BioLineRx Reports Year End 2016 Financial Results
Highlights and achievements in 2016 and to date:
Acquired Agalimmune Ltd. , aUK -based biopharmaceutical company developing immunotherapeutic cancer treatments, thereby broadening and bolstering BioLineRx's presence in immuno-oncology. Agalimmune's novel lead compound, AGI-134, harnesses the body's pre-existing, highly abundant, anti-alpha-Gal antibodies to drive a patient-specific, systemic, anti-tumor response for various cancer indications. AGI-134 may also bring about a long-lasting, protective, follow-on, anti-tumor immune response, and has exhibited synergies in combination with check-point inhibitor therapies;- Signed extensive immuno-oncology collaboration with Genentech, a member of the
Roche Group , for several Phase 1b studies for BL-8040 in combination with Genentech's Atezolizumab, in multiple solid tumor indications, including pancreatic cancer, gastric cancer and non-small cell lung cancer, as well as AML. The collaboration may also be expanded into additional indications; - Signed immuno-oncology collaboration with MSD (known as Merck in the US and
Canada ), and subsequently initiated a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA®; - Initiated Phase 2b immuno-oncology collaboration with
MD Anderson Cancer Center for additional BL-8040 and KEYTRUDA combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD andMD Anderson Cancer Center ; - Reported partial results data on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment. Interim results support BL-8040 as a one-day dosing regimen for rapid mobilization of substantial amounts of stem cells, a significant improvement over the current standard of care which requires four-to-six daily injections of G-CSF.
- In-licensed three new projects under strategic collaboration with
Novartis , including two novel liver fibrosis/failure projects, and a novel anti-inflammatory treatment for dry eye syndrome; - Presented growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including the
American Society of Hematology (ASH),Society of Hematologic Oncology (SOHO), andAmerican Association for Cancer Research (AACR); - Expanded geographic reach with new joint venture in
China for development of novel drug candidates; and - Appointed
Philip A. Serlin as CEO.
Expected upcoming significant milestones for 2017 and 2018:
- Initiation of Phase 2/3 registrational study for BL-8040 in stem-cell mobilization for autologous transplantation expected in H2 2017;
- Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, expected by year end;
- Partial results from the immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA® expected in H2 2017; top line results expected in H2 2018;
- Initiation of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezolizumab in multiple solid tumor indications and AML expected in H2 2017; partial results expected in H2 2018; and
- Initiation of Phase 1 immuno-oncology study for AGI-134 in multiple solid tumor indications expected in H1 2018.
"We remain focused on building a robust clinical-stage oncology and immunology therapeutic pipeline offering us exciting potential business opportunities. We believe BioLineRx is at a very significant stage, with key milestones in the next 12-18 months," Mr. Serlin concluded.
Financial Results for the Year Ended
Research and development expenses for the year ended
Sales and marketing expenses for the year ended
General and administrative expenses for the year ended
The Company's operating loss for the year ended
Net non-operating income of
Net financial income for the year ended
The Company's net loss for the year ended
The Company held
Net cash used in operating activities for the year ended
Net cash provided by investing activities for the year ended
Net cash provided by financing activities for the year ended
Conference Call and Webcast Information
BioLineRx will hold a conference call today,
(Tables follow)
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML and is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 2 study in stem cell mobilization for allogeneic transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is expected to initiate a first-in-man study in the first half of 2018. 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
BioLineRx Ltd. |
|||
December 31, |
|||
2015 |
2016 |
||
in USD thousands |
|||
Assets |
|||
CURRENT ASSETS |
|||
Cash and cash equivalents |
5,544 |
2,469 |
|
Short-term bank deposits |
42,119 |
33,154 |
|
Prepaid expenses |
229 |
255 |
|
Other receivables |
291 |
223 |
|
Total current assets |
48,183 |
36,101 |
|
NON-CURRENT ASSETS |
|||
Long-term prepaid expenses |
58 |
52 |
|
Property and equipment, net |
2,909 |
2,605 |
|
Intangible assets, net |
152 |
181 |
|
Total non-current assets |
3,119 |
2,838 |
|
Total assets |
51,302 |
38,939 |
|
Liabilities and equity |
|||
CURRENT LIABILITIES |
|||
Current maturities of long-term bank loan |
93 |
93 |
|
Accounts payable and accruals: |
|||
Trade |
1,910 |
2,590 |
|
Other |
1,137 |
978 |
|
Total current liabilities |
3,140 |
3,661 |
|
NON-CURRENT LIABILITIES |
|||
Long-term bank loan, net of current maturities |
344 |
250 |
|
Warrants |
208 |
1 |
|
Total non-current liabilities |
552 |
251 |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
|||
Total liabilities |
3,692 |
3,912 |
|
EQUITY |
|||
Ordinary shares |
1,455 |
1,513 |
|
Share premium |
196,201 |
199,567 |
|
Capital reserve |
10,735 |
10,569 |
|
Other comprehensive loss |
(1,416) |
(1,416) |
|
Accumulated deficit |
(159,365) |
(175,206) |
|
Total equity |
47,610 |
35,027 |
|
Total liabilities and equity |
51,302 |
38,939 |
BioLineRx Ltd.
|
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Year ended December 31, |
||||||
2014 |
2015 |
2016 |
||||
in USD thousands |
||||||
RESEARCH AND DEVELOPMENT EXPENSES |
(11,866) |
(11,489) |
(11,177) |
|||
SALES AND MARKETING EXPENSES |
(1,589) |
(1,003) |
(1,352) |
|||
GENERAL AND ADMINISTRATIVE EXPENSES |
(3,800) |
(3,704) |
(3,984) |
|||
OPERATING LOSS |
(17,255) |
(16,196) |
(16,513) |
|||
NON-OPERATING INCOME, NET |
3,061 |
1,445 |
214 |
|||
FINANCIAL INCOME |
3,566 |
457 |
480 |
|||
FINANCIAL EXPENSES |
(448) |
(106) |
(22) |
|||
NET LOSS |
(11,076) |
(14,400) |
(15,841) |
|||
OTHER COMPREHENSIVE LOSS - |
||||||
CURRENCY TRANSLATION DIFFERENCES |
(2,834) |
- |
- |
|||
COMPREHENSIVE LOSS |
(13,910) |
(14,400) |
(15,841) |
|||
in USD |
||||||
LOSS PER ORDINARY SHARE – BASIC AND DILUTED |
(0.34) |
(0.28) |
(0.28) |
|||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
32,433,883 |
51,406,434 |
56,144,727 |
|||
BioLineRx Ltd. |
||||||
Ordinary |
Share |
Capital |
Other |
Accumulated |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2014 |
640 |
134,390 |
9,163 |
1,418 |
(133,889) |
11,722 |
CHANGES IN 2014: |
||||||
Issuance of share capital, net |
415 |
32,523 |
- |
- |
- |
32,938 |
Employee stock options exercised |
- |
22 |
(22) |
- |
- |
- |
Employee stock options expired |
- |
396 |
(396) |
- |
- |
- |
Share-based compensation |
- |
- |
1,055 |
- |
- |
1,055 |
Other comprehensive loss |
- |
- |
- |
(2,834) |
- |
(2,834) |
Comprehensive loss for the year |
- |
- |
- |
- |
(11,076) |
(11,076) |
BALANCE AT DECEMBER 31, 2014 |
1,055 |
167,331 |
9,800 |
(1,416) |
(144,965) |
31,805 |
CHANGES IN 2015: |
||||||
Issuance of share capital, net |
400 |
28,653 |
- |
- |
- |
29,053 |
Employee stock options expired |
- |
217 |
(217) |
- |
- |
- |
Share-based compensation |
- |
- |
1,152 |
- |
- |
1,152 |
Comprehensive loss for the year |
- |
- |
- |
(14,400) |
(14,400) |
|
BALANCE AT DECEMBER 31, 2015 |
1,455 |
196,201 |
10,735 |
(1,416) |
(159,365) |
47,610 |
CHANGES IN 2016: |
||||||
Issuance of share capital, net |
57 |
2,126 |
- |
- |
- |
2,183 |
Employee stock options exercised |
1 |
171 |
(172) |
- |
- |
- |
Employee stock options expired |
- |
1,069 |
(1,069) |
- |
- |
- |
Share-based compensation |
- |
- |
1,075 |
- |
- |
1,075 |
Comprehensive loss for the year |
- |
- |
- |
- |
(15,841) |
(15,841) |
BALANCE AT DECEMBER 31, 2016 |
1,513 |
199,567 |
10,569 |
(1,416) |
(175,206) |
35,027 |
BioLineRx Ltd. |
|||
Year ended December 31, |
|||
2014 |
2015 |
2016 |
|
in USD thousands |
|||
CASH FLOWS - OPERATING ACTIVITIES |
|||
Net loss |
(11,076) |
(14,400) |
(15,841) |
Adjustments required to reflect net cash used in operating |
(4,674) |
232 |
1,328 |
Net cash used in operating activities |
(15,750) |
(14,168) |
(14,513) |
CASH FLOWS - INVESTING ACTIVITIES |
|||
Investments in short-term deposits |
(57,186) |
(63,130) |
(32,982) |
Maturities of short-term deposits |
37,650 |
50,083 |
42,334 |
Maturities of restricted deposits |
- |
166 |
- |
Purchase of property and equipment |
(187) |
(2,683) |
(52) |
Purchase of intangible assets |
(6) |
(36) |
(3) |
Net cash provided by (used in) investing activities |
(19,729) |
(15,600) |
9,297 |
CASH FLOWS - FINANCING ACTIVITIES |
|||
Issuance of share capital and warrants, net of issuance costs |
32,635 |
29,053 |
2,183 |
Proceeds of bank loan |
- |
467 |
- |
Repayments of bank loan |
- |
(31) |
(93) |
Net cash provided by financing activities |
32,635 |
29,489 |
2,090 |
DECREASE IN CASH AND CASH EQUIVALENTS |
(2,844) |
(279) |
(3,126) |
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR |
8,899 |
5,790 |
5,544 |
EXCHANGE DIFFERENCES ON CASH AND CASH |
(265) |
33 |
51 |
CASH AND CASH EQUIVALENTS - END OF YEAR |
5,790 |
5,544 |
2,469 |
BioLineRx Ltd. |
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Year ended December 31, |
|||
2014 |
2015 |
2016 |
|
in USD thousands |
|||
APPENDIX |
|||
Adjustments required to reflect net cash used in operating |
|||
Income and expenses not involving cash flows: |
|||
Depreciation and amortization |
269 |
441 |
482 |
Write-off of intangible assets |
105 |
- |
- |
Retirement benefit obligations |
(42) |
- |
- |
Long-term prepaid expenses |
(6) |
(9) |
6 |
Exchange differences on cash and cash equivalents |
(261) |
(33) |
(51) |
Gain on adjustment of warrants to fair value |
(3,454) |
(1,292) |
(207) |
Commitment fee paid by issuance of share capital |
303 |
- |
- |
Share-based compensation |
1,055 |
1,152 |
1,075 |
Interest and exchange differences on short-term deposits |
(2,787) |
(182) |
(387) |
Interest and linkage differences on bank loan |
- |
1 |
(1) |
Interest and exchange differences on restricted deposits |
(20) |
- |
- |
(4,838) |
78 |
917 |
|
Changes in operating asset and liability items: |
|||
Decrease (increase) in prepaid expenses and other receivables |
80 |
(42) |
42 |
Increase in accounts payable and accruals |
84 |
196 |
369 |
164 |
154 |
411 |
|
(4,674) |
232 |
1,328 |
|
Supplementary information on investing and financing |
|||
Credit received in connection with purchase of property and equipment and intangible assets |
143 |
87 |
152 |
Supplementary information on interest received in cash |
97 |
173 |
453 |
Contact:
PCG Advisory
Investor Relations
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-year-end-2016-financial-results-300428355.html
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