TEL AVIV, Israel, Aug. 8, 2017 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company
focused on oncology and immunology, today reports its financial
results for the second quarter ended June
30, 2017.
Highlights and achievements during the second quarter
2017 and to date:
Continued execution on multiple clinical development programs
for the Company's lead project, BL-8040:
- 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;
- Reported regulatory submissions of three Phase 1b/2 trials for
BL-8040 in combination with atezolizumab, Genentech's anti-PDL1
cancer immunotherapy agent, in pancreatic, gastric and non-small
cell lung cancers, under immunotherapy collaboration with
Genentech, a member of the Roche Group. All three studies will be
conducted as part of MORPHEUS, Roche's Novel Cancer Immunotherapy
Development Platform, and are expected to commence in H2 2017;
- Reported filing of regulatory submissions to commence Phase
1b/2 trial for BL-8040 in combination with Genentech's atezolizumab
in acute myeloid leukemia (AML), to be led by BioLineRx. This study
is expected to commence in H2 2017;
- Announced initiation of first Phase 1b/2 trial under
immunotherapy collaboration with Genentech - in pancreatic
cancer;
The Company also announced an additional, direct investment by
BVF Partners, L.P., its largest shareholder, increasing its
economic interest in the Company to 24.9%. The $9.6 million investment was priced at
$1.13 per unit, each unit consisting
of 1 ordinary share, 0.35 of Series A warrant with an exercise
price of $2.00 per share, and 0.35 of
Series B warrant with an exercise price of $4.00 per share. The warrants are
exercisable for a period of 4 years.
Expected significant upcoming milestones for 2017 and
2018:
- Partial results from immuno-oncology Phase 2a study in
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 planned for H2
2017;
- Initiation of Phase 1b/2 immuno-oncology studies for BL-8040 in
combination with Genentech's atezolizumab in gastric cancer and
non-small cell lung cancer, as well as AML, all expected in H2
2017; partial results expected in H2 2018;
- Initiation of Phase 1 immuno-oncology study for AGI-134 in
several solid tumor indications expected in H1 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, remarked, "We are pleased to report second
quarter-to-date activities that reinforce our focus to deliver on
our objectives. This included timely initiation of our cancer
immunotherapy collaboration with Genentech for pancreatic cancer,
as well as regulatory advancements for additional indications in
other solid tumors, AML, and stem cell mobilization. Thus, by the
end of the year, we remain poised to have one Phase 3 and seven
Phase 2 or 1b/2 clinical trials up and running, in addition to
announcing partial results in our Phase 2 study in pancreatic
cancer under our immunotherapy collaboration with Merck."
"We are also pleased to have received a strong vote of
confidence from BVF Partners last month. The $9.6 million direct investment we received will
allow us to accelerate the development of our clinical programs.
With over $60 million in cash on a
pro forma basis, including BVF's investment, as of June 30th, we have a strong balance
sheet which will enable us to fully execute on our current
operating plans," Mr. Serlin concluded.
Financial Results for the Second Quarter Ended June 30, 2017
Research and development expenses for the three months ended
June 30, 2017 were $4.0 million, an increase of $1.3 million, or 48.2%, compared to $2.7 million for the three months ended
June 30, 2016. The increase resulted
primarily from spending on AGI-134 and BL-8040 in the 2017 period.
Research and development expenses for the six months ended
June 30, 2017 were $7.7 million, an increase of $2.4 million, or 45.0%, compared to $5.3 million for the six months ended
June 30, 2016. The reason for the
increase is the same as that presented in the three-month
comparison above.
Sales and marketing expenses for the three months ended
June 30, 2017 were $0.3 million, similar to the comparable period in
2016. Sales and marketing expenses for the six months ended
June 30, 2017 were $1.0 million, an increase of $0.5 million, or 86.3%, compared to $0.5 million for the six months ended
June 30, 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
June 30, 2017 were $0.8 million, similar to the comparable period in
2016. General and administrative expenses for the six months ended
June 30, 2017 were $1.8 million, similar to the comparable period in
2016.
The Company's operating loss for the three months ended
June 30, 2017 amounted to
$5.2 million, compared with an
operating loss of $3.9 million for
the corresponding 2016 period. The Company's operating loss for the
six months ended June 30, 2017
amounted to $10.5 million, compared
with an operating loss of $7.6
million for the corresponding 2016 period.
Non-operating income (expenses) for the three and six months
ended June 30, 2017 and 2016 were not
material, and primarily relate to fair-value adjustments of warrant
liabilities on the balance sheet.
Net financial income amounted to $0.3
million for the three months ended June 30, 2017 compared to net financial income of
$0.1 million for the three months
ended June 30, 2016. Net financial
income amounted to $0.8 million for
the six months ended June 30, 2017
compared to net financial income of $0.2
million for the six months ended June
30, 2016. The increase in net financial income relates
primarily to gains recorded on foreign currency hedging
transactions and investment income earned on our bank deposits.
The Company's net loss for the three months ended June 30, 2017 amounted to $4.9 million, compared with a net loss of
$3.7 million for the corresponding
2016 period. The Company's net loss for the six months ended
June 30, 2017 amounted to
$9.8 million, compared with a net
loss of $7.2 million for the
corresponding 2016 period.
The Company held $52.6 million in
cash, cash equivalents and short-term bank deposits as of
June 30, 2017. In July 2017, the Company completed a direct
placement of its securities for net proceeds of $9.5
million.
Net cash used in operating activities was $8.0 million for the six months ended
June 30, 2017, compared with net cash
used in operating activities of $7.5
million for the six months ended June
30, 2016. The $0.5 million
increase in net cash used in operating activities during the
six-month period in 2017, compared to the six-month period in 2016,
was primarily the result of an increase in the Company's operating
loss in the 2017 period.
Net cash used in investing activities for the six months ended
June 30, 2017 was $16.0 million, compared to net cash provided by
investing activities of $4.2 million
for the six months ended June 30,
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 six months
ended June 30, 2017 was $28.3 million, compared to net cash provided by
financing activities of $1.6 million
for the six months ended June 30,
2016. The increase in cash flows from financing activities
primarily reflects the public offering completed in April 2017.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, August 8, 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 August 11,
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 acute myeloid leukemia (AML), is
in the midst of a Phase 2b study as an AML consolidation treatment
and a Phase 1b/2 study in pancreatic cancer, 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
Pharma AG 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 Inc., 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 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
|
(UNAUDITED)
|
|
|
|
|
December 31,
|
June
30,
|
|
2016
|
2017
|
|
in USD
thousands
|
Assets
|
|
|
CURRENT
ASSETS
|
|
|
Cash and cash
equivalents
|
2,469
|
6,946
|
Short-term bank
deposits
|
33,154
|
45,616
|
Prepaid
expenses
|
255
|
560
|
Other
receivables
|
223
|
541
|
Total current assets
|
36,101
|
53,663
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
Long-term prepaid
expenses
|
52
|
53
|
Property and
equipment, net
|
2,605
|
2,463
|
Intangible assets,
net
|
181
|
6,869
|
Total non-current assets
|
2,838
|
9,385
|
Total assets
|
38,939
|
63,048
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES
|
|
|
Current maturities of
long-term bank loan
|
93
|
93
|
Accounts payable and
accruals:
|
|
|
Trade
|
2,590
|
4,262
|
Other
|
978
|
1,059
|
Total current liabilities
|
3,661
|
5,414
|
NON-CURRENT
LIABILITIES
|
|
|
Long-term bank loan,
net of current maturities
|
250
|
203
|
Warrants
|
1
|
1
|
Total non-current liabilities
|
251
|
204
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
Total liabilities
|
3,912
|
5,618
|
|
|
|
EQUITY
|
|
|
Ordinary
shares
|
1,513
|
2,570
|
Share
premium
|
199,567
|
231,368
|
Other comprehensive
loss
|
(1,416)
|
(1,416)
|
Capital
reserve
|
10,569
|
9,866
|
Accumulated
deficit
|
(175,206)
|
(184,958)
|
Total equity
|
35,027
|
57,430
|
Total liabilities and equity
|
38,939
|
63,048
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
(UNAUDITED)
|
|
|
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|
2016
|
2017
|
2016
|
2017
|
|
in USD
thousands
|
in USD
thousands
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
(2,740)
|
(4,062)
|
(5,279)
|
(7,652)
|
SALES AND
MARKETING EXPENSES
|
(272)
|
(288)
|
(520)
|
(969)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(854)
|
(844)
|
(1,843)
|
(1,874)
|
OPERATING
LOSS
|
(3,866)
|
(5,194)
|
(7,642)
|
(10,495)
|
NON-OPERATING
INCOME (EXPENSES)
|
48
|
(4)
|
196
|
(9)
|
FINANCIAL
INCOME
|
88
|
304
|
232
|
761
|
FINANCIAL
EXPENSES
|
(5)
|
(3)
|
(9)
|
(9)
|
|
|
|
|
|
NET LOSS AND
COMPREHENSIVE LOSS
|
(3,735)
|
(4,897)
|
(7,223)
|
(9,752)
|
|
|
|
|
|
|
in
USD
|
in
USD
|
LOSS PER ORDINARY
SHARE - BASIC AND DILUTED
|
(0.07)
|
(0.05)
|
(0.13)
|
(0.13)
|
|
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY
SHARE
|
56,423,601
|
94,487,470
|
55,651,371
|
76,571,351
|
|
|
|
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED INTERIM
STATEMENTS OF CHANGES IN EQUITY
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
Ordinary
|
Share
|
Other
|
Capital
|
Accumulated
|
|
|
shares
|
premium
|
reserves
|
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
|
|
|
|
|
|
|
|
|
Ordinary
|
Share
|
Other
|
Capital
|
Accumulated
|
|
|
shares
|
premium
|
reserves
|
reserve
|
deficit
|
Total
|
|
in USD
thousands
|
BALANCE AT JANUARY
1, 2017
|
1,513
|
199,567
|
(1,416)
|
10,569
|
(175,206)
|
35,027
|
CHANGES FOR SIX
MONTHS ENDED JUNE 30, 2017:
|
|
|
|
|
|
|
Issuance of share
capital, net
|
1,056
|
30,241
|
-
|
-
|
-
|
31,297
|
Employee stock
options exercised
|
1
|
320
|
-
|
(321)
|
-
|
-
|
Employee stock
options forfeited and expired
|
-
|
1,240
|
-
|
(1,240)
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
-
|
858
|
-
|
858
|
Comprehensive loss
for the period
|
-
|
-
|
-
|
-
|
(9,752)
|
(9,752)
|
BALANCE AT JUNE
30, 2017
|
2,570
|
231,368
|
(1,416)
|
9,866
|
(184,958)
|
57,430
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
Six months ended
June 30,
|
|
2016
|
2017
|
|
in USD
thousands
|
|
|
|
CASH FLOWS -
OPERATING ACTIVITIES
|
|
|
Comprehensive loss for
the period
|
(7,223)
|
(9,752)
|
Adjustments required
to reflect net cash used in operating activities (see appendix
below)
|
(223)
|
1,746
|
Net cash used in
operating activities
|
(7,446)
|
(8,006)
|
|
|
|
CASH FLOWS -
INVESTING ACTIVITIES
|
|
|
Investments in
short-term deposits
|
(19,804)
|
(36,422)
|
Maturities of
short-term deposits
|
24,182
|
24,233
|
Purchase of property
and equipment
|
(164)
|
(90)
|
Purchase of intangible
assets
|
(24)
|
(3,721)
|
Net cash provided by
(used in) investing activities
|
4,190
|
(16,000)
|
|
|
|
CASH FLOWS -
FINANCING ACTIVITIES
|
|
|
Issuances of share
capital, net
|
1,595
|
28,312
|
Repayments of bank
loan
|
(48)
|
(47)
|
Net cash provided by
financing activities
|
1,547
|
28,265
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,709)
|
4,259
|
CASH AND CASH
EQUIVALENTS – BEGINNING
OF
PERIOD
|
5,544
|
2,469
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
42
|
218
|
CASH AND CASH
EQUIVALENTS - END OF PERIOD
|
3,877
|
6,946
|
|
|
|
BioLineRx
Ltd.
|
APPENDIX TO CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
Six months ended
June 30,
|
|
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
|
245
|
250
|
Long-term prepaid
expenses
|
4
|
(1)
|
Interest and exchange
rate differences on short-term deposits
|
(204)
|
(273)
|
Share-based
compensation
|
582
|
858
|
Exchange differences
on cash and cash equivalents
|
(42)
|
(218)
|
Gain on adjustment of
warrants to fair value
|
(193)
|
-
|
|
392
|
616
|
|
|
|
Changes in
operating asset and liability items:
|
|
|
Increase in prepaid
expenses and other receivables
|
(352)
|
(623)
|
Increase (decrease) in
accounts payable and accruals
|
(263)
|
1,753
|
|
(615)
|
1,130
|
|
(223)
|
1,746
|
|
|
|
|
|
|
Supplementary
information on interest received in cash
|
192
|
258
|
|
|
|
|
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
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content:http://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2017-financial-results-300501015.html
SOURCE BioLineRx Ltd