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BioLineRx Ltd.
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By:
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/s/ Philip A. Serlin
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Philip A. Serlin
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Chief Executive Officer
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• |
Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment
with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177 originally planned), and top-line data, including full primary and secondary
efficacy endpoints, is anticipated in early second quarter of 2021. In parallel, the Company is proceeding with all activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA
meeting with the FDA planned for the second half of 2021.
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• |
Reported positive final results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 study evaluating motixafortide in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage
IV pancreatic ductal adenocarcinoma (PDAC). The results of the study showed substantial improvement as compared to historical results across all study endpoints. The Company is currently planning next development steps for this program,
including discussions with potential collaboration partners and development of a protocol for a randomized controlled study.
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• |
Announced initiation of a Phase 2 investigator-initiated clinical trial evaluating motixafortide in combination with LIBTAYO® and chemotherapy in first-line metastatic PDAC. The study is led by Columbia University.
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Announced initiation of a Phase 1b investigator-initiated clinical trial evaluating motixafortide in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.
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Completed underwritten public offering with gross proceeds of $34.5 million.
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Top-line results from the Phase 3 GENESIS trial in SCM in early Q2 2021.
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• |
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.
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Pre-NDA meeting with the FDA for SCM in the second half of 2021
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• |
NDA submission for SCM in the first half of 2022
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December 31,
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||||||||
2019
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2020
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|||||||
in USD thousands
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||||||||
Assets
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||||||||
CURRENT ASSETS
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||||||||
Cash and cash equivalents
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5,297
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16,831
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||||||
Short-term bank deposits
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22,192
|
5,756
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||||||
Prepaid expenses
|
108
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152
|
||||||
Other receivables
|
613
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141
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||||||
Total current assets
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28,210
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22,880
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||||||
NON-CURRENT ASSETS
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||||||||
Property and equipment, net
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1,816
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1,341
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||||||
Right-of-use assets, net
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1,650
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1,355
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Intangible assets, net
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21,891
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21,714
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Total non-current assets
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25,357
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24,410
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Total assets
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53,567
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47,290
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Liabilities and equity
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||||||||
CURRENT LIABILITIES
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||||||||
Current maturities of long-term loans
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2,692
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3,092
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||||||
Accounts payable and accruals:
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||||||||
Trade
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7,794
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5,918
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||||||
Other
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1,280
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1,440
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||||||
Lease liabilities
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202
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191
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||||||
Total current liabilities
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11,968
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10,641
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||||||
NON-CURRENT LIABILITIES
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||||||||
Warrants
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658
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10,218
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Long-term loans, net of current maturities
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5,799
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2,740
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Lease liabilities
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1,762
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1,661
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Total non-current liabilities
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8,219
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14,619
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COMMITMENTS AND CONTINGENT LIABILITIES
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||||||||
Total liabilities
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20,187
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25,260
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EQUITY
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||||||||
Ordinary shares
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4,692
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9,870
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||||||
Share premium
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265,938
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279,241
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||||||
Capital reserve
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12,132
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12,322
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||||||
Other comprehensive loss
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(1,416
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)
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(1,416
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)
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Accumulated deficit
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(247,966
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)
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(277,987
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)
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Total equity
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33,380
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22,030
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||||||
Total liabilities and equity
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53,567
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47,290
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Year ended December 31,
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||||||||||||
2018
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2019
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2020
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||||||||||
in USD thousands
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||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
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(19,808
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)
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(23,438
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)
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(18,173
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)
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||||||
SALES AND MARKETING EXPENSES
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(1,362
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)
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(857
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)
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(840
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)
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GENERAL AND ADMINISTRATIVE EXPENSES
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(4,435
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)
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(3,816
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)
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(3,914
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)
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OPERATING LOSS
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(25,605
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)
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(28,111
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)
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(22,927
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)
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NON-OPERATING INCOME (EXPENSES), NET
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2,397
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4,165
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(5,701
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)
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FINANCIAL INCOME
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719
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777
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236
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|||||||||
FINANCIAL EXPENSES
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(473
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)
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(2,277
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)
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(1,629
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)
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NET LOSS AND COMPREHENSIVE LOSS
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(22,962
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)
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(25,446
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)
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(30,021
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)
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in USD
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LOSS PER ORDINARY SHARE – BASIC AND DILUTED
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(0.21
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)
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(0.17
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)
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(0.12
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)
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WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
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108,595,702
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146,407,055
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252,844,394
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Ordinary shares
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Share premium
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Capital reserve
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Other comprehensive
loss |
Accumulated deficit
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Total
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|||||||||||||||||||
in USD thousands
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||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2018
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2,836
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240,682
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10,337
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(1,416
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)
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(199,558
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)
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52,881
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||||||||||||||||
CHANGES IN 2018:
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||||||||||||||||||||||||
Issuance of share capital, net
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263
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8,567
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-
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-
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-
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8,830
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||||||||||||||||||
Employee stock options exercised
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11
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415
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(380
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)
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-
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-
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46
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|||||||||||||||||
Employee stock options forfeited and expired
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-
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528
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(528
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)
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-
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-
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-
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|||||||||||||||||
Share-based compensation
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-
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-
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2,526
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-
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-
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2,526
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Comprehensive loss for the year
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-
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-
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-
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-
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(22,962
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)
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(22,962
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)
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||||||||||||||||
BALANCE AT DECEMBER 31, 2018
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3,110
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250,192
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11,955
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(1,416
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)
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(222,520
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)
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41,321
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||||||||||||||||
CHANGES IN 2019:
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Issuance of share capital, net
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1,580
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14,165
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-
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-
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-
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15,745
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||||||||||||||||||
Employee stock options exercised
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2
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83
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(84
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)
|
-
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-
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1
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|||||||||||||||||
Employee stock options forfeited and expired
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-
|
1,498
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(1,498
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)
|
-
|
-
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-
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|||||||||||||||||
Share-based compensation
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-
|
-
|
1,759
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-
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-
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1,759
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||||||||||||||||||
Comprehensive loss for the year
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-
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-
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-
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-
|
(25,446
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)
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(25,446
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)
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||||||||||||||||
BALANCE AT DECEMBER 31, 2019
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4,692
|
265,938
|
12,132
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(1,416
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)
|
(247,966
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)
|
33,380
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||||||||||||||||
CHANGES IN 2020:
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||||||||||||||||||||||||
Issuance of share capital, net
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4,777
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9,395
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-
|
-
|
-
|
14,172
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||||||||||||||||||
Warrants exercised
|
393
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2,826
|
-
|
-
|
-
|
3,219
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||||||||||||||||||
Employee stock options exercised
|
8
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228
|
(228
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)
|
-
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-
|
8
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|||||||||||||||||
Employee stock options forfeited and expired
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-
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854
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(854
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)
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-
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-
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-
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|||||||||||||||||
Share-based compensation
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-
|
-
|
1,272
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-
|
-
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1,272
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||||||||||||||||||
Comprehensive loss for the year
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-
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-
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-
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-
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(30,021
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)
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(30,021
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)
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BALANCE AT DECEMBER 31, 2020
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9,870
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279,241
|
12,322
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(1,416
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)
|
(277,987
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)
|
22,030
|
Year ended December 31,
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||||||||||||
2018
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2019
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2020
|
||||||||||
in USD thousands
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||||||||||||
CASH FLOWS - OPERATING ACTIVITIES
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||||||||||||
Net loss
|
(22,962
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)
|
(25,446
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)
|
(30,021
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)
|
||||||
Adjustments required to reflect net cash used in operating activities (see appendix below)
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(1,230
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)
|
2,780
|
6,815
|
||||||||
Net cash used in operating activities
|
(24,192
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)
|
(22,666
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)
|
(23,206
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)
|
||||||
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||||||
Realization of long-term investment
|
1,500
|
-
|
-
|
|||||||||
Investments in short-term deposits
|
(26,500
|
)
|
(43,545
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)
|
(33,500
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)
|
||||||
Maturities of short-term deposits
|
44,771
|
48,875
|
50,168
|
|||||||||
Purchase of property and equipment
|
(173
|
)
|
(67
|
)
|
-
|
|||||||
Purchase of intangible assets
|
(10,043
|
)
|
(6
|
)
|
-
|
|||||||
Net cash provided by investing activities
|
9,555
|
5,257
|
16,668
|
|||||||||
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||||||
Issuance of share capital and warrants, net of issuance cost
|
3,830
|
20,297
|
21,215
|
|||||||||
Employee stock options exercised
|
46
|
1
|
8
|
|||||||||
Proceeds of long-term loan and warrants, net of issuance costs
|
9,632
|
-
|
-
|
|||||||||
Repayment of loans
|
(411
|
)
|
(889
|
)
|
(3,133
|
)
|
||||||
Repayments of lease liabilities
|
-
|
(215
|
)
|
(224
|
)
|
|||||||
Net cash provided by financing activities
|
13,097
|
19,194
|
17,866
|
|||||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,540
|
)
|
1,785
|
11,328
|
||||||||
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
5,110
|
3,404
|
5,297
|
|||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(166
|
)
|
108
|
206
|
||||||||
CASH AND CASH EQUIVALENTS - END OF YEAR
|
3,404
|
5,297
|
16,831
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
APPENDIX
|
||||||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||||||
Income and expenses not involving cash flows:
|
||||||||||||
Depreciation and amortization
|
545
|
940
|
934
|
|||||||||
Long-term prepaid expenses
|
5
|
56
|
-
|
|||||||||
Exchange differences on cash and cash equivalents
|
166
|
(108
|
)
|
(206
|
)
|
|||||||
Fair value adjustments of warrants
|
(1,743
|
)
|
(4,634
|
)
|
5,142
|
|||||||
Share-based compensation
|
2,526
|
1,759
|
1,272
|
|||||||||
Interest and exchange differences on short-term deposits
|
(645
|
)
|
(775
|
)
|
(232
|
)
|
||||||
Interest on loans
|
123
|
647
|
474
|
|||||||||
Gain on realization of long-term investment
|
(500
|
)
|
-
|
-
|
||||||||
Warrant issuance costs
|
-
|
417
|
594
|
|||||||||
Exchange differences on lease liability
|
-
|
154
|
125
|
|||||||||
477
|
(1,544
|
)
|
8,103
|
|||||||||
Changes in operating asset and liability items:
|
||||||||||||
Decrease (increase) in prepaid expenses and other receivables
|
(934
|
)
|
1,106
|
428
|
||||||||
Increase (decrease) in accounts payable and accruals
|
(773
|
)
|
3,218
|
(1,716
|
)
|
|||||||
(1,707
|
)
|
4,324
|
(1,288
|
)
|
||||||||
(1,230
|
)
|
2,780
|
6,815
|
|||||||||
Supplemental information on interest received in cash
|
834
|
868
|
381
|
|||||||||
Supplemental information on interest paid in cash
|
165
|
1,198
|
994
|
|||||||||
Supplemental information on non-cash transactions
|
5,000
|
147
|
1,251
|