BioLineRx Reports First Quarter 2019 Financial Results and Provides Corporate Update
TEL AVIV, Israel, May 14, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2019 and provided a corporate update.
Highlights and achievements during the first quarter 2019 and subsequent period:
-- Presented successful engraftment data from Phase 3 GENESIS trial of
BL-8040 in multiple myeloma patients at 45(th) Annual Meeting of
European Society for Blood and Marrow Transplantation. These data follow
previously announced successful mobilization data which led the Data
Monitoring Committee to recommend proceeding to the randomized
placebo-controlled Part 2 of the study.
-- Received FDA Orphan Drug Designation for BL-8040 for the treatment of
pancreatic cancer. This is an addition to prior orphan drug designations
that have been granted for BL-8040 in AML and stem cell mobilization.
-- Received approval from the FDA for Investigational New Drug (IND)
application for AGI-134, which will enable expansion of the ongoing
Phase 1/2a study, currently being carried out in the UK and Israel, to
the US by the first half of 2020.
"As we progress through 2019, we are approaching important data milestones with our lead program, the CXCR4 antagonist BL-8040, in two cancer indications with high unmet medical need," said Philip Serlin, Chief Executive Officer of BioLineRx. "In pancreatic cancer, an extremely difficult cancer indication to treat, we are optimistic that we can build upon the encouraging results that we observed in the dual combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 and Merck's KEYTRUDA with the addition of chemotherapy, and we are eager to see top-line results for the triple combination arm of the study by the end of this year. Similarly, in consolidation AML, we look forward to important data from our Phase 2b trial that will help inform later stage development of this promising program."
"In parallel, our second clinical candidate, AGI-134, is progressing through a phase 1/2a clinical trial, and we anticipate initial safety data later this year as we look to efficiently advance this promising candidate into the second part of the study where we can assess efficacy in multiple tumor types. We continue to execute on our clinical development plan, and believe these upcoming data readouts can drive near-term value creation while generating additional partnering interest," Mr. Serlin concluded.
Expected significant milestones through end of 2019 and early 2020:
-- Top-line results from the Phase 2 triple combo pancreatic cancer trial
of BL-8040, KEYTRUDA and chemotherapy under the Company's collaboration
with Merck in the second half of 2019;
-- Potential interim results from the Phase 2 AML consolidation study in
the second half of 2019;
-- Initial safety results from part 1 of the Phase 1/2a trial of AGI-134 in
the second half of 2019;
-- Top-line results from one or more of the ongoing solid tumor trials
under the Company's collaboration with Genentech, potentially by the end
of 2019 or early 2020.
Financial Results for the Quarter Ended March 31, 2019
Research and development expenses for the quarter ended March 31, 2019 were $4.4 million, a decrease of $0.7 million, or 13.4%, compared to $5.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.
Sales and marketing expenses for the quarter ended March 31, 2019 were $0.3 million, a decrease of $0.2 million, or 47%, compared to $0.5 million for the comparable period in 2018. The decrease resulted primarily from a one-time compensation payment in the 2018 period, as well as a decrease in share-based compensation.
General and administrative expenses for the quarter ended March 31, 2019 were $0.9 million, a decrease of $0.2 million, or 13.5% compared to $1.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.
The Company's operating loss for the quarter ended March 31, 2019 amounted to $5.6 million, compared with an operating loss of $6.6 million for the comparable period in 2018.
Non-operating expenses amounted to $0.3 million for the quarter ended March 31, 2019, compared with non-operating income of $0.5 million for the comparable period in 2018. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on our balance sheet. Non-operating income for the three months ended March 31, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet. These fair-value adjustments were highly influenced by the Company's share price at each period end (revaluation date).
Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2019 compared to an immaterial amount of net financial expenses for the three months ended March 31, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the 2018 period primarily relate to losses recorded on foreign currency hedging transactions, offset by investment income earned on bank deposits.
The Company's net loss for the quarter ended March 31, 2019 amounted to $6.2 million, similar to the comparable period in 2018.
The Company held $40.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2019.
Net cash used in operating activities was $4.6 million for the three months ended March 31, 2019, compared with net cash used in operating activities of $6.8 million for the three months ended March 31, 2018. The $2.2 million decrease in net cash used in operating activities during the three-month period in 2019, compared to the three-month period in 2018, was primarily the result of changes in operating asset and liability items between the two periods - i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a decrease in accounts payable and accruals in 2018.
Net cash used in investing activities was $9.3 million for the three months ended March 31, 2019, compared to net cash provided by investing activities of $8.1 million for the three months ended March 31, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.
Net cash provided by financing activities was $14.9 million for the three months ended March 31, 2019, compared to net cash provided by financing activities of $1.4 million for the three months ended March 31, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, May 14, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0644 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 16, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5925 internationally.
(Tables follow)
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. 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 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 being investigated in 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, on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and KEYTRUDA® (pembrolizumab), 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 28, 2019. 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,
---
2018 2019
in USD thousands
Assets
CURRENT ASSETS
Cash
and
cash
equivalents 3,404 4,384
Short-
term
bank
deposits 26,747 36,224
Prepaid
expenses 488 583
Other
receivables 1,339 458
Total
current
assets 31,978 41,649
NON-CURRENT ASSETS
Long-
term
prepaid
expenses 56 55
Property
and
equipment,
net 2,227 2,143
Right-
of-
use
assets - 1,797
Intangible
assets,
net 21,972 21,950
Total
non-
current
assets 24,255 25,945
Total
assets 56,233 67,594
Liabilities and equity
CURRENT LIABILITIES
Current
maturities
of
long-
term
loans 895 1,636
Accounts payable and accruals:
Trade 4,493 4,817
Other 1,363 989
Lease
liabilities - 693
---
Total
current
liabilities 6,751 8,135
NON-CURRENT LIABILITIES
Warrants 323 5,213
Long-
term
loans,
net
of
current
maturities 7,838 7,228
Lease
liabilities - 1,130
---
Total
non-
current
liabilities 8,161 13,571
COMMITMENTS AND CONTINGENT LIABILITIES
Total
liabilities 14,912 21,706
EQUITY
Ordinary
shares 3,110 3,928
Share
premium 250,192 259,860
Capital
reserve 11,955 12,191
Other
comprehensive
loss (1,416) (1,416)
Accumulated
deficit (222,520) (228,675)
Total
equity 41,321 45,888
Total
liabilities
and
equity 56,233 67,594
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three months ended March
31,
2018 2019
---
in USD thousands
RESEARCH AND DEVELOPMENT
EXPENSES (5,070) (4,392)
SALES AND MARKETING EXPENSES (484) (256)
GENERAL AND ADMINISTRATIVE
EXPENSES (1,075) (930)
---
OPERATING LOSS (6,629) (5,578)
NON-OPERATING INCOME
(EXPENSES), NET 462 (340)
FINANCIAL INCOME 175 210
FINANCIAL EXPENSES (206) (447)
---
NET LOSS AND COMPREHENSIVE
LOSS (6,198) (6,155)
===
LOSS PER ORDINARY SHARE -
BASIC AND DILUTED (0.06) (0.05)
===
WEIGHTED AVERAGE NUMBER OF
SHARES USED IN 106,169,273 132,979,984
CALCULATION OF LOSS PER ORDINARY SHARE
===
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Other comprehensive
loss
Ordinary shares Share premium Capital Reserve 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
Other comprehensive
loss
Ordinary shares Share premium Capital Reserve Accumulated deficit
Total
---
in USD thousands
BALANCE AT JANUARY 1, 2019 3,110 250,192 11,955 (1,416) (222,520) 41,321
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2019:
Issuance of share capital, net 817 9,620 10,437
Employee stock options exercised 1 18 (18) 1
Employee stock options forfeited and expired - 30 (30)
Share-based compensation - 284 284
Comprehensive loss for the period - (6,155) (6,155)
---
BALANCE AT MARCH 31, 2019 3,928 259,860 12,191 (1,416) (228,675) 45,888
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Three months
ended
March 31,
2018 2019
---
in USD thousands
CASH FLOWS -OPERATING
ACTIVITIES
Comprehensive
loss for
the period (6,198) (6,155)
Adjustments
required to
reflect net
cash used
in
operating
activities
(see (609) 1,533
appendix below)
---
Net cash
used in
operating
activities (6,807) (4,622)
---
CASH FLOWS -INVESTING
ACTIVITIES
Investments
in short-
term
deposits (4,000) (21,510)
Maturities
of short-
term
deposits 12,167 12,228
Purchase of
property
and
equipment (54) (31)
Purchase of
intangible
assets (29)
---
Net cash
provided
by (used
in)
investing
activities 8,084 (9,313)
---
CASH FLOWS -FINANCING
ACTIVITIES
Issuance of
share
capital
and
warrants,
net of
issuance
costs 1,423 14,989
Employee
stock
options
exercised - 1
Repayments
of loans (23) (23)
Repayments
of lease
liabilities - (50)
---
Net cash
provided
by
financing
activities 1,400 14,917
---
INCREASE IN
CASH AND
CASH
EQUIVALENTS 2,677 982
CASH AND
CASH
EQUIVALENTS
-
BEGINNING 5,110 3,404
OF PERIOD
EXCHANGE
DIFFERENCES
ON CASH
AND CASH
EQUIVALENTS 23 (2)
---
CASH AND
CASH
EQUIVALENTS
-END OF
PERIOD 7,810 4,384
===
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW
STATEMENTS
(UNAUDITED)
Three months
ended
March 31,
2018 2019
---
in USD
thousands
Adjustments required to reflect net
cash used in operating activities:
Income and expenses not involving
cash flows:
Depreciation and
amortization 140 213
Long-term prepaid
expenses 1 1
Exchange
differences on
cash and cash
equivalents (23) 2
Gain on adjustment
of warrants to
fair value (465) (79)
Share-based
compensation 916 284
Warrant issuance
costs - 417
Interest and
exchange
differences on
short-term
deposits (182) (195)
Interest and
linkage
differences on
loans (1) 154
---
386 797
---
Changes in operating asset and
liability items:
Decrease
(increase) in
prepaid expenses
and other
receivables (453) 786
Decrease in
accounts payable
and accruals (542) (50)
---
(995) 736
---
(609) 1,533
===
Supplemental
information on
interest received
in cash 167 229
===
Supplemental
information on
non-cash
transaction: - 1,878
Initial establishment of right-of-
use assets against lease
liabilities
===
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
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SOURCE BioLineRx Ltd.
