EX-99.1 2 exhibit_1.htm REGISTRANT'S PRESS RELEASE DATED MAY 28, 2024
Exhibit 1


FOR IMMEDIATE RELEASE

BioLineRx Reports First Quarter 2024 Financial Results and Recent Corporate
and Portfolio Updates
 
- Steady growth in APHEXDA® adoption in first full quarter post-approval -

- Among top 80 transplant centers, secured APHEXDA formulary placement to date at
institutions representing ~26% of stem cell transplant procedures performed - on track
to reach stated goal of ~35% by end of Q2 -

- Announced new data in abstract accepted at the American Society of Clinical Oncology (ASCO)
2024 Annual Meeting on pilot phase of ongoing Phase 2b pancreatic cancer clinical trial
collaboration with Columbia University -

- Collaboration partner Gloria Biosciences’ motixafortide HSC mobilization bridging study IND was
filed and approved by the Center for Drug Evaluation of the National Medical Products
Administration in China. Anticipate clinical trial initiation 2H 2024 -

- Completed debt and equity financing totaling $26 million to support U.S. commercialization of
APHEXDA and advance lifecycle expansion activities -

- Management to host conference call today, May 28, at 8:30 am EDT -

TEL AVIV, Israel, May 28, 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 first quarter ended March 31, 2024, and provided recent corporate and portfolio updates.

“In this first full quarter post APHEXDA® approval, we were pleased by the steady growth in adoption and repeat purchases by transplant centers, which is consistent with our expectations during this foundational period,” said Philip Serlin, Chief Executive Officer of BioLineRx. “This growth comes as we see continued increases in the number of transplant centers that have completed Pharmacy & Therapeutics committee reviews and granted approval for APHEXDA usage.  As a reminder, end users of APHEXDA are well defined, with 80 of the 212 U.S. transplant centers performing approximately 85% of all transplant procedures.  Importantly, among these top 80 transplant centers, we’ve secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed, keeping us on track to reach our stated goal of 35% by the end of Q2.

“In our major pipeline program in pancreatic cancer, we continue to see strong data emerge from the pilot phase of the Phase 2 PDAC trial sponsored by Columbia University. Last week we announced new data in an accepted ASCO abstract on paired pre- and on-treatment biopsy data that show a significant increase in CD8+ T-cell density in tumors from all 11 patients treated—further reinforcing our belief in the potential of the combination of motixafortide with a PD-1 inhibitor to treat this very challenging cancer with substantial unmet need.


“Finally, we are also making great progress pursuing motixafortide’s potential to support gene therapy for patients with sickle cell disease, which requires significant quantities of hematopoietic stem cells.   This is an important growth program, and we are actively working with a number of leaders in the gene therapy field, while looking forward to the second half of this year when early data from our collaboration with Washington University in St. Louis is expected.”

Corporate Updates
 

Accessed $20 million in non-dilutive debt financing from previously announced agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital) and completed a $6 million registered direct equity offering.  Funds will be used to support ongoing commercialization of APHEXDA in the U.S. and to advance lifecycle expansion activities
 

Strengthened motixafortide intellectual property estate with notice of allowance for U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing protections offered by Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in the U.S. following last year’s FDA approval of APHEXDA 

APHEXDA Launch Updates
 

Among top 80 transplant centers, secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed – on track to reach stated goal of ~35% by end of Q2 and ~60% by year-end 2024
 

Granted “pass through” status from the Centers for Medicare and Medicaid Services (CMS), ensuring that reimbursement for APHEXDA for Medicare and certain commercial payers will be separate from payment bundling methodologies when administered in the hospital outpatient setting

Clinical Portfolio Updates
 
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
 
Multiple Myeloma
 

Presented posters at both the American Society for Apheresis 2024 Annual Meeting on April 17, 2024, and the International Society for Pharmacoeconomics and Outcomes Research on April 6, 2024.  The posters reviewed apheresis center efficiency between CXCR4 antagonists, including APHEXDA, in patients with multiple myeloma, as well as economic model data on APHEXDA for HSC mobilization in patients with multiple myeloma
 

Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND 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
 

Pancreatic Ductal Adenocarcinoma (mPDAC)
 

Announced new data in an abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on the pilot phase of the ongoing CheMo4METPANC Phase 2 clinical trial collaboration with Columbia University, including new analysis of paired pre- and on-treatment biopsy samples.  The presentation will be held on June 1, 2024 in Chicago, IL
 

Announced first patient dosed in the randomized CheMo4METPANC Phase 2 clinical trial, an expansion of the pilot phase single-arm study, evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in 108 patients with metastatic pancreatic cancer
 

Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in China assessing 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
 
Sickle Cell Disease (SCD) & Gene Therapy


Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. Anticipate initial data in 2H 2024
 
First Quarter 2024 Financial Results
 

Total revenue for the first three months ended March 31, 2024 was $6.9 million.  The Company did not record any revenue during the first quarter of 2023. Revenue for the quarter reflect a portion of the upfront payment from the Gloria Biosciences license agreement and a milestone payment achieved under the same license agreement, which collectively amounted to $5.9 million, as well as $0.9 million of net revenue from product sales of APHEXDA in the U.S.
 

Cost of revenue for the first three months ended March 31, 2024 was $1.5 million. The Company did not record any cost of revenue during the first quarter of 2023. The cost of revenue for the quarter primarily reflects sub-license fees on a milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales
 

Research and development expenses for the first three months ended March 31, 2024 were $2.5 million, compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, as well as termination of the development of AGI-134
 

Sales and marketing expenses for the first three months ended March 31, 2024 were $6.3 million, compared to $3.9 million for the same period in 2023. The increase resulted primarily from the ramp-up of commercialization activities related to motixafortide, including headcount costs associated with fully hired field team
 


General and administrative expenses for the first three months ended March 31, 2024 were $1.4 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from a small increase in share-based compensation
 

Non-operating income for the first three months ended March 31, 2024 was $4.5 million, compared to non-operating expenses of $2.9 million for the same period in 2023. Non-operating expenses and income primarily relate to the non-cash revaluation of outstanding warrants resulting from changes in the Company’s share price during the respective periods
 

Net loss for the first three months ended March 31, 2024 was $0.7 million, compared to $12.2 million for the same period in 2023. The net loss for the 2024 period included $4.5 million in non-cash income, compared to non-operating expenses of $2.9 million for the same period in 2023, both specifically related to the revaluation of warrants
 

As of March 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million. This amount does not include $6.0 million in gross proceeds received from a registered direct offering and a $20.0 million drawdown of the second tranche from the existing loan agreement with BlackRock, which were both completed in April 2024. 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 May 30, 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,
   
March 31,
 
   
2023
   
2024
 
   
in USD thousands
 
Assets
           
CURRENT ASSETS
           
Cash and cash equivalents
   
4,255
     
5,990
 
Short-term bank deposits
   
38,739
     
22,183
 
Trade receivables
   
358
     
2,832
 
Prepaid expenses
   
1,048
     
1,290
 
Other receivables
   
830
     
507
 
Inventory
   
1,953
     
2,889
 
Total current assets
   
47,183
     
35,691
 
                 
NON-CURRENT ASSETS
               
Property and equipment, net
   
473
     
411
 
Right-of-use assets, net
   
1,415
     
1,308
 
Intangible assets, net
   
14,854
     
14,190
 
Total non-current assets
   
16,742
     
15,909
 
Total assets
   
63,925
     
51,600
 
                 
Liabilities and equity
               
CURRENT LIABILITIES
               
Current maturities of long-term loan
   
3,145
     
3,680
 
Contract liabilities
   
12,957
     
9,027
 
Accounts payable and accruals:
               
Trade
   
10,869
     
8,256
 
Other
   
3,353
     
2,455
 
Current maturities of lease liabilities
   
528
     
467
 
Warrants
   
11,932
     
7,488
 
Total current liabilities
   
42,784
     
31,373
 
                 
NON-CURRENT LIABILITIES
               
Long-term loan, net of current maturities
   
6,628
     
5,938
 
Lease liabilities
   
1,290
     
1,229
 
Total non-current liabilities
   
7,918
     
7,167
 
COMMITMENTS AND CONTINGENT LIABILITIES
               
Total liabilities
   
50,702
     
38,540
 
                 
EQUITY
               
Ordinary shares
   
31,355
     
31,355
 
Share premium
   
355,482
     
355,482
 
Warrants
   
1,408
     
1,408
 
Capital reserve
   
17,000
     
17,533
 
Other comprehensive loss
   
(1,416
)
   
(1,416
)
Accumulated deficit
   
(390,606
)
   
(391,302
)
Total equity
   
13,223
     
13,060
 
Total liabilities and equity
   
63,925
     
51,600
 


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

   
Three months ended March 31,
 
   
2023
   
2024
 
   
in USD thousands
 
REVENUES
   
-
     
6,855
 
COST OF REVENUES
   
-
     
(1,455
)
GROSS PROFIT
   
-
     
5,400
 
RESEARCH AND DEVELOPMENT EXPENSES
   
(3,684
)
   
(2,494
)
SALES AND MARKETING EXPENSES
   
(3,874
)
   
(6,342
)
GENERAL AND ADMINISTRATIVE EXPENSES
   
(1,298
)
   
(1,386
)
OPERATING LOSS
   
(8,856
)
   
(4,822
)
NON-OPERATING INCOME (EXPENSES), NET
   
(2,916
)
   
4,490
 
FINANCIAL INCOME
   
537
     
565
 
FINANCIAL EXPENSES
   
(927
)
   
(929
)
NET LOSS AND COMPREHENSIVE LOSS
   
(12,162
)
   
(696
)
                 
   
in USD
 
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
   
(0.01
)
   
(0.00
)
                 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE
   
922,958,942
     
1,086,589,165
 


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

   
Ordinary shares
   
Share premium
   
Warrants
   
Capital reserve
   
Other comprehensive loss
   
Accumulated 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 THREE MONTHS ENDED MARCH 31, 2023:
                                                       
Employee stock options expired
   
-
     
66
     
-
     
(66
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
-
     
435
     
-
     
-
     
435
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(12,162
)
   
(12,162
)
BALANCE AT MARCH 31, 2023
   
27,100
     
339,042
     
1,408
     
15,134
     
(1,416
)
   
(342,154
)
   
39,114
 

   
Ordinary shares
   
Share premium
   
Warrants
   
Capital reserve
   
Other comprehensive loss
   
Accumulated 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 THREE MONTHS ENDED MARCH 31, 2024:
                                                       
Share-based compensation
   
-
     
-
     
-
     
533
     
-
     
-
     
533
 
Comprehensive loss for the period
   
-
     
-
     
-
     
-
     
-
     
(696
)
   
(696
)
BALANCE AT MARCH 31, 2024
   
31,355
     
355,482
     
1,408
     
17,533
     
(1,416
)
   
(391,302
)
   
13,060
 


BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Three months ended
March 31,
 
   
2023
   
2024
 
   
in USD thousands
 
             
CASH FLOWS - OPERATING ACTIVITIES
           
Comprehensive loss for the period
   
(12,162
)
   
(696
)
Adjustments required to reflect net cash used in operating activities
 (see appendix below)
   
4,146
     
(13,413
)
Net cash used in operating activities
   
(8,016
)
   
(14,109
)
                 
CASH FLOWS - INVESTING ACTIVITIES
               
Investments in short-term deposits
   
(5,500
)
   
-
 
Maturities of short-term deposits
   
12,271
     
16,719
 
Purchase of property and equipment
   
(32
)
   
(32
)
Purchase of intangible assets
   
(97
)
   
-
 
Net cash provided by investing activities
   
6,642
     
16,687
 
                 
CASH FLOWS - FINANCING ACTIVITIES
               
Repayments of loan
   
-
     
(765
)
Repayments of lease liabilities
   
(49
)
   
(129
)
Net cash used in financing activities
   
(49
)
   
(894
)
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(1,423
)
   
1,684
 
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD
   
10,587
     
4,255
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(98
)
   
51
 
CASH AND CASH EQUIVALENTS - END OF PERIOD
   
9,066
     
5,990
 


BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
 
   
Three months ended
March 31,
 
   
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
   
259
     
897
 
Exchange differences on cash and cash equivalents
   
98
     
(51
)
Fair value adjustments of warrants
   
3,040
     
(4,444
)
Share-based compensation
   
435
     
533
 
Interest on short-term deposits
   
(497
)
   
(163
)
Interest on loan
   
630
     
610
 
Exchange differences on lease liabilities
   
(92
)
   
(25
)
     
3,873
     
(2,643
)
                 
Changes in operating asset and liability items:
               
Increase in trade receivables
   
-
     
(2,474
)
Increase in inventory
   
-
     
(936
)
Decrease (increase) in prepaid expenses and other receivables
   
(121
)
   
81
 
Increase (decrease) in accounts payable and accruals
   
394
     
(3,511
)
Decrease in contract liabilities
   
-
     
(3,930
)
     
273
     
(10,770
)
     
4,146
     
(13,413
)
                 
Supplemental information on interest received in cash
   
276
     
357
 
                 
Supplemental information on interest paid in cash
   
311
     
255
 
                 
Changes in right-of-use asset and lease liabilities
   
66
     
32