TEL AVIV, Israel, May 22, 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 first quarter ended March 31, 2018.
Highlights and achievements during the first quarter 2018
and to date:
Steady progress made on multiple clinical trials for the
Company's lead oncology program, BL-8040:
- 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
liver metastases in almost half of the pancreatic cancer patients
who underwent a biopsy, as well as an increase in the number of
total immune cells in the peripheral blood, alongside a decrease in
the frequency of peripheral blood regulatory T cells (Tregs) – all
of which support the mechanism of action proposed by pre-clinical
studies. Study enrollment has been completed, with top-line
results expected in H2 2018;
- Results from 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; primary endpoint of collection of ≥2 million CD34
cells/kg recipient weight after up to 2 leukapheresis (LP) sessions
was reached in over 90% of patients (100% of patients at optimal
BL-8040 dose of 1.25 mg/kg); all 19 transplanted recipients were
successfully engrafted with BL-8040-mobilized grafts, and
preliminary graft-versus-host disease (GVHD) data are in line with
current standard-of-care incidence rates;
- 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.
In the BL-8040 dose selected for expansion (1.5 mg/kg), the overall
response rate was 39% (N=23) and median overall survival for this
cohort was 9.2 months with 1-year and 2-year survival rates of
31.6% and 21.1%, respectively;
- 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, thus providing significant additional patent protection
in AML, one of BL-8040's key indications.
The Company also announced advancements made in its second
immuno-oncology compound, AGI-134:
- Pre-clinical data presented at ASCO-SITC showed direct
regression of established primary tumors after injection with
AGI-134 in the majority of mice treated, and that this regression
is associated with activation of the innate immune system;
- Notice of Allowance issued by the United States Patent and
Trademark Office (USPTO) for a patent application claiming the use
of AGI-134 for the treatment of solid cancer tumors; this patent,
when issued, will be valid until May
2035 with a possibility of up to five years patent term
extension. Additional corresponding patent applications for AGI-134
are pending in Europe,
Japan, China, Canada, Australia and Israel.
Expected significant upcoming milestones for 2018:
- Results from the lead-in part of the Phase 3 GENESIS study in
stem-cell mobilization for autologous transplantation are due
mid-year 2018;
- Top-line results in immuno-oncology Phase 2a COMBAT study in
pancreatic cancer for BL-8040 in combination with KEYTRUDA, under
collaboration with Merck, expected in H2 2018;
- Initiation of Phase 1/2a immuno-oncology study for AGI-134 in
several solid tumor indications expected in mid-2018;
- Additional overall long-term survival data from Phase 2a trial
in relapsed/refractory AML to be presented at EHA in June 2018;
- Full top-line results of Phase 2 study for BL-8040 in stem-cell
mobilization for allogeneic transplantation to be presented at the
23rd Congress of European Hematology Association (EHA)
in June 2018.
Philip A. Serlin, Chief Executive
Officer of BioLineRx, stated, "We continue to strongly focus on
clinical execution of our oncology programs. Since the beginning of
2018, we have made significant progress with BL-8040, our lead
clinical asset, with clinical results from our Phase 2a COMBAT
study in pancreatic cancer showing robust mobilization and
increased infiltration of anti-tumor-specific T cells into the
tumor microenvironment; positive results from our Phase 2 study in
allogeneic bone marrow transplantation; very encouraging overall
survival data from our proof-of-concept Phase 2a study in
relapsed/refractory AML; as well as significant strengthening of
our patent protection for BL-8040 in the AML space. In addition, we
also reported very encouraging pre-clinical data on our
near-clinical second oncology asset, AGI-134, demonstrating induced
regression of primary tumors following intra-tumoral injection.
"Over the next three to nine months, we look forward to
reporting on key milestones. This includes the results from the
lead-in part of our Phase 3 GENESIS trial in autologous stem cell
mobilization, data read-outs from our Phase 2a COMBAT study in
pancreatic cancer, and initiation of a Phase 1/2a study in multiple
solid tumor indications for AGI-134," concluded Mr. Serlin.
Financial Results for the First Quarter Ended March 31, 2018
Research and development expenses for the three months ended
March 31, 2018 were $5.1 million, an increase of $1.5 million, or 41.2%, compared to $3.6 million for the three months ended
March 31, 2017. The increase resulted
primarily from higher expenses associated with new BL-8040 clinical
studies commenced during 2017, spending on our new AGI-134
near-clinical project, and higher expenses related to our BL-1230
project.
Sales and marketing expenses for the three months ended
March 31, 2018 were $0.5 million, a decrease of $0.2 million, or 28.9%, compared to $0.7 million for the three months ended
March 31, 2017. The decrease resulted
primarily from one-time legal fees related to AGI-134 incurred in
the 2017 period.
General and administrative expenses for the three months ended
March 31, 2018 were $1.1 million, similar to the comparable period in
2017.
The Company's operating loss for the quarter ended March 31, 2018 amounted to $6.6 million, compared with an operating loss of
$5.3 million for the quarter ended
March 31, 2017.
Non-operating income (expenses) for both periods primarily
relate to fair-value adjustments of warrant liabilities. These
fair-value adjustments were highly influenced by the Company's
share price at each period end (revaluation date).
The Company recorded an immaterial amount of net financial
expenses for the three months ended March
31, 2018 compared to net financial income of $0.5 million for the three months ended
March 31, 2017. Net financial
expenses for the 2018 period primarily relate 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 March 31, 2018 amounted to $6.2 million, compared with a net loss of
$4.9 million for the corresponding
period.
The Company held $44.2 million in
cash, cash equivalents and short-term bank deposits as of
March 31, 2018.
Net cash used in operating activities was $6.8 million for the three months ended
March 31, 2018, compared with net
cash used in operating activities of $3.8
million for the three months ended March 31, 2017. The $3.0
million increase in net cash used in operating activities
during the three-month period in 2018, compared to the three-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.
Net cash provided by investing activities was $8.1 million for the three months ended
March 31, 2018, compared to net cash
provided by investing activities of $1.4
million for the three months ended March 31, 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 period.
Net cash provided by financing activities was $1.4 million for the three months ended
March 31, 2018, compared to net cash
provided by financing activities of $2.1
million for the three months ended March 31, 2017. The cash flows from financing
activities result primarily from funding under an ATM facility in
the 2018 period and a share purchase agreement with Lincoln Park
Capital in the 2017 period.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, May 22, 2018 at 10:00 a.m.
EDT. To access the conference call, please dial
+1-888-281-1167 from the U.S. or +972-3-918-0685 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 May 25,
2018; please dial +1-877-456-0009 from the U.S. or
+972-3-925-5942 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 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,
|
March
31,
|
|
2017
|
2018
|
|
in USD
thousands
|
Assets
|
|
|
CURRENT
ASSETS
|
|
|
Cash and cash
equivalents
|
5,110
|
7,810
|
Short-term bank
deposits
|
44,373
|
36,388
|
Prepaid
expenses
|
307
|
564
|
Other
receivables
|
586
|
782
|
Total current assets
|
50,376
|
45,544
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
Long-term prepaid
expenses
|
61
|
60
|
Long-term
investment
|
1,000
|
1,000
|
Property and
equipment, net
|
2,505
|
2,432
|
Intangible assets,
net
|
7,023
|
7,039
|
Total non-current assets
|
10,589
|
10,531
|
Total assets
|
60,965
|
56,075
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES
|
|
|
Current maturities of
long-term bank loan
|
93
|
93
|
Accounts payable and
accruals:
|
|
|
Trade
|
5,516
|
4,941
|
Other
|
1,113
|
1,146
|
Total current liabilities
|
6,722
|
6,180
|
NON-CURRENT
LIABILITIES
|
|
|
Long-term bank loan,
net of current maturities
|
157
|
133
|
Warrants
|
1,205
|
740
|
Total non-current liabilities
|
1,362
|
873
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
Total liabilities
|
8,084
|
7,053
|
|
|
|
EQUITY
|
|
|
Ordinary
shares
|
2,836
|
2,874
|
Share
premium
|
240,682
|
242,177
|
Capital
reserve
|
10,337
|
11,143
|
Other comprehensive
loss
|
(1,416)
|
(1,416)
|
Accumulated
deficit
|
(199,558)
|
(205,756)
|
Total equity
|
52,881
|
49,022
|
Total liabilities and equity
|
60,965
|
56,075
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
(UNAUDITED)
|
|
|
Three months ended
March 31,
|
|
2017
|
2018
|
|
in USD
thousands
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
(3,590)
|
(5,070)
|
SALES AND
MARKETING EXPENSES
|
(681)
|
(484)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(1,030)
|
(1,075)
|
OPERATING
LOSS
|
(5,301)
|
(6,629)
|
NON-OPERATING
INCOME (EXPENSES), NET
|
(5)
|
462
|
FINANCIAL
INCOME
|
457
|
175
|
FINANCIAL
EXPENSES
|
(6)
|
(206)
|
NET LOSS AND
COMPREHENSIVE LOSS
|
(4,855)
|
(6,198)
|
|
|
|
|
|
LOSS PER ORDINARY
SHARE - BASIC AND DILUTED
|
(0.08)
|
(0.06)
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE
|
58,620,094
|
106,169,273
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
|
(UNAUDITED)
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary
shares
|
Share
premium
|
Capital
Reserve
|
Other
comprehensive
loss
|
Accumulated
deficit
|
Total
|
|
in USD
thousands
|
BALANCE AT JANUARY
1, 2018
|
2,836
|
240,682
|
10,337
|
(1,416)
|
(199,558)
|
52,881
|
CHANGES FOR THREE
MONTHS ENDED MARCH 31, 2018:
|
|
|
|
|
|
|
Issuance of share
capital, net
|
37
|
1,386
|
-
|
-
|
-
|
1,423
|
Employee stock
options exercised
|
1
|
29
|
(30)
|
-
|
-
|
-
|
Employee stock
options forfeited and expired
|
-
|
80
|
(80)
|
-
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
916
|
-
|
-
|
916
|
Comprehensive loss
for the period
|
-
|
-
|
-
|
-
|
(6,198)
|
(6,198)
|
BALANCE AT
MARCH 31, 2018
|
2,874
|
242,177
|
11,143
|
(1,416)
|
(205,756)
|
49,022
|
|
|
|
|
|
|
|
BioLineRx
Ltd.
|
CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
|
Three months
ended
March
31,
|
|
2017
|
2018
|
|
in USD
thousands
|
|
|
|
CASH FLOWS -
OPERATING ACTIVITIES
|
|
|
Comprehensive loss for
the period
|
(4,855)
|
(6,198)
|
Adjustments required
to reflect net cash used in operating activities
(see appendix below)
|
1,062
|
(609)
|
Net cash used in
operating activities
|
(3,793)
|
(6,807)
|
|
|
|
CASH FLOWS -
INVESTING ACTIVITIES
|
|
|
Investments in
short-term deposits
|
(7,013)
|
(4,000)
|
Maturities of
short-term deposits
|
12,143
|
12,167
|
Purchase of property
and equipment
|
(45)
|
(54)
|
Purchase of intangible
assets
|
(3,718)
|
(29)
|
Net cash provided by
investing activities
|
1,367
|
8,084
|
|
|
|
CASH FLOWS -
FINANCING ACTIVITIES
|
|
|
Issuance of share capital,
net of issuance costs
|
2,087
|
1,423
|
Repayments of bank
loan
|
(23)
|
(23)
|
Net cash provided by
financing activities
|
2,064
|
1,400
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(362)
|
2,677
|
CASH AND CASH
EQUIVALENTS – BEGINNING
OF
PERIOD
|
2,469
|
5,110
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
94
|
23
|
CASH AND CASH
EQUIVALENTS - END OF PERIOD
|
2,201
|
7,810
|
|
|
|
BioLineRx
Ltd.
|
APPENDIX TO CONDENSED
CONSOLIDATED INTERIM CASH FLOW STATEMENTS
|
(UNAUDITED)
|
|
|
|
|
Three months
ended
March
31,
|
|
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
|
119
|
140
|
Long-term prepaid
expenses
|
(3)
|
1
|
Exchange differences
on cash and cash equivalents
|
(94)
|
(23)
|
Gain on adjustment of
warrants to fair value
|
-
|
(465)
|
Share-based
compensation
|
472
|
916
|
Interest and exchange
differences on short-term deposits
|
(143)
|
(182)
|
Interest and linkage
differences on bank loan
|
-
|
(1)
|
|
351
|
386
|
|
|
|
Changes in
operating asset and liability items:
|
|
|
Increase in prepaid
expenses and other receivables
|
(802)
|
(453)
|
Increase (decrease) in
accounts payable and accruals
|
1,513
|
(542)
|
|
711
|
(995)
|
|
1,062
|
(609)
|
|
|
|
|
|
|
Supplementary
information on interest received in cash
|
137
|
167
|
|
|
|
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