Annual / Quarterly Financial Statement • Feb 12, 2019
Annual / Quarterly Financial Statement
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| Results for the fourth quarter and full year 2018 | 4 |
|---|---|
| Operational review | 8 |
| Financial review | 14 |
| Condensed consolidated statement of profit and loss and other comprehensive income |
16 |
| Condensed consolidated statement of financial position | 17 |
| Condensed consolidated statement of changes in equity | 18 |
| Condensed consolidated statement of cash flow | 19 |
| Selected notes to the interim consolidated financial statements | 20 |
| Medical and biological terms | 30 |
BerGenBio (OSE:BGBIO) is a clinical-stage biopharmaceutical company developing innovative drugs for aggressive diseases, including immune evasive, drug resistant and metastatic cancers.
Superior monotherapy efficacy of bemcentinib in relapsed/refractory (R/R) AML/MDS patients reported at ASH 2018 – a possible first registration path
• Selected as a poster discussion at ESMO and presented as poster at SITC 2018
• Team strengthened and expanded, particularly in key medical, clinical operations and regulatory functions in preparation for advancing bemcentinib into the next stages of clinical development
"BerGenBio made important progress in 2018 and met all its key operational milestones. The strength of the clinical data coupled with correlation with AXL biomarker expression has allowed us to confirm our clinical development strategy in AML and NSCLC. In 2019 we will focus on initiating late stage clinical trials in these indications and we look forward to providing further details and updates during the coming year."
| (NOK million) | Q4 2018 | Q4 2017 | FY 2018 | FY 2017 |
|---|---|---|---|---|
| Operating revenues | 2.3 | 0 | 2.3 | 0 |
| Operating expenses | 53.2 | 47.5 | 196.9 | 183.7 |
| Operating profit (loss) | -50.9 | -47.5 | -194.5 | -183.7 |
| Profit (loss) after tax | -51.1 | -47.6 | -191.7 | -182.2 |
| Basic and diluted earnings (loss) | ||||
| per share (NOK) | -0.93 | -0.96 | -3.60 | -4.01 |
| Net cash flow in the period | -37.8 | -28.8 | -9.9 | 208.5 |
| Cash position end of period | 360.4 | 370.3 | 360.4 | 370.3 |
Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 (60)
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2017 2018 2018 2018 2018
BerGenBio is a biopharmaceutical company developing novel medicines for aggressive diseases, including advanced, immune-evasive and treatment-resistant cancers. The company has a portfolio of multiple clinical assets targeting the receptor tyrosine kinase AXL which is a recognised target driving cancer aggressiveness and immune suppression.
Bemcentinib, the company's lead asset, is a potentially first-in-class, highly selective, potent, oral, small-molecule AXL inhibitor, and has achieved clinical proof-of-concept as a monotherapy in AML/MDS and in combination in lung cancer. Randomised, late stage clinical trials based on this data will start during 2019.
A broad investigator-initiated clinical trial programme is exploring the wider potential of bemcentinib in disease indications with high unmet medical need, KOL support and strong scientific rationale; with a view to develop future label expansion opportunities.
BerGenBio's second clinical asset is BGB149, a first-in-class anti-AXL antibody, currently in phase I studies in healthy volunteers.
BerGenBio's licence partner ADC Therapeutics has advanced ADCT-601, a novel AXLtargeting ADC, into clinical development in patients with advanced solid tumours.
The totality of clinical data with lead asset bemcentinib, plus the pipeline of other AXL inhibitors, combined with a robust financial position, provides a strong foundation to create and deliver significant value for shareholders.
The Board considers that the results emerging from the clinical development programme with bemcentinib, particularly in AML and NSCLC, have established sufficient clinical proof-ofconcept to warrant initiation of randomised late stage clinical trials in these indications during 2019. Additional clinical data will be reported at future medical congresses by the company.
BerGenBio maintains complete strategic flexibility for bemcentinib's future development and commercialisation aimed at creating maximum value for shareholders including potential partnering as well as "go-to market" strategies in select indications and territories.
Important progress in 2018: clinical PoC data confirm focus for next stages of development
During 2018, BerGenBio provided clinical readouts on all of its ongoing phase II monotherapy and combination trials confirming that bemcentinib is generally well tolerated and efficacy correlates with AXL biomarkers.
Based on clinical data generated in 2018, the company has confirmed its focus for the next stages of bemcentinib's development: Randomised late stage clinical studies in AML and NSCLC will start during 2019. Accelerated routes to approval will be pursued where appropriate.
To support this next phase of development, BerGenBio has further strengthened its operations, in particular the medical, clinical operations and regulatory teams.
Pipeline opportunities for bemcentinib are being explored through the cost-effective support of Investigator Led Studies, leveraging BerGenBio's leadership position in understanding AXL biology.
BGB149, a novel and wholly owned, therapeutic anti-AXL antibody, entered phase I clinical studies in January 2019 thus expanding the company's pipeline of clinical stage AXL targeting assets.
The company ended 2018 with a robust cash position and is well-positioned to execute its strategy for bemcentinib and BGB149.
The company's initial focus is to develop bemcentinib as a novel therapy for non-small cell lung cancer (NSCLC) and AML/MDS.
Modern treatment approaches in NSCLC focus on combination therapy to enhance patient responses to established regimens that have shown some efficacy, but only in a minority of patients. Effective combination agents are predicted to drive differentiation in the NSCLC market, which accounts for a significant proportion of oncology drug revenues and growth.
BerGenBio has focussed its PoC phase II programme on key combinations with established therapies for first and second line NSCLC treatment, which are explored across three clinical trials:
During 2018, BerGenBio presented clinical data from each of these trials at major international cancer congresses, including the American Society of Clinical Oncology (ASCO) meeting in June, the 19th Annual World Conference on Lung Cancer (WCLC) in September, and the annual meeting of the Society for Immunotherapy of Cancer (SITC) in November.
The totality of the data presented during 2018, coupled with the finding that efficacy correlated with proprietary AXL biomarkers, confirmed bemcentinibs' proposed mode of action, and informed the company's strategy advancing bemcentinib into late stage clinical trials in NSCLC.
Key data reported during 2018 are summarised below.
Bemcentinib + KEYTRUDA (BGBC008): First stage (of two) met efficacy endpoint – superior anti-tumour effect and progression-free survival observed in AXL-positive patients – second stage is open and actively enrolling
KEYTRUDA is a novel immune checkpoint inhibitor which is highly effective in NSCLC as a 1L and 2L treatment. As a monotherapy however it only works well in patients with high PD-L1 expression which constitute less than 25% of 2L patients. The balance of patients are either negative for PD-L1 (c. 40% of 2L patients) or exhibit only low expression (c. 35%). PD-L1 negative and low positive patients show only 7 and 14% ORR to KEYTRUDA monotherapy, respectively, and a 2 months median progression free survival (mPFS) 1.
Developing a combination agent that enhances responses to KEYTRUDA, particularly in PD-L1 negative or low patients, therefore is a significant unmet medical need.
The BGBC008 study is investigating the efficacy of bemcentinib in combination with KEYTRUDA in previously treated, immunotherapy naïve patients with advanced NSCLC.
Key data reported on the first stage (n=24 patients) of the study which successfully met its endpoint* indicate that bemcentinib is effective in enhancing responses and is well tolerated (as presented at ASCO, WCLC and SITC 2018):
Stage 2 of the trial (a further 24 patients) is open and recruiting well. Preliminary results from stage 2 and updated results from the overall study will be available during 1H 2019
Bemcentinib + TARCEVA (BGBC004): Median PFS in first-line combination therapy has surpassed that of TARCEVA monotherapy – patient recruitment complete
TARCEVA is indicated for NSCLC that is driven by a mutation in the EGFR gene, the most common driver mutation in NSCLC.
Although response rates to TARCEVA are initially high, nearly all patients develop resistance over time. PFS for TARCEVA in first line is approximately 10 months.
The BGBC004 study is designed to test if adding bemcentinib to TARCEVA in 1L or 2L EGFR mutation-driven NSCLC may prevent or reverse acquired resistance to TARCEVA, respectively.
Patient recruitment into BGBC004 is complete; key data reported suggests that bemcentinib has the potential to reverse and prevent resistance to TARCEVA with a favourable safety profile:
Bemcentinib + docetaxel chemotherapy (BGBIL005): Superior response rates to docetaxel chemotherapy in NSCLC patients who have exhausted all treatment options
Docetaxel is emerging as a key 2L and 3L option in patients who progress on approved therapy regimens containing immune-, targeted and / or platinum-containing chemotherapy. Response rates to docetaxel chemotherapy are below 10% with an mPFS of 3-4 months.
The investigator-led, open-label study BGBIL005 is evaluating if combining bemcentinib with docetaxel chemotherapy is safe and can improve outcomes.
Patient recruitment into the study is progressing and, in September, an update of clinical findings from 11 patients evaluated was presented at WCLC: Bemcentinib/docetaxel combination was generally well tolerated, with 2 PRs (18%) and 6 SDs (55%) reported, including patients progressed on or after at least one prior immunotherapy regimen.
Novel treatment paradigms in this indication focus on improving outcomes in the predominantly elderly patient population who cannot tolerate intensive chemotherapy. Here, the aim is to either add to responses achieved with low dose chemotherapy or the so-called hypomethylating drugs or offer effective monotherapies, potentially in select patient populations.
BerGenBio's phase II PoC programme in leukaemia has therefore been focussed on investigating the use of bemcentinib in patients unfit for intensive therapy:
Key results reported on becmentinib's effect when given as a monotherapy in R/R AML/MDS confirm that the therapy is well tolerated and has anti-leukaemic activity in these patients who have exhausted all other approved treatment options. The evidence is particularly strong in patients with low levels of soluble AXL (sAXL), a biomarker thought to be inversely correlated with AXL receptor activity:
Enrolment is complete into the phase II cohort assessing bemcentinib combined with decitabine (a hypomethylating agent) in firstline AML. Analysis of the activity of the combination will be announced as appropriate and submitted for presentation at a future medical congress.
Investigator-led trials: exploring the broader opportunity for bemcentinib based on the broad role of AXL in aggressive cancers
BerGenBio explores additional pipeline opportunities for bemcentinib in a cost-effective and resource-efficient way by supporting Investigator-led trials through provision of scientific and regulatory input, supply of bemcentinib drug and a biomarker research programme.
Investigator-led studies are ongoing or planned in the following indications: metastatic melanoma, mesothelioma, pancreatic cancer, glioblastoma and MDS. Updated results from these studies will be presented at future clinical congresses as appropriate.
While the company's focus remains clearly on initiating randomised, late stage trials with bemcentinib in oncology indications, preclinical research in non-oncology indications suggests a wider clinical role for the drug, this may be incorporated into the future development strategy.
There is growing evidence that AXL plays a key role as a mediator of disease progression in several fibrotic indications, including idiopathic pulmonary fibrosis (IPF) and chronic liver disease, including non-alcoholic steatohepatitis (NASH).
BGB149 is a fully humanised anti-AXL function blocking monoclonal antibody, developed and wholly-owned by BerGenBio. BGB149 shows high affinity and selectivity for human AXL and a strong inhibitory effect on AXL signalling in preclinical studies.
In 2018, BerGenBio established a robust, high yielding manufacturing process for BGB149, phase I clinical trials started January 2019. First-in-patient phase Ib trials with BGB149 will be initiated in H2 2019.
ADCT-601 is composed of a humanised monoclonal antibody against human AXL (BGB601) discovered by BerGenBio, conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. BGB601 was out-licensed for ADC development to ADCT.
In January 2019, BerGenBio's licence partner ADC Therapeutics (ADCT) announced that the first patient was dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting ADC in patients with advanced solid tumours.
Progress through the programme will trigger milestone payments from ADCT to BerGenBio.
Tissue- and blood-based biomarkers show promise for development as companion diagnostics
In parallel with its clinical trials, BerGenBio continues to investigate biomarkers that are predictive of a clinical response to AXLtargeting agents, for development as companion diagnostics. Such diagnostics could allow patient selection for future clinical trials and ultimately support the registration process for bemcentinib.
BerGenBio will continue these studies to develop companion diagnostics for use in future studies and for future clinical use.
Clinical operations teams strengthened to support the next phase of development
During 2018, the company has further strengthened its operations, particularly the medical, clinical operations and regulatory capabilities, as it expands its pipeline and prepares to advance bemcentinib to the next stages of clinical development.
Alan Barge MD was appointed as Interim Chief Medical Officer and member of the leadership team in November. Dr Barge is a boardcertified oncologist and haematologist, with more than 25 years of experience in cancer drug development, spent primarily at AstraZeneca and Amgen among others developing Iressa® (gefitinib) for NSCLC.
Further, Dr Tone Bjaaland joined as Director of Clinical Operations. She brings more than 25 years' experience in clinical research and further strengthens the team.
At the end of 2018, the company had 21 employees and contractors in clinical operations based out of its Oxford, UK, site.
Dr Susan Foden decided, for personal reasons, to stand down from her position as a Nonexecutive Director and left the Board of Directors at the end of December 2018. The company's Board Nominations Committee is working on recruiting a new board member and its proposals will be made at the Annual General Meeting on 13 March 2019.
In April, the company announced it had raised NOK 187.5 million (USD 24 m) in gross proceeds through an oversubscribed private placement. The placement was directed towards institutional investors primarily in the USA including those specialising in the biotechnology sector, bringing added geographical diversity and increased sector specialism to the company's shareholder base.
At the end of 2018, BerGenBio had a cash position (NOK 360 m).
In September, BerGenBio served Notice of Arbitration to Rigel pursuant to a License Agreement for bemcentinib entered into as of 29 June 2011. The arbitration aims to resolve a dispute between the companies with respect to the interpretation and application of certain provisions of the Agreement, particularly as they relate to the rights and obligations of the parties in the event of the licensing or sale of bemcentinib by BerGenBio.
(Figures in brackets = same period 2017 unless stated otherwise)
Revenue for the fourth quarter and full year 2018 amounted to NOK 2.3 million (0.0 million). The revenue represents a preclinical milestone from an out-license agreement with ADCT.
Total operating expenses for the fourth quarter and the full year 2018, respectively, amounted to NOK 53.2 million (NOK 47.5 million) and NOK 196.9 million (NOK 183.7 million). Employee expenses were NOK 6.8 million (NOK 10.3 million) for the quarter and NOK 38.0 million (NOK 28.8 million) for the full year 2018. The increase mainly due to increase in staff and increase in provisions for social security tax on employee options as a result of increase of the share price during the year.
Other operating expenses amounted to NOK 46.5 million (NOK 37.2 million) for the quarter. For the full year 2018 other operating expenses amounted to NOK 158.7 million (154.7 million). A significant element of the operating expenses in 2017 related to a phase II milestone payment to Rigel Pharmaceuticals Inc., amounting to NOK 27.8 million.
In 2018 the clinical development expenses have increased significantly mainly due to execution of a broad phase II clinical study programme in various indications during the year.
The operating loss for the quarter came to NOK 50.9 million (NOK 47.5 million) and NOK 194.5 million (NOK 183.7 million) for the full year 2018, reflecting the level of research and development activities described above.
Net financial items were NOK -0.2 million (NOK -0.1 million) for the fourth quarter and NOK 2.8 million (1.5 million) for the full year 2018.
Losses after tax for the fourth quarter were NOK 51.1 million (NOK 47.6 million) and NOK 191.7 million (NOK 182.2 million) for the full year 2018.
Total assets at 31 December 2018 decreased to NOK 378.8 million (NOK 384.3 million at year-end 2017), mainly due to cash spent on operating activities adjusted for the capital raise from the private placement completed in April 2018 raised NOK 187.5 million.
Total liabilities were NOK 41.5 million (NOK 34.0 million at year-end 2017).
Total equity as of 31 December 2018 was NOK 337.3 million (NOK 350.4 million at year-end 2017), corresponding to an equity ratio of 89.0% (91.2%).
Net cash flow from operating activities was negative by NOK 186.7 million for the full year 2018 (NOK 168.1 million), mainly driven by the ongoing development and research activities.
Net cash flow used in investing activities during the full year was negative by NOK 0.2 million (NOK 0.3 million).
Net cash flow from financing activities was NOK 177.0 million (NOK 377.0 million), reflecting the share issue in April 2018 in relation to the private placement.
Cash and cash equivalents decreased to NOK 360.4 million (NOK 370.4 million at year-end 2017).
The board today considered and approved the condensed, consolidated financial statement of the twelve months ending December 31, 2018 for BerGenBio.
Stein H. Annexstad, Chairman Sveinung Hole
Jon Øyvind Eriksen Hilde Furberg Kari Grønås
Stener Kvinnsland Richard Godfrey, CEO
| (NOK 1000) Unaudited | Note | Q4 2018 | Q4 2017 | FY 2018 | FY 2017 |
|---|---|---|---|---|---|
| Revenue | 2,335 | 0 | 2,335 | 0 | |
| Expenses | |||||
| Employee benefit expenses | 3 | 6,756 | 10,302 | 38,012 | 28,827 |
| Depreciation | 37 | 41 | 204 | 193 | |
| Other operating expenses | 6 | 46,452 | 37,168 | 158,658 | 154,687 |
| Total operating expenses | 53,245 | 47,511 | 196,874 | 183,708 | |
| Operating profit | -50,910 | -47,511 | -194,539 | -183,708 | |
| Finance income | 1,216 | 912 | 4,857 | 4,168 | |
| Finance expense | 1,380 | 1,035 | 2,065 | 2,668 | |
| Financial items, net | -164 | -122 | 2,792 | 1,500 | |
| Profit before tax | -51,074 | -47,633 | -191,747 | -182,208 | |
| Income tax expense | 0 | 0 | 0 | 0 | |
| Profit after tax | -51,074 | -47,633 | -191,747 | -182,208 | |
| Other comprehensive income Items which will not be reclassified over profit and loss |
|||||
| Actuarial gains and losses on defined benefit pension plans |
0 | 0 | 0 | 0 | |
| Total comprehensive income for the period | -51,074 | -47,633 | -191,747 | -182,208 | |
| Earnings per share: | |||||
| - Basic and diluted per share | 7 | -0.93 | -0.96 | -3.60 | -4.01 |
| (NOK 1000) Unaudited | Note | 31 DEC 2018 | 31 DEC 2017 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 581 | 557 | |
| Total non-current assets | 581 | 557 | |
| Current assets | |||
| Other current assets | 5, 8 | 17,831 | 13,430 |
| Cash and cash equivalents | 360,413 | 370,350 | |
| Total current assets | 378,245 | 383,780 | |
| TOTAL ASSETS | 378,826 | 384,336 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Paid in capital | |||
| Share capital | 9 | 5,471 | 4,992 |
| Share premium | 9 | 309,791 | 325,018 |
| Other paid in capital | 4, 9 | 22,018 | 20,340 |
| Total paid in capital | 337,280 | 350,350 | |
| Total equity | 337,280 | 350,350 | |
| Non-current liabilities | |||
| Pension liability | 10 | 0 | 0 |
| Total non-current liabilities | 0 | 0 | |
| Current liabilities | |||
| Accounts payable | 23,939 | 21,575 | |
| Other current liabilities | 12,875 | 9,391 | |
| Provisions | 4,732 | 3,020 | |
| Total current liabilities | 41,546 | 33,986 | |
| Total liabilities | 41,546 | 33,986 | |
| TOTAL EQUITY AND LIABILITIES | 378,826 | 384,336 |
| (NOK 1000) Unaudited | Note | Share capital |
Share premium |
Other paid in capital |
Total equity |
|---|---|---|---|---|---|
| Balance at 1 January 2018 | 4,992 | 325,018 | 20,340 | 350,350 | |
| Loss for the period | -191,747 | -191,747 | |||
| Other comprehensive income (loss) for the period, net of income tax |
|||||
| Total comprehensive income for the period | 0 | -191,747 | 0 | -191,747 | |
| Recognition of share-based payments | 3, 4 | 1,678 | 1,678 | ||
| Issue of ordinary shares | 9 | 479 | 190,047 | 190,525 | |
| Paid in, not registed capital raise | 9 | - | |||
| Share issue costs | -13,527 | -13,527 | |||
| Balance at 31 December 2018 | 5,471 | 309,791 | 22,018 | 337,280 |
| (NOK 1000) Unaudited | Note | Share capital |
Share premium |
Other paid in capital |
Total equity |
|---|---|---|---|---|---|
| Balance at 1 January 2017 | 3,369 | 131,875 | 18,026 | 153,270 | |
| Loss for the period Other comprehensive income (loss) for the period, net of income tax |
-182,208 | -182,208 | |||
| Total comprehensive income for the period | 0 | -182,208 | 0 | -182,208 | |
| Recognition of share-based payments Issue of ordinary shares Paid in, not registed capital raise |
3, 4 9 9 |
1,623 | 400,673 | 2,314 | 2,314 402,296 |
| Share issue costs | -25,322 | -25,322 | |||
| Balance at 31 December 2017 | 4,992 | 325,018 | 20,340 | 350,350 |
| (NOK 1000) Unaudited | Note | FY 2018 | FY 2017 |
|---|---|---|---|
| Cash flow from operating activities | |||
| Loss before tax | -191,747 | -182,208 | |
| Non-cash adjustments to reconcile loss before tax to net cash flows | |||
| Depreciation of property, plant and equipment | 204 | 193 | |
| Calculated interest element on convertible loan | 0 | 0 | |
| Share-based payment expense | 3, 4 | 1,678 | 2,314 |
| Movement in provisions and pensions | 1,712 | -1,823 | |
| Working capital adjustments: | |||
| Decrease in trade and other receivables and prepayments | -4,401 | -1,128 | |
| Increase in trade and other payables | 5,847 | 14,543 | |
| Net cash flow from operating activities | -186,706 | -168,109 | |
| Cash flows from investing activities | |||
| Purchase of property, plant and equipment | -228 | -340 | |
| Net cash flow used in investing activities | -228 | -340 | |
| Cash flows from financing activities | |||
| Proceeds from issue of share capital | 9 | 176,998 | 376,974 |
| Paid in, not registered capital increase | 9 | 0 | |
| Net cash flow from financing activities | 176,998 | 376,974 | |
| Net increase/(decrease) in cash and cash equivalents | -9,936 | 208,525 | |
| Cash and cash equivalents at beginning of period | 370,350 | 161,825 | |
| Cash and cash equivalents at end of period | 360,413 | 370,350 |
BerGenBio ASA ("the Company") and its subsidiary (together "the Group") is a clinical stage biopharmaceutical company focused on developing novel medicines for aggressive diseases, including advanced, treatment-resistant cancers. BerGenBio ASA is a limited public liability company incorporated and domiciled in Norway. The address of the registered office is Jonas Lies vei 91, 5009 Bergen, Norway. The condensed interim financial information is unaudited. These interim financial statements cover the three-months period ended 31 December 2018 and were approved for issue by the Board of Directors on 11 February 2019.
The interim condensed consolidated financial statements for the Group have been prepared in accordance with IAS 34 Interim Financial Reporting, as adopted by the EU. The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements and should be read in conjunction with BerGenBio's annual financial statements as at 31 December 2017.
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 2017, except for the adoption of new standards and interpretations effective as of 1 January 2018. The accounting policies are also consistent with those followed in preparation of Q1, Q2 and Q3 2018.
The new and amended standards and interpretations from IFRS that were adopted by the EU with effect from 2018 did not have any significant impact on the reporting for 2018.
The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
Basis for consolidation The consolidated financial statements comprise the financial statements of the Company and its subsidiary as at 31 December 2018. 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 is 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 187 million was successfully completed in April 2018, 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.
| For the twelwe months ended 31 December |
|||
|---|---|---|---|
| 2018 | 2017 | ||
| Salaries | 24 941 | 22 860 | |
| Social security tax | 4 465 | 3 296 | |
| Pension expense | 2 066 | 1 770 | |
| Bonus | 2 199 | 2,170 | |
| Share option expense employees | 1 678 | 2 314 | |
| Accrued social security tax on share options | 1 712 | -1 823 | |
| Other remuneration | 2 327 | 749 | |
| Government grants 1) | -1 376 | -2 508 | |
| Total payroll and related expenses | 38 012 | 28 827 | |
| Average number of full time equivalent employees | 24 | 24 |
1) See also note 5 for government grants
| Option holder | Number of options outstanding |
Grant date | Expiry date | Exercise price (NOK) |
|---|---|---|---|---|
| Richard Godfrey | 50,000 | 1-Sep-10 | 31-Dec-19 | 5.65 |
| 100,000 | 27-May-11 | 31-Dec-19 | 7.56 | |
| 75,000 | 21-Jun-12 | 31-Dec-19 | 10.62 | |
| 150,000 | 3-Sep-13 | 3-Sep-21 | 10.62 | |
| 75,000 | 13-Jun-13 | 13-Jun-21 | 10.62 | |
| 120,000 | 11-Jun-14 | 11-Jun-22 | 11.15 | |
| 275,000 | 22-May-15 | 22-May-23 | 16.01 | |
| 100,000 | 1-Jan-16 | 1-Jan-24 | 24.00 | |
| 122,484 | 23-May-18 | 23-May-26 | 45.70 | |
| 50,000 | 31-Oct-18 | 31-Oct-26 | 28.50 | |
| James B Lorens | 50,000 | 10-Sep-10 | 31-Dec-19 | 5.65 |
| 25,000 | 27-May-11 | 31-Dec-19 | 7.56 | |
| 75,000 | 21-Jun-12 | 31-Dec-19 | 10.62 | |
| 55,000 | 3-Sep-13 | 3-Sep-21 | 10.62 | |
| 100,000 | 13-Jun-13 | 13-Jun-21 | 10.62 | |
| 70,000 | 11-Jun-14 | 11-Jun-22 | 11.15 | |
| 275,000 | 22-May-15 | 22-May-23 | 16.01 | |
| 50,000 | 1-Jan-16 | 1-Jan-24 | 24.00 | |
| 10,707 | 23-May-18 | 23-May-26 | 46.70 | |
| 7,000 | 31-Oct-18 | 31-Oct-26 | 28.50 | |
| Anthony Brown | 100,000 | 2-Sep-15 | 2-Sep-23 | 16.01 |
| 50,000 | 1-Jan-16 | 1-Jan-24 | 24.00 | |
| 26,499 | 23-May-18 | 23-May-26 | 46.70 | |
| 10,000 | 31-Oct-18 | 31-Oct-26 | 28.50 | |
| Rune Skeie | 24,090 | 23-May-18 | 23-May-26 | 46.70 |
| 20,000 | 31-Oct-18 | 31-Oct-26 | 28.50 | |
| Tone Bjaaland | 45,000 | Oct 2018 | Oct 2026 | 28.50 |
| Susan Foden1) | 100,000 | 18-Jun-12 | 18-Jun-20 | 10.62 |
| 55,000 | 3-Sep-13 | 3-Sep-21 | 10.62 | |
| 25,000 | 20-Jun-13 | 20-Jun-21 | 10.62 | |
| 50,000 | 19-Jun-14 | 19-Jun-22 | 11.15 | |
| 37,500 | 1-Feb-16 | 1-Feb-24 | 24.00 | |
| Hilde Furberg | 25,000 | 1-Feb-16 | 1-Feb-24 | 24.00 |
| Kari Grønås | 15,000 | 1-Feb-16 | 1-Feb-24 | 24.00 |
| 2,418,280 |
1) Susan Foden resigned from BoD 1 January 2019.
In the annual general meeting on the 22nd of March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was split into 100 shares with a nominal value of NOK 0.10. The overview above takes into account the share split.
The Group has a share option scheme for employees. Each option gives the right to acquire one share in BerGenBio on 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.
Options vest annually in equal tranches over a three-year period following the date of grant.
The following equity incentive schemes were in place in the current year:
| Number of options |
Grant date | Expiry date | Exercise price |
|
|---|---|---|---|---|
| Granted in September 2010 | 225,000 | Sep 2010 | Dec 2017/2019 | 5.65 |
| Granted in May 2011 | 175,000 | May 2011 | Dec 2017/2019 | 7.56 |
| Granted in June 2012 | 285,000 | Jun 2012 | Dec 2017/2019 | 10.62 |
| Granted in June 2012 | 225,000 | Jun 2012 | Jun 2020 | 10.62 |
| Granted in June 2013 | 360,000 | Jun 2013 | Jun 2021 | 10.62 |
| Granted in September 2013 | 400,000 | Sep 2013 | Sep 2021 | 10.62 |
| Granted in June 2014 | 280,000 | Jun 2014 | Jun 2022 | 11.15 |
| Granted in May 2015 | 650,000 | May 2015 | May 2023 | 16.01 |
| Granted in September 2015 | 260,000 | Sep 2015 | Sep 2021 | 16.01 |
| Granted in January 2016 | 400,000 | Jan 2016 | Jan 2024 | 24.00 |
| Granted in February 2016 | 122,500 | Feb 2016 | Feb 2024 | 24.00 |
| Granted in December 2017 | 50,000 | Dec 2017 | Dec 2025 | 22.00 |
| Granted in May | 385,027 | May 2018 | May 2026 | 46.70 |
| Granted in October 2018 | 277,000 | Oct 2018 | Oct 2026 | 28.50 |
| Forfeited in 2015 1) | -7,500 | 10.62 | ||
| Forfeited in 2016 1) | -50,000 | 16.01 | ||
| Forfeited and cancelled in 2017 1) | -220,000 | 12.33 | ||
| Exercised in 2017 1) | -230,000 | 9.98 | ||
| Exercised in 2018 1) | -160,000 | 19.01 | ||
| Forfeited in 2018 1) | -245,513 | 26.27 | ||
| Total | 3,181,514 |
In the annual general meeting on the 22nd of March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was split into 100 shares with a nominal value of NOK 0.10. The overview above takes into account the share split.
1) The exercise price is calculated as the weighted average exercise price of the forfeited, cancelled and exercised options.
| Total options | 2018 | 2017 | |||
|---|---|---|---|---|---|
| Number of options |
Weighted average exercise price |
Number of options |
Weighted average exercise price |
||
| Balance at 1 January | 2,925,000 | 14.20 | 3,325,000 | 13.66 | |
| Granted during the period | 662 027 | 39.08 | 50 000 | 22.00 | |
| Exercised during the period | -160 000 | 19.01 | -230 000 | 9.98 | |
| Forfeited and cancelled | -245 513 | 26.27 | -220 000 | 12.33 | |
| Balance at 31 December | 3,181,514 | 18.21 | 2,925,000 | 14.20 |
There were granted 385,027 options in the three months period ended 31 December 2018. In 2017 in the same period there were granted 50,000 options.
| Vested options | For the twelve months ended 31 December | |
|---|---|---|
| 2018 | 2017 | |
| Options vested at 1 January | 2,891,667 | 2,211,900 |
| Exercised and forfeited in the period | -310,000 | -280 000 |
| Vested in the period | 16 667 | 959 767 |
| Options vested at 31 December | 2,598,334 | 2,891,667 |
| Total outstanding number of options | 3,181,514 | 2,925,000 |
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. Options vest annually in equal tranches over a three-year period following the date of grant dependent on employment. The Group has estimated an expected vesting date and this date is used as basis for the expected lifetime. The Group expects the options to be exercised earlier than the expiry date. For Options granted earlier than 2014, the mean of the expected vesting date and expiry date has been used to calculate expected lifetime due to the lack of exercise pattern history for the Group and experience from other companies in combination with the relatively long lifetime of these options (up to 8 years).
For valuation purposes 43% expected future volatility has been applied. As the Group recently went public it has limited history of volatility in its share price, therefore the historical volatility of similar listed companies has been used as a benchmark for expected volatility.
For the twelve month period ending 31 December 2018 the value of the share options expensed through the profit or loss amounts to NOK 1.7 million (for the same period in 2017: NOK 2.3 million). In addition a provision for social security contributions on share options of NOK 1.7 million (for the same period in 2017: NOK -1,8 million) is recognised based on the difference between the share price and exercise price on exercisable option as at the end of the period.
Government grants have been recognised in the profit or loss as a reduction of related expense with the following amounts:
| For the twelve months ended 31 December | ||||
|---|---|---|---|---|
| 2018 | 2017 | |||
| Payroll and related expenses | 1,376 | 2,508 | ||
| Other operating expenses | 18,847 | 19,971 | ||
| Total | 20,223 | 22,479 |
Grants receivable as at 31 December are detailed as follows:
| For the twelve months ended 31 December | |||
|---|---|---|---|
| 2018 | 2017 | ||
| Grants from Research Council, BIA | 2,297 | 4,840 | |
| Grants from Research Council, PhD | 0 | 0 | |
| Grants from Innovation Norway | 5,400 | 0 | |
| Grants from SkatteFunn | 7,933 | 6,958 | |
| Total | 15,630 | 11,798 |
The Company currently has two grants from the Research Council, programs for user-managed innovation arena (BIA). The first BIA grant ("Novel therapeutics targeting the EMT/AXL pathway in aggressive cancers") totals to NOK 13.2 million and covers the period from May 2014 to April 2017. The Group has recognised NOK 0.0 million (2017: NOK 1.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
The second 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 2.9 million in Q4 2018 (Q4 2017: NOK 2.5 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
The third BIA grant ("Investigator-Initiated Trials for AXL driven cancers with high unmet clinical need") totals to NOK 15.1 million and covers the period from February 2017 to January 2021. The Group has recognised NOK 4.0 million in Q4 2018 (Q4 2017: NOK 4.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
BerGenBio has been awarded four grants supporting Industrial PhDs for the period from September 2010 through July 2017. 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 0.0 million in 2018 (2017: NOK 0.4 million) classified partly as reduction of payroll and related expenses and partly as a 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 2016 until the end of 2017. The Group has also been approved for SkatteFunn from 2018 to 2019. The Group has recognised NOK 7.9 million in Q4 2018 (Q4 2017: NOK 7.0 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. The grant may be withdrawn under certain circumstances. The Group has recognised NOK 5.4 million in Q4 2018 (Q4 2017: NOK 7.2 million) classified as cost reduction of other operating expenses.
| For the twelve months ended 31 December |
||
|---|---|---|
| 2018 | 2017 | |
| Program expenses, clinical trials and research | 133,699 | 93,195 |
| Milestone and license payments to Rigel Pharmaceuticals | 0 | 27,921 |
| Office rent and expenses | 1,950 | 1,553 |
| Consultants R&D projects | 10,290 | 12,519 |
| Patent and licence expenses | 3,289 | 4,424 |
| Other operating expenses | 28,278 | 35,046 |
| Government grants | -18,847 | -19,971 |
| Total | 158,658 | 154,687 |
| For the twelve months ended 31 December |
||
|---|---|---|
| 2018 | 2017 | |
| Loss for the period (NOK 1,000) | -191,747 | -182,208 |
| Average number of outstanding shares during the year | 53,284,520 | 45,494,721 |
| Earnings (loss) per share - basic and diluted (NOK) | -3.60 | -4.01 |
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.
| 31 Dec 2018 | 31 Dec 2017 | |
|---|---|---|
| Government grants | 15,630 | 11,798 |
| Refundable VAT | 1,356 | 458 |
| Prepaid expenses | 488 | 438 |
| Other receivables | 358 | 735 |
| Total | 17,831 | 13,430 |
The Group has one class of shares and all shares carry equal voting rights.
In the annual general meeting on the 22nd of March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was split into 100 shares with a nominal value of NOK 0.10.
| As of 31 December | Number of shares | Nominal value (NOK) |
Book value (NOK) |
|---|---|---|---|
| Ordinary shares 2018 | 54,711,446 | 0.10 | 5,471,144.60 |
| Ordinary shares 2017 | 49,922,200 | 0.10 | 4,992,220.00 |
| For the twelve months ended 31 December | ||
|---|---|---|
| 2018 | 2017 | |
| Ordinary shares at 1 January | 49,922,200 | 336,922 |
| Issue of ordinary shares, prior to share split | 500 | |
| Effect of share split (1 to 100) 22 March 2017 | 33,404,778 | |
| Issue of ordinary shares | 4,789,246 | 16,180,000 |
| Ordinary shares at 31 December | 54,711,446 | 49,922,200 |
| Shareholder | Number of shares |
Percentage share of total shares |
|
|---|---|---|---|
| METEVA AS | 14,923,000 | 27.3% | |
| INVESTINOR AS | 6,609,800 | 12.1% | |
| SARSIA SEED AS | 2,117,900 | 3.9% | |
| VERDIPAPIRFONDET ALFRED BERG GAMBA | 1,937,000 | 3.5% | |
| DATUM INVEST AS | 1,485,467 | 2.7% | |
| KLP AKSJENORGE | 1,331,867 | 2.4% | |
| EUROCLEAR BANK S.A./N.V. | NOM | 1,275,027 | 2.3% |
| SARSIA DEVELOPMENT AS | 1,175,000 | 2.1% | |
| VPF NORDEA KAPITAL | 1,173,187 | 2.1% | |
| VPF NORDEA AVKASTNING | 1,125,902 | 2.1% | |
| MP PENSJON PK | 1,117,455 | 2.0% | |
| BERA AS | 1,084,800 | 2.0% | |
| KOMMUNAL LANDSPENSJONSKASSE | 892,886 | 1.6% | |
| NORSK INNOVASJONSKAPITAL II AS | 856,170 | 1.6% | |
| VERDIPAPIRFONDET ALFRED BERG NORGE | 801,556 | 1.5% | |
| NORRON SICAV - TARGET | 800,000 | 1.5% | |
| J.P. MORGAN BANK LUXENBOURG S.A. | NOM | 657,232 | 1.2% |
| VERDIPAPIRFONDET ALFRED BERG AKTIV | 574,391 | 1.0% | |
| NORDA ASA | 536,281 | 1.0% | |
| VERDIPAPIRFONDET DELPHI NORGE | 475,714 | 0.9% | |
| Top 20 shareholders | 40,950,635 | 74.8% | |
| Total other shareholders | 13,760,811 | 25.2% | |
| Total number of shares | 54,711,446 | 100.0% |
The Board of Directors have been granted a mandate from the general meeting held on 14 May 2018 to increase the share capital with up to NOK 547,114 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 2019 and 30 June 2019.
The Board of Directors have been granted a mandate from the general meeting held on 9 March 2018 to increase the share capital with up to NOK 499,222 by subscription of new shares. In April 2018 there was issued 4,629,246 new shares under this proxy at a nominal value of 462,924.60.
| Position | Employed since | 31 Dec 2018 | 31 Dec 2017 | |
|---|---|---|---|---|
| Richard Godfrey 1) | Chief Executive Officer |
January 2009 | 160,408 | 160,408 |
| James Bradley Lorens | Scenior Scientific Adviser |
January 2009 | 250,000 | 250,000 |
| Total shares held by management | 410,408 | 410,408 |
1) Richard Godfrey holds 160,408 shares in the Company through Gnist Holding AS.
| Position | Served since | 31 Dec 2018 | 31 Dec 2017 | |
|---|---|---|---|---|
| Stein H. Annexstad 1) | Chairman | February 2016 | 7,539 | 7,539 |
| Susan Foden 4) | Board Member | September 2011 | 6,700 | 6,700 |
| Hilde Furberg 2) | Board Member | June 2015 | 3,769 | 3,769 |
| Kari Grønås 3) | Board Member | February 2016 | 4,522 | 4,522 |
| Total shares held by members of the Board of Directors | 22,530 | 22,530 |
1) Stein H. Annexstad holds 7,539 shares in the Company through Holstein AS, a closely associated company of Stein H. Annexstad.
2) Hilde Furberg holds 3,769 shares in the Company through Borkenholm AS, a closely associated company of Hilde Furberg.
3) Kari Grønås holds 4,522 shares in the Company through K og K AS, a closely associated company of Kari Grønås.
4) Susan Foden resigned from BoD 1 January 2019.
BerGenBio ASA is required to have an occupational pension scheme in accordance with the Norwegian law on mandatory occupational pension ("lov om obligatorisk tjenestepensjon"). The Company has a pension scheme which complies with the Norwegian law on mandatory occupational pension.
As of 1 October 2016, BerGenBio transitioned from a defined benefit scheme to a defined contribution scheme.
| Adenocarcinoma | Cancerous tumour that can occur in several parts of the body and that forms in mucus-secreting glands throughout the body. It can occur in many different places in the body and is most prevalent in the following cancer types; lung cancer, prostate cancer, pancreatic cancer, oesophageal cancer and colorectal cancer. Adenocarcinomas are part of the larger grouping of carcinomas. |
|---|---|
| ADCT601 | BGB601 (ADCT-601) is an antibody drug conjugate (ADC) composed of a humanised IgG1 antibody against human AXL that is linked to a cytotoxin. |
| 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. |
| API | Active pharmaceutical ingredient. |
| 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. |
| CML | Chronic myelogenous leukaemia. |
|---|---|
| CMOs | Contract manufacturing organisations. |
| Comorbidity | The presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder. |
| CR | Complete response |
| CRO | Contract research organisation. |
| CTL | Cytotoxic T-lymphocytes. Key effector cells of the body's immune response to cancer. |
| Cytarabine | A chemotherapy agent used mainly in the treatment of cancers of white blood cells such as acute myeloid leukaemia (AML). |
| DCR | Disease control rate |
| Decitabine | A cancer treatment drug used for acute myeloid leukaemia (AML). |
| Docetaxel | A clinically well-established anti-mitotic chemotherapy medication that works by interfering with cell division. |
| EHA | European Hematology Association |
| Epithelial state | A state of the cell where the cells are stationary, typically forming layers and tightly connected and well ordered. They lack mobility tending to serve their specific bodily function by being anchored in place. |
| Epithelial tumour cell | Tumour cells in an epithelial state. |
| EGFR inhibitors | Epidermal growth factor receptor inhibitors. EGFRs play an important role in controlling normal cell growth, apoptosis and other cellular functions, but mutations of EGFRs can lead to continual or abnormal activation of the receptors causing unregulated EGFR inhibitors are either tyrosine kinase inhibitors or monoclonal antibodies that slow down or stop cell growth. |
| EMT | Epithelial-mesenchymal transition, a cellular process that makes cancer cells evade the immune system, escape the tumour and acquire drug resistant properties. |
| EMT inhibitors | Compounds that inhibit AXL and other targets that in turn prevent the formation of aggressive cancer cells with stem-cell like properties. |
| Erlotinib | A drug used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on epidermal growth factor receptor (EGFR). |
| ESMO | European Society for Medical Oncology |
| IHC | Immunohistochemistry |
| In vivo | Studies within living organisms. |
| In vitro | Studies in cells in a laboratory environment using test tubes, petri dishes etc. |
|---|---|
| IPF | Idiopathic Pulmonary Fibrosis |
| 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. |
| NASH | Nonalcoholic Steatohepatitis |
| 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 |
| TNBC | Triple negative breast cancer. |
| WCLC | World Conference on Lung Cancer |
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.
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, Nicholas Brown & Carina Jurs Consilium Strategic Communications Telephone: +44 20 3709 5700 E-mail: [email protected]
BerGenBio ASA Jonas Lies vei 91, 5009 Bergen, Norway
Telephone: + 47 535 01 564 E-mail: [email protected]
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