TEL AVIV, Israel, Nov. 21, 2017 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company
focused on oncology and immunology, today reports its financial
results for the third quarter ended September 30, 2017.
Highlights and achievements during the third quarter
2017 and to date:
Continued execution on multiple clinical development studies for
BL-8040, the Company's lead oncology program:
- Initiation of two additional Phase 1b/2 studies under
collaboration with Genentech, following the first study which was
initiated in July 2017. All studies
are exploring the combination of BL-8040 with Tecentriq
(atezolizumab), Genentech's anti-PDL1 cancer immunotherapy
agent.
-
- Phase 1b/2 trial for the maintenance treatment of patients with
intermediate- and high-risk acute myeloid leukemia (AML) who have
achieved complete response (CR) following induction and
consolidation therapy.
- Phase 1b/2 trial for the treatment of gastric cancer.
This study is conducted as part of MORPHEUS, Roche's Novel Cancer
Immunotherapy Development Platform.
- Completion of enrollment to the COMBAT study, which is
investigating the combination of BL-8040 and Merck's PD-1
inhibitor, Keytruda, in the treatment of pancreatic cancer
patients.
- Regulatory submission to initiate Phase 3 pivotal study with
BL-8040 as novel stem cell mobilization treatment for autologous
bone-marrow transplantation, expected to commence by the end of
2017, following receipt of regulatory approvals; and
- Several abstracts accepted to key scientific conferences:
-
- Oral presentation at the American Society of Hematology (ASH)
in December 2017 of pre-clinical data
supporting BL-8040 as a robust mobilizer of hematopoietic stem
cells associated with long-term engraftment.
- Poster presentation at the ASCO GI conference of partial
results from the monotherapy portion of the Phase 2a COMBAT study
in pancreatic cancer. The abstract for this presentation will be
published prior to the conference in January
2018.
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 to be announced at ASCO GI
conference in January 2018; top line
results expected in H2 2018;
- Initiation of Phase 3 pivotal study for BL-8040 in stem-cell
mobilization for autologous transplantation, expected by the end of
2017;
- Initiation of Phase 1b/2 immuno-oncology study for BL-8040 in
combination with Genentech's atezolizumab for non-small cell lung
cancer, expected by early 2018. Partial results in Phase 1b/2 solid
tumors and AML trials in collaboration with Genentech are 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 third
quarter-to-date activities that continue to demonstrate clinical
and regulatory execution on our multiple programs. This included
timely initiation of the studies under our cancer immunotherapy
collaboration with Genentech for gastric cancer and AML, as well as
finalization of all preparations for initiation of our Phase 3
GENESIS study in stem cell mobilization. We are also very excited
about the completion of enrollment to the COMBAT study, which will
allow us to report topline results as planned in H2 2018. By
year-end 2017, we remain on track to have one Phase 3 and seven
Phase 2 or 1b/2 clinical trials up and running, and in January 2018 we plan to announce partial results
from our Phase 2 study in pancreatic cancer under our immunotherapy
collaboration with Merck."
Financial Results for the Third Quarter Ended September 30, 2017
Research and development expenses for the three months ended
September 30, 2017 were $5.7 million, an increase of $2.7 million, or 91.4%, compared to $3.0 million for the three months ended
September 30, 2016. The increase
resulted primarily from spending on the recently acquired AGI-134
near-clinical project and from higher expenses in 2017 associated
with new BL-8040 studies commenced during the third quarter of 2016
and during 2017. Research and development expenses for the nine
months ended September 30, 2017 were
$13.3 million, an increase of
$5.1 million, or 61.6%, compared to
$8.2 million for the nine months
ended September 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
September 30, 2017 were $0.2 million, a decrease of $0.2 million, or 39.1%, compared to $0.4 million for the three months ended
September 30, 2016. The decrease
resulted primarily from market research activities related to
BL-8040, as well as legal expenses related to business development
collaborations and in-licensing activities, in the 2016 period.
Sales and marketing expenses for the nine months ended September 30, 2017 were $1.2 million, an increase of $0.3 million, or 31.2%, compared to $0.9 million for the nine months ended
September 30, 2016. The increase
resulted primarily from one-time legal fees related to AGI-134.
General and administrative expenses for the three months ended
September 30, 2017 were $1.1 million, similar to the comparable period in
2016. General and administrative expenses for the nine months ended
September 30, 2017 were $3.0 million, similar to the comparable period in
2016.
The Company's operating loss for the three months ended
September 30, 2017 amounted to
$7.1 million, compared with an
operating loss of $4.5 million for
the corresponding 2016 period. The Company's operating loss for the
nine months ended September 30, 2017
amounted to $17.6 million, compared
with an operating loss of $12.1
million for the corresponding 2016 period. The increase in
operating loss reflects a significant increase in research and
development expenses for the respective periods.
Non-operating income (expenses) for the three and nine months
ended September 30, 2017 and 2016
primarily relate to fair-value adjustments of warrant liabilities
on the Company's balance sheet. Non-operating expenses for the
three-month and nine-month periods ended September 30, 2017 primarily result from a
$0.3 million fair-value adjustment of
derivative liabilities on account of the warrants issued in the
direct placement conducted in July
2017. These fair-value adjustments are highly influenced by
the Company's share price at each period end (revaluation
date).
Net financial income amounted to $0.2
million for the three months ended September 30, 2017, similar to the comparable
period in 2016. Net financial income amounted to $0.9 million for the nine months ended
September 30, 2017 compared to net
financial income of $0.4 million for
the nine months ended September 30,
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 three months ended September 30, 2017 amounted to $7.2 million, compared with a net loss of
$4.3 million for the corresponding
2016 period. The Company's net loss for the nine months ended
September 30, 2017 amounted to
$17.0 million, compared with a net
loss of $11.6 million for the
corresponding 2016 period.
The Company held $55.0 million in
cash, cash equivalents and short-term bank deposits as of
September 30, 2017.
Net cash used in operating activities was $14.2 million for the nine months ended
September 30, 2017, compared with net
cash used in operating activities of $10.4
million for the nine months ended September 30, 2016. The $3.8 million increase in net cash used in
operating activities during the nine-month period in 2017, compared
to the nine-month period in 2016, was primarily the result of
increased research and development expenses in the 2017 period.
Net cash used in investing activities for the nine months ended
September 30, 2017 was $19.5 million, compared to net cash provided by
investing activities of $7.3 million
for the nine months ended September 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 acquisition of Agalimmune and
investment in iPharma.
Net cash provided by financing activities for the nine months
ended September 30, 2017 was
$37.7 million, compared to net cash
provided by financing activities of $1.5
million for the nine months ended September 30, 2016. The increase in cash flows
from financing activities primarily reflects our public offering
completed in April 2017 and the
registered direct placement completed in July 2017.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, November 21, 2017, at 10:00 a.m. EST. To access the conference call,
please dial 1-888-407-2553 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 at the
Investor Relations page of BioLineRx's website. A dial-in replay of
the call will be available until November
24, 2017; please dial 1-866-500-4953 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/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,
|
September
30,
|
|
2016
|
2017
|
|
in USD
thousands
|
Assets
|
|
|
CURRENT
ASSETS
|
|
|
Cash and cash
equivalents
|
2,469
|
6,712
|
Short-term bank
deposits
|
33,154
|
48,295
|
Prepaid
expenses
|
255
|
282
|
Other
receivables
|
223
|
558
|
Total current assets
|
36,101
|
55,847
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
Long-term prepaid
expenses
|
52
|
60
|
Long-term
investment
|
-
|
1,000
|
Property and
equipment, net
|
2,605
|
2,365
|
Intangible assets,
net
|
181
|
6,855
|
Total non-current assets
|
2,838
|
10,280
|
Total assets
|
38,939
|
66,127
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES
|
|
|
Current maturities of
long-term bank loan
|
93
|
93
|
Accounts payable and
accruals:
|
|
|
Trade
|
2,590
|
4,349
|
Other
|
978
|
1,084
|
Total current liabilities
|
3,661
|
5,526
|
NON-CURRENT
LIABILITIES
|
|
|
Long-term bank loan,
net of current maturities
|
250
|
180
|
Warrants
|
1
|
1,396
|
Total non-current liabilities
|
251
|
1,576
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
Total liabilities
|
3,912
|
7,102
|
|
|
|
EQUITY
|
|
|
Ordinary
shares
|
1,513
|
2,809
|
Share
premium
|
199,567
|
239,606
|
Other comprehensive
loss
|
(1,416)
|
(1,416)
|
Capital
reserve
|
10,569
|
10,227
|
Accumulated
deficit
|
(175,206)
|
(192,201)
|
Total equity
|
35,027
|
59,025
|
Total liabilities and equity
|
38,939
|
66,127
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
(UNAUDITED)
|
|
|
Three months
ended
September 30,
|
Nine months ended
September 30,
|
|
2016
|
2017
|
2016
|
2017
|
|
in USD
thousands
|
in USD
thousands
|
RESEARCH AND
DEVELOPMENT EXPENSES, NET
|
(2,954)
|
(5,654)
|
(8,233)
|
(13,306)
|
SALES AND
MARKETING EXPENSES
|
(409)
|
(249)
|
(928)
|
(1,218)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(1,125)
|
(1,154)
|
(2,968)
|
(3,028)
|
OPERATING
LOSS
|
(4,488)
|
(7,057)
|
(12,129)
|
(17,552)
|
NON-OPERATING
INCOME (EXPENSES), NET
|
(14)
|
(333)
|
182
|
(342)
|
FINANCIAL
INCOME
|
172
|
153
|
403
|
914
|
FINANCIAL
EXPENSES
|
(4)
|
(6)
|
(12)
|
(15)
|
|
|
|
|
|
NET LOSS AND
COMPREHENSIVE LOSS
|
(4,334)
|
(7,243)
|
(11,556)
|
(16,995)
|
|
|
|
|
|
|
in
USD
|
in
USD
|
LOSS PER ORDINARY
SHARE - BASIC AND DILUTED
|
(0.08)
|
(0.07)
|
(0.21)
|
(0.20)
|
|
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE
|
56,426,202
|
101,874,372
|
55,912,486
|
85,106,723
|
|
|
|
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
|
(UNAUDITED)
|
|
|
Ordinary
shares
|
Share
premium
|
Other
comprehensive loss
|
Capital
reserve
|
Accumulated
deficit
|
Total
|
|
in USD
thousands
|
BALANCE AT JANUARY
1, 2016
|
1,455
|
196,201
|
(1,416)
|
10,735
|
(159,365)
|
47,610
|
CHANGES FOR NINE
MONTHS ENDED SEPTEMBER 30, 2016:
|
|
|
|
|
|
|
Issuance of share
capital, net
|
4
|
1,591
|
-
|
-
|
-
|
1,595
|
Employee stock
options exercised
|
1
|
128
|
-
|
(128)
|
-
|
1
|
Employee stock
options forfeited and expired
|
-
|
460
|
-
|
(460)
|
-
|
-
|
Share-based
compensation
|
|
|
|
959
|
|
959
|
Comprehensive loss
for the period
|
-
|
-
|
-
|
-
|
(11,556)
|
(11,556)
|
BALANCE AT
SEPTEMBER 30, 2016
|
1,460
|
198,380
|
(1,416)
|
11,106
|
(170,921)
|
38,609
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary
shares
|
Share
premium
|
Other
comprehensive loss
|
Capital
reserve
|
Accumulated
deficit
|
Total
|
|
in USD
thousands
|
BALANCE AT JANUARY
1, 2017
|
1,513
|
199,567
|
(1,416)
|
10,569
|
(175,206)
|
35,027
|
CHANGES FOR NINE
MONTHS ENDED SEPTEMBER 30, 2017:
|
|
|
|
|
|
|
Issuance of share
capital, net
|
1,295
|
38,388
|
-
|
-
|
-
|
39,683
|
Employee stock
options exercised
|
1
|
326
|
-
|
(326)
|
-
|
1
|
Employee stock
options forfeited and expired
|
-
|
1,325
|
-
|
(1,325)
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
-
|
1,309
|
-
|
1,309
|
Comprehensive loss
for the period
|
-
|
-
|
-
|
-
|
(16,995)
|
(16,995)
|
BALANCE AT
SEPTEMBER 30, 2017
|
2,809
|
239,606
|
(1,416)
|
10,227
|
(192,201)
|
59,025
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
Nine months
ended
September
30,
|
|
2016
|
2017
|
|
in USD
thousands
|
|
|
|
CASH FLOWS -
OPERATING ACTIVITIES
|
|
|
Comprehensive loss for
the period
|
(11,556)
|
(16,995)
|
Adjustments required
to reflect net cash used in operating activities (see appendix
below)
|
1,128
|
2,772
|
Net cash used in
operating activities
|
(10,428)
|
(14,223)
|
|
|
|
CASH FLOWS -
INVESTING ACTIVITIES
|
|
|
Long-term
investment
|
-
|
(1,000)
|
Investments in
short-term deposits
|
(28,978)
|
(48,029)
|
Maturities of
short-term deposits
|
36,480
|
33,327
|
Purchase of property
and equipment
|
(164)
|
(109)
|
Purchase of intangible
assets
|
(24)
|
(3,721)
|
Net cash provided by
(used in) investing activities
|
7,314
|
(19,532)
|
|
|
|
CASH FLOWS -
FINANCING ACTIVITIES
|
|
|
Issuance of share
capital and warrants, net of issuance costs
|
1,595
|
37,761
|
Repayments of bank
loan
|
(72)
|
(70)
|
Proceeds from exercise
of employee stock options
|
1
|
-
|
Net cash provided by
financing activities
|
1,524
|
37,691
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,590)
|
3,936
|
CASH AND CASH
EQUIVALENTS – BEGINNING
OF
PERIOD
|
5,544
|
2,469
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
60
|
307
|
CASH AND CASH
EQUIVALENTS - END OF PERIOD
|
4,014
|
6,712
|
|
|
|
BioLineRx
Ltd.
|
APPENDIX TO CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
Nine months
ended
September
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
|
368
|
381
|
Long-term prepaid
expenses
|
4
|
(8)
|
Interest and exchange
rate differences on short-term deposits
|
(277)
|
(439)
|
Share-based
compensation
|
959
|
1,309
|
Warrant issuance
costs
|
-
|
17
|
Exchange differences
on cash and cash equivalents
|
(60)
|
(307)
|
Loss (gain) on
adjustment of warrants to fair value
|
(179)
|
316
|
|
815
|
1,269
|
|
|
|
Changes in
operating asset and liability items:
|
|
|
Decrease (Increase) in
prepaid expenses and other receivables
|
14
|
(362)
|
Increase in accounts
payable and accruals
|
299
|
1,865
|
|
313
|
1,503
|
|
1,128
|
2,772
|
|
|
|
|
|
|
Supplementary
information on interest received in cash
|
310
|
378
|
Supplementary
non-cash investment (see Note 4b)
|
-
|
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
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SOURCE BioLineRx Ltd