Quarterly Report • Aug 18, 2020
Quarterly Report
Open in ViewerOpens in native device viewer


Set against the unprecedented backdrop of a global pandemic, this has been an eventful period for BerGenBio. During this time we have continued our focus on progressing clinical trials of our lead candidate bemcentinib in non-small cell lung cancer (NSCLC) and Acute Myeloid Leukaemia (AML) and more recently COVID-19, while ensuring that the safety and wellbeing of our staff and the patients participating in our clinical trials has been and remains our top priority.
The COVID-19 crisis has and will likely continue to delay clinical trials throughout the sector and will invariably impact patient recruitment into BerGenBio clinical studies and extend previously anticipated timelines. The impact of the pandemic on our clinical trials has continued through the second quarter, but we are pleased that new patients continue to be recruited into our clinical studies with bemcentinib, and already enrolled patients have been able to continue their treatment throughout the restrictions.
BerGenBio's work is centred around the understanding of AXL, a cell surface protein that renders cancers highly aggressive, immuneevasive and resistant to therapy with conventional drugs. BerGenBio is a world leader in understanding AXL biology and its role in mediating aggressive disease. Our product pipeline has been developed in line with the hypothesis that blocking AXL activity represents a novel approach to prevent cancer survival mechanisms and to improve the efficacy of chemotherapy, targeted therapy and immuno-oncology drugs.
We continue to make progress, with a latest milestone in NSCLC trial announced at the Next Gen Immuno-Oncology Congress conference where 6 of the 7 identified AXL positive patients reported clinical benefit and data showed a 2.5-fold improvement in [median] Progression-free Survival.
Bemcentinib selectively inhibits AXL kinase activity, blocking viral entry and enhancing the anti-viral type I interferon response, a key cellular defence mechanism against viral infection. We are hopeful that bemcentinib can play a role in the global effort to find suitable treatment options for COVID-19 patients. The drug was selected to be part of the UK funded ACcelerating COVID-19 Research & Development platform (ACCORD) trial back in April. At the end of July, the UK Research and Innovation's (UKRI) decided to cease grant funding and new patient recruitment was halted. This decision reflected the significant decrease in incidence of COVID-19 in the UK and difficulty recruiting a sufficient number of patients. However, BerGenBio is in late stage set-up of a similar study to ACCORD in a country of high COVID-19 incidence, and will update the market as soon as we can.
Post-period end, we were pleased to report the first patient dosed in a new phase Ib/IIa study of bemcentinib in recurrent glioblastoma (brain cancer). This study is funded by National Cancer Institute (NCI), and will open at up to 15 hospitals in the USA.
The Company remains in a strong cash position, with two drug candidates backed by pioneering biology, continued favourable clinical results and important data readouts on the horizon in two major cancer indications, as well as a potential COVID-19 treatment. This is an exciting time for us.
BerGenBio maintained its clinical research focus with its lead drug candidate bemcentinib, a novel once-a-day, orally administered, highly selective inhibitor of AXL, a cell surface protein that renders cancers highly aggressive, immune-evasive and resistant to therapy with conventional drugs.
BerGenBio's primary focus is to confirm the clinical position of bemcentinib in second line treatment AML and NSCLC patients, phase II trials to achieve this remain ongoing.
BerGenBio has adapted its operations to function efficiently despite the impact from the ongoing COVID-19 crisis, the health, safety and well-being of our employees and their families, our patients and collaborators remains our priority. Although there has been an adverse impact on development timelines across the industry, our clinical trials have continued recruiting patients and encouraging clinical data continues to be reported. Increasingly research clinical trial sites are re-opening and new patients are being enrolled into our studies.
| (NOK million) | Q2 2020 | Q2 2019 | YTD 2020 | YTD 2019 | FY 2019 |
|---|---|---|---|---|---|
| Operating revenues | 0,0 | 0,0 | 0,0 | 8,7 | 8,9 |
| Operating expenses | 64,7 | 52,0 | 121,0 | 106,5 | 213,3 |
| Operating profit (-loss) | -64,7 | -52,0 | -121,0 | -97,8 | -204,4 |
| Profit (-loss) after tax | -67,3 | -52,8 | -115,8 | -97,1 | -199,3 |
| Basic and diluted earnings | |||||
| (loss) per share (NOK) | -0,86 | -0,95 | -1,59 | -1,76 | -3,43 |
| Net cash flow in the period | 412,3 | 19,0 | 571,3 | -35,2 | -107,2 |
| Cash position end of period | 828,4 | 324,4 | 828,4 | 324,4 | 253,6 |



| Q2 | Q3 | Q4 | Q1 | Q2 | Q2 | Q3 | Q4 | Q1 | Q2 | Q2 | Q3 | Q4 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2019 | 2019 | 2020 | 2020 | 2019 | 2019 | 2019 | 2020 | 2020 | 2019 | 2019 | 2019 | Q1 2020 |
OVERVIEW &
Bemcentinib is currently undergoing clinical development as a treatment for Acute Myeloid Leukaemia (AML) and Myelodysplastic syndromes (MDS).
Trials are currently in progress to evaluate the safety and efficacy of bemcentinib in AML and MDS patients as; a monotherapy in second line or later patients with relapsed or refractory AML or MDS; or in combination with low-dose cytarabine (LDAC) in second-line relapsed AML patients.
The Company plans that updated preliminary clinical and translational data for the Phase II Bemcentinib / LDAC combination study will be presented at the American Society of Haematology (ASH) in December 2020.
Bemcentinib selectively inhibits AXL kinase activity, blocking viral entry and enhancing the anti-viral type I interferon response, a key cellular defence mechanism against viral infection. Furthermore, it is well tolerated by patients and administered in simple once a day capsule format.
In April, BerGenBio announced the selection of bemcentinib in a UK Government-backed national ACCORD study. The ACCORD study is a multicentre, seamless, Phase II adaptive randomisation platform trial to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised UK NHS patients. Bemcentinib was chosen as the first candidate. and the first patient was dosed in June. However the incidence of COVID-19 in the UK drastically reduced and at the end of July, the UK Research and Innovation's (UKRI) decided to cease grant funding. Subsequently the University Hospital Southampton NHS Trust notified all sites in the ACCORD programme to cease recruitment of new patients into the trial for all candidate agents. Patients already recruited, including those dosed with bemcentinib, will continue on treatment as per the protocol. The decision to halt the study reflected the significant decrease in incidence of COVID- 19 in the UK and difficulty recruiting a sufficient number of patients and in no way reflected any interpretation of the efficacy or safety of the any of the candidate agents.
However, the company is in the late stage set-up phase to sponsor and conduct a similar study to ACCORD in a country of high COVID-19 incidence and expects to be in a position to update the market in the near future.
Updated cohort B1 clinical and translational data from a Phase II clinical trial combining bemcentinib with Merck's anti-PD-1 therapy KEYTRUDA® in patients with advanced NSCLC having progressed on previous CPI therapy was presented at the Next Gen Immuno-Oncology Congress. The trial included 12 evaluable patients for cAXL, BerGenBio's proprietary composite-AXL (cAXL) immunohistochemistry biomarker. 7 of these 12 patients were cAXL positive, 6 of these 7 patients reported clinical benefit and 2.5-fold improvement in mPFS. The Company plans that preliminary topline clinical and translational data from BGBC008 cohort C1 trial will be presented at the World Congress of Lung Cancer Annual Meeting Jan 2021.
drugs in refractory NSCLC patients.
In July the first patient was dosed in an investigator initiated trial (IIT) assessing bemcentinib in recurrent glioblastoma (GBM). The study will enrol up to 20 recurrent GBM patients, at up to 15 sites in the USA. Increased expression of the receptor tyrosine kinase AXL is significantly correlated with poor prognosis in GBM patients and preclinical data has suggested that bemcentinib may be a promising therapeutic agent for GBM, particularly in post-irradiation mesenchymal-transformed GBM tumors. A comprehensive translational research programme will run in parallel with the clinical trial.

AXL is a cell surface protein that renders cancers highly aggressive, immune-evasive and resistant to therapy with conventional drugs.
BerGenBio is a world leader in understanding AXL biology and its role in mediating aggressive disease.
The Company has successfully translated its world-leading research of AXL's biological role and function into two first-in-class clinical development candidates: the highly selective, oral small molecule AXL inhibitor bemcentinib and the novel, wholly owned anti-AXL humanised monoclonal antibody (mAb) tilvestamab.
The ability to predict which patients may benefit most from treatment with a selective AXL inhibitor could be an important success factor in clinical trials, as well as for registration and later reimbursement of these novel drugs. This insight underpins BerGenBio's strategy of extensive biomarker discovery, and development of a companion diagnostic in parallel to the clinical programme. Results obtained thus far in parallel to the Phase II programme with bemcentinib are encouraging and show bemcentinib yields greater clinical benefit in patients that can be identified by these biomarkers and companion diagnostic tests.

Bemcentinib's clinical development is focused on 2L refractory lung cancer and relapsed acute myloid leukaemia. Internal clinical development is supplemented by a broad Investigator-Initiated-Trial (IIT) programme in multiple oncology indications and COVID-19.
Tilvestamab, a wholly owned anti-AXL antibody and the company's second clinical candidate, is currently undergoing Phase 1 testing.
| Candidate | Targeted Indication |
Discovery | Preclinical | Phase I | Phase II | Registrational |
|---|---|---|---|---|---|---|
| Bemcentinib monotherapy |
>2L AML & MDS | Ph II safety and POC efficacy demonstrated in 39 patient trial | ||||
| Bemcentinib combination with LDAC |
2L AML | Ph IIb Safety demonstrated, efficacy POC expansion study- 20 pts. | ||||
| 2L NSCLC chemo refractory |
Ph II POC efficacy demonstrated in 50 patient trial, end points met | |||||
| Bemcentinib combination with Keytruda |
2L NSCLC CPI refractory |
Ph II stage 1, 13 pts. met ORR proof of concept end point Expansion 16 pts. | ||||
| MERCK | 2L NSCLC CPI+chemo refractory |
Ph II POC study ongoing 29 pts | ||||
| Bemcentinib monotherapy |
Hospital COVID19 Patients |
In set up stage | ||||
| Tilvestamab (BGB149) | Phase I | Ph la HV SAD complete | Ph Ib MAD in set up |
| Candidate | Sponsor | Targeted Indication |
Dimensions | Phase I | Phase II | Registrational |
|---|---|---|---|---|---|---|
| Bemcentinib | Uni. Hospital Southampton / UKRI funded UK Research and Innovation |
COVID19 | Monotherapy | Randomised Phase II - 15 day treatment | ||
| European MDS Cooperative Group |
2L AML | Monotherapy | open-label, single-arm , phase II study. | |||
| 2L MDS | Monotherapy | open-label, single-arm , phase II study | ||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Recurrent Glioblastoma |
Monotherapy | Ph I safety study | |||
| University of Leicester MERCK |
Relapse Mesothelioma |
+ pembrolizumab | Set up | |||
| Haukeland University Hospital |
1L Metastatic Melanoma |
+ pembrolizumab or +Dabrafenib/Trametinib |
Randomised Phase II | |||
| UT Southwestern Medical Center |
2-4L Stage 4 NSCLC |
+ docetaxel | Ph I safety study | |||
| UT Southwestern Medical Center |
1L metastatic or recurrent PDAC |
+ Nab-paclitaxel+ Gemcitabine+ Cisplatin |
Ph I safety study |

The Company remains well positioned to deliver its stated strategic priorities:
BerGenBio continues to progress its clinical development strategy with bemcentinib, focussed on AML and NSCLC, with the intention of creating maximum value for shareholders. This, underpinned by the recent fundraise and potential applications for bemcentinib to other cancers and infectious diseases, means the Company has a strong foundation for growth.
As new data emerges, the Board grows increasingly confident that clinical proof-of-concept has been established for AXL inhibition in cancer therapy. Additional data from ongoing clinical trials will further support the future development strategy for bemcentinib.

The Group operates in a highly competitive industry sector with many large players and may be subject to rapid and substantial technological change. The long term impact of the COVID-19 crisis remains unclear although no greater for BerGenBio than any other business in the sector.
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.

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.
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 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 2020 and the Group considers its credit risk as low.
Liquidity is monitored on a continued basis by Group management. The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives. Management considers the Group's liquidity situation to be satisfactory. The Group secured equity funding of NOK 220 million in January 2020, NOK 500 million in May 2020 and additional NOK 20 million in July 2020.
The Group's lead product candidate, bemcentinib (BGB324), is currently in Phase II clinical trials and the Group's clinical studies may not prove to be successful.
The Group operates in a highly competitive industry sector with many large players and is subject to rapid and substantial technological change.
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.
(Figures in brackets = same period 2019 unless stated otherwise)
Revenue for the second quarter 2020 amounted to NOK 0.0 million (NOK 0 million) and for the six months ended 30 June 2020 NOK 0 million (NOK 8.7 million). The revenue in 2019 was clinical milestone payments from ADCT.
Total operating expenses for the second quarter 2020 amounted to NOK 64.7 million (NOK 52.0 million) and for the six months ended 30 June 2020 NOK 121.0 million (NOK 106.5 million).
Employee expenses in the second quarter were NOK 19.9 million (NOK 8.7.million) and for the six months ended 30 June NOK 29.7 million (NOK 16.2 million). The increase in Q2 2020 compared to Q2 2019 is mainly a P&L non cash effect of increase in accruals for social and security tax on employee share option as a result of a positive development in the company's share price in the quarter.
Other operating expenses amounted to NOK 44.7 million (NOK 43.0 million) for the second quarter and NOK 90.9 million (NOK 89.9 million) for the six months ended 30 June 2020. Operating expenses are driven by the expansion of ongoing clinical trials and preparations for new clinical trials. Payment terms for some of the clinical trials are milestone based.
The operating loss for the second quarter came to NOK 64.7 million (NOK 52.0 million) and for the six months ended 30 June 2020 NOK 121.0 million (NOK 97.8 million), reflecting the level of activity related to the clinical trials BerGenBio are conducting. The first half 2019 operational loss where reduced by milestone revenues in 2019.
Net financial items amounted to a loss of NOK 2.6 million (NOK 0.8 million) for the second quarter results from a foreign exchange rate development. For the six months ended 30 June 2020 the net financial items amounted to a gain of NOK 5.1 million (NOK 0.7 million).
Losses after tax for the first quarter were NOK 67.3 million (NOK 52.8 million) and for the six months ended 30 June 2020 NOK 115.8 million (NOK 97.1 million).
Total assets at 30 June 2020 increased to NOK 844.4 million (NOK 433.8 million at 31 March 2020) mainly due to the operational loss in the period and reflecting the private placement completed in January raising gross NOK 220.0 million and May raising gross 500.0 million.
Total liabilities were NOK 56.5 million at 30 June 2020 (NOK 54.6 million at 31 March 2020).
Total equity as of 30 June 2020 was 788.0 million (NOK 379.2 million at 31 March 2020), corresponding to an equity ratio of 93.3% (87.4% at 31 March 2020).
Net cash flow from operating activities was negative by NOK 50.0 million in the second quarter (negative by 53.0 million) and NOK 109.1 million for the six months ended 20 June 2020 (108.6 million), mainly driven by the level of activity in the clinical trials.
Net cash flow from investing during the second quarter was NOK 0 million (NOK 0.1 million) and for the six months ended 30 June 2020 NOK 0.2 million (NOK 0.3 million).
Net cash flow from financing activities in second quarter 2020 was NOK 462.4 million (NOK 71.9 million) and for the six months ended 30 June 2020 NOK 680.2 million (NOK 73.1 million) representing the private placement completed in the first quarter at gross NOK 220.0 million and second quarter at gross NOK 500.0 million.
Cash and cash equivalents increased to NOK 828.4 million by 30 June 2020 (NOK 419.4 by 31 March 2020).

The Board today considered and approved the condensed, consolidated financial statement of the six months ending 30 June 2020 for BerGenBio.
Sveinung Hole, Chairman Pamela A. Trail
Stener Kvinnsland Grunde Eriksen
Debra Barker Richard Godfrey, CEO
The Board today considered and approved the condensed, consolidated financial statement for the six months ending 30 June 2020 for BerGenBio. The half year report has been prepared in accordance
with IAS 34 Interim Financial Reporting as endorsed by the EU and additional Norwegian regulation.
We confirm, to the best of our knowledge that the financial statements for the period 1 January to 30 June 2020 have been prepared in accordance with current applicable accounting standards, and give a true and fair view of the assets, liabilities, financial position and profit or loss of the entity and the group taken as a whole.
We also confirm that the Board of Directors' Report includes a true and fair view of the development and performance of the business and the position of the entity and the group, together with a description of the principal risks and uncertainties facing the entity and the group.
Sveinung Hole, Chairman Pamela A. Trail
Stener Kvinnsland Grunde Eriksen
Debra Barker Richard Godfrey, CEO

| (NOK 1000) Unaudited | Note | Q2 2020 | Q2 2019 | YTD 2020 | YTD 2019 | FY 2019 |
|---|---|---|---|---|---|---|
| Revenue | 0 | 0 | 0 | 8,682 | 8,900 | |
| Expenses | ||||||
| Payroll and other related employee cost Employee share option cost |
3, 10 3 |
12,429 7,426 |
11,253 -2,525 |
22,797 6,887 |
18,679 -2,491 |
34,533 1,184 |
| Depreciation | 2 | 196 | 196 | 392 | 392 | 785 |
| Other operating expenses | 6 | 44,668 | 43,041 | 90,879 | 89 885 | 176,773 |
| Total operating expenses | 64,718 | 51,965 | 120,955 | 106 465 | 213,274 | |
| Operating profit | -64,718 | -51,965 | -120,955 | -97 783 | -204,374 | |
| Finance income | 3,525 | 1,509 | 12,032 | 3,270 | 11,530 | |
| Finance expense | 6,081 | 2,331 | 6,914 | 2,585 | 6,434 | |
| Financial items, net | -2,557 | -822 | 5,118 | 685 | 5,096 | |
| Profit before tax | -67,275 | -52,787 | -115,837 | -97 098 | -199,278 | |
| Income tax expense | 0 | 0 | 0 | 0 | 0 | |
| Profit after tax | -67,275 | -52,787 | -115,837 | -97,098 | -199,278 | |
| Other comprehensive income | ||||||
| Items which will not be reclassified over profit and loss |
||||||
| Actuarial gains and losses on defined benefit pension plans |
0 | 0 | 0 | 0 | 0 | |
| Total comprehensive income for the period |
-67,275 | -52,787 | -115,837 | -97,098 | -199 278 |
|
| Earnings per share: | ||||||
| - Basic and diluted per share | 7 | -0.86 | -0.95 | -1.59 | -1.76 | -3.43 |

| (NOK 1000) Unaudited | Note | 30 JUN 2020 | 30 JUN 2019 | 31 DEC 2019 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 2 | 582 | 1,367 | 974 |
| Total non-current assets | 582 | 1,367 | 974 | |
| Other current assets | 5, 8 | 15,434 | 23,259 | 15,818 |
| Cash and cash equivalents | 828,386 | 324,379 | 253,586 | |
| Total current assets | 843,819 | 347,637 | 269,404 | |
| TOTAL ASSETS | 844,401 | 349,004 | 270,378 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Paid in capital | ||||
| Share capital | 9 | 8,673 | 6,054 | 6,108 |
| Share premium | 9 | 749,916 | 285,489 | 187,786 |
| Other paid in capital | 4, 9 | 29,336 | 23,743 | 25,860 |
| Total paid in capital | 787,925 | 315,286 | 219,754 | |
| Total equity | 787,925 | 315,286 | 219,754 | |
| Non-current liabilities | ||||
| Long term debt | 0 | 248 | 0 | |
| Total non-current liabilities | 0 | 248 | 0 | |
| Current liabilities | ||||
| Accounts payable | 31,186 | 25,977 | 26,746 | |
| Other current liabilities | 19,806 | 6,977 | 21,803 | |
| Provisions | 5,485 | 516 | 2,074 | |
| Total current liabilities | 56,476 | 33,470 | 50,624 | |
| Total liabilities | 56,476 | 33,718 | 50,624 | |
| TOTAL EQUITY AND LIABILITIES | 844,401 | 349,004 | 270,378 |
| (NOK 1000) Unaudited | Note | Share capital |
Share premium | Other paid in capital |
Total equity |
|---|---|---|---|---|---|
| Balance at 1 January 2020 | 6,108 | 187,786 | 25,860 | 219,754 | |
| Loss for the period Other comprehensive income (loss) for the period, |
-115,837 | -115,837 | |||
| net of income tax | 0 | 0 | |||
| Total comprehensive income for the period | 0 | -115,837 | 0 | -115,837 | |
| Recognition of share-based payments | 3, 4 | 3,476 | 3,476 | ||
| Issue of ordinary shares | 9 | 2,565 | 718,256 | 720,821 | |
| Share issue costs | -40,289 | -40,289 | |||
| Transactions with owners | 2,565 | 677,967 | 3,476 | 684,008 | |
| Balance at 30 June 2020 | 8,673 | 749,916 | 29,336 | 787,925 |
| (NOK 1000) Unaudited | Note | Share capital |
Share premium | Other paid in capital |
Total equity |
|---|---|---|---|---|---|
| Balance at 1 January 2019 | 5,471 | 309,791 | 22,018 | 337,280 | |
| Loss for the period Other comprehensive income (loss) for the period, |
-97,098 | -97,098 | |||
| net of income tax | 0 | 0 | |||
| Total comprehensive income for the period | 0 | -97,098 | 0 | -97,098 | |
| Recognition of share-based payments | 3, 4 | 1,725 | 1,725 | ||
| Issue of ordinary shares | 9 | 583 | 77,672 | 78,255 | |
| Share issue costs | -4,875 | -4,875 | |||
| Transactions with owners | 583 | 72,797 | 1,725 | 75,104 | |
| Balance at 30 June 2019 | 6,054 | 285,489 | 23,743 | 315,286 |

| (NOK 1000) Unaudited | Note | Q2 2020 | Q2 2019 | YTD 2020 | YTD 2019 | FY 2019 |
|---|---|---|---|---|---|---|
| Cash flow from operating activities | ||||||
| Loss before tax | -67,275 | -52,787 | -115,837 | -97,098 | -199,278 | |
| Adjustments for: Depreciation of property, plant and equipment |
196 | 196 | 392 | 392 | 785 | |
| Share-based payment expense | 3, 4 | 2,422 | 989 | 3,476 | 1,725 | 3,842 |
| Movement in provisions and pensions Currency gains not related to operating |
5,004 | -3,573 | 3,411 | -3,968 | -2,658 | |
| activities | 3,361 | 1,299 | -3,542 | 795 | -332 | |
| Net interest received | 0 | -105 | -151 | -281 | -2,206 | |
| Working capital adjustments: Decrease in trade and other receivables and prepayments |
-1,830 | 4,596 | 384 | -5,427 | 2,013 | |
| Increase in trade and other payables | 8,082 | -3,618 | 2,763 | -4,746 | 11,151 | |
| Net cash flow from operating activities | -50,039 | -53,004 | -109,104 | -108,608 | -186,683 | |
| Cash flows from investing activities | ||||||
| Net interest received Purchase of property, plant and |
0 | 105 | 151 | 281 | 2,206 | |
| equipment Net cash flow used in investing |
0 | 0 | 0 | 0 | 0 | |
| activities | 0 | 105 | 151 | 281 | 2,206 | |
| Cash flows from financing activities | ||||||
| Proceeds from issue of share capital | 9 | 500,830 | 76,768 | 720,821 | 78,255 | 82,785 |
| Share issue costs | 9 | -38,378 | -4,875 | -40,289 | -4,875 | -4 875 |
| Repayment of lease liabilities | -63 | -33 | -322 | -292 | -593 | |
| Net cash flow from financing activities | 462,389 | 71,860 | 680,211 | 73,088 | 77,317 | |
| Effects of exchange rate changes on cash and cash equivalents |
-3,361 | -1,299 | 3,542 | -795 | 332 | |
| Net increase/(decrease) in cash and cash equivalents |
412,350 | 18,962 | 571,258 | -35 239 | -107,160 | |
| Cash and cash equivalents at beginning of period |
419,397 | 306,717 | 253,586 | 360 413 | 360,413 | |
| Cash and cash equivalents at end of period |
828,386 | 324,379 | 828,386 | 324 379 | 253,586 |
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 sixt-months period ended 30 June 2020 and were approved for issue by the Board of Directors on 17 August 2020.
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 2019, except for the adoption of new standards and interpretations effective as of 1 January 2020.
The new and amended standards and interpretations from IFRS that were adopted by the EU with effect from 2020 did not have any significant impact on the reporting for Q2 2020.
The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
The consolidated financial statements comprise the financial statements of the Company and its subsidiary as of 30 June 2020. The subsidiary is BerGenBio Limited, located in Oxford in the United Kingdom and is 100% owned and controlled by the parent company BerGenBio ASA
Preparation of the accounts in accordance with IFRS requires the use of judgment, estimates and assumptions that have consequences for recognition in the balance sheet of assets and liabilities and recorded revenues and expenses. The use of estimates and assumptions are based on the best discretionary judgment of the Group's management. The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives.
Capital markets are used as a source of liquidity when this is appropriate and when conditions in these markets are acceptable. A private placement and capital increase of gross NOK 220 million was completed in January 2020 and a private placement and capital increase of gross NOK 500 million was competed in May 2020, and thus the Board of Directors has reasonable expectation that the Group will maintain adequate resources to continue in operational existence for the foreseeable future. The interim financial statements are prepared under the going concern assumption.
In addition a subsequent repair offering was completed in July 2020 raising additional gross NOK 20 million.


| For the sixt months ended 30 June |
|||||
|---|---|---|---|---|---|
| Q2 2020 | Q2 2019 | 2020 | 2019 | ||
| Salaries | 10,036 | 9,330 | 18,712 | 15,434 | |
| Social security tax | 1,826 | 1,351 | 3,071 | 2,459 | |
| Pension expense | 748 | 657 | 1,394 | 1,139 | |
| Bonus | 0 | 0 | 0 | 0 | |
| Other remuneration | 104 | 184 | 208 | 333 | |
| Government grants 1) | -285 | -269 | -588 | -686 | |
| Total payroll and other employee related cost |
12,428 | 11,253 | 22,797 | 18,679 | |
| Share option expense employees | 2,422 | 989 | 3,476 | 1,725 | |
| Accrued social security tax on share options | 5,004 | -3,513 | 3,411 | -4,216 | |
| Total employee share option cost | 7,426 | -2,525 | 6,887 | -2,491 | |
| Total employee benefit cost | 19,854 | 8,728 | 29,684 | 16,187 | |
| Average number of full time equivalent employees |
36 | 24 |
1) See also note 5 for government grants
The Group has a Long Term Incentive Program for employees, an option scheme program. Each option gives the right to acquire one share in BerGenBio at exercise.
The Group has a share option program to ensure focus and align the Group's long term performance with shareholder values and interest. Most of the employees in the Group take part in the option program. The program also serves to retain and attract senior management.
The exercise price for options granted is set at the market price of the shares at the time of grant of the options. In general, for options granted after 2012 the options expire eight years after the date of grant.
Primarily the options vest annually in equal tranches over a three-year period following the date of grant.

| For the sixt months ended 30 June |
||||||
|---|---|---|---|---|---|---|
| Total options | 2020 | 2019 | ||||
| Number of options |
Weighted average exercise price |
Number of options |
Weighted average exercise price |
|||
| Balance at 1 January | 2,569,547 | 21,07 | 3,181,514 | 18,20 | ||
| Granted during the period | 2,026,663 | 15,00 | 784,629 | 25,00 | ||
| Exercised during the period | -102,500 | 11,15 | -330,000 | 12,33 | ||
| Forfeited and cancelled | -51,052 | 28,91 | -332,865 | 28,69 | ||
| Balance at 30 June | 4,442,658 | 18,44 | 3,303,278 | 19,34 |
2,026,663 options were granted in the sixt months period ended 30 June 2020 and 784,629 options were granted in the sixt months period ended 30 June 2019
| Vested options | For the sixt months ended 30 June |
||
|---|---|---|---|
| 2020 | 2019 | ||
| Options vested at 1 January | 1,701,981 | 2,598,334 | |
| Exercised and forfeited in the period | -22,370 | -191,999 | |
| Vested in the period | 155,263 | ||
| Options vested at 30 June | 1,834,874 | 2,406,335 | |
| Total outstanding number of options | 4,442,658 | 3,303,278 |
The options are valued using the Black-Scholes model.
The risk free interest rates are based on rates from Norges Bank and Oslo Børs on the Grant Date (bonds and certificates) equal to the expected term of the option being valued. Where there is no exact match between the term of the interest rates and the term of the options, interpolation is used to estimate a comparable term.
The vesting period is the period during which the conditions to obtain the right to exercise must be satisfied. Most of the options vest dependent on certain conditions. The Group has estimated an expected vesting date and this date is used as basis for the expected lifetime. The Group expects the options to be exercised earlier than the expiry date. For Options granted earlier than 2014, the mean of the expected vesting date and expiry date has been used to calculate expected lifetime due to the lack of exercise pattern history for the Group and experience from other companies in combination with the relatively long lifetime of these options (up to 8 years).
For valuation purposes 43% expected future volatility has been applied. As the Group recently went public it has limited history of volatility in its share price, therefore the historical volatility of similar listed companies has been used as a benchmark for expected volatility.
For the sixt month period ending 30 June the value of the share options expensed through the profit or loss amounts to NOK 3.5 million (for the same period in 2019: NOK 1.7 million). In addition a provision for social security contributions on share options of NOK 3.4 million (for the same period in 2019: NOK – 4.2 million) is recognised based on the difference between the share price and exercise price on exercisable option as at the end of the period.

| Option holder | Number of options outstanding 30 June 2020 |
Number of options outstanding 30 June 2019 |
|
|---|---|---|---|
| Richard Godfrey | Chief Executive Officer | 1,542,617 | 1,129,284 |
| James B Lorens | Chief Scientific Officer | 767,040 | 588,507 |
| Rune Skeie | Chief Financial Officer | 242,757 | 96,090 |
| James Barnes | Director of Operations | 237,400 | 59,400 |
| Hani Gabra | Chief Medical Officer | 208,000 | 0 |
| Gro Gausdal | Director of Research & Bergen Site Leader | 143,376 | 91,709 |
| Endre Kjærland | Associate Diretor of IP and Contracts | 130,525 | 88,525 |
| Alison Messom | Director of Clinical Operations | 108,000 | 0 |
| Total, member of management and Board of Directors |
3,379,715 | 2,053,515 |

Government grants have been recognised in the profit and loss as a reduction of related expense with the following amounts:
| Q2 2020 | Q2 2019 | YTD 2020 | YTD 2019 | |
|---|---|---|---|---|
| Employee benefit expenses |
285 | 269 | 588 | 686 |
| Other operating expenses | 2,812 | 3,174 | 5,610 | 7,499 |
| Total | 3,097 | 3,442 | 6,198 | 8,186 |
| 30 June 2020 | 30 June 2019 | |
|---|---|---|
| Grants from Research Council, BIA | 1,272 | 1,567 |
| Grants from Innovation Norway | -272 | 6,597 |
| Grants from SkatteFunn | 10,408 | 12,022 |
| Grants R&D UK | 1,457 | 0 |
| Total grants receivable | 12,865 | 20,185 |
The Company currently has now two grants from the Research Council, programs for user-managed innovation arena (BIA) in 2020. One additional grant ended in April 2019.
The first BIA grant ("Axl targeting therapeutics to treat fibrotic diseases") totals to NOK 12.0 million and covers the period from April 2015 to April 2019. The Group has recognised NOK 0.9 million in Q2 2019 classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
The second BIA grant ("Investigator-Initiated Trials for AXL driven cancers with high unmet clinical need") totals to NOK 15.1 million and covers the period from February 2017 to January 2021. The Group has recognised NOK 1.6 million in Q2 2020 (Q2 2019: NOK 2.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
The third BIA grant ("AXL as a therapeutic target in fibrosis; biology and biomarkers") has been awarded from 2019 and amount up to NOK 10.7 million. The Group has recognised NOK 2.2 million in Q2 2020 (Q2 2019: NOK 0.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
BerGenBio has been awarded a NOK 24 million (USD2.85m) 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 received NOK 7.2 million in Q4 2017 of this grant and further NOK 12 mililion in Q3 2019. The grant may be withdrawn under certain circumstances. The Group has recognised NOK 0.0 million in Q2 2020 (Q2 2019: NOK 1.2 million) classified as cost reduction of other operating expenses.
R&D projects have been approved for SkatteFunn (a Norwegian government R&D tax incentive program designed to stimulate R&D in Norwegian trade and industry) for the period from 2018 until the end of 2020. The Group has recognised NOK 2.4 million in Q2 2020 (Q2 2019: NOK 4.1 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
BerGenBio Limited, a 100% subsidary of BerGenBio ASA, has been granted R&D tax grants in UK for 2017 and 2018. R&D grants are approved retrospectively by application. Grants for 2017 and 2018 have been approved and received in 2019. Application for R&D grants are expected to be approved for 2019. The Group has in 2019 recognised NOK 3.2 classified as reduction of payroll and related expenses for the years 2017, 2018 and 2019.

| For the sixt months |
ended 30 June |
|||
|---|---|---|---|---|
| Q2 2020 | Q2 2019 | 2020 | 2019 | |
| Program expenses, clinical trials and research | 32,676 | 34 669 | 70,007 | 68,296 |
| Office rent and expenses | 572 | 314 | 1,129 | 702 |
| Consultants R&D projects | 5,943 | 4,015 | 10,066 | 7,857 |
| Patent and licence expenses | 2,490 | 694 | 3,453 | 1,430 |
| Other operating expenses | 5,798 | 6,523 | 11,834 | 19,100 |
| Government grants | -2,812 | -3,174 | -5,610 | -7,499 |
| Total | 44,668 | 43,041 | 90,879 | 89 885 |
| For the sixt months ended 30 June |
|||
|---|---|---|---|
| 2020 | 2019 | ||
| Loss for the period (NOK 1,000) | -115,837 | -97,098 | |
| Average number of outstanding shares during the year | 72,644,058 | 55,128,774 | |
| Earnings (loss) per share - basic and diluted (NOK) | -1.59 | -1.76 |
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.
| 30 Jun 2020 | 30 Jun 2019 | |
|---|---|---|
| Government grants | 12,865 | 20,185 |
| Refundable VAT | 285 | 1,334 |
| Prepaid expenses | 941 | 798 |
| Other receivables | 1,342 | 941 |
| Total | 15,434 | 23,259 |
| As of 30 June | Number of shares |
Nominal value (NOK) |
Book value (NOK) |
|---|---|---|---|
| Ordinary shares 2020 | 86 725 805 | 0.10 | 8 672 580,50 |
| Ordinary shares 2019 | 60 536 590 | 0.10 | 6 053 659,00 |
| For the sixt months ended 30 June |
|||
|---|---|---|---|
| Changes in the outstanding number of shares | 2020 | 2019 | |
| Ordinary shares at 1 January | 61,076,590 | 54,711,446 | |
| Issue of ordinary shares | 25,649,215 | 5,825,144 | |
| Ordinary shares at 30 June | 86,725,805 | 60,536,590 |

| Shareholder | Number of shares |
% share of total shares |
|
|---|---|---|---|
| METEVA AS | 21,956,141 | 25,3% | |
| INVESTINOR AS | 7,270,780 | 8,4% | |
| FJARDE AP-FONDEN | 3,431,356 | 4,0% | |
| VERDIPAPIRFONDET ALFRED BERG GAMBA | 3,008,561 | 3,5% | |
| SARSIA SEED AS | 2,117,900 | 2,4% | |
| BERA AS | 1,712,426 | 2,0% | |
| MP PENSJON PK | 1,662,493 | 1,9% | |
| VERDIPAPIRFONDET KLP AKSJENORGE | 1,615,258 | 1,9% | |
| VERDIPAPIRFONDET NORDEA KAPITAL | 1,524,740 | 1,8% | |
| VERDIPAPIRFONDET NORDEA AVKASTNING | 1,510,174 | 1,7% | |
| VERDIPAPIRFONDET NORDEA NORGE VERD | 1,252,488 | 1,4% | |
| SARSIA DEVELOPMENT AS | 1,175,000 | 1,4% | |
| KOMMUNAL LANDSPENSJONSKASSE | 1,147,650 | 1,3% | |
| VERDIPAPIRFONDET ALFRED BERG NORGE | 1,106,606 | 1,3% | |
| Skandinaviska Enskilda Banken AB | NOM | 1,097,993 | 1,3% |
| MOHN | 850,000 | 1,0% | |
| MARSTIA INVEST AS | 850,000 | 1,0% | |
| ALTITUDE CAPITAL AS | 780,000 | 0,9% | |
| VERDIPAPIRFONDET ALFRED BERG AKTIV | 768,198 | 0,9% | |
| VERDIPAPIRFONDET NORDEA NORGE PLUS | 750,060 | 0,9% | |
| Top 20 shareholders | 55,587,824 | 64,1% | |
| Total other shareholders | 31,137,981 | 35,9% | |
| Total number of shares | 86,725,805 | 100,0% |
The Board of Directors has been granted a mandate from the general meeting held on 16 March 2020 to increase the share capital with up to NOK 732,919 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 2021 and 30 June 2021. In May 2020 there was issued 102,500 new shares under this proxy at a nominal value of NOK 10,250. 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 16 March 2020 to increase the share capital with up to NOK 1,465,838 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2021 and 30 June 2021. In May 2020 there was issued 13,325,000 shares under this proxy at a nominal value of NOK 1,332,500.
The Board of Directors has been granted a mandate from the extraordinary general meeting held on 19 June 2020 to increase the share capital with up to NOK 1,764,516 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2021 and 30 June 2021.

| Position | Employed since | 30 June 2020 | 30 June 2019 | |
|---|---|---|---|---|
| Richard Godfrey 1) | Chief Executive Officer |
January 2009 | 21,005 | 167,815 |
| James Bradley Lorens | Chief Scientific Officer |
January 2009 | 280,039 | 250,000 |
| Endre Kjærland | Associate director Contracts and IP |
July 2011 | 3,262 | 1,508 |
| Total shares held by management | 304,306 | 419,323 |
1) Richard Godfrey holds 21,005 shares in the Company at 30 June 2020 through Gnist Holding AS.
| Position | Served since | 30 Jun 2020 | 30 Jun 2019 | |
|---|---|---|---|---|
| Sveinung Hole 1) | Chairman | September 2010 | 107,394 | 107,394 |
| Stener Kvinnsland | Board Member | February 2015 | 104,444 | 104,444 |
| Total shares held by members of the Board of Directors | 211,838 | 211,838 |
1) Sveinung Hole holds 104,444 shares in the Company through Svev AS, a wholly owned company of Sveinung Hole, and 2,950 shares directly
Grunde Eirksen (board member) is CEO in Altitude Capital AS. Altitude Capital AS is holding 780,000 shares in BerGenBio ASA at 30 June 2020.
BerGenBio ASA is required to have an occupational pension scheme in accordance with the Norwegian law on required occupational pension ("lov om obligatorisk tjenestepensjon"). The Company has a pension scheme which complies with the Act on Mandatory company pensions.

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

| EMT inhibitors | Compounds that inhibit AXL and other targets that in turn prevent the formation of aggressive cancer cells with stem-cell like properties. |
|---|---|
| Erlotinib | A drug used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on epidermal growth factor receptor (EGFR). |
| ESMO | European Society for Medical Oncology |
| IHC | Immunohistochemistry |
| In vivo | Studies within living organisms. |
| In vitro | Studies in cells in a laboratory environment using test tubes, petri dishes etc. |
| MAb | Monoclonal antibodies. Monospecific antibodies that are made by identical immune cells that are all clones of a unique parent cell, in contrast to polyclonal antibodies which are antibodies obtained from the blood of an immunized animal and thus made by several different immune cells. |
| Mesenchymal state | A state of the cell where the cells have loose or no interactions, do not form layers and are less well ordered. They are mobile, can have invasive properties and have the potential to differentiate into more specialised cells with a specific function. |
| Mesenchymal cancer cells | Cancer cells in a mesenchymal state, meaning that they are aggressive with stem-cell like properties. |
| Metastatic cancers | A cancer that has spread from the part of the body where it started (the primary site) to other parts of the body. |
| Myeloid leukaemia | A type of leukaemia affecting myeloid tissue. Includes acute myeloid leukaemia (AML) and chronic myelogenous leukaemia. |
| NSCLC | Non-small cell lung cancer. |
| ORR | Overall response rate |
| Paclitaxel | A medication used to treat a number of types of cancer including ovarian cancer, breast cancer, lung cancer and pancreatic cancer among others. |
| PD-L1 | Programmed death-ligand 1 |
| PFS | Progression-free survival |
| Phase I | The phase I clinical trials where the aim is to show that a new drug or treatment, which has proven to be safe for use in animals, may also be given safely to people. |
| Phase Ib | Phase Ib is a multiple ascending dose study to investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug candidate, looking at safety and tolerability. |
| Phase II | The phase II clinical trials where the goal is to provide more detailed information about the safety of the treatment and its effect. Phase II trials are performed on larger groups than in Phase I. |
| Phase III | In the phase III clinical trials data are gathered from large numbers of patients to find out whether the drug candidate is better and possibly has fewer side effects than the current standard treatment. |
| PR | Partial Response |
| Receptor tyrosine kinase | High-affinity cell surface receptors for many polypeptide growth factors, cytokines and hormones. Receptor tyrosine kinases have been shown not only to be key regulators of normal cellular processes but also to have a critical role in the development and progression of many types of cancer. |
| RECIST | Response Evaluation Criteria In Solid Tumors, a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. |
| R/R | Relapsed/Refractory |
| sAXL | Soluble AXL |
| SITC | Society ImmunoTherapy Cancer |
| Small molecule | A small molecule is a low molecular weight (<900 Daltons) organic compound that may help regulate a biological process, with a size on the order of 10-9m. |
| Squamous cell carcinoma | Is an uncontrolled growth of abnormal cells arising in the squamous cells, which compose most of the skin's upper layers. Squamous cell carcinoma is the second most common form of skin cancer. |
| T790M | Over 50% of acquired resistance to EGFR tyrosine kinase inhibitors is caused by a mutation in EGFR called T790M |
| Tilvestamab | Former BGB149, BerGenBio's AXL inhibitor antibody, currently completed Phase 1a. |
| WCLC | World Conference on Lung Cancer |
Jonas Lies vei 91, 5009 Bergen, Norway Telephone: + 47 535 01 564 E-mail: [email protected]
Richard Godfrey CEO
CFO Telephone: + 47 917 86 513 E-mail: [email protected]
Jan Petter Stiff, Crux Advisers Telephone: +47 995 13 891 E-mail: [email protected]
Mary-Jane Elliot, Chris Welsh, Lucy Featherstone, Carina Jurs Consilium Strategic Communications Telephone: +44 20 3709 5700 E-mail: [email protected]
Joseph Pantginis Telephone: +1 646 975 6968 E-mail: [email protected]

Soumit Roy Telephone: +1 646 454 2714 E-mail: [email protected]
Pål Falck Telephone:+47 229 37 229 E-mail: [email protected]
Patrik Ling Telephone: +46 8 473 48 43 E-mail: [email protected]

Mick Cooper, PhD Telephone: +44 20 3637 5042 [email protected]rg
Link to reports from Trinity Delta: https://www.bergenbio.com/investors/analyst-coverage/
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]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.