BioLineRx Reports Third Quarter 2020 Financial Results and Provides Corporate Update
TEL AVIV, Israel, Nov. 23, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2020 and provides a corporate update.
Significant events and achievements during the third quarter 2020 and subsequent period:
-- Reported positive results from a pre-planned interim analysis of GENESIS
Phase 3 trial of motixafortide for stem cell mobilization (SCM) in
multiple myeloma patients. The Data Monitoring Committee (DMC) found
statistically significant evidence favoring treatment with motixafortide
in the primary endpoint, and subsequently issued a recommendation to
cease patient enrollment immediately. In accordance with the DMC's
recommendation, study enrollment was completed at 122 patients (instead
of 177 as originally planned). SCM is the Company's most efficient path
to registration;
-- Announced initiation of Phase 2 investigator-initiated study of
motixafortide in combination with LIBTAYO(®) and chemotherapy in
first-line PDAC. The study is being run by Columbia University;
-- Announced initiation of investigator-initiated Phase 1b study, led by
Wolfson Medical Center in Holon, Israel, to evaluate motixafortide in
patients hospitalized with acute respiratory distress syndrome (ARDS)
secondary to COVID-19 and other respiratory viral infections;
-- Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which
had been temporarily suspended in the second quarter of 2020 due to
clinical operating risks associated with the COVID-19 pandemic;
-- Conducted interim analysis for Phase 2b BLAST study in consolidation
AML; analysis did not demonstrate statistically significant effect in
primary endpoint; DMC recommended not to continue the study.
"The past several months have been very exciting for BioLineRx, highlighted by the very positive result of the interim analysis of our Phase 3 GENESIS study in stem cell mobilization" stated Philip Serlin, Chief Executive Officer of BioLineRx. "A statistically significant benefit in the primary endpoint was observed by combining motixafortide with the standard of care, G-CSF, leading the DMC to recommend that we cease study enrollment at 122 patients, instead of the 177 originally planned. We look forward to publishing final results of the study in the first half of next year, as we continue to advance motixafortide toward registration.
"With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we've had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.
"Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year's ESMO IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA(®), together with chemotherapy, will prove beneficial to survival as well.
"The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers," Mr. Serlin concluded.
Upcoming Expected Milestones
-- Overall final results, including PFS and OS data, from the
COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC
by the end of 2020;
-- Final results from the Phase 3 GENESIS trial in SCM in the first half of
2021;
-- Preliminary results of the Phase 1b study in ARDS in the first half of
2021;
-- Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid
tumors in the second half of 2021;
-- Data from the Columbia University-initiated study of motixafortide in
combination with LIBTAYO(®) and chemotherapy in first-line PDAC in
mid-2022;
Financial Results for the Quarter Ended September 30, 2020
Research and development expenses for the three months ended September 30, 2020 were $3.5 million, a decrease of $2.1 million compared to $5.6 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 and from lower expenses associated with the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Research and development expenses for the nine months ended September 30, 2020 were $13.5 million, a decrease of $1.7 million, compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic mentioned above.
Sales and marketing expenses for three months ended September 30, 2020 were $0.3 million, an increase of $0.1 million compared to $0.2 million for the comparable period in 2019. The increase resulted primarily from consultancy services and market research for motixafortide offset by a decrease in payroll and related expenses related to a reduction in headcount. Sales and marketing expenses for the nine months ended September 30, 2020 were $0.7 million, similar to the comparable period in 2019.
General and administrative expenses for the three months ended September 30, 2020 were $0.9, similar to the comparable period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $2.8 million, similar to the comparable period in 2019.
The Company's operating loss for the three months ended September 30, 2020 amounted to $4.6 million, compared to an operating loss of $6.6 million for the comparable period in 2019. The Company's operating loss for the nine months ended September 30, 2020 was $17.1 million, compared to $18.7 million for the comparable period in 2019.
Non-operating income (expenses) for the three- and nine-month periods ended September 30, 2020 and 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses and issuance expenses of the Company's ATM program.
Net financial expenses for the three months ended September 30, 2020 amounted to $0.3 million compared to net financial expenses of $0.4 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the nine months ended September 30, 2020 amounted to $0.9 million, similar to the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.
The Company's net loss for the three months ended September 30, 2020 amounted to $4.6 million, compared with a net loss of $3.9 million for the comparable period in 2019. The Company's net loss for the nine months ended September 30, 2020 amounted to $18.0 million, compared with a net loss of $15.6 million for the comparable period in 2019.
The Company held $20.8 million in cash, cash equivalents and short-term bank deposits as of September 30, 2020.
Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2020, compared with net cash used in operating activities of $17.2 million for the nine months ended September 30, 2019. The $0.6 million increase in net cash used in operating activities during the nine-month period in 2020 was primarily the result of the decrease in accounts payable and accruals in the 2020 period.
Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2020, compared to net cash provided by investing activities of $2.1 million for the nine months ended September 30, 2019. 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 $10.9 million for the nine months ended September 30, 2020, compared to net cash provided by financing activities of $16.6 million for the nine months ended September 30, 2019. The cash flows in 2020 primarily reflect the May and June financings and the net proceeds from the Company's ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of our ADSs in February 2019, as well as net proceeds from the ATM facility.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, November 23, 2020 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US 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 November 25, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5929 internationally.
(Tables follow)
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA(®) and chemotherapy under a collaboration agreement with MSD.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
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. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
December 31, September 30,
---
2019 2020
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents 5,297 6,552
Short-term bank deposits 22,192 14,275
Prepaid expenses 108 269
Other receivables 613 327
Total current assets 28,210 21,423
NON-CURRENT ASSETS
Property and equipment,
net 1,816 1,462
Right-of-use assets,
net 1,650 1,423
Intangible assets, net 21,891 21,731
Total non-current assets 25,357 24,616
Total assets 53,567 46,039
Liabilities and equity
CURRENT LIABILITIES
Current maturities of
long-term loans 2,692 2,969
Accounts payable and accruals:
Trade 7,794 5,933
Other 1,280 1,374
Lease liabilities 202 200
Total current liabilities 11,968 10,476
NON-CURRENT LIABILITIES
Warrants 658 5,600
Long-term loans, net of
current maturities 5,799 3,554
Lease liabilities 1,762 1,601
Total non-current
liabilities 8,219 10,755
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities 20,187 21,231
EQUITY
Ordinary shares 4,692 8,281
Share premium 265,938 271,107
Capital reserve 12,132 12,835
Other comprehensive loss (1,416) (1,416)
Accumulated deficit (247,966) (265,999)
Total equity 33,380 24,808
Total liabilities and
equity 53,567 46,039
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three months ended
September 30, Nine months ended
September 30,
---
2019 2020 2019 2020
---
in USD thousands in USD thousands
---
RESEARCH AND DEVELOPMENT EXPENSES (5,558) (3,484) (15,252) (13,546)
SALES AND MARKETING EXPENSES (201) (309) (683) (666)
GENERAL AND ADMINISTRATIVE EXPENSES (884) (856) (2,763) (2,843)
OPERATING LOSS (6,643) (4,649) (18,698) (17,055)
NON-OPERATING INCOME (EXPENSES), NET 3,055 294 3,976 (80)
FINANCIAL INCOME 247 39 628 214
FINANCIAL EXPENSES (597) (302) (1,484) (1,112)
NET LOSS AND COMPREHENSIVE LOSS (3,938) (4,618) (15,578) (18,033)
in USD in USD
---
LOSS PER ORDINARY SHARE - BASIC AND DILUTED (0.03) (0.02) (0.11) (0.08)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN 296,508,550 142,527,942 231,380,969
CALCULATION OF LOSS PER ORDINARY SHARE
148,920,707
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Ordinary Share Capital
Shares
premium reserve
Other Accumulated deficit Total
comprehensive
loss
---
in USD thousands
BALANCE AT JANUARY 1, 2019 3,110 250,192 11,955 (1,416) (222,520) 41,321
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30,
2019:
Issuance of share capital, net 1,018 11,266 12,284
Employee stock options exercised 1 53 (53) 1
Employee stock options forfeited and expired - 919 (919)
Share-based compensation - 1,170 1,170
Comprehensive loss for the period - (15,578) (15,578)
---
BALANCE AT SEPTEMBER 30, 2019 4,129 262,430 12,153 (1,416) (238,098) 39,198
Ordinary Share
Shares
premium
Capital
reserve Other Accumulated
deficit Total
Comprehensive
Loss
in USD thousands
BALANCE AT JANUARY 1, 2020 4,692 265,938 12,132 (1,416) (247,966) 33,380
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2020:
Issuance of share capital, net 3,581 4,754 8,335
Employee stock options exercised 8 224 (224) 8
Employee stock options forfeited and expired - 191 (191)
Share-based compensation - 1,118 1,118
Comprehensive loss for the period - (18,033) (18,033)
---
BALANCE AT SEPTEMBER 30, 2020 8,281 271,107 12,835 (1,416) (265,999) 24,808
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Ordinary Share Capital
Other
Accumulated
Comprehensive
Shares premium reserve
Loss
deficit Total
in USD thousands
BALANCE AT JULY 1, 2019 4,001 261,522 11,835 (1,416) (234,160) 41,782
CHANGES FOR THREE MONTHS ENDED
SEPTEMBER 30, 2019:
Issuance of share capital, net 128 829 957
Employee stock options exercised 26 (26)
Employee stock options forfeited and
expired 53 (53)
Share-based compensation 397 397
Comprehensive loss for the period (3,938) (3,938)
BALANCE AT SEPTEMBER 30, 2019 4,129 262,430 12,153 (1,416) (238,098) 39,198
Other
Comprehensive
Ordinary Share Capital
Accumulated
Shares premium Reserve
Loss
deficit Total
in USD thousands
BALANCE AT JULY 1, 2020 8,281 271,107 12,639 (1,416) (261,381) 29,230
CHANGES FOR THREE MONTHS ENDED
SEPTEMBER 30, 2020:
Issuance of share capital, net
Employee stock options exercised
Employee stock options forfeited and
expired
Share-based compensation 196 196
Comprehensive loss for the period (4,618) (4,618)
BALANCE AT SEPTEMBER 30, 2020 8,281 271,107 12,835 (1,416) (265,999) 24,808
BioLineRx Ltd
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Nine months ended
September 30,
2019 2020
---
in USD thousands
CASH FLOWS -OPERATING ACTIVITIES
Comprehensive
loss for the
period (15,578) (18,033)
Adjustments
required to
reflect net
cash used in
operating
activities (1,658) 259
(see appendix below)
Net cash used in
operating
activities (17,236) (17,774)
---
CASH FLOWS -INVESTING ACTIVITIES
Investments in
short-term
deposits (34,517) (28,500)
Maturities of
short-term
deposits 36,637 36,626
Purchase of
property and
equipment (54) (1)
---
Net cash
provided by
investing
activities 2,066 8,125
---
CASH FLOWS -FINANCING ACTIVITIES
Issuance of
share capital
and warrants,
net of issuance
costs 16,836 13,411
Employee stock
options
exercised 1 8
Repayments of
loans (70) (2,338)
Repayments of
lease
liabilities (165) (162)
---
Net cash
provided by
financing
activities 16,602 10,919
---
INCREASE IN CASH
AND CASH
EQUIVALENTS 1,432 1,270
CASH AND CASH
EQUIVALENTS -
BEGINNING 3,404 5,297
OF PERIOD
EXCHANGE
DIFFERENCES ON
CASH AND CASH
EQUIVALENTS 49 (15)
---
CASH AND CASH
EQUIVALENTS -
END OF PERIOD 4,885 6,552
===
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW
STATEMENTS
(UNAUDITED)
Nine months
ended
September 30,
2019 2020
---
in USD thousands
Adjustments required to reflect
net cash used in operating
activities:
Income and expenses not involving
cash flows:
Depreciation
and
amortization 667 737
Long-term
prepaid
expenses (3)
Exchange
differences
on cash and
cash
equivalents (49) 15
Fair value
adjustments
of warrants (4,429) (727)
Share-based
compensation 1,170 1,118
Warrant
issuance
costs 417 593
Interest and
exchange
differences
on short-
term
deposits (628) (209)
Interest on
loans 512 370
Exchange
differences
on lease
liability - 4
---
(2,343) 1,901
---
Changes in operating asset and
liability items:
Decrease in
prepaid
expenses and
other
receivables 265 125
---
Increase
(decrease)
in accounts
payable and
accruals 420 (1,767)
---
685 (1,642)
---
(1,658) 259
===
Supplemental
information
on interest
received in
cash 628 342
===
Supplemental
information
on interest
paid in cash 782 671
===
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SOURCE BioLineRx Ltd.
