EX-99 2 exhibit_1.htm REGISTRANT'S PRESS RELEASE DATED MAY 20, 2020
Exhibit 1


For Immediate Release

BioLineRx Reports First Quarter 2020 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 -
 
- Key data readouts in AML and stem cell mobilization expected by year-end -

- Management to hold conference call today, May 20, at 10:00 am EDT -

TEL AVIV, Israel, May 20, 2020 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2020 and provides a corporate update.

Highlights and achievements during the first quarter 2020 and subsequent period:
 

 •
Completed recruitment of the triple combination arm of the COMBAT/KEYNOTE-202 study;
 

 •
Continued to advance the COMBAT/KEYNOTE-202 study toward progression free survival (PFS) and overall survival (OS) data in mid-2020;
 

 •
Received Orphan Drug Designation for motixafortide (BL-8040) for the Treatment of Pancreatic Cancer in Europe;
 

 •
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.
 
“The ongoing COVID-19 pandemic has caused an unprecedented disruption in business activities and continues to impact drug development timelines around the world,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “During this crisis, we have remained in close contact with our principal investigators, and we remain on track to report important survival data from the triple combination arm of our ongoing Phase 2a COMBAT/KEYNOTE-202 study in advanced second-line pancreatic cancer mid-year, consistent with our prior guidance. The compelling and sustained preliminary response data on 22 evaluable patients that we reported in December give us hope that the combination of motixafortide, KEYTRUDA® and chemotherapy could represent a significant breakthrough in one of the most difficult to treat cancers.
 
“We also continue to expect results from our ongoing BLAST Phase 2b study of motixafortide in consolidation therapy for AML patients and our GENESIS Phase 3 trial in stem cell mobilization for autologous transplantation in multiple myeloma patients by the end of this year.
 
“Development of our second clinical candidate, AGI-134, has been impacted by COVID-19, as enrollment in the Phase 1/2a trial has been temporarily suspended. We now expect data from that study in the second half of next year.
 
“We have taken swift actions in response to the pandemic to conserve cash and ensure that we can successfully navigate through this unprecedented time. But we remain as enthusiastic as ever about the broad therapeutic potential of motixafortide to treat a broad range of cancers, and we look forward to three important data readouts this year,” Mr. Serlin concluded.
 
Upcoming 2020 and 2021 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 BLAST Phase 2b AML consolidation study in the second half of 2020;
 

 •
Results from the GENESIS Phase 3 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, which were initially expected by year-end 2020, are now anticipated in the second half of 2021 due to a temporary suspension of recruitment caused by the COVID-19 pandemic.
 
Financial Results for the Quarter Ended March 31, 2020
 
Research and development expenses for the quarter ended March 31, 2020 were $5.4 million, an increase of $1.0 million, or 23.5%, compared to $4.4 million for the comparable period in 2019. The increase resulted primarily from higher expenses associated with the motixafortide COMBAT clinical trial as well as an increase in share-based compensation.
 
Sales and marketing expenses for the quarter ended March 31, 2020 were $0.2 million, a decrease of $0.1 million, or 31.6%, compared to $0.3 million for the comparable period in 2019. The decrease resulted primarily from a decrease in payroll and related expenses.
 
General and administrative expenses for the quarter ended March 31, 2020 were $1.2 million, an increase of $0.3 million, or 33.7%, compared to $0.9 million for the comparable period in 2019. The increase resulted primarily from an increase in share-based compensation.
 
The Company's operating loss for the quarter ended March 31, 2020 amounted to $6.8 million, compared to an operating loss of $5.6 million for the comparable period in 2019.
 
Non-operating income amounted to $0.5 million for the quarter ended March 31, 2020, compared to non-operating expense of $0.3 million for the comparable period in 2019. Non-operating income for the three months ended March 31, 2020 primarily relates to fair-value adjustments of warrant liabilities on the Company’s balance sheet. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on the Company’s balance sheet.
 
2
Net financial expenses amounted to $0.3 million for the quarter ended March 31, 2020, compared to net financial expenses of $0.2 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.
 
The Company's net loss for the quarter ended March 31, 2020 amounted to $6.6 million, compared with a net loss of $6.2 million for the comparable period in 2019.
 
The Company held $21.2 million in cash, cash equivalents and short-term bank deposits as of March 31, 2020.
 
Net cash used in operating activities was $6.7 million for the quarter ended March 31, 2020, compared with net cash used in operating activities of $4.6 million for the comparable period in 2019. The $2.1 million increase in net cash used in operating activities during the three-month period in 2020, compared to the three-month period in 2019, was primarily the result of changes in operating asset and liability items in the two periods, i.e., an increase in prepaid expenses and other receivables in 2020 versus a decrease in 2019, as well as higher decrease in accounts payable and accruals in 2020 versus 2019.
 
Net cash provided by investing activities was $6.2 million for the quarter ended March 31, 2020, compared to net cash used in investing activities of $9.3 million for the comparable period in 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 was $0.4 million for the quarter ended March 31, 2020, compared to net cash provided by financing activities of $14.9 million for the comparable period in 2019. The decrease 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, May 20, 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 May 22, 2020; please dial +1-888-782-4291 from the US or +972-3-925-5928 internationally.

(Tables follow)

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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

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

4
 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)

             
   
December 31,
    
March 31,
  
   
2019
    
2020
  
   
in USD thousands
  
Assets
            
CURRENT ASSETS
            
Cash and cash equivalents
    
5,297
      
5,072
  
Short-term bank deposits
    
22,192
      
16,109
  
Prepaid expenses
    
108
      
277
  
Other receivables
    
613
      
682
  
Total current assets
    
28,210
      
22,140
  
                 
NON-CURRENT ASSETS
                
Property and equipment, net
    
1,816
      
1,698
  
Right-of-use assets, net
    
1,650
      
1,565
  
Intangible assets, net
    
21,891
      
21,768
  
Total non-current assets
    
25,357
      
25,031
  
Total assets
    
53,567
      
47,171
  
                 
Liabilities and equity
                
CURRENT LIABILITIES
                
Current maturities of long-term loans
    
2,692
      
2,777
  
Accounts payable and accruals:
                
Trade
    
7,794
      
7,489
  
Other
    
1,280
      
1,303
  
Lease liabilities
    
202
      
197
  
Total current liabilities
    
11,968
      
11,766
  
NON-CURRENT LIABILITIES
                
Warrants
    
658
      
182
  
Long-term loans, net of current maturities
    
5,799
      
5,076
  
Lease liabilities
    
1,762
      
1,639
  
Total non-current liabilities
    
8,219
      
6,897
  
COMMITMENTS AND CONTINGENT LIABILITIES
                
Total liabilities
    
20,187
      
18,663
  
                 
EQUITY
                
Ordinary shares
    
4,692
      
4,907
  
Share premium
    
265,938
      
267,140
  
Capital reserve
    
12,132
      
12,488
  
Other comprehensive loss
    
(1,416
)
    
(1,416
)
Accumulated deficit
    
(247,966
)
    
(254,611
)
Total equity
    
33,380
      
28,508
  
Total liabilities and equity
    
53,567
      
47,171
  

5

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

   
Three months ended March 31,
  
   
2019
    
2020
  
   
in USD thousands
  
RESEARCH AND DEVELOPMENT EXPENSES
    
(4,392
)
    
(5,422
)
SALES AND MARKETING EXPENSES
    
(256
)
    
(175
)
GENERAL AND ADMINISTRATIVE EXPENSES
    
(930
)
    
(1,243
)
OPERATING LOSS
    
(5,578
)
    
(6,840
)
NON-OPERATING INCOME (EXPENSES), NET
    
(340
)
    
469
  
FINANCIAL INCOME
    
210
      
140
  
FINANCIAL EXPENSES
    
(447
)
    
(414
)
NET LOSS AND COMPREHENSIVE LOSS
    
(6,155
)
    
(6,645
)
                 
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
    
(0.05
)
    
(0.04
)
                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
    CALCULATION OF LOSS PER ORDINARY SHARE
    
132,979,984
      
176,454,423
  

6

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

   
Ordinary shares
    
Share premium
    
Capital Reserve
    
Other comprehensive loss
    
Accumulated deficit
    
Total
  
   
in USD thousands
  
BALANCE AT JANUARY 1, 2019
    
3,110
      
250,192
      
11,955
      
(1,416
)
    
(222,520
)
    
41,321
  
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2019:
                                                
Issuance of share capital, net
    
817
      
9,620
      
-
      
-
      
-
      
10,437
  
Employee stock options exercised
    
1
      
18
      
(18
)
    
-
      
-
      
1
  
Employee stock options forfeited and expired
    
-
      
30
      
(30
)
    
-
      
-
      
-
  
Share-based compensation
    
-
      
-
      
284
      
-
      
-
      
284
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
(6,155
)
    
(6,155
)
BALANCE AT MARCH 31, 2019
    
3,928
      
259,860
      
12,191
      
(1,416
)
    
(228,675
)
    
45,888
  

   
Ordinary shares
    
Share premium
    
Capital Reserve
    
Other comprehensive loss
    
Accumulated deficit
    
Total
  
   
in USD thousands
  
BALANCE AT JANUARY 1, 2020
    
4,692
      
265,938
      
12,132
      
(1,416
)
    
(247,966
)
    
33,380
  
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2020:
                                                
Issuance of share capital, net
    
208
      
895
      
-
      
-
      
-
      
1,103
  
Employee stock options exercised
    
7
      
204
      
(204
)
    
-
      
-
      
7
  
Employee stock options forfeited and expired
    
-
      
103
      
(103
)
    
-
      
-
      
-
  
Share-based compensation
    
-
      
-
      
663
      
-
      
-
      
663
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
(6,645
)
    
(6,645
)
BALANCE AT MARCH 31, 2020
    
4,907
      
267,140
      
12,488
      
(1,416
)
    
(254,611
)
    
28,508
  

7
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)

   
Three months ended
March 31,
  
   
2019
    
2020
  
   
in USD thousands
  
             
CASH FLOWS - OPERATING ACTIVITIES
            
Comprehensive loss for the period
    
(6,155
)
    
(6,645
)
Adjustments required to reflect net cash used in operating activities
 (see appendix below)
    
1,533
      
(93
)
Net cash used in operating activities
    
(4,622
)
    
(6,738
)
                 
CASH FLOWS - INVESTING ACTIVITIES
                
Investments in short-term deposits
    
(21,510
)
    
(6,000
)
Maturities of short-term deposits
    
12,228
      
12,191
  
Purchase of property and equipment
    
(31
)
    
-
  
Net cash provided by (used in) investing activities
    
(9,313
)
    
6,191
  
                 
CASH FLOWS - FINANCING ACTIVITIES
                
Issuance of share capital and warrants, net of issuance costs
    
14,989
      
1,103
  
Employee stock options exercised
    
1
      
7
  
Repayments of loans
    
(23
)
    
(682
)
Repayments of lease liabilities
    
(50
)
    
(41
)
Net cash provided by financing activities
    
14,917
      
387
  
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    
982
      
(160
)
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
    
3,404
      
5,297
  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
    
(2
)
    
(65
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
    
4,384
      
5,072
  

8
 
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Three months ended
March 31,
  
   
2019
    
2020
  
   
in USD thousands
  
             
Adjustments required to reflect net cash used in operating activities:
            
Income and expenses not involving cash flows:
            
Depreciation and amortization
    
213
      
321
  
Long-term prepaid expenses
    
1
      
-
  
Exchange differences on cash and cash equivalents
    
2
      
65
  
Fair value adjustments of warrants
    
(79
)
    
(476
)
Share-based compensation
    
284
      
663
  
Warrant issuance costs
    
417
      
-
  
Interest and exchange differences on short-term deposits
    
(195
)
    
(108
)
Interest on loans
    
154
      
44
  
Exchange differences on lease liability
    
-
      
(82
)
     
797
      
427
  
                 
Changes in operating asset and liability items:
                
Decrease (increase) in prepaid expenses and other receivables
    
786
      
(238
)
Decrease in accounts payable and accruals
    
(50
)
    
(282
)
     
736
      
(520
)
     
1,533
      
(93
)
                 
Supplemental information on interest received in cash
    
229
      
184
  
                 
Supplemental information on interest paid in cash
    
238
      
275
  

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