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BioLineRx Ltd. - 1498403 - 2021
0001498403false--12-312021Q2

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 August 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 August 18, 2021, the Registrant issued a press release announcing its financial results for the three and six months ended June 30, 2021. The Registrant is also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of June 30, 2021 and for the three and six months then ended. Attached hereto are the following exhibits:
 
This Form 6-K, the text under the heading “Financial Results for the Quarter Ended June 30, 2021” in Exhibit 1, and Exhibit 2 and Exhibit 3 are 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: August 18, 2021
 

 

Exhibit 1


For Immediate Release

BioLineRx Reports Second Quarter 2021 Financial Results
and Provides Corporate Update

- Company aggressively proceeding with activities in support of NDA submission
for Motixafortide in stem cell mobilization targeted for H1 2022 -
 
- Cash and cash equivalents of $66 million at June 30, 2021 -
 
- Management to hold conference call today, August 18, at 10:00 am EDT -

Tel Aviv, Israel, August 18, 2021 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2021 and provides a corporate update.

Significant events and achievements during the second quarter 2021 and subsequent period:


Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized enough cells for transplantation with only one administration of Motixafortide and in only one apheresis session.


Based on the positive results from the GENESIS study, the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year. This is consistent with prior guidance.


Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard-of-care and primary mobilization agent (in combination with G-CSF). The aim of the study is to demonstrate significant clinical benefits and cost savings from reduced numbers of doses and apheresis sessions, higher rates of transplantation and quality-of-life benefits in Motixafortide- treated patients; initial data on track to be announced in the second half of this year.



Ended the second quarter on a solid financial footing, with cash and cash equivalents of $66 million.

“Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we announced in May, we are working vigorously to submit an NDA in the first half of next year,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “If approved, this would be transformative for BioLineRx as we would have a commercial-stage molecule in multiple myeloma and significant potential clinical utility in other cancer indications as well, most notably pancreatic cancer.”

Mr. Serlin continued, “GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem cells necessary for transplantation – in approximately 90% of cases with only one dose of Motixafortide and in one apheresis session – potentially resulting in significant clinical benefits for patients and cost savings for payers. We believe there is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard-of-care for all multiple myeloma patients, not only for those patients who are poor mobilizers. To that end, we are advancing a pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new stem-cell-mobilization treatment paradigm.

“In parallel with these activities, the versatility of Motixafortide demonstrated in studies to date has attracted interest from potential partners, and we continue to engage in productive discussions.”

“We are very well financed with $66 million of cash, sufficient to bring Motixafortide through potential FDA approval in SCM while continuing to advance our other clinical programs,” concluded Mr. Serlin.

Upcoming Significant Expected Milestones:


Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021;


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


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


NDA submission for SCM in the first half of 2022;


Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined.

2

 
Financial Results for the Quarter Ended June 30, 2021

Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%, compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide, and a timing difference related to a tax credit received in respect of AGI-134. Research and development expenses for the six months ended June 30, 2021 were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the six months ended June 30, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials and a timing difference related to a tax credit received in respect of AGI-134; offset by higher expenses related to Motixafortide NDA supporting activities and by an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period.

Sales and marketing expenses for the three months ended June 30, 2021 were $0.3 million, an increase of $0.1 million, or 81.3%, compared to $0.2 million for the three months ended June 30, 2020. The increase resulted primarily from consultancy services related to Motixafortide. Sales and marketing expenses for the six months ended June 30, 2021 were $0.5 million, an increase of $0.1 million, or 35.6%, compared to $0.4 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

General and administrative expenses for the three months ended June 30, 2021 were $1.0 million, an increase of $0.3 million, or 40.3%, compared to $0.7 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the six months ended June 30, 2021 were $2.1 million, an increase of $0.1 million, or 3.7%, compared to $2.0 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

The Company's operating loss for the three months ended June 30, 2021 amounted to $6.5 million, compared to an operating loss of $5.6 million for the comparable period in 2020. The Company’s operating loss for the six months ended June 30, 2021 was $12.0 million, compared to $12.4 million for the comparable period in 2020.

Non-operating expenses for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

3

Net financial expenses for the three months ended June 30, 2021 amounted to $0.1 million compared to net financial expenses of $0.4 million for the three months ended June 30, 2020. Net financial expenses for the six months ended June 30, 2021 amounted to $0.3 million compared to net financial expenses of $0.6 million for the six months ended June 30, 2020. Net financial expenses for all periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company's net loss for the three months ended June 30, 2021 amounted to $6.8 million, similar to the comparable period in 2020. The Company’s net loss for the six months ended June 30, 2021 amounted to $17.0 million, compared with a net loss of $13.4 million for the comparable period in 2020. The increase in net loss between the six-month periods results from an increase in 2021 non-operating expenses in connection with fair-value adjustments of warrant liabilities on the Company’s balance sheet.

The Company held $66 million in cash, cash equivalents and short-term bank deposits as of June 30, 2021.

Net cash used in operating activities was $13.1 million for the six months ended June 30, 2021, compared with net cash used in operating activities of $12.3 million for the six months ended June 30, 2020. The $0.8 million increase in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a larger increase in prepaid expenses and other receivables in 2021 versus 2020, as well as a larger decrease in accounts payable and accruals in 2021 versus 2020.

Net cash used in investing activities was $42.3 million for the six months ended June 30, 2021, compared to net cash provided by investing activities of $0.6 million for the six months ended June 30, 2020. 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 $56.0 million for the six months ended June 30, 2021, compared to net cash provided by financing activities of $12.0 million for the six months ended June 30, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of our ADSs in January 2021, warrant exercises, and net proceeds from the ATM Facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information
 
BioLineRx will hold a conference call today, Wednesday, August 18, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US 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.

4

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 20, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

(Tables follow)

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, and is currently in preparations for an NDA submission. 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 also 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.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)

   
December 31,
   
June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
16,831
     
17,484
 
Short-term bank deposits
   
5,756
     
48,083
 
Prepaid expenses
   
152
     
837
 
Other receivables
   
141
     
668
 
Total current assets
   
22,880
     
67,072
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
1,341
     
1,136
 
Right-of-use assets, net
   
1,355
     
1,415
 
Intangible assets, net
   
21,714
     
21,706
 
Total non-current assets
   
24,410
     
24,257
 
Total assets
   
47,290
     
91,329
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loan
   
3,092
     
3,354
 
Accounts payable and accruals:
               
Trade
   
5,918
     
5,318
 
Other
   
1,440
     
1,071
 
Lease liabilities
   
191
     
174
 
Total current liabilities
   
10,641
     
9,917
 
NON-CURRENT LIABILITIES
               
Warrants
   
10,218
     
4,812
 
Long-term loan, net of current maturities
   
2,740
     
1,006
 
Lease liabilities
   
1,661
     
1,701
 
Total non-current liabilities
   
14,619
     
7,519
 
COMMITMENTS AND CONTINGENT LIABILITIES
               
Total liabilities
   
25,260
     
17,436
 
                 
EQUITY
               
Ordinary shares
   
9,870
     
20,496
 
Share premium
   
279,241
     
335,887
 
Warrants
   
-
     
975
 
Capital reserve
   
12,322
     
12,972
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(277,987
)
   
(295,021
)
Total equity
   
22,030
     
73,893
 
Total liabilities and equity
   
47,290
     
91,329
 

6

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

   
Three months ended June 30,
   
Six months ended June 30,
 
   
2020
   
2021
   
2020
   
2021
 
   
in USD thousands
   
in USD thousands
 
RESEARCH AND DEVELOPMENT EXPENSES
   
(4,640
)
   
(5,139
)
   
(10,062
)
   
(9,417
)
SALES AND MARKETING EXPENSES
   
(182
)
   
(330
)
   
(357
)
   
(484
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(744
)
   
(1,044
)
   
(1,987
)
   
(2,061
)
OPERATING LOSS
   
(5,566
)
   
(6,513
)
   
(12,406
)
   
(11,962
)
NON-OPERATING EXPENSES, NET
   
(843
)
   
(217
)
   
(374
)
   
(4,778
)
FINANCIAL INCOME
   
35
     
130
     
175
     
247
 
FINANCIAL EXPENSES
   
(396
)
   
(242
)
   
(810
)
   
(541
)
NET LOSS AND COMPREHENSIVE LOSS
   
(6,770
)
   
(6,842
)
   
(13,415
)
   
(17,034
)

   
in USD
   
in USD
 
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
   
(0.03
)
   
(0.01
)
   
(0.07
)
   
(0.03
)
                                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
   
220,317,889
     
669,138,994
     
198,277,447
     
614,780,845
 

7

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

   
Ordinary
   
Share
         
Capital
   
Other
Comprehensive
   
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT JANUARY 1, 2020
   
4,692
     
265,938
     
-
     
12,132
     
(1,416
)
   
(247,966
)
   
33,380
 
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2020:
                                                       
Issuance of share capital, net
   
3,581
     
4,754
     
-
     
-
     
-
     
-
     
8,335
 
Employee stock options exercised
   
8
     
224
     
-
     
(224
)
   
-
     
-
     
8
 
Employee stock options forfeited and expired
   
-
     
191
     
-
     
(191
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
922
     
-
     
-
     
922
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(13,415
)
   
(13,415
)
BALANCE AT JUNE 30, 2020
   
8,281
     
271,107
     
-
     
12,639
     
(1,416
)
   
(261,381
)
   
29,230
 

   
Ordinary
   
Share
         
Capital
   
Other
Comprehensive
   
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT JANUARY 1, 2021
   
9,870
     
279,241
     
-
     
12,322
     
(1,416
)
   
(277,987
)
   
22,030
 
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2021:
                                                       
Issuance of share capital and warrants, net
   
8,386
     
37,495
     
975
     
-
     
-
     
-
     
46,856
 
Warrants exercised
   
2,235
     
18,967
     
-
     
-
     
-
     
-
     
21,202
 
Employee stock options exercised
   
5
     
41
     
-
     
(39
)
   
-
     
-
     
7
 
Employee stock options forfeited and expired
   
-
     
143
     
-
     
(143
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
832
     
-
     
-
     
832
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(17,034
)
   
(17,034
)
BALANCE AT JUNE 30, 2021
   
20,496
     
335,887
     
975
     
12,972
     
(1,416
)
   
(295,021
)
   
73,893
 

8


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

   
Ordinary
   
Share
         
Capital
   
Other
Comprehensive
   
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT APRIL 1, 2020
   
4,907
     
267,140
     
-
     
12,488
     
(1,416
)
   
(254,611
)
   
28,508
 
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2020:
                                                       
Issuance of share capital, net
   
3,373
     
3,859
     
-
     
-
     
-
     
-
     
7,232
 
Employee stock options exercised
   
1
     
20
     
-
     
(20
)
   
-
     
-
     
1
 
Employee stock options forfeited and expired
   
-
     
88
     
-
     
(88
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
259
     
-
     
-
     
259
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(6,770
)
   
(6,770
)
BALANCE AT JUNE 30, 2020
   
8,281
     
271,107
     
-
     
12,639
     
(1,416
)
   
(261,381
)
   
29,230
 

   
Ordinary
   
Share
         
Capital
   
Other
Comprehensive
   
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT APRIL 1, 2021
   
18,731
     
321,920
     
975
     
12,616
     
(1,416
)
   
(288,179
)
   
64,647
 
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2021:
                                                       
Issuance of share capital, net
   
1,581
     
12,516
     
-
     
-
     
-
     
-
     
14,097
 
Warrants exercised
   
184
     
1,444
     
-
     
-
     
-
     
-
     
1,628
 
Employee stock options exercised
   
-
     
3
     
-
     
(1
)
   
-
     
-
     
2
 
Employee stock options forfeited and expired
   
-
     
4
     
-
     
(4
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
361
     
-
     
-
     
361
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(6,842
)
   
(6,842
)
BALANCE AT JUNE 30, 2021
   
20,496
     
335,887
     
975
     
12,972
     
(1,416
)
   
(295,021
)
   
73,893
 

9


BioLineRx Ltd.
 CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
 (UNAUDITED)
 
   
Six months ended June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
             
CASH FLOWS - OPERATING ACTIVITIES
           
Comprehensive loss for the period
   
(13,415
)
   
(17,034
)
Adjustments required to reflect net cash used in operating activities
(see appendix below)
   
1,112
     
3,977
 
Net cash used in operating activities
   
(12,303
)
   
(13,057
)
                 
CASH FLOWS – INVESTING ACTIVITIES
               
Investments in short-term deposits
   
(23,751
)
   
(58,000
)
Maturities of short-term deposits
   
24,335
     
15,776
 
Purchase of property and equipment
   
(1
)
   
(38
)
Net cash provided by (used in) investing activities
   
583
     
(42,262
)
                 
CASH FLOWS – FINANCING ACTIVITIES
               
Issuance of share capital and warrants, net of issuance costs
   
13,411
     
46,856
 
Exercise of warrants
   
-
     
10,907
 
Employee stock options exercised
   
8
     
7
 
Repayments of loans
   
(1,331
)
   
(1,648
)
Repayments of lease liabilities
   
(121
)
   
(122
)
Net cash provided by financing activities
   
11,967
     
56,000
 
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
247
     
681
 
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
   
5,297
     
16,831
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(21
)
   
(28
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
   
5,523
     
17,484
 

10

BioLineRx Ltd.
 APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
 (UNAUDITED)
 
   
Six months ended June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
             
Adjustments required to reflect net cash used in operating activities:
           
Income and expenses not involving cash flows:
           
Depreciation and amortization
   
533
     
362
 
Exchange differences on cash and cash equivalents
   
21
     
28
 
Fair value adjustments of warrants
   
(250
)
   
4,889
 
Share-based compensation
   
922
     
832
 
Warrant issuance costs
   
593
     
-
 
Interest and exchange differences on short-term deposits
   
(171
)
   
(103
)
Interest on loans
   
36
     
176
 
Exchange differences on lease liability
   
(8
)
   
(26
)
     
1,676
     
6,158
 
                 
Changes in operating asset and liability items:
               
Increase in prepaid expenses and other receivables
   
(146
)
   
(1,212
)
  Decrease in accounts payable and accruals
   
(418
)
   
(969
)
     
(564
)
   
(2,181
)
     
1,112
     
3,977
 
                 
Supplemental information on interest received in cash
   
300
     
39
 
                 
Supplemental information on interest paid in cash
   
534
     
350
 
                 
Supplemental information on non-cash transactions:
               
Acquisition of right-of-use asset
   
-
     
171
 
                 
Exercise of warrants (portion related to accumulated fair value adjustments)
   
-
     
10,295
 
 

11
BioLineRx Ltd. - 1498403 - 2021
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Exhibit 2
 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2021
 
 

 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2021
 
TABLE OF CONTENTS
 
  
Page
 
F-1
 
F-2
 
F-3-F-4
 
F-5-F-6
 
F-7-F-10
 
 

 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
 
   
December 31,
   
June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
16,831
     
17,484
 
Short-term bank deposits
   
5,756
     
48,083
 
Prepaid expenses
   
152
     
837
 
Other receivables
   
141
     
668
 
Total current assets
   
22,880
     
67,072
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
1,341
     
1,136
 
Right-of-use assets, net
   
1,355
     
1,415
 
Intangible assets, net
   
21,714
     
21,706
 
Total non-current assets
   
24,410
     
24,257
 
Total assets
   
47,290
     
91,329
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loan
   
3,092
     
3,354
 
Accounts payable and accruals:
               
Trade
   
5,918
     
5,318
 
Other
   
1,440
     
1,071
 
Lease liabilities
   
191
     
174
 
Total current liabilities
   
10,641
     
9,917
 
NON-CURRENT LIABILITIES
               
Warrants
   
10,218
     
4,812
 
Long-term loan, net of current maturities
   
2,740
     
1,006
 
Lease liabilities
   
1,661
     
1,701
 
Total non-current liabilities
   
14,619
     
7,519
 
COMMITMENTS AND CONTINGENT LIABILITIES
           
Total liabilities
   
25,260
     
17,436
 
                 
EQUITY
               
Ordinary shares
   
9,870
     
20,496
 
Share premium
   
279,241
     
335,887
 
Warrants
   
-
     
975
 
Capital reserve
   
12,322
     
12,972
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(277,987
)
   
(295,021
)
Total equity
   
22,030
     
73,893
 
Total liabilities and equity
   
47,290
     
91,329
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 


BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
 
   
Three months ended June 30,
   
Six months ended June 30,
 
   
2020
   
2021
   
2020
   
2021
 
   
in USD thousands
   
in USD thousands
 
RESEARCH AND DEVELOPMENT EXPENSES
   
(4,640
)
   
(5,139
)
   
(10,062
)
   
(9,417
)
SALES AND MARKETING EXPENSES
   
(182
)
   
(330
)
   
(357
)
   
(484
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(744
)
   
(1,044
)
   
(1,987
)
   
(2,061
)
OPERATING LOSS
   
(5,566
)
   
(6,513
)
   
(12,406
)
   
(11,962
)
NON-OPERATING EXPENSES, NET
   
(843
)
   
(217
)
   
(374
)
   
(4,778
)
FINANCIAL INCOME
   
35
     
130
     
175
     
247
 
FINANCIAL EXPENSES
   
(396
)
   
(242
)
   
(810
)
   
(541
)
NET LOSS AND COMPREHENSIVE LOSS
   
(6,770
)
   
(6,842
)
   
(13,415
)
   
(17,034
)
                                 
   
in USD
   
in USD
 
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
   
(0.03
)
   
(0.01
)
   
(0.07
)
   
(0.03
)
                                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
   
220,317,889
     
669,138,994
     
198,277,447
     
614,780,845
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
 

F -  2


 
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
 
   
 
Ordinary
   
 
Share
         
 
Capital
   
Other
Comprehensive
   
 
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT JANUARY 1, 2020
   
4,692
     
265,938
     
-
     
12,132
     
(1,416
)
   
(247,966
)
   
33,380
 
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2020:
                                                       
Issuance of share capital, net
   
3,581
     
4,754
     
-
     
-
     
-
     
-
     
8,335
 
Employee stock options exercised
   
8
     
224
     
-
     
(224
)
   
-
     
-
     
8
 
Employee stock options forfeited and expired
   
-
     
191
     
-
     
(191
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
922
     
-
     
-
     
922
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(13,415
)
   
(13,415
)
BALANCE AT JUNE 30, 2020
   
8,281
     
271,107
     
-
     
12,639
     
(1,416
)
   
(261,381
)
   
29,230
 
 
   
 
Ordinary
   
 
Share
         
 
Capital
   
Other
Comprehensive
   
 
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT JANUARY 1, 2021
   
9,870
     
279,241
     
-
     
12,322
     
(1,416
)
   
(277,987
)
   
22,030
 
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2021:
                                                       
Issuance of share capital and warrants, net
   
8,386
     
37,495
     
975
     
-
     
-
     
-
     
46,856
 
Warrants exercised
   
2,235
     
18,967
     
-
     
-
     
-
     
-
     
21,202
 
Employee stock options exercised
   
5
     
41
     
-
     
(39
)
   
-
     
-
     
7
 
Employee stock options forfeited and expired
   
-
     
143
     
-
     
(143
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
832
     
-
     
-
     
832
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(17,034
)
   
(17,034
)
BALANCE AT JUNE 30, 2021
   
20,496
     
335,887
     
975
     
12,972
     
(1,416
)
   
(295,021
)
   
73,893
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F -  3


 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
 
   
 
Ordinary
   
 
Share
         
 
Capital
   
Other
Comprehensive
   
 
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT APRIL 1, 2020
   
4,907
     
267,140
     
-
     
12,488
     
(1,416
)
   
(254,611
)
   
28,508
 
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2020:
                                                       
Issuance of share capital, net
   
3,373
     
3,859
     
-
     
-
     
-
     
-
     
7,232
 
Employee stock options exercised
   
1
     
20
     
-
     
(20
)
   
-
     
-
     
1
 
Employee stock options forfeited and expired
   
-
     
88
     
-
     
(88
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
259
     
-
     
-
     
259
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(6,770
)
   
(6,770
)
BALANCE AT JUNE 30, 2020
   
8,281
     
271,107
     
-
     
12,639
     
(1,416
)
   
(261,381
)
   
29,230
 
 
   
 
Ordinary
   
 
Share
           
 
Capital
   
Other
Comprehensive
   
 
Accumulated
         
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT APRIL 1, 2021
   
18,731
     
321,920
     
975
     
12,616
     
(1,416
)
   
(288,179
)
   
64,647
 
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2021:
                                                       
Issuance of share capital, net
   
1,581
     
12,516
     
-
     
-
     
-
     
-
     
14,097
 
Warrants exercised
   
184
     
1,444
     
-
     
-
     
-
     
-
     
1,628
 
Employee stock options exercised
   
-
     
3
     
-
     
(1
)
   
-
     
-
     
2
 
Employee stock options forfeited and expired
   
-
     
4
     
-
     
(4
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
361
     
-
     
-
     
361
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(6,842
)
   
(6,842
)
BALANCE AT JUNE 30, 2021
   
20,496
     
335,887
     
975
     
12,972
     
(1,416
)
   
(295,021
)
   
73,893
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
 

F -  4


 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Six months ended June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
CASH FLOWS - OPERATING ACTIVITIES
           
Comprehensive loss for the period
   
(13,415
)
   
(17,034
)
Adjustments required to reflect net cash used in operating activities (see appendix below)
   
1,112
     
3,977
 
Net cash used in operating activities
   
(12,303
)
   
(13,057
)
                 
CASH FLOWS – INVESTING ACTIVITIES
               
Investments in short-term deposits
   
(23,751
)
   
(58,000
)
Maturities of short-term deposits
   
24,335
     
15,776
 
Purchase of property and equipment
   
(1
)
   
(38
)
Net cash provided by (used in) investing activities
   
583
     
(42,262
)
                 
CASH FLOWS – FINANCING ACTIVITIES
               
Issuance of share capital and warrants, net of issuance costs
   
13,411
     
46,856
 
Exercise of warrants
   
-
     
10,907
 
Employee stock options exercised
   
8
     
7
 
Repayments of loans
   
(1,331
)
   
(1,648
)
Repayments of lease liabilities
   
(121
)
   
(122
)
Net cash provided by financing activities
   
11,967
     
56,000
 
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
247
     
681
 
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
   
5,297
     
16,831
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(21
)
   
(28
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
   
5,523
     
17,484
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
 

F -  5


 
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Six months ended June 30,
 
   
2020
   
2021
 
   
in USD thousands
 
             
Adjustments required to reflect net cash used in operating activities:
           
Income and expenses not involving cash flows:
           
Depreciation and amortization
   
533
     
362
 
Exchange differences on cash and cash equivalents
   
21
     
28
 
Fair value adjustments of warrants
   
(250
)
   
4,889
 
Share-based compensation
   
922
     
832
 
Warrant issuance costs
   
593
     
-
 
Interest and exchange differences on short-term deposits
   
(171
)
   
(103
)
Interest on loans
   
36
     
176
 
Exchange differences on lease liability
   
(8
)
   
(26
)
     
1,676
     
6,158
 
                 
Changes in operating asset and liability items:
               
Increase in prepaid expenses and other receivables
   
(146
)
   
(1,212
)
 Decrease in accounts payable and accruals
   
(418
)
   
(969
)
     
(564
)
   
(2,181
)
     
1,112
     
3,977
 
                 
Supplemental information on interest received in cash
   
300
     
39
 
                 
Supplemental information on interest paid in cash
   
534
     
350
 
                 
Supplemental information on non-cash transactions:
               
Acquisition of right-of-use asset
   
-
     
171
 
                 
Exercise of warrants (portion related to accumulated fair value adjustments)
   
-
     
10,295
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F -  6


 
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
 
NOTE 1 – GENERAL INFORMATION
 
  a.
General
 
BioLineRx Ltd. (“BioLineRx”), headquartered in Modi’in, Israel, was incorporated and commenced operations in April 2003. BioLineRx and its subsidiaries (collectively, the “Company”) are engaged in the development of therapeutics, primarily in clinical stages, with a focus on the field of oncology.
 
The Company’s American Depositary Shares (“ADSs”) are traded on the NASDAQ Capital Market, and its ordinary shares are traded on the Tel Aviv Stock Exchange (“TASE”). Each ADS represents 15 ordinary shares.
 
In March 2017, the Company acquired Agalimmune Ltd. (“Agalimmune”), a privately held company incorporated in the United Kingdom, with a focus on the field of immuno-oncology.
 
Although the Company has succeeded in generating significant revenues from a number of out-licensing transactions in the past, it cannot determine with reasonable certainty if and when it will become profitable on a current basis. Management believes that the Company’s current cash and other resources will be sufficient to fund its projected cash requirements into the first half of 2024. However, in the event that the Company does not begin to generate sustainable cash flows from its operating activities in the future, the Company will need to carry out significant cost reductions or raise additional funding.
 
  b.
Approval of financial statements
 
The condensed consolidated interim financial statements of the Company as of June 30, 2021, and for the six months then ended, were approved by the Board of Directors on August 15, 2021, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer and the Chief Financial Officer.

 

F -  7


 
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)

 

NOTE 2 – BASIS OF PREPARATION
 
The Company’s condensed consolidated interim financial statements as of June 30, 2021 and for the three and six months then ended (the “interim financial statements”) have been prepared in accordance with International Accounting Standard No. 34, “Interim Financial Reporting” (“IAS 34”). These interim financial statements, which are unaudited, do not include all disclosures necessary for a fair statement of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards (“IFRS”). The condensed consolidated interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2020 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
 
The preparation of financial statements in conformity with IFRS requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity and expenses, as well as the related disclosures of contingent assets and liabilities, in the process of applying the Company’s accounting policies. These inputs also consider, among other things, the implications of the COVID-19 pandemic on the Company’s activities, and the resultant effects on critical and significant accounting estimates, most significantly in relation to the value of intangible assets. The COVID-19 pandemic has spread to many countries throughout the world, including to the United States, Europe and Israel, where the Company currently manufactures its therapeutic candidates and conducts its clinical trials. The Company has previously experienced some recruitment delays from the deepening and extended impact of COVID-19 on its clinical trials; however, at present, the Company does not believe these delays will significantly impact its clinical development plans. Future developments related to COVID-19 are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as its overall economic impact, and more specifically its effects on the financial markets. All estimates made by the Company related to the impact of COVID-19 in its financial statements may change in future periods. Actual results could differ from those estimates.

 

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES
 
The accounting policies and calculation methods applied in the preparation of these interim financial statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2020 and for the year then ended.

 

F -  8


 
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)

 

NOTE 4 – AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW
 
In September 2020, the Company entered into an ATM sales agreement with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as sales agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remains in effect. The Company agreed to pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility.
 
During the six months period ended June 30, 2021, the Company issued a total of 3,920,539 ADSs for total gross proceeds of $16.0 million. From the effective date of the agreement through the issuance date of this report, 7,381,101 ADSs were sold under the program for total gross proceeds of approximately $24.5 million, leaving an available balance under the facility of approximately $0.5 million as of the issuance date of this report.

 

NOTE 5 – UNDERWRITTEN PUBLIC OFFERING
 
In January 2021, the Company completed an underwritten public offering of 14,375,000 of its ADSs at a public offering price of $2.40 per ADS. The offering raised total gross proceeds of $34.5 million, with net proceeds of $31.4 million after deducting fees and expenses. In addition, warrants to purchase 718,750 ADSs were granted to the underwriters. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $3.00 per ADS.
 
The warrants have been classified as shareholders’ equity, with initial recognition at fair value on the date issued. The total issuance costs initially allocated to the warrants were recorded as an offset to share premium.
 
The fair value of the warrants on the issuance date was approximately $1.0 million, which was recorded as issuance costs, and computed using the Black and Scholes option pricing model, based upon the then current price of an ADS, a risk-free interest rate of approximately 0.45% and an average standard deviation of approximately 73.8%.
 

F -  9


 
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
 
NOTE 6 – SHAREHOLDERS’ EQUITY
 
As of December 31, 2020 and June 30, 2021, share capital is composed of ordinary shares, as follows:
 
 
   
Number of ordinary shares
 
   
December 31,
   
June 30,
 
   
2020
   
2021
 
             
Authorized share capital
   
1,500,000,000
     
1,500,000,000
 
                 
Issued and paid-up share capital
   
349,169,545
     
696,748,668
 
 
   
In USD and NIS
 
   
December 31,
   
June 30,
 
   
2020
   
2021
 
             
Authorized share capital (in NIS)
   
150,000,000
     
150,000,000
 
                 
Issued and paid-up share capital (in NIS)
   
34,916,955
     
69,674,867
 
                 
Issued and paid-up share capital (in USD)
   
9,869,795
     
20,496,207
 

 

 
F - 10

 

Exhibit 3

OPERATING AND FINANCIAL REVIEW

You should read the following discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K, as well as in our Annual Report on Form 20-F filed on February 23, 2021 (the “Annual Report”).

Forward Looking Statements