TEL AVIV, Israel, May 25, 2017 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company
focused on oncology and immunology, today reports its financial
results for the first quarter ended March
31, 2017.
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 and MD 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., a UK-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.
Philip A. Serlin, Chief Executive
Officer of BioLineRx, remarked, "Our 2017 activities have fueled
significant excitement at BioLineRx, as we reinforced our position
in the high value field of immuno-oncology following our
acquisition of a second novel drug compound, AGI-134, and
strengthened our balance sheet to fund our main development
objectives with support from key fundamental investors. We
ended the first quarter with pro forma cash of $57 million, including net proceeds of
$26 million from our recent public
offering, sufficient to fund – and accelerate - our clinical
programs, including both BL-8040 and AGI-134, through late
2019."
"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 March 31, 2017
Research and development expenses for the three months ended
March 31, 2017 were $3.6 million, an increase of $1.1 million, or 41%, compared to $2.5 million for the three months ended
March 31, 2016. The increase resulted
primarily from an increase in spending on BL-8040 and an increase
in spending on new projects.
Sales and marketing expenses for the three months ended
March 31, 2017 were $0.7 million, an increase of $0.4 million, or 175%, compared to $0.3 million for the three months ended
March 31, 2016. The increase resulted
primarily from market research activities and one-time professional
fees related to business development activities.
General and administrative expenses for the three months ended
March 31, 2017 were $1.0 million, similar to the comparable period in
2016.
The company's operating loss for the three months ended
March 31, 2017 amounted to
$5.3 million, compared with an
operating loss of $3.8 million for
the corresponding 2016 period.
Non-operating income (expenses) for the three months ended
March 31, 2017 and 2016 were not
material, and primarily related to fair-value adjustments of
warrant liabilities.
Net financial income amounted to $0.5
million for the three months ended March 31, 2017, compared to net financial income
of $0.1 million for the corresponding
2016 period. The increase in net financial income related primarily
to gains recorded on foreign currency hedging transactions.
The Company's net loss for the three months ended March 31, 2017 amounted to $4.9 million, compared with a net loss of
$3.5 million for the corresponding
2016 period.
The Company held $30.4 million in
cash, cash equivalents and short-term bank deposits as of
March 31, 2017. In April 2017, the Company completed an underwritten
public offering of its American Depositary Shares for net proceeds
of $26.2 million.
Net cash used in operating activities for the three months ended
March 31, 2017 was $3.8 million, compared with net cash used in
operating activities of $4.2 million
for the three months ended March 31,
2016. The $0.4 million
decrease in net cash used in operating activities was primarily the
result of an increase in trade payables and accruals.
Net cash provided by investing activities for the three months
ended March 31, 2017 was $1.4 million, compared to net cash provided by
investing activities of $1.7 million
for the three months ended March 31,
2016. The changes in cash flows from investing activities
relate primarily to investments in, and maturities of, short-term
bank deposits, as well as the investment in Agalimmune.
Net cash provided by financing activities for the three months
ended March 31, 2017 was $2.1 million, compared to net cash provided by
financing activities of $1.6 million
for the three months ended March 31,
2016. The increase in cash flows from financing activities
primarily reflects funding under the share purchase agreement with
LPC.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, March 25, 2017, at 10:00
a.m. EDT. 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 at the
Investor Relations page of BioLineRx's website. A dial-in replay of
the call will be available until May 28,
2017; please dial 1-877-456-0009 from the U.S. or
+972-3-925-5946 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 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 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 studies
for multiple solid tumor indications and AML.
For additional information on BioLineRx, please visit the
Company's website at 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 23,
2017. 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
|
|
|
|
|
|
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
Vivian Cervantes
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 BioLineRx Ltd.