- 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. $(BLRX)$ (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.
"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 $20.9 million, sufficient to fund operations,
as currently planned, into the first half of 2027.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at IR@biolinerx.com.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is expected to initiate in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.
The Company's first approved product, APHEXDA$(R)$ (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 DILUTED
ATTRIBUTABLE TO OWNERS OF
THE COMPANY (0.06) (0.01) (0.00)
=========== ============= =============
WEIGHTED AVERAGE NUMBER OF
SHARES USED IN CALCULATION
OF BASIC AND DILUTED LOSS
PER ORDINARY SHARE 963,365,525 1,198,107,761 2,465,272,604
=========== ============= =============
BioLineRx Ltd.
STATEMENTS OF CHANGES IN EQUITY
Equity attributable to owners of the Company
------------------------------------------------------------------------------
Other Non-
Share Capital comprehensive Accumulated controlling
Ordinary shares premium Warrants reserve loss deficit interest 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
warrants and (3,060)
warrants, net 174,322 4,712 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
warrants and
warrants, net 978,340 27,273 (22,260) 501 - - - - 5,514
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 activities (see
appendix below) 38,006 (34,652) (6,048)
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
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