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BerGenBio

Quarterly Report Nov 14, 2023

3555_rns_2023-11-14_75aeaf71-f95e-4ade-9707-fb2f24037e35.pdf

Quarterly Report

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Interim report third quarter 2023

Corporate highlights

"We are pleased to report continued advancement of our focused strategy to study our lead compound bemcentinib, a highly selective AXL inhibitor, in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the STK11 gene (STK11m).

The increasing recognition of STK11m as a poor prognostic factor for 1L NSCLC patients, as evidenced by real-world data presented at prestigious medical conferences, continues to substantiate high unmet medical needs and our clinical data continues to validate the potential role of bemcentinib in combination with standard of care therapies to improve the outcome for these patients.

During the quarter, we activated additional clinical trial sites in the US and prepared for the addition of sites in Europe in anticipation of the expected initiation of the Ph2a portion of our study in 1L NSCLC STK11m patients in the first half of 2024.

Our operating expenses in the quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022 reflecting the effects of our focused strategy and cost containments implemented in connection with the Rights Issue.

At 30th September 2023 our cash position stood at NOK 169.3 million. We believe that our singular focus on advancing bemcentinib in 1L NSCLC STK11m combined with the potential funding from the exercise of outstanding warrants issued in the Rights Issue enables us to generate data that can position the significant potential of bemcentinib in NSCLC."

Martin Olin

Chief Executive Officer

Recent Highlights

  • Continued advancement of BGBC016 Ph1b/2a trial in 1L NSCLC STK11m patients
    • Additional trial sites activated and preparations for Ph2a initiated
  • Multiple presentations at prestigious medical/scientific meetings
  • Focused strategy has resulted in significant cost-containment in Q3 2023
  • Completed Rights Issue with warrant component to potentially extend runway

Q3 2023 Financial highlights

(NOK million) Q3 2023 Q3 2022 YTD 2023 YTD 2022 FY 2022
Operating revenues 0,0 0,0 0,0 0,0 0,4
Operating expenses 28,1 62,4 148,3 229,2 306,0
Operating profit
(-loss)
-28,1 -62,4 -148,3 -229,2 -305,6
Profit (-loss) after
tax
-27,9 -59,8 -148,8 -224,9 -302,1
Basic and diluted earnings (loss) per share (NOK) -0.01 -0.67 -0.15 -2.54 -3.41
Net cash flow in the period -55,4 -65,1 14,7 -206,9 -282,1
Cash position end of period 169,3 225,1 169,3 225,1 150,8

Q3 2023 and post period clinical highlights

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 STK11m 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 STK11m and no actionable mutations. Sites in the US have been activated and enrollment is ongoing while expansion into European sites is well underway, with regulatory approval to proceed in the US and several European countries.

The Phase 1b portion of the study is evaluating 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. To date, no significant safety concerns have arisen in the Phase 1b study.

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 STK11m.

A significant subgroup comprising of up to 20 % (> 30,000 patients in US and EU5) of 1L non-squamous NSCLC patients harbor STK11m, 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.

Post-quarter, the Company announced that the final data from the BGBC008 study (2L+ NSCLC, bemcentinib in combination with pembrolizumab) was presented on October 23rd at the European Society for Medical Oncology (ESMO) 2023 Annual Meeting held in Madrid. The Company believes that these data along with study BGBIL005 (2L+ NSCLC, bemcentinib in combination with docetaxel) provide clinical evidence of the anti-tumor 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. We expect to report additional clinical data at upcoming major medical meetings during the remainder of 2023, including at the Annual Meetings of the Society for Immunotherapy of Cancer (SITC) and the American Society of Hematology (ASH).

Q3 2023 and post period clinical highlights

Clinical Development (Continued)

Description of the 2L+ NSCLC Trial (BGBC008)

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 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 patients treated in subsequent therapies (3L+) following treatment with bemcentinib + pembrolizumab identified a higher than expected response rate, potentially pointing to long-lasting immune response benefits.
  • 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 PD-L1 negative patients respond less well to immune checkpoint inhibition, potentially providing an opportunity to expand the patient population eligible for treatment with bemcentinib.

• The combination of bemcentinib and pembrolizumab appeared to benefit patients with mutations associated with poor outcome with available therapies, including STK11, KRAS, KEAP-1 and SMARCA4 mutations. These mutational patient populations may represent an incremental opportunity for bemcentinib and will be further assessed in our on-going BGBC016 study in 1L patients.

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 for the treatment of severe respiratory infections.

On April 25, 2023, the Company decided to pause the bemcentinib arm of the Phase 2b EU-SolidAct trial evaluating bemcentinib in hospitalized COVID-19 patients due to the limited number of hospitalizations observed across all European countries. The Company and the EU-SolidAct have agreed to maintain this study on pause until and unless such time both parties agree to resume the trial arm due to increased COVID hospitalizations or should a new pandemic arise.

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

Q3 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.

Warrants

The outstanding warrants issued in the Rights Issue can be exercised in two defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume-weighted average price (VWAP) of the Company's shares on the Oslo Stock Exchange over the three last trading days prior to the exercise period less 30%, but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional information and instructions for exercise of warrants can be found on the Company's website in the Investor section.

Organization

Our Chief Operating Officer James Barnes, decided to pursue new opportunities and will leave the company during December 2023. In connection with the implementation of the focused strategy, the role of Chief Operating Officer will not be replaced.

Q3 2023 Financial review

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

Revenue for the third quarter 2023 amounted to NOK 0.0 million (NOK 0.0 million) and year to date (YTD) 2023 NOK 0.0 million (NOK 0.0 million).

Total operating expenses for the third quarter 2023 amounted to NOK 28.1 million (NOK 62.4 million) and YTD 2023 NOK 148.3 million (NOK 229.2 million).

Payroll and other employee related costs in the third quarter were NOK 13.7 million (NOK 13.6 million) and YTD 2023 NOK 45.0 million (NOK 49.8 million). Adjusted for one-offs, timing differences and development in currency rates, the third quarter of 2023 reflects the underlying decrease in the average FTE's.

As part of the focused strategy, FTE's have been reduced from 30 FTE's end of Q3 2022 to 18 FTE's end of Q3 2023.

Employee share option costs in the third quarter were NOK 0.8 million (NOK 0.5 million) and YTD 2023 NOK 2.6 million (NOK 1.3 million).

Other operating expenses amounted to NOK 13.5 million (NOK 48.2 million) for the third quarter and NOK 100.5 million (NOK 177.3 million) YTD. Operating expenses were mainly driven by activities in the development program reflecting the effects of the focused strategy previously announced where the Company currently is focusing on 1L NSCLC STK11m compared to Q3 2022 where additional studies were active and open. In addition, the Q3 2023 operating expenses is positively affected by the closure of clinical studies by NOK 5.7 million.

The operating loss for the third quarter amounts to NOK 28.1 million (NOK 62.4 million) and YTD 2023 NOK 148.3 million (NOK 229.2 million), reflecting the operations and settlements during the quarter and decrease in headcount after restructuring.

Net financial items amounted to a profit of NOK 0.2 million (NOK 2.6 million) for the third quarter related to net loss on foreign exchanges and

interest on cash deposit. YTD 2023 the net financial items amounted to a loss of NOK 0.5 million (profit of NOK 4.3 million).

Losses after tax for the third quarter were NOK 27.9 million (NOK 59.8 million) and YTD 2023 NOK 148.8 million (NOK 224.9 million).

Financial Position

Total assets as of 30 September 2023 decreased to NOK 188.0 million (NOK 240.4 million as of 30 June 2023), mainly due to the operational loss in the period and payment of short-term debt.

Total liabilities were NOK 26.8 million as of 30 September 2023 (NOK 52.4 million as of 30 June 2023).

Total equity as of 30 September 2023 was NOK 161.2 million (NOK 188.0 million as of 30 June 2023), corresponding to an equity ratio of 85.7% (78.2% as of 30 June 2023).

Cash Flow

Net cash flow to operating activities was NOK 55.3 million in the third quarter (NOK 65.8 million) and NOK 203.0 million YTD 2023 (NOK 210.7 million), mainly driven by the operating results in the quarter and payment of short-term liabilities.

Net cash flow from investing during the third quarter was NOK 0.0 million (NOK 0.8 million) and YTD 2023 NOK 0.4 million (NOK 1.0 million).

Net cash flow from financing activities in the third quarter 2023 was negative by NOK 0.1 million (negative NOK 0.1 million) and YTD 2023 NOK 217.3 million (NOK 2.8 million).

Cash and cash equivalents decreased to NOK 169.3 million by 30 September 2023 (NOK 226.0 by 30 June 2023 and NOK 225.1 by 30 September 2022).

Q3 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, 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 pipeline focused on the development of bemcentinib within NSCLC STK11m and respiratory diseases.

The previously 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.

The cash position at end of Q3 2023 was NOK 169 million. A singular focused strategy combined with potential proceeds from the exercise of the Warrants issued as part of the rights issue in June, will in the opinion of the Board enable the Group to maintain adequate resources to continue the advancement bemcentinib in NSCLC towards delivering new treatment options for patients in need and value for shareholders.

The Board today considered and approved the condensed, consolidated financial statement of the nine months ending 30 September 2023 for BerGenBio.

Bergen 13 November 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 Q3 2023 Q3 2022 YTD 2023 YTD 2022 FY 2022
Revenue 0 0 0 0 389
Expenses
Payroll and other related employee cost 3 13,679 13,621 45,047 49,847 66,143
Employee
share
option
cost
3 829 481 2,597 1,272 2,546
Depreciation 2 109 140 122 771 883
Other
operating expenses
6 13,473 48,186 100,508 177,342 236,451
Total operating expenses 28,090 62,428 148,275 229,231 306,024
Operating profit/-loss -28,090 -62,428 -148,275 -229,231 -305,635
Finance income 4,077 6,420 9,198 12,793 15,027
Finance expense 3,919 3,789 9,688 8,495 11,514
Financial items, net 158 2,631 -490 4,298 3,513
Profit before
tax
-27,932 -59,797 -148,765 -224,933 -302,122
Income tax
expense
0 0 0 0 0
Profit after
tax
-27,932 -59,797 -148,765 -224,933 -302,122
Other
comprehensive
income
Items which may be reclassified over
profit and loss
Exchange differences on translation of
foreign operations
228 276 1,425 231 -484
Total comprehensive income for the
period
-27,704 -59,520 -147,340 -224,702 -302,606
Earnings
per share:
-
Basic and diluted per share
7 -0.01 -0.67 -0.15 -2.54 -3.41

Condensed consolidated statement of financial position

(NOK 1000) Unaudited Note 30 SEP 2023 30 SEP 2022 31 DEC 2022
ASSETS
Non-current
assets
Property, plant and equipment 532 156 43
Total non-current
assets
532 156 43
Current
assets
Other
current
assets
5, 8 18,151 10,289 15,860
Cash and cash equivalents 169,314 225,072 150,803
Total current
assets
187,465 235,361 166,663
TOTAL ASSETS 187,997 235,517 166,706
EQUITY AND LIABILITIES
Equity
Paid
in capital
Share
capital
9 262,053 8,866 8,866
Share
premium
9 0 113,684 35,780
Other
paid
in capital
4, 9 46,449 42,349 43,852
Total paid
in capital
308,503 164,899 88,498
Retained
earnings
9 -147,340 0 0
Total equity 161,163 164,899 88,498
Non-current
liabilities
Long term debt 2 101 0 275
Total non-current
liabilities
101 0 275
Current
liabilities
Accounts
payable
15,097 32,218 29,634
Other
current
liabilities
11,636 38,400 48,299
Total current
liabilities
26,733 70,618 77,933
Total liabilities 26,834 70,618 78,208
TOTAL EQUITY AND LIABILITIES 187,997 235,517 166,706

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 -148,765 -148,765
Other comprehensive income (loss) for the
period, net of income tax
1,425 1,425
Total comprehensive income for the
period
0 0 0 -147,340 -147,340
Recognition of share-based payments 3, 4 2,597 2,597
Issue of ordinary shares 9 253,187 253,187
Share issue costs 9 -35,780 -35,780
Transactions with owners 253,187 -35,780 2,597 0 220,004
Balance at 30 September 2023 262,053 0 46,449 -147,340 161,163
(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
-224,933 0 -224,933
Other comprehensive income (loss) for the
period, net of income tax
231 0 231
Total comprehensive income for the period 0 -224,702 0 0 -224,702
Recognition of share-based payments 3, 4 1,964 0 1,964
Issue of ordinary shares 9 21 3,198 0 3,218
Share issue costs 9 -7 0 -7
Transactions with owners 21 3,191 1,964 0 5,175
Balance at 30 September 2022 8,866 113,684 41,928 0 164,899

Interim Report Third Quarter 2023

Condensed consolidated statement of cash flow

(NOK 1000) Unaudited Note Q3 2023 Q3 2022 YTD 2023 YTD 2022 FY 2022
Cash flow from operating activities
Profit (loss) before
tax
-27,932 -59,520 -148,765 -224,702 -302,122
Adjustments
for:
Depreciation of property, plant and
equipment
109 140 122 771 883
Share-based
payment
expense
3, 4 829 421 2,597 1,964 3,466
Movement in provisions and pensions -969 -969
Currency -gains/+loss not related to
operating activities
1,453 2,023 -2,410 5,065 3,280
Net interest
received
-480 -358 -1,009 -2,949
Working
capital
adjustments:
Decrease/-increase in trade and other
receivables and prepayments
-3,714 3,036 -2,291 2,109 -3,462
Increase/-decrease in trade and other
payables
-26,091 -11,447 -51,889 6,051 13,641
Net cash flow from operating
activities
-55,346 -65,828 -202,994 -210,721 -288,231
Cash flows from investing activities
Interest
received
480 358 1,009 2,949
Purchase of property, plant and
equipment
Sale of property, plant and equipment 299 299 299
Net cash flow used in investing
activities
0 778 358 1,308 3,248
Cash flows from financing activities
Proceeds from issue of share capital 9 - 253,187 3,218 3,218
Share
issue
costs
9 - -35,780 -7 -7
Cash payments for the principal portion
of the lease liability
-96 - -96 -307 -307
Net cash flow from financing activities -96 0 217,311 2,904 2,904
Effects of exchange rate changes on
cash and cash equivalents
-1,225 -2,023 3,836 -5,065 -3,764
Net increase/(decrease) in cash and
cash equivalents
-55,442 -65,049 14,675 -206,509 -282,080
Cash and cash equivalents at beginning
of period
225,981 292,144 150,803 436,646 436,646
Cash and cash equivalents at end of
period
169,314 225,072 169,314 225,072 150,803

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 nine-months period ended 30 September 2023 respectively and were approved for issue by the Board of Directors on 13 November 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 September 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, the company secured in total gross NOK 250 million in new equity from a rights issue. The cash position at end of Q3 2023 was NOK 169 million. A singular focused strategy combined with potential proceeds from the exercise of the Warrants issued as part of the rights issue in June, will in the opinion of the Board enable the Group to maintain adequate resources to continue the advancement bemcentinib in NSCLC towards delivering new treatment options for patients in need and value for shareholders. The interim financial statements are prepared under the going concern assumption.

Note 3 Payroll and related expenses

Q3 2023 Q3 2022 YTD 2023 YTD 2022
Salaries 8,306 8,922 31,054 39,623
Social security tax 1,461 1,674 4,563 5,082
Pension expense 1,032 899 2,860 3,206
Other remuneration, incl. restructuring 2,947 2,469 7,079 2,964
Government grants 1) -68 -342 -509 -1,027
Total payroll and other employee related cost 13,678 13,621 45,047 49,847
Share option expense employees 830 421 2,597 1,964
Change in accrued social security tax on share
options
0 59 0 -692
Total employee share option cost 830 481 2,597 1,272
Total employee benefit cost 14,508 14,102 47,645 51,119
Average number of full-time equivalent employees 26 34 27 34
FTE end of period 18 30

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
Weighted
average
Number
of
exercise
options
price
YTD 2022
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 -959 147 26.38
Balance at 30 September 3,843,382 15.10 2,396,473 22.21

0 options were granted in the nine months period ended 30 September 2023 and 0 options were granted in the nine months period ended 30 September 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 -713,088
Vested
in the
period
799,742 832,844
Options vested
at 30 September
2,325,800 1,660,924
Total outstanding number of options 3,843,382 2,396,473

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 nine months period ending 30 September the value of the share options expensed through the profit or loss amounts to NOK 2.6 million (for the same period in 2022: NOK 2.0 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 - 0,7 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 Sep 2023 Weighted Average Strike Price 2023 Number of options outstanding 30 Sep 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 James Barnes Chief Operating Officer 411,522 16.57 301,522 19.85 1,958,619 598,619

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

Q3 2023 Q3 2022 YTD 2023 YTD 2022
Payroll and related expenses 68 342 509 1,027
Other
operating expenses
1,120 1,242 3,449 4,069
Total 1,187 1,584 3,957 5,096

Grants receivable as of 30 September are

detailed as follows:

30 Sep 2023 30 Sep 2022
Grants from Research Council, BIA 0 172
Grants from Research Council, PhD 227 132
Grants from SkatteFunn 8,312 3,562
Grants
R&D UK
4,153 4,323
Total 12,693 8,189

Note 5 Government grants (continued)

BIA grants from the Research Council:

The Company received 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") was awarded from 2019 and amount up to NOK 10.7 million. The Group has recognized NOK 0.0 million YTD 2023 (2022: NOK 0.3 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 fellows' doctoral work. The Group has recognized NOK 0.4 million YTD 2023 (2022 : NOK 1.2 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 3.6 million YTD 2023 (2022: NOK 3.6 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 (bemcentinib) 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

Q3 2023 Q3 2022 YTD 2023 YTD 2022
Program expenses, clinical trials and research 7,332 40,955 71,402 146,010
Office rent and expenses 428 977 2,119 2,699
Consultants R&D projects 2,435 1,467 7,027 5,686
Patent and licence
expenses
570 1,288 4,200 4,627
Other
operating expenses
3,827 4,741 19,209 22,389
Government grants -1,119 -1,242 -3,449 -4,069
Total 13,473 48,186 100,508 177,342

Note 7 Earnings per share

Q3 2023 Q3 2022 YTD 2023 YTD 2022
Loss for the period (NOK 1,000) -27,932 -59,520 -148,765 -224,702
Average number of outstanding shares
during the period
2,620,532,532 88,660,532 1,024,543,199 88,628,391
Earnings (loss) per share - basic and
diluted (NOK)
-0.01 -0.67 -0.15 -2.54

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 12,693 8,189
Refundable VAT 0 134
Prepaid expenses 5,458 1,680
Other
receivables
0 286
Total 18,151 10,289

Note 9 Share capital and shareholder information

As of
30 September
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 at 30 September 2,620,532,532 88,660,532

Note 9 Share capital and shareholder information (continued)

Ownership structure as of 30 September 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 %
MP PENSJON PK 57,069,659 2.2 %
BERA AS 55,768,426 2.1 %
NORDNET LIVSFORSIKRING AS 47,093,883 1.8 %
NORDNET BANK AB NOMINEE 42,846,488 1.6 %
SARSIA DEVELOPMENT AS 33,675,000 1.3 %
AVANZA BANK AB NOMINEE 32,379,429 1.2 %
RONGEVÆR 30,369,946 1.2 %
DNB BANK ASA NOMINEE 27,962,260 1.1 %
MARSTIA INVEST AS 26,833,824 1.0 %
JAKOB HATTELAND HOLDING AS 25,200,000 1.0 %
MOHN MARIT 24,817,824 0.9 %
HØSE AS 21,006,588 0.8 %
HOLØ 20,500,000 0.8 %
RO INVEST AS 20,000,000 0.8 %
ZAIM 12,000,000 0.5 %
DANSKE BANK A/S NOMINEE 11,139,174 0.4 %
JAHATT AS 10,075,000 0.4 %
BJØRKEHAGEN AS 10,000,000 0.4 %
Top 20 shareholders 1,427,985,102 54.5 %
Total other
shareholders
1,192,547,430 45.5 %
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. In June 2023, the share capital was increased by NOK 3,187,200 by use of this board proxy.

Note 9 Share capital and shareholder information (continued)

Shares in the Group held by the senior management group

Position Employed
since
Warrants
30 Sep
2023
Shares
30 Sep
2023
Shares
30 Sep
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
James Barnes Chief Operating Officer March
2019
129,595 259,190 0
Total shares held by management 1,259,190 2,555,480 37,100

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

Position Served
since
Warrants
30 Sep
2023
Shares
30 Sep
2023
Shares
30 Sep
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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