Press Release: BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update

Dow Jones
27 May

- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease -

- New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting --

- APHEXDA performing well under Ayrmid stewardship -

- Management to host conference call today, May 27(th) , at 8:30 am EDT -

TEL AVIV, Israel, May 27, 2025 /PRNewswire/ -- BioLineRx Ltd. $(BLRX)$ (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update.

"Following our announcement last November that we out-licensed APHEXDA$(R)$, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."

"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.

Financial Updates

   -- Completed financing in January 2025 raising gross proceeds of $10 
      million. 
 
   -- Successfully reduced operating expense run rate by over 70% beginning 
      January 1, 2025, through the APHEXDA program transfer to Ayrmid and the 
      resulting shutdown of the Company's U.S. commercial operations in Q4 
      2024, as well as additional headcount and other operating expense 
      reductions. 
 
   -- Reaffirms cash runway through the second half of 2026. 

APHEXDA Performance Update

   -- APHEXDA generated sales of $1.4 million in the first quarter of 2025, 
      providing royalty revenues to the Company of $0.3 million. 

Clinical Updates

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

   -- Additional trial sites were activated for the CheMo4METPANC Phase 2b 
      clinical trial, which is expected to have a positive impact on patient 
      recruitment. Full enrollment in the randomized trial, which is being led 
      by Columbia University, and supported by both Regeneron and BioLineRx, is 
      planned for completion in 2027, with a prespecified interim analysis 
      planned when 40% of progression free survival $(PFS)$ events are observed. 
 
   -- An abstract featuring updated data from the pilot phase of the ongoing 
      CheMo4METPANC clinical trial has been accepted for a poster presentation 
      at the 2025 ASCO Annual Meeting on Saturday, May 31st. Key highlights 
      include: 
 
          -- Two patients underwent definitive treatment for metastatic 
             pancreatic cancer: one had complete resolution of all 
             radiologically detected liver lesions and underwent definitive 
             radiation to the primary pancreatic tumor, and one had a sustained 
             partial response and underwent pancreaticoduodenectomy with 
             pathology demonstrating a complete response. 
 
          -- An analysis of pre- and on-treatment biopsies revealed that 
             CD8+ T-cell tumor infiltration increased across all eleven 
             patients treated with the motixafortide combination. 

Sickle Cell Disease $(SCD)$ & Gene Therapy

   -- Enrollment is continuing into the multi-center Phase 1 clinical trial 
      evaluating motixafortide for the mobilization of CD34+ hematopoietic stem 
      cells (HSCs) used in the development of gene therapies for patients with 
      Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's 
      Research Hospital. 
 
   -- Reported continued progress of 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 is 
      sponsored by Washington University School of Medicine in St. Louis. 

Financial Results for the Quarter Ended March 31, 2025

   -- Revenues for the three-month period ended March 31, 2025 were $0.3 
      million, a decrease of $6.6 million, compared to revenues of $6.9 million 
      for the three-month period ended March 31, 2024. The significant decrease 
      in revenues from 2024 to 2025 reflects the one-time revenues recorded in 
      2024 relating to the out-licensing transaction with Gloria during the 
      fourth quarter of 2023, as well as the change in the Company's operations 
      following the out-licensing of APHEXDA to Ayrmid during the fourth 
      quarter of 2024. The revenues in 2025 reflect the royalties paid by 
      Ayrmid from the commercialization of APHEXDA in stem cell mobilization in 
      the U.S. The revenues in 2024 primarily reflect a portion of the up-front 
      payment received by the Company and a milestone payment achieved under 
      the license agreement with Gloria, which collectively amounted to $5.9 
      million, as well as $0.9 million of net revenues from product sales of 
      APHEXDA in the U.S. 
 
   -- Cost of revenues for the three-month period ended March 31, 2025 was 
      immaterial, compared to cost of revenues of $1.5 million for the 
      three-month period ended March 31, 2024. The cost of revenues in 2025 
      reflects sub-license fees on royalties paid by Ayrmid from the 
      commercialization of APHEXDA in stem cell mobilization in the U.S. The 
      cost of revenues in 2024 primarily reflects sub-license fees on a 
      milestone payment received under the Gloria 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 three months ended March 31, 
      2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to 
      $2.5 million for the three months ended March 31, 2024. The decrease 
      resulted primarily from lower expenses related to motixafortide due to 
      the out-licensing of U.S. rights to Ayrmid, as well as a decrease in 
      payroll and share-based compensation, primarily due to a decrease in 
      headcount. 
 
   -- There were no sales and marketing expenses for the three months ended 
      March 31, 2025, compared to $6.3 million for the three months ended March 
      31, 2024. The decrease resulted primarily from the shutdown of U.S. 
      commercial operations in the fourth quarter of 2024 following the Ayrmid 
      out-licensing transaction. 
 
   -- General and administrative expenses for the three months ended March 31, 
      2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to 
      $1.4 million for the three months ended March 31, 2024. The decrease 
      resulted primarily from a decrease in payroll and share-based 
      compensation, primarily due to a decrease in headcount, as well as small 
      decreases in a number of general and administrative expenses. 
 
   -- Net non-operating income for the three months ended March 31, 2025 was 
      $7.6 million, compared to net non-operating income of $4.5 million for 
      the three months ended March 31, 2024. Non-operating income for both 
      periods primarily relates to fair-value adjustments of warrant 
      liabilities on the balance sheet, as a result of changes in the Company's 
      share price. 
 
   -- Net financial expenses for the three months ended March 31, 2025 were 
      $0.1 million, compared to net financial expenses of $0.4 million for the 
      three months ended March 31, 2024. Net financial expenses for both 
      periods primarily relate to loan interest paid, partially offset by 
      investment income earned on bank deposits. 
 
   -- Net income for the quarter ended March 31, 2025 was $5.1 million, 
      compared to $0.7 million for the quarter ended March 31, 2024. 
 
   -- As of March 31, 2025, the Company had cash, cash equivalents, and 
      short-term bank deposits of $26.4 million 

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 29, 2025; 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(R) (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 and manufacturing 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.

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 success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, the expected cash runway, and BioLineRx's business strategy. 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 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; 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 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; 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, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; 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; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, 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 31, 2025. 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.

 
                           BioLineRx Ltd. 
   CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION 
                             (UNAUDITED) 
                                              December 31,  March 31, 
                                              ------------  --------- 
                                                  2024        2025 
                                              ------------  --------- 
                                                 in USD thousands 
                                              ----------------------- 
Assets 
CURRENT ASSETS 
Cash and cash equivalents                           10,436      9,036 
Short-term bank deposits                             9,126     17,333 
Trade receivables                                    2,476      1,469 
Prepaid expenses                                       443        312 
Other receivables                                    1,478        452 
Inventory                                            3,145      3,315 
                                              ------------  --------- 
         Total current assets                       27,104     31,917 
                                              ------------  --------- 
 
NON-CURRENT ASSETS 
Property and equipment, net                            386        299 
Right-of-use assets, net                               967        863 
Intangible assets, net                              10,449     10,431 
                                              ------------  --------- 
         Total non-current assets                   11,802     11,593 
                                              ------------  --------- 
         Total assets                               38,906     43,510 
                                              ============  ========= 
 
Liabilities and equity 
CURRENT LIABILITIES 
Current maturities of long-term loan                 4,479      4,684 
Accounts payable and accruals: 
    Trade                                            5,583      4,693 
    Other                                            3,131      1,751 
Current maturities of lease liabilities                522        440 
Warrants                                             1,691      2,462 
                                              ------------  --------- 
         Total current liabilities                  15,406     14,030 
                                              ------------  --------- 
 
NON-CURRENT LIABILITIES 
Long-term loan, net of current maturities            8,958      7,633 
Lease liabilities                                    1,081        985 
                                              ------------  --------- 
         Total non-current liabilities              10,039      8,618 
                                              ------------  --------- 
COMMITMENTS AND CONTINGENT LIABILITIES 
    Total liabilities                               25,445     22,648 
                                              ------------  --------- 
 
EQUITY 
Ordinary shares                                     38,097     62,570 
Share premium                                      353,693    333,627 
Warrants                                             5,367      3,686 
Capital reserve                                     17,547     17,095 
Other comprehensive loss                           (1,416)    (1,416) 
Accumulated deficit                              (399,827)  (394,700) 
                                              ------------  --------- 
         Total equity                               13,461     20,862 
                                              ------------  --------- 
         Total liabilities and equity               38,906     43,510 
                                              ============  ========= 
 
 
                               BioLineRx Ltd. 
  CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) 
                                 (UNAUDITED) 
                                               Three months ended March 31, 
                                              ------------------------------ 
                                                   2024            2025 
                                              --------------  -------------- 
                                                     in USD thousands 
                                              ------------------------------ 
REVENUES: 
    License revenues                                   5,931             255 
    Product sales, net                                   924               - 
                                              --------------  -------------- 
         Total revenues                                6,855             255 
COST OF REVENUES                                     (1,455)            (34) 
GROSS PROFIT                                           5,400             221 
RESEARCH AND DEVELOPMENT EXPENSES                    (2,494)         (1,623) 
SALES AND MARKETING EXPENSES                         (6,342)               - 
GENERAL AND ADMINISTRATIVE EXPENSES                  (1,386)           (989) 
                                              --------------  -------------- 
OPERATING LOSS                                       (4,822)         (2,391) 
NON-OPERATING INCOME (EXPENSES), NET                   4,490           7,644 
FINANCIAL INCOME                                         565             294 
FINANCIAL EXPENSES                                     (929)           (420) 
                                              --------------  -------------- 
NET INCOME (LOSS) AND COMPREHENSIVE INCOME 
 (LOSS)                                                (696)           5,127 
                                              ==============  ============== 
 
                                                          in USD 
                                              ------------------------------ 
EARNINGS )LOSS( PER ORDINARY SHARE - BASIC 
 AND DILUTED                                          (0.00)            0.00 
                                              ==============  ============== 
 
WEIGHTED AVERAGE NUMBER OF SHARES USED IN 
 CALCULATION OF EARNINGS )LOSS( PER ORDINARY 
 SHARE                                         1,086,589,165   2,217,728,234 
                                              ==============  ============== 
 
 
 
                                      BioLineRx Ltd. 
               CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY 
                                        (UNAUDITED) 
                                                            Other 
                Ordinary   Share              Capital   compre-hensive  Accumulated 
                 shares   pre-mium  Warrants  re-serve       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 
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 
                ========  ========  ========  ========  ==============  ===========  ====== 
 
                Ordinary   Share              Capital   Other compre-   Accumulated 
                 shares   pre-mium  Warrants  re-serve   hensive loss     deficit     Total 
                --------  --------  --------  --------  --------------  -----------  ------ 
                                             in USD thousands 
                --------------------------------------------------------------------------- 
BALANCE AT 
 JANUARY 1, 
 2025             38,097   353,693     5,367    17,547         (1,416)    (399,827)  13,461 
CHANGES FOR 
THREE MONTHS 
ENDED MARCH 
31, 2025: 
Issuance of 
 share 
 capital, 
 pre-funded 
 warrants and 
 warrants, 
 net              16,415  (14,836)       501         -               -            -   2,080 
Pre-funded 
 warrants 
 exercised         8,058   (5,876)   (2,182)         -               -            -       - 
Employee stock 
 options 
 expired               -       646         -     (646)               -            -       - 
Share-based 
 compensation          -         -         -       194               -            -     194 
Comprehensive 
 income for 
 the period            -         -         -         -               -        5,127   5,127 
                --------  --------  --------  --------  --------------  -----------  ------ 
BALANCE AT 
 MARCH 31, 
 2025             62,570   333,627     3,686    17,095         (1,416)    (394,700)  20,862 
                ========  ========  ========  ========  ==============  ===========  ====== 
 
 
 
                               BioLineRx Ltd. 
             CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS 
                                 (UNAUDITED) 
                                                         Three months ended 
                                                              March 31, 
                                                        -------------------- 
                                                          2024       2025 
                                                        ---------  --------- 
                                                          in USD thousands 
                                                        -------------------- 
 
CASH FLOWS - OPERATING ACTIVITIES 
 Comprehensive income (loss) for the period                 (696)      5,127 
 Adjustments required to reflect net cash used in 
  operating activities  (see appendix below)             (13,413)    (7,718) 
                                                        ---------  --------- 
     Net cash used in operating activities               (14,109)    (2,591) 
                                                        ---------  --------- 
 
CASH FLOWS - INVESTING ACTIVITIES 
 Investments in short-term deposits                             -   (12,307) 
 Maturities of short-term deposits                         16,719      4,130 
 Purchase of property and equipment                          (32)          - 
                                                        ---------  --------- 
     Net cash provided by (used in) investing 
      activities                                           16,687    (8,177) 
                                                        ---------  --------- 
 
CASH FLOWS - FINANCING ACTIVITIES 
 Issuance of share capital, pre-funded warrants and 
  warrants, net of issuance costs                               -     10,697 
 Repayments of loan                                         (765)    (1,120) 
 Repayments of lease liabilities                            (129)      (127) 
                                                        ---------  --------- 
     Net cash provided by (used in) financing 
      activities                                            (894)      9,450 
                                                        ---------  --------- 
 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS            1,684    (1,318) 
CASH AND CASH EQUIVALENTS -- BEGINNING OF PERIOD            4,255     10,436 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS              51       (82) 
                                                        ---------  --------- 
CASH AND CASH EQUIVALENTS - END OF PERIOD                   5,990      9,036 
                                                        =========  ========= 
 
 
 
                              BioLineRx Ltd. 
      APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS 
                                (UNAUDITED) 
                                                       Three months ended 
                                                            March 31, 
                                                      -------------------- 
                                                         2024       2025 
                                                      ----------  -------- 
                                                        in USD thousands 
                                                      -------------------- 
 
 
Adjustments required to reflect net cash used in 
operating activities: 
 Income and expenses not involving cash flows: 
     Depreciation and amortization                           897       165 
     Exchange differences on cash and cash 
      equivalents                                           (51)        82 
     Fair value adjustments of warrants                  (4,444)   (8,311) 
     Warrant issuance costs                                    -       702 
     Share-based compensation                                533       194 
     Interest on short-term deposits                       (163)      (30) 
     Interest on loan                                        610         - 
     Exchange differences on lease liabilities              (25)       (7) 
                                                      ----------  -------- 
                                                         (2,643)   (7,205) 
                                                      ----------  -------- 
 
 Changes in operating asset and liability items: 
     Decrease (increase) in trade receivables            (2,474)     1,007 
     Increase in inventory                                 (936)     (170) 
     Decrease in prepaid expenses and other 
      receivables                                             81     1,157 
     Decrease in accounts payable and accruals           (3,511)   (2,507) 
     Decrease in contract liabilities                    (3,930)         - 
                                                      ----------  -------- 
                                                        (10,770)     (513) 
                                                      ----------  -------- 
                                                        (13,413)   (7,718) 
                                                      ==========  ======== 
 
 
 Supplemental information on interest received in 
  cash                                                       357       236 
                                                      ==========  ======== 
 
 Supplemental information on interest paid in cash           255       361 
                                                      ==========  ======== 
 
 Supplemental information on non-cash transactions: 
     Changes in right-of-use asset and lease 
      liabilities                                             32        44 
                                                      ==========  ======== 
     Warrant issuance costs                                    -       237 
                                                      ==========  ======== 
 
 
 
 

Logo: https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg

Contacts:

United States

Irina Koffler

LifeSci Advisors, LLC

IR@biolinerx.com

Israel

Moran Meir

LifeSci Advisors, LLC

moran@lifesciadvisors.com

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SOURCE BioLineRx Ltd.

 

(END) Dow Jones Newswires

May 27, 2025 07:00 ET (11:00 GMT)

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