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Name | Symbol | Market | Type |
---|---|---|---|
BioLineRx Ltd | NASDAQ:BLRX | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0343 | -4.78% | 0.684 | 0.6826 | 0.73 | 0.72 | 0.682 | 0.72 | 113,612 | 22:00:44 |
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
On August 30, 2023, the Registrant issued a press release announcing its financial results for the three and six months ended June 30, 2023. The Registrant is also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of
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BioLineRx Ltd.
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By:
|
/s/ Philip Serlin
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Philip Serlin
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Chief Executive Officer
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|
• |
On track for September 9, 2023 PDUFA target action date on NDA for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma
|
• |
Signed exclusive license agreement to develop and commercialize motixafortide in Asia with concurrent equity investment; license agreement includes $15 million upfront payment, plus potential development, regulatory and sales milestones,
and tiered double-digit royalties, as well as various development obligations for the licensee, including the planned initiation in China of a registrational study in stem-cell mobilization and a randomized Phase 2/3 study in first-line
pancreatic cancer; straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants; effectiveness and closing of transactions is contingent upon approval by Israeli Innovation Authority of license agreement
within four months of execution, and other closing conditions
|
• |
Announced publication in Nature Medicine of GENESIS Phase 3 clinical trial data evaluating motixafortide and G-CSF in stem cell mobilization for autologous transplantation in multiple myeloma
|
• |
Announced initiation of randomized, investigator-initiated Phase 2 clinical trial in collaboration with Columbia University, with joint funding of the study by Regeneron and BioLineRx, assessing motixafortide in combination with the PD-1
inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with mPDAC. Anticipate initial patient data in 2023. A poster of the amended clinical trial design
was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June
|
• |
Continued to advance plans for a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell
mobilization for gene therapies in sickle cell disease. Anticipate trial initiation later this year
|
• |
Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022. Study met primary endpoint for safety and
tolerability and demonstrated immune activity across multiple biomarkers
|
• |
Research and development expenses for the three months ended June 30, 2023 were $3.0 million, a decrease of $2.4 million, or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from
lower expenses related to NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
|
• |
Sales and marketing expenses for the three months ended June 30, 2023 were $5.6 million, an increase of $4.4 million, or 383.9% compared to $1.2 million for the three months ended June 30, 2022. The increase resulted primarily from the
ramp-up of pre-launch activities related to motixafortide
|
• |
General and administrative expenses for the three months ended June 30, 2023 were $1.3 million, an increase of $0.3 million, or 24.4% compared to $1.0 million for the three months ended June 30,
2022. The increase resulted primarily from an increase in payroll and related expenses due to a small increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses
|
• |
Net loss for the three months ended June 30, 2023 was $18.5 million, compared to $7.4 million for the three months ended June 30, 2022. The Company's net loss for the six months ended June 30, 2023 amounted to $30.7 million, compared to
$12.4 million for the six months ended June 30, 2022. The increases in net loss for both the three and six months ended June 30, 2023 were due primarily to a non-operating expense of approximately $7.8 million and $10.8 million respectively,
related to the revaluation of outstanding warrants resulting from an increase in the Company’s share price over the preceding three and six months
|
• |
As of June 30, 2023, the Company held cash, cash equivalents, and short-term bank deposits of $32.8 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024. This amount does
not include $29.6 million in total funding from the exclusive license agreement and equity investment announced today, which the Company anticipates closing in Q3 subject to formal transaction approval by the Israeli Innovation Authority
and other closing conditions
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December 31,
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June 30,
|
|||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
10,587
|
10,104
|
||||||
Short-term bank deposits
|
40,495
|
22,711
|
||||||
Prepaid expenses
|
198
|
1,749
|
||||||
Other receivables
|
721
|
128
|
||||||
Total current assets
|
52,001
|
34,692
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
726
|
648
|
||||||
Right-of-use assets, net
|
1,772
|
1,583
|
||||||
Intangible assets, net
|
21,885
|
22,013
|
||||||
Total non-current assets
|
24,383
|
24,244
|
||||||
Total assets
|
76,384
|
58,936
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
1,542
|
3,078
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
6,966
|
6,733
|
||||||
Other
|
1,744
|
2,260
|
||||||
Current maturities of lease liabilities
|
427
|
375
|
||||||
Total current liabilities
|
10,679
|
12,446
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Warrants
|
4,509
|
15,352
|
||||||
Long-term loan, net of current maturities
|
8,626
|
8,495
|
||||||
Lease liabilities
|
1,729
|
1,589
|
||||||
Total non-current liabilities
|
14,864
|
25,436
|
||||||
Total liabilities
|
25,543
|
37,882
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
27,100
|
27,100
|
||||||
Share premium
|
338,976
|
339,045
|
||||||
Warrants
|
1,408
|
1,408
|
||||||
Capital reserve
|
14,765
|
15,616
|
||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
Accumulated deficit
|
(329,992
|
)
|
(360,699
|
)
|
||||
Total equity
|
50,841
|
21,054
|
||||||
Total liabilities and equity
|
76,384
|
58,936
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
in USD thousands
|
in USD thousands
|
|||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(5,395
|
)
|
(3,006
|
)
|
(9,830
|
)
|
(6,690
|
)
|
||||||||
SALES AND MARKETING EXPENSES
|
(1,158
|
)
|
(5,604
|
)
|
(1,795
|
)
|
(9,478
|
)
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(1,049
|
)
|
(1,305
|
)
|
(2,056
|
)
|
(2,603
|
)
|
||||||||
OPERATING LOSS
|
(7,602
|
)
|
(9,915
|
)
|
(13,681
|
)
|
(18,771
|
)
|
||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
458
|
(7,733
|
)
|
1,726
|
(10,649
|
)
|
||||||||||
FINANCIAL INCOME
|
80
|
440
|
147
|
977
|
||||||||||||
FINANCIAL EXPENSES
|
(379
|
)
|
(1,337
|
)
|
(565
|
)
|
(2,264
|
)
|
||||||||
NET LOSS AND COMPREHENSIVE LOSS
|
(7,443
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)
|
(18,545
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)
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(12,373
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)
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(30,707
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)
|
in USD
|
in USD
|
|||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.01
|
)
|
(0.02
|
)
|
(0.02
|
)
|
(0.03
|
)
|
||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
715,365,554
|
922,958,942
|
715,260,781
|
922,958,942
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2022
|
21,066
|
339,346
|
975
|
13,157
|
(1,416
|
)
|
(305,041
|
)
|
68,087
|
|||||||||||||||||||
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2022: |
||||||||||||||||||||||||||||
Issuance of share capital, net
|
89
|
177
|
-
|
-
|
-
|
-
|
266
|
|||||||||||||||||||||
Employee stock options exercised
|
2
|
12
|
-
|
(12
|
)
|
-
|
-
|
2
|
||||||||||||||||||||
Employee stock options expired
|
-
|
135
|
-
|
(135
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
586
|
-
|
-
|
586
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(12,373
|
)
|
(12,373
|
)
|
|||||||||||||||||||
BALANCE AT JUNE 30, 2022
|
21,157
|
339,670
|
975
|
13,596
|
(1,416
|
)
|
(317,414
|
)
|
56,568
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2023: |
||||||||||||||||||||||||||||
Employee stock options expired
|
-
|
69
|
-
|
(69
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
920
|
-
|
-
|
920
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(30,707
|
)
|
(30,707
|
)
|
|||||||||||||||||||
BALANCE AT JUNE 30, 2023
|
27,100
|
339,045
|
1,408
|
15,616
|
(1,416
|
)
|
(360,699
|
)
|
21,054
|
Six months ended June 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Net loss for the period
|
(12,373
|
)
|
(30,707
|
)
|
||||
Adjustments required to reflect net cash used in operating activities
(see appendix below) |
498
|
13,009
|
||||||
Net cash used in operating activities
|
(11,875
|
)
|
(17,698
|
)
|
||||
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(9,000
|
)
|
(6,006
|
)
|
||||
Maturities of short-term deposits
|
24,141
|
24,000
|
||||||
Purchase of property and equipment
|
(62
|
)
|
(99
|
)
|
||||
Purchase of intangible assets
|
-
|
(153
|
)
|
|||||
Net cash provided by investing activities
|
15,079
|
17,742
|
||||||
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
Issuance of share capital and warrants, net of issuance costs
|
266
|
-
|
||||||
Employee stock options exercised
|
2
|
-
|
||||||
Repayments of loan
|
(1,812
|
)
|
-
|
|||||
Repayments of lease liabilities
|
(88
|
)
|
(183
|
)
|
||||
Net cash used in financing activities
|
(1,632
|
)
|
(183
|
)
|
||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
1,572
|
(139
|
)
|
|||||
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD
|
12,990
|
10,587
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(562
|
)
|
(344
|
)
|
||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
14,000
|
10,104
|
Six months ended June 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
314
|
457
|
||||||
Exchange differences on cash and cash equivalents
|
562
|
344
|
||||||
Fair value adjustments of warrants
|
(1,673
|
)
|
10,843
|
|||||
Share-based compensation
|
586
|
920
|
||||||
Interest and exchange differences on short-term deposits
|
(142
|
)
|
(210
|
)
|
||||
Interest on loan
|
68
|
1,405
|
||||||
Exchange differences on lease liability
|
(205
|
)
|
(75
|
)
|
||||
(490
|
)
|
13,684
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in prepaid expenses and other receivables
|
(688
|
)
|
(958
|
)
|
||||
Increase in accounts payable and accruals
|
1,676
|
283
|
||||||
988
|
(675
|
)
|
||||||
498
|
13,009
|
|||||||
Supplemental information on interest received in cash
|
146
|
761
|
||||||
Supplemental information on interest paid in cash
|
217
|
640
|
||||||
Supplemental information on non-cash transactions:
|
||||||||
Acquisition of right-of-use asset
|
-
|
66
|
Page | ||
F-1 | ||
F-2 | ||
F-3 | ||
F-4 - F-5 | ||
F-6 - F-12 |
December 31,
|
June 30,
|
|||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
|
|
||||||
Short-term bank deposits
|
|
|
||||||
Prepaid expenses
|
|
|
||||||
Other receivables
|
|
|
||||||
Total current assets
|
|
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
|
|
||||||
Right-of-use assets, net
|
|
|
||||||
Intangible assets, net
|
|
|
||||||
Total non-current assets
|
|
|
||||||
Total assets
|
|
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
|
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
|
|
||||||
Other
|
|
|
||||||
Current maturities of lease liabilities
|
|
|
||||||
Total current liabilities
|
|
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Warrants
|
|
|
||||||
Long-term loan, net of current maturities
|
|
|
||||||
Lease liabilities
|
|
|
||||||
Total non-current liabilities
|
|
|
||||||
Total liabilities
|
|
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
|
|
||||||
Share premium
|
|
|
||||||
Warrants
|
|
|
||||||
Capital reserve
|
|
|
||||||
Other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total equity
|
|
|
||||||
Total liabilities and equity
|
|
|
F - 1
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
in USD thousands
|
in USD thousands
|
|||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
SALES AND MARKETING EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
OPERATING LOSS
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
|
(
|
)
|
|
(
|
)
|
||||||||||
FINANCIAL INCOME
|
|
|
|
|
||||||||||||
FINANCIAL EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
NET LOSS AND COMPREHENSIVE LOSS
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
in USD
|
in USD
|
|||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
|
|
|
|
F - 2
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2022
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2022: |
||||||||||||||||||||||||||||
Issuance of share capital, net
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Employee stock options exercised
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
Employee stock options expired
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
Share-based compensation
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Comprehensive loss for the period
|
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
BALANCE AT JUNE 30, 2022
|
|
|
|
|
(
|
)
|
(
|
)
|
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2023: |
||||||||||||||||||||||||||||
Employee stock options expired
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
Share-based compensation
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Comprehensive loss for the period
|
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
BALANCE AT JUNE 30, 2023
|
|
|
|
|
(
|
)
|
(
|
)
|
|
F - 3
Six months ended June 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Net loss for the period
|
(
|
)
|
(
|
)
|
||||
Adjustments required to reflect net cash used in operating activities
(see appendix below) |
|
|
||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(
|
)
|
(
|
)
|
||||
Maturities of short-term deposits
|
|
|
||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Purchase of intangible assets
|
|
(
|
)
|
|||||
Net cash provided by investing activities
|
|
|
||||||
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
Issuance of share capital and warrants, net of issuance costs
|
|
|
||||||
Employee stock options exercised
|
|
|
||||||
Repayments of loan
|
(
|
)
|
|
|||||
Repayments of lease liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in financing activities
|
(
|
)
|
(
|
)
|
||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
(
|
)
|
|||||
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD
|
|
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(
|
)
|
(
|
)
|
||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
|
|
F - 4
Six months ended June 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Exchange differences on cash and cash equivalents
|
|
|
||||||
Fair value adjustments of warrants
|
(
|
)
|
|
|||||
Share-based compensation
|
|
|
||||||
Interest and exchange differences on short-term deposits
|
(
|
)
|
(
|
)
|
||||
Interest on loan
|
|
|
||||||
Exchange differences on lease liability
|
(
|
)
|
(
|
)
|
||||
(
|
)
|
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in prepaid expenses and other receivables
|
(
|
)
|
(
|
)
|
||||
Increase in accounts payable and accruals
|
|
|
||||||
|
(
|
)
|
||||||
|
|
|||||||
Supplemental information on interest received in cash
|
|
|
||||||
Supplemental information on interest paid in cash
|
|
|
||||||
Supplemental information on non-cash transactions:
|
||||||||
Acquisition of right-of-use asset
|
|
|
F - 5
a. |
General
|
b. |
Going concern
|
F - 6
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 – GENERAL INFORMATION (cont.)
b. |
Going concern (cont.) |
Management’s plans include the independent commercialization of the Company’s product and, if and when required, raising capital through the issuance of debt or equity securities, or capital inflows from strategic partnerships. There are no assurances, however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and/or raising capital, it may need to reduce activities, or curtail or cease operations.
|
c. |
Approval of financial statements
The condensed consolidated interim financial statements of the Company as of June 30, 2023, and for the three and six months then ended, were approved by the Board of Directors on August 22, 2023, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer, and the Chief Financial Officer.
|
F - 7
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing will bear interest at a fixed annual rate of
The loan's current value includes the accrual of effective interest, including estimated future royalties.
F - 8
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
The fair value of the warrants is computed using the Black-Scholes option pricing model and is determined by using a level 3 valuation technique. The fair value of the warrants upon issuance was computed based on the then-current price of an ADS, a risk-free interest rate of
The fair value of the warrants amounted to $
The changes in fair value from December 31, 2022 through June 30, 2023 of $
As of June 30, 2023, none of these warrants had been exercised.
The placement agent warrants have been classified in shareholders’ equity, with initial recognition at fair value on the date issued, using the same assumptions as the investor warrants.
F - 9
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
Number of ordinary shares
|
||||||||
December 31,
|
June 30,
|
|||||||
2022
|
2023
|
|||||||
Authorized share capital
|
|
|
||||||
Issued and paid-up share capital
|
|
|
In USD and NIS
|
||||||||
December 31,
|
June 30,
|
|||||||
2022
|
2023
|
|||||||
Authorized share capital (in NIS)
|
|
|
||||||
Issued and paid-up share capital (in NIS)
|
|
|
||||||
Issued and paid-up share capital (in USD)
|
|
|
F - 10
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
F - 11
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
• |
the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate development
efforts;
|
• |
our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical
trials;
|
• |
our receipt of regulatory approvals for our therapeutic candidates and the timing of other regulatory filings and approvals, including
our ability to secure adequate and viable pricing and reimbursement coverage of any marketed product;
|
• |
the clinical development, commercialization and market acceptance of our therapeutic candidates;
|
• |
our ability to establish and maintain corporate and academic collaborations and licensees, including the collaboration contemplated in
the license;
|
• |
our ability to integrate new therapeutic candidates and new personnel;
|
• |
the interpretation or characterization of the properties and characteristics of our therapeutic candidates and of the results obtained
with our therapeutic candidates in preclinical studies or clinical trials;
|
• |
the implementation of our business model and strategic plans for our business and therapeutic candidates;
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and
our ability to operate our business without infringing the intellectual property rights of others;
|
• |
estimates of our expenses, future revenues, capital requirements and our needs for and ability to access sufficient additional financing;
|
• |
risks related to changes in healthcare laws, rules and regulations in the United States, Asia or elsewhere;
|
• |
competitive companies, technologies and our industry, including generic entrants;
|
• |
risks related to unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
liquidity risk; and
|
• |
statements as to the impact of the political and security situation in Israel on our business.
|
➢ |
In March 2015, we reported successful top-line results from a Phase 1 safety and efficacy trial for the use of motixafortide as a novel stem cell mobilization treatment for
allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem.
|
➢ |
In March 2016, we initiated a Phase 2 trial for
motixafortide in allogeneic stem cell transplantation, conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology. In May 2018, we announced positive top-line results of this study
showing, among other things, that a single injection of motixafortide mobilized sufficient amounts of CD34+ cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of granulocyte colony-stimulating factor, or G-CSF, the current standard of care.
|
➢ |
In December 2017, we commenced a randomized, placebo-controlled Phase 3 registrational trial for motixafortide, known as the
GENESIS trial, for the mobilization of HSCs for autologous transplantation in patients with multiple myeloma. The trial began with a lead-in period for dose confirmation, which was to include 10-30 patients and then progress to the
placebo-controlled main part, which was designed to include 177 patients in more than 25 centers. Following review of the positive results from treatment of the first 11 patients, the Data Monitoring Committee, or DMC, recommended that the
lead-in part of the study be stopped and that we should move immediately to the second part. Additional positive results from the lead-in period were reported at the annual meeting of the European Society for Blood and Marrow
Transplantation held in March 2019, where it was announced that HSCs mobilized by motixafortide in combination with G-CSF were successfully engrafted in all 11 patients.
|
➢ |
In August 2020, we announced a decision to perform an interim analysis on approximately 65% of the original study sample size, primarily based on a significantly
lower-than-anticipated patient-dropout rate in the study. In October 2020, we announced positive results from the interim analysis. Based on the statistically significant evidence favoring treatment with motixafortide, the study’s independent
DMC issued a recommendation to us that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s recommendation, study enrollment was completed at
122 patients. In May 2021, we announced positive top-line results from the Phase 3 trial. Based on an analysis of data on all 122 enrolled patients (the intent to treat population) we found highly statistically significant evidence across all
primary and secondary endpoints favoring motixafortide in addition to G-CSF, as compared to placebo plus G-CSF (p<0.0001). The addition of motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one
apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. The combination was also found to be generally well tolerated with a favorable safety profile.
|
➢ |
In October 2021, we announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using
motixafortide as a primary stem cell mobilization agent on top of G-CSF, versus G-CSF alone, in multiple myeloma patients undergoing autologous stem-cell transplantation (ASCT). The study was performed by the Global Health Economics and
Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial. The study concluded that the addition of motixafortide to G-CSF (the current standard of care) is associated with a
statistically significant decrease in health resource utilization (HRU) during the ASCT process, compared to G-CSF alone. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions, lifetime
estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$19,000 (not including the cost of motixafortide), versus G-CSF alone.
|
➢ |
In March 2022, we announced results from a follow-on pharmacoeconomic study performed by the HEOR team of IQVIA. This study indirectly evaluated the cost-effectiveness of using
motixafortide as a primary stem cell mobilization agent in combination with G-CSF, against plerixafor in combination with G-CSF, in multiple myeloma patients undergoing ASCT. The additional study results show that motixafortide in combination
with G-CSF, versus plerixafor in combination with G-CSF, demonstrates a statistically significant decrease in HRU during the ASCT process. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions,
lifetime estimates show QALY benefits and net cost savings of ~$30,000 (not including the cost of motixafortide), versus plerixafor plus G-CSF. The study findings strengthen the assessment that the use of motixafortide in combination with
G-CSF, as the potential new standard of care in mobilization for ASCT, would be a cost-effective option in the United States, based on accepted willingness-to-pay (WTP) values for healthcare payers.
|
➢ |
We believe these results, together with the highly significant and clinically meaningful data from the GENESIS trial, strongly support the potential use of motixafortide, on
top of G-CSF, as the standard of care in stem cell mobilization for autologous stem cell transplantation. In this regard, in June 2022, we appointed biopharmaceutical veteran executive, Holly W. May, as our Chief Commercial Officer and in
September 2022 we announced our U.S. commercialization plan for motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients and appointed Ms. May as President of our U.S. subsidiary, with
responsibility for the commercial planning, positioning, and launch oversight for motixafortide in the stem cell mobilization indication across the U.S. market, assuming FDA approval. If approved, we intend to commercialize motixafortide in
the U.S. independently in order to accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate.
|
➢ |
In March 2023, we entered into a clinical
collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial in which motixafortide will be evaluated as a monotherapy and in combination with natalizumab (VLA-4 inhibitor), as novel
regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in Sickle Cell Disease (SCD). The study will enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial’s
primary objective is to assess the safety and tolerability of motixafortide alone and in combination with natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the
number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the pharmacokinetics of CD34+ HSPCs
mobilization to peripheral blood in response to motixafortide alone and motixafortide plus natalizumab in SCD patients. The study is anticipated to begin enrollment in 2023 (although timelines, as well as other study related decisions, are
ultimately controlled by the independent investigator-sponsor and are, therefore, subject to change).
|
➢ |
In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy. Based on
this collaboration, in September 2016 we initiated a Phase 2a study, known as the COMBAT/KEYNOTE-202 study, focusing on evaluating the safety and efficacy of motixafortide in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1
therapy, in 37 patients with metastatic pancreatic adenocarcinoma, or PDAC. The study was an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the combination of these therapies
as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T-cells into the tumor and their reactivity. Top-line results showed that the dual combination demonstrated encouraging disease control and
overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported motixafortide’s ability to induce infiltration of tumor-reactive T-cells into the tumor, while reducing the number of immune
regulatory cells.
|
➢ |
In July 2018, we announced the expansion of the COMBAT/KEYNOTE-202 study under the collaboration to include a triple combination arm investigating the safety, tolerability and
efficacy of motixafortide, KEYTRUDA ® and chemotherapy. We initiated this arm of the trial in December 2018. In December 2019, we announced that preliminary data from the study indicated that the triple combination therapy showed a high level
of disease control, including seven partial responders and 10 patients with stable disease out of 22 evaluable patients. In February 2020, we completed the recruiting of a total of 43 patients for the study and in December 2020, we announced
the final results of the study. The results of the study showed substantial improvement as compared to comparable historical results of other pancreatic cancer studies across all study endpoints. Of the 38 evaluable patients, median overall
survival was 6.5 months, median progression free survival was 4.0 months, confirmed overall response rate was 13.2%, overall response rate was 21.2% and disease control rate was 63.2%. The combination was generally well tolerated, with a
safety profile consistent with the individual safety profile of each component alone; adverse event and severe adverse event profiles were as expected with chemotherapy-based treatment regimens.
|
➢ |
In August 2016, in the framework of an agreement with MD Anderson Cancer Center, or MD Anderson, we entered into an additional collaboration for the investigation of
motixafortide in combination with KEYTRUDA in pancreatic cancer. The focus of this study, in addition to assessing clinical response, was the mechanism of action by which both drugs might synergize, as well as multiple assessments to evaluate
the biological anti-tumor effects induced by the combination. We supplied motixafortide for this Phase 2b study, which commenced in January 2017. Final results from this study (based on a cut-off in July 2019 from 20 enrolled patients out of
which 15 were evaluable) showed that the dual combination demonstrated clinical activity and encouraging overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported motixafortide’s
ability to induce infiltration of tumor-reactive T-cells into the tumor.
|
➢ |
In October 2020, we announced that motixafortide will be tested in combination with the anti-PD-1 cemiplimab (LIBTAYO®) and standard-of-care chemotherapy (gemcitabine and
nab-paclitaxel) in first-line PDAC. This investigator-initiated Phase 2, single-arm study, led by Columbia University, initially enrolled 10 PDAC patients in a pilot phase. In July 2023, we announced initiation of an amended randomized study,
based on preliminary pre-defined data from the single-arm pilot phase, in a total of 102 patients. The primary endpoint of the study is progression free survival. Secondary endpoints include safety and tolerability, duration of clinical
benefit and overall survival. Data from the pilot stage of the study is planned for submission to a congress later this year.
|
➢ |
In June 2022, we entered into a collaboration agreement with GenFleet Therapeutics, or GenFleet, an immuno-oncology focused biopharmaceutical company based in China, to advance
motixafortide through a randomized Phase 2b clinical trial in PDAC. On August 29, 2023, the Company and Genfleet mutually agreed to terminate their collaboration agreement.
|
➢ |
During the first half of 2020, we initiated the evaluation of motixafortide as a potential therapy for acute respiratory distress syndrome, or ARDS, resulting from COVID-19 and
other viral infections In this regard, substantial data is emerging regarding the involvement of neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to COVID-19 and other viral
infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed pulmonary tissue. Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, we believe that
motixafortide may be of potential benefit for patients with ARDS. Following our initial evaluation, in November 2020, we announced initiation of a Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral
infections. The study is an investigator-initiated study, led by Wolfson Medical Center, in Israel, to evaluate motixafortide in patients hospitalized with ARDS. The primary endpoint of the study is to assess the safety of motixafortide in
these patients; respiratory parameters and inflammatory biomarkers will be assessed as exploratory endpoints. Up to 25 patients will be enrolled in the study, with a preliminary analysis planned after ten patients have completed the initial
treatment period. Results of the preliminary analysis are expected in 2023 (although timelines are ultimately controlled by the independent investigator and are therefore subject to change).
|
➢ |
In addition to the above, we are currently conducting, or planning to conduct, a number of investigator-initiated, open-label studies in a variety of indications, to support
the interest of the scientific and medical communities in exploring additional uses for motixafortide. These studies serve to potentially further elucidate the mechanism of action for motixafortide. The results of studies such as these are
presented from time to time at relevant professional conferences.
|
➢ |
Motixafortide has been granted three Orphan Drug Designations by the FDA: for use to mobilize HSCs from the bone marrow to peripheral blood for collection in autologous or
allogeneic transplantation (granted in July 2012); for the treatment of AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February 2019). In January 2020, the European Medicines Agency, or EMA, granted
Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
|
➢ |
In September 2022, the FDA approved APHEXDA as motixafortide’s trade name.
|
Project
|
Status
|
Expected Near Term Milestones
|
||
motixafortide
|
1.
|
Phase 3 registration study in autologous stem cell mobilization (GENESIS) completed; top-line results announced in May 2021 showed highly statistically
significant evidence across all primary and secondary endpoints favoring motixafortide in combination with G-CSF (p<0.0001). In addition, the combination was found to be safe and well tolerated. Pharmaco-economic studies showed positive
results regarding the cost-effectiveness of using motixafortide versus both G-CSF alone and plerixafor in combination with G-CSF. NDA submission made in September 2022, and in November 2022 the FDA accepted for review the NDA with a PDUFA
target action date of September 9, 2023.
|
1.
|
FDA decision on NDA filing expected in third quarter of 2023
|
2.
|
Investigator-initiated randomized clinical trial in first-line metastatic PDAC patients, based on preliminary data from the single-arm pilot phase.
|
2.
|
Data from the pilot stage of the Phase 2 study is planned for submission to a congress later in 2023
|
|
3.
|
Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections
|
3.
|
Data from the study is anticipated in 2023*
|
|
.
|
.
|
|||
4.
|
Phase 1 study for gene therapies in SCD
|
4.
|
Initiation of the study is expected in 2023*
|
|
AGI-134
|
Phase 1/2a study completed. Results announced December 2022. The study met its primary endpoint of safety and tolerability. Generation of an immune response
and markers of clinical efficacy were assessed as secondary endpoints.
|
Determination of next steps for the program during 2023
|
• |
the number of sites included in the clinical trials;
|
• |
the length of time required to enroll suitable patients;
|
• |
the number of patients that participate, and are eligible to participate, in the clinical trials;
|
• |
the duration of patient follow-up;
|
• |
whether the patients require hospitalization or can be treated on an outpatient basis;
|
• |
the development stage of the therapeutic candidate; and
|
• |
the efficacy and safety profile of the therapeutic candidate.
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Research and development expenses, net
|
5,395
|
3,006
|
(2,389
|
)
|
9,830
|
6,690
|
(3,140
|
)
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Sales and marketing expenses
|
1,158
|
5,604
|
4,446
|
1,795
|
9,478
|
7,683
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
General and administrative expenses
|
1,049
|
1,305
|
256
|
2,056
|
2,603
|
547
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Non-operating income (expenses), net
|
458
|
(7,733
|
)
|
(8,191
|
)
|
1,726
|
(10,649
|
)
|
(12,375
|
)
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Financial income
|
80
|
440
|
360
|
147
|
977
|
830
|
||||||||||||||||||
Financial expenses
|
(379
|
)
|
(1,337
|
)
|
(958
|
)
|
(565
|
)
|
(2,264
|
)
|
(1,699
|
)
|
||||||||||||
Net financial income (expenses)
|
(299
|
)
|
(897
|
)
|
(598
|
)
|
(418
|
)
|
(1,287
|
)
|
(869
|
)
|
• |
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
• |
the scope, prioritization and number of our clinical trials and other research and development programs;
|
• |
the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
|
• |
the costs of the development and expansion of our operational infrastructure;
|
• |
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
|
• |
our success in effecting out-licensing arrangements with third parties;
|
• |
the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing
agreements;
|
• |
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
• |
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
• |
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
|
• |
the costs of acquiring or undertaking development and commercialization efforts for any future product candidates;
|
• |
the magnitude of our general and administrative expenses;
|
• |
interest and principal payments on the loan from Kreos Capital;
|
• |
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates;
|
• |
market conditions;
|
• |
payments to the IIA; and
|
• |
the impact of any resurgence of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above.
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
(in U.S. dollars)
|
||||||||||||||||
Loss per ADS – basic and diluted
|
(0.16
|
)
|
(0.30
|
)
|
(0.26
|
)
|
(0.50
|
)
|
December 31,
2022
|
June 30,
2023
|
|||||||
(in number of ADSs)
|
||||||||
Authorized share capital
|
166,666,667
|
166,666,667
|
||||||
Issued and paid-up capital
|
61,530,596
|
61,530,596
|
Document and Entity Information |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Document And Entity Information [Abstract] | |
Entity Registrant Name | BioLineRx Ltd. |
Entity Central Index Key | 0001498403 |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2023 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Period Focus | Q2 |
Document Fiscal Year Focus | 2023 |
Entity File Number | 001-35223 |
Entity Address, Address Line One | 2 HaMa’ayan Street |
Entity Address, Address Line Two | Modi’in |
Entity Address, Postal Zip Code | 7177871 |
Entity Address, Country | IL |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Income Statement Abstract | ||||
RESEARCH AND DEVELOPMENT EXPENSES | $ (3,006) | $ (5,395) | $ (6,690) | $ (9,830) |
SALES AND MARKETING EXPENSES | (5,604) | (1,158) | (9,478) | (1,795) |
GENERAL AND ADMINISTRATIVE EXPENSES | (1,305) | (1,049) | (2,603) | (2,056) |
OPERATING LOSS | (9,915) | (7,602) | (18,771) | (13,681) |
NON-OPERATING INCOME (EXPENSES), NET | (7,733) | 458 | (10,649) | 1,726 |
FINANCIAL INCOME | 440 | 80 | 977 | 147 |
FINANCIAL EXPENSES | (1,337) | (379) | (2,264) | (565) |
NET LOSS AND COMPREHENSIVE LOSS | $ (18,545) | $ (7,443) | $ (30,707) | $ (12,373) |
LOSS PER ORDINARY SHARE - BASIC | $ (0.02) | $ (0.01) | $ (0.03) | $ (0.02) |
LOSS PER ORDINARY SHARE - DILUTED | $ (0.02) | $ (0.01) | $ (0.03) | $ (0.02) |
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE | 922,958,942 | 715,365,554 | 922,958,942 | 715,260,781 |
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) - USD ($) $ in Thousands |
Ordinary shares [Member] |
Share premium [Member] |
Warrants [Member] |
Capital reserve [Member] |
Other comprehensive loss [Member] |
Accumulated deficit [Member] |
Total |
---|---|---|---|---|---|---|---|
BALANCE at Dec. 31, 2021 | $ 21,066 | $ 339,346 | $ 975 | $ 13,157 | $ (1,416) | $ (305,041) | $ 68,087 |
CHANGES FOR | |||||||
Issuance of share capital, net | 89 | 177 | 0 | 0 | 0 | 0 | 266 |
Employee stock options exercised | 2 | 12 | 0 | (12) | 0 | 0 | 2 |
Employee stock options expired | 0 | 135 | 0 | (135) | 0 | 0 | 0 |
Share-based compensation | 0 | 0 | 0 | 586 | 0 | 0 | 586 |
Comprehensive loss for the period | 0 | 0 | 0 | 0 | 0 | (12,373) | (12,373) |
BALANCE at Jun. 30, 2022 | 21,157 | 339,670 | 975 | 13,596 | (1,416) | (317,414) | 56,568 |
BALANCE at Dec. 31, 2022 | 27,100 | 338,976 | 1,408 | 14,765 | (1,416) | (329,992) | 50,841 |
CHANGES FOR | |||||||
Employee stock options expired | 0 | 69 | 0 | (69) | 0 | 0 | 0 |
Share-based compensation | 0 | 0 | 0 | 920 | 0 | 0 | 920 |
Comprehensive loss for the period | 0 | 0 | 0 | 0 | 0 | (30,707) | (30,707) |
BALANCE at Jun. 30, 2023 | $ 27,100 | $ 339,045 | $ 1,408 | $ 15,616 | $ (1,416) | $ (360,699) | $ 21,054 |
GENERAL INFORMATION |
6 Months Ended | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||
Disclosure of general information [Abstract] | |||||||||||||
GENERAL INFORMATION |
NOTE 1 – GENERAL INFORMATION
BioLineRx Ltd. (“BioLineRx”), headquartered in Modi’in, Israel, was incorporated and commenced operations in April 2003. BioLineRx and its subsidiaries (collectively, the “Company”) are engaged in the development of therapeutics, primarily in pre-commercialization and clinical stages, with a focus on the field of oncology.
The Company’s American Depositary Shares (“ADSs”) are traded on the NASDAQ Capital Market, and its ordinary shares are traded on the Tel Aviv Stock Exchange (“TASE”). Each ADS represents 15 ordinary shares.
In March 2017, the Company acquired Agalimmune Ltd. (“Agalimmune”), a privately held company incorporated in the United Kingdom, with a focus on the field of immuno-oncology. In April 2022, the Company re-activated BioLineRx USA, Inc., a previously inactive subsidiary incorporated in the US, to engage in pre-commercialization and commercialization activities associated with the potential launch of motixafortide for stem-cell mobilization in the US. In this regard, the US Food and Drug Administration (“FDA”) has accepted for review and filed the Company’s New Drug Application (“NDA”) for motixafortide in stem cell mobilization for autologous transplantation for multiple myeloma patients, and has assigned the NDA a Prescription Drug User Fee Act (“PDUFA”) target action date of September 9, 2023.
The Company has incurred accumulated losses in the amount of $361 million through June 30, 2023, and it expects to continue incurring losses and negative cash flows from operations until its product or products reach commercial profitability. Company management monitors rolling forecasts of the Company’s liquidity reserves on the basis of anticipated cash flows and maintains liquidity balances at levels that are sufficient to meet its needs. Management believes that the Company’s current cash and other resources will be sufficient to fund its projected cash requirements into the first half of 2024.
The execution of an independent commercialization plan for motixafortide in the US implies an increased level of expenses prior to and following launch of the product. However, as is common with FDA approvals of innovative pharmaceutical products, there is significant uncertainty regarding the receipt of approval, as well as the timing and scope of any potential approval ultimately received in order to launch commercialization of the product. Therefore, the Company’s cash flow projections are subject to various risks and uncertainties concerning their fulfilment, and these factors and the risk inherent in the Company’s operations may cast significant doubt on the Company’s ability to continue as a going concern. These consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
References in these IFRS financial statements to matters that may cast significant doubt about the Company’s ability to continue as a going concern also raise substantial doubt as contemplated by the PCAOB standards.
|
BASIS OF PREPARATION |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Disclosure of basis of preparation [Abstract] | |
BASIS OF PREPARATION |
NOTE 2 – BASIS OF PREPARATION
The Company’s condensed consolidated interim financial statements as of June 30, 2023 and for the three and six months then ended (the “interim financial statements”) have been prepared in accordance with International Accounting Standard No. 34, “Interim Financial Reporting” (“IAS 34”). These interim financial statements, which are unaudited, do not include all disclosures necessary for a fair presentation of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards (“IFRS”). The condensed consolidated interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2022 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS. The results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
The preparation of financial statements in conformity with IFRS requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity and expenses, as well as the related disclosures of contingent assets and liabilities, in the process of applying the Company’s accounting policies. These inputs also consider, among other things, the implications of pandemics and wars across the globe on the Company’s activities, and the resultant effects on critical and significant accounting estimates, most significantly in relation to the value of intangible assets. In this regard, U.S. and global markets are currently experiencing volatility and disruption following the escalation of geopolitical tensions and the ongoing military conflict between Russia and Ukraine. Although the length and impact of the ongoing military conflict are highly unpredictable, the conflict in Ukraine could lead to market disruptions, including significant volatility in commodity prices, credit and the capital markets. As of the date of release of these financial statements, the Company estimates there are no material effects of this conflict on its financial position and results of operations.
|
SIGNIFICANT ACCOUNTING POLICIES |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Disclosure of significant accounting policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES
The accounting policies and calculation methods applied in the preparation of these interim financial statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2022 and for the year then ended.
|
AT-THE-MARKET ("ATM") SALES AGREEMENT WITH HCW |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Disclosure Of Issuances Of Share Capital [Abstract] | |
AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW |
NOTE 4 – AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW
The Company maintains an ATM facility with H.C. Wainwright & Co., LLC (“HCW”) pursuant to an ATM sales agreement entered into in September 2021. In accordance with the agreement, the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as a sales agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remains in effect. The Company has agreed to pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. During the six months ended June 30, 2023, no ADSs were issued by the Company. From the effective date of the agreement through the issuance date of this report, 608,651 ADSs have been sold under the program for total gross proceeds of approximately $1.4 million.
|
LONG-TERM LOAN |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Borrowings [abstract] | |
LONG-TERM LOAN |
NOTE 5 – LONG-TERM LOAN
In September 2022, the Company entered into a $40 million loan agreement with Kreos Capital VII Aggregator SCSp (“Kreos Capital”). Pursuant to the agreement, the first tranche of $10 million was drawn down by the Company following execution of the definitive agreement, after completion of certain customary conditions to closing. The remaining $30 million will be made available in two additional tranches subject to the achievement of pre-specified milestones. The tranches are available for drawdown at the Company’s discretion at various time points through October 1, 2024.
Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing will bear interest at a fixed annual rate of 9.5% (~11.0%, including associated cash fees). As security for the loan, Kreos Capital received a first-priority secured interest in all Company assets, including intellectual property, and the Company undertook to maintain a minimum cash balance. In addition, Kreos Capital will be entitled to mid-to-high single-digit royalties on motixafortide sales, up to a pre-defined cap.
The loan's current value includes the accrual of effective interest, including estimated future royalties. |
WARRANTS FROM SEPTEMBER 2022 OFFERING |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Warranty provision [abstract] | |
WARRANTS FROM SEPTEMBER 2022 OFFERING |
NOTE 6 – WARRANTS FROM SEPTEMBER 2022 OFFERING
In September 2022, the Company completed a registered direct offering of 13,636,365 ADSs at a price of $1.10 per ADS. In concurrent private placements, the Company issued to investors in the offering unregistered warrants to purchase 13,636,365 ADSs. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.15 per ADS. In addition, the Company granted to the placement agent in the offering, as part of the placement fee, warrants to purchase 681,818 ADSs. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.375 per ADS. Gross proceeds from the offering totaled $15.0 million, with net proceeds of $13.5 million, after deducting fees and expenses. The offering consideration allocated to the placement agent warrants amounted to $0.4 million.
The warrants issued to the investors have been classified as a non-current financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the issuance date and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive loss.
The fair value of the warrants is computed using the Black-Scholes option pricing model and is determined by using a level 3 valuation technique. The fair value of the warrants upon issuance was computed based on the then-current price of an ADS, a risk-free interest rate of 3.62%, and an average standard deviation of 82.5%. The gross consideration initially allocated to the investor warrants amounted to $9.1 million, with total issuance costs initially allocated to the warrants amounting to $0.8 million.
The fair value of the warrants amounted to $15,345,000 as of June 30, 2023, ($4,502,000 as of December 31, 2022) and was based on the then current price of an ADS, a risk-free interest rate of 4.3%, (4.1% as of December 31, 2022), an average standard deviation of 84.1%, (85.5% as of December 31, 2022), and on the remaining contractual life of the warrants.
The changes in fair value from December 31, 2022 through June 30, 2023 of $10,843,000 have been recorded as non-operating expenses in the statement of comprehensive loss.
As of June 30, 2023, none of these warrants had been exercised.
The placement agent warrants have been classified in shareholders’ equity, with initial recognition at fair value on the date issued, using the same assumptions as the investor warrants. |
SHAREHOLDERS' EQUITY |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of classes of share capital [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHAREHOLDERS' EQUITY |
NOTE 7 – SHAREHOLDERS’ EQUITY
As of December 31, 2022 and June 30, 2023, share capital is composed of ordinary shares, as follows:
|
SUBSEQUENT EVENTS |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Disclosure of non-adjusting events after reporting period [abstract] | |
SUBSEQUENT EVENTS |
NOTE 8 – SUBSEQUENT EVENTS
On August 27, 2023, the Company entered into a license agreement (the “License Agreement”) with Hong Seng Technology Limited (“HST”) and Guangzhou Gloria Biosciences Co., Ltd. (“Gloria” and together with HST, the “Purchaser Parties” or the “Licensee”), pursuant to which the Company granted HST an exclusive, royalty-bearing, sublicensable license to develop and commercialize motixafortide in Asia (other than Israel and certain other countries) (collectively, the “Territory”) and to engage and authorize Gloria to perform services under the License Agreement in the Territory. In addition, the Company granted the Licensee a first offer right with respect to the grant of certain rights in motixafortide outside of the Territory. Effectiveness of the License Agreement is conditioned, among other things, upon obtaining the consent of the Israeli Innovation Authority (the “IIA”) within four months from the execution of the License Agreement.
Pursuant to the terms of the License Agreement, the Licensee is required to deposit a $15 million upfront payment in escrow within seven days after execution of the License Agreement, which will be released from escrow and transferred to the Company on the date that consent of the License Agreement is provided by the IIA, so long as that consent is obtained within four months from the execution of the License Agreement. The Company is also entitled to up to $49 million based on the achievement of certain development and regulatory milestones in China and Japan, and up to $197 million in sales milestones based on defined sales targets of motixafortide in the Territory. In addition, the Company is eligible to receive tiered double-digit royalties (ranging from 10-20%), on a country-by-country basis, on aggregate net sales of motixafortide in the Territory during the initial royalty term of at least 15 years, with a reduction of the royalties payable following the end of the initial royalty term as well as upon the occurrence of certain events. In the event that the Company does not receive FDA approval of motixafortide from the FDA by end of 2023, the development and regulatory milestones will only be partially payable, and all royalty rates will be reduced to single digit royalties.
The License Agreement provides that the Company will supply motixafortide to the Licensee during the term on a cost plus basis for commercial supply, while supply for development purposes will be on a cost-plus basis except that in certain limited circumstances the supply will be at a reduced cost, with the Company bearing a portion of the cost to be applied against any future royalties. The Licensee has a right but not an obligation after the effective date of the License Agreement to select to manufacture motixafortide itself or through a designated party.
In connection with the entry into the License Agreement, on August 27, 2023, the Company also entered into a share purchase agreement (the “Purchase Agreement”) with the Purchaser Parties, pursuant to which the Company agreed to sell and issue in a private placement an aggregate of 6,829,137 ADSs of the Company, at a purchase price of $2.136 per ADS. Aggregate gross proceeds from the sale are expected to be approximately $14.6 million and are to be deposited into escrow pending closing. The closing is subject to certain closing conditions including, among other things, receipt of the IIA consent and effectiveness of the License Agreement, actual receipt by the Company in its bank account of the purchase price for the ADSs following release from escrow, as well as other customary closing conditions. No warrants were issued in the transaction.
|
SHAREHOLDERS' EQUITY (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of classes of share capital [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share Capital |
|
GENERAL INFORMATION (Narrative) (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Disclosure of general information [Abstract] | ||
Accumulatewd losses | $ (360,699) | $ (329,992) |
AT-THE-MARKET ("ATM") SALES AGREEMENT WITH HCW (Narrative) (Details) - HCW [Member] - USD ($) $ in Millions |
6 Months Ended | |
---|---|---|
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||
Aggregate Offering Price | $ 25.0 | |
Percentage of commission on sales agreement | 3.00% | |
Gross proceeds from issuing shares | $ 1.4 | |
Number of American depositary shares sold | 608,651 |
LONG-TERM LOANS (Narrative) (Details) - Loan Agreement With Kreos Capital [Member] $ in Millions |
1 Months Ended |
---|---|
Sep. 30, 2022
USD ($)
| |
Disclosure of detailed information about borrowings [line items] | |
Amount of loan agreement | $ 40 |
Bottom of range [member] | |
Disclosure of detailed information about borrowings [line items] | |
Percentage of annual interest of cash fees | 9.50% |
Top of range [member] | |
Disclosure of detailed information about borrowings [line items] | |
Percentage of annual interest of cash fees | 11.00% |
First tranche [Member] | |
Disclosure of detailed information about borrowings [line items] | |
Amount of loan agreement | $ 10 |
Second tranche [Member] | |
Disclosure of detailed information about borrowings [line items] | |
Amount of loan agreement | $ 30 |
SHAREHOLDERS' EQUITY (Schedule of Share Capital) (Details) |
Jun. 30, 2023
ILS (₪)
shares
|
Jun. 30, 2023
USD ($)
shares
|
Dec. 31, 2022
ILS (₪)
shares
|
Dec. 31, 2022
USD ($)
shares
|
---|---|---|---|---|
Number of Ordinary Shares | ||||
Authorized share capital | 2,500,000,000 | 2,500,000,000 | 2,500,000,000 | 2,500,000,000 |
Issued and paid-up share capital | 922,958,942 | 922,958,942 | 922,958,942 | 922,958,942 |
Authorized share capital | ₪ | ₪ 250,000,000 | ₪ 250,000,000 | ||
Issued and paid-up share capital | ₪ 92,295,894 | $ 27,100,201 | ₪ 92,295,894 | $ 27,100,201 |
1 Year BioLineRx Chart |
1 Month BioLineRx Chart |
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