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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
 (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  
       
Dated: March 12, 2020



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 FacebookTwitter, 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