BioLineRx Reports First Quarter 2026 Financial Results and Provides Corporate Update
- 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,
"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
"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 ofMarch 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 ; andMoffit 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.
- The first patient was dosed at
- 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 forMay 29-June 2 , inChicago, 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 andBioLineRx . 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
- 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 endedMarch 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 endedMarch 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 endedMarch 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 endedMarch 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 endedMarch 31, 2026 , compared to net non-operating income of$7.6 million for the three months endedMarch 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 endedMarch 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 endedMarch 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 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® (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
Contacts:
IR@biolinerx.com
moran@lifesciadvisors.com
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CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
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(UNAUDITED) |
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2025 |
2026 |
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in USD thousands |
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Assets |
|
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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 |
|
|
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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 |
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|
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Liabilities and equity |
|
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CURRENT LIABILITIES |
|
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Current maturities of long-term loan |
4,479 |
4,479 |
|
Accounts payable and accruals: |
|
|
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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 |
|
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|
|
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NON-CURRENT LIABILITIES |
|
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Long-term loan, net of current maturities |
4,460 |
3,359 |
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Lease liabilities |
977 |
979 |
|
Total non-current liabilities |
5,437 |
4,338 |
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COMMITMENTS AND CONTINGENT LIABILITIES |
|
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Total liabilities |
17,560 |
17,962 |
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EQUITY |
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Equity attributable to owners of the Company: |
|
|
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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 |
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Total equity |
23,345 |
20,835 |
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Total liabilities and equity |
40,905 |
38,797 |
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CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) |
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(UNAUDITED) |
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Three months ended |
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2025 |
2026 |
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in USD thousands |
|
|
|
|
|
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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) |
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NET INCOME (LOSS) AND COMPREHENSIVE INCOME |
5,127 |
(2,588) |
|
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ATTRIBUTION OF NET INCOME (LOSS) AND |
|
|
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To owners of the Company |
5,127 |
(1,601) |
|
To non-controlling interests |
- |
(987) |
|
|
5,127 |
(2,588) |
|
|
|
|
|
|
in USD |
|
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EARNINGS (LOSS) PER ORDINARY SHARE – BASIC AND |
0.00 |
(0.00) |
|
|
|
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WEIGHTED AVERAGE NUMBER OF SHARES USED IN |
2,217,728,234 |
2,660,228,740 |
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CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY |
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(UNAUDITED) |
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Equity attributable to owners of the Company |
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Ordinary shares |
Share |
Warrants |
Capital |
Other |
Accumulated |
Non- |
Total |
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in shares 000's |
in USD thousands |
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BALANCE AT |
1,336,670 |
38,097 |
353,693 |
5,367 |
17,547 |
(1,416) |
(399,827) |
- |
13,461 |
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CHANGES FOR THREE MONTHS ENDED |
|
|
|
|
|
|
|
|
|
|
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Issuance of share capital, pre-funded warrants and warrants, net |
600,128 |
16,415 |
(14,836) |
501 |
- |
- |
- |
- |
2,080 |
|
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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 |
2,232,602 |
62,570 |
333,627 |
3,686 |
17,095 |
(1,416) |
(394,700) |
- |
20,862 |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
Equity attributable to owners of the Company |
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||||||
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|
Ordinary shares |
Share |
Warrants |
Capital |
Other |
Accumulated |
Non- |
Total |
|
|
|
in shares 000's |
in USD thousands |
|||||||
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BALANCE AT |
2,610,814 |
73,428 |
327,584 |
3,686 |
15,916 |
(1,416) |
(401,002) |
5,149 |
23,345 |
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CHANGES FOR THREE MONTHS |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
- |
- |
- |
- |
78 |
- |
- |
- |
78 |
|
Comprehensive loss for the year |
- |
- |
- |
- |
- |
- |
(1,601) |
(987) |
(2,588) |
|
BALANCE AT |
2,610,814 |
73,428 |
327,584 |
3,686 |
15,994 |
(1,416) |
(402,603) |
4,162 |
20,835 |
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CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS |
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(UNAUDITED) |
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Three months ended |
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2025 |
2026 |
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in USD thousands |
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CASH FLOWS - OPERATING ACTIVITIES |
|
|
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Comprehensive income (loss) for the period |
5,127 |
(2,588) |
|
Adjustments required to reflect net cash used in operating activities |
(7,718) |
308 |
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Net cash used in operating activities |
(2,591) |
(2,280) |
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CASH FLOWS - INVESTING ACTIVITIES |
|
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Investments in short-term deposits |
(12,307) |
(5,181) |
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Maturities of short-term deposits |
4,130 |
7,890 |
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Purchase of property and equipment |
- |
(6) |
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Net cash provided by (used in) investing activities |
(8,177) |
2,703 |
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CASH FLOWS - FINANCING ACTIVITIES |
|
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Issuance of share capital, pre-funded warrants and warrants, net of |
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) |
|
|
|
|
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DECREASE IN CASH AND CASH EQUIVALENTS |
(1,318) |
(757) |
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CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD |
10,436 |
3,250 |
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EXCHANGE DIFFERENCES ON CASH AND CASH |
(82) |
11 |
|
CASH AND CASH EQUIVALENTS - END OF PERIOD |
9,036 |
2,504 |
|
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|
|
|
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APPENDIX TO CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS |
||
|
(UNAUDITED) |
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|
|
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|
|
Three months ended |
|
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|
2025 |
2026 |
|
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in USD thousands |
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APPENDIX |
|
|
|
|
|
|
|
Adjustments required to reflect net cash used in operating |
|
|
|
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 |
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 |
- |
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