Highlights and achievements during second quarter of 2016 and to date:
- Submission of regulatory filings to initiate Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA®, under immuno-oncology collaboration with Merck announced earlier this year
- Signing of additional immuno-oncology collaboration, this time with
MD Anderson Cancer Center , for second Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA - Continued enrollment in large (n=194), randomized Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment
- Commercial launch of BL-5010 as OTC treatment for non-surgical removal of skin lesions by Omega Pharma (a division of
Perrigo ), following CE Mark approval in March - In-licensing of liver fibrosis project under
Novartis collaboration Philip A. Serlin appointed Chief Executive Officer, effectiveOctober 2016
Expected upcoming significant milestones for remainder of 2016:
- Initiation of Phase 2a study in pancreatic cancer, under immuno-oncology collaboration with Merck, following expected regulatory approval in Q3 2016
- Second Phase 2a immuno-oncology study in pancreatic cancer, under collaboration with
MD Anderson Cancer Center , expected to commence by end of 2016 - Full set of data from Phase 2a study for BL-8040 in r/r AML to be presented at the
Society of Hematologic Oncology (SOHO) annual meeting,September 7-10, 2016 , inHouston, Texas - Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016
- Regulatory submission for BL-7010 clinical efficacy study, for marketing purposes as food supplement
- Expansion of commercial rollout of BL-5010 by Omega to additional countries and development of 2nd OTC indication for the product
"We are pleased to have entered into an immuno-oncology collaboration with MD Anderson for a second Phase 2a study of BL-8040 with Merck's KEYTRUDA in pancreatic cancer, which provides additional validation of the potential of our lead oncology drug platform in the cancer immunotherapy space. We continue to examine other potential collaborations in this space. In addition, we are looking forward to announcing full results from our successful Phase 2a study for relapsed and refractory AML at the upcoming
"BL-5010, our first product in the market, is already being sold in a number of countries in
"In closing, we ended the second quarter with
Financial Results for Second Quarter 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
Non-operating income (expenses) for the three and six months ended
Financial income (expenses), net for the three and six months ended
The Company's net loss for the three months ended
The Company held
Net cash used in operating activities was
Net cash provided by 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 end
(Tables follow)
About BioLineRx
BioLineRx is a 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
BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company'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 Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
BioLineRx Ltd. |
||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
||
(UNAUDITED) |
||
December 31, |
June 30, |
|
2015 |
2016 |
|
in USD thousands |
||
Assets |
||
CURRENT ASSETS |
||
Cash and cash equivalents |
5,544 |
3,877 |
Short-term bank deposits |
42,119 |
37,945 |
Prepaid expenses |
229 |
324 |
Other receivables |
291 |
548 |
Total current assets |
48,183 |
42,694 |
NON-CURRENT ASSETS |
||
Long-term prepaid expenses |
58 |
54 |
Property and equipment, net |
2,909 |
2,770 |
Intangible assets, net |
152 |
162 |
Total non-current assets |
3,119 |
2,986 |
Total assets |
51,302 |
45,680 |
Liabilities and equity |
||
CURRENT LIABILITIES |
||
Current maturities of long-term bank loan |
93 |
93 |
Accounts payable and accruals: |
||
Trade |
1,910 |
1,732 |
Other |
1,137 |
980 |
Total current liabilities |
3,140 |
2,805 |
NON-CURRENT LIABILITIES |
||
Long-term bank loan, net of current maturities |
344 |
296 |
Warrants |
208 |
15 |
Total non-current liabilities |
552 |
311 |
COMMITMENTS AND CONTINGENT LIABILITIES |
||
Total liabilities |
3,692 |
3,116 |
EQUITY |
||
Ordinary shares |
1,455 |
1,459 |
Share premium |
196,201 |
197,858 |
Other comprehensive loss |
(1,416) |
(1,416) |
Capital reserve |
10,735 |
11,251 |
Accumulated deficit |
(159,365) |
(166,588) |
Total equity |
47,610 |
42,564 |
Total liabilities and equity |
51,302 |
45,680 |
BioLineRx Ltd. |
|||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS |
|||||
(UNAUDITED) |
|||||
Three months ended June 30, |
Six months ended June 30, |
||||
2015 |
2016 |
2015 |
2016 |
||
in USD thousands |
in USD thousands |
||||
RESEARCH AND DEVELOPMENT EXPENSES, NET |
(2,891) |
(2,740) |
(6,102) |
(5,279) |
|
SALES AND MARKETING EXPENSES |
(299) |
(272) |
(559) |
(520) |
|
GENERAL AND ADMINISTRATIVE EXPENSES |
(976) |
(854) |
(1,832) |
(1,843) |
|
OPERATING LOSS |
(4,166) |
(3,866) |
(8,493) |
(7,642) |
|
NON-OPERATING INCOME (EXPENSES), NET |
(847) |
48 |
(887) |
196 |
|
FINANCIAL INCOME |
205 |
88 |
278 |
232 |
|
FINANCIAL EXPENSES |
(2) |
(5) |
(19) |
(9) |
|
NET LOSS AND COMPREHENSIVE LOSS |
(4,810) |
(3,735) |
(9,121) |
(7,223) |
|
in USD |
in USD |
||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED |
(0.09) |
(0.07) |
(0.19) |
(0.13) |
|
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
53,562,019 |
56,423,601 |
48,095,879 |
55,651,371 |
|
BioLineRx Ltd. |
||||||
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY |
||||||
(UNAUDITED) |
||||||
Other |
||||||
Ordinary |
Share |
comprehensive |
Capital |
Accumulated |
||
shares |
premium |
loss |
reserve |
deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2015 |
1,055 |
167,331 |
(1,416) |
9,800 |
(144,965) |
31,805 |
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2015: |
||||||
Issuance of share capital, net |
393 |
28,252 |
- |
- |
- |
28,645 |
Share-based compensation |
- |
- |
- |
487 |
- |
487 |
Comprehensive loss for the period |
- |
- |
- |
- |
(9,121) |
(9,121) |
BALANCE AT JUNE 30, 2015 |
1,448 |
195,583 |
(1,416) |
10,287 |
(154,086) |
51,816 |
Other |
||||||
Ordinary |
Share |
comprehensive |
Capital |
Accumulated |
||
shares |
premium |
loss |
reserve |
deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2016 |
1,455 |
196,201 |
(1,416) |
10,735 |
(159,365) |
47,610 |
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2016: |
||||||
Issuance of share capital, net |
4 |
1,591 |
- |
- |
- |
1,595 |
Employee stock options forfeited and expired |
- |
66 |
- |
(66) |
- |
- |
Share-based compensation |
- |
- |
- |
582 |
- |
582 |
Comprehensive loss for the period |
- |
- |
- |
- |
(7,223) |
(7,223) |
BALANCE AT JUNE 30, 2016 |
1,459 |
197,858 |
(1,416) |
11,251 |
(166,588) |
42,564 |
BioLineRx Ltd. |
||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Six months ended June 30, |
||
2015 |
2016 |
|
in USD thousands |
||
CASH FLOWS - OPERATING ACTIVITIES |
||
Comprehensive loss for the period |
(9,121) |
(7,223) |
Adjustments required to reflect net cash used in operating activities |
1,976 |
(223) |
Net cash used in operating activities |
(7,145) |
(7,446) |
CASH FLOWS - INVESTING ACTIVITIES |
||
Investments in short-term deposits |
(39,184) |
(19,804) |
Maturities of short-term deposits |
22,738 |
24,182 |
Maturities of restricted deposits |
166 |
- |
Purchase of property and equipment |
(1,586) |
(164) |
Purchase of intangible assets |
(7) |
(24) |
Net cash provided by (used in) investing activities |
(17,873) |
4,190 |
CASH FLOWS - FINANCING ACTIVITIES |
||
Issuances of share capital, net |
28,645 |
1,595 |
Repayments of bank loan |
- |
(48) |
Net cash provided by financing activities |
28,645 |
1,547 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
3,627 |
(1,709) |
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD |
5,790 |
5,544 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
(13) |
42 |
CASH AND CASH EQUIVALENTS - END OF PERIOD |
9,404 |
3,877 |
BioLineRx Ltd. |
||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
(UNAUDITED) |
||
Six months ended June 30, |
||
2015 |
2016 |
|
in USD thousands |
||
Adjustments required to reflect net cash used in operating activities: |
||
Income and expenses not involving cash flows: |
||
Depreciation and amortization |
195 |
245 |
Long-term prepaid expenses |
(8) |
4 |
Interest and exchange rate differences on short-term deposits |
(49) |
(204) |
Share-based compensation |
487 |
582 |
Exchange differences on cash and cash equivalents |
13 |
(42) |
Loss (gain) on adjustment of warrants to fair value |
887 |
(193) |
1,525 |
392 |
|
Changes in operating asset and liability items: |
||
Increase in prepaid expenses and other receivables |
(425) |
(352) |
Increase (decrease) in accounts payable and accruals |
876 |
(263) |
451 |
(615) |
|
1,976 |
(223) |
|
Supplementary information on investing activities not involving cash flows: |
||
Property and equipment acquired on supplier trade credit |
512 |
- |
Supplementary information on interest received in cash |
30 |
192 |
Contact:
PCG Advisory
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2016-financial-results-300312350.html
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