TEL AVIV, Israel, Aug. 13, 2018 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical
company focused on oncology and immunology, today reports its
financial results for the second quarter ended June 30, 2018.
Highlights and achievements during the second quarter
2018 and to date:
Continued progress made on multiple clinical trials for the
Company's lead oncology program, BL-8040:
- Positive data from successful completion of first lead-in
patient cohort of the GENESIS trial, a double-blind,
placebo-controlled, Phase 3 trial comparing BL-8040 in combination
with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone,
for the mobilization of hematopoietic stem cells (HSCs) used for
autologous transplantation in multiple myeloma patients. Results
from first 11 patients prompted Data Monitoring Committee (DMC) to
recommend early continuation to randomized placebo-controlled part
2 of trial; data show that 9/11 patients (82%) reached primary
endpoint threshold of ≥ 6x106 CD34 cells/kg with only
one dose of BL-8040 and in up to 2 apheresis sessions;
- Expansion of immuno-oncology collaboration with Merck &
Co., Inc., Kenilworth, N.J.
(Merck), supporting a Phase 2a program investigating BL-8040 in
combination with KEYTRUDA in pancreatic cancer patients. Under the
expansion, a triple combination arm investigating the safety,
tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy
will be added to the ongoing COMBAT/KEYNOTE-202 study, with a
specific focus on second line patients;
- Presentation at the 2018 European Hematology Association (EHA)
Conference of very encouraging long-term overall survival results
in Phase 2a trial in relapsed/refractory AML, demonstrating that
the combination of BL-8040 with high-dose Cytarabine (HiDAC)
significantly improved overall survival, compared with historical
data for HiDAC monotherapy;
- Grant of European patent covering use of BL-8040 with
Cytarabine for treating AML; valid through March 2034 with up to five years' patent term
extension.
The Company also announced advancements made in its second
immuno-oncology compound,
AGI-134:
- Initiation of multicenter, open-label Phase 1/2a study in the
UK and Israel, with possible
expansion to the US and additional countries in Europe in 2019; study will evaluate the safety
and tolerability of AGI-134, as a monotherapy and in combination
with an immune checkpoint inhibitor, in unresectable metastatic
solid tumors.
Expected significant milestones in next 18 months:
- Top-line results in immuno-oncology Phase 2a COMBAT study in
pancreatic cancer for BL-8040 in combination with KEYTRUDA, under
collaboration with Merck, to be presented at the European Society
for Medical Oncology (ESMO) Congress in October 2018;
- Partial results in Phase 1b/2
study in pancreatic cancer under Genentech immuno-oncology
collaboration, investigating BL-8040 in combination with
Genentech's atezolizumab, expected in H2 2018;
- Potential interim analysis of Phase 2b BLAST study in AML consolidation in
mid-2019:
- Results from additional cohort in Phase 2a COMBAT study under
expansion of Merck collaboration, investigating triple combination
of BL-8040, KEYTRUDA and chemotherapy in pancreatic cancer, by end
of 2019;
"We are very encouraged by the clinical results achieved to-date
in the major indications being developed under our BL-8040
platform, as we continue to advance the asset towards
registration," stated Philip A.
Serlin, Chief Executive Officer of BioLineRx.
"Specifically, positive results from the initial lead-in cohort in
the Phase 3 GENESIS trial, and the resulting DMC recommendation for
an early continuation to the randomized, double-blind,
placebo-controlled part of the trial, is an important clinical
achievement for BL-8040. The data continue to demonstrate BL-8040's
robust efficacy in stem-cell mobilization for autologous
transplantation, including the potential to reduce the number of
required apheresis sessions to one session in the majority of
patients, versus multiple sessions under current practice. Building
on this success, data from our ongoing COMBAT Phase 2a
immuno-oncology trial support continued development in pancreatic
cancer, as we expand our collaboration with Merck, with the
addition to the existing study of a new cohort with 30-50 patients
investigating the triple combination of BL-8040, KEYTRUDA and
chemotherapy. The new cohort will focus on second-line pancreatic
cancer patients and we are hopeful for significant synergies from
the triple drug combination in this very difficult-to-treat
population."
Mr. Serlin added, "In addition, we are excited about the data we
continue to accumulate from our Phase 2a study in
relapsed/refractory AML, with further significant improvement in
overall survival data recently presented at EHA. We are focused on
determining the appropriate next clinical development steps for
this indication, in light of this very encouraging data. With
regarding to our second main asset, AGI-134, we were pleased to
initiate a Phase 1/2a study in multiple solid tumors. AGI-134
represents a new mechanistic class of cancer immunotherapies with a
unique and highly differentiated mode of action, and we are pleased
to begin our clinical evaluation of its potential."
"Over the next few quarters, we look forward to reporting on key
milestones. These include top line results in our Phase 2a COMBAT
study, partial results in the Phase 1b/2 pancreatic cancer trial under our
collaboration with Genentech, and a potential interim analysis on
the Phase 2b BLAST study in AML
consolidation therapy," concluded Mr. Serlin.
Financial Results for the Second Quarter Ended June 30, 2018
Research and development expenses for the three months ended
June 30, 2018 were $4.5 million, an increase of $0.4 million, or 10.4%, compared to $4.1 million for the three months ended
June 30, 2017. The increase resulted
primarily from higher expenses associated with AGI-134, including
final preparations for initiation of the Phase 1/2a study, and
expenses associated with BL-1230. Research and development expenses
for the six months ended June 30,
2018 were $9.6 million, an
increase of $1.9 million, or 24.9%,
compared to $7.7 million for the six
months ended June 30, 2017. The
increase resulted primarily from higher expenses associated with
new BL-8040 clinical studies commenced during 2017, as well as
higher expenses associated with AGI-134, including final
preparations for initiation of the Phase 1/2a study, and expenses
associated with BL-1230.
Sales and marketing expenses for the three months ended
June 30, 2018 were $0.4 million, an increase of $0.1 million, or 25%, compared to $0.3 million for the three months ended
June 30, 2017. The increase resulted
primarily from one-time consulting fees related to market research
in the 2018 period. Sales and marketing expenses for the six months
ended June 30, 2018 were $0.9 million, a decrease of $0.1 million, or 12.9%, compared to $1.0 million for the six months ended
June 30, 2017. The decrease resulted
primarily from one-time legal fees related to AGI-134 paid in the
2017 period.
General and administrative expenses for the three months ended
June 30, 2018 were $0.9 million, similar to the comparable period in
2017. General and administrative expenses for the six months ended
June 30, 2018 were $1.9 million, similar to the comparable period in
2017.
The Company's operating loss for the three months ended
June 30, 2018 amounted to
$5.7 million, compared with an
operating loss of $5.2 million for
the corresponding 2017 period. The Company's operating loss for the
six months ended June 30, 2018
amounted to $12.4 million, compared
with an operating loss of $10.5
million for the corresponding 2017 period.
Non-operating income (expenses) for the three and six months
ended June 30, 2018 primarily relate
to fair-value adjustments of warrant liabilities on the Company's
balance sheet and the capital gain from realization of the
investment in iPharma. Non-operating income (expenses) for the
three and six months ended June 30,
2017 primarily relate to fair-value adjustments of warrant
liabilities on the Company's balance sheet.
Net financial income amounted to $0.3
million for the three months ended June 30, 2018, similar to the comparable period
in 2017. Net financial income for both periods relates primarily to
gains recorded on foreign currency hedging transactions and
investment income earned on bank deposits. Net financial income
amounted to $0.3 million for the six
months ended June 30, 2018, compared
to net financial income of $0.8
million for the six months ended June
30, 2017. Net financial income for the 2018 period primarily
relates to investment income earned on bank deposits, offset by
losses recorded on foreign currency hedging transactions. Net
financial income for the 2017 period relates primarily to gains
recorded on foreign currency hedging transactions and investment
income earned on bank deposits.
The Company's net loss for the three months ended June 30, 2018 amounted to $4.8 million, compared with a net loss of
$4.9 million for the corresponding
period. The Company's net loss for the six months ended
June 30, 2018 amounted to
$11.0 million, compared with a net
loss of $9.8 million for the
corresponding 2017 period.
The Company held $41.1 million in
cash, cash equivalents and short-term bank deposits as of
June 30, 2018.
Net cash used in operating activities was $13.0 million for the six months ended
June 30, 2018, compared with net cash
used in operating activities of $8.0
million for the six months ended June
30, 2017. The $5.0 million
increase in net cash used in operating activities during the
six-month period in 2018, compared to the six-month period in 2017,
was the result of increased research and development expenses in
the 2018 period, as well as a decrease in accounts payable and
accruals.
Net cash provided by investing activities was $10.8 million for the six months ended
June 30, 2018, compared to net cash
used in investing activities of $16.0
million for the six months ended June
30, 2017. 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
in 2017 and realization of the investment in iPharma in 2018.
Net cash provided by financing activities was $2.8 million for the six months ended
June 30, 2018, compared to net cash
provided by financing activities of $28.3
million for the six months ended June
30, 2017. The decrease in cash flows from financing
activities reflects the public offering completed in April 2017.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, August 13, 2018 at 10:00
a.m. EDT. To access the conference call, please dial
+1-888-281-1167 from the U.S. or +972-3-918-0664 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 August 16,
2018; please dial +1-877-456-0009 from the U.S. or
+972-3-925-5937 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 has recently initiated a Phase 1/2a study. 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 is conducting 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 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.
BioLineRx
Ltd.
|
|
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|
|
|
(UNAUDITED)
|
|
|
|
|
|
|
December 31,
|
June
30,
|
|
2017
|
2018
|
|
in USD
thousands
|
Assets
|
|
|
CURRENT
ASSETS
|
|
|
Cash and cash
equivalents
|
5,110
|
5,789
|
Short-term bank
deposits
|
44,373
|
35,339
|
Prepaid
expenses
|
307
|
1,231
|
Other
receivables
|
586
|
438
|
Total current assets
|
50,376
|
42,797
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
Long-term prepaid
expenses
|
61
|
63
|
Long-term
investment
|
1,000
|
-
|
Property and
equipment, net
|
2,505
|
2,318
|
Intangible assets,
net
|
7,023
|
7,035
|
Total non-current assets
|
10,589
|
9,416
|
Total assets
|
60,965
|
52,213
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES
|
|
|
Current maturities of
long-term bank loan
|
93
|
93
|
Accounts payable and
accruals:
|
|
|
Trade
|
5,516
|
4,128
|
Other
|
1,113
|
1,117
|
Total current liabilities
|
6,722
|
5,338
|
NON-CURRENT
LIABILITIES
|
|
|
Long-term bank loan,
net of current maturities
|
157
|
109
|
Warrants
|
1,205
|
580
|
Total non-current liabilities
|
1,362
|
689
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
Total liabilities
|
8,084
|
6,027
|
|
|
|
EQUITY
|
|
|
Ordinary
shares
|
2,836
|
2,920
|
Share
premium
|
240,682
|
243,883
|
Capital
reserve
|
10,337
|
11,343
|
Other comprehensive
loss
|
(1,416)
|
(1,416)
|
Accumulated
deficit
|
(199,558)
|
(210,544)
|
Total equity
|
52,881
|
46,186
|
Total liabilities and equity
|
60,965
|
52,213
|
BioLineRx
Ltd.
|
|
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
|
(UNAUDITED)
|
|
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|
2017
|
2018
|
2017
|
2018
|
|
in USD
thousands
|
in USD
thousands
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
(4,062)
|
(4,484)
|
(7,652)
|
(9,554)
|
SALES AND
MARKETING EXPENSES
|
(288)
|
(360)
|
(969)
|
(844)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(844)
|
(883)
|
(1,874)
|
(1,958)
|
OPERATING
LOSS
|
(5,194)
|
(5,727)
|
(10,495)
|
(12,356)
|
NON-OPERATING
INCOME (EXPENSES), NET
|
(4)
|
663
|
(9)
|
1,125
|
FINANCIAL
INCOME
|
304
|
287
|
761
|
462
|
FINANCIAL
EXPENSES
|
(3)
|
(11)
|
(9)
|
(217)
|
|
|
|
|
|
NET LOSS AND
COMPREHENSIVE LOSS
|
(4,897)
|
(4,788)
|
(9,752)
|
(10,986)
|
|
|
|
|
|
|
in
USD
|
in
USD
|
LOSS PER ORDINARY
SHARE - BASIC AND DILUTED
|
(0.05)
|
(0.05)
|
(0.13)
|
(0.10)
|
|
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY
SHARE
|
94,487,470
|
106,630,704
|
76,571,351
|
106,524,332
|
|
|
|
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
|
|
|
|
|
|
CONDENSED INTERIM
STATEMENTS OF CHANGES IN EQUITY
|
|
|
(UNAUDITED)
|
|
|
|
|
|
|
|
Ordinary
|
Share
|
Other
Comprehensive
|
Capital
|
Accumulated
|
|
|
shares
|
premium
|
loss
|
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
|
|
|
|
|
|
|
|
|
Ordinary
|
Share
|
Other
Comprehensive
|
Capital
|
Accumulated
|
|
|
shares
|
premium
|
loss
|
reserve
|
deficit
|
Total
|
|
in USD
thousands
|
|
BALANCE AT JANUARY
1, 2018
|
2,836
|
240,682
|
(1,416)
|
10,337
|
(199,558)
|
52,881
|
CHANGES FOR SIX
MONTHS ENDED JUNE 30, 2018:
|
|
|
|
|
|
|
Issuance of share
capital, net
|
83
|
2,764
|
-
|
-
|
-
|
2,847
|
Employee stock
options exercised
|
-
|
399
|
-
|
(399)
|
-
|
-
|
Employee stock
options forfeited and expired
|
1
|
38
|
-
|
(39)
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
-
|
1,444
|
-
|
1,444
|
Comprehensive loss
for the period
|
-
|
-
|
-
|
-
|
(10,986)
|
(10,986)
|
BALANCE AT JUNE
30, 2018
|
2,920
|
243,883
|
(1,416)
|
11,343
|
(210,544)
|
46,186
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
|
CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
|
Six months ended
June 30,
|
|
2017
|
2018
|
|
in USD
thousands
|
|
|
|
CASH FLOWS -
OPERATING ACTIVITIES
|
|
|
Comprehensive loss for
the period
|
(9,752)
|
(10,986)
|
Adjustments required
to reflect net cash used in operating activities (see appendix
below)
|
1,746
|
(2,054)
|
Net cash used in
operating activities
|
(8,006)
|
(13,040)
|
|
|
|
CASH FLOWS -
INVESTING ACTIVITIES
|
|
|
Investments in
short-term deposits
|
(36,422)
|
(15,000)
|
Maturities of
short-term deposits
|
24,233
|
24,385
|
Proceeds from
realization of long-term investment
|
-
|
1,500
|
Purchase of property
and equipment
|
(90)
|
(76)
|
Purchase of intangible
assets
|
(3,721)
|
(37)
|
Net cash provided by
(used in) investing activities
|
(16,000)
|
10,772
|
|
|
|
CASH FLOWS -
FINANCING ACTIVITIES
|
|
|
Issuances of share
capital, net
|
28,312
|
2,847
|
Repayments of bank
loan
|
(47)
|
(47)
|
Net cash provided by
financing activities
|
28,265
|
2,800
|
|
|
|
INCREASE IN CASH
AND CASH EQUIVALENTS
|
4,259
|
532
|
CASH AND CASH
EQUIVALENTS – BEGINNING
OF
PERIOD
|
2,469
|
5,110
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
218
|
147
|
CASH AND CASH
EQUIVALENTS - END OF PERIOD
|
6,946
|
5,789
|
|
|
|
BioLineRx
Ltd.
|
|
|
APPENDIX TO CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
|
|
(UNAUDITED)
|
|
|
|
|
|
|
Six months ended
June 30,
|
|
2017
|
2018
|
|
in USD
thousands
|
|
|
|
|
|
|
|
Adjustments
required to reflect net cash used in operating
activities:
|
|
|
Income and expenses
not involving cash flows:
|
|
|
Depreciation and
amortization
|
250
|
288
|
Long-term prepaid
expenses
|
(1)
|
(2)
|
Exchange differences
on cash and cash equivalents
|
(218)
|
(147)
|
Gain on adjustment of
warrants to fair value
|
-
|
(625)
|
Gain on realization of
long-term investment
|
-
|
(500)
|
Share-based
compensation
|
858
|
1,444
|
Interest and exchange
rate differences on short-term deposits
|
(273)
|
(351)
|
Interest and linkage
differences on bank loan
|
-
|
(1)
|
|
616
|
106
|
|
|
|
Changes in
operating asset and liability items:
|
|
|
Increase in prepaid
expenses and other receivables
|
(623)
|
(776)
|
Increase (decrease) in
accounts payable and accruals
|
1,753
|
(1,384)
|
|
1,130
|
(2,160)
|
|
1,746
|
(2,054)
|
|
|
|
|
|
|
Supplementary
information on interest received in cash
|
258
|
377
|
|
|
|
|
Supplementary
non-cash investment
|
2,985
|
-
|
|
|
|
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
View original
content:http://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2018-financial-results-300695895.html
SOURCE BioLineRx Ltd.