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6-K
BIOLINERX LTD. filed this Form 6-K on 03/10/2016
Entire Document
 
zk1618172.htm


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 2016
_______________________
 
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 þ   Form 40-F o
 
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 o   No þ
 
 
 

 
 
On March 10, 2016, the registrant will issue 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 Company 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 Financial and Operating Officer
 
 
Dated: March 10, 2016
 
 


exhibit_1.htm


Exhibit 1
 
For immediate release

BioLineRx Reports Year End 2015 Financial Results
 
Tel Aviv, Israel - March 10, 2016 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reported its financial results for the year ended December 31, 2015.

Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “2015 was a year of significant progress for BioLineRx on several fronts, as we advanced our lead therapeutic clinical programs both from a development and regulatory perspective, and entered into an exciting new collaboration in the immuno-oncology space.”

“During the past year, we enhanced and expanded the development strategy for our BL-8040 cancer therapy platform, which is currently being investigated for multiple cancer and hematological indications. These include a Phase 2 study for treating relapsed and refractory AML patients, top line results of which are expected by the end of this month. Results from the first part of this trial continue to demonstrate substantial mobilization of leukemic cells from the bone marrow to the peripheral blood and robust induction of cancer cell apoptosis, which, combined with the reported 38% composite remission rate, strongly suggest that BL-8040 has potent anti-leukemic activity. In addition, we are also assessing BL-8040 as an AML consolidation treatment in a large Phase 2b study that is currently up and running at full steam. Successful top-line safety and efficacy results were also reported from a Phase 1 study in stem cell mobilization, supporting BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care. We now await receipt of regulatory approval in order to begin, by the end of the month, a Phase 2 trial for BL-8040 as a stem cell mobilizer for allogeneic transplantation. Finally, we are advancing an ongoing Phase 1/2 study for BL-8040 as a novel treatment for hMDS and AA, two bone marrow failure conditions.”

“We recently entered the exciting field of immuno-oncology through our collaboration with Merck, a pioneer and world leader in cancer immunotherapy. A Phase 2 study is planned to commence by mid-year investigating BL-8040 in combination with KEYTRUDA®, Merck’s anti-PD-1 immunotherapy, in patients with metastatic pancreatic cancer. Although there have been significant advances in the immuno-oncology field, many cancer types, such as pancreatic cancer, remain resistant to immunotherapy, and combination treatments appear to offer a better chance to treat these cancers. We are therefore enthusiastic about this opportunity to evaluate the potential of our lead drug candidate as a combination therapy with immune checkpoint inhibitors. We are also planning to commence a Phase 2a trial for BL-8040 in the second half of 2016, for the treatment of AML patients with the FLT3-ITD mutation. With the guidance and insight of our newly established Oncology Scientific Advisory Board, consisting of world-renowned key opinion leaders, we look forward to realizing the potential of this promising oncology platform and to reaching several meaningful development milestones during 2016.”

“BL-7010, for the treatment of celiac disease and gluten sensitivity, which was found to be safe and well tolerated in a Phase 1/2 trial in celiac patients, has recently received confirmation for the medical device designation pathway in Europe. Over the past year, we have invested considerable efforts in examining the potential of BL-7010 as a food supplement, in order to address the multi-billion dollar market for gluten sensitivity, which we believe has a significantly shorter time to market than drug or device pathways, especially in the US market. We are currently conducting a number of activities towards the development of BL-7010 as a food supplement, including the development of a suitable product formulation, preparation of the documents necessary for a GRAS designation submission, and preparations for a relatively small clinical trial to support future marketing efforts. We expect to complete these activities by mid-2017, in order to support future expected partnering discussions for the food supplement market in the US and other relevant territories. We also plan to continue to evaluate the pathway in Europe for celiac disease and intend to make a decision about the timing and scope of the next efficacy study for European registration over the next few months.”
 
 
 

 

 
“Regarding BL-5010, our partner Omega Pharma, now part of Perrigo, is swiftly progressing with its development as an OTC solution for the non-surgical removal of benign skin lesions. Omega Pharma submitted a CE Mark application for BL-5010 during the third quarter of 2015, and has completed the initial manufacturing process automation to support the product’s commercial launch, expected during 2016. We also look forward to the potential expansion of this product to other markets and to non-OTC indications.”

“During 2015, we invested significant efforts in our new strategic collaboration with Novartis and have been jointly evaluating promising therapeutic candidates to be developed under the collaboration. In addition, we continue to explore other collaboration possibilities for maximizing the value of our current pipeline assets, including some of our non-core programs.”

Dr. Savitsky concluded, “Yesterday, we announced the appointment of Dr. Merril Gersten as our new Chief Scientific Officer. Merril brings with her many years of leadership in both academia and the pharma industry in the US. I am confident that she will bring great value to BioLineRx and I am very excited to begin working with her. Finally, with almost $48 million on our balance sheet, we remain well capitalized to execute on our development programs and achieve significant milestones across our expanded therapeutic pipeline well into 2018.”

Financial Results for Year Ended December 31, 2015
Research and development expenses for the year ended December 31, 2015 were $11.5 million, a decrease of $0.4 million, or 3.4%, compared to $11.9 million for the year ended December 31, 2014. The decrease resulted primarily from a decrease in spending on BL-7010 and various other projects, partially offset by increased spending on BL-8040.

Sales and marketing expenses for the year ended December 31, 2015 were $1.0 million, a decrease of $0.6 million, or 37.5%, compared to $1.6 million for the year ended December 31, 2014. The decrease resulted primarily from professional fees related to business development activities carried out in 2014, including professional services related to the strategic collaboration agreement with Novartis and the out-licensing agreement with Omega Pharma regarding BL-5010.

General and administrative expenses for the year ended December 31, 2015 were $3.7 million, a decrease of $0.1 million, or 2.6%, compared to $3.8 million for the year ended December 31, 2014. The decrease primarily resulted from a decrease in salary-related payments, partially offset by a small increase in professional fees.

The Company’s operating loss for the year ended December 31, 2015 amounted to $16.2 million, compared with an operating loss of $17.3 million for the year ended December 31, 2014.

The Company recognized net non-operating income of $1.4 million for the year ended December, 2015, compared to net non-operating income of $3.1 million for the year ended December 31, 2014. Non-operating income for both periods primarily relates to fair-value adjustments of liabilities on account of warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (i.e., warrant revaluation date).
 
 
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Net financial income amounted to $0.4 million for the year ended December 31, 2015, compared to net financial income of $3.1 million for the year ended December 31, 2014. Net financial income for 2015 primarily relates to investment income earned on bank deposits, partially offset by banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate prior to adoption of the dollar as the Company’s functional and reporting currency, effective as of January 1, 2015.

The Company’s net loss for the year ended December 31, 2015 amounted to $14.4 million, compared with a net loss of $11.1 million for the year ended December 31, 2014.

The Company held $47.7 million in cash, cash equivalents and short-term bank deposits as of December 31, 2015.

Net cash used in operating activities for the year ended December 31, 2015 was $14.2 million, compared to $15.8 million for the year ended December 31, 2014. The decrease in net cash used in operating activities in 2015 was primarily the result of a decrease in the Company’s operating loss.

Net cash used in investing activities for the year ended December 31, 2015 was $15.6 million, compared to $19.7 million for the year ended December 31, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2015 was $29.5 million, compared to $32.6 million for the year ended December 31, 2014. The cash flows in 2015 primarily reflect the underwritten public offering of the Company’s ADSs in March 2015. The cash flows in 2014 primarily reflect the underwritten public offering of the Company’s ADSs in March 2014, as well as the investment made by Novartis pursuant to the strategic collaboration agreement with them signed in December 2014.

Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its year-end 2015 results today, March 10, 2016, at 10:00 a.m. EST. To access the conference call, please dial 1-888-407-2553 from the US, or +972-3-918-0644 internationally. The call will also be available via live webcast through BioLineRx’s website. A replay of the conference call will be available approximately two hours after completion of the live conference call. To access the replay, please dial 1-888-254-7270 from the US or +972-3-925-5945 internationally. The replay will be available through March 13, 2016.

(Tables follow)

About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, 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 is in the midst of a Phase 2 study for relapsed/refractory AML, has recently initiated a Phase 2b study as an AML consolidation treatment, has recently initiated a Phase 1/2 study in hMDS and AA, and has successfully completed a Phase 1 study in stem cell mobilization; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates, and has recently signed a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2 study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®.
 
 
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For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.

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 10, 2016. 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:
PCG Advisory
Vivian Cervantes
Investor Relations
212-554-5482
vivian@pcgadvisory.com

or

Tsipi Haitovsky
Public Relations
+972-3-624-0871
tsipihai5@gmail.com
 
 
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BioLineRx Ltd.
 
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

   
December 31,
 
   
2013
   
2014
   
2015
 
   
in USD thousands
 
Assets
                 
CURRENT ASSETS
                 
Cash and cash equivalents
    8,899       5,790       5,544  
Short-term bank deposits
    9,319       28,890       42,119  
Prepaid expenses
    258       221       229  
Other receivables
    360       257       291  
Total current assets
    18,836       35,158       48,183  
                         
NON-CURRENT ASSETS
                       
Restricted deposits
    165       166       -  
Long-term prepaid expenses
    49       49       58  
Property and equipment, net
    712       721       2,909  
Intangible assets, net
    253       117       152  
Total non-current assets
    1,179       1,053       3,119  
Total assets
    20,015       36,211       51,302  
                         
Liabilities and equity
                       
CURRENT LIABILITIES
                       
Current maturities of long-term bank loan
    -       -       93  
Accounts payable and accruals:
                       
Trade
    2,289       1,654       1,910  
Other
    764       1,252       1,137  
Total current liabilities
    3,053       2,906       3,140  
                         
NON-CURRENT LIABILITIES
                       
Long-term bank loan, net of current maturities
    -       -       344  
Warrants
    5,240       1,500       208  
Total non-current liabilities
    5,240       1,500       552  
COMMITMENTS AND CONTINGENT LIABILITIES
                       
Total liabilities
    8,293       4,406       3,692  
                         
EQUITY
                       
Ordinary shares
    640       1,055       1,455  
Share premium
    134,390       167,331       196,201  
Other comprehensive income (loss)
    1,418       (1,416 )     (1,416 )
Capital reserve
    9,163       9,800       10,735  
Accumulated deficit
    (133,889 )     (144,965 )     (159,365 )
Total equity
    11,722       31,805       47,610  
Total liabilities and equity
    20,015       36,211       51,302  
 
 
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BioLineRx Ltd.
 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

   
Year ended December 31,
 
   
2013
   
2014
   
2015
 
   
in USD thousands
 
                   
RESEARCH AND DEVELOPMENT EXPENSES, NET
    (12,208 )     (11,866 )     (11,489 )
SALES AND MARKETING EXPENSES
    (1,136 )     (1,589 )     (1,003 )
GENERAL AND ADMINISTRATIVE EXPENSES
    (3,664 )     (3,800 )     (3,704 )
OPERATING LOSS
    (17,008 )     (17,255 )     (16,196 )
NON-OPERATING INCOME, NET
    1,161       3,061       1,445  
FINANCIAL INCOME
    720       3,566       457  
FINANCIAL EXPENSES
    (1,897 )     (448 )     (106 )
NET LOSS
    (17,024 )     (11,076 )     (14,400 )
OTHER COMPREHENSIVE INCOME (LOSS):
                       
CURRENCY TRANSLATION DIFFERENCES
    1,097       (2,834 )     -  
COMPREHENSIVE LOSS
    (15,927 )     (13,910 )     (14,400 )
 
   
in USD
 
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
    (0.76 )     (0.34 )     (0.28 )
                         
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
    22,488,516       32,433,883       51,406,434  

 
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BioLineRx Ltd.
 
CONSOLIDATED CASH FLOW STATEMENTS

   
Year ended December 31,
 
   
2013
   
2014
   
2015
 
   
in USD thousands
 
CASH FLOWS - OPERATING ACTIVITIES
                 
Net loss
    (17,024 )     (11,076 )     (14,400 )
Adjustments required to reflect net cash used in operating activities (see appendix below)
    (2,501 )     (4,674 )     232  
Net cash used in operating activities
    (19,525 )     (15,750 )     (14,168 )
                         
CASH FLOWS - INVESTING ACTIVITIES
                       
Investments in short-term deposits
    (35,665 )     (57,186 )     (63,130 )
Maturities of short-term deposits
    29,669       37,650       50,083  
Maturities of restricted deposits
    795       -       166  
Purchase of property and equipment
    (85 )     (187 )     (2,683 )
Purchase of intangible assets
    (32 )     (6 )     (36 )
Net cash used in investing activities
    (5,318 )     (19,729 )     (15,600 )
                         
CASH FLOWS - FINANCING ACTIVITIES
                       
Issuance of share capital and warrants, net of issuance costs
    15,108       32,635       29,053  
Proceeds of bank loan
    -       -       467  
Repayments of bank loan
    (37 )     -       (31 )
Proceeds from exercise of employee stock options
    3       -       -  
Net cash provided by financing activities
    15,074       32,635       29,489  
                         
DECREASE IN CASH AND CASH EQUIVALENTS
    (9,769 )     (2,844 )     (279 )
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
    18,307       8,899       5,790  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
    361       (265 )     33  
CASH AND CASH EQUIVALENTS - END OF YEAR
    8,899       5,790       5,544  

 
7

 
 
BioLineRx Ltd.
 
CONSOLIDATED CASH FLOW STATEMENTS

   
Year ended December 31,
 
   
2013
   
2014
   
2015
 
   
in USD thousands
 
APPENDIX
                 
                   
Adjustments required to reflect net cash used in operating activities:
                 
                   
Income and expenses not involving cash flows:
                 
Depreciation and amortization
    318       269       441  
Write-off of intangible assets
    38       105       -  
Retirement benefit obligations
    2       (42 )     -  
Long-term prepaid expenses
    10       (6 )     (9 )
Exchange differences on cash and cash equivalents
    653       (261 )     (33 )
Warrant issuance costs
    130       -       -  
Gain on adjustment of warrants to fair value
    (1,432 )     (3,454 )     (1,292 )
Commitment fee paid by issuance of share capital
    -       303       -  
Share-based compensation
    842       1,055       1,152  
Interest and exchange differences on short-term deposits
    395       (2,787 )     (182 )
Interest and linkage differences on bank loan
    (3 )     -       1  
Interest and exchange differences on restricted deposits
    11       (20 )     -  
      964       (4,838 )     78  
                         
Changes in operating asset and liability items:
                       
Decrease (increase) in trade accounts receivable and other receivables
    253       80       (42 )
Increase (decrease) in accounts payable and accruals
    (3,718 )     84       196  
      (3,465 )     164       154  
                         
      (2,501 )     (4,674 )     232  
                         
Supplementary information on investing and financing activities not involving cash flows:
                       
Credit received in connection with purchase of property and equipment
    -       143       87  
                         
Supplementary information on interest received in cash
    139       97       173  

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