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BerGenBio

Quarterly Report Aug 27, 2023

3555_rns_2023-08-27_7e3bc5d5-b040-491c-acc7-d215f5767647.pdf

Quarterly Report

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Interim report second quarter and half year 2023

Corporate highlights

"For the second quarter we are pleased to report the outcomes of our cost-savings efforts and the successful closure of the Rights Issue. In combination this will fund our planned activities into the fourth quarter of 2024 and potentially into the second half of 2025 if all granted warrants at the Rights Issue are exercised.

Our highest priority is to progress the ongoing Phase 1b/2a clinical trial in first-line STK11m NSCLC patients ("BGBC016") where we are working towards enrolling the Phase 1b cohorts and initiating the Ph 2a part. During the second quarter, we obtained a wealth of additional clinical data which further validate the efficacy and tolerability of our lead compound bemcentinib. The data provide us with strong confidence in our focused strategy to study the compound's potential to treat 1L NSCLC patients harboring STK11 mutations. Further, explorative biomarker data from our BGBC008 trial (2L NSCLC) indicate that bemcentinib in combination with pembrolizumab provides encouraging survival benefits in patients harboring other hardto-treat mutations such as KRAS and KEAP1.

During 2023, we have seen increased awareness for the need for improved treatments for this prevalent patient population with high unmet needs.".

Martin Olin Chief Executive Officer

Recent highlights

  • May 2023: data presented at the prestigious ASCO 2023 oral presentation confirming bemcentinib + pembrolizumab achieved primary efficacy endpoint in investigator led study in mesothelioma
  • May 2023: announcement of top line data from BGBC003 in AML & MDS indicating monotherapy benefit of bemcentinib
  • June 2023: secured gross proceeds of NOK 250 in a Rights Issue

Q2 2023 Financial highlights

(NOK million) Q2 2023 Q2 2022 YTD 2023 YTD 2022 FY 2022
Operating revenues 0,0 0,0 0,0 0,0 0,4
Operating expenses 47,8 88,2 120,2 166,8 306.0
Operating profit
(-loss)
-47,8 -88,2 -120,2 -166,8 -305,6
Profit (-loss) after
tax
-48,8 -84,1 -120,8 -165,1 -302,1
Basic and diluted earnings (loss) per share
(NOK)
-0,15 -0,95 -0,57 -1,86 -3.41
Net cash flow in the period 154,2 -70,3 79,0 -141,5 -282,1
Cash position end of period 226,0 292,1 226,0 292,1 150,8

Cash position

Clinical Development

Bemcentinib

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

Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe respiratory infections. Its novel mechanisms of action and primary accumulation in the lungs uniquely position it to address these severe lung diseases.

Oncology: NSCLC

1L STK11m NSCLC (BGBC016)

We continue to advance our focused strategy through the conduct of BGBC016, a global, open-label Phase 1b/2a trial designed to determine the safety, tolerability and efficacy of bemcentinib in combination with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. Sites in the US have been activated and enrolment is ongoing while expansion into European sites is well underway, with regulatory approval to proceed received from regulatory authorities in the US and several European countries.

The Phase 1b dose escalation portion of the study evaluates the safety and feasibility of three different doses of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion will assess the safety and efficacy of up to two doses of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

A significant subgroup comprising of up to 20% (> 30,000 patients in US and EU5) of 1L non-squamous NSCLC patients harbor STK11 mutations, which are associated with immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data suggests that STK11m NSCLC patients almost universally express AXL in tumors and/or on immune cells, resulting in the development of drug resistance, immune evasion, and metastases.

The data from the BGBC008 (2L+ NSCLC, bemcentinib in combination with pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with docetaxel) trials provide clinical evidence of the antitumor effects of bemcentinib and its ability to modulate the tumor microenvironment to enhance the effects of immunotherapy and chemotherapy. We believe that the reversal of the effects of AXL with bemcentinib holds the promise of providing substantial survival benefits to NSCLC patients and specifically in patients harboring STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1.

Clinical Development (Continued)

2L+ NSCLC Trial (BGBC008)

Additional biomarker analyses of the BGBC008 data in the second quarter yielded promising data which further support the potential for bemcentinib in our on-going 1L STK11m NSCLC trial and may represent an opportunity to further expand the patient populations that may benefit from the addition of bemcentinib to their treatment regimens. The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received at least one prior line of therapy: chemotherapy, immunotherapy or the combination.

  • An updated analysis of AXL biomarker status indicates that the presence of AXL expression on either tumor cells and/or immune cells is predictive of improved survival in patients treated with bemcentinib + pembrolizumab. The vast majority (88%) of patients met the criteria for AXL presence (AXL positive patients) and obtained clinically meaningful benefits:
    • Median overall survival was highly statistically significant at p=0.001 in AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
    • Median progression free survival was 6.0 mos. in AXL positive patients vs. 5.8 AXL negative patients
  • Analysis of available data for those patients who received subsequent therapies (3L+) following treatment with bemcentinib + pembrolizumab in 2L identified a higher-than-expected response rate, potentially pointing to long-lasting immune response benefits induced by bemcentinib.
  • Data from the BGBC008 study also indicate that patients with PD-L1 negative (TPS score <1) benefit from the combination treatment of bemcentinib and pembrolizumab.
  • Currently the PD-L1 negative patient population is not widely treated with immune checkpoint inhibitors; this observation might provide an opportunity to expand the patient population eligible for treatment.
  • The combination of bemcentinib and pembrolizumab appeared to benefit patients with mutations associated with poor outcome with the currently available therapies, including STK11, KRAS, KEAP-1 and SMARCA4 mutations. These mutational patient populations may represent an incremental opportunity for future study with bemcentinib and will be further assessed in our on-going BGBC016 study in 1L patients.

Clinical Development (Continued)

Oncology: Relapsed/Refractory AML/MDS

In the second quarter, topline results of the Phase 1b/2a BGBC003 multicenter open-label study of bemcentinib as a single agent and in combination with low-dose cytarabine (LDAC) or decitabine in patients with acute myeloid leukemia or as a single agent in patients with myelodysplastic syndrome were released.

  • Two cohorts of patients in BGBC003 were treated with bemcentinib as a single agent (monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R) AML, (n=11), bemcentinib provided an ORR of 18.2% and a mOS of 18 months. In Cohort B4, in patients with relapsed/high risk MDS, bemcentinib monotherapy provided an ORR of 18.8% with a mOS of 9.2 months.
  • Furthermore, bemcentinib in combination with the chemotherapy LDAC appeared to provide substantial mOS benefit to patients with R/R AML (n=27) achieving an ORR of 18.5% and a mOS of 8 months.

Oncology: Mesothelioma

In the second quarter, topline results of the investigator led BGBIL011/MiST3 mesothelioma trial were presented on June 5, 2023, in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) conference in an abstract titled: Bemcentinib and pembrolizumab in patients with relapsed mesothelioma: MiST3, a phase IIa trial with cellular and molecular correlates of efficacy. Key results include:

  • 26 patients with relapsed mesothelioma were enrolled in MiST3 and all received at least one dose of bemcentinib and pembrolizumab.
  • The primary endpoint of disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI: 29.2, 63.4).
  • Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of 38.5% (95% CI: 20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95% CI: 4.4, 34.9).
  • The combination of bemcentinib and pembrolizumab was generally safe and welltolerated.

In totality, the Company is very encouraged by the additional clinical data generated with bemcentinib and reported year-to-date 2023. Our current activities are focused on 1L NSCLC STK11m patients; however, we believe these additional datasets may expand the potential of bemcentinib beyond STK11m NSCLC patients to also benefit other hard-totreat NSCLC mutations.

Clinical Development (Continued)

Severe Respiratory Infections (SRIs)

The Company believes that bemcentinib blocks viral entry and replication, stimulates the innate immune system, and promotes lung tissue repair positioning it well for the treatment of severe respiratory infections.

On April 25, 2023, the Company decided to pause the Phase 2b trial evaluating bemcentinib in hospitalized

COVID-19 patients until a potential acceleration in hospitalizations warrant further evaluation of bemcentinib in this population.

Bemcentinib is currently being evaluated in preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS) and initial results are expected during 2023.

Q2 2023 and post period corporate highlights

Corporate Activities

Rights Offering

On June 13, 2023, the Company completed a rights issue raising gross proceeds of NOK 250m. The proceeds from this offering including any additional proceeds from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L STK11m NSCLC patients, preclinical studies in severe respiratory infections and for general corporate purposes.

Focused organizational structure aligned with strategy

The Company has taken measures to further reduce its operational costs including a significant reduction in workforce and total compensation to the executive management and the board of directors. This includes a transition of the CSO to a part-time consultancy position. These prudent actions will reduce total operating expenses by at least 30% compared to historic operational expenses when fully implemented.

Q2 2023 Financial review

Financial Results (Figures in brackets = same period 2022 unless stated otherwise)

Revenue for the second quarter 2023 amounted to NOK 0 million (NOK 0 million) and for the first half year 2023 NOK 0 million (NOK 0 million).

Total operating expenses for the second quarter 2023 amounted to NOK 47.8 million (NOK 88.2 million) and for the first half year 2023 NOK 120.2 million (NOK 166.8 million).

Payroll and other employee related cost in the second quarter was NOK 17.5 million (NOK 21.1 million) and for the first half year 2023 NOK 31.4 million (NOK 36.2 million). The decrease in Q2 2023 and YTD compared to 2022 is related to the effect of the restructuring announced in May 2022.

Employee share option cost in the second quarter was NOK 0.2 million (negative cost of NOK - 0.6 million) and for the first half year 2023 NOK 1.8 million (NOK 0.8 million). The change in cost in Q2 2023 and YTD compared to 2022 is a noncash effect due to the reduction in social security tax provision on share options driven by a decrease in share price as well as effect of restructuring.

Other operating expenses amounted to NOK 30.1 million (NOK 67.4 million) for the second quarter and NOK 87.0 million (NOK 129.2 million) for the first half year 2023. Operating expenses are driven by the timing of cost of the clinical trials and drug manufacturing in preparation for clinical trial launches.

The operating loss for the second quarter came to NOK 47.8 million (NOK 88.2 million) and for the first half year 2023 NOK 120.2 million (NOK 166.8 million), reflecting the level of activity related to the clinical trials BerGenBio is conducting.

Net financial items amounted to a loss of NOK -1.1 million (profit of NOK 4.2 million) for the second quarter affected by loss on foreign exchange and reduced interest due to lower cash deposits. For the first half year 2023 the net financial items amounted to a loss of NOK - 0.7 million (profit of NOK 1.7 million).

Losses after tax for the second quarter were NOK 48.8 million (NOK 84.1 million) and for the first half year 2023 NOK 120.8 million (NOK 165.1 million).

Financial Position

Total assets as of 30 June 2023 increased to NOK 240.4 million (NOK 85.6 million as of 31 March 2023) mainly due to the proceeds from the Rights Issue completed in June 2023 reduced by the operational loss in the period.

Total liabilities were NOK 52.4 million as of 30 June 2023 (NOK 67.3 million as of 31 March 2023).

Total equity as of 30 June 2023 was NOK 188.0 million (NOK 18.3 million as of 31 March 2023), corresponding to an equity ratio of 78.2% (21.4% as of 31 March 2023).

Cash Flow

Net cash flow from operating activities was negative by NOK 63.3 million in the second quarter (negative by NOK 70.7 million) and NOK 138.7 million for the first half year 2023 (NOK 144.9 million), mainly driven by the level of activity in the clinical trials and drug development.

Net cash flow from investing during the second quarter was NOK 0.1 million (NOK 0.4 million) and for the first half year 2023 NOK 0.4 million (NOK 0.5 million).

Net cash flow from financing activities in second quarter 2023 was NOK 217.4 million (negative by NOK 0.1 million) and for the first half year 2023 NOK 217.4 million (NOK 2.9 million).

Cash and cash equivalents increased to NOK 226.0 million by 30 June 2023 from NOK 73.0 by 31 March 2023 (and a decrease from NOK 292.1 by 30 June 2022).

Q2 2023 Risk, uncertainties and outlook

Risk and uncertainties

BerGenBio is exposed to a number of risk factors: Financial risks, technology risks, competitive risks, patent and IP risks and regulatory and commercial risks.

The Risk and uncertainties section of the board of directors' report in the Annual report from 2022 contains a detailed description of these risks.

Outlook

The Company continues its work towards several upcoming milestones, to be achieved across the Company's clinical pipeline focused on the development of bemcentinib within NSCLC STK11m and respiratory diseases.

The recently announced clinical top line data from the trials in 2L NSCLC (BGBC008 and BGBIL005) in the opinion of the Company shows promising clinical benefit of bemcentinib in NSCLC supporting the on-going trial in 1L STK11m NSCLC patients.

With the net proceeds from the gross NOK 250 million rights issue, the actions taken to reduce its operational costs including a significant reduction in workforce and total compensation to the executive management and the board of directors, the Company is positioned to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders.

The cash position at end of Q2 2023 funds the planned activities into Q4 2024, excluding any net proceeds from exercise of warrants issued as part of the Rights Issue.

Responsibility Statement

The board today considered and approved the condensed, consolidated financial statement for the six months ending 30 June 2023 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 2023 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.

Bergen 22 August 2023 Board of Directors and CEO of BerGenBio ASA

Anders Tullgren, Chairman Sally Bennett Sveinung Hole

Debra Barker Martin Olin, CEO

Condensed consolidated statement of profit and loss and other comprehensive income

(NOK 1000) Unaudited Note Q2 2023 Q2 2022 YTD 2023 YTD 2022 FY 2022
Revenue 0 0 0 0 389
Expenses
Payroll and other related employee
cost
3 17,455 21,149 31,369 36,226 66,143
Employee
share
option
cost
3 198 -605 1,768 791 2,546
Depreciation 2 7 314 14 631 883
Other operating expenses 6 30,103 67,380 87,035 129,156 236,451
Total operating expenses 47,762 88,238 120,185 166,804 306,024
Operating profit -47,762 -88,238 -120,185 -166,804 -305,635
Finance income 2,008 5,970 5,121 6,373 15,027
Finance expense 3,081 1,802 5,769 4,706 11,514
Financial items, net -1,073 4,168 -648 1,667 3,513
Profit before tax -48,836 -84,070 -120,833 -165,136 -302,122
Income tax expense 0 0 0 0
Profit after
tax
-48,836 -84,070 -120,833 -165,136 0
-302,122
Other
comprehensive
income
Items which may be reclassified
over profit and loss
Exchange differences on translation
of foreign operations
932 -86 1,197 -45 -484
Total comprehensive income for
the period
-47,903 -84,156 -119,636 -165,182 -302,606
Earnings per share:
-
Basic and diluted per share
7 -0.15 -0.95 -0.57 -1.86 -3.41

Condensed consolidated statement of financial position

(NOK 1000) Unaudited 30 JUN 2023 30 JUN 2022 31 DEC 2022
ASSETS
Non-current
assets
Property, plant and equipment 29 560 43
Total non-current assets 29 560 43
Current
assets
Other current assets 5, 8 14,437 13,325 15,860
Cash and cash equivalents 225,981 292,144 150,803
Total current assets 240,417 305,469 166,663
TOTAL ASSETS 240,446 306,030 166,706
EQUITY AND LIABILITIES
Equity
Paid in capital
Share capital 9 262,053 8,866 8,866
Share premium 9 0 173,204 35,780
Other paid in capital 4, 9 45,620 41,928 43,852
Total paid in capital 307,673 223,998 88,498
Retained earnings 9 -119,636 0 0
Total equity 188,037 223,998 88,498
Non-current liabilities
Long term debt 2 0 651 275
Total non-current liabilities 0 651 275
Current liabilities
Accounts payable 39,906 26,040 29,634
Other current liabilities 12,504 55,340 48,299
Provisions 0 0 0
Total current liabilities 52,409 81,381 77,933
Total liabilities 52,409 82,031 78,208
TOTAL EQUITY AND LIABILITIES 240,446 306,030 166,706

Condensed consolidated statement of changes in equity

(NOK 1000) Unaudited Note Share
capital
Share
premium
Other
paid
in
capital
Retained
earnings
Total
equity
Balance at 1 January
2023
8,866 35,780 43,852 0 88,498
Loss for the period -120,833 -120,833
Other comprehensive income (loss) for the
period, net of income tax
1,197 1,197
Total comprehensive income for the
period
0 0 0 -119,636 -119,636
Recognition of share-based payments 3, 4 1,768 1,768
Issue of ordinary shares 9 253,187 253,187
Share issue costs 9 -35,780 -35,780
Transactions with owners 253,187 -35,780 1,768 0 219,175
Balance at 30 June 2023 262,053 0 45,620 -119,636 188,037
(NOK 1000) Unaudited Note Share
capital
Share
premium
Other
paid
in
capital
Retained
earnings
Total
equity
Balance at 1 January
2022
8,846 335,195 40,386 0 384,426
Loss for the
period
-165,136 -165,136
Other comprehensive income (loss) for the
period, net of income tax
-45 -45
Total comprehensive income for the period 0 -165,182 0 0 -165,182
Recognition of share-based payments 3, 4 1,543 1,543
Issue of ordinary shares 9 21 3,198 3,218
Share issue costs 9 -7 -7
Transactions with owners 21 3,191 1,543 0 4,754
Balance at 30 June 2022 8,866 173,204 41,928 0 223,998

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited Note Q2 2023 Q2 2022 YTD 2023 YTD 2022 FY 2022
Cash flow from operating activities
Profit (loss) before
tax
-48,836 -84,156 -120,833 -165,182 -302,122
Adjustments
for:
Depreciation of property, plant and
equipment
7 314 14 631 883
Share-based payment expense 3, 4 198 114 1,768 1,543 3,466
Movement in provisions and
pensions
-887 -969 -969
Currency -gains/+loss not related to
operating activities
2,125 5,363 5,060 3,042 3,280
Net interest received -70 -445 -358 -530 -2,949
Working capital adjustments:
Decrease/-increase in trade and
other receivables and prepayments
-1,849 -1,429 1,423 -927 -3,462
Decrease/-increase in trade and
other payables
-14,873 10,433 -25,798 17,498 13,641
Net cash flow from operating
activities
-63,298 -70,694 -138,724 -144,894 -288,231
Cash flows from investing activities
Interest
received
70 445 358 530 2,949
Purchase of property, plant and
equipment
Sale of property, plant and
equipment
299
Net cash flow used in investing
activities
70 445 358 530 3,248
Cash flows from financing activities
Proceeds from issue of share capital 9 253,187 253,187 3,218 3,218
Share issue costs 9 -35,780 -35,780 -7 -7
Cash payments for the principal
portion of the lease liability
-74 -307 -307
Net cash flow from financing
activities
217,407 -74 217,407 2,904 2,904
Effects of exchange rate changes on
cash and cash equivalents
-1,192 -5,363 -3,863 -3,042 -3,764
Net increase/(decrease) in cash and
cash equvivalents
154,179 -70,323 79,041 -141,460 -282,080
Cash and cash equivalents at
beginning of period
72,994 367,829 150,803 436,646 436,646
Cash and cash equivalents at end of
period
225,981 292,144 225,981 292,144 150,803

Selected notes to the interim consolidated financials

Note 1 Corporate information

BerGenBio ASA ("the Company") and its subsidiary (together "the Group") is a clinical stage biopharmaceutical company focused on developing novel medicines for aggressive diseases, including cancer and severe respiratory infections.

BerGenBio ASA is a public limited liability company incorporated and domiciled in Norway. The address of the registered office is Møllendalsbakken 9, 5009 Bergen, Norway.

The condensed interim financial information is unaudited. These interim financial statements cover the three and six-months period ended 30 June 2023 respectively and were approved for issue by the Board of Directors on 22 August 2023.

Note 2

Basis for preparation and significant accounting policies

Basis for preparation and significant accounting policies

The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group's annual financial statements for the year ended 31 December 2022.

No new standards have been applied in 2023.

Amounts are in Norwegian kroner (NOK) and presented in 1,000 NOK unless stated otherwise. The functional currency of the group is NOK.

Basis for consolidation

The consolidated financial statements comprise the financial statements of the Company and its subsidiary as of 30 June 2023. The subsidiary is BerGenBio Limited, located in Oxford in the United Kingdom and is 100% owned and controlled by the parent company BerGenBio ASA.

Estimates and assumptions

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

Capital markets are used as a source of liquidity when this is appropriate and when conditions in these markets are acceptable. In June 2023 period the company secured in total gross NOK 250 million in new equity from the rights issue. Cash position at end of Q2 2023 was NOK 226 million, and the Board of Directors has reasonable expectation that the Group will maintain adequate resources to continue in operational existence for the foreseeable future. The interim financial statements are prepared under the going concern assumption.

Note 3 Payroll and related expenses

Q2 2023 Q2 2022 YTD 2023 YTD 2022
Salaries 11,324 15,388 22,748 27,684
Social security tax 1,556 1,657 3,102 3,407
Pension expense 929 1,268 1,828 2,308
Short term incentive 0 0 0 0
Other remuneration, incl. restructuring 3,814 3,178 4,131 3,512
Government grants 1) -168 -342 -441 -685
Total payroll and other employee related cost 17,455 21,149 31,369 36,226
Share option expense employees 198 114 1,768 1,543
Change in accrued social security tax on share
options
0 -719 0 -752
Total employee share option cost 198 -605 1,768 791
Total employee benefit cost 17,653 20,544 33,137 37,016
Average number of full-time equivalent employees 28 38 28 40

1) See note 5 for government grants

Note 4 Employee share option program

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

The Group has a share option program to ensure focus and align the Group's long-term performance with shareholder values and interest. Most of the employees in the Group take part in the option program. The program also serves to attract and retain senior management. The exercise price for options granted is set at the market price of the shares at the time of grant of the options. In general, 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.

Note 4 Employee share option program (continued)

Total options YTD 2023 YTD 2022
Number
of
options
Weighted
average
exercise
price
Number
of
options
Weighted
average
exercise
price
Balance at 1 January 4,219,845 15.13 3,560,897 22.96
Granted
during the
period
Exercised
during the
period
-205,277 15.68
Forfeited
and cancelled
-376 463 15.38 -831 326 27.52
Balance at 30 June 3,843,382 15.10 2,524,294 22.05

0 options were granted in the three months period ended 30 June 2023 and 0 options were granted in the three months period ended 30 June 2022.

Vested
options
YTD 2023 YTD 2022
Options vested
at 1 January
1,615,066 1,541,168
Exercised and forfeited in the period -89,008 -641,088
Vested
in the
period
609,742 832,844
Options vested
at 30 June
2,135,800 1,732,924
Total outstanding number of options 3,843,382 2,524,294

The options are valued using the Black-Scholes model.

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

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

For valuation purposes 55,81 % expected future volatility has been applied.

For the sixt months period ending 30 June the value of the share options expensed through the profit or loss amounts to NOK 1.8 million (for the same period in 2022: NOK 1.5 million). In addition, a change in provision for social security contributions on share options of NOK -0.0 million (for the same period in 2022: NOK - 0.6 million). The provision for social security contribution is calculated on the difference between the share price and exercise price on exercisable option as at the end of the period.

Note 4 Employee share option program (continued)

Option holder Number of options outstanding 30 June 2023 Weighted Average Strike Price 2023 Number of options outstanding 30 June 2022 Weighted Average Strike Price 2022 Martin Olin Chief Executive Officer 950,000 7.59 0 0 Rune Skeie Chief Financial Officer 397,097 18.90 297,097 22.71 Cristina Oliva Chief Medical Officer 200,000 7.59 0 0 Nigel McCracken Chief Scientific Officer 275,000 7.59 0 0 James Barnes Chief Operating Officer 411,522 16.57 301,522 19.85 2,233,619 598,619

Members of senior management participating in the option program

Note 5 Government grants

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

Q2 2023 Q2 2022 YTD 2023 YTD 2022
Payroll and related
expenses
168 342 441 685
Other
operating expenses
1 151 1 414 2,329 2 827
Total 1,319 1,756 2,770 3,512

Grants receivable as of 30 June are detailed as follows:

30 Jun
2023
30 Jun
2022
Grants from Research Council, BIA 0 172
Grants from Research Council, PhD 227 265
Grants from SkatteFunn 7,125 7,125
Grants
R&D UK
4,354 4,262
Total 11,707 11,823

Note 5 Government grants (continued)

BIA grants from the Research Council:

The Company currently had one grant from the Research Council, programs for user-managed innovation arena (BIA) that ended in 2022.

The BIA grant ("AXL as a therapeutic target in fibrosis; biology and biomarkers") has been awarded from 2019 and amount up to NOK 10.7 million. The Group has recognised NOK 0.0 million YTD 2023 (2022: NOK 0.2 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses

PhD grants from the Research Council:

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

The Group has recognised NOK 0.4 million YTD 2023 (2022 : NOK 0.8 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

SkatteFunn:

R&D projects have been approved for SkatteFunn (a Norwegian government R&D tax incentive program designed to stimulate R&D in Norwegian trade and industry) for the period from 2021 until the end of 2024. The Group has recognised NOK 2.4 million YTD 2023 (2022: NOK 2.4 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.

Innovation Norway:

BerGenBio has been awarded a NOK 24 million (USD 2.85m) 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 has by end of 2020 recognised and received the total grant of NOK 24 million. The grant may be withdrawn under certain circumstances.

R&D tax grants UK:

BerGenBio Limited, a 100% subsidary of BerGenBio ASA, has been granted R&D tax grants in UK from 2017. R&D grants are approved retrospect by application. The Group has YTD 2023 recognised NOK 0.0 million (2022: NOK 0.0 mill) classified as reduction of payroll and related expenses for the year 2023.

Note 6 Other operating expenses

Q2 2023 Q2 2022 YTD 2023 YTD 2022
Program expenses, clinical trials and research 19,463 53,276 64,069 105,055
Office rent and expenses 876 994 1,692 1,722
Consultants R&D projects 1,697 1,762 4,591 4,219
Patent and licence
expenses
1,895 2,510 3,630 3,339
Other
operating expenses
7,323 10,252 15,382 17,648
Government grants -1,151 -1,414 -2,329 -2,827
Total 30,103 67,380 87,035 129,156

Note 7 Earnings per share

Q2 2023 Q2 2022 YTD 2023 YTD 2022
Loss for the period (NOK 1,000) -48,836 -84,156 -120,833 -165,182
Average number of outstanding shares
during the period
336,613,763 88,660,532 213,322,101 88,612,055
Earnings (loss) per share - basic and
diluted (NOK)
-0.15 -0.95 -0.57 -1.86

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.

Note 8 Other current assets

YTD 2023 YTD 2022
Government grants 11,707 11,823
Refundable VAT 774 259
Prepaid expenses 1,956 1,214
Other
receivables
0 29
Total 14,437 13,325

Note 9 Share capital and shareholder information

As of
30 June
Number
of
shares
Nominal
value
(NOK)
Book value
(NOK)
Ordinary
shares
2023
2,620,532,532 0.10 262,053,253.20
Ordinary
shares
2022
88,660,532 0.10 8,866,053.20

Changes in the outstanding number of shares

YTD 2023 YTD 2022
Ordinary shares on January 1st 88,660,532 88,455,255
Issue of ordinary shares 2,531,872,000 205,277
Ordinary shares on June 30th 2,620,532,532 88,660,532

Note 9 Share capital and shareholder information (continued)

Ownership structure as of 30 June 2023

Shareholder Number
of
shares
Percentage
share of total
shares
METEVA AS 704,815,981 26.9 %
INVESTINOR DIREKTE AS 214,431,620 8.2 %
DNB BANK ASA NOMINEE 192,134,520 7.3 %
MP PENSJON PK 60,893,267 2.3 %
BERA AS 52,118,026 2.0 %
NORDNET BANK AB NOMINEE 51,142,878 2.0 %
NORDNET LIVSFORSIKRING AS 40,688,300 1.6 %
AVANZA BANK AB NOMINEE 34,951,331 1.3 %
SARSIA DEVELOPMENT AS 33,675,000 1.3 %
JAKOB HATTELAND HOLDING AS 25,200,000 1.0 %
MOHN MARIT 24,817,824 0.9 %
MARSTIA INVEST AS 25,019,424 1.0 %
HØSE AS 21,006,588 0.8 %
RO INVEST AS 20,000,000 0.8 %
KONVEGENS INVEST AS 15,451,000 0.6 %
ZAIM 12,000,000 0.5 %
BIRK VENTURE AS 12,000,000 0.5 %
JAHATT AS 10,075,000 0.4 %
BJØRKEHAGEN AS 10,000,000 0.4 %
BERGEN KOMMUNALE PENSJONSKASSE 9,300,000 0.4 %
Top 20 shareholders 1,569,720,759 59.9 %
Total other shareholders 1,050,811,773 40.1 %
Total number of shares 2,620,532,532 100.0 %

The Annual General Meeting held 22 May 2023 approved to issue up to 2.5 billion new shares in a rights issue, and additional up to 1.25 billion warrants. The rights issue was successfully completed 13 June 2023 and fully subscribed. 2.5 billion shares was issued and 1.25 billion warrants. The warrants is a right to receive one share at a predefined issue price in specific windows.

The Board of Directors has been granted a mandate from the general meeting held on 22 May 2023 to increase the share capital with up to NOK 12,909,000 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 2024 and 30 June 2024. See note 4 for more information about the share incentive program and number of options granted.

The Board of Directors has been granted a mandate from the general meeting held on 22 May 2023 to increase the share capital with up to NOK 72,773,210 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2024 and 30 June 2024.

Note 9 Share capital and shareholder information (continued)

Shares in the Group held by the senior management group

Position Employed
since
Warrants
30 June
2023
Shares
30 June
2023
Shares
30 June
2022
Martin Olin Chief Ecexutive Officer September 2021 1,000,000 2,037,100 37,100
Rune Skeie Chief Financial
Officer
March 2018 129,595 259,190 0
Nigel McCracken Chief Scientific Officer March
2021
142,554 285,108 0
James Barnes Chief Operating Officer March
2019
129,595 259,190 0
Total shares held by management 1,401,744 2,840,588 37,100

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

Position Served
since
Warrants
30 June
2023
Shares
30 June
2023
Shares
30 June
2022
Anders Tullgren Chairman January 2022 704,910 1,459,820 50,000
Sveinung Hole 1) Board member September 2010 1,000,000 2,000,000 107 394
Sally Bennett Board member December 2020 157,413 314,826 0
Debra Barker Board member March 2019 155,513 311,027 0
Total shares held by members of the Board of Directors 2,017,836 4,085,673 157,394

1) Sveinung Hole holds 2,000,000 (104,444) shares in the Company through Svev AS, a wholly owned company of Sveinung Hole, and 0 (2,950 ) shares directly.

Address

Mollendalsbakken 9, 5867 Bergen, Norway Møllendalsbakken 9, 5009 Bergen, Norway

Phone Number

  • 47 559 61 159

E-mail

[email protected]

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