BioLineRx Reports Second Quarter 2014 Financial Results
“BL-8040 is currently in the midst of the dose-escalation part of a
Phase 2 trial for the treatment of AML, which is being conducted at
several world-leading cancer research centers in the U.S. and
“We also announced unblinded results of our Phase 1/2 safety study for
BL-7010, our novel, non-absorbable, orally available, co-polymer
intended for the treatment of celiac disease. BL-7010 showed no serious
or dose-limiting adverse events after the 14-day repeated administration
stage of the study, and pharmacokinetic analyses confirmed that there
was no systemic exposure to BL-7010. This is significant, as the lack of
systemic absorption may allow BL-7010 to be regulated as a medical
device in
“As for BL-1040, our novel resorbable polymer solution for the prevention of ventricular remodeling following an acute myocardial infarction (AMI), PRESERVATION I, the ongoing CE Mark registration trial, continues to advance towards completion in the hands of our out-licensing partner, Bellerophon. Over 200 patients have been enrolled in the study, which is designed to enroll a total of approximately 300 patients. We continue to expect Bellerophon to complete enrollment by the end of the year, with study completion anticipated around mid-2015.
“Finally, as part of our ongoing efforts to investigate novel pipeline assets, we announced the in-licensing of BL-1110 for the treatment of neuropathic pain. While we remain focused primarily on the clinical development of our lead oncology and immunology programs, BioLineRx will continue to look at earlier-stage opportunities, based on our proven ability to identify such compounds, in order to enhance and maintain our development pipeline.”
Financial Results for Quarter and Six Months Ended
Research and development expenses for the three months ended
Sales and marketing expenses for the three months ended
General and administrative expenses for the three months ended
The Company’s operating loss for the three months ended
The Company’s net non-operating income amounted to
The Company’s net financial expense amounted to
The Company’s net loss for the three months ended
The Company held
Net cash used in operating activities was
Net cash used in investing activities for the six months ended
Net cash provided by financing activities for the six months ended
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its second quarter 2014
results today,
(Tables follow)
About BioLineRx
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial; BL-8040 for treating acute myeloid leukemia (AML) and other hematological indications, which is in the midst of a Phase 2 study; and BL-7010 for celiac disease, which is in the midst of a Phase 1/2 study.
For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.
Various statements in this release concerning BioLineRx’s future
expectations constitute “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. These
statements include words such as “may,” “expects,” “anticipates,”
“believes,” and “intends,” and describe opinions about future events.
These forward-looking statements involve known and unknown risks and
uncertainties that may cause the actual results, performance or
achievements of BioLineRx to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Some of these risks are: changes in
relationships with collaborators; the impact of competitive products and
technological changes; risks relating to the development of new
products; and the ability to implement technological improvements. These
and other factors are more fully discussed in the “Risk Factors” section
of BioLineRx’s most recent annual report on Form 20-F filed with the
BioLineRx Ltd. |
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CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
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(UNAUDITED) |
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|
Convenience |
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December 31, | June 30, | June 30, | ||||||||||
2013 | 2014 | 2014 | ||||||||||
NIS in thousands | In thousands | |||||||||||
Assets | ||||||||||||
CURRENT ASSETS | ||||||||||||
Cash and cash equivalents | 30,888 | 28,963 | 8,424 | |||||||||
Short-term bank deposits | 32,345 | 84,994 | 24,722 | |||||||||
Prepaid expenses | 896 | 970 | 282 | |||||||||
Other receivables | 1,249 | 1,422 | 414 | |||||||||
Total current assets | 65,378 | 116,349 | 33,842 | |||||||||
NON-CURRENT ASSETS | ||||||||||||
Restricted deposits | 573 | 568 | 165 | |||||||||
Long-term prepaid expenses | 169 | 162 | 47 | |||||||||
Property and equipment, net | 2,471 | 2,333 | 678 | |||||||||
Intangible assets, net | 878 | 853 | 248 | |||||||||
Total non-current assets | 4,091 | 3,916 | 1,138 | |||||||||
Total assets | 69,469 | 120,265 | 34,980 | |||||||||
Liabilities and equity | ||||||||||||
CURRENT LIABILITIES | ||||||||||||
Accounts payable and accruals: | ||||||||||||
Trade | 7,945 | 6,397 | 1,860 | |||||||||
Other | 2,499 | 3,057 | 889 | |||||||||
Total current liabilities | 10,444 | 9,454 | 2,749 | |||||||||
NON-CURRENT LIABILITIES | ||||||||||||
Retirement benefit obligations | 152 | 152 | 44 | |||||||||
Warrants | 18,187 | 10,130 | 2,947 | |||||||||
Total non-current liabilities | 18,339 | 10,282 | 2,991 | |||||||||
COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||||||
Total liabilities | 28,783 | 19,736 | 5,740 | |||||||||
EQUITY | ||||||||||||
Ordinary shares | 2,414 | 3,411 | 992 | |||||||||
Share premium | 509,857 | 588,622 | 171,210 | |||||||||
Capital reserve | 34,192 | 35,794 | 10,411 | |||||||||
Accumulated deficit | (505,777 | ) | (527,298 | ) | (153,373 | ) | ||||||
Total equity | 40,686 | 100,529 | 29,240 | |||||||||
Total liabilities and equity | 69,469 | 120,265 | 34,980 | |||||||||
BioLineRx Ltd. | ||||||||||||||||||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS |
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(UNAUDITED) |
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Convenience translation |
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Three months |
Six months |
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Three months ended |
Six months ended |
ended |
ended |
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2013 | 2014 | 2013 | 2014 | 2014 | 2014 | |||||||||||||||||||
NIS in thousands | USD in thousands | |||||||||||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (12,087 | ) | (9,677 | ) | (31,530 | ) | (19,187 | ) | (2,815 | ) | (5,581 | ) | ||||||||||||
SALES AND MARKETING EXPENSES | (1,063 | ) | (987 | ) | (1,834 | ) | (2,270 | ) | (287 | ) | (660 | ) | ||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | (3,604 | ) | (2,888 | ) | (7,126 | ) | (6,351 | ) | (840 | ) | (1,847 | ) | ||||||||||||
OPERATING LOSS | (16,754 | ) | (13,552 | ) | (40,490 | ) | (27,808 | ) | (3,942 | ) | (8,088 | ) | ||||||||||||
NON-OPERATING INCOME, NET | 1,579 | 962 | 13,841 | 6,845 | 280 | 1,991 | ||||||||||||||||||
FINANCIAL INCOME | 1,320 | 121 | 1,983 | 1,067 | 35 | 310 | ||||||||||||||||||
FINANCIAL EXPENSES | (1,713 | ) | (1,653 | ) | (3,742 | ) | (1,625 | ) | (480 | ) | (473 | ) | ||||||||||||
COMPREHENSIVE LOSS FOR THE PERIOD | (15,568 | ) | (14,122 | ) | (28,408 | ) | (21,521 | ) | (4,107 | ) | (6,260 | ) | ||||||||||||
NIS | USD | |||||||||||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.069 | ) | (0.042 | ) | (0.132 | ) | (0.071 | ) | (0.012 | ) | (0.021 | ) | ||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE | 226,191,857 | 340,050,724 | 215,502,443 | 305,039,680 | 340,050,724 | 305,039,680 | ||||||||||||||||||
BioLineRx Ltd. | ||||||||||||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
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(UNAUDITED) |
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Convenience |
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Six months ended June 30, |
Six months |
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2013 | 2014 | 2014 | ||||||||||
NIS in thousands | In thousands | |||||||||||
CASH FLOWS - OPERATING ACTIVITIES | ||||||||||||
Comprehensive loss for the period | (28,408 | ) | (21,521 | ) | (6,260 | ) | ||||||
Adjustments required to reflect net cash used in operating activities (see appendix below) | (13,133 | ) | (5,414 | ) | (1,575 | ) | ||||||
Net cash used in operating activities | (41,541 | ) | (26,935 | ) | (7,835 | ) | ||||||
CASH FLOWS - INVESTING ACTIVITIES | ||||||||||||
Investments in short-term deposits | (75,008 | ) | (107,211 | ) | (31,184 | ) | ||||||
Maturities of short-term deposits | 52,257 | 53,732 | 15,629 | |||||||||
Maturities of restricted deposits | 1,550 | - | - | |||||||||
Additions to property and equipment | (132 | ) | (311 | ) | (90 | ) | ||||||
Additions to intangible assets | (79 | ) | (10 | ) | (3 | ) | ||||||
Net cash used in investing activities | (21,412 | ) | (53,800 | ) | (15,648 | ) | ||||||
CASH FLOWS - FINANCING ACTIVITIES | ||||||||||||
Repayments of bank loan | (127 | ) | - | - | ||||||||
Issuance of share capital and warrants, net | 46,101 | 78,590 | 22,859 | |||||||||
Proceeds from exercise of employee stock options | * | * | * | |||||||||
Net cash provided by financing activities | 45,974 | 78,590 | 22,859 | |||||||||
DECREASE IN CASH AND CASH EQUIVALENTS | (16,979 | ) | (2,145 | ) | (624 | ) | ||||||
CASH AND CASH EQUIVALENTS – BEGINNING
OF PERIOD |
68,339 | 30,888 | 8,984 | |||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (1,128 | ) | 220 | 64 | ||||||||
CASH AND CASH EQUIVALENTS - END OF PERIOD | 50,232 | 28,963 | 8,424 | |||||||||
* Less than 1,000 |
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BioLineRx Ltd. | ||||||||||||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
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(UNAUDITED) |
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Convenience |
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Six months ended June 30, |
Six months |
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2013 | 2014 | 2014 | ||||||||||
NIS in thousands | In thousands | |||||||||||
Adjustments required to reflect net cash used in operating activities: | ||||||||||||
Income and expenses not involving cash flows: | ||||||||||||
Depreciation and amortization | 578 | 484 | 141 | |||||||||
Impairment of intangible assets | 138 | - | - | |||||||||
Long-term prepaid expenses | 34 | 7 | 2 | |||||||||
Exchange differences on cash and cash equivalents | 1,128 | (220 | ) | (64 | ) | |||||||
Share-based compensation | 1,626 | 1,733 | 504 | |||||||||
Warrant issuance costs | 470 | - | - | |||||||||
Gain on adjustment of warrants to fair value | (14,498 | ) | (8,057 | ) | (2,344 | ) | ||||||
Commitment fee paid by issuance of share capital | - | 1,041 | 303 | |||||||||
Interest and exchange differences on short-term deposits | 972 | 830 | 241 | |||||||||
Interest and linkage on bank loan | (10 | ) | - | - | ||||||||
Interest and exchange differences on restricted deposits | 17 | 5 | 2 | |||||||||
(9,545 | ) | (4,177 | ) | (1,215 | ) | |||||||
Changes in operating asset and liability items: | ||||||||||||
Decrease (increase) in trade accounts receivable and
other receivables |
1,405 | (247 | ) | (72 | ) | |||||||
Decrease in accounts payable and accruals | (4,993 | ) | (990 | ) | (288 | ) | ||||||
(3,588 | ) | (1,237 | ) | (360 | ) | |||||||
(13,133 | ) | (5,414 | ) | (1,575 | ) | |||||||
Supplementary information on interest received in cash | 323 | 96 | 28 | |||||||||
Source: BioLineRx
Tiberend
Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
+1-212-375-2664
jdrumm@tiberend.com
or
Andrew
Mielach
+1-212-375-2694
amielach@tiberend.com
or
BioLineRx
Tsipi
Haitovsky
Public Relations
+972-3-6240871
tsipihai5@gmail.com