BioLineRx Reports First Quarter 2013 Results
Recent Highlights:
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BL-7040 (IBD) – Received positive results from a Phase 2 proof-of-concept study to evaluate the effectiveness of BL-7040 for the treatment of inflammatory bowel disease (IBD) |
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Immediate next steps include evaluating the most advantageous ways to progress with this therapeutic candidate from a clinical and business perspective, including examining potential additional indications. Plans also include accelerating discussions with potential co-development and licensing partners. | ||
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BL-8040 (AML) – Received U.S. regulatory approvals to commence a Phase 2a trial for the treatment of relapsed/refractory acute myeloid leukemia (AML); trial to be conducted at three sites in the U.S. and five sites in Israel, with initial patient enrollment expected in Q2 2013; partial results expected in Q4 2013 and final results expected in the second half of 2014 |
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BL-1040 (ventricular remodeling) – Recruitment commenced at U.S. sites for the PRESERVATION I clinical trial, a CE Mark registration trial for BL-1040 (BCM), a novel medical device for the prevention of ventricular remodeling following an acute myocardial infarction; there are currently multiple active sites recruiting in six countries |
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BL-5010 (skin lesions) – Reached final stages of development for proprietary pen-like applicator for BL-5010, a novel formulation of two acids being developed for the non-surgical removal of skin lesions; planning to commence pivotal CE-Mark registration trial for European approval in the second half of 2013 |
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BL-8020 (HCV) – Commenced a Phase 1/2 clinical trial to evaluate the effectiveness of an orally-available, interferon-free treatment for Hepatitis C (HCV) at two sites in France, following approval from the French regulatory authorities; partial results expected in Q4 2013; final results expected in the first half of 2014 |
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BL-1020 (schizophrenia) – Disappointing results of interim analysis for the Phase 2/3 CLARITY trial led to termination of the trial; full unblinded study data is expected during Q3 2013 |
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BL-9010 (severe asthma) – Added a novel, bi-specific antibody for the treatment of severe and persistent asthma to the main therapeutic pipeline, following promising pre-clinical data |
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Capital Raise – $8 million direct equity placement to the OrbiMed Group was completed in February 2013 |
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“In the past few months, we have seen major progress on a number of
clinical and pre-clinical programs in our pipeline, which offer exciting
opportunities to address unmet medical needs in a wide range of
therapeutic areas. We believe our active programs offer significant
potential for patients around the world, as well as for the future
success of our Company and its shareholders,” stated
“The PRESERVATION I study being conducted by our partner,
“We continue to accelerate development of our clinical pipeline, with three of our compounds completing significant milestones since the beginning of the year. Our BL-7040 compound for IBD completed a Phase 2a open-label, proof-of-concept study with very encouraging and positive results. We are now evaluating next steps for BL-7040 in order to identify the best way to move forward from both a clinical and business perspective, including examining potential additional indications. In parallel, we are also planning to accelerate discussions with potential co-development and licensing partners for this asset.”
“In addition, BL-8040, for hematological cancers, one of our most
exciting programs, just received
“Finally, we recently reported enrollment of the first patient in our
Phase 1/2 trial for BL-8020, an oral treatment for HCV, at a leading
hospital in
Financial Results for Q1 2013:
During the three 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 the three months ended
Non-operating income for the three months ended
Net financial expenses for the three months ended
Net loss for the three months ended
As of
Net cash used in operating activities was
Net cash used in investing activities for the three months ended
Net cash provided by financing activities for the three months ended
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its first quarter 2013
results today,
(Tables follow)
About BioLineRx
BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet
medical needs or with advantages over currently available therapies.
BioLineRx’s current portfolio consists of seven clinical stage
candidates: BL-1040, for prevention of pathological cardiac remodeling
following a myocardial infarction, which has been out-licensed to
BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company
performs feasibility assessment studies and development through
pre-clinical and clinical stages, with partial funding from the Israeli
Government’s
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. | ||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
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(UNAUDITED) |
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Convenience |
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December 31, | March 31, | March 31, | ||||
2012 | 2013 | 2013 | ||||
NIS in thousands | In thousands | |||||
Assets | ||||||
CURRENT ASSETS | ||||||
Cash and cash equivalents | 68,339 | 46,638 | 12,785 | |||
Short-term bank deposits | 11,459 | 55,805 | 15,297 | |||
Prepaid expenses | 804 | 843 | 231 | |||
Other receivables | 2,254 | 2,581 | 707 | |||
Total current assets | 82,856 | 105,867 | 29,020 | |||
NON-CURRENT ASSETS | ||||||
Restricted deposits | 3,513 | 1,950 | 535 | |||
Long-term prepaid expenses | 204 | 192 | 53 | |||
Property and equipment, net | 3,172 | 2,947 | 807 | |||
Intangible assets, net | 1,063 | 1,056 | 290 | |||
Total non-current assets | 7,952 | 6,145 | 1,685 | |||
Total assets | 90,808 | 112,012 | 30,705 | |||
Liabilities and equity | ||||||
CURRENT LIABILITIES | ||||||
Current maturities of long-term bank loan | 137 | 54 | 15 | |||
Accounts payable and accruals: | ||||||
Trade | 12,283 | 21,873 | 5,996 | |||
OCS | 6,148 | - | - | |||
Other | 5,443 | 5,300 | 1,453 | |||
Total current liabilities | 24,011 | 27,227 | 7,464 | |||
NON-CURRENT LIABILITIES | ||||||
Retirement benefit obligations | 143 | 143 | 39 | |||
Warrants | 10,725 | 10,625 | 2,913 | |||
Total non-current liabilities | 10,868 | 10,768 | 2,952 | |||
COMMITMENTS AND CONTINGENT LIABILITIES | ||||||
Total liabilities | 34,879 | 37,995 | 10,416 | |||
EQUITY | ||||||
Ordinary shares | 1,837 | 2,225 | 610 | |||
Share premium | 464,629 | 494,749 | 135,622 | |||
Capital reserve | 33,802 | 34,222 | 9,381 | |||
Accumulated deficit | (444,339) | (457,179) | (125,324) | |||
Total equity | 55,929 | 74,017 | 20,289 | |||
Total liabilities and equity | 90,808 | 112,012 | 30,705 | |||
BioLineRx Ltd. | |||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS |
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(UNAUDITED) |
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Convenience |
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Three months ended |
Three months |
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2012 | 2013 | 2013 | |||||||
NIS in thousands | In thousands | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (14,675 | ) | (19,443 | ) | (5,330 | ) | |||
SALES AND MARKETING EXPENSES | (766 | ) | (771 | ) | (211 | ) | |||
GENERAL AND ADMINISTRATIVE EXPENSES | (3,525 | ) | (3,522 | ) | (965 | ) | |||
OPERATING LOSS | (18,966 | ) | (23,736 | ) | (6,506 | ) | |||
NON-OPERATING INCOME, NET | 2,819 | 12,262 | 3,361 | ||||||
FINANCIAL INCOME | 446 | 663 | 182 | ||||||
FINANCIAL EXPENSES | (2,231 | ) | (2,029 | ) | (556 | ) | |||
NET LOSS AND COMPREHENSIVE LOSS | (17,932 | ) | (12,840 | ) | (3,519 | ) | |||
NIS | USD | ||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.12 | ) | (0.06 | ) | (0.02 | ) | |||
BioLineRx Ltd. |
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CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
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(UNAUDITED) |
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Convenience |
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Three months ended |
Three months |
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2012 | 2013 | 2013 | |||||||
NIS in thousands | In thousands | ||||||||
CASH FLOWS - OPERATING ACTIVITIES | |||||||||
Comprehensive loss for the period | (17,932 | ) | (12,840 | ) | (3,519 | ) | |||
Adjustments required to reflect net cash used in operating activities (see appendix below) | 5,012 | (6,353 | ) | (1,741 | ) | ||||
Net cash used in operating activities | (12,920 | ) | (19,193 | ) | (5,260 | ) | |||
CASH FLOWS - INVESTING ACTIVITIES | |||||||||
Investments in short-term deposits | (22,872 | ) | (56,695 | ) | (15,542 | ) | |||
Maturities of short-term deposits | 45,338 | 11,412 | 3,128 | ||||||
Maturities of restricted deposits | - | 1,550 | 425 | ||||||
Purchase of property and equipment | (382 | ) | (42 | ) | (11 | ) | |||
Purchase of intangible assets | (16 | ) | (30 | ) | (8 | ) | |||
Net cash provided by (used in) investing activities | 22,068 | (43,805 | ) | (12,008 | ) | ||||
CASH FLOWS - FINANCING ACTIVITIES | |||||||||
Repayments of bank loan | (77 | ) | (76 | ) | (21 | ) | |||
Issuance of share capital and warrants, net of issuance expenses | 52,453 | 42,091 | 11,538 | ||||||
Proceeds from exercise of employee stock options | * | * | * | ||||||
Net cash provided by financing activities | 52,376 | 42,015 | 11,517 | ||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 61,524 | (20,983 | ) | (5,751 | ) | ||||
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
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33,061 | 68,339 | 18,733 | ||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
(836 | ) | (718 | ) | (197 | ) | |||
CASH AND CASH EQUIVALENTS - END OF PERIOD | 93,749 | 46,638 | 12,785 | ||||||
* Represents an amount 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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Three months ended |
Three months |
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2012 | 2013 | 2013 | |||||||
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 | 406 | 304 | 83 | ||||||
Long-term prepaid expenses | (1 | ) | 12 | 3 | |||||
Exchange differences on cash and cash equivalents | 836 | 718 | 197 | ||||||
Interest and exchange differences on short-term deposits | 1,904 | 937 | 257 | ||||||
Interest and linkage on bank loan | (5 | ) | (7 | ) | (2 | ) | |||
Share-based compensation | 965 | 999 | 273 | ||||||
Warrant issuance costs | 1,204 | 470 | 130 | ||||||
Gain on adjustment of warrants to fair value | (4,023 | ) | (12,732 | ) | (3,490 | ) | |||
Interest and exchange differences on restricted deposits | 4 | 13 | 4 | ||||||
1,290 | (9,286 | ) | (2,545 | ) | |||||
Changes in operating asset and liability items: | |||||||||
Decrease (increase) in trade accounts receivable and other receivables |
1,673 | (366 | ) | (100 | ) | ||||
Increase in accounts payable and accruals | 2,049 | 3,299 | 904 | ||||||
3,722 | 2,933 | 804 | |||||||
5,012 | (6,353 | ) | (1,741 | ) | |||||
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Supplementary information on interest received in cash | 601 | 316 | 87 |
Source:
KCSA Strategic Communications
Garth Russell, 1 212-896-1250
grussell@kcsa.com
or
Todd
Fromer, 1 212-896-1215
tfromer@kcsa.com
or
Tsipi
Haitovsky, Public Relations
+972-3-6240871
tsipih@netvision.net.il