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BerGenBio

Quarterly Report May 24, 2022

3555_rns_2022-05-24_4a87cad5-a90a-4669-926d-8bfd8d08ff7f.pdf

Quarterly Report

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INTERIM REPORT FIRST QUARTER 2022

Table of Contents

  • CEO Statement
  • Highlights for the first quarter 2022
  • Key Financial Figures
  • Overview & R&D Pipeline
  • Strategic priorities & outlook
  • Risk and uncertainties
  • 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 and Analyst coverage

Richard Godfrey Chief Executive Officer of BerGenBio Martin Olin Chief Executive Officer at BerGenBio

"I am pleased to provide an update to shareholders on our main activities and achievements during the 1st quarter of 2022.

Earlier this month, we provided an update on the Company's strategy. BerGenBio's mission remains unchanged, and we believe that the announced focus provides an optimal path to unlock the potential of AXL inhibition as a transformative treatment modality for severe diseases.

By focusing the development of our lead asset bemcentinib on two key areas, STK11 mutated (STK11m) 1st line non-small cell lung cancer (NSCLC) and COVID-19, we believe we have defined the path to efficiently advance BerGenBio's clinical and commercial potential. Both indications represent significant unmet medical needs and our defined plans for each of these indications provides a strong foundation for bringing new drugs to market with the aim of achieving better outcomes for patients and the generation of significant value for our shareholders.

Lung cancer of which NSCLC accounts for approx. 85% is the biggest cancer killer in both women and men. Each year more than 200.000 people are diagnosed and more than 150.000 die from lung cancer. Although, treatment with immune checkpoint inhibitors (ICIs) has transformed the outcome for many patients a large portion of NSCLC patients do not benefit from treatment with ICIs due to resistance or molecular drivers.

A mutation in the STK11/LBK1 gene represents such a driver mutation and is present in up to 20% of NSCLC patients – showing poor response to standard of care therapy with ICI. We believe bemcentinib potentially offers a transformative treatment modality for this significant unmet medical need. Bemcentinib has been shown to restore the activity of ICIs in preclinical studies and we have early clinical data in STK11m patients indicating response to bemcentinib in combination with the immune checkpoint inhibitor pembrolizumab.

Richard Godfrey Chief Executive Officer of BerGenBio Martin Olin Chief Executive Officer at BerGenBio

We are in an advantageous strategic position. Bemcentinib is the only selective AXL inhibitor in development for STK11m patients and has been grated Fast Track status by the FDA. With STK11 recognized as a predictor of poor outcome in NSCLC patients, with no specific therapeutic approaches available today, we believe there is a potential for an accelerated approval pathway. Additionally, we are continuing our collaboration with UT Southwestern Medical Center (Texas) to further enhance the understanding of bemcentinib role and mode of action relevant to the STK11 mutation. The exclusive license to inventions relevant for bemcentinib in STK11 mutations provides us with a strong position in pursuing this significant opportunity.

We are currently preparing to initiate a Phase Ib/2a study in STK11m NSCLC patients in the second half of 2022.

COVID-19 is a novel variant of SARS-COV-2 leading to severe implications for some patients being infected. Despite the success of vaccine programs and recent approvals of new therapies more than three million deaths have been reported due to COVID-19 in the last twelve months and we believe that a medical need for effective treatments for hospitalized patients remains.

We are encouraged by the strong efficacy signal of bemcentinib recently reported from the ACCORD2 study of hospitalized COVID-19 patients. We believe that bemcentinib has potential as a treatment with broad variant coverage, with a mode of action likely to be unaffected by future viral mutations.

Bemcentinib had been accepted into the EUSolidAct platform where it will be assessed in up to 500 hospitalized COVID-19 patients. If the positive results from the ACCORD2 trial are replicated in the larger EU-SolidAct study, the Company believes that this could warrant Emergency Use Authorizations, based on precedents.

We have recently strengthened the senior leadership team with the appointment of Cristina Oliva as our new Chief Medical Officer. Cristina has extensive leadership experience leading oncology drug development programs across big pharma, biotech and CRO environments.

Tilvestamab and other potential indications for bemcentinib such as 2nd line NSCLC, 2nd line AML and MDS, will in accordance with the priorities described be de-prioritized for the time being.

With a focused strategy and rightsized organization, I believe we are well positioned to unlock significant potential value related to the two indications selected and define the path to market."

Martin Olin CEO

Operational Highlights Q1 2022 (including post-period end)

  • Post-period end, business strategy update announced, focusing on two key indications; 1st line STK11m non-small cell lung cancer (NSCLC) and COVID-19.
  • Primary endpoint met in hospitalized COVID-19 patients in complete data analysis of ACCORD2 (BGBIL019), a randomized phase II study of bemcentinib in combination with standard of care (SoC) therapy.
  • Presented clinical trial data from Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) at 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
  • Cristina Oliva, MD appointed as Chief Medical Officer, bringing over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and Clinical Research Organizations.
  • Publication of a peer-reviewed article entitled "AXL targeting restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through expansion of TCF1+ CD8+ T cells" in the journal Cell Reports Medicine.
  • Announced inclusion of bemcentinib, in the EUSolidAct platform study of hospitalized COVID-19 patients designed to enroll up to 500 patients across European centers participating in the EUSolidAct platform.

Financial Highlights – first quarter 2022

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

  • Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the first quarter 2022
  • Total operating expenses for the first quarter were NOK 78.6 million (NOK 83.4 million)
  • The operating loss for the first quarter came to NOK 78.6 million (NOK 83.4 million)
  • Cash and cash equivalents amounted to NOK 367.8 million at the end of the first quarter 2022 (NOK 436.6 million by end of December 2021)

Q1 2022 FINANCIAL

Key financial figures

(NOK million) Q1 2022 Q1 2021 FY 2021
Operating revenues 0,0 0,0 0,8
Operating expenses 78,6 83,4 315,2
Operating profit (-loss) -78,6 -83,4 -314,5
Profit (-loss) after tax -81,1 -81,2 -309,4
Basic and diluted earnings (loss) per share (NOK) -0.92 -0.93 -3.52
Net cash flow in the period -71,1 -62,7 -284,2
Cash position end of period 367,8 659,4 436,6

Operating loss

Cash flow

Cash position

OVERVIEW &

In May 2022 BerGenBio announced an updated strategy based on two key indications; 1st line non-small cell lung cancer (NSCLC) and COVID-19, which the Company believes offer the optimal path towards translating BerGenBio's strong scientific foundation into significant value generation.

Non-Small Cell Lung Cancer (NSCLC)

Lung cancer of which NSCLC accounts for 85% is the largest cancer indication with more than 200.000 patients diagnosed each year and more than 150.000 deaths annually. While ICIs have transformed the treatment of NSCLC (and other cancers) a large subset of NSCLC patients do not benefit from the treatment with ICIs due to resistance and/or molecular drivers. STK11 mutations represent such a molecular driver / resistance situation and is present in up to 20% of NSCLC cases. STK11 mutations have been reported by multiple sources to be a poor prognostic factor, showing little or no benefit of ICI treatment.

Preclinical and clinical data has identified the patients with STK11 mutation as a population who may benefit from treatment with bemcentinib. In March a peer-reviewed article in the journal Cell Reports Medicine identified AXL as a critical targetable driver of immune suppression in STK11/LKB1 mutated NSCLC. The latest data was announced at SITC in November. In pre-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1 blockade was evaluated in the absence and presence of bemcentinib. Systemic inhibition of AXL with bemcentinib resulted in the expansion of tumor associated T cells and restored therapeutic response to anti-PD-1 check point inhibition.

In parallel, data from our Phase II bemcentinib and pembrolizumab combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable patients with identified STK11 mutations demonstrated objective clinical response / clinical benefit to the combination of bemcentinib and pembrolizumab.

In November 2021, we received FDA Fast Track designation for bemcentinib in combination with an anti-PD1/L1 agent as treatment for patients with STK11 altered advanced/metastatic NSCLC without actionable mutations. We have secured an exclusive license to intellectual property covering the treatment of STK11 patients with bemcentinib and plan to initiate a safety and efficacy combination trial assessing bemcentinib in combination with anti PD-L1 immunotherapy and chemotherapy in first line NSCLC.

OVERVIEW &

COVID-19

Although several treatment modalities have been rapidly developed and adopted during the pandemic, there is still a large number of hospitalized patients that remain in need of improved therapeutic options for COVID-19 and we believe that there is still a need for better inhospital oral treatments to improve patient outcomes.

We believe that the mechanism of action of bemcentinib limits progression of acute lung injury caused by respiratory infections such as COVID-19 and facilitates tissue healing, positioning it as a treatment modality for acute respiratory diseases. Importantly, bemcentinib accumulates very well in lung tissue and this further supports its potential within respiratory diseases.

In January 2022 BerGenBio and Oslo University Hospital announced that bemcentinib will be studied as part of the EU funded EUSolidAct trial in hospitalized covid-19 patients.

The EU-SolidAct trial is a multi-center, randomized, adaptive Phase II and III platform trial, the master protocol of which has been developed to evaluate potential treatments in hospitalized patients with COVID-19. Under the trial, bemcentinib will be studied in up to 500 hospitalized COVID-19 patients. In support of the trial, BerGenBio will provide bemcentinib drug material and incremental funding of costs related to the bemcentinib sub-protocol. The platform will provide access to a large number of sites across Europe and an established infrastructure at significantly reduced cost to BerGenBio and we expect this trial to commence in H1 2022.

In April, BerGenBio presented clinical trial data from its Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Data showed that bemcentinib treatment (up to 14 days) provides early and sustained protection, limiting clinical deterioration in patients. Bemcentinib treated patients were discharged earlier from the hospital, required less supplementary oxygen, and demonstrated a significant reduction in the need for intubation or ventilation.

In April 2022, BerGenBio reported that the primary efficacy endpoint was met in a complete data analysis of a randomized phase II study of bemcentinib in combination with standard of care (SoC) therapy, ACCORD2 (BGBIL019), in hospitalized COVID-19 patients. 90% of patients treated with bemcentinib + SoC experienced a clinical response by day 29 as defined by either a two-point improvement in World Health Organization (WHO) category from baseline score, or discharge from hospital, whichever arose sooner. This compared to 69% with a clinical response to SoC treatment alone, showing statistical significance. A posthoc analysis of the data from both studies identified a sub-group of patients with higher disease severity in whom evidence of a treatment benefit with bemcentinib was observed.

If the positive results from the ACCORD2 trial are replicated in the larger EU-SolidAct study, the Company believes that this could warrant Emergency Use Authorizations, based on precedents.

STRATEGIC PRIORITIES &

Strategic Priorities

BerGenBio's aim is to continue its assessment of the potential of the clinical stage AXL inhibitor bemcentinib as a transformative treatment for severe diseases. Our strategic priorities are to:

  • Pursue the 1st line NSCLC opportunity for patients harboring STK11 mutations
  • Pursue the potential application of bemcentinib as a treatment for COVID-19 and respiratory disease, initially via the EU-SolidAct sponsored platform, through which a confirmatory randomized placebo-controlled trial will be conducted to position bemcentinib as a treatment modality in hospitalized COVID-19 patients

In retaining global rights to bemcentinib, BerGenBio maintains complete strategic flexibility for its future development and commercialization. It is anticipated that the high novelty of bemcentinib plus its promising therapeutic profile, particularly in combination with existing therapies, could make it and future pipeline candidates attractive targets for partnering. A go-to market strategy may also be considered in selected indications in discrete territories, where greater value for shareholders could be created.

Outlook

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

Having completed a strategic review of operations following the appointment of Martin Olin as CEO, 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 attractive commercial opportunities.

The Company remains funded to deliver on its milestones 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.

Interim Report First 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 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.

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.

Management considers the Group's liquidity situation 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 first quarter 2022 amounted to NOK 0.0 million (NOK 0.0 million).

Total operating expenses for the first quarter 2022 amounted to NOK 78.5 million (NOK 83.4 million).

Employee expenses in the first quarter were NOK 16.5 million (NOK 16.4 million). Payroll expenses slightly increased and share option cost decreased compared to Q1 2021.

Other operating expenses amounted to NOK 61.8 million (NOK 66.6 million) for the first quarter. The decrease is mainly driven by level of clinical trials and drug development activities.

The operating loss for the quarter came to NOK 78.6 million (NOK 83.4 million).

Net financial items amounted to a loss of NOK

2.5 million (gain of NOK 2.2 million) for the first quarter. Net financial items is driven by change in currency rates on bank deposits in other currencies than NOK.

Losses after tax for the first quarter were NOK 81.1 million (NOK 81.2 million).

Financial Position

Total assets as of 31 March 2022 decreased to NOK 380.6 million (NOK 450.2 million at year end 2021) mainly due to the operational loss in the period.

Total liabilities were NOK 72.6 million as of 31 March 2022 (NOK 65.8 million at year end 2021).

Total equity as of 31 March 2022 was NOK 308.0 million (NOK 384.4 million at year end 2021), corresponding to an equity ratio of 80.9 % (85.4% at year end 2021).

Cash Flow

Net cash flow from operating activities was negative by NOK 74.2 million in the quarter (negative by 70.8 million), mainly driven by the level of activity in the clinical trials and other operating activities.

Net cash flow from investing during the first quarter was NOK 0.1 million (NOK 0.0 million).

Net cash flow from financing activities in first quarter 2022 was positive by NOK 3.0 million (NOK 8.1 million).

Cash and cash equivalents decreased to NOK 367.82 million as of 31 March 2022 (NOK 436.6 million at year end 2021).

The Board today considered and approved the condensed, consolidated financial statement of the three months ending 31 March 2022 for BerGenBio.

Bergen 23 May 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 Q1 2022 Q1 2021 FY 2021
Revenue 0 0 774
Expenses
Payroll and other related employee cost
Employee share option cost
3, 10
3
15,077
1,396
14,491
1,947
69,929
4,116
Depreciation 2 317 335 1,312
Other operating expenses 6 61,776 66,645 239,880
Total operating expenses 78,566 83,419 315,237
Operating profit (-loss) -78,566 -83,419 -314,464
Finance income 403 4 369 15,993
Finance expense 2,904 2,194 10,894
Financial items, net
Profit (-loss) before tax
-2,501
-81,067
2,175
-81,244
5,100
-309,364
Income tax expense 0 0 0
Profit (-loss) after tax -81,067 -81,244 -309,364
Other comprehensive income
Items that may be reclassified to profit and loss in
subsequent periods
Translation effects 41 0 -112
Total comprehensive income (-loss) for the
period
-81,026 -81,244 -309,476
Earnings per share:
- Basic and diluted per share 7 -0.92 -0.93 -3.52

Condensed consolidated statement of financial position

(NOK 1000) Unaudited Note 31 MAR 2022 31 MAR 2021 31 DEC 2021
ASSETS
Non-current assets
Property, plant and equipment 875 2 168 1,191
Total non-current assets 875 2 168 1,191
Other current assets 5, 8 11,896 11,657 12,398
Cash and cash equivalents 367,829 659,388 436,646
Total current assets 379,725 671,045 449,045
TOTAL ASSETS 380,600 673,213 450,236
EQUITY AND LIABILITIES
Equity
Paid in capital
Share capital 9 8,866 8,782 8,846
Share premium 9 257,360 555,251 335,195
Other paid in capital 4, 9 41,814 35,243 40,386
Total paid in capital 308,041 599,276 384,426
Total equity 308,041 599,276 384,426
Non-current liabilities
Long term debt 796 1,309 942
Total non-current liabilities 796 1,309 942
Current liabilities
Accounts payable 15,028 32,701 26,726
Other current liabilities 55,848 35,163 37,172
Provisions 887 4,764 969
Total current liabilities 71,763 72,628 64,868
Total liabilities
TOTAL EQUITY AND
72,560 73,937 65,810
LIABILITIES 380,600 673,213 450,236

Condensed consolidated statement of changes in equity

(NOK 1000) Unaudited Note Share
capital
Share premium Other paid
in capital
Total equity
Balance as of 1 January 2022 8,846 335,195 40,386 384,426
Loss for the period
Other comprehensive income (loss) for the period,
-81,067 -81,067
net of income tax 41 41
Total comprehensive income for the
period 0 -81,026 0 -81,026
Recognition of share-based payments 3, 4 1,429 1,429
Issue of ordinary shares 9 21 3,198 3,218
Share issue costs 9 -7 -7
Transactions with owners 21 3,191 1,429 4,640
Balance as of 31 March 2022 8,866 257,360 41,814 308,041
(NOK 1000) Unaudited Note Share
capital
Share premium Other paid
in capital
Total equity
Balance as of
1 January
2021
8,726 628,231 33,272 670,229
Loss for the period
Other comprehensive income (loss) for the
-81 244 -81,244
period,
net of income tax
0 0
Total comprehensive income for the
period 0 -81,244 0 -81,244
Recognition
of
share-based
payments
3, 4 1,971 1,971
Issue
of
ordinary
shares
9 56 8,279 8,336
Share issue costs 9 -15 -15
Transactions
with
owners
56 8,264 1,971 10,291
Balance as of 31 March 2021 8,782 555,251 35,243 599,276

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited Note Q1 2022 Q1 2021 FY 2021
Cash flow from operating activities
Loss before tax -81,026 -81,244 -309,364
Adjustments for:
Depreciation of property, plant and
equipment
317 335 1,312
Share-based payment expense 3, 4 1,429 1,971 7,113
Movement in provisions and pensions -82 -1,244 -5,039
Currency gains not related to operating
activities
-2,320 -436 667
Net interest received -85 0 -3,130
Working capital adjustments:
Decrease in trade and other receivables and
prepayments
502 2,571 1,830
Increase in trade and other payables 7,065 7,255 3,270
Net cash flow from operating activities -74 200 -70,793 -303,340
Cash flows from investing activities
Net interest received 85 0 3,130
Purchase of property, plant and equipment
Net cash flow from investing activities 85 0 3,130
Cash flows from financing activities
Proceeds from issue of share capital 9 3,218 8,336 16,629
Share issue costs 9 -7 -15 -70
Repayment of lease liabilities -234 -217 -565
Net cash flow from financing activities 2 978 8,104 15,995
Effects of exchange rate changes on
cash and cash equivalents
2,320 436 -779
Net increase/(decrease) in cash and
cash equivalents
-71,137 -62,689 -284,216
Cash and cash equivalents at beginning
of period
436,646 721,641 721,641
Cash and cash equivalents at end of period 367,829 659,388 436,646

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, treatment-resistant cancers and 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 31 March 2022 and were approved for issue by the Board of Directors on 23 May 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 Q1 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 31 March 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 Q1 2022 was NOK 368 million, and 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

Q1 2022 Q1 2021
Salaries 12,296 12,116
Social security tax 1,750 1,622
Pension expense 1,039 909
Short term incentive 0 0
Other remuneration and employee expenses 334 225
Government grants 1) -342 -380
Total payroll and other employee related cost 15,077 14,491
Share option expense employees 1,429 1,971
Change in accrued social security tax on share options -33 -23
Total employee share option cost 1,396 1,947
Total employee benefit cost 16,473 16,439
Average number of full time equivalent employees
1) See also note 5 for government grants
43 44

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 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.

Total options
Q1 2022
Q1 2021
Weighted
Number of
average
options
exercise
price
Number of
options
Weighted
average
exercise
price
Balance as of 1 January 3,560,897 22,96 4,209,233 18,45
Granted during the period 0 0,00 0 0,00
Exercised during the period -205,277 15,68 -561,599 14,84
Forfeited and cancelled -605,651 29,39 -71,124 22,91
Balance as of 31 March 2,749,969 22,09 3,576,510 18,93

0 options were granted in the three months period ended 31 March 2022 and 0 options were granted in the three months period ended 31 March 2021.

Vested options
Q1 2022 Q1 2021
Options vested as of 1 January 1,541,168 1,887,201
Exercised and forfeited in the period -641,088 -589,522
Vested in the period 0 0
Options vested as of 31 March 900,080 1,297,679
Total outstanding number of options 2,749,969 3,576,510

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 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 66,54 % expected future volatility has been applied.

For the three months period ending 31 March the value of the share options expensed through the profit or loss amounts to NOK 1,4 million (for the same period in 2021: NOK 2.0 million). In addition, a change in provision for social security contributions on share options of NOK -0.03 million (for the same period in 2021: NOK - 0.02 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
31 Mar 2022
Weighted
Average
Strike
Price 2022
Number of
options
outstanding
31 Mar 2021
Weighted
Average
Strike Price
2021
Rune Skeie Chief Financial Officer 297,097 22,71 242,757 21,40
James Barnes Chief Operating Officer 301,522 19,85 237,400 17,50
598,619 480,157

Government grants

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

Q1 2022 Q1 2021
Employee benefit expenses 342 380
Other operating expenses 1,414 575
Total 1,756 955

Grants receivable as of 31 March are detailed as follows:

31 Mar 2022 31 Mar 2021
Grants from Research Council, BIA 154 566
Grants from Research Council, PhD 415 389
Grants from SkatteFunn 5,937 4,750
Grants R&D UK 4,089 4,243
Total grants receivable 10,595 9,948

BIA grants from the Research Council of Norway:

The Company currently has one grant from the Research Council, programs 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 amounts up to NOK 10.7 million. The Group has recognised NOK 0.2 million in Q1 2022 (Q1 2021: NOK 0.6 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 has been 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 recognised NOK 0.4 million in Q1 2022 (Q1 2021 : NOK 0.4 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 recognised 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 recognised NOK 1.2 million in Q1 2022 (Q1 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 retrospectively by application. The Group has in 2022 recognized NOK 4.1 (2021: NOK 4.2 mill) classified as reduction of payroll and related expenses for the year 2021.

Other operating expenses

Q1 2022 Q1 2021
Program expenses, clinical trials and research 51,779 53,666
Office rent and expenses 729 386
Consultants R&D projects 2,457 4,149
Patent and licence expenses 829 2,044
Other operating expenses 7,396 6,974
Government grants -1,414 -575
Total 61,776 66,645

Earnings per share

Q1 2022 Q1 2021
Loss for the period (NOK 1,000) -81,026 -81,244
Average number of outstanding shares during the year 88,563,039 87,434,703
Earnings (loss) per share - basic and diluted (NOK) -0,92 -0,93

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 Mar 2022 31 Mar 2021
Government grants 10,595 9,948
Refundable VAT 320 560
Prepaid expenses 951 1,115
Other receivables 30 34
Total 11,896 11,657

Share capital and shareholder information

As of 31 March Number of
shares
Nominal value
(NOK)
Book value
(NOK)
Ordinary shares 2022 88,660,532 0.10 8,866,053.20
Ordinary shares 2021 87,821,582 0.10 8,782,158.20
Changes in the outstanding number of shares Q1 2022 Q1 2021
Ordinary shares as of 1 January 88,455,255 87,259,983
Issue of ordinary shares 205,277 561,599
Ordinary shares as of 31 March 88,660,532 87,821,582

Ownership structure 31 03 2022:

Shareholder Number of
shares
% share of
total shares
METEVA AS 24,039,650 27,1 %
INVESTINOR DIREKTE AS 7,270,780 8,2 %
FJARDE AP-FONDEN 4,487,493 5,1 %
SARSIA SEED AS 2,117,900 2,4 %
BERA AS 1,712,426 1,9 %
J.P. MORGAN SE NOMINEE I 1,538,631 1,7 %
VERDIPAPIRFONDET NORDEA AVKASTNING 1,510,174 1,7 %
VERDIPAPIRFONDET KLP AKSJENORGE 1,440,000 1,6 %
SARSIA DEVELOPMENT AS 1,175,000 1,3 %
NORDNET LIVSFORSIKRING AS 1,140,085 1,3 %
VERDIPAPIRFONDET NORDEA KAPITAL 1,078,020 1,2 %
VERDIPAPIRFONDET NORDEA NORGE PLUS 909,260 1,0 %
VERDIPAPIRFONDET NORDEA NORGE VERD 864,688 1,0 %
MOHN, MARIT 850,000 1,0 %
MARSTIA INVEST AS 850,000 1,0 %
MOHN, LOUISE 509,676 0,6 %
J.P. MORGAN SE NOMINEE II 430,541 0,5 %
RO INVEST AS 350,000 0,4 %
ZAIM, KEVIN 341,000 0,4 %
BIRK VENTURE AS 330,000 0,4 %
Top 20 shareholders 52,945,324 59,7 %
Total other shareholders 35,715,208 40,3 %
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 31 Mar 2022 31 Mar 2021
Martin Olin Chief Executive
Officer
September 2021 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 31 Mar 2022 31 Mar 2021
Sveinung Hole 1) Board member September 2010 107,394 107,394
Anders Tullgren Chair January 2022 25,000 0
Total shares held by members of the Board of Directors 132,394 107,394

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.

3) Anders Tullgren elected to chairman of the board in January 2022 held 25,000 shares by 31 December 2021.

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.

Subsequent events

In May 2022, the Company announced a strategy focusing on NSCLC STK11m and COVID-19 and a rightsizing of the organisation. This decision has not affected any financial items in this Q1 2022 report.

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
CPI Authority/Ethics Committee approval is granted in the country where the trial is taking place.
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.

ESMO European Society for Medical Oncology
EU-SolidAct The EU-SolidAct trial is part of EU-RESPONSE, a pan-European research project involved with rapid
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

Mary-Jane Elliot, Chris Welsh, Lucy Featherstone,

Consilium Strategic Communications

E-mail: [email protected]

Telephone: +44 20 3709 5700

BerGenBio ASA

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

Investor Relations

[email protected]

Martin Olin CEO

Rune Skeie CFO

Analyst coverage

H.C. Wainwright & Co

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

Media Relations

Carnegie

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

Arctic Securities

Lars Mørland Knudsen Telephone:+47 41 70 72 80 E-mail: [email protected]m

DNB Markets

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

Sponsored analyst research:

Edison Group

Pooya Hemami Telephone: +44 203 077 5700 [email protected]m

Edison Group

Harry Shrives Telephone: +44 203 077 5700 [email protected]m

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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