- On track to initiate Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) by end of this month -
- GLIX1 is positioned to potentially address unmet needs for novel and more effective cancer treatments by targeting DNA damage response mechanisms -
- Management to host conference call today, March 23, at 8:30 am EDT -
TEL AVIV, Israel, March 23, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its audited financial results for the year ended December 31, 2025, and provided a corporate update.
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"Since our last quarterly update, we have been working diligently to move forward with a Phase 1/2a first-in-human clinical trial of GLIX1 in glioblastoma, and I am pleased to report that we expect to initiate the study by the end of this month, with the commencement of patient enrollment shortly thereafter," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1, the lead asset that we acquired through our collaboration with Hemispherian, is a unique molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models, excellent blood-brain-barrier penetration and a favorable safety profile in toxicology studies. We are eager to establish the safety, recommended dose and proof-of-concept in order to advance this promising candidate through an efficient development pathway.
"In parallel, we continue to conduct pre-clinical activities in support of further development of GLIX1 in additional cancer indications with high unmet needs, and, separately, we are also conducting studies to further investigate and affirm the potential synergistic effect of GLIX1 in combination with PARP inhibitors, as we work to maximize the value of the GLIX1 opportunity.
"In metastatic pancreatic cancer, enrollment has accelerated in the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide, which is being led by Columbia University and supported by both Regeneron and BioLineRx, and we continue to anticipate that a prespecified interim/futility analysis will read out in 2026. We believe PDAC represents another opportunity to introduce a much-needed new treatment option to patients suffering from a very challenging tumor type, while creating sustained value for our company," Mr. Serlin concluded.
Corporate Updates
- Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers.
- Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types.
- Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years.
Financial Updates
- With $20.9 million on its balance sheet as of December 31, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027.
Clinical Updates
GLIX1
- On track to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma by the end of the month.
- Three renowned academic centers are planned to participate in this clinical trial: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, NYU Langone Health, led by Dr. Alexandra M. Miller and Moffit Cancer Center, led by Dr. Patrick Grogan.
- The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.
- The Phase 2a expansion part of the trial is planned to include various population cohorts, including GBM (newly diagnosed and/or recurrent), as well as additional cancers with/without standard of care (e.g., PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for rapid and effective advanced clinical development.
- Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
- Enrollment has accelerated in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
- A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026.
Sickle Cell Disease (SCD) & Gene Therapy
- Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in December.
- A second SCD study, sponsored by St. Jude Children's Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs for gene therapies for patients with SCD (NCT06442761).
APHEXDA Performance Update
- For the full-year 2025, APHEXDA sales were $6.7 million, which provided royalty revenue to the Company of $1.2 million.
Financial Results for the Year ended December 31, 2025
- Revenues for the year ended December 31, 2025 were $1.2 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the up-front payment received by the Company under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid License Agreement and $6.0 million of net revenues from product sales of APHEXDA in the United States.
- Cost of revenues for the year ended December 31, 2025 were $0.2 million, compared to cost of revenues of $9.3 million for the year ended December 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 the amortization of intangible assets, sub-license fees on the up-front payment received for the Ayrmid License Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as 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 year ended December 31, 2025 were $8.1 million, a decrease of $1.1 million, or 11.5%, compared to $9.2 million for the year ended December 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, offset by expenses related to initiation of the GLIX1 project.
- There were no sales and marketing expenses for the year ended December 31, 2025, compared to $23.6 million for the year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license agreement.
- General and administrative expenses for the year ended December 31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3%, compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of general and administrative expenses.
- Non-operating income (expenses) for the years ended December 31, 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses.
- Net financial income for the year ended December 31, 2025 was $0.2 million, compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income for 2025 relates to investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to loan agreement with BlackRock, partially offset by investment income earned on bank deposits.
- Net loss for the year ended December 31, 2025 was $2.0 million, compared to $9.2 million for the year ended December 31, 2024.
- As of December 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $20.9 million, sufficient to fund operations, as currently planned, into the first half of 2027.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at IR@biolinerx.com.
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 March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is expected to initiate in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.
The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and developed by Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University.
Learn more about who we are, what we do, and how we do it at?www.biolinerx.com, or on?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 expectations with regard to clinical trials of motixafortide and GLIX1, expected timing of clinical readouts, 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 GLIX1 and motixafortide 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 GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide 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 that BioLineRx's 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 need 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; 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 23, 2026. 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
Irina Koffler
LifeSci Advisors, LLC
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
December 31,
2024 2025
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents 10,436 3,250
Short-term bank deposits 9,126 17,626
Trade receivables 2,476 46
Prepaid expenses 443 201
Other receivables 1,478 410
Inventory 3,145 2,148
Total current assets 27,104 23,681
NON-CURRENT ASSETS
Property and equipment, net 386 160
Right-of-use assets, net 967 696
Intangible assets, net 10,449 16,368
Total non-current assets 11,802 17,224
Total assets 38,906 40,905
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loan 4,479 4,479
Accounts payable and accruals:
Trade 5,583 3,493
Other 3,131 1,743
Current maturities of lease liabilities 522 234
Warrants 1,691 2,174
Total current liabilities 15,406 12,123
NON-CURRENT LIABILITIES
Long-term loan, net of current maturities 8,958 4,460
Lease liabilities 1,081 977
Total non-current liabilities 10,039 5,437
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities 25,445 17,560
EQUITY
Equity attributable to owners of the Company:
Ordinary shares 38,097 73,428
Share premium 353,693 327,584
Warrants 5,367 3,686
Capital reserve 17,547 15,916
Other comprehensive loss (1,416) (1,416)
Accumulated deficit (399,827) (401,002)
Total equity attributable to owners of the Company 13,461 18,196
Non-controlling interest 5,149
Total equity 13,461 23,345
Total liabilities and equity 38,906 40,905
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Year ended December 31,
2023 2024 2025
in USD thousands
REVENUES:
License revenues 4,610 22,917 1,180
Product sales, net 190 6,023
Total revenues 4,800 28,940 1,180
COST OF REVENUES (3,692) (9,263) (230)
GROSS
PROFIT 1,108 19,677 950
RESEARCH AND DEVELOPMENT EXPENSES (12,519) (9,149) (8,093)
SALES AND MARKETING EXPENSES (25,270) (23,605)
GENERAL AND ADMINISTRATIVE EXPENSES (6,310) (6,321) (3,144)
IMPAIRMENT OF INTANGIBLE ASSETS (6,703) (1,010)
OPERATING LOSS (49,694) (20,408) (10,287)
NON-OPERATING INCOME (EXPENSES), NET (10,819) 18,435 8,077
FINANCIAL INCOME 2,068 1,871 1,464
FINANCIAL EXPENSES (2,169) (9,119) (1,280)
LOSS AND COMPREHENSIVE LOSS (60,614) (9,221) (2,026)
ATTRIBUTION OF LOSS AND
COMPREHENSIVE LOSS
To owners of the Company (60,614) (9,221) (1,175)
To non-controlling interests (851)
(60,614) (9,221) (2,026)
in USD
LOSS PER ORDINARY SHARE - BASIC AND (0.06) (0.01) (0.00)
DILUTED ATTRIBUTABLE TO OWNERS OF
THE COMPANY
WEIGHTED AVERAGE NUMBER OF SHARES 963,365,525 1,198,107,761 2,465,272,604
USED IN CALCULATION OF BASIC AND
DILUTED LOSS PER ORDINARY SHARE
BioLineRx Ltd.
STATEMENTS OF CHANGES IN EQUITY
Equity attributable to owners of the Company
Other comprehensive Non-
loss
Share premium Capital Accumulated controlling
reserve deficit interest
Ordinary shares Warrants Total
in shares
000's
in USD thousands
BALANCE AT JANUARY 1, 2023 922,959 27,100 338,976 1,408 14,765 (1,416) (329,992) 50,841
CHANGES IN 2023:
Issuance of share capital, net 124,955 3,242 10,847 14,089
Warrants exercised 38,182 1,000 5,559 6,559
Employee stock options exercised 493 13 45 (31) 27
Employee stock options expired - 55 (55)
Share-based compensation - 2,321 2,321
Comprehensive loss for the year - (60,614) (60,614)
BALANCE AT DECEMBER 31, 2023 1,086,589 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223
CHANGES IN 2024:
Issuance of share capital, pre-funded 174,322
warrants and warrants, net 4,712 (3,060) 6,650 8,302
Pre-funded warrants exercised 74,989 2,009 682 (2,691)
Employee stock options exercised 770 21 50 (49) 22
Employee stock options expired - 539 (539)
Share-based compensation - 1,135 1,135
Comprehensive loss for the year - (9,221) (9,221)
BALANCE AT DECEMBER 31, 2024 1,336,670 38,097 353,693 5,367 17,547 (1,416) (399,827) 13,461
CHANGES IN 2025:
Issuance of share capital, pre-funded 978,340 27,273 (22,260) 501 5,514
warrants and warrants, net
Pre-funded warrants exercised 295,804 8,058 (5,876) (2,182)
Employee stock options expired - 2,027 (2,027)
Share-based compensation - 396 396
Non-controlling interest - 6,000 6,000
Comprehensive loss for the year - (1,175) (851) (2,026)
BALANCE AT DECEMBER 31, 2025 2,610,814 73,428 327,584 3,686 15,916 (1,416) (401,002) 5,149 23,345
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended December 31,
2023 2024 2025
in USD thousands
CASH FLOWS - OPERATING ACTIVITIES
Loss (60,614) (9,221) (2,026)
Adjustments required to reflect net cash used in operating 38,006 (34,652) (6,048)
activities (see appendix below)
Net cash used in operating activities (22,608) (43,873) (8,074)
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits (47,588) (26,350) (36,644)
Maturities of short-term deposits 49,329 55,778 28,126
Purchase of property and equipment (116) (53) (25)
Purchase of intangible assets (181) (1) (2)
Net cash provided by (used in) investing activities 1,444 29,374 (8,545)
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital, pre-funded warrants and warrants, 14,089 16,357 13,894
net of issuance costs
Exercise of warrants 2,928
Employee stock options exercised 27 22
Proceeds from long-term loan, net of issuance costs - 19,223
Repayments of loan (1,543) (14,433) (4,498)
Repayments of lease liabilities (445) (511) (512)
Net cash provided by financing activities 15,056 20,658 8,884
INCREASE (
DECREASE) IN CASH AND CASH (6,108) 6,159 (7,735)
EQUIVALENTS
CASH AND CASH EQUIVALENTS - BEGINNING 10,587 4,255 10,436
OF YEAR
EXCHANGE DIFFERENCES ON CASH AND CASH (224) 22 549
EQUIVALENTS
CASH AND CASH EQUIVALENTS - END OF YEAR 4,255 10,436 3,250
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended December 31,
2023 2024 2025
in USD thousands
APPENDIX
Adjustments required to reflect net cash used in
operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization 1,384 4,065 523
Loss on disposal of property and equipment - 25
Exchange differences on cash and cash equivalents 224 (22) (549)
Fair value adjustments of warrants 11,054 (18,965) (8,599)
Share-based compensation 2,321 1,135 396
Interest and exchange differences on short-term 15 185 18
deposits
Interest on loan 1,148 (1,126)
Warrant issuance costs - 669 702
Exchange differences on lease liabilities (42) (31) 177
Intangible assets impairment 6,703 1,010
Loss on abandonment of right-of-use asset - 246
22,807 (12,834) (7,307)
Changes in operating asset and liability items:
Decrease (increase) in trade receivables (358) (2,118) 2,430
Decrease (increase) in inventory (1,953) (1,192) 997
Decrease (increase) in prepaid expenses and other (959) (43) 1,310
receivables
Increase (decrease) in accounts payable and accruals 5,512 (5,508) (3,478)
Increase (decrease) in contract liabilities 12,957 (12,957)
15,199 (21,818) 1,259
38,006 (34,652) (6,048)
Supplemental information on interest received in cash 2,020 1,992 1,153
Supplemental information on interest paid in cash 1,111 10,387 1,268
Supplemental information on non-cash transactions:
Changes in right-of-use asset and lease liabilities 149 327 (57)
Fair value of exercised warrants (portion related to 3,631
accumulated fair value adjustments)
Intangible asset acquired in connection with GLIX1 - 6,000
collaboration transaction
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