EX-99 2 exhibit_1.htm REGISTRANT'S PRESS RELEASE DATED NOVEMBER 25, 2024.
Exhibit 1

 
For Immediate Release

BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to
Drive Shareholder Value

- Executed license agreement with Ayrmid Ltd. for APHEXDA® (motixafortide) for $10 million upfront,
up to $87 million in commercial milestones, and 18-23% tiered royalties on sales -

- Received $9 million equity investment from certain funds managed by Highbridge
Capital Management, LLC-

- Entered into agreement to reduce and restructure long-term debt by ~$16.5 million -

- Annual operational expenses expected to decline by over 70% following out-license of APHEXDA®
(motixafortide) commercial program to Ayrmid -

- Company to continue to support motixafortide PDAC program while evaluating additional assets for
development in rare diseases and oncology –

- Management to host conference call today, November 25, at 8:30 am EDT -

TEL AVIV, Israel, November 25, 2024 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the third quarter ended September 30, 2024, and provided updates on strategic actions designed to drive shareholder value.

“The license agreement for APHEXDA that we announced last week was made possible by the tremendous work of our commercial team, who through their hard work proved the significant value that APHEXDA can bring to transplant centers and patients,” said Philip Serlin, Chief Executive Officer of BioLineRx.  “Our launch progress attracted Ayrmid, who will now, through Gamida Cell, continue to build on the strong commercial foundation that has been laid.  We would like to thank our employees for their outstanding contributions to APHEXDA growth and expect this innovative product to reach even more patients with the additional resources from Ayrmid.

“Looking forward, our streamlined and nimble company has a new financial foundation supported by sales royalties and potential milestone payments, which will allow our experienced team to develop important new therapies in rare disease and oncology that address areas with high unmet need.  We will also focus on advancing our motixafortide PDAC program through existing collaborations that require de-minimis investment.  Through this strategy, we anticipate delivering near- and long-term value for our shareholders,” Mr. Serlin concluded.

Corporate Updates

 •
Executed license agreement with Ayrmid Ltd. to develop and commercialize APHEXDA® (motixafortide) in all indications except solid tumors, and across all territories except Asia


o
License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23%

o
BioLineRx will supply motixafortide on a cost-plus basis, for both commercial and development supply

o
Certain members of the BioLineRx U.S.-based commercial organization will be transitioned to Ayrmid Pharma Ltd.


•
Received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC, to support BioLineRx’s pipeline expansion
 

 •
Operating expense run-rate expected to decrease by more than 70% beginning January 1, 2025 through APHEXDA commercial program transfer and additional headcount reductions
 

 •
Company intends to evaluate additional asset opportunities in 2025, with a focus on early-stage clinical programs in oncology or rare diseases that address major areas of unmet need

Financial Updates

 •
Executed repayment and restructuring agreement with BlackRock EMEA Venture and Growth Lending to repay $16.5 million of approximately $29 million in total debt due; remaining balance will be paid over the next three years at the existing fixed annual interest rate of 9.5 percent
 

 •
As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million
 

 •
Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to Blackrock, the Company’s cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million, which management believes will be sufficient to fund operations into 2026, as currently planned
 
APHEXDA Launch Updates

 •
Aphexda achieved 10 percent market share milestone of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications
 

 •
Institutions ordering APHEXDA increased by 40 percent in the third quarter

Clinical Portfolio Updates
Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

 •
Continued enrollment in the CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University.  In addition to Columbia, patient enrollment has begun at Brown University, and three additional sites are anticipated to begin enrollment over the next two quarters. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed
 
2
Multiple Myeloma

 •
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 1H 2025
 

 •
Gloria Biosciences has received regulatory approval to commercialize APHEXDA in the Boao Region of China and Macao, areas in Asia that do not require a bridging study
 
Sickle Cell Disease (SCD) & Gene Therapy

 •
Announced oral presentation at ASH 2024 on initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).  Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle.  The presentation will occur at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 7-10, 2024, in San Diego, California

Third Quarter 2024 Financial Results

 •
Total revenue for the three months ended September 30, 2024 was $4.9 million.  The Company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million, as well as $1.7 million of net revenue from product sales of APHEXDA in the U.S.
 

 •
Cost of revenue for the three months ended September 30, 2024 was $0.8 million. The Company did not record any cost of revenue during the third 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 September 30, 2024 were $2.6 million, compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and a decrease in payroll and share-based compensation
 

 •
Sales and marketing expenses for the three months ended September 30, 2024 were $5.5 million, compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide
 

 •
General and administrative expenses for the three months ended September 30, 2024 were $1.4 million, compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A expenses
 

 •
Net loss for the three months ended September 30, 2024 was $5.8 million, compared to net loss of $16.0 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income, compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash revaluation of warrants


•
As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million.

3
Third Quarter Results Conference Call and Webcast
BioLineRx will report its third quarter 2024 results on November 25, 2024.  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 November 27, 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 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, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia).  BioLineRx is utilizing its end-to-end expertise in development, regulatory affairs, manufacturing and commercialization to advance its innovative pipeline and ensure 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.  

Cautionary Note Regarding Forward-Looking Statements (BioLineRx)
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 success of the license agreement with Ayrmid, expectations with regard to clinical trials of motixafortide, statements relating to the equity investment offering, including as to the consummation of the offering described above, the expected gross proceeds therefrom and the timing of the closings of the offering and the license agreement. 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

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

   
December 31,
    
September 30,
  
   
2023
    
2024
  
   
in USD thousands
  
Assets
            
CURRENT ASSETS
            
Cash and cash equivalents
    
4,255
      
8,836
  
Short-term bank deposits
    
38,739
      
20,337
  
Trade receivables
    
358
      
3,611
  
Prepaid expenses
    
1,048
      
1,171
  
Other receivables
    
830
      
350
  
Inventory
    
1,953
      
3,544
  
Total current assets
    
47,183
      
37,849
  
                 
NON-CURRENT ASSETS
                
Property and equipment, net
    
473
      
249
  
Right-of-use assets, net
    
1,415
      
1,398
  
Intangible assets, net
    
14,854
      
13,246
  
Total non-current assets
    
16,742
      
14,893
  
Total assets
    
63,925
      
52,742
  
                 
Liabilities and equity
                
CURRENT LIABILITIES
                
Current maturities of long-term loan
    
3,145
      
9,822
  
Contract liabilities
    
12,957
      
2,255
  
Accounts payable and accruals:
                
Trade
    
10,869
      
4,633
  
Other
    
3,353
      
3,370
  
Current maturities of lease liabilities
    
528
      
517
  
Warrants
    
11,932
      
4,365
  
Total current liabilities
    
42,784
      
24,962
  
NON-CURRENT LIABILITIES
                
Long-term loan, net of current maturities
    
6,628
      
17,982
  
Lease liabilities
    
1,290
      
1,293
  
Total non-current liabilities
    
7,918
      
19,275
  
CONTINGENT LIABILITIES
                
Total liabilities
    
50,702
      
44,237
  
                 
EQUITY
                
Ordinary shares
    
31,355
      
34,430
  
Share premium
    
355,482
      
353,005
  
Warrants
    
1,408
      
1,408
  
Capital reserve
    
17,000
      
17,718
  
Other comprehensive loss
    
(1,416
)
    
(1,416
)
Accumulated deficit
    
(390,606
)
    
(396,640
)
Total equity
    
13,223
      
8,505
  
Total liabilities and equity
    
63,925
      
52,742
  

5
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)

   
Three months ended September 30,
    
Nine months ended September 30,
  
   
2023
    
2024
    
2023
    
2024
  
   
in USD thousands
    
in USD thousands
  
REVENUES
    
-
      
4,943
      
-
      
17,191
  
COST OF REVENUES
    
-
      
(822
)
    
-
      
(3,174
)
GROSS PROFIT
    
-
      
4,121
      
-
      
14,017
  
RESEARCH AND DEVELOPMENT EXPENSES
    
(2,727
)
    
(2,565
)
    
(9,417
)
    
(7,284
)
SALES AND MARKETING EXPENSES
    
(8,131
)
    
(5,553
)
    
(17,609
)
    
(18,310
)
GENERAL AND ADMINISTRATIVE EXPENSES
    
(1,499
)
    
(1,390
)
    
(4,102
)
    
(4,405
)
OPERATING LOSS
    
(12,357
)
    
(5,387
)
    
(31,128
)
    
(15,982
)
NON-OPERATING INCOME (EXPENSES), NET
    
(3,141
)
    
756
      
(13,790
)
    
13,053
  
FINANCIAL INCOME
    
312
      
434
      
1,289
      
1,534
  
FINANCIAL EXPENSES
    
(837
)
    
(1,625
)
    
(3,101
)
    
(4,639
)
NET LOSS AND COMPREHENSIVE LOSS
    
(16,023
)
    
(5,822
)
    
(46,730
 )
    
(6,034
)
                                 
   
in USD
    
in USD
  
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
    
(0.02
)
    
(0.00
)
    
(0.05
)
    
(0.01
)
                                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
    
929,058,619
      
1,199,485,845
      
925,014,511
      
1,161,448,634
  

6
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 NINE MONTHS ENDED SEPTEMBER 30, 2023:
                                                        
Issuance of share capital, net
    
361
      
1,535
      
-
      
-
      
-
      
-
      
1,896
  
Warrants exercised
    
865
      
4,855
      
-
      
-
      
-
      
-
      
5,720
  
Employee stock options exercised
    
6
      
18
      
-
      
(9
)
    
-
      
-
      
15
  
Employee stock options expired
    
-
      
78
      
-
      
(78
)
    
-
      
-
      
-
  
Share-based compensation
    
-
      
-
      
-
      
1,392
      
-
      
-
      
1,392
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
-
      
(46,730
)
    
(46,730
)
BALANCE AT SEPTEMBER 30, 2023
    
28,332
      
345,462
      
1,408
      
16,070
      
(1,416
)
    
(376,722
)
    
13,134
  

   
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 NINE MONTHS ENDED SEPTEMBER 30, 2024:
                                                        
Issuance of share capital and warrants, net
    
3,056
      
(3,056
)
    
-
      
-
      
-
      
-
      
-
  
Employee stock options exercised
    
19
      
56
      
-
      
(48
)
    
-
      
-
      
27
  
Employee stock options expired
    
-
      
523
      
-
      
(523
)
    
-
      
-
      
-
  
Employee stock options forfeiture
    
-
      
-
      
-
      
(88
)
    
-
      
-
      
(88
)
Share-based compensation
    
-
      
-
      
-
      
1,377
      
-
      
-
      
1,377
  
Comprehensive loss for the period
    
-
      
-
      
-
      
-
      
-
      
(6,034
)
    
(6,034
)
BALANCE AT SEPTEMBER 30, 2024
    
34,430
      
353,005
      
1,408
      
17,718
      
(1,416
)
    
(396,640
)
    
8,505
  

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

   
Nine months ended September 30,
  
   
2023
    
2024
  
   
in USD thousands
  
             
CASH FLOWS - OPERATING ACTIVITIES
            
Net loss for the period
    
(46,730
)
    
(6,034
)
Adjustments required to reflect net cash used in operating activities (see appendix below)
    
19,131
      
(29,229
)
Net cash used in operating activities
    
(27,599
)
    
(35,263
)
                 
CASH FLOWS – INVESTING ACTIVITIES
                
Investments in short-term deposits
    
(13,882
)
    
(26,350
)
Maturities of short-term deposits
    
36,000
      
44,626
  
Purchase of property and equipment
    
(100
)
    
(59
)
Purchase of intangible assets
    
(179
)
    
-
  
Net cash provided by investing activities
    
21,839
      
18,217
  
                 
CASH FLOWS – FINANCING ACTIVITIES
                
Issuance of share capital and warrants, net of issuance costs
    
1,896
      
5,358
  
Exercise of warrants
    
2,530
      
-
  
Employee stock options exercised
    
15
      
27
  
Net proceeds from loan
    
-
      
19,223
  
Repayments of loan
    
(802
)
    
(2,461
)
Repayments of lease liabilities
    
(323
)
    
(380
)
Net cash provided by financing activities
    
3,316
      
21,767
  
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    
(2,444
)
    
4,721
  
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
    
10,587
      
4,255
  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
    
(416
)
    
(140
)
CASH AND CASH EQUIVALENTS - END OF PERIOD
    
7,727
      
8,836
  

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

   
Nine months ended September 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
    
678
      
2,213
  
Exchange differences on cash and cash equivalents
    
416
      
140
  
Fair value adjustments of warrants
    
13,968
      
(13,567
)
Share-based compensation
    
1,392
      
1,289
  
Interest on short-term deposits
    
136
      
126
  
Interest on loan
    
2,170
      
1,269
  
Exchange differences on lease liability
    
(122
)
    
67
  
Issuance cost of warrants
    
-
      
642
  
     
18,638
      
(7,821
)
                 
Changes in operating asset and liability items:
                
   Increase in trade receivables
    
-
      
(3,253
)
   Decrease (increase) in prepaid expenses and other receivables
    
(566
)
    
357
  
Increase in inventory
    
(1,352
)
    
(1,591
)
Increase (decrease) in accounts payable and accruals
    
2,411
      
(6,219
)
Decrease in contract liabilities
    
-
      
(10,702
)
     
493
      
(21,408
)
     
19,131
      
(29,229
)
                 
Supplemental information on interest received in cash
    
1,268
      
1,644
  
                 
Supplemental information on interest paid in cash
    
833
      
1,586
  
                 
Supplemental information on non-cash transactions:
                
Changes in right-of-use asset and lease liabilities
    
66
      
305
  

9