRO Contract research organisation.
CTL Cytotoxic T-lymphocytes. Key effector cells of the body's immune response to cancer.
Cytarabine A chemotherapy agent used mainly in the treatment of cancers of white blood cells such as acute
myeloid leukaemia (AML).
DCR Disease control rate
Decitabine A cancer treatment drug used for acute myeloid leukaemia (AML).
Docetaxel A clinically well-established anti-mitotic chemotherapy medication that works by interfering with cell
division.
EHA European Hematology Association
Epithelial state A state of the cell where the cells are stationary, typically forming layers and tightly connected and
well ordered. They lack mobility tending to serve their specific bodily function by being anchored in
place.
EGFR inhibitors Epidermal growth factor receptor inhibitors. EGFRs play an important role in controlling normal cell
growth, apoptosis and other cellular functions, but mutations of EGFRs can lead to continual or
abnormal activation of the receptors causing unregulated EGFR inhibitors are either tyrosine kinase
inhibitors or monoclonal antibodies that slow down or stop cell growth.
EMT Epithelial-mesenchymal transition, a cellular process that makes cancer cells evade the immune
system, escape the tumour and acquire drug resistant properties.

EMT inhibitors Compounds that inhibit AXL and other targets that in turn prevent the formation of aggressive cancer
cells with stem-cell like properties.
Erlotinib A drug used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types
of cancer. It is a reversible tyrosine kinase inhibitor, which acts on epidermal growth factor receptor
(EGFR).
ESMO European Society for Medical Oncology
IHC Immunohistochemistry
In vivo Studies within living organisms.
In vitro Studies in cells in a laboratory environment using test tubes, petri dishes etc.
MAb Monoclonal antibodies. Monospecific antibodies that are made by identical immune cells that are all
clones of a unique parent cell, in contrast to polyclonal antibodies which are antibodies obtained
from the blood of an immunized animal and thus made by several different immune cells.
Mesenchymal state A state of the cell where the cells have loose or no interactions, do not form layers and are less well
ordered. They are mobile, can have invasive properties and have the potential to differentiate into
more specialised cells with a specific function.
Mesenchymal cancer cells Cancer cells in a mesenchymal state, meaning that they are aggressive with stem-cell like
properties.
Metastatic cancers A cancer that has spread from the part of the body where it started (the primary site) to other parts of
the body.
Myeloid leukaemia A type of leukaemia affecting myeloid tissue. Includes acute myeloid leukaemia (AML) and chronic
myelogenous leukaemia.
NSCLC Non-small cell lung cancer.
ORR Overall response rate
Paclitaxel A medication used to treat a number of types of cancer including ovarian cancer, breast cancer, lung
cancer and pancreatic cancer among others.
PD-L1 Programmed death-ligand 1
PFS Progression-free survival
Phase I The phase I clinical trials where the aim is to show that a new drug or treatment, which has proven to
be safe for use in animals, may also be given safely to people.
Phase Ib Phase Ib is a multiple ascending dose study to investigate the pharmacokinetics and
pharmacodynamics of multiple doses of the drug candidate, looking at safety and tolerability.
Phase II The phase II clinical trials where the goal is to provide more detailed information about the safety of
the treatment and its effect. Phase II trials are performed on larger groups than in Phase I.
Phase III In the phase III clinical trials data are gathered from large numbers of patients to find out whether the
drug candidate is better and possibly has fewer side effects than the current standard treatment.
PR Partial Response
Receptor tyrosine kinase High-affinity cell surface receptors for many polypeptide growth factors, cytokines and hormones.
Receptor tyrosine kinases have been shown not only to be key regulators of normal cellular
processes but also to have a critical role in the development and progression of many types of
cancer.
RECIST Response Evaluation Criteria In Solid Tumors, a set of published rules that define when cancer
patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
R/R Relapsed/Refractory
sAXL Soluble AXL
SITC Society ImmunoTherapy Cancer
Small molecule A small molecule is a low molecular weight (<900 Daltons) organic compound that may help regulate
a biological process, with a size on the order of 10-9m.
Squamous cell carcinoma Is an uncontrolled growth of abnormal cells arising in the squamous cells, which compose most of
the skin's upper layers. Squamous cell carcinoma is the second most common form of skin cancer.
T790M Over 50% of acquired resistance to EGFR tyrosine kinase inhibitors is caused by a mutation in
EGFR called T790M
Tilvestamab Former BGB149, BerGenBio's AXL inhibitor antibody, currently completed Phase 1a.
WCLC World Conference on Lung Cancer

Contact us

BerGenBio ASA

Jonas Lies vei 91, 5009 Bergen, Norway Telephone: + 47 535 01 564 E-mail: [email protected]

Investor Relations

Richard Godfrey CEO

Rune Skeie CFO Telephone: + 47 917 86 513 E-mail: [email protected]

Media Relations in Norway

Jan Petter Stiff, Crux Advisers Telephone: +47 995 13 891 E-mail: [email protected]

International Media Relations

Mary-Jane Elliot, Chris Welsh, Lucy Featherstone, Nicholas Brown, Carina Jurs & Taiana De Ruyck Soares Consilium Strategic Communications Telephone: +44 20 3709 5700 E-mail: [email protected]

Analyst coverage

H.C. Wainwright & Co

Joseph Pantginis Telephone: +1 646 975 6968 E-mail: [email protected]

ABG Sundal Collier

Arctic Securities

Telephone:+47 229 37 229 E-mail: [email protected]

Pål Falck

Viktor Sundberg Telephone: +46 8 566 286 41 E-mail: [email protected]

Jones Trading

Soumit Roy Telephone: +1 646 454 2714 E-mail: [email protected]

Sponsored analyst research:

Trinity Delta

Mick Cooper, PhD Telephone: +44 20 3637 5042 mcooper@trinitydelta.org

Link to reports from Trinity Delta: https://www.bergenbio.com/investors/analyst-coverage/

Disclaimer

This Report contains certain forward-looking statements relating to the business, financial performance and/or results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in this Report, including assumptions, opinions and views of the Company or cited from other sources are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. None of the Company or any of their parent or subsidiary undertakings or any such person's officers or employees provides any assurance that the assumptions underlying such forward-looking statements are free from errors nor do any of them accept any responsibility for the future accuracy of the opinions expressed in this Presentation or the actual occurrence of the forecasted developments. The Company assumes no obligation, except as required by law, to update any forward-looking statements or to conform these forward-looking statements to our actual results.

Telephone: + 47 535 01 564 E-mail: [email protected]

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