SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2020
_______________________
BioLineRx Ltd.
(Translation of registrant’s name into English)
_______________________
2 HaMa’ayan Street
Modi’in 7177871, Israel
Modi’in 7177871, Israel
(Address of Principal Executive Offices)
_______________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ☒ Form 40-F ☐
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
Yes ☐ No ☒
On March 12, 2020, the registrant issued the press release which is filed as Exhibit 1 to this Report on Form 6-K.
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by
the registrant under the Securities Act of 1933.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
|
BioLineRx Ltd.
|
|||
|
|
By:
|
/s/ Philip Serlin | |
| Philip Serlin | |||
| Chief Executive Officer | |||
Exhibit 1
For Immediate Release
BioLineRx Reports Year-End 2019 Financial Results
and Provides Corporate Update
- On track to
report progression free survival and overall survival data from triple
combination arm of
ongoing COMBAT/KEYNOTE-202 Phase 2a trial in mid-2020 -
- Management to hold conference call today,
March 12, at 10:00 am EDT -
TEL AVIV, Israel, March 12, 2020 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company
focused on oncology, today reports its financial results for the year ended December 31, 2019 and provides a corporate update.
Highlights and achievements during the fourth quarter 2019 and subsequent period:
| • |
Presented updated preliminary Phase 2a data from the triple combination arm of the COMBAT/KEYNOTE-202 study, under collaboration with Merck, evaluating the safety, tolerability and efficacy of motixafortide (BL-8040) in combination
with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line metastatic pancreatic cancer, demonstrating a 32% overall response rate and a 77% disease control rate out of 22 evaluable patients at that time, with median
duration of clinical benefit for all 17 patients with disease control (7 partial response and 10 stable disease patients) of 7.8 months; and reiterated expectation for progression free survival and overall survival data in mid-2020;
|
| • |
Completed recruitment (N=43) of the triple combination arm of the COMBAT/KEYNOTE-202 study;
|
| • |
Announced Notice of Allowance from USPTO for a broad patent covering motixafortide in combination with anti-PD-1 for the treatment of any and all types of cancer;
|
| • |
Received Orphan Drug Designation for motixafortide for the treatment of pancreatic cancer in Europe;
|
| • |
Presented positive triple-combination preclinical data from the evaluation of motixafortide in combination with an anti-PD-1 and chemotherapy in pancreatic cancer, supporting motixafortide’s mechanism of action and providing
additional strong rationale for the triple-combination clinical study, at the Society for Immunotherapy of Cancer Annual Meeting (SITC).
|
“We achieved a significant milestone during the fourth quarter of 2019 with the announcement of preliminary data from the ongoing
triple combination arm of our COMBAT/KEYNOTE-202 study in second-line pancreatic cancer,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “The promising initial results demonstrated robust and durable responses to the triple combination
treatment, with an overall response rate almost double the current chemotherapy standard-of-care treatment in second-line patients, and a trend of patients receiving treatment for an extended period that move from stable disease to partial response. Looking ahead, we have now fully enrolled this study and remain on track to announce progression free and overall survival data in mid-year.
“In parallel, our late-stage trials of motixafortide in AML and stem cell mobilization are progressing, and we also look forward to
these key data readouts later this year.
“Regarding our second clinical oncology candidate, the universal anti-cancer vaccine AGI-134, we successfully completed the
dose-escalation Part 1 of the ongoing Phase 1/2a clinical trial in a range of solid tumor types, and are currently advancing Part 2 of the study as expeditiously as possible. We look forward to initial results of Part 2 by year-end 2020,” Mr.
Serlin concluded.
Upcoming 2020 Milestones
| • |
Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study in mid-2020;
|
| • |
Interim results from the Phase 2b AML consolidation study in the second half of 2020;
|
2
| • |
Top-line results from Phase 3 GENESIS registrational study in stem cell mobilization in the second half of 2020;
|
| • |
Initial results from Part 2 of Phase 1/2a trial of AGI-134 by year-end 2020.
|
Financial Results for the Year Ended December 31, 2019
Research and development expenses for the year ended December 31, 2019 were $23.4 million, an increase of $3.6 million, or 18.3%,
compared to $19.8 million for the year ended December 31, 2018. The increase resulted primarily from higher expenses associated with the motixafortide GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to BL-1230, a
project that was terminated in 2018, as well as a decrease in payroll and share-based compensation.
Sales and marketing expenses for the year ended December 31, 2019 were $0.9 million, a decrease of $0.5 million, or 37.0%, compared to
$1.4 million for the year ended December 31, 2018. The decrease resulted primarily from a decrease in payroll and related expenses, including a one-time compensation payment in the 2018 period.
General and administrative expenses for the year ended December 31, 2019 were $3.8 million, a decrease of $0.6 million, or 14.0%
compared to $4.4 million for the year ended December 31, 2018. The decrease resulted primarily from a decrease in share-based compensation.
The Company's operating loss for the year ended December 31, 2019 amounted to $28.1 million, compared to an operating loss of $25.6
million for the year ended December 31, 2018.
Non-operating income amounted to $4.2 million for the year ended December 31, 2019, compared to non-operating income of $2.4 million
for the year ended December 31, 2018. Non-operating income for the year ended December 31, 2019 primarily relates to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses. Non-operating
income for the year ended December 31, 2018 primarily relates to fair-value adjustments of warrant liabilities on the Company’s balance sheet, as well as a capital gain from realization of the investment in iPharma.
Net financial expenses amounted to $1.5 million for the year ended December 31, 2019 compared to net financial income of $0.2 million
for the year ended December 31, 2018. Net financial expenses for the year ended December 31, 2019 primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the year ended December 31,
2018 primarily relates to investment income earned on bank deposits, offset by interest paid on loans.
3
The Company's net loss for the year ended December 31, 2019 amounted to $25.5 million, compared with a net loss of $23.0 million for
the year ended December 31, 2018.
The Company held $27.5 million in cash, cash equivalents and short-term bank deposits as of December 31, 2019.
Net cash used in operating activities for the year ended December 31, 2019 was $22.7 million, compared to $24.2 million for the year
ended December 31, 2018. The $1.5 million decrease in net cash used in operating activities in 2019 was primarily the result of changes in operating asset and liability items in the two periods., i.e., a decrease in prepaid expenses and other
receivables in 2019 versus an increase in 2018, as well as an increase in accounts payable and accruals in 2019 versus a decrease in 2018.
Net cash provided by investing activities for the year ended December 31, 2019 was $5.3 million, compared to $9.6 million for the year
ended December 31, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during both periods, the acquisition of an additional 20% economic interest in
Motixafortide in 2018, as well as a realization of the investment in iPharma during 2018.
Net cash provided by financing activities for the year ended December 31, 2019 was $19.2 million, compared to $13.1 million for the
year ended December 31, 2018. The cash flows in 2019 primarily reflect the underwritten public offering of ADSs in February 2019, as well as net proceeds from the ATM program. The cash flows in 2018 reflect
the net proceeds of the loan from Kreos Capital, as well as net proceeds from the ATM program.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, March 12, 2020 at 10:00 a.m. EDT. To access the conference call, please dial
+1-888-668-9141 from the US or +972-3-918-0609 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 March 14, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5927 internationally.
(Tables follow)
4
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 2a study for
the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell
mobilization for autologous bone-marrow transplantation.
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. 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 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
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
5
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
December 31,
|
||||||||
|
2018
|
2019
|
|||||||
|
in USD thousands
|
||||||||
|
Assets
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
3,404
|
5,297
|
||||||
|
Short-term bank deposits
|
26,747
|
22,192
|
||||||
|
Prepaid expenses
|
488
|
108
|
||||||
|
Other receivables
|
1,339
|
613
|
||||||
|
Total current assets
|
31,978
|
28,210
|
||||||
|
NON-CURRENT ASSETS
|
||||||||
|
Long-term prepaid expenses
|
56
|
-
|
||||||
|
Property and equipment, net
|
2,227
|
1,816
|
||||||
|
Right-of-use assets, net
|
-
|
1,650
|
||||||
|
Intangible assets, net
|
21,972
|
21,891
|
||||||
|
Total non-current assets
|
24,255
|
25,357
|
||||||
|
Total assets
|
56,233
|
53,567
|
||||||
|
Liabilities and equity
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Current maturities of long-term loans
|
895
|
2,692
|
||||||
|
Accounts payable and accruals:
|
||||||||
|
Trade
|
4,493
|
7,794
|
||||||
|
Other
|
1,363
|
1,280
|
||||||
|
Lease liabilities
|
-
|
202
|
||||||
|
Total current liabilities
|
6,751
|
11,968
|
||||||
|
NON-CURRENT LIABILITIES
|
||||||||
|
Warrants
|
323
|
658
|
||||||
|
Long-term loans, net of current maturities
|
7,838
|
5,799
|
||||||
|
Lease liabilities
|
-
|
1,762
|
||||||
|
Total non-current liabilities
|
8,161
|
8,219
|
||||||
|
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
|
Total liabilities
|
14,912
|
20,187
|
||||||
|
EQUITY
|
||||||||
|
Ordinary shares
|
3,110
|
4,692
|
||||||
|
Share premium
|
250,192
|
265,938
|
||||||
|
Capital reserve
|
11,955
|
12,132
|
||||||
|
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
|
Accumulated deficit
|
(222,520
|
)
|
(247,966
|
)
|
||||
|
Total equity
|
41,321
|
33,380
|
||||||
|
Total liabilities and equity
|
56,233
|
53,567
|
||||||
6
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
Year ended December 31,
|
||||||||||||
|
2017
|
2018
|
2019
|
||||||||||
|
in USD thousands
|
||||||||||||
|
RESEARCH AND DEVELOPMENT EXPENSES
|
(19,510
|
)
|
(19,808
|
)
|
(23,438
|
)
|
||||||
|
SALES AND MARKETING EXPENSES
|
(1,693
|
)
|
(1,362
|
)
|
(857
|
)
|
||||||
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
(4,037
|
)
|
(4,435
|
)
|
(3,816
|
)
|
||||||
|
OPERATING LOSS
|
(25,240
|
)
|
(25,605
|
)
|
(28,111
|
)
|
||||||
|
NON-OPERATING INCOME (EXPENSES), NET
|
(260
|
)
|
2,397
|
4,165
|
||||||||
|
FINANCIAL INCOME
|
1,169
|
719
|
777
|
|||||||||
|
FINANCIAL EXPENSES
|
(21
|
)
|
(473
|
)
|
(2,277
|
)
|
||||||
|
NET LOSS AND COMPREHENSIVE LOSS
|
(24,352
|
)
|
(22,962
|
)
|
(25,446
|
)
|
||||||
|
in USD
|
||||||||||||
|
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
|
(0.27
|
)
|
(0.21
|
)
|
(0.17
|
)
|
||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
89,970,713
|
108,595,702
|
146,407,055
|
|||||||||
7
BioLineRx Ltd.
STATEMENTS OF CHANGES IN EQUITY
|
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 IN 2017:
|
||||||||||||||||||||||||
|
Issuance of share capital, net
|
1,322
|
39,376
|
-
|
-
|
-
|
40,698
|
||||||||||||||||||
|
Employee stock options exercised
|
1
|
328
|
(329
|
)
|
-
|
-
|
-
|
|||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
1,411
|
(1,411
|
)
|
-
|
-
|
-
|
|||||||||||||||||
|
Share-based compensation
|
-
|
-
|
1,508
|
-
|
-
|
1,508
|
||||||||||||||||||
|
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(24,352
|
)
|
(24,352
|
)
|
||||||||||||||||
|
BALANCE AT DECEMBER 31, 2017
|
2,836
|
240,682
|
10,337
|
(1,416
|
)
|
(199,558
|
)
|
52,881
|
||||||||||||||||
|
CHANGES IN 2018:
|
||||||||||||||||||||||||
|
Issuance of share capital, net
|
263
|
8,567
|
-
|
-
|
-
|
8,830
|
||||||||||||||||||
|
Employee stock options exercised
|
11
|
415
|
(380
|
)
|
-
|
-
|
46
|
|||||||||||||||||
|
Employee stock options forfeited expired
|
-
|
528
|
(528
|
)
|
-
|
-
|
-
|
|||||||||||||||||
|
Share-based compensation
|
-
|
-
|
2,526
|
-
|
-
|
2,526
|
||||||||||||||||||
|
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(22,962
|
)
|
(22,962
|
)
|
||||||||||||||||
|
BALANCE AT DECEMBER 31, 2018
|
3,110
|
250,192
|
11,955
|
(1,416
|
)
|
(222,520
|
)
|
41,321
|
||||||||||||||||
|
CHANGES IN 2019:
|
||||||||||||||||||||||||
|
Issuance of share capital, net
|
1,580
|
14,165
|
-
|
-
|
-
|
15,745
|
||||||||||||||||||
|
Employee stock options exercised
|
2
|
83
|
(84
|
)
|
-
|
-
|
1
|
|||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
1,498
|
(1,498
|
)
|
-
|
-
|
-
|
|||||||||||||||||
|
Share-based compensation
|
-
|
-
|
1,759
|
-
|
-
|
1,759
|
||||||||||||||||||
|
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(25,446
|
)
|
(25,446
|
)
|
||||||||||||||||
|
BALANCE AT DECEMBER 31, 2019
|
4,692
|
265,938
|
12,132
|
(1,416
|
)
|
(247,966
|
)
|
33,380
|
||||||||||||||||
8
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
|
Year ended December 31,
|
||||||||||||
|
2017
|
2018
|
2019
|
||||||||||
|
in USD thousands
|
||||||||||||
|
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||||||
|
Net loss
|
(24,352
|
)
|
(22,962
|
)
|
(25,446
|
)
|
||||||
|
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
3,805
|
(1,230
|
)
|
2,780
|
||||||||
|
Net cash used in operating activities
|
(20,547
|
)
|
(24,192
|
)
|
(22,666
|
)
|
||||||
|
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||||||
|
Increase in long-term investment
|
(1,000
|
)
|
-
|
-
|
||||||||
|
Realization of long-term investment
|
-
|
1,500
|
-
|
|||||||||
|
Investments in short-term deposits
|
(44,016
|
)
|
(26,500
|
)
|
(43,545
|
)
|
||||||
|
Maturities of short-term deposits
|
33,327
|
44,771
|
48,875
|
|||||||||
|
Purchase of property and equipment
|
(338
|
)
|
(173
|
)
|
(67
|
)
|
||||||
|
Purchase of intangible assets
|
(3,900
|
)
|
(10,043
|
)
|
(6
|
)
|
||||||
|
Net cash provided by (used in) investing activities
|
(15,927
|
)
|
9,555
|
5,257
|
||||||||
|
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||||||
|
Issuance of share capital and warrants, net of issuance cost
|
38,773
|
3,830
|
20,297
|
|||||||||
|
Employee stock options exercised
|
-
|
46
|
1
|
|||||||||
|
Proceeds of long-term loan and warrants, net of issuance costs
|
-
|
9,632
|
-
|
|||||||||
|
Repayment of loans
|
(93
|
)
|
(411
|
)
|
(889
|
)
|
||||||
|
Repayments of lease liabilities
|
-
|
-
|
(215
|
)
|
||||||||
|
Net cash provided by financing activities
|
38,680
|
13,097
|
19,194
|
|||||||||
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
2,206
|
(1,540
|
)
|
1,785
|
||||||||
|
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
2,469
|
5,110
|
3,404
|
|||||||||
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
435
|
(166
|
)
|
108
|
||||||||
|
CASH AND CASH EQUIVALENTS - END OF YEAR
|
5,110
|
3,404
|
5,297
|
|||||||||
9
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
|
Year ended December 31,
|
||||||||||||
|
2017
|
2018
|
2019
|
||||||||||
|
in USD thousands
|
||||||||||||
|
APPENDIX
|
||||||||||||
|
Adjustments required to reflect net cash used in operating activities:
|
||||||||||||
|
Income and expenses not involving cash flows:
|
||||||||||||
|
Depreciation and amortization
|
481
|
545
|
940
|
|||||||||
|
Long-term prepaid expenses
|
(9
|
)
|
5
|
56
|
||||||||
|
Exchange differences on cash and cash equivalents
|
(435
|
)
|
166
|
(108
|
)
|
|||||||
|
Fair value adjustments of warrants
|
127
|
(1,743
|
)
|
(4,634
|
)
|
|||||||
|
Share-based compensation
|
1,508
|
2,526
|
1,759
|
|||||||||
|
Interest and exchange differences on short-term deposits
|
(530
|
)
|
(645
|
)
|
(775
|
)
|
||||||
|
Interest on loans
|
-
|
123
|
647
|
|||||||||
|
Gain on realization of long-term investment
|
-
|
(500
|
)
|
-
|
||||||||
|
Warrant issuance costs
|
17
|
-
|
417
|
|||||||||
|
Exchange differences on lease liability
|
-
|
-
|
154
|
|||||||||
|
1,159
|
477
|
(1,544
|
)
|
|||||||||
|
Changes in operating asset and liability items:
|
||||||||||||
|
Decrease (increase) in prepaid expenses and other receivables
|
(415
|
)
|
(934
|
)
|
1,106
|
|||||||
|
Increase (decrease) in accounts payable and accruals
|
3,061
|
(773
|
)
|
3,218
|
||||||||
|
2,646
|
(1,707
|
)
|
4,324
|
|||||||||
|
3,805
|
(1,230
|
)
|
2,780
|
|||||||||
|
Supplemental information on interest received in cash
|
494
|
834
|
868
|
|||||||||
|
Supplemental information on interest paid in cash
|
12
|
165
|
1,198
|
|||||||||
|
Supplemental information on non-cash transactions
|
2,985
|
5,000
|
147
|
|||||||||
10