BioLineRx Reports First Quarter 2017 Financial Results
Highlights and achievements during the first quarter 2017 and to date:
Continued advancing the Company's lead project, BL-8040, in an extensive clinical development program:
- Announced plans to initiate Phase 3 pivotal study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation in H2 2017, following successful meeting with the
FDA .
- 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 cancer immunotherapy collaboration between MSD andMD Anderson Cancer Center .
- Reported partial results on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation. 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; and
- Reported filing of regulatory submissions to commence a Phase 1b trial for BL-8040 in combination with Genentech's atezolizumab in acute myeloid leukemia (AML), which will be led by BioLineRx. This study is expected to commence in H2 2017.
In parallel, the Company made significant progress in expanding and accelerating its growth potential:
Acquired Agalimmune Ltd. , aUK -based biopharmaceutical company developing cancer immunotherapy treatments, thereby broadening and bolstering BioLineRx's position in immuno-oncology with a second novel lead compound, AGI-134;
- Completed underwritten public offering of American Depository Shares for net proceeds of
$26.2 million , which will be used to fund a number of clinical trials, including a Phase 3 pivotal study for BL-8040 in autologous stem-cell mobilization, as well as the aggressive clinical development of both BL-8040 and AGI-134 in the immuno-oncology space.
Expected significant upcoming milestones for 2017 and 2018:
- Partial results from 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 3 pivotal study for BL-8040 in stem-cell mobilization for autologous transplantation in H2 2017;
- Initiation of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's atezolizumab in pancreatic, gastric, and non-small cell lung cancer, as well as AML, expected in H2 2017; partial results expected in H2 2018;
- Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, top line results expected by year end 2017; and
- Initiation of Phase 1 immuno-oncology study for AGI-134 in several solid tumor indications expected in H1 2018.
"With important catalysts in the next 12-18 months, our team is driven and focused on advancing our asset pipeline. We look forward to providing updates as we execute on our plans," Mr. Serlin concluded.
Financial Results for the First 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 months ended
Net financial income amounted to
The Company's net loss for the three months ended
The Company held
Net cash used in operating activities for the three months ended
Net cash provided by 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 today,
A replay of the conference call will be available approximately two hours after completion of the live conference call at the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until
(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, is in the midst of a Phase 2b study as an AML consolidation treatment and is expected to initiate a Phase 3 study in stem cell mobilization for autologous 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. |
||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
||
December 31, |
March 31, |
|
2016 |
2017 |
|
in USD thousands |
||
Assets |
||
CURRENT ASSETS |
||
Cash and cash equivalents |
2,469 |
2,201 |
Short-term bank deposits |
33,154 |
28,167 |
Prepaid expenses |
255 |
700 |
Other receivables |
223 |
580 |
Total current assets |
36,101 |
31,648 |
NON-CURRENT ASSETS |
||
Long-term prepaid expenses |
52 |
55 |
Property and equipment, net |
2,605 |
2,540 |
Intangible assets, net |
181 |
6,875 |
Total non-current assets |
2,838 |
9,470 |
Total assets |
38,939 |
41,118 |
Liabilities and equity |
||
CURRENT LIABILITIES |
||
Current maturities of long-term bank loan |
93 |
93 |
Accounts payable and accruals: |
||
Trade |
2,590 |
3,450 |
Other |
978 |
1,631 |
Total current liabilities |
3,661 |
5,174 |
NON-CURRENT LIABILITIES |
||
Long-term bank loan, net of current maturities |
250 |
227 |
Warrants |
1 |
1 |
Total non-current liabilities |
251 |
228 |
COMMITMENTS AND CONTINGENT LIABILITIES |
||
Total liabilities |
3,912 |
5,402 |
EQUITY |
||
Ordinary shares |
1,513 |
1,642 |
Share premium |
199,567 |
205,892 |
Capital reserve |
10,569 |
9,659 |
Other comprehensive loss |
(1,416) |
(1,416) |
Accumulated deficit |
(175,206) |
(180,061) |
Total equity |
35,027 |
35,716 |
Total liabilities and equity |
38,939 |
41,118 |
BioLineRx Ltd. |
||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS |
||
Three months ended March 31, |
||
2016 |
2017 |
|
in USD thousands |
||
RESEARCH AND DEVELOPMENT EXPENSES |
(2,539) |
(3,590) |
SALES AND MARKETING EXPENSES |
(248) |
(681) |
GENERAL AND ADMINISTRATIVE EXPENSES |
(989) |
(1,030) |
OPERATING LOSS |
(3,776) |
(5,301) |
NON-OPERATING INCOME (EXPENSES) |
148 |
(5) |
FINANCIAL INCOME |
143 |
457 |
FINANCIAL EXPENSES |
(4) |
(6) |
NET LOSS AND COMPREHENSIVE LOSS |
(3,489) |
(4,855) |
in USD |
||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED |
(0.06) |
(0.08) |
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
54,870,561 |
58,620,094 |
BioLineRx Ltd. |
||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY |
||||||
Ordinary shares |
Share premium |
Capital Reserve |
Other comprehensive loss |
Accumulated deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2016 |
1,455 |
196,201 |
10,735 |
(1,416) |
(159,365) |
47,610 |
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2016: |
||||||
Issuance of share capital, net |
4 |
1,591 |
- |
- |
- |
1,595 |
Share-based compensation |
- |
- |
286 |
- |
- |
286 |
Comprehensive loss for the period |
- |
- |
- |
- |
(3,489) |
(3,489) |
BALANCE AT MARCH 31, 2016 |
1,459 |
197,792 |
11,021 |
(1,416) |
(162,854) |
46,002 |
Ordinary shares |
Share premium |
Capital Reserve |
Other comprehensive loss |
Accumulated deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2017 |
1,513 |
199,567 |
10,569 |
(1,416) |
(175,206) |
35,027 |
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2017: |
||||||
Issuance of share capital, net |
128 |
4,944 |
- |
- |
- |
5,072 |
Employee stock options exercised |
1 |
296 |
(297) |
- |
- |
- |
Employee stock options forfeited and expired |
- |
1,085 |
(1,085) |
- |
- |
- |
Share-based compensation |
- |
- |
472 |
- |
- |
472 |
Comprehensive loss for the period |
- |
- |
- |
- |
(4,855) |
(4,855) |
BALANCE AT MARCH 31, 2017 |
1,642 |
205,892 |
9,659 |
(1,416) |
(180,061) |
35,716 |
BioLineRx Ltd. |
||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
Three months ended March 31, |
||
2016 |
2017 |
|
in USD thousands |
||
CASH FLOWS - OPERATING ACTIVITIES |
||
Net loss for the period |
(3,489) |
(4,855) |
Adjustments required to reflect net cash used in operating activities (see appendix below) |
(695) |
1,062 |
Net cash used in operating activities |
(4,184) |
(3,793) |
CASH FLOWS - INVESTING ACTIVITIES |
||
Investments in short-term deposits |
(10,300) |
(7,013) |
Maturities of short-term deposits |
12,102 |
12,143 |
Purchase of property and equipment |
(137) |
(45) |
Purchase of intangible assets |
(11) |
(3,718) |
Net cash provided by investing activities |
1,654 |
1,367 |
CASH FLOWS - FINANCING ACTIVITIES |
||
Issuance of share capital and warrants, net of issuance costs |
1,595 |
2,087 |
Repayments of bank loan |
(23) |
(23) |
Net cash provided by financing activities |
1,572 |
2,064 |
DECREASE IN CASH AND CASH EQUIVALENTS |
(958) |
(362) |
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD |
5,544 |
2,469 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
(2) |
94 |
CASH AND CASH EQUIVALENTS - END OF PERIOD |
4,584 |
2,201 |
BioLineRx Ltd. |
||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
||
Three months ended March 31, |
||
2016 |
2017 |
|
in USD thousands |
||
Adjustments required to reflect net cash used in operating activities: |
||
Income and expenses not involving cash flows: |
||
Depreciation and amortization |
122 |
119 |
Long-term prepaid expenses |
2 |
(3) |
Exchange differences on cash and cash equivalents |
2 |
(94) |
Gain on adjustment of warrants to fair value |
(148) |
- |
Share-based compensation |
286 |
472 |
Interest and exchange differences on short-term deposits |
(106) |
(143) |
Interest and linkage differences on bank loan |
(1) |
- |
157 |
351 |
|
Changes in operating asset and liability items: |
||
Increase in prepaid expenses and other receivables |
(342) |
(802) |
Increase (Decrease) in accounts payable and accruals |
(510) |
1,513 |
(852) |
711 |
|
(695) |
1,062 |
|
Supplementary information on interest received in cash |
103 |
137 |
Supplementary non-cash investment (see Note 4b) |
2,985 |
|
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-first-quarter-2017-financial-results-300463810.html
SOURCE