TEL AVIV, Israel, March 6, 2018 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology, today
reports its financial results for the year ended December 31, 2017.
Highlights and achievements in 2017 and to
date:
Continued progress and execution according to plan on multiple
clinical trials for the Company's lead oncology program,
BL-8040:
- Initiation of pivotal Phase 3 GENESIS study with BL-8040 as
novel stem cell mobilization treatment for autologous bone-marrow
transplantation, following successful meeting with the FDA earlier
in the year;
- Partial monotherapy results from Phase 2a COMBAT study,
investigating the combination of BL-8040 and Merck's PD-1
inhibitor, Keytruda® (pembrolizumab), in pancreatic
cancer, showed significantly increased infiltration of T cells into
the tumor, as well as robust mobilization of immune cells;
- Initiation of three Phase 1b/2
studies under collaboration with Genentech, exploring the
combination of BL-8040 with Tecentriq® (atezolizumab),
Genentech's anti-PD-L1 cancer immunotherapy agent;
- Overall long-term survival results in Phase 2a trial in
relapsed/refractory AML demonstrated that the combination of
BL-8040 with high-dose Ara-C (HiDAC) significantly improved overall
survival, compared with historical data of HiDAC
monotherapy;
- Partial results of Phase 2 study for BL-8040 as novel stem cell
mobilization treatment for allogeneic bone-marrow transplantation
support BL-8040 as a one-day dosing regimen for rapid mobilization
of stem cells.
The Company also announced progress in expanding and
accelerating its growth potential and strengthening its balance
sheet:
- Acquired Agalimmune Ltd., a UK-based biopharmaceutical company
developing cancer immunotherapy treatments, thereby broadening
BioLineRx's position in the immuno-oncology field with a second
novel lead compound, AGI-134. Pre-clinical data presented at
ASCO-SITC showed complete tumor regression in the majority of mice
treated with AGI-134;
- Completed underwritten public offering of American Depository
Shares for gross proceeds of $28.9
million led by BVF Partners, L.P; the Company also received
an additional $9.6 million direct
investment from BVF Partners.
Expected significant upcoming milestones for 2018:
- Top-line results in immuno-oncology Phase 2a COMBAT study in
pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA,
expected in H2 2018;
- Results from the lead-in stage of the Phase 3 GENESIS study in
stem-cell mobilization, expected in H2 2018;
- Initiation of Phase 1b/2
immuno-oncology study for BL-8040 in combination with Genentech's
atezolizumab for non-small cell lung cancer. Partial results in
Phase 1b/2 trials under collaboration
with Genentech expected in H2 2018;
- Initiation of Phase 1/2a immuno-oncology study for AGI-134 in
several solid tumor indications expected in mid-2018;
- Top-line results of Phase 2 study for BL-8040 in stem-cell
mobilization for allogeneic transplantation expected by
mid-2018.
Philip A. Serlin, Chief Executive
Officer of BioLineRx, stated, "We are very proud of the continued
advancement and on-target execution of our oncology programs in
2017. During the year, we initiated several clinical studies for
our lead asset, BL-8040, including our first pivotal Phase 3 study
in autologous stem-cell mobilization, as well as a number of
studies under our immunotherapy collaborations with Genentech and
MD Anderson Cancer Center. Furthermore, we announced encouraging
clinical results demonstrating the therapeutic potential of BL-8040
– the recently reported partial results from the monotherapy stage
of our Phase 2a COMBAT study in pancreatic cancer showed robust
mobilization and increased infiltration of anti-tumor-specific T
cells into the tumor microenvironment, supporting previously
reported BL-8040 data; and BL-8040 in combination with Ara-C
demonstrated significant improvement in overall survival in our
phase 2a study in relapsed/refractory AML."
"We are also excited by the potential of our second oncology
asset, AGI-134, acquired in early 2017, with new pre-clinical data
demonstrating induced regression of primary tumors following
intratumoral injection. We expect to initiate a Phase 1/2a study
for this product in multiple solid tumors by mid-2018. We will
continue the steady execution on all our programs during 2018, and
we look forward to reporting on key milestones over the next six to
12 months, including data read-outs from several Phase 2 studies
and lead-in results from our Phase 3 trial in autologous stem cell
mobilization," concluded Mr. Serlin.
Financial Results for the Year Ended December 31, 2017
Research and development expenses for the year ended
December 31, 2017 were $19.5 million, an increase of $8.3 million, or 74.6%, compared to $11.2 million for the year ended December 31, 2016. The increase resulted
primarily from higher expenses in 2017 associated with new BL-8040
clinical studies commenced during the third quarter of 2016 and
during 2017, as well as spending on the Company's recently acquired
AGI-134 near-clinical project.
Sales and marketing expenses for the year ended December 31, 2017 were $1.7 million, an increase of $0.3 million, or 25.2%, compared to $1.4 million for the year ended December 31, 2016. The increase resulted
primarily from one-time legal fees related to AGI-134.
General and administrative expenses for the year ended
December 31, 2017 were $4.0 million, similar to those for the year ended
December 31, 2016.
The Company's operating loss for the year ended December 31, 2017 amounted to $25.2 million, compared with an operating loss of
$16.5 million for the year ended
December 31, 2016. The increase in
operating loss reflects the significant increase in research and
development expenses during 2017.
Non-operating expenses amounted to $0.3
million for the year ended December
31, 2017, compared with non-operating income of $0.2 million for the year ended December 31, 2016. Non-operating expenses and
income for both years primarily relate to fair-value adjustments of
warrant liabilities on the Company's balance sheet.
Net financial income amounted to $1.1
million for the year ended December
31, 2017 compared to net financial income of $0.5 million for the year ended December 31, 2016. The increase in net financial
income relates primarily to gains recorded on foreign currency
hedging transactions and higher investment income due to higher
levels of cash and short-term bank deposits.
The Company's net loss for the year ended December 31, 2017 amounted to $24.4 million, compared with an operating loss of
$15.8 million for the year ended
December 31, 2016.
The Company held $49.5 million in
cash, cash equivalents and short-term bank deposits as of
December 31, 2017.
Net cash used in operating activities for the year ended
December 31, 2017 was $20.5 million, compared to $14.5 million for the year ended December 31, 2016. The $6.0 million increase in net cash used in
operating activities in 2017 was primarily the result of increased
research and development expenses.
Net cash used in investing activities for the year ended
December 31, 2017 was $15.9 million, compared to net cash provided by
investing activities of $9.3 million
for the year ended December 31, 2016.
The changes in cash flows from investing activities relate
primarily to investments in, and maturities of, short-term bank
deposits during the respective periods, as well as the acquisition
of Agalimmune and the investment in iPharma during 2017.
Net cash provided by financing activities for the year ended
December 31, 2017 was $38.7 million, compared to $2.1 million for the year ended December 31, 2016. The cash flows in 2017
primarily reflect the underwritten public offering of ADSs in
March 2017 and the direct placement
of ADSs and warrants to BVF Partners in July
2017.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, March 6, 2018 at 10:00
a.m. EST. To access the conference call, please dial
+1-888-668-9141 from the U.S. or +972-3-918-0609 internationally.
The call will also be available via webcast and can be accessed
through the Investor Relations page of BioLineRx's website. Please
allow extra time prior to the call to visit the site and download
any necessary software to listen to the live broadcast.
A replay of the conference call will be available approximately
two hours after completion of the live conference call on the
Investor Relations page of BioLineRx's website. A dial-in replay of
the call will be available until March 9,
2018; please dial +1-888-326-9310 from the U.S. or
+972-3-925-5901 internationally.
(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 has initiated 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 mid-2018. In
addition, BioLineRx has a strategic collaboration with Novartis for
the co-development of selected Israeli-sourced novel drug
candidates; a collaboration agreement with MSD (known as Merck in
the US and Canada), on the basis
of which the Company has initiated a Phase 2a study in pancreatic
cancer using the combination of BL-8040 and Merck's
KEYTRUDA®; and a collaboration agreement with Genentech,
a member of the Roche Group, to investigate the combination of
BL-8040 and Genentech's atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications
and AML.
For additional information on BioLineRx, please visit the
Company's website at http://www.biolinerx.com, where you can review
the Company's SEC filings, press releases, announcements and
events. BioLineRx industry updates are also regularly updated on
Facebook, Twitter, and LinkedIn.
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 6,
2018. 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.
Contact:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-646-863-6274
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
December
31,
|
|
2016
|
2017
|
|
in
USD thousands
|
Assets
|
|
|
CURRENT
ASSETS
|
|
|
Cash and cash
equivalents
|
2,469
|
5,110
|
Short-term bank
deposits
|
33,154
|
44,373
|
Prepaid
expenses
|
255
|
307
|
Other
receivables
|
223
|
586
|
Total current assets
|
36,101
|
50,376
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
Long-term prepaid
expenses
|
52
|
61
|
Long-term
investment
|
-
|
1,000
|
Property and
equipment, net
|
2,605
|
2,505
|
Intangible assets,
net
|
181
|
7,023
|
Total non-current assets
|
2,838
|
10,589
|
Total assets
|
38,939
|
60,965
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES
|
|
|
Current maturities of
long-term bank loan
|
93
|
93
|
Accounts payable and
accruals:
|
|
|
Trade
|
2,590
|
5,516
|
Other
|
978
|
1,113
|
Total current liabilities
|
3,661
|
6,722
|
|
|
|
NON-CURRENT
LIABILITIES
|
|
|
Long-term bank loan,
net of current maturities
|
250
|
157
|
Warrants
|
1
|
1,205
|
Total non-current liabilities
|
251
|
1,362
|
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
Total liabilities
|
3,912
|
8,084
|
|
|
|
EQUITY
|
|
|
Ordinary
shares
|
1,513
|
2,836
|
Share
premium
|
199,567
|
240,682
|
Capital
reserve
|
10,569
|
10,337
|
Other comprehensive
loss
|
(1,416)
|
(1,416)
|
Accumulated
deficit
|
(175,206)
|
(199,558)
|
Total equity
|
35,027
|
52,881
|
Total liabilities and equity
|
38,939
|
60,965
|
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
Year ended
December 31,
|
|
|
2015
|
2016
|
2017
|
|
|
in USD
thousands
|
|
|
|
|
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
(11,489)
|
(11,177)
|
(19,510)
|
SALES AND
MARKETING EXPENSES
|
(1,003)
|
(1,352)
|
(1,693)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(3,704)
|
(3,984)
|
(4,037)
|
OPERATING
LOSS
|
(16,196)
|
(16,513)
|
(25,240)
|
NON-OPERATING
INCOME (EXPENSES), NET
|
1,445
|
214
|
(260)
|
FINANCIAL
INCOME
|
457
|
480
|
1,169
|
FINANCIAL
EXPENSES
|
(106)
|
(22)
|
(21)
|
NET LOSS AND
COMPREHENSIVE LOSS
|
(14,400)
|
(15,841)
|
(24,352)
|
|
|
|
|
|
in USD
|
|
LOSS PER ORDINARY
SHARE – BASIC AND DILUTED
|
(0.28)
|
(0.28)
|
(0.27)
|
|
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY
SHARE
|
51,406,434
|
56,144,727
|
89,970,713
|
|
|
|
|
|
|
|
|
|
|
|
|
BioLineRx Ltd.
STATEMENTS OF CHANGES IN EQUITY
|
Ordinary
shares
|
Share
premium
|
Capital
reserve
|
Other
comprehensive
loss
|
Accumulated
deficit
|
Total
|
|
in USD thousands
|
BALANCE AT JANUARY
1, 2015
|
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
|
CHANGES IN
2017:
|
|
|
|
|
|
|
Issuance of
share capital, net
|
1,322
|
39,376
|
-
|
-
|
-
|
40,698
|
Employee stock
options exercised
|
1
|
328
|
(329)
|
-
|
-
|
-
|
Employee stock
options expired
|
-
|
1,411
|
(1,411)
|
-
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
1,508
|
-
|
-
|
1,508
|
Comprehensive
loss for the year
|
-
|
-
|
-
|
-
|
(24,352)
|
(24,352)
|
BALANCE AT
DECEMBER 31, 2017
|
2,836
|
240,682
|
10,337
|
(1,416)
|
(199,558)
|
52,881
|
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
|
Year ended
December 31,
|
|
2015
|
2016
|
2017
|
|
in USD
thousands
|
CASH FLOWS -
OPERATING ACTIVITIES
|
|
|
|
Net loss
|
(14,400)
|
(15,841)
|
(24,352)
|
Adjustments required to
reflect net cash used in operating activities (see appendix
below)
|
232
|
1,328
|
3,805
|
Net cash used in
operating activities
|
(14,168)
|
(14,513)
|
(20,547)
|
|
|
|
|
CASH FLOWS -
INVESTING ACTIVITIES
|
|
|
|
Long-term
investment
|
-
|
-
|
(1,000)
|
Investments in short-term
deposits
|
(63,130)
|
(32,982)
|
(44,016)
|
Maturities of short-term
deposits
|
50,083
|
42,334
|
33,327
|
Maturities of restricted
deposits
|
166
|
-
|
-
|
Purchase of property and
equipment
|
(2,683)
|
(52)
|
(338)
|
Purchase of intangible
assets
|
(36)
|
(3)
|
(3,900)
|
Net cash provided by
(used in) investing activities
|
(15,600)
|
9,297
|
(15,927)
|
|
|
|
|
CASH FLOWS -
FINANCING ACTIVITIES
|
|
|
|
Issuance of share capital
and warrants, net of issuance costs
|
29,053
|
2,183
|
38,773
|
Proceeds of bank
loan
|
467
|
-
|
-
|
Repayments of bank
loan
|
(31)
|
(93)
|
(93)
|
Net cash provided by
financing activities
|
29,489
|
2,090
|
38,680
|
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(279)
|
(3,126)
|
2,206
|
CASH AND CASH
EQUIVALENTS - BEGINNING
OF
YEAR
|
5,790
|
5,544
|
2,469
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
33
|
51
|
435
|
CASH AND CASH
EQUIVALENTS - END OF YEAR
|
5,544
|
2,469
|
5,110
|
|
|
|
|
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
|
Year ended
December 31,
|
|
2015
|
2016
|
2017
|
|
in USD
thousands
|
APPENDIX
|
|
|
|
|
|
|
|
Adjustments
required to reflect net cash used in operating
activities:
|
|
|
|
Income and expenses
not involving cash flows:
|
|
|
|
Depreciation and
amortization
|
441
|
482
|
481
|
Long-term prepaid
expenses
|
(9)
|
6
|
(9)
|
Exchange differences
on cash and cash equivalents
|
(33)
|
(51)
|
(435)
|
Loss (gain) on
adjustment of warrants to fair value
|
(1,292)
|
(207)
|
127
|
Share-based
compensation
|
1,152
|
1,075
|
1,508
|
Interest and exchange
differences on short-term deposits
|
(182)
|
(387)
|
(530)
|
Interest and linkage
differences on bank loan
|
1
|
(1)
|
-
|
Warrant issuance
costs
|
-
|
-
|
17
|
|
78
|
917
|
1,159
|
|
|
|
|
Changes in
operating asset and liability items:
|
|
|
|
Decrease (increase) in
prepaid expenses and other receivables
|
(42)
|
42
|
(415)
|
Increase in accounts
payable and accruals
|
196
|
369
|
3,061
|
|
154
|
411
|
2,646
|
|
|
|
|
|
232
|
1,328
|
3,805
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplementary
information on interest received in cash
|
173
|
453
|
494
|
|
|
|
|
Supplementary
non-cash investment (see Note 19)
|
-
|
-
|
2,985
|
|
|
|
|
|
|
|
|
Debt
reconciliation for 2017:
|
|
|
|
|
Long-term bank
loan
|
Warrants
|
Total
|
Debt as of January 1,
2017
|
343
|
1
|
344
|
Cash flows
|
(93)
|
1,077
|
984
|
Other non-cash
movements
|
-
|
127
|
127
|
Debt as
of December 31, 2017
|
250
|
1,205
|
1,455
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:http://www.prnewswire.com/news-releases/biolinerx-reports-year-end-2017-financial-results-300608804.html
SOURCE BioLineRx Ltd.