- Announced first patient dosed in Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) -
- Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide (TMZ)-resistant patient-derived xenograft model -
- Management to host conference call today, May 27, at 8:30 am EDT -
TEL AVIV, Israel, May 27, 2026 /PRNewswire/ -- BioLineRx Ltd. $(BLRX)$ (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended March 31, 2026, and provided a corporate update.
"Since our last quarterly update, we achieved a significant milestone for our company and for the GLIX1 development program with the dosing of the first patient in our Phase 1/2a clinical trial of GLIX1 in glioblastoma," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We are also very encouraged by compelling new pre-clinical data showing that GLIX1 demonstrated robust dose-dependent tumor-growth inhibition and survival benefit in orthotopic cell-derived xenograft $(CDX)$ GBM models. Furthermore, in a newly completed subcutaneous TMZ-resistant patient-derived xenograft $(PDX)$ GBM model, GLIX1 demonstrated a robust anti-tumor effect while no effect was observed with TMZ, highlighting the potential to address the very high unmet need in GBM."
"In the coming days, we look forward to engaging with the broader oncology community at this year's ASCO meeting with two abstracts featuring GLIX1. The abstracts highlight its novel mechanism of action and provide strong rationale for the development of GLIX1 in GBM as well as in other cancers. They also highlight that in safety studies in animals GLIX1 was safe up to the highest feasible doses tested, supporting the combination with other anti-cancer agents. Furthermore, the abstracts highlight the compelling mechanistic rationale for combining GLIX1 with PARP inhibitors supported by synergistic effect in cell lines across diverse cancers including from tumor types typically less responsive to PARP inhibition."
Financial Updates
-- With $17.4 million on its balance sheet as of March 31, 2026, BioLineRx
is maintaining its cash runway guidance into the first half of 2027.
Development Updates
GLIX1
-- Phase 1/2a clinical trial of GLIX1 in glioblastoma and other cancers
initiated in March 2026.
-- The first patient was dosed at NYU Langone Health under the
supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology &
Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer
Center.
-- Two additional leading cancer centers are participating in the
study: Northwestern University, led by Dr. Roger Stupp and Dr.
Ditte Primdahl; and Moffit Cancer Center, led by Dr. Patrick
Grogan. Additional sites may be added to the study at a later
date.
-- 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.
-- The Phase 2a expansion part of the trial is planned to include
additional indications, including newly diagnosed GBM, as well as
select cancers, with GLIX1 as monotherapy or in combination with
standard of care (including in combination with PARP inhibitors).
These cohorts are expected to identify preliminary efficacy, PD
assessments and dose optimization data, serving as the basis for a
rapid and effective advanced clinical development plan.
-- Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM
across multiple in-vivo studies, including a temozolomide (TMZ)-resistant
patient-derived xenograft model
-- Announced two abstracts on GLIX1 that were selected for publication
during the American Society of Clinical Oncology (ASCO) Annual Meeting,
which is scheduled for May 29-June 2, in Chicago, IL.
-- Pre-clinical activities in support of clinical development for GLIX1 in
additional cancer indications, including in combination with PARP
inhibitors, are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
-- Enrollment is continuing 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.
APHEXDA Performance Update
-- APHEXDA sales for the first quarter of 2026 were $2.7 million, which
provided royalty revenues to the company of $0.5 million.
Financial Results for the Quarter ended March 31, 2026
-- Revenues for the three months ended March 31, 2026 were $0.5 million, an
increase of $0.2 million, compared to revenues of $0.3 million for the
three months ended March 31, 2025. The increase in revenues from 2025 to
2026 reflects an increase in royalties paid by Ayrmid from the
commercialization of APHEXDA.
-- Cost of revenues for the three months ended March 31, 2026 was $0.1
million, compared to immaterial cost of revenues for the three months
ended March 31, 2025. The cost of revenues reflects sub-license fees on
royalties paid by Ayrmid from the commercialization of APHEXDA.
-- Research and development expenses for the three months ended March 31,
2026 were $2.5 million, an increase of $0.9 million, or 55.8%, compared
to $1.6 million for the three months ended March 31, 2025. The increase
resulted primarily from expenses related to the new GLIX1 project.
-- General and administrative expenses for the three months ended March 31,
2026 were $0.9 million, a decrease of $0.1 million, or 13.3%, compared to
$1.0 million for the three months ended March 31, 2025. The decrease
resulted primarily from a decrease in legal expenses, as well as a
decrease in a number of other general and administrative expenses.
-- Net non-operating income amounted to $0.5 million for the three months
ended March 31, 2026, compared to net non-operating income of $7.6
million for the three months ended March 31, 2025. Non-operating income
for the periods primarily relates to non-cash fair-value adjustments of
warrant liabilities, as a result of changes in the Company's share price,
offset by warrant offering expenses.
-- Net financial expenses for the three months ended March 31, 2026 were
immaterial compared to net financial expenses of $0.1 million for the
three months ended March 31, 2025. Net financial expenses for the periods
primarily relate to interest paid on loans, partially offset by
investment income earned on bank deposits.
-- Net loss for the quarter ended March 31, 2026 was $2.6 million, compared
to net income of $5.1 million for the quarter ended March 31, 2025.
-- As of March 31, 2026, the Company had cash, cash equivalents, and
short-term bank deposits of $17.4 million.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 28, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial was initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.
The Company's first approved product, APHEXDA$(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 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 the planned Phase 1/2a GLIX1 clinical trial, expected timing of a clinical readout, 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
Chuck Padala
LifeSci Advisors, LLC
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,
------------ ---------
2025 2026
------------ ---------
in USD thousands
-----------------------
Assets
CURRENT ASSETS
Cash and cash equivalents 3,250 2,504
Short-term bank deposits 17,626 14,849
Prepaid expenses 201 181
Other receivables 456 1,891
Inventory 2,148 2,157
------------ ---------
Total current assets 23,681 21,582
------------ ---------
NON-CURRENT ASSETS
Property and equipment, net 160 146
Right-of-use assets, net 696 721
Intangible assets, net 16,368 16,348
------------ ---------
Total non-current assets 17,224 17,215
------------ ---------
Total assets 40,905 38,797
============ =========
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loan 4,479 4,479
Accounts payable and accruals:
Trade 3,493 4,905
Other 1,743 2,249
Current maturities of lease liabilities 234 253
Warrants 2,174 1,738
------------ ---------
Total current liabilities 12,123 13,624
------------ ---------
NON-CURRENT LIABILITIES
Long-term loan, net of current maturities 4,460 3,359
Lease liabilities 977 979
------------ ---------
Total non-current liabilities 5,437 4,338
------------ ---------
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities 17,560 17,962
------------ ---------
EQUITY
Equity attributable to owners of the Company:
Ordinary shares 73,428 73,428
Share premium 327,584 327,584
Warrants 3,686 3,686
Capital reserve 15,916 15,994
Other comprehensive loss (1,416) (1,416)
Accumulated deficit (401,002) (402,603)
------------ ---------
Total equity attributable to owners of the
Company 18,196 16,673
Non-controlling interest 5,149 4,162
------------ ---------
Total equity 23,345 20,835
------------ ---------
Total liabilities and equity 40,905 38,797
============ =========
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
Three months ended March 31,
------------------------------
2025 2026
-------------- --------------
in USD thousands
------------------------------
ROYALTY REVENUES 255 477
COST OF REVENUES (34) (95)
-------------- --------------
GROSS PROFIT 221 382
RESEARCH AND DEVELOPMENT EXPENSES (1,623) (2,528)
GENERAL AND ADMINISTRATIVE EXPENSES (989) (858)
-------------- --------------
OPERATING LOSS (2,391) (3,004)
NON-OPERATING INCOME, NET 7,644 458
FINANCIAL INCOME 294 208
FINANCIAL EXPENSES (420) (250)
-------------- --------------
NET INCOME (LOSS) AND COMPREHENSIVE INCOME
(LOSS) 5,127 (2,588)
============== ==============
ATTRIBUTION OF NET INCOME (LOSS) AND
COMPREHENSIVE INCOME (LOSS)
To owners of the Company 5,127 (1,601)
To non-controlling interests - (987)
-------------- --------------
5,127 (2,588)
============== ==============
in USD
EARNINGS (LOSS) PER ORDINARY SHARE -- BASIC
AND DILUTED ATTRIBUTABLE TO OWNERS OF THE
COMPANY 0.00 (0.00)
============== ==============
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF BASIC AND DILUTED EARNINGS
(LOSS) PER ORDINARY SHARE 2,217,728,234 2,660,228,740
============== ==============
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
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,
2025 1,336,670 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 600,128 16,415 (14,836) 501 - - - - 2,080
Pre-funded
warrants
exercised 295,804 8,058 (5,876) (2,182) - - - - -
Employee stock
options
expired - - 646 - (646) - - - -
Share-based
compensation - - - - 194 - - - 194
Comprehensive
income for
the year - - - - - - 5,127 - 5,127
--------- ------ -------- -------- ------- ------------- ----------- ----------- ------
BALANCE AT
MARCH 31,
2025 2,232,602 62,570 333,627 3,686 17,095 (1,416) (394,700) - 20,862
========= ====== ======== ======== ======= ============= =========== =========== ======
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,
2026 2,610,814 73,428 327,584 3,686 15,916 (1,416) (401,002) 5,149 23,345
CHANGES FOR
THREE MONTHS
ENDED MARCH
31, 2026:
Share-based
compensation - - - - 78 - - - 78
Comprehensive
loss for the
year - - - - - - (1,601) (987) (2,588)
--------- ------ ------- -------- ------- ------------- ----------- ----------- -------
BALANCE AT
MARCH 31,
2026 2,610,814 73,428 327,584 3,686 15,994 (1,416) (402,603) 4,162 20,835
========= ====== ======= ======== ======= ============= =========== =========== =======
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three months ended March 31,
------------------------------
2025 2026
--------------- -------------
in USD thousands
------------------------------
CASH FLOWS - OPERATING ACTIVITIES
Comprehensive income (loss) for the period 5,127 (2,588)
Adjustments required to reflect net cash
used in operating activities (see
appendix below) (7,718) 308
---------------
Net cash used in operating activities (2,591) (2,280)
---------------
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits (12,307) (5,181)
Maturities of short-term deposits 4,130 7,890
Purchase of property and equipment - (6)
--------------- -------------
Net cash provided by (used in) investing
activities (8,177) 2,703
--------------- -------------
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital, pre-funded
warrants and warrants, net of
issuance costs 10,697 -
Repayments of loan (1,120) (1,120)
Repayments of lease liabilities (127) (60)
--------------- -------------
Net cash provided by (used in) financing
activities 9,450 (1,180)
--------------- -------------
DECREASE IN CASH AND CASH EQUIVALENTS (1,318) (757)
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD 10,436 3,250
EXCHANGE DIFFERENCES ON CASH AND CASH
EQUIVALENTS (82) 11
--------------- -------------
CASH AND CASH EQUIVALENTS - END OF PERIOD 9,036 2,504
=============== =============
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three months ended March 31,
-------------------------------
2025 2026
--------------- --------------
in USD thousands
-------------------------------
APPENDIX
Adjustments required to reflect net cash used
in operating activities:
Income and expenses not involving cash
flows:
Depreciation and amortization 165 88
Exchange differences on cash and cash
equivalents 82 (11)
Fair value adjustments of warrants (8,311) (436)
Share-based compensation 194 78
Interest and exchange differences on
short-term deposits (30) 68
Warrant issuance costs 702 -
Exchange differences on lease
liabilities (7) 8
--------------- --------------
(7,205) (205)
--------------- --------------
Changes in operating asset and liability
items:
Decrease in trade receivables 1,007 46
Increase in inventory (170) (9)
Decrease (increase) in prepaid expenses
and other receivables 1,157 (1,461)
Increase (decrease) in accounts payable
and accruals (2,507) 1,937
--------------- --------------
(513) 513
--------------- --------------
(7,718) 308
=============== ==============
Supplemental information on interest received
in cash 236 259
=============== ==============
Supplemental information on interest paid in
cash 361 245
=============== ==============
Supplemental information on non-cash
transactions:
Changes in right-of-use asset and lease
liabilities 44 73
=============== ==============
Warrant issuance costs 237 -
=============== ==============
Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302782918.html
SOURCE BioLineRx Ltd.
(END) Dow Jones Newswires
May 27, 2026 07:00 ET (11:00 GMT)