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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 February 2021

Commission file number: 001-35223
 
_______________________
 
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 if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____


 
On February 23, 2021 the registrant issued the press release which is filed as Exhibit 1 to this Report on Form 6-K.
 

 
 
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 A. Serlin
 
 
 
Philip A. Serlin
 
 
 
Chief Executive Officer
 
 
Dated: February 23, 2021


 
 
 
 
 

 
 

 

Exhibit 1



For Immediate Release

BioLineRx Reports Year-End 2020 Financial Results
and Provides Corporate Update

- Phase 3 GENESIS study in stem-cell mobilization (SCM) showed statistically significant
positive results for primary endpoint in interim analysis; enrollment ceased early;
top-line data expected early Q2 2021 -

- Final results from Phase 2a COMBAT/KEYNOTE-202 study of motixafortide in
pancreatic ductal adenocarcinoma (PDAC) showed substantial improvement
as compared to historical results across all study endpoints -

- Management to hold conference call today, February 23, at 10:00 am EST -

Tel Aviv, Israel, February 23, 2021 -- 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, 2020 and provides a corporate update.

Significant events and achievements during the fourth quarter 2020 and subsequent period:


Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177 originally planned), and top-line data, including full primary and secondary efficacy endpoints, is anticipated in early second quarter of 2021. In parallel, the Company is proceeding with all activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of 2021.


Reported positive final results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 study evaluating motixafortide in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC). The results of the study showed substantial improvement as compared to historical results across all study endpoints. The Company is currently planning next development steps for this program, including discussions with potential collaboration partners and development of a protocol for a randomized controlled study.




Announced initiation of a Phase 2 investigator-initiated clinical trial evaluating motixafortide in combination with LIBTAYO® and chemotherapy in first-line metastatic PDAC. The study is led by Columbia University.
 

Announced initiation of a Phase 1b investigator-initiated clinical trial evaluating motixafortide in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.


Completed underwritten public offering with gross proceeds of $34.5 million.

“The fourth quarter 2020 was perhaps our most significant so far, having achieved positive data milestones in two programs with significant unmet medical needs – stem-cell mobilization and PDAC,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “The Phase 3 SCM interim data that we reported in October were overwhelmingly positive, and based on the DMC’s recommendation, we ceased enrollment at 122 out of the originally planned 177 patients. We now look forward to presenting full top-line results from the study, including data related to 100 days of post-transplantation follow-up, by early second quarter of this year. SCM remains our most expeditious path to registration, and we therefore view these data as potentially transformational for our company. In parallel, we are moving forward very aggressively with all activities in support of an NDA submission, which we expect in the first half of next year.

“We are equally excited about the final results from our Phase 2a COMBAT/KEYNOTE-202 PDAC study that we announced in December last year. The data demonstrated that the triple combination of motixafortide, KEYTRUDA and chemotherapy outperformed historical data across all endpoints, including median overall survival, median progression free survival, confirmed and overall response rates and disease control rate. In a cancer population as difficult to treat as second-line metastatic PDAC, and even more specifically those patients initially diagnosed with unresectable stage IV disease, we view these results as highly encouraging and are planning our next development steps forward in this program, likely in collaboration with a biopharmaceutical partner.

“Finally, subsequent to the end of the year, we strengthened our balance sheet through a financing that resulted in gross proceeds of $34.5 million. These funds will allow us to continue to execute on our strategy for motixafortide in both SCM and PDAC, while in parallel advancing our second clinical candidate, the anti-cancer immunotherapy AGI-134, through clinical development. In summary, we exited 2020 on a very positive note, with two data sets that demonstrate both the effectiveness and versatility of motixafortide across multiple indications, and we plan to build upon these successes this year,” concluded Mr. Serlin.

2


Upcoming Significant Expected Milestones


Top-line results from the Phase 3 GENESIS trial in SCM in early Q2 2021.


Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.


Pre-NDA meeting with the FDA for SCM in the second half of 2021


NDA submission for SCM in the first half of 2022

Financial Results for the Year Ended December 31, 2020
Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2 million, or 22.5%, compared to $23.4 million for the year ended December 31, 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019, from lower expenses associated with the motixafortide  COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share-based compensation and payroll due to a company-wide salary reduction related to the COVID-19 pandemic.

Sales and marketing expenses for the year ended December 31, 2020 were $0.8 million, similar to sales and marketing expenses for the year ended December 31, 2019.

General and administrative expenses for the year ended December 31, 2020 were $3.9 million, an increase of $0.1 million, or 2.6% compared to $3.8 million for the year ended December 31, 2019. The increase resulted primarily from an increase in D&O insurance expenses and share-based compensation, offset by small decreases in a number of G&A expenses.

The Company's operating loss for the year ended December 31, 2020 amounted to $22.9 million, compared to an operating loss of $28.1 million for the year ended December 31, 2019.

Non-operating expenses amounted to $5.7 million for the year ended December 31, 2020, compared to non-operating income of $4.2 million for the year ended December 31, 2019. Non-operating expenses for the year ended December 31, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, warrant offering expenses and ATM issuance expenses. 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.

Net financial expenses amounted to $1.4 million for the year ended December 31, 2020, compared to net financial expenses of $1.5 million for the year ended December 31, 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

3


The Company's net loss for the year ended December 31, 2020 amounted to $30.0 million, compared with a net loss of $25.5 million for the year ended December 31, 2019.

The Company held $22.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2020. Subsequent to year end, the Company raised gross proceeds of $34.5 million in an underwritten public offering, and received another $9.8 million in gross proceeds from the exercise of outstanding warrants.

Net cash used in operating activities for the year ended December 31, 2020 was $23.2 million, compared to $22.7 million for the year ended December 31, 2019. The $0.5 million increase in 2020 was primarily the result of a decrease in accounts payable and accruals.

Net cash provided by investing activities for the year ended December 31, 2020 was $16.7 million, compared to $5.3 million for the year ended December 31, 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 for the year ended December 31, 2020 was $17.9 million, compared to $19.2 million for the year ended December 31, 2019. The cash flows in 2020 primarily reflect the registered direct offerings of the Company’s ADSs in May and June 2020, as well as net proceeds from the ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of the Company’s ADSs in February 2019, as well as net proceeds from the ATM program.

Conference Call and Webcast Information
BioLineRx will hold a conference call today, Thursday, February 23, 2021 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610  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 February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 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 that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

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.

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 COVID-19 pandemic; 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 February 23, 2021. 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

Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
moran@lifesciadvisors.com
 

5


BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
   
December 31,
 
   
2019
   
2020
 
   
in USD thousands
 
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
5,297
     
16,831
 
Short-term bank deposits
   
22,192
     
5,756
 
Prepaid expenses
   
108
     
152
 
Other receivables
   
613
     
141
 
Total current assets
   
28,210
     
22,880
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
1,816
     
1,341
 
Right-of-use assets, net
   
1,650
     
1,355
 
Intangible assets, net
   
21,891
     
21,714
 
Total non-current assets
   
25,357
     
24,410
 
Total assets
   
53,567
     
47,290
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loans
   
2,692
     
3,092
 
Accounts payable and accruals:
               
Trade
   
7,794
     
5,918
 
Other
   
1,280
     
1,440
 
Lease liabilities
   
202
     
191
 
Total current liabilities
   
11,968
     
10,641
 
                 
NON-CURRENT LIABILITIES
               
Warrants
   
658
     
10,218
 
Long-term loans, net of current maturities
   
5,799
     
2,740
 
Lease liabilities
   
1,762
     
1,661
 
Total non-current liabilities
   
8,219
     
14,619
 
                 
COMMITMENTS AND CONTINGENT LIABILITIES
               
Total liabilities
   
20,187
     
25,260
 
                 
EQUITY
               
Ordinary shares
   
4,692
     
9,870
 
Share premium
   
265,938
     
279,241
 
Capital reserve
   
12,132
     
12,322
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(247,966
)
   
(277,987
)
Total equity
   
33,380
     
22,030
 
Total liabilities and equity
   
53,567
     
47,290
 
 
6


 
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
 
   
Year ended December 31,
 
   
2018
   
2019
   
2020
 
   
in USD thousands
 
                   
RESEARCH AND DEVELOPMENT EXPENSES
   
(19,808
)
   
(23,438
)
   
(18,173
)
SALES AND MARKETING EXPENSES
   
(1,362
)
   
(857
)
   
(840
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(4,435
)
   
(3,816
)
   
(3,914
)
OPERATING LOSS
   
(25,605
)
   
(28,111
)
   
(22,927
)
NON-OPERATING INCOME (EXPENSES), NET
   
2,397
     
4,165
     
(5,701
)
FINANCIAL INCOME
   
719
     
777
     
236
 
FINANCIAL EXPENSES
   
(473
)
   
(2,277
)
   
(1,629
)
NET LOSS AND COMPREHENSIVE LOSS
   
(22,962
)
   
(25,446
)
   
(30,021
)

   
in USD
 
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
   
(0.21
)
   
(0.17
)
   
(0.12
)
                         
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
   
108,595,702
     
146,407,055
     
252,844,394
 


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, 2018
   
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 and 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
 
CHANGES IN 2020:
                                               
  Issuance of share capital, net
   
4,777
     
9,395
     
-
     
-
     
-
     
14,172
 
  Warrants exercised
   
393
     
2,826
     
-
     
-
     
-
     
3,219
 
  Employee stock options exercised
   
8
     
228
     
(228
)
   
-
     
-
     
8
 
  Employee stock options forfeited and expired
   
-
     
854
     
(854
)
   
-
     
-
     
-
 
  Share-based compensation
   
-
     
-
     
1,272
     
-
     
-
     
1,272
 
  Comprehensive loss for the year
   
-
     
-
     
-
     
-
     
(30,021
)
   
(30,021
)
BALANCE AT DECEMBER 31, 2020
   
9,870
     
279,241
     
12,322
     
(1,416
)
   
(277,987
)
   
22,030
 


8


 
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
 
   
Year ended December 31,
 
   
2018
   
2019
   
2020
 
   
in USD thousands
 
CASH FLOWS - OPERATING ACTIVITIES
                 
Net loss
   
(22,962
)
   
(25,446
)
   
(30,021
)
Adjustments required to reflect net cash used in operating activities (see appendix below)
   
(1,230
)
   
2,780
     
6,815
 
Net cash used in operating activities
   
(24,192
)
   
(22,666
)
   
(23,206
)
                         
CASH FLOWS - INVESTING ACTIVITIES
                       
Realization of long-term investment
   
1,500
     
-
     
-
 
     Investments in short-term deposits
   
(26,500
)
   
(43,545
)
   
(33,500
)
     Maturities of short-term deposits
   
44,771
     
48,875
     
50,168
 
Purchase of property and equipment
   
(173
)
   
(67
)
   
-
 
Purchase of intangible assets
   
(10,043
)
   
(6
)
   
-
 
Net cash provided by investing activities
   
9,555
     
5,257
     
16,668
 
                         
CASH FLOWS - FINANCING ACTIVITIES
                       
Issuance of share capital and warrants, net of issuance cost
   
3,830
     
20,297
     
21,215
 
     Employee stock options exercised
   
46
     
1
     
8
 
     Proceeds of long-term loan and warrants, net of issuance costs
   
9,632
     
-
     
-
 
     Repayment of loans
   
(411
)
   
(889
)
   
(3,133
)
     Repayments of lease liabilities
   
-
     
(215
)
   
(224
)
Net cash provided by financing activities
   
13,097
     
19,194
     
17,866
 
                         
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(1,540
)
   
1,785
     
11,328
 
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
   
5,110
     
3,404
     
5,297
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(166
)
   
108
     
206
 
CASH AND CASH EQUIVALENTS - END OF YEAR
   
3,404
     
5,297
     
16,831
 

9


 
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
 
   
Year ended December 31,
 
   
2018
   
2019
   
2020
 
   
in USD thousands
 
APPENDIX
                 
                   
Adjustments required to reflect net cash used in operating activities:
                 
Income and expenses not involving cash flows:
                 
Depreciation and amortization
   
545
     
940
     
934
 
Long-term prepaid expenses
   
5
     
56
     
-
 
Exchange differences on cash and cash equivalents
   
166
     
(108
)
   
(206
)
Fair value adjustments of warrants
   
(1,743
)
   
(4,634
)
   
5,142
 
Share-based compensation
   
2,526
     
1,759
     
1,272
 
Interest and exchange differences on short-term deposits
   
(645
)
   
(775
)
   
(232
)
Interest on loans
   
123
     
647
     
474
 
Gain on realization of long-term investment
   
(500
)
   
-
     
-
 
Warrant issuance costs
   
-
     
417
     
594
 
Exchange differences on lease liability
   
-
     
154
     
125
 
     
477
     
(1,544
)
   
8,103
 
                         
Changes in operating asset and liability items:
                       
Decrease (increase) in prepaid expenses and other receivables
   
(934
)
   
1,106
     
428
 
Increase (decrease) in accounts payable and accruals
   
(773
)
   
3,218
     
(1,716
)
     
(1,707
)
   
4,324
     
(1,288
)
                         
     
(1,230
)
   
2,780
     
6,815
 
                         
Supplemental information on interest received in cash
   
834
     
868
     
381
 
                         
Supplemental information on interest paid in cash
   
165
     
1,198
     
994
 
                         
Supplemental information on non-cash transactions
   
5,000
     
147
     
1,251
 

10