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BerGenBio

Quarterly Report Nov 15, 2022

3555_iss_2022-11-15_2038b068-6b6b-4727-812d-f0745ce586fb.pdf

Quarterly Report

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INTERIM REPORT THIRD QUARTER 2022

Table of Contents

Q3 2022 CORPORATE

"The recent initiation of two clinical trials and bolstering of our cash position has been transformational for the Company as we continue to execute on our strategy.

Mounting evidence substantiates that AXL plays a significant role in exacerbating many severe cancers and respiratory diseases.

We believe that AXL inhibition by our lead compound, bemcentinib, can make a lifechanging difference in patients suffering from STK11m NSCLC and hospitalized COVID -19."

Martin Olin Chief Executive Officer

Ø Randomized first patient in the Phase 2b EU-SolidAct platform for hospitalized COVID-19 patients

Ø Initiated Phase 1b/2a trial in 1st line NSCLC patients harboring STK11 mutations

Ø In a difficult financial environment BerGenBio strengthened its financial position by securing a NOK 100 million loan facility from its largest shareholder. In addition to the cash position of NOK 225 million end of September 2022 the loan facility enables the Company to continue pursuing its focused strategy.

Q3 2022 FINANCIAL

Key financial figures

(NOK million) Q3 2022 Q3 2021 YTD 2022 YTD 2021 FY 2021
Operating revenues 0,0 0,0 0,0 0,0 0,8
Operating expenses 62,4 71,4 229,2 247,1 315,2
Operating profit (-loss) -62,4 -71,4 -229,2 -247,1 -314,5
Profit (-loss) after tax -59,8 -70,5 -224,9 -240,6 -309,4
Basic and diluted earnings (loss) per
share (NOK) -0.67 -0.80 -2.54 -2.74 -3.52
Net cash flow in the period -65,0 -61.7 -206,5 -208,2 -284,2
Cash position end of period 225,1 509,4 225,1 509,4 436,6

Operating loss

Cash flow

Cash position

Q3 2022 QUARTERLY

Clinical Development

Bemcentinib

BerGenBio's lead compound, bemcentinib, is a potentially first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in a number of deleterious effects in cancer and severe respiratory diseases. Bemcentinib inhibits AXL activation to prevent the progression of serious disease through the modulation of resistance mechanisms and the adaptive immune system.

BerGenBio is advancing bemcentinib in two lung indications, STK11 mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19 patients, where bemcentinib's novel mechanisms of action and primary accumulation in the lungs make it uniquely positioned to address significant unmet medical needs.

First-Line STK11m NSCLC

Subsequent to the quarter end, BerGenBio announced in October the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care in 1st line NSCLC, the checkpoint inhibitor pembrolizumab and platinum doublet chemotherapy, for the treatment of 1st line NSCLC patients harboring STK11 mutations.

Approximately 20% of non-squamous NSCLC patients harbor STK11 mutations, which are a recognized resistance mechanism for anti-PD-1/L1 therapy and currently result in a poor prognosis with standard of care treatment in 1st line NSCLC. The Company believes that STK11m patients almost universally express AXL, causing a severely immunosuppressed tumor microenvironment, the development of drug resistance, immune evasion and metastasis. Preclinical and clinical data suggest that bemcentinib's inhibition of AXL on immune and cancer cells sensitizes STK11m NSCLC patients to checkpoint inhibitors and improves the effects of chemotherapy.

The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in 1st line untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no other actionable comutations. The first patient is expected to begin treatment in the fourth quarter of 2022.

Q3 2022 QUARTERLY

Hospitalized COVID-19 Patients

BerGenBio announced in September that the first patient was randomized in a Phase 2b trial evaluating bemcentinib in hospitalized COVID-19 patients. The trial is part of the EU-SolidAct platform, a pan-European research project designed to investigate treatment options for hospitalized patients with COVID-19 and emerging infectious diseases.

Higher levels of AXL expression and activation caused by COVID-19 infection have been linked to an increase in disease severity. The interaction of AXL and SARS-CoV-2 is believed to promote the entry and enhancement of infection in pulmonary and bronchial epithelial cells. Through the inhibition of AXL, bemcentinib blocks viral entry, stimulates the innate immune system and promotes lung tissue repair.

The Phase 2b, multi-center, randomized, placebo-controlled trial will enroll up to 500 patients, includes 68 clinical sites in 8 countries and is sponsored by Oslo University Hospital, Norway, in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France, and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN).

Update on Relapsed/Recurrent AML (BGBC003) and 2L NSCLC (BGBC008) studies

In study BGBC003 of Relapsed/Recurrent AML patients, the last patient completed their last visit in late Q2, with database lock completed in Q3. In study BGBC008 of 2L NSCLC patients, the last patient's last visit occurred in Q4 2022. The Company expects to provide results of these studies following database lock and subsequent data analysis in H1 of 2023.

Corporate Activities

Following the end of the third quarter, BerGenBio announced in October that it secured up to NOK 100 million as a shareholder loan facility from Meteva AS, a 27.23% shareholder in BerGenBio. In addition to the Company's existing cash position, the facility will enable BerGenBio to continue advancing its lead compound, bemcentinib, in 1L STK11m NSCLC and hospitalized COVID-19 patients.

Interim Report Third Quarter 2022

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 are holding part of the 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 2022 and the Group considers its credit risk as low.

Funding and liquidity risk

Liquidity is monitored on a continuing 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.

Funding of ongoing operations is and will be for some time depending on external sources, mainly equity contributions. Significant changes to financial market conditions, may affect the climate for investor investments.

In October 2022 the Company secured a shareholder loan facility of up to NOK 100 million and the Groups liquidity situation is considered to be satisfactory.

Non-financial risks

Technology risk

The Group's lead product candidate, bemcentinib, 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.

Patent and IP risks

The success of the company will highly depend on the company's ability to obtain and maintain patent protection for its products, methods, processes and other technologies, to prevent third parties from infringing proprietary rights of the company and to operate without infringing the proprietary rights of third parties. To date, the company holds certain exclusive patent rights in major markets. The patent rights are limited in time. The company cannot predict the range of protection any patents will afford against competitors and competing technologies, including whether third parties will find ways to invalidate the patents, obtain patents claiming aspects similar to those covered by the company's patents and patents applications, and whether the company may be subject to litigation proceedings.

Regulatory & Commercial 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.

COVID-19

The long-term impact of the COVID-19 crisis remains unclear although no greater for BerGenBio than any other business in the sector. Our ability to conduct clinical trials at the expected pace is a risk factor in the evolving pandemic.

FINANCIAL

Financial Results

(Figures in brackets = same period 2021 unless stated otherwise)

Revenue for the third quarter 2022 amounted to NOK 0.0 million (NOK 0.0 million) and year to date (YTD) 2022 NOK 0.0 million (NOK 0 million).

Total operating expenses for the third quarter 2022 amounted to NOK 62.4 million (NOK 71.4 million) and YTD 2022 NOK 229.2 million (NOK 247.1 million).

Payroll and other employee related cost in the third quarter were NOK 13.6 million (NOK 26.7 million) and YTD 2022 NOK 49.8 million (NOK 57.3 million). The decrease in the quarter and YTD year on year is related to severance payment to departing CEO in Q3 2021 and the effect of decreased headcount due to rightsizing of the organization in connection with the company's focused strategy announced in May 2022.

Employee share option costs in the third quarter were NOK 0.5 million (NOK -0.6 million) and YTD 2022 NOK 1.3 million (NOK 1.9 million). The decrease YTD year on year is a non-cash effect of decrease in accruals for national insurance cost driven by a decrease in the share price.

Other operating expenses amounted to NOK 48.2 million (NOK 45.0 million) for the third quarter and NOK 177.3 million (NOK 187.0 million) YTD. Operating expenses are mainly driven by activities in the development programs.

The operating loss for the third quarter amounts to NOK 62.4 million (NOK 71.4 million) and YTD 2022 NOK 229.2 million (NOK 247.1 million), reflecting the level of activity related to the development programs BerGenBio is conducting.

Net financial items amounted to a profit of NOK 2.6 million (profit of NOK 0.9 million) for the third quarter related to net gain on foreign exchanges and interest on cash deposit. YTD 2022 the net financial items amounted to a profit of NOK 4.3 million (profit of NOK 6.5 million).

Losses after tax for the third quarter were NOK 59.8 million (NOK 70.5 million) and YTD 2022 NOK 224.9 million (NOK 240.6 million).

Financial Position

Total assets as of 30 September 2022 decreased to NOK 235.5 million (NOK 306.0 million as of 30 June 2022) mainly due to the operational loss in the period.

Total liabilities were NOK 70.6 million as of 30 September 2022 (NOK 82.0 million as of 30 June 2022).

Total equity as of 30 September 2022 was NOK 164.9 million (NOK 224.0 million as of 30 June 2022), corresponding to an equity ratio of 70.0% (73.2% as of 30 June 2022).

Cash Flow

Net cash flow to operating activities was NOK 65.8 million in the third quarter (NOK 67.2 million) and NOK 210.7 million YTD 2022 (NOK 223.8 million), mainly driven by the level of activity in the development programs.

Net cash flow from investing during the third quarter was NOK 0.8 million (NOK 0.4 million) and YTD 2022 NOK 1.3 million (NOK 0.6 million).

Net cash flow from financing activities in the third quarter 2022 was NOK 0 million (NOK 5.0 million) and YTD 2022 NOK 2.9 million (NOK 15.0 million).

Cash and cash equivalents decreased to NOK 225.0 million by 30 September 2022 (NOK 292.1 by 30 June 2022 and NOK 509.4 by 30 September 2021).

Outlook

The Board's aim is to continue its work towards a number of upcoming milestones, to be achieved across the Company's oncology and infectious diseases pipeline.

The Company has reiterated its focus on the clinical development of bemcentinib within NSCLC STK11m and respiratory diseases (initially COVID-19). Each of the therapeutic areas represents in the opinion of the Board attractive commercial opportunities.

With the announcement of the shareholder loan facility of up to NOK 100 million in October 2022 the Company has secured liquidity to progress its activities and with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders.

The Board today considered and approved the condensed, consolidated financial statement of the nine months ending 30 September 2022 for BerGenBio.

Bergen 14 November 2022

Board of Directors and CEO of BerGenBio ASA

Anders Tullgren, Chairman Sally Bennett

Sveinung Hole François Thomas

Debra Barker Martin Olin, CEO

Condensed consolidated statement of profit and loss and other comprehensive income

(NOK 1000) Unaudited Note Q3 2022 Q3 2021 YTD 2022 YTD 2021 FY 2021
Revenue 0 0 0 0 774
Expenses
Payroll and other related employee
cost
3, 10 13,621 26,669 49,847 57,297 69,929
Employee share option cost 3 481 -562 1,272 1,851 4,116
Depreciation 2 140 335 771 1,005 1,312
Other operating expenses 6 48,186 44,977 177,342 186,990 239,880
Total operating expenses 62,428 71,419 229,231 247,143 315,237
Operating profit (-loss) -62,428 -71,419 -229,231 -247,143 -314,464
Finance income 6,420 3,028 12,793 11,966 15,993
Finance expense 3,789 2,107 8,495 5,420 10,894
Financial items, net 2,631 920 4,298 6,545 5,100
Profit (-loss) before tax -59,797 -70,498 -224,933 -240,598 -309,364
Income tax expense 0 0 0 0 0
Profit (-loss) after tax -59,797 -70,498 -224,933 -240,598 -309,364
Other comprehensive income
Items that may be reclassified to profit
and loss in subsequent periods
Translation effects 276 0 231 0 -112
Total comprehensive income (-loss)
for the period
-59,520 -70,498 -224,702 -240,598 -309,476
Earnings per share:
- Basic and diluted per share 7 -0.67 -0.80 -2.54 -2.74 -3.52

Condensed consolidated statement of financial position

(NOK 1000) Unaudited Note 30 SEP 2022 30 SEP 2021 31 DEC 2021
ASSETS
Non-current assets
Property, plant and equipment 156 1,498 1,191
Total non-current assets 156 1,498 1,191
Other current assets 5, 8 10,289 4,086 12,398
Cash and cash equivalents 225,072 509,408 436,646
Total current assets 235,361 513,494 449,045
TOTAL ASSETS 235,517 514,992 450,236
EQUITY AND LIABILITIES
Equity
Paid in capital
Share capital 9 8,866 8,825 8,846
Share premium 9 113,684 400,875 335,195
Other paid in capital 4, 9 42,349 38,219 40,386
Paid in, not registered capital 9 0 2,201 2,201
Total paid in capital 164,899 450,120 384,426
Total equity 164,899 450,120 384,426
Non-current liabilities
Long term debt 0 1,016 942
Total non-current liabilities 0 1,016 942
Current liabilities
Accounts payable 32,218 22,283 26,726
Other current liabilities 38,400 40,572 37,172
Provisions 0 1,002 969
Total current liabilities 70,618 63,857 64,868
Total liabilities 70,618 64,872 65,810
TOTAL EQUITY AND
LIABILITIES
235,517 514,992 450,236

Condensed consolidated statement of changes in equity

(NOK 1000) Unaudited Note Share
capital
Share
premium
Other paid in
capital
Paid in, not
registered
Total
equity
Balance as of 1 January 2022 8,846 335,195 40,386 0 384,426
Loss for the period -224,933 -224,933
Other comprehensive income (loss) for the
period, net of income tax
231 231
Total comprehensive income for the
period
0 -224,702 0 0 -224,702
Recognition of share-based payments 3, 4 1,964 1,964
Issue of ordinary shares 9 21 3,198 3,218
Share issue costs 9 -7 -7
Transactions with owners 21 3,191 1,964 0 5,175
Balance as of 30 September 2022 8,866 113,684 42,349 0 164,899
(NOK 1000) Unaudited NoteShare capital Share
premium
Other paid in
capital
Paid in, not
registered
Total
equity
Balance as of 1 January 2021 8,726 628,231 33,272 0 670,229
Loss for the period -240,598 -240,598
Other comprehensive income (loss) for the
period, net of income tax
0 0
Total comprehensive income for the
period
0 -240,598 0 0 -240,598
Recognition of share-based payments 3, 4 4,947 4,947
Issue of ordinary shares 9 99 13,279 13,378
Share issue costs 9 -38 -38
Paid in, not registered capital 2,201 2,201
Transactions with owners 99 13,241 4,947 2,201 20,489
Balance as of 30 September 2021 8,825 400,875 38,219 2,201 450,120

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited Note Q3 2022 Q3 2021 YTD 2022 YTD 2021 FY 2021
Cash flow from operating activities
Loss before tax -59,520 -70,498 -224,702 -240,598 -309,476
Adjustments for:
Depreciation of property, plant and
equipment
140 335 771 1,005 1,312
Share-based payment expense 3, 4 421 433 1,964 4,947 7,113
Movement in provisions and pensions 0 -1,437 -969 -5,006 -5,039
Currency gains not related to operating
activities
2,023 2,935 5,065 3,998 779
Net interest received -480 -419 -1,009 -558 -3,130
Working capital adjustments:
Decrease in trade and other
receivables and
prepayments
3,036 4,823 2,109 10,142 1,830
Increase in trade and other payables -11,447 -3,352 6,051 2,234 3,270
Net cash flow from operating activities -65,828 -67,179 -210,721 -223,835 -303,340
Cash flows from investing activities
Net interest received 480 419 1,009 558 3,130
Sale of property, plant and equipment 299 0 299 0 0
Net cash flow from investing activities 778 419 1,308 558 3,130
Cash flows from financing activities
Proceeds from issue of share capital 9 0 5,292 3,218 15,579 16,629
Share issue costs 9 0 0 -7 -38 -70
Repayment of lease liabilities 0 -221 -307 -499 -565
Net cash flow from financing activities 0 5,071 2,904 15,043 15,995
Effects of exchange rate changes on
cash and cash equivalents
-2,023 -2,935 -5,065 -3,998 -779
Net increase/(decrease) in cash and
cash equivalents
-65,049 -61,689 -206,509 -208,235 -284,216
Cash and cash equivalents at beginning
of period
292,144 574,033 436,646 721,641 721,641
Cash and cash equivalents at end of
period
225,072 509,408 225,072 509,409 436,646

SELECTED NOTES TO THE INTERIM CONSOLIDATED FINANCIAL

Note 1 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 cancers and patients hospitalized with COVID-19.

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 three-months period ended 30 September 2022 and were approved for issue by the Board of Directors on 14 November 2022.

Note 2

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 2021.

The new and amended standards and interpretations from IFRS that were adopted by the EU with effect from 2021 did not have any significant impact on the reporting for Q3 2022.

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

Amounts are in Norwegian kroner (NOK) unless stated otherwise. The functional currency of the group is NOK. BerGenBio Limited has changed functional currency to GBP from 1 November 2021.

Basis for consolidation

The consolidated financial statements comprise the financial statements of the Company and its subsidiary as of 30 September 2022. 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. The company secured in total NOK 740 million in new equity funding during 2020. Cash position at end of Q3 2022 was NOK 225 million, and with the addition of the up to NOK 100 million shareholder loan facility announced in October 2022 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.

Payroll and related expenses

(NOK 1000)
Q3 2022 Q3 2021 YTD 2022 YTD 2021
Salaries 10,885 22,827 41,586 48,540
Social security tax 2,087 3,263 5,494 6,429
Pension expenses 899 1,210 3,206 3,272
Short term incentive 0 0 0 0
Other remuneration and employee expenses 93 239 588 684
Government grants 1) -342 -870 -1,027 -1,628
Total payroll and other employee related cost 13,621 26,669 49,847 57,297
Share option expense employees 421 433 1,964 4,947
Change in accrued social security tax on share
options
59 -996 -692 -3,096
Total employee share option cost 481 -562 1,272 1,851
Total employee benefit cost 14,102 26,107 51,119 59,148
Average number of full time equivalent employees 34 45

1) See also note 5 for government grants

Employee share option program

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

The program ensures focus and aligns 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 attract and retain 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.

Primarily the options vest annually in equal tranches over a three-year period following the date of grant.

0 options were granted in the nine months period ended 30 September 2022 and 1.379.871 options were granted in the nine months period ended 30 September 2021.

Balance as of 30 September 2,396,473 22.21 3,703,766 22.76

Vested options First nine months
2022 2021
Options vested as of 1 January 1,541,168 1,887,201
Exercised and forfeited in the period -713,088 -1,153,195
Vested in the period 832,844 847,160
Options vested as of 30 September 1,660,924 1,581,166
Total outstanding number of options 2,396,473 3,703,766

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. 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 valuation purposes 66,54 % expected future volatility has been applied.

For the nine months period ending 30 September the value of the share options expensed through the profit or loss amounts to NOK 2.0 million (for the same period in 2021: NOK 4.9 million). In addition, a change in provision for social security contributions on share options of NOK -0.7 million (for the same period in 2021: NOK - 3.1 million). The provision for social security contribution is calculated on the difference between the share price and exercise price on exercisable option as at the end of the period.

Members of senior management participating in the option program

Option holder Position Number of
options
outstanding
30 Sep 2022
Weighted
Average
Strike Price
2022
Number of
options
outstanding
30 Sep 2021
Weighted
Average
Strike Price
2021
Rune Skeie Chief Financial Officer 297,097 22,71 297,097 22,71
James Barnes Chief Operating Officer 301,522 19,85 301,522 19,85
598,619 598,619

Government grants

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

(NOK 1000)
Q3 2022 Q3 2021 YTD 2022 YTD 2021
Employee benefit expenses 342 870 1,027 1,628
Other operating expenses 1,242 578 4,069 1,730
Total 1,584 1,447 5,096 3,358

Grants receivable as of 30 September are detailed as follows:

30 Sep
2022
30 Sep
2021
Grants from Research Council, BIA 172 189
Grants from Research Council, PhD 132 130
Grants from SkatteFunn 3,562 0
Grants R&D UK 4,323 2,640
Total grants receivable 8,189 2,959

BIA grants from the Research Council of Norway:

Company currently has one grant from the Research Council, program for user-managed innovation arena (BIA) in 2022.

The 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 recognized NOK 0.3 million in Q3 2022 (Q3 2021: NOK 1.7 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses

PhD grants from the Research Council of Norway:

BerGenBio was awarded two grants supporting industrial PhD's in 2020. The fellowship covers 50 % of the established current rates for doctoral research fellowships and an operating grant to cover up to 50 % of additional costs related to costly laboratory testing connected with the research fellow's doctoral work.

The Group has recognized NOK 1.2 million in Q3 2022 (Q3 2021 : NOK 1.2 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 (USD 2.85 million) grant from Innovation Norway to support the clinical development of BGB324 in combination with Merck & Co.'s KEYTRUDA® (pembrolizumab) in patients with advanced lung cancer. The grant from Innovation Norway 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 has by end of 2020 recognized and received the total grant of NOK 24 million. The grant may be withdrawn under certain circumstances.

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 2021 until the end of 2023. The Group has recognized NOK 3.6 million in Q3 2022 (Q3 2021: NOK 0.0 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% subsidiary of BerGenBio ASA, has been granted R&D tax grants in UK from 2017. R&D grants are approved retrospect by application. The Group has in first nine months 2022 recognized NOK 0.0 (first nine months year 2021: NOK 0.0 mill).

Other operating expenses

(NOK 1000) Q3 2022 Q3 2021 YTD 2022 YTD 2021
Program expenses, clinical trials and research 40,955 29,413 146,010 148,196
Office rent and expenses 977 623 2,699 1,618
Consultants R&D projects 1,467 2,507 5,686 10,330
Patent and licence expenses 1,288 1,496 4,626 5,570
Other operating expenses 4,741 11,516 22,389 23,006
Government grants -1,242 -578 -4,069 -1,730
Total 48,186 44,977 177,342 186,990

Earnings per share

Q3 2022 Q3 2021 YTD 2022 YTD 2021
Loss for the period (NOK 1,000) -59,520 -70,498 -224,702 -240,598
Average number of outstanding
shares during the period
88,660,532 88,081,614 88,628,391 87,801,061
Earnings (loss) per share -
basic and diluted (NOK)
-0.67 -0.80 -2.54 -2.74

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

(NOK 1000) 30 Sep 2022 30 Sep 2021
Government grants 8,189 2,959
Refundable VAT 134 0
Prepaid expenses 1,680 1,067
Other receivables 286 60
Total 10,289 4,086

Share capital and shareholder information

As of 30 September Number of
shares
Nominal value
(NOK)
Book value
(NOK)
Ordinary shares 2022 88,660,532 0.10 8,866,053.20
Ordinary shares 2021 88,247,755 0.10 8,824,775.50
Changes in the outstanding number of shares YTD 2022 YTD 2021
Ordinary shares as of 1 January 88,455,255 87,259,983
Issue of ordinary shares 205,277 977,772
Ordinary shares as of 30 September 88,660,532 88,247,755

Ownership structure 30 09 2022:

Shareholder Number of
shares
% share of
total shares
METEVA AS 24,139,650 27.2 %
INVESTINOR DIREKTE AS 7,270,780 8.2 %
FJARDE AP-FONDEN 4,487,493 5.1 %
SARSIA SEED AS 2,117,900 2.4 %
J.P. Morgan SE NOMINEE I 1,726,731 1.9 %
BERA AS 1,712,426 1.9 %
VERDIPAPIRFONDET NORDEA AVKASTNING 1,510,174 1.7 %
SARSIA DEVELOPMENT AS 1,175,000 1.3 %
VERDIPAPIRFONDET NORDEA NORGE PLUS 909,260 1.0 %
VERDIPAPIRFONDET NORDEA KAPITAL 889,920 1.0 %
VERDIPAPIRFONDET NORDEA NORGE VERD 864,688 1.0 %
MARIT MOHN 850,000 1.0 %
MARSTIA INVEST AS 850,000 1.0 %
VERDIPAPIRFONDET KLP AKSJENORGE IN 568,766 0.6 %
LOUISE MOHN 509,676 0.6 %
J.P. Morgan SE NOMINEE II 430,541 0.5 %
NORDNET LIVSFORSIKRING AS 390,764 0.4 %
HØSE AS 383,111 0.4 %
MP PENSJON PK 372,783 0.4 %
RO INVEST AS 350,000 0.4 %
Top 20 shareholders 51,509,663 58.1 %
Total other shareholders 37,150,869 41.9 %
Total number of shares 88,660,532 100.0 %

The Board of Directors has been granted a mandate from the general meeting held on 28 April 2022 to increase the share capital with up to NOK 883,605 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 2023 and 30 June 2023. 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 28 April 2022 to increase the share capital with up to NOK 1,773,210 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2023 and 30 June 2023.

Shares in the Group held by the management group

Position Employed since 30 Sep 2022 30 Sep 2021
Martin Olin Chief Executive
Officer
September 2022 37,100 0
Total shares held by management 37,100 0

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

Position Served since 30 Sep 2022 30 Sep 2021
Anders Tullgren Chairman January 2022 50,000 0
Sveinung Hole 1) Board member September 2010 107,394 107,394
Total shares held by members of the Board of Directors 157,394 107,394

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.

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.

MEDICAL AND BIOLOGICAL

ACCORD Accelerating COVID-19 Research & Development
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
ASH American Society of Hematology
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 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.
cAXL Composite AXL
CDx Companion diagnostics
Checkpoint inhibitors The immune system depends on multiple checkpoints 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.
CPI Immune checkpoint inhibitor
CR Complete response
CRi Complete response with incomplete recovery of peripheral counts
CRO Contract research organisation.
DCR Disease control rate
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.
23
ESMO European Society for Medical Oncology
The EU-SolidAct trial is part of EU-RESPONSE, a pan-European research project involved with rapid
EU-SolidAct and coordinated investigation of new and repurposed medication to treat Covid-19 during the
ongoing pandemic. EU-SolidAct is an Adaptive Platform Trial.
FDA Food and Drug Administration
Glioblastoma Is the most aggressive of the gliomas, a collection of tumours arising from glia or their precursors
within the central nervous system. Gliomas are divided into four grades, grade 4 or glioblastoma
multiforme (GBM) is the most aggressive of these and is the most common in humans.
HR-MDS High Risk Myelodysplastic Syndromes
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.
MDS Myelodysplastic Syndrome
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
PDAC Pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer and a notoriously
lethal disease
PD-1 Programmed death 1
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
SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2
sAXL Soluble AXL
SITC Society for Immunotherapy of Cancer
SoC Standard of care
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.
Tilvestamab Former BGB149, BerGenBio's AXL inhibitor antibody.
UKRI UK Research and Innovation
WCLC World Conference on Lung Cancer

Contact us

BerGenBio ASA

Jonas Lies vei 91, 5009 Bergen, Norway Telephone: + 47 53 50 15 64 E-mail: [email protected] Investor Relations [email protected]m

Graham Morrell Head of IR

Martin Olin CEO

Rune Skeie CFO

Analyst coverage

H.C. Wainwright & Co

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

DNB Markets

Geir Hiller Holom

Telephone: +47 977 66 583 E-mail: geir.hiller.holom@dnb.no

Patrik Ling

Telephone: +46 8 473 48 43 E-mail: patrik.ling@dnb.se

Carnegie

Arvid Necander Telephone: +46 8 5886 8846 E-mail: arvid.necander@carnegie.se

Ulrik Trattner Telephone: +46 8 5886 8589 E-mail: ulrik.trattner@carnegie.se

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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