0001498403false--12-31Q2

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 2024
 
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

 
On August 15, 2024, the Registrant issued a press release announcing its financial results for the three and six months ended June 30, 2024. The Registrant is also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of June 30, 2024 and for the three and six months then ended. Attached hereto are the following exhibits:
 
 
 
 
This Form 6-K, the text under the heading “Second Quarter 2024 Financial Results” in Exhibit 1, 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 A. Serlin
 
 
 
Philip A. Serlin
 
 
 
Chief Executive Officer
 
 
Dated: August 15, 2024
 



Exhibit 99.1

FOR IMMEDIATE RELEASE

BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate
and Portfolio Updates
 
- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37%
of stem cell transplant procedures performed, surpassing stated goal for quarter;
on-track to reach goal of ~60% by end of Q4 -

- Doubled the number of centers ordering APHEXDA during the second quarter -

- Entered into clinical trial agreement with St. Jude Children’s Research Hospital to evaluate
motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease -

- Management to host conference call today, August 15, at 8:30 am EDT -

TEL AVIV, Israel, August 15, 2024 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates.

“We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent,” said Philip Serlin, Chief Executive Officer of BioLineRx.  “Importantly, among our targeted top 80 transplant centers, we’ve secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal.  Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers’ growing recognition of the value that APHEXDA offers relative to other mobilization agents.  Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.

“Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children’s Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy.  This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.).  APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients.  The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection.  We look forward to seeing early data from the Wash U. Phase 1 trial later this year.”


APHEXDA Launch Updates
 

Among top 80 transplant centers, secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, exceeding the company’s stated goal for the quarter; on track to achieve ~60% by year-end 2024
 

Saw double the number of centers ordering APHEXDA during the second quarter as compared to the first quarter, which contributed to quarter-over-quarter net revenue growth of 100%
 
Clinical Portfolio Updates
 
Motixafortide
 
Multiple Myeloma
 

Presented a poster at the American Society for Apheresis (ASFA) 2024 Annual Meeting on April 17, 2024, demonstrating that transplant centers (averaging, for example, 20 transplants per month), when switching to G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF in combination with plerixafor
 

Presented a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on April 6, 2024, showing that even with APHEXDA’s higher drug acquisition cost compared to other mobilization regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the combination of G-CSF plus APHEXDA may confer a similar or better overall financial impact while providing centers and patients with an improved mobilization experience


Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China.  Anticipate initiation of pivotal clinical trial in 2H 2024
 
Sickle Cell Disease (SCD) & Gene Therapy
 

Entered into clinical trial agreement with St. Jude Children’s Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease.  The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD.  Anticipate first patient dosed in September 2024 and initial data in 2025
 

Reported continuing enrollment of patients into a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease.  The trial, in collaboration with Washington University School of Medicine in St. Louis, has been expanded from five to 10 patients.  Anticipate initial data in 2H 2024
 
Pancreatic Ductal Adenocarcinoma (mPDAC)
 

Presented positive biopsy data from the completed pilot phase of the ongoing CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held on June 1, 2024 in Chicago, IL.  New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach (P=0.007).  Enrollment in the randomized trial targeting 108 patients continues with full enrollment anticipated in 2027
 

Completed design of Phase 2b randomized clinical trial in China with collaboration partner Gloria Biosciences intended to assess motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
 

Second Quarter 2024 Financial Results
 

Total revenue for the three months ended June 30, 2024 was $5.4 million.  The Company did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S.
 

Cost of revenue for the three months ended June 30, 2024 was $0.9 million. The Company did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales
 

Research and development expenses for the three months ended June 30, 2024 were $2.2 million, compared to $3.0 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, termination of the development of AGI-134 and a decrease in share-based compensation
 

Sales and marketing expenses for the three months ended June 30, 2024 were $6.4 million, compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with a fully hired field team
 

General and administrative expenses for the three months ended June 30, 2024 were $1.6 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from an increase in legal and certain other expenses
 

Net income for the three months ended June 30, 2024 was $0.5 million, compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both primarily related to the non-cash revaluation of warrants
 

As of June 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025
 

Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company'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. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company’s first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
 
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
 
Forward Looking Statement
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 "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors 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; whether BioLineRx’s collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; 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, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize 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 and ability to access sufficient additional financing, including any unexpected costs or delays in the  commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. 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 26, 2024. 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.

Contacts:

United States
John Lacey
BioLineRx
IR@biolinerx.com

Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com


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

   
December 31,
   
June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
4,255
     
9,623
 
Short-term bank deposits
   
38,739
     
30,437
 
Trade receivables
   
358
     
3,179
 
Prepaid expenses
   
1,048
     
1,581
 
Other receivables
   
830
     
656
 
Inventory
   
1,953
     
3,634
 
Total current assets
   
47,183
     
49,110
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
473
     
344
 
Right-of-use assets, net
   
1,415
     
1,452
 
Intangible assets, net
   
14,854
     
13,690
 
Total non-current assets
   
16,742
     
15,486
 
Total assets
   
63,925
     
64,596
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loan
   
3,145
     
10,656
 
Contract liabilities
   
12,957
     
5,477
 
Accounts payable and accruals:
               
Trade
   
10,869
     
6,266
 
Other
   
3,353
     
2,530
 
Current maturities of lease liabilities
   
528
     
500
 
Warrants
   
11,932
     
5,087
 
Total current liabilities
   
42,784
     
30,516
 
NON-CURRENT LIABILITIES
               
Long-term loan, net of current maturities
   
6,628
     
18,790
 
Lease liabilities
   
1,290
     
1,309
 
Total non-current liabilities
   
7,918
     
20,099
 
CONTINGENT LIABILITIES
               
Total liabilities
   
50,702
     
50,615
 
                 
EQUITY
               
Ordinary shares
   
31,355
     
34,411
 
Share premium
   
355,482
     
352,428
 
Warrants
   
1,408
     
1,408
 
Capital reserve
   
17,000
     
17,968
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(390,606
)
   
(390,818
)
Total equity
   
13,223
     
13,981
 
Total liabilities and equity
   
63,925
     
64,596
 




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

   
Three months ended
June 30,
   
Six months ended
June 30,
 
   
2023
   
2024
   
2023
   
2024
 
   
in USD thousands
   
in USD thousands
 
REVENUES
   
-
     
5,393
     
-
     
12,248
 
COST OF REVENUES
   
-
     
(897
)
   
-
     
(2,352
)
GROSS PROFIT
   
-
     
4,496
     
-
     
9,896
 
RESEARCH AND DEVELOPMENT EXPENSES
   
(3,006
)
   
(2,225
)
   
(6,690
)
   
(4,719
)
SALES AND MARKETING EXPENSES
   
(5,604
)
   
(6,415
)
   
(9,478
)
   
(12,757
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(1,305
)
   
(1,629
)
   
(2,603
)
   
(3,015
)
OPERATING LOSS
   
(9,915
)
   
(5,773
)
   
(18,771
)
   
(10,595
)
NON-OPERATING INCOME (EXPENSES), NET
   
(7,733
)
   
7,807
     
(10,649
)
   
12,297
 
FINANCIAL INCOME
   
440
     
535
     
977
     
1,100
 
FINANCIAL EXPENSES
   
(1,337
)
   
(2,085
)
   
(2,264
)
   
(3,014
)
NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
   
(18,545
)
   
484
     
(30,707
)
   
(212
)
                                 
   
in USD
   
in USD
 
EARNINGS (LOSS) PER SHARE ATTRIBUTABLE TO ORDINARY SHAREHOLDERS
                               
BASIC
   
(0.02
)
   
0.00
     
(0.03
)
   
(0.00
)
DILUTED
   
(0.02
)
   
0.00
     
(0.03
)
   
(0.00
)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF EARNINGS (LOSS) PER SHARE
                               
BASIC
   
922,958,942
     
1,197,582,901
     
922,958,942
     
1,142,221,033
 
DILUTED
   
922,958,942
     
1,197,582,901
     
922,958,942
     
1,142,221,033
 


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, 2023
   
27,100
     
338,976
     
1,408
     
14,765
     
(1,416
)
   
(329,992
)
   
50,841
 
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2023:
                                                       
Employee stock options expired
   
-
     
69
     
-
     
(69
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
920
     
-
     
-
     
920
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(30,707
)
   
(30,707
)
BALANCE AT JUNE 30, 2023
   
27,100
     
339,045
     
1,408
     
15,616
     
(1,416
)
   
(360,699
)
   
21,054
 

   

Ordinary
   

Share
         

Capital
   
Other
comprehensive
   

Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
BALANCE AT JANUARY 1, 2024
   
31,355
     
355,482
     
1,408
     
17,000
     
(1,416
)
   
(390,606
)
   
13,223
 
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2024:
                                                       
Issuance of share capital and warrants, net
   
3,056
     
(3,056
)
   
-
     
-
     
-
     
-
     
-
 
Employee stock options forfeiture
                           
(66
)
                   
(66
)
Share-based compensation expenses
   
-
     
-
     
-
     
1,036
     
-
     
-
     
1,036
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(212
)
   
(212
)
BALANCE AT JUNE 30, 2024
   
34,411
     
352,426
     
1,408
     
17,970
     
(1,416
)
   
(390,818
)
   
13,981
 




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

   
Six months ended June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
             
CASH FLOWS - OPERATING ACTIVITIES
           
Comprehensive loss for the period
   
(30,707
)
   
(212
)
Adjustments required to reflect net cash used in operating activities (see appendix below)
   
13,009
     
(25,226
)
Net cash used in operating activities
   
(17,698
)
   
(25,438
)
                 
CASH FLOWS – INVESTING ACTIVITIES
               
Investments in short-term deposits
   
(6,006
)
   
(20,559
)
Maturities of short-term deposits
   
24,000
     
28,660
 
Purchase of property and equipment
   
(99
)
   
(59
)
Purchase of intangible assets
   
(153
)
   
-
 
Net cash provided by investing activities
   
17,742
     
8,042
 
                 
CASH FLOWS – FINANCING ACTIVITIES
               
Issuance of share capital and warrants, net of issuance cost
   
-
     
5,565
 
Net proceeds from loan
   
-
     
19,223
 
Repayments of loan
           
(1,547
)
Repayments of lease liabilities
   
(183
)
   
(256
)
Net cash provided by (used in) financing activities
   
(183
)
   
22,985
 
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(139
)
   
5,589
 
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
   
10,587
     
4,255
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(344
)
   
(221
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
   
10,104
     
9,623
 


 
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Six months ended June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
             
Adjustments required to reflect net cash used in operating activities:
           
Income and expenses not involving cash flows:
           
Depreciation and amortization
   
457
     
1,373
 
Exchange differences on cash and cash equivalents
   
344
     
221
 
Fair value adjustments of warrants
   
10,843
     
(12,845
)
Share-based compensation
   
920
     
970
 
Interest on short-term deposits
   
(210
)
   
201
 
Interest on loan
   
1,405
     
1,997
 
Exchange differences on lease liabilities
   
(75
)
   
189
 
Issuance cost of warrants
   
-
     
642
 
     
13,684
     
(7,252
)
                 
Changes in operating asset and liability items:
               
Increase in trade receivables
   
-
     
(2,821
)
Increase in prepaid expenses and other receivables
   
(958
)
   
(359
)
Increase in inventory
   
-
     
(1,681
)
Increase (decrease) in accounts payable and accruals
   
283
     
(5,633
)
Decrease in contract liabilities
   
-
     
(7,480
)
     
(675
)
   
(17,974
)
     
13,009
     
(25,226
)
                 
Supplemental information on interest received in cash
   
761
     
931
 
                 
Supplemental information on interest paid in cash
   
640
     
971
 
                 
Supplemental information on non-cash transactions:
               
Changes in right-of-use asset and lease liabilities
   
66
     
58
 
Warrant issuance costs
   
-
     
207
 







0001498403 2024-06-30 0001498403 2024-01-01 2024-06-30 0001498403 2023-01-01 2023-06-30 0001498403 2023-12-31 0001498403 2022-12-31 0001498403 2023-06-30 0001498403 2024-04-01 2024-06-30 0001498403 2023-04-01 2023-06-30 0001498403blrx:LoanAgreementWithKreosCapitalMember 2022-09-01 2022-09-30 0001498403blrx:FirstTrancheMemberblrx:LoanAgreementWithKreosCapitalMember 2022-09-01 2022-09-30 0001498403blrx:SecondTrancheMemberblrx:LoanAgreementWithKreosCapitalMember 2022-09-01 2022-09-30 0001498403ifrs-full:BottomOfRangeMemberblrx:LoanAgreementWithKreosCapitalMember 2022-09-01 2022-09-30 0001498403ifrs-full:TopOfRangeMemberblrx:LoanAgreementWithKreosCapitalMember 2022-09-01 2022-09-30 0001498403blrx:LoanAgreementWithKreosCapitalMember 2024-04-01 2024-04-30 0001498403ifrs-full:RetainedEarningsMember 2022-12-31 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2022-12-31 0001498403ifrs-full:CapitalReserveMember 2022-12-31 0001498403ifrs-full:WarrantsMember 2022-12-31 0001498403ifrs-full:SharePremiumMember 2022-12-31 0001498403ifrs-full:IssuedCapitalMember 2022-12-31 0001498403ifrs-full:RetainedEarningsMember 2023-01-01 2023-06-30 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2023-01-01 2023-06-30 0001498403ifrs-full:CapitalReserveMember 2023-01-01 2023-06-30 0001498403ifrs-full:WarrantsMember 2023-01-01 2023-06-30 0001498403ifrs-full:SharePremiumMember 2023-01-01 2023-06-30 0001498403ifrs-full:IssuedCapitalMember 2023-01-01 2023-06-30 0001498403ifrs-full:RetainedEarningsMember 2023-12-31 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2023-12-31 0001498403ifrs-full:CapitalReserveMember 2023-12-31 0001498403ifrs-full:WarrantsMember 2023-12-31 0001498403ifrs-full:SharePremiumMember 2023-12-31 0001498403ifrs-full:IssuedCapitalMember 2023-12-31 0001498403ifrs-full:RetainedEarningsMember 2024-01-01 2024-06-30 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2024-01-01 2024-06-30 0001498403ifrs-full:CapitalReserveMember 2024-01-01 2024-06-30 0001498403ifrs-full:WarrantsMember 2024-01-01 2024-06-30 0001498403ifrs-full:SharePremiumMember 2024-01-01 2024-06-30 0001498403ifrs-full:IssuedCapitalMember 2024-01-01 2024-06-30 0001498403ifrs-full:RetainedEarningsMember 2024-06-30 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2024-06-30 0001498403ifrs-full:CapitalReserveMember 2024-06-30 0001498403ifrs-full:WarrantsMember 2024-06-30 0001498403ifrs-full:SharePremiumMember 2024-06-30 0001498403ifrs-full:IssuedCapitalMember 2024-06-30 0001498403ifrs-full:RetainedEarningsMember 2023-06-30 0001498403blrx:MiscellaneousOtherComprehensiveLossMember 2023-06-30 0001498403ifrs-full:CapitalReserveMember 2023-06-30 0001498403ifrs-full:WarrantsMember 2023-06-30 0001498403ifrs-full:SharePremiumMember 2023-06-30 0001498403ifrs-full:IssuedCapitalMember 2023-06-30 0001498403blrx:BiokineTherapeuticsLtdMember 2024-06-01 2024-06-16 0001498403 2023-02-01 2023-02-05 0001498403blrx:LicenseAgreementMember 2023-10-01 2023-10-31 0001498403blrx:LicenseAgreementMembersrt:MinimumMember 2023-10-01 2023-10-31 0001498403blrx:LicenseAgreementMembersrt:MaximumMember 2023-10-01 2023-10-31 0001498403blrx:PurchaseAgreementMember 2023-10-01 2023-10-31 0001498403 2023-10-01 2023-10-31 0001498403blrx:ScmLicenseMember 2023-10-01 2023-12-31 0001498403blrx:ScmSupportServicesMember 2023-01-01 2023-12-31 0001498403blrx:PDACPerformanceObligationMember 2024-01-01 2024-06-30 0001498403blrx:LicenseAgreementMember 2024-04-01 2024-06-30 0001498403blrx:LicenseAgreementMember 2024-01-01 2024-06-30 0001498403blrx:HcwMember 2024-06-30 0001498403blrx:HcwMember 2024-01-01 2024-06-30 0001498403blrx:April2024OfferingMemberblrx:AmericanDepositarySharesMember 2024-04-01 2024-04-30 0001498403blrx:April2024OfferingMemberblrx:AmericanDepositarySharesMember 2024-04-30 0001498403blrx:April2024OfferingMember 2024-04-01 2024-04-30 0001498403blrx:AmericanDepositarySharesMember 2024-04-30 0001498403blrx:April2024OfferingMemberifrs-full:WarrantsMember 2024-04-01 2024-04-30 0001498403blrx:April2024OfferingMemberifrs-full:WarrantsMember 2024-04-30 0001498403blrx:April2024OfferingMemberifrs-full:WarrantsMember 2024-01-01 2024-06-30 0001498403blrx:April2024OfferingMember 2024-01-01 2024-06-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMember 2022-09-01 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMember 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMemberblrx:InvestorsMember 2022-09-01 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMemberblrx:InvestorsMember 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMemberblrx:PlacementAgentsDesigneesMember 2022-09-01 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMemberblrx:PlacementAgentsDesigneesMember 2022-09-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMember 2024-01-01 2024-06-30 0001498403blrx:September2022OfferingMemberifrs-full:WarrantsMember 2023-01-01 2023-12-31 0001498403blrx:September2022OfferingMember 2024-01-01 2024-06-30 iso4217:ILS xbrli:pure xbrli:shares iso4217:USD iso4217:USDxbrli:shares

Exhibit 2
 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2024
 

 
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2024
 
TABLE OF CONTENTS
 
  
Page
 
F-1
 
F-2
 
F-3
 
F-4 - F-5
 
F-6 - F-14
 

 

BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
 
   
December 31,
   
June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
             
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
4,255
     
9,623
 
Short-term bank deposits
   
38,739
     
30,437
 
Trade receivables
   
358
     
3,179
 
Prepaid expenses
   
1,048
     
1,581
 
Other receivables
   
830
     
656
 
Inventory
   
1,953
     
3,634
 
Total current assets
   
47,183
     
49,110
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
473
     
344
 
Right-of-use assets, net
   
1,415
     
1,452
 
Intangible assets, net
   
14,854
     
13,690
 
Total non-current assets
   
16,742
     
15,486
 
Total assets
   
63,925
     
64,596
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loan
   
3,145
     
10,656
 
Contract liabilities
   
12,957
     
5,477
 
Accounts payable and accruals:
               
Trade
   
10,869
     
6,266
 
Other
   
3,353
     
2,530
 
Current maturities of lease liabilities
   
528
     
500
 
Warrants
   
11,932
     
5,087
 
Total current liabilities
   
42,784
     
30,516
 
NON-CURRENT LIABILITIES
               
Long-term loan, net of current maturities
   
6,628
     
18,790
 
Lease liabilities
   
1,290
     
1,309
 
Total non-current liabilities
   
7,918
     
20,099
 
CONTINGENT LIABILITIES
           
Total liabilities
   
50,702
     
50,615
 
                 
EQUITY
               
Ordinary shares
   
31,355
     
34,411
 
Share premium
   
355,482
     
352,428
 
Warrants
   
1,408
     
1,408
 
Capital reserve
   
17,000
     
17,968
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(390,606
)
   
(390,818
)
Total equity
   
13,223
     
13,981
 
Total liabilities and equity
   
63,925
     
64,596
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F - 1


 

BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
 
   
Three months ended June 30,
   
Six months ended June 30,
 
   
2023
   
2024
   
2023
   
2024
 
   
in USD thousands
   
in USD thousands
 
                                 
REVENUES
   
-
     
5,393
     
-
     
12,248
 
COST OF REVENUES
   
-
     
(897
)
   
-
     
(2,352
)
GROSS PROFIT
   
-
     
4,496
     
-
     
9,896
 
RESEARCH AND DEVELOPMENT EXPENSES
   
(3,006
)
   
(2,225
)
   
(6,690
)
   
(4,719
)
SALES AND MARKETING EXPENSES
   
(5,604
)
   
(6,415
)
   
(9,478
)
   
(12,757
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(1,305
)
   
(1,629
)
   
(2,603
)
   
(3,015
)
OPERATING LOSS
   
(9,915
)
   
(5,773
)
   
(18,771
)
   
(10,595
)
NON-OPERATING INCOME (EXPENSES), NET
   
(7,733
)
   
7,807
     
(10,649
)
   
12,297
 
FINANCIAL INCOME
   
440
     
535
     
977
     
1,100
 
FINANCIAL EXPENSES
   
(1,337
)
   
(2,085
)
   
(2,264
)
   
(3,014
)
NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
   
(18,545
)
   
484
     
(30,707
)
   
(212
)
                                 
   
in USD
   
in USD
 
EARNINGS (LOSS) PER SHARE ATTRIBUTABLE TO ORDINARY SHAREHOLDERS
                               
BASIC
   
(0.02
)
   
0.00
 
   
(0.03
)
   
(0.00
)
DILUTED
   
(0.02
)
   
0.00
 
   
(0.03
)
   
(0.00
)
                                 

WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF EARNINGS (LOSS) PER SHARE

                               
BASIC
   

922,958,942

     

1,197,582,901

     

922,958,942

     

1,142,221,033

 
DILUTED
   
922,958,942
     
1,197,582,901
     
922,958,942
     
1,142,221,033
 
 
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, 2023
   
27,100
     
338,976
     
1,408
     
14,765
     
(1,416
)
   
(329,992
)
   
50,841
 
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2023:
                                                       
Employee stock options expired
   
-
     
69
     
-
     
(69
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
920
     
-
     
-
     
920
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(30,707
)
   
(30,707
)
BALANCE AT JUNE 30, 2023
   
27,100
     
339,045
     
1,408
     
15,616
     
(1,416
)
   
(360,699
)
   
21,054
 
 
   
 
Ordinary
   
 
Share
         
 
Capital
   
Other
comprehensive
   
 
Accumulated
       
   
shares
   
premium
   
Warrants
   
reserve
   
loss
   
deficit
   
Total
 
   
in USD thousands
 
                                                         
BALANCE AT JANUARY 1, 2024
   
31,355
     
355,482
     
1,408
     
17,000
     
(1,416
)
   
(390,606
)
   
13,223
 
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2024:
                                                       
Issuance of share capital and warrants, net
   
3,056
     
(3,056
)
   
-
     
-
     
-
     
-
     
-
 
Employee stock options forfeiture
                           
(66
)
                   
(66
)
Share-based compensation expenses
   
-
     
-
     
-
     
1,036
     
-
     
-
     
1,036
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(212
)
   
(212
)
BALANCE AT JUNE 30, 2024
   
34,411
     
352,426
     
1,408
     
17,970
     
(1,416
)
   
(390,818
)
   
13,981
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F - 3


 

BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Six months ended June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
             
CASH FLOWS - OPERATING ACTIVITIES
           
Comprehensive loss for the period
   
(30,707
)
   
(212
)
Adjustments required to reflect net cash used in operating activities
(see appendix below)
   
13,009
     
(25,226
)
Net cash used in operating activities
   
(17,698
)
   
(25,438
)
                 
CASH FLOWS – INVESTING ACTIVITIES
               
Investments in short-term deposits
   
(6,006
)
   
(20,559
)
Maturities of short-term deposits
   
24,000
     
28,660
 
Purchase of property and equipment
   
(99
)
   
(59
)
Purchase of intangible assets
   
(153
)
   
-
 
Net cash provided by investing activities
   
17,742
     
8,042
 
                 
CASH FLOWS – FINANCING ACTIVITIES
               
Issuance of share capital and warrants, net of issuance cost
   
-
     
5,565
 
Net proceeds from loan
   
-
     
19,223
 
Repayments of loan
           
(1,547
)
Repayments of lease liabilities
   
(183
)
   
(256
)
Net cash provided by (used in) financing activities
   
(183
)
   
22,985
 
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(139
)
   
5,589
 
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD
   
10,587
     
4,255
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(344
)
   
(221
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
   
10,104
     
9,623
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F - 4


 

BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Six months ended June 30,
 
   
2023
   
2024
 
   
in USD thousands
 
             
Adjustments required to reflect net cash used in operating activities:
           
Income and expenses not involving cash flows:
           
Depreciation and amortization
   
457
     
1,373
 
Exchange differences on cash and cash equivalents
   
344
     
221
 
Fair value adjustments of warrants
   
10,843
     
(12,845
)
Share-based compensation
   
920
     
970
 
Interest on short-term deposits
   
(210
)
   
201
 
Interest on loan
   
1,405
     
1,997
 
Exchange differences on lease liabilities
   
(75
)
   
189
 
Issuance cost of warrants
   
-
     
642
 
     
13,684
     
(7,252
)
Changes in operating asset and liability items:
               
Increase in trade receivables
   
-
     
(2,821
)
Increase in prepaid expenses and other receivables
   
(958
)
   
(359
)
Increase in inventory
   
-
     
(1,681
)
Increase (decrease) in accounts payable and accruals
   
283
     
(5,633
)
Decrease in contract liabilities
   
-
     
(7,480
)
     
(675
)
   
(17,974
)
     
13,009
     
(25,226
)
                 
Supplemental information on interest received in cash
   
761
     
931
 
                 
Supplemental information on interest paid in cash
   
640
     
971
 
                 
Supplemental information on non-cash transactions:
               
Changes in right-of-use asset and lease liabilities
   
66
     
58
 
Warrant issuance costs
   
-
     
207
 
 
The accompanying notes are an integral part of these condensed consolidated interim financial statements.

F - 5


 

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 (primarily in clinical stages) and commercialization of therapeutics, with a focus on the fields of oncology and hematology.
 
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.
 
The Company has two substantially wholly owned subsidiaries: (i) BioLineRx USA, Inc., incorporated in the U.S., and engaged in commercialization activities associated with the launch of motixafortide for stem-cell mobilization in the U.S.; and (ii) Agalimmune Ltd., incorporated in the United Kingdom, and engaged in clinical development activities with a focus on the field of immuno-oncology. In December 2023, the Company notified the former shareholders of Agalimmune Ltd. of its decision to terminate the development of AGI-134, the principal asset of Agalimmune Ltd., with an effective termination date of March 15, 2024.
 
In September 2023, the U.S. Food and Drug Administration (“FDA”) approved motixafortide in stem cell mobilization for autologous transplantation for multiple myeloma patients, and the Company has begun to independently commercialize motixafortide in the U.S.
 
  b.
Israel-Hamas war
 
On October 7, 2023, an unprecedented invasion was launched against Israel from the Gaza Strip by terrorists from the Hamas terrorist organization that infiltrated Israel’s southern border and other areas within the country, attacking civilians and military targets while simultaneously launching extensive rocket attacks on the Israeli civilian population. These attacks resulted in extensive deaths, injuries and the kidnapping of civilians and soldiers. In response, the Security Cabinet of the State of Israel declared war against Hamas, with commencement of a military campaign against the terrorist organization, in parallel to its continued rocket and terror attacks. In addition, Hezbollah, an Islamist terrorist group that controls large portions of southern Lebanon, has attacked military and civilian targets in Northern Israel, to which Israel has responded, and the Islamic Republic of Iran launched an unprecedented missile attack against Israel in April 2024. To date, the State of Israel continues to be at war with Hamas and in an armed conflict with Hezbollah.
 
The Company’s headquarters and principal development operations are located in the State of Israel. In addition, most of its key employees, officers and directors are residents of Israel. The ongoing war with Hamas has not, to date, materially impacted the Company’s business or operations. Furthermore, the Company does not expect any disruption to its programs or operations as a result of this situation. Nevertheless, at this time, it is not possible to predict the intensity or duration of Israel’s war against Hamas, nor how this conflict will ultimately affect the Company’s ongoing business and operations, nor Israel’s economy in general.
 

F - 6


 

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

 
NOTE 1 – GENERAL INFORMATION (cont.)
 
  c.
Going concern
 
The Company has incurred accumulated losses in the amount of $391 million through June 30, 2024, and it expects to continue incurring losses and negative cash flows from operations until its product or products reach commercial profitability. Company management monitors rolling forecasts of the Company’s liquidity reserves on the basis of anticipated cash flows and seeks to maintain liquidity balances at levels that are sufficient to meet its needs. Management believes that the Company’s current cash and other resources will be sufficient to fund its projected cash requirements into 2025.
 
The execution of an independent commercialization plan for motixafortide in the U.S. implies an increased level of expenses prior to and following launch of the product, as well as uncertainty regarding the timing of commercial profitability. Therefore, the Company’s cash flow projections are subject to various risks and uncertainties concerning their fulfilment, and these factors and the risks inherent in the Company’s operations indicate that a material uncertainty exists that may cast significant doubt (or raise substantial doubt as contemplated by PCAOB standards) on the Company’s ability to continue as a going concern. These consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
 
Management’s plans include the independent commercialization of the Company’s product, as aforementioned, and, if and when required, raising capital through the issuance of debt or equity securities, or capital inflows from strategic partnerships. There are no assurances, however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and/or raising capital, it may need to reduce activities, or curtail or cease operations.
 
  d.
Approval of financial statements
 
The condensed consolidated interim financial statements of the Company as of June 30, 2024, and for the three and six months then ended, were approved by the Board of Directors on August 14, 2024, 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, 2024 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 presentation of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”). The condensed consolidated interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2023 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, 2024 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 pandemics and wars across the globe (including the Israel-Hamas war) on the Company’s activities, and the resulting effects on critical and significant accounting estimates, most significantly in relation to the value of intangible assets, license revenue recognition, fair value of warrants, and measurement of allowance for accruals of chargebacks, rebates and returns. In this regard, U.S. and global markets are currently experiencing volatility and disruption following the escalation of geopolitical tensions. As of the date of release of these financial statements, the Company estimates there are no material effects of those geopolitical tensions on its financial position and results of operations.

 

NOTE 3 – MATERIAL ACCOUNTING POLICIES

 

  a.
General
 
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, 2023 and for the year then ended, except for the reclassification of warrant liabilities to from non-current liabilities to current liabilities, as described in Note 3b.
 

F - 8


 

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

 
NOTE 3 – MATERIAL ACCOUNTING POLICIES (cont.)
 
  b.
New international financial reporting standards, amendments to standards and new interpretations
 
Classification of Liabilities as Current or Non-Current (Amendment to IAS 1)
 
The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are classified as either current or noncurrent, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the entity’s expectations or events after the reporting date (e.g., the receipt of a waiver or a breach of covenant). The amendments also clarify what IAS 1 means when it refers to the ‘settlement’ of a liability. The amendments may affect the classification of liabilities, particularly for entities that previously considered management’s intentions to determine classification and for some liabilities that can be converted into equity.
 
The Company adopted these amendments effective January 1, 2024. The impact on the Company’s financial statements of these amendments was the reclassification of the Company’s warrant liabilities from non-current to current as of its effective date. The Company has retrospectively applied the amendments in these interim financial statements and, accordingly, has retrospectively adjusted the comparative balance sheet for December 31, 2023 to reclassify its warrant liabilities ($11,932 as of December 31, 2023) from non-current to current. Adoption of the amendments had no other impact on the Company’s financial statements.
 
IFRS 18, Presentation and Disclosure in the Financial Statements
 
This standard replaces the international accounting standard IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statements of income, as follows: (1) operating profit and (2) profit before financing and tax. In addition, income statement items will be classified into three defined categories: operating, investment and financing. The standard also includes a requirement to provide a separate disclosure in the financial statements regarding the use of management-defined performance measures (“non-GAAP measures”), and specific instructions were added for the grouping and splitting of items in the financial statements and in the notes to the financial statements. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption.

 

NOTE 4 – AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW
 
The Company maintains an ATM facility with H.C. Wainwright & Co., LLC (“HCW”) pursuant to an ATM sales agreement entered into in September 2021. In accordance with the agreement, the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as a 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 has 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 ended June 30, 2024, no ADSs were issued by the Company. From the effective date of the agreement through the issuance date of this report, 2,109,858 ADSs have been sold under the program for total gross proceeds of approximately $4.4 million and total fees of approximately $0.1 million.

 

F - 9


 

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

 
NOTE 5 – LONG-TERM LOAN
 
In September 2022, the Company entered into a $40 million loan agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital) (“BlackRock”). Pursuant to the agreement, the first tranche of $10 million was drawn down by the Company upon closing, with the remaining $30 million to be made available in two additional tranches subject to the achievement of pre-specified milestones. The tranches are available for drawdown at the Company’s discretion at various time points through October 1, 2024. In April 2024, the Company completed a drawdown of the $20 million second tranche of the loan agreement.
 
Each tranche of the loan carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing bear interest at a fixed annual rate of 9.5% (~11.0%, including associated cash fees). As security for the loan, BlackRock received a first-priority secured interest in all Company assets, including intellectual property, and the Company undertook to maintain a minimum cash balance. In addition, BlackRock is entitled to mid-to-high single-digit royalties on motixafortide sales in the U.S., up to a pre-defined cap.
 
The loan's current value includes the accrual of effective interest, including estimated future royalties.

 

NOTE 6 – CONTINGENT LIABILITIES
 
On January 5, 2023, a putative securities class action complaint was filed in the U.S. against the Company and its Chief Executive Officer. The complaint claims that the Company made false and materially misleading statements and failed to disclose material adverse facts pertaining to its financial position with regard to the development of motixafortide and that the Company would require a loan and a securities offering to commercialize motixafortide. The complaint asserted a putative class period of February 23, 2021 to September 19, 2022, inclusive, and seeked certification as a class action and an unspecified amount of damages. On July 5, 2023, an amended complaint was filed, alleging the same claims and adding the Company’s Chief Financial Officer. On September 5, 2023, the Company, its Chief Executive Officer and its Chief Financial Officer filed a motion to dismiss the amended complaint in its entirety and, on July 15, 2024, the court granted the order to dismiss without prejudice. The Company also received, on February 5, 2023, a substantially similar lawsuit and motion to approve the lawsuit as a class action in the Tel Aviv District Court. The total amount claimed in Tel Aviv, if the lawsuit is certified as a class action, is approximately NIS 113.5 million (approximately $32 million). The outcome of the legal proceeding in the Tel Aviv District Court is uncertain at this point, although the Company anticipates it will likely be dismissed following dismissal of the U.S. claim. Notwithstanding, the Company believes that it is without merit and intends to vigorously defend itself against such action.

 

On June 16, 2024, Biokine Therapeutics Ltd. (“Biokine”), filed a complaint with the District Court of Jerusalem against the Company. The complaint alleges breach of contract and a purported failure to make certain payments to Biokine under the Company’s in-licensing agreement with Biokine for motixafortide. The lawsuit seeks compensatory damages in the amount of approximately $6.5 million and a declaratory judgment in favor of Biokine. The Company believes the claim is without merit and intends to vigorously defend itself against such action.

 

NOTE 7 – EQUITY FINANCINGS
 
  a.
Warrants from September 2022 offering
 
   
In September 2022, the Company completed a registered direct offering of 13,636,365 ADSs at a price of $1.10 per ADS. The Company also issued to investors in the offering unregistered warrants to purchase 13,636,365 ADSs. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.15 per ADS. In addition, the Company granted to the placement agent in the offering, as part of the placement fee, warrants to purchase 681,818 ADSs. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.375 per ADS. Gross proceeds from the offering totaled $15.0 million, with net proceeds of $13.5 million, after deducting fees and expenses. The offering consideration allocated to the placement agent warrants amounted to $0.4 million.
 
The warrants issued to the investors have been classified as a financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the issuance date and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive loss.
 
The fair value of the warrants is computed using the Black-Scholes option pricing model. The fair value of the warrants upon issuance was computed based on the then-current price of an ADS, a risk-free interest rate of 3.62%, and an average standard deviation of 82.5%. The gross consideration initially allocated to the investor warrants amounted to $9.1 million, with total issuance costs initially allocated to the warrants amounting to $0.8 million.
 
The fair value of the warrants amounted to $2,599,000 as of June 30, 2024 (December 31, 2023 - $11,905,000), and was based on the then current price of an ADS, a risk-free interest rate of 4.50%, an average standard deviation of 82.5%, and on the remaining contractual life of the warrants.
 
The changes in fair value for the six months ended June 30, 2024 of $9,306,000 have been recorded as non-operating income in the statement of comprehensive loss. As of June 30, 2024, 2,545,455 of these warrants had been exercised.
 
The placement agent warrants have been classified in shareholders’ equity, with initial recognition at fair value on the date issued, using the same assumptions as the investor warrants.
 

F - 10


 

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

 
NOTE 7 – EQUITY FINANCINGS (cont.)

 

  b.
April 2024 offering
 
   
In April 2024, the Company completed a registered direct offering of 7,500,000 ADSs at a price of $0.80 per ADS. The Company also issued to investors in the offering unregistered warrants to purchase 7,500,000 ADSs. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.80 per ADS. Gross proceeds from the offering totaled $6.0 million, with net proceeds of $5.4 million, after deducting fees and expenses.
 
The warrants have been classified as a financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the issuance date and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive income (loss).
 
   
The fair value of the warrants is computed using the Black-Scholes option pricing model and is determined by using a level 3 valuation technique. The fair value of the warrants upon issuance was computed based on the then-current price of an ADS, a risk-free interest rate of 4.21%, and an average standard deviation of 84.7%. The fair value initially allocated to the investor warrants amounted to $6,250,000, with total issuance costs initially allocated to the warrants amounting to $642,000.
 
Due to a difference between the fair value at initial recognition and the transaction price (“day 1 loss”), upon initial recognition, the fair value of the warrants was adjusted by the amount of $