GLIX1 first patient dosed as BioLineRx (NASDAQ: BLRX) flags going concern risk
BioLineRx reported first quarter 2026 results showing a net loss of $2.6M, compared with net income of $5.1M a year earlier, as research and development spending increased. Royalty revenue from partnerships rose to $0.5M, reflecting initial APHEXDA commercialization.
Cash, cash equivalents and short-term deposits totaled $17.4M as of March 31, 2026, with negative operating cash flow of $2.3M for the quarter. Management expects existing resources to fund operations into the first half of 2027, but explicitly notes material uncertainty that may cast significant doubt on the company’s ability to continue as a going concern.
Strategically, BioLineRx is pivoting to an R&D-focused model centered on oncology and rare diseases. The lead asset GLIX1 advanced with the first patient dosed in a Phase 1/2a glioblastoma trial, backed by encouraging preclinical data and Orphan Drug Designation in the US and EU. Motixafortide, already approved as APHEXDA for stem-cell mobilization, is now out-licensed globally, while the company retains development rights in solid tumors including metastatic pancreatic cancer supported by an ongoing Phase 2b trial.
Positive
- None.
Negative
- Going concern uncertainty: Management reports an accumulated deficit of $402.6M, cash and deposits of $17.4M as of March 31, 2026, funding only into the first half of 2027, and states that these factors create material uncertainty about the ability to continue as a going concern.
Insights
Q1 2026 shows GLIX1 progress but heightened going concern risk.
BioLineRx is transitioning into a lean, development-stage biotech built around GLIX1 for glioblastoma and motixafortide in solid tumors. The first patient dosed in the GLIX1 Phase 1/2a study and robust preclinical data strengthen the scientific story in a high‑need cancer.
Financially, the picture is more challenging. Quarterly royalty revenue was only $477K, while the company posted a net loss of $2.6M and negative operating cash flow of $2.3M. With $17.4M in cash and deposits and an accumulated deficit of $402.6M, management states resources last only into the first half of 2027.
Management explicitly discloses that these factors create material uncertainty about continuing as a going concern and plans to rely on partnership inflows and potential new equity or debt financing. Investors will need to track future updates on the GLIX1 Phase 1/2a trial and the Phase 2b pancreatic cancer study, as well as any capital-raising steps discussed in subsequent filings.
Key Figures
Key Terms
going concern financial
Orphan Drug Designation regulatory
at-the-market ("ATM") sales agreement financial
Phase 1/2a clinical trial medical
patient-derived xenograft (PDX) model medical
non-operating income financial
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BioLineRx Ltd.
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By:
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/s/ Philip A. Serlin
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Philip A. Serlin
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Chief Executive Officer
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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.
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Phase 1/2a clinical trial of GLIX1 in glioblastoma and other cancers initiated in March 2026.
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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.
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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.
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| o |
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.
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| o |
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.
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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
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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.
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Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications, including in combination with PARP inhibitors, are ongoing.
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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).
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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.
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APHEXDA sales for the first quarter of 2026 were $2.7 million, which provided royalty revenues to the company of $0.5 million.
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| • |
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.
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| • |
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.
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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.
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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.
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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.
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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.
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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.
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As of March 31, 2026, the Company had cash, cash equivalents, and short-term bank deposits of $17.4 million.
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December 31,
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March 31,
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|||||||
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2025
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2026
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|||||||
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in USD thousands
|
||||||||
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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
|
||||||
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Total assets
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40,905
|
38,797
|
||||||
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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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||||||||
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Trade
|
3,493
|
4,905
|
||||||
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Other
|
1,743
|
2,249
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||||||
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Current maturities of lease liabilities
|
234
|
253
|
||||||
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Warrants
|
2,174
|
1,738
|
||||||
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Total current liabilities
|
12,123
|
13,624
|
||||||
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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
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17,560
|
17,962
|
||||||
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EQUITY
|
||||||||
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Equity attributable to owners of the Company:
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||||||||
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Ordinary shares
|
73,428
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73,428
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||||||
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Share premium
|
327,584
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327,584
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||||||
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Warrants
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3,686
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3,686
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Capital reserve
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15,916
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15,994
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Other comprehensive loss
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(1,416
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)
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(1,416
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)
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Accumulated deficit
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(401,002
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)
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(402,603
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)
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Total equity attributable to owners of the Company
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18,196
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16,673
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Non-controlling interest
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5,149
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4,162
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Total equity
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23,345
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20,835
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Total liabilities and equity
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40,905
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38,797
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||||||
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Three months ended March 31,
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||||||||
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2025
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2026
|
|||||||
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in USD thousands
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||||||||
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ROYALTY REVENUES
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255
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477
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||||||
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COST OF REVENUES
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(34
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)
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(95
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)
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GROSS PROFIT
|
221
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382
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||||||
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RESEARCH AND DEVELOPMENT EXPENSES
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(1,623
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)
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(2,528
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)
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GENERAL AND ADMINISTRATIVE EXPENSES
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(989
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)
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(858
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)
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OPERATING LOSS
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(2,391
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)
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(3,004
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)
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NON-OPERATING INCOME, NET
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7,644
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458
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FINANCIAL INCOME
|
294
|
208
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||||||
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FINANCIAL EXPENSES
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(420
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)
|
(250
|
)
|
||||
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NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
|
5,127
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(2,588
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)
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|||||
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ATTRIBUTION OF NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)
|
||||||||
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To owners of the Company
|
5,127
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(1,601
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)
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|||||
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To non-controlling interests
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-
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(987
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)
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|||||
|
5,127
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(2,588
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)
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||||||
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in USD
|
||||||||
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EARNINGS (LOSS) PER ORDINARY SHARE – BASIC AND DILUTED ATTRIBUTABLE TO OWNERS OF THE COMPANY
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0.00
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(0.00
|
)
|
|||||
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WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE
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2,217,728,234
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2,660,228,740
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||||||
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Equity attributable to owners of the Company
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Non-controlling interest
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Total
|
||||||||||||||||||||||||||||||||||
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Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive
loss |
Accumulated deficit
|
|||||||||||||||||||||||||||||||
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in shares 000’s
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in USD thousands
|
|||||||||||||||||||||||||||||||||||
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BALANCE AT JANUARY 1, 2025
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1,336,670
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38,097
|
353,693
|
5,367
|
17,547
|
(1,416
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)
|
(399,827
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)
|
-
|
13,461
|
|||||||||||||||||||||||||
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CHANGES FOR THREE MONTHS ENDED MARCH 31, 2025:
|
||||||||||||||||||||||||||||||||||||
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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
|
Non-controlling interest
|
Total
|
||||||||||||||||||||||||||||||||||
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive
loss |
Accumulated deficit
|
|||||||||||||||||||||||||||||||
|
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
|
|||||||||||||||||||||||||
|
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
|
||||||
|
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
|
-
|
|
Page
|
||
|
Condensed consolidated interim statements of financial position
|
1
|
|
|
Condensed consolidated interim statements of comprehensive income (loss)
|
2
|
|
|
Condensed consolidated interim statements of changes in equity
|
3
|
|
|
Condensed consolidated interim cash flow statements
|
4-5
|
|
|
Notes to the condensed consolidated interim financial statements
|
6-16
|
|
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
|
||||||
|
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
|
||||||
|
Equity attributable to owners of the Company
|
Non-controlling interest
|
Total
|
||||||||||||||||||||||||||||||||||
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive
loss |
Accumulated deficit
|
|||||||||||||||||||||||||||||||
|
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
|
Non-controlling interest
|
Total
|
||||||||||||||||||||||||||||||||||
|
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other comprehensive
loss |
Accumulated deficit
|
|||||||||||||||||||||||||||||||
|
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
|
|||||||||||||||||||||||||
|
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
|
||||||
|
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
|
-
|
| a. |
General
|
| b. |
War in Israel
|
| c. |
Going concern
|
| d. |
Approval of financial statements
|
| a. |
General
|
| b. |
New international financial reporting standards, amendments to standards and new interpretations
|
| a. |
September 2022 offering
|
| b. |
April 2024 offering
|
| c. |
Securities purchase agreement – Highbridge
|
| d. |
January 2025 offering
|
| d. |
January 2025 offering (cont.)
|
|
Warrants
|
||||
|
in USD thousands
|
||||
|
Balance as of December 31, 2025
|
2,174
|
|||
|
Changes during 2026:
|
||||
|
Changes in fair value through profit and loss
|
(436
|
)
|
||
|
Balance as of March 31, 2026
|
1,738
|
|||
|
Number of ordinary shares
|
||||||||
|
December 31,
|
March 31,
|
|||||||
|
2025
|
2026
|
|||||||
|
Authorized share capital
|
20,000,000,000
|
20,000,000,000
|
||||||
|
Issued and paid-up share capital
|
2,610,814,390
|
2,610,814,390
|
||||||
|
In USD and NIS
|
||||||||
|
December 31,
|
March 31,
|
|||||||
|
2025
|
2026
|
|||||||
|
Authorized share capital (in NIS)
|
2,000,000,000
|
2,000,000,000
|
||||||
|
Issued and paid-up share capital (in NIS)
|
261,081,439
|
261,081,439
|
||||||
|
Issued and paid-up share capital (in USD)
|
73,428,375
|
73,428,375
|
||||||
|
•
|
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 our preclinical studies, clinical trials and other therapeutic candidate development efforts;
|
|
•
|
our ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete our preclinical studies or clinical trials;
|
|
•
|
whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results;
|
|
•
|
our 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;
|
|
•
|
our ability to establish, manage, and maintain corporate collaborations, as well as the ability of our collaborators to execute on their development and commercialization plans;
|
|
|
•
|
our ability to integrate new therapeutic candidates and new personnel, as well as new collaborations;
|
|
•
|
the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials;
|
|
•
|
the implementation of our business model and strategic plans for our business and therapeutic candidates;
|
|
•
|
the scope of protection that we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without
infringing the intellectual property rights of others;
|
|
•
|
estimates of our expenses, future revenues, capital requirements and our 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 our industry;
|
|
•
|
our ability to maintain the listing of our ADSs on Nasdaq;
|
|
•
|
statements as to the impact of the political and security situation in Israel on our business, which may exacerbate the magnitude of the factors discussed above; and
|
|
•
|
those factors referred to in “Risk Factors” in our Annual Report.
|


| Project | Status | Expected Near Term Milestones | ||
|
GLIX1
|
1.
|
Phase 1/2a study for the treatment of recurrent and progressive GBM and other high-grade gliomas
|
1.
|
First patient dosed in April 2026; updates to the Phase 1/2a study expected in H2 2026, with full data from the Phase 1 part anticipated in 2027
|
|
Motixafortide
|
2.
|
FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients.
|
2.
|
Out-licensed to Ayrmid in November 2024; five-year long-term follow-up of GENESIS patients ongoing
|
|
3.
|
Reported preliminary data in September 2023 from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC. Of 11 patients with metastatic pancreatic cancer enrolled, 7
patients (64%) experienced partial response (PR), of which 6 (55%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%) experienced stable disease, resulting in a disease
control rate of 91%. Based on these encouraging preliminary results, study was substantially revised to a multi-institution, randomized Phase 2b trial of 108 patients. In May 2025, reported updated results from the pilot phase indicating that
four of 11 patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC - 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 and peripheral blood mononuclear cells
(PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
|
3.
|
First patient dosed in randomized study in February 2024. Interim futility analysis planned for 2026 and full enrollment projected for 2027*
|
|
|
4.
|
Phase 1 study for gene therapies in SCD (with Washington University School of Medicine in St. Louis)**, which was initiated in December 2023
|
4.
|
Study completed during 2025. Final results from the study were presented at ASH Annual Meeting in December 2025. A summary of the published abstract is disclosed in this report above - see “Motixafortide”, “Stem
cell mobilization”, “Sickle Cell Disease”
|
|
|
5.
|
Phase 1 study for gene therapies in SCD (with St. Jude Children’s Research Hospital, Inc.)**
|
5.
|
First patient dosed in February 2025, with data planned in 2026*
|
|
|
6.
|
IND approved in China for initiation of pivotal bridging study in SCM under license agreement with Gloria
|
6.
|
First patient dosed in December 2025
|
|
|
7.
|
Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria
|
7.
|
IND submission and protocol finalization is currently delayed***
|
|
|
*
|
These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent investigators and are subject to change.
|
|
**
|
Study to be continued under the Ayrmid License Agreement
|
|
***
|
The planned study of motixafortide in China under the Gloria License Agreement is currently not advancing according to schedule and it is unclear when such study will be initiated, if at all.
|
|
|
•
|
the number of sites included in the clinical trials;
|
|
|
•
|
the length of time required to enroll suitable patients;
|
|
|
|
|
|
|
•
|
the number of patients that participate, and are eligible to participate, in the clinical trials;
|
|
|
•
|
the duration of patient follow-up;
|
|
|
|
|
|
|
•
|
whether the patients require hospitalization or can be treated on an outpatient basis;
|
|
|
•
|
the development stage of the therapeutic candidate; and
|
|
|
•
|
the efficacy and safety profile of the therapeutic candidate.
|
|
Three months ended
March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
Royalty revenues
|
255
|
477
|
222
|
|||||||||
|
Three months ended
March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
Cost of revenues
|
34
|
95
|
61
|
|||||||||
|
Three months ended March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
Research and development expenses
|
1,623
|
2,528
|
905
|
|||||||||
|
Three months ended March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
General and administrative expenses
|
989
|
858
|
(131
|
)
|
||||||||
|
Three months ended March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
Non-operating income (expenses), net
|
7,644
|
458
|
(7,186
|
)
|
||||||||
|
Three months ended March 31,
|
||||||||||||
|
2025
|
2026
|
Increase (decrease)
|
||||||||||
|
(in thousands of U.S. dollars)
|
||||||||||||
|
Financial income
|
294
|
208
|
(86
|
)
|
||||||||
|
Financial expenses
|
(420
|
)
|
(250
|
)
|
170
|
|||||||
|
Net financial income (expenses)
|
(126
|
)
|
(42
|
)
|
84
|
|||||||
|
•
|
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
|
•
|
the scope, prioritization and number of our clinical trials and other research and development programs;
|
|
•
|
the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
|
|
•
|
the costs of the development and expansion of our operational infrastructure;
|
|
•
|
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
|
|
•
|
our success in effecting out-licensing arrangements with third parties;
|
|
•
|
the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing agreements;
|
|
•
|
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
|
•
|
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
|
•
|
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
|
|
•
|
the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates;
|
|
•
|
the magnitude of our general and administrative expenses;
|
|
•
|
interest and principal payments on the loan from BlackRock;
|
|
•
|
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; and
|
|
•
|
market conditions.
|
|
Three months ended
March 31,
|
||||||||
|
2025
|
2026
|
|||||||
|
(in U.S. dollars)
|
||||||||
|
Earnings (loss) per ADS – basic and diluted
|
1.40
|
(0.58
|
)
|
|||||
|
Earnings (loss) per ordinary share – basic and diluted
|
0.00
|
(0.00
|
)
|
|||||
|
December 31, 2025
|
March 31,
2026
|
|||||||
|
(in number of ADSs)
|
||||||||
|
Authorized share capital
|
33,333,333
|
33,333,333
|
||||||
|
Issued and paid-up capital
|
4,351,357
|
4,351,357
|
||||||