EX-99 2 exhibit_1.htm REGISTRANT'S PRESS RELEASE DATED AUGUST 6, 2019

Exhibit 1


For Immediate Release

BioLineRx Reports Second Quarter 2019 Financial Results
and Provides Corporate Update

On track for Phase 2 data read-out in pancreatic cancer by year-end 2019

Management to hold conference call today, August 6, at 10:00 am EDT

TEL AVIV, Israel, August 6, 2019 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2019 and provides a corporate update.

Highlights and achievements during the second quarter 2019 and subsequent period:


 •
Continued to advance multiple clinical trials of its lead therapeutic candidates, BL-8040 and AGI-134, and anticipates top-line data from the triple combination arm of the COMBAT/KEYNOTE-202 pancreatic cancer trial by year-end.


•
Received approval from the FDA for an Investigational New Drug (IND) application for AGI-134, which will enable expansion of the ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.

“BL-8040, our lead drug candidate, is rapidly advancing in multiple promising programs. The triple combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2 study of BL-8040, KEYTRUDA® and chemotherapy in metastatic pancreatic cancer is progressing as planned, and top-line results are expected by year end. AML consolidation also remains an important indication in our BL-8040 development plan, and we, with our partners, continue to progress our BLAST Phase 2b study towards a robust interim analysis. In addition, the GENESIS Phase 3 study in stem cell mobilization, our most advanced indication and most direct path to registration, is progressing as planned with top-line results expected in the second half of next year,” stated Philip Serlin, Chief Executive Officer of BioLineRx.

“Regarding our second clinical candidate, the universal anti-cancer vaccine AGI-134, we continue to advance our phase 1/2a clinical trial toward initial safety data later this year, and with the acceptance of our IND, we look forward to the next part of the study, which will assess potential efficacy. Taken together, we believe our broad development pipeline provides multiple opportunities for long-term value creation and we are diligently working toward that goal,” Mr. Serlin concluded.

Upcoming Milestones

Second half of 2019


 •
Top-line results from COMBAT/KEYNOTE-202 Phase 2 pancreatic cancer trial
 

 •
Initial safety results from part 1 of Phase 1/2a trial of AGI-134
 

 •
Potential interim results from Phase 2b AML consolidation study
 

 •
Initiation of monotherapy basket arm of Part 2 of Phase 1/2a trial of AGI-134
 
2020


 •
Progression-free survival (PFS) and overall survival (OS) data from COMBAT/KEYNOTE-202 trial in mid-2020
 

 •
Top-line results from Phase 3 GENESIS registration trial in stem-cell mobilization in second half of 2020

Financial Results for the Second Quarter Ended June 30, 2019

Research and development expenses for the three months ended June 30, 2019 were $5.3 million, an increase of $0.8 million, or 18%, compared to $4.5 million for the three months ended June 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials. Research and development expenses for the six months ended June 30, 2019 were $9.7 million, an increase of $0.1 million, or 2%, compared to $9.6 million for the six months ended June 30, 2018. The small increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated, as well as a decrease in payroll and related expenses.

2
Sales and marketing expenses for the three months ended June 30, 2019 were $0.2 million, a decrease of $0.1 million, or 37%, compared to $0.3 million for the three months ended June 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses. Sales and marketing expenses for the six months ended June 30, 2019 were $0.5 million, a decrease of $0.4 million, or 43%, compared to $0.9 million for the six months ended June 30, 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 three months ended June 30, 2019 were $0.9 million, similar to the comparable period in 2018. General and administrative expenses for the six months ended June 30, 2019 were $1.9 million, similar to the comparable period in 2018.

The Company’s operating loss for the three months ended June 30, 2019 was $6.5 million, compared to $5.7 million for the three months ended June 30, 2018. The Company’s operating loss for the six months ended June 30, 2019 was $12.1 million, compared to $12.4 million for the comparable period in 2018.

Non-operating income for the three and six months ended June 30, 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 six months ended June 30, 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 $0.3 million for the three months ended June 30, 2019 compared to net financial income of $0.3 million for the three months ended June 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions. Net financial expenses amounted to $0.5 million for the six months ended June 30, 2019 compared to net financial income of $0.3 million for the six months ended June 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions.

3
The Company’s net loss for the three months ended June 30, 2019 amounted to $5.5 million, compared with a net loss of $4.8 million for the comparable period in 2018. The Company’s net loss for the six months ended June 30, 2019 amounted to $11.6 million, compared with a net loss of $11.0 million for the comparable period in 2018.

The Company held $35.2 million in cash, cash equivalents and short-term bank deposits as of June 30, 2019.

Net cash used in operating activities was $11.1 million for the six months ended June 30, 2019, compared with net cash used in operating activities of $13.0 million for the six months ended June 30, 2018. The $1.9 million decrease in net cash used in operating activities during the six-month period in 2019, compared to the six-month period in 2018, 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 a higher decrease in accounts payable and accruals in 2018.

Net cash used in investing activities was $3.1 million for the six months ended June 30, 2019, compared to net cash provided by investing activities of $10.8 million for the six months ended June 30, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and the realization of the investment in iPharma in 2018.
 
Net cash provided by financing activities was $15.7 million for the six months ended June 30, 2019, compared to net cash provided by financing activities of $2.8 million for the six months ended June 30, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.
 
Conference Call and Webcast Information

BioLineRx will hold a conference call today, August 6, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0644 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 August 8, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

(Tables follow)

4
About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. The Company in-licenses novel compounds, 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 has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is being investigated in a Phase 1/2a study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD, on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and KEYTRUDA® (pembrolizumab), and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s atezolizumab in two Phase 1b/2 studies for solid tumor indications.

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 28, 2019. 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.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)

   
December 31,
    
June 30,
  
   
2018
    
2019
  
   
in USD thousands
  
Assets
            
CURRENT ASSETS
            
Cash and cash equivalents
    
3,404
      
4,972
  
Short-term bank deposits
    
26,747
      
30,256
  
Prepaid expenses
    
488
      
451
  
Other receivables
    
1,339
      
528
  
Total current assets
    
31,978
      
36,207
  
                 
NON-CURRENT ASSETS
                
Long-term prepaid expenses
    
56
      
60
  
Property and equipment, net
    
2,227
      
2,047
  
Right-of-use assets
    
-
      
1,716
  
Intangible assets, net
    
21,972
      
21,928
  
Total non-current assets
    
24,255
      
25,751
  
Total assets
    
56,233
      
61,958
  
                 
Liabilities and equity
                
CURRENT LIABILITIES
                
Current maturities of long-term loans
    
895
      
2,395
  
Accounts payable and accruals:
                
Trade
    
4,493
      
4,565
  
Other
    
1,363
      
927
  
Lease liabilities
    
-
      
672
  
Total current liabilities
    
6,751
      
8,559
  
NON-CURRENT LIABILITIES
                
Warrants
    
323
      
3,938
  
Long-term loans, net of current maturities
    
7,838
      
6,583
  
Lease liabilities
    
-
      
1,096
  
Total non-current liabilities
    
8,161
      
11,617
  
COMMITMENTS AND CONTINGENT LIABILITIES
                
Total liabilities
    
14,912
      
20,176
  
                 
EQUITY
                
Ordinary shares
    
3,110
      
4,001
  
Share premium
    
250,192
      
261,522
  
Capital reserve
    
11,955
      
11,835
  
Other comprehensive loss
    
(1,416
)
    
(1,416
)
Accumulated deficit
    
(222,520
)
    
(234,160
)
Total equity
    
41,321
      
41,782
  
Total liabilities and equity
    
56,233
      
61,958
  

6

BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)

   
Three months ended June 30,
    
Six months ended June 30,
  
   
2018
    
2019
    
2018
    
2019
  
   
in USD thousands
    
in USD thousands
  
RESEARCH AND DEVELOPMENT EXPENSES
    
(4,484
)
    
(5,302
)
    
(9,554
)
    
(9,694
)
SALES AND MARKETING EXPENSES
    
(360
)
    
(226
)
    
(844
)
    
(482
)
GENERAL AND ADMINISTRATIVE EXPENSES
    
(883
)
    
(949
)
    
(1,958
)
    
(1,879
)
OPERATING LOSS
    
(5,727
)
    
(6,477
)
    
(12,356
)
    
(12,055
)
NON-OPERATING INCOME, NET
    
663
      
1,261
      
1,125
      
921
  
FINANCIAL INCOME
    
287
      
171
      
462
      
381
  
FINANCIAL EXPENSES
    
(11
)
    
(440
)
    
(217
)
    
(887
)
                                 
NET LOSS AND COMPREHENSIVE LOSS
    
(4,788
)
    
(5,485
)
    
(10,986
)
    
(11,640
)
                                 
   
in USD
    
in USD
  
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
    
(0.05
)
    
(0.04
)
    
(0.10
)
    
(0.08
)
                                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
    
106,630,704
      
145,461,598
      
106,524,332
      
139,270,178
  


7

BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)

   
Ordinary
    
Share
    
Capital
    
Other
Comprehensive
    
Accumulated
        
   
shares
    
premium
    
reserve
    
loss
    
deficit
    
Total
  
   
in USD thousands
  
BALANCE AT JANUARY 1, 2018
    
2,836
      
240,682
      
10,337
      
(1,416
)
    
(199,558
)
    
52,881
  
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2018:
                                                
Issuance of share capital, net
    
83
      
2,764
      
-
      
-
      
-
      
2,847
  
Employee stock options exercised
    
1
      
38
      
(39
)
    
-
      
-
      
-
  
Employee stock options forfeited and expired
    
-
      
399
      
(399
)
    
-
      
-
      
-
  
Share-based compensation
    
-
      
-
      
1,444
      
-
      
-
      
1,444
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
(10,986
)
    
(10,986
)
BALANCE AT JUNE 30, 2018
    
2,920
      
243,883
      
11,343
      
(1,416
)
    
(210,544
)
    
46,186
  

   
Ordinary
    
Share
    
Capital
    
Other
Comprehensive
    
Accumulated
        
   
shares
    
premium
    
reserve
    
loss
    
deficit
    
Total
  
   
in USD thousands
  
BALANCE AT JANUARY 1, 2019
    
3,110
      
250,192
      
11,955
      
(1,416
)
    
(222,520
)
    
41,321
  
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2019:
                                                
Issuance of share capital, net
    
890
      
10,437
      
-
      
-
      
-
      
11,327
  
Employee stock options exercised
    
1
      
27
      
(27
)
    
-
      
-
      
1
  
Employee stock options forfeited and expired
    
-
      
866
      
(866
)
    
-
      
-
      
-
  
Share-based compensation
    
-
      
-
      
773
      
-
      
-
      
773
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
(11,640
)
    
(11,640
)
BALANCE AT JUNE 30, 2019
    
4,001
      
261,522
      
11,835
      
(1,416
)
    
(234,160
)
    
41,782
  

8
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)

   
Six months ended June 30,
  
   
2018
    
2019
  
   
in USD thousands
  
             
CASH FLOWS - OPERATING ACTIVITIES
            
Comprehensive loss for the period
    
(10,986
)
    
(11,640
)
Adjustments required to reflect net cash used in operating activities (see appendix below)
    
(2,054
)
    
573
  
Net cash used in operating activities
    
(13,040
)
    
(11,067
)
                 
CASH FLOWS - INVESTING ACTIVITIES
                
Investments in short-term deposits
    
(15,000
)
    
(27,510
)
Maturities of short-term deposits
    
24,385
      
24,441
  
Proceeds from realization of long-term investment
    
1,500
      
-
  
Purchase of property and equipment
    
(76
)
    
(53
)
Purchase of intangible assets
    
(37
)
    
-
  
Net cash provided by (used in) investing activities
    
10,772
      
(3,122
)
                 
CASH FLOWS - FINANCING ACTIVITIES
                
Issuances of share capital and warrants, net of issuance cost
    
2,847
      
15,879
  
Employee stock options exercised
    
-
      
1
  
Repayments of loans
    
(47
)
    
(47
)
Repayments of lease liabilities
    
-
      
(110
)
Net cash provided by financing activities
    
2,800
      
15,723
  
                 
INCREASE IN CASH AND CASH EQUIVALENTS
    
532
      
1,534
  
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
    
5,110
      
3,404
  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
    
147
      
34
  
CASH AND CASH EQUIVALENTS - END OF PERIOD
    
5,789
      
4,972
  

9


BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)

   
Six months ended June 30,
  
   
2018
    
2019
  
   
in USD thousands
  
             
Adjustments required to reflect net cash used in operating activities:
            
Income and expenses not involving cash flows:
            
Depreciation and amortization
    
288
      
439
  
Long-term prepaid expenses
    
(2
)
    
(4
)
Exchange differences on cash and cash equivalents
    
(147
)
    
(34
)
Gain on adjustment of warrants to fair value
    
(625
)
    
(1,354
)
Gain on realization of long-term investment
    
(500
)
    
-
  
Share-based compensation
    
1,444
      
773
  
Warrant issuance costs
    
-
      
417
  
Interest and exchange rate differences on short-term deposits
    
(351
)
    
(440
)
Interest on loans
    
(1
)
    
292
  
     
106
      
89
  
                 
Changes in operating asset and liability items:
                
Decrease (increase) in prepaid expenses and other receivables
    
(776
)
    
848
  
  Decrease in accounts payable and accruals
    
(1,384
)
    
(364
)
     
(2,160
)
    
484
  
     
(2,054
)
    
573
  
                 
Supplemental information on interest received in cash
    
377
      
442
  
                 
Supplemental information on interest paid in cash
    
167
      
477
  
                 
Supplemental information on non-cash transaction -
                
Initial establishment of right-of-use assets against lease liabilities
    
-
      
1,878
  


10