BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update
- Net income increased significantly to $5.1 million from $0.7 million YoY
- Successful cost reduction with operating expenses down 70%
- Strong cash position of $26.4 million with runway through H2 2026
- Completed $10 million financing in January 2025
- Promising clinical data from CheMo4METPANC trial showing complete response in some patients
- Revenue decreased significantly to $0.3 million from $6.9 million YoY
- APHEXDA sales of $1.4 million generated modest royalties of $0.3 million
- Full enrollment in CheMo4METPANC trial not expected until 2027
Insights
BioLineRx reports $5.1M Q1 profit, reduces expenses 70%, extends cash runway while advancing clinical pipeline post-APHEXDA licensing.
BioLineRx's Q1 2025 results reveal a company in transition following the strategic out-licensing of APHEXDA to Ayrmid in late 2024. The company posted a net income of $5.1 million for the quarter, a substantial improvement from $0.7 million in Q1 2024, though this profit largely stems from non-operational sources—primarily $7.6 million in fair-value adjustments of warrant liabilities due to share price changes.
The financials show both challenge and opportunity. Revenues plummeted to just $0.3 million from $6.9 million year-over-year, reflecting the shift from direct commercialization to a royalty-based model for APHEXDA, which generated $1.4 million in sales during Q1. More importantly, BioLineRx has successfully executed a dramatic 70% reduction in operating expenses following the shutdown of U.S. commercial operations, with research and development expenses down 35% to $1.6 million and general administrative expenses reduced by 29% to $1.0 million.
The company's cash position stands at $26.4 million following a $10 million financing in January, which management projects will sustain operations through the second half of 2026. This runway provides BioLineRx time to identify and acquire new assets in oncology and rare diseases, with CEO Philip Serlin expressing optimism about announcing a "meaningful transaction" in 2025.
On the clinical front, motixafortide continues development with additional sites activated for the CheMo4METPANC Phase 2b trial in pancreatic cancer, although full enrollment isn't expected until 2027. Encouraging data from the pilot phase will be presented at ASCO, including complete resolution of liver lesions in one patient and evidence of increased CD8+ T-cell tumor infiltration across all treated patients. Additional Phase 1 trials evaluating motixafortide for stem cell mobilization in sickle cell disease gene therapies continue to progress.
The dramatic reduction in operating expenses coupled with extended cash runway gives BioLineRx breathing room to execute its pivot from commercial operations to a development-focused model while seeking new assets. However, investors should recognize that current profitability is non-operational, and future growth depends entirely on successful asset acquisition and development.
- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease -
- New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting –
- APHEXDA performing well under Ayrmid stewardship -
- Management to host conference call today, May 27th, at 8:30 am EDT -
"Following our announcement last November that we out-licensed APHEXDA®, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."
"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.
Financial Updates
- Completed financing in January 2025 raising gross proceeds of
$10 million - Successfully reduced operating expense run rate by over
70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company'sU.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions. - Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update
- APHEXDA generated sales of
$1.4 million $0.3 million
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
- Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when
40% of progression free survival (PFS) events are observed. - An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO Annual Meeting on Saturday, May 31st. Key highlights include:
- Two patients underwent definitive treatment for metastatic pancreatic cancer: 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 revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy
- Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital.
- Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in
St. Louis .
Financial Results for the Quarter Ended March 31, 2025
- Revenues for the three-month period ended March 31, 2025 were
$0.3 million $6.6 million $6.9 million U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to$5.9 million $0.9 million U.S. - Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of
$1.5 million U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in theU.S. , as well as amortization of intangible assets and cost of goods sold on product sales. - Research and development expenses for the three months ended March 31, 2025 were
$1.6 million $0.9 million 34.9% , compared to$2.5 million U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. - There were no sales and marketing expenses for the three months ended March 31, 2025, compared to
$6.3 million U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. - General and administrative expenses for the three months ended March 31, 2025 were
$1.0 million $0.4 million 28.6% , compared to$1.4 million - Net non-operating income for the three months ended March 31, 2025 was
$7.6 million $4.5 million - Net financial expenses for the three months ended March 31, 2025 were
$0.1 million $0.4 million - Net income for the quarter ended March 31, 2025 was
$5.1 million $0.7 million - As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of
$26.4 million
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product is APHEXDA® (motixafortide), with an indication in the
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and 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 potential success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, 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 BioLineRx's therapeutic candidates, 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 its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA 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 BioLineRx 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 needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) | |||
December 31, | March 31, | ||
2024 | 2025 | ||
in USD thousands | |||
Assets | |||
CURRENT ASSETS | |||
Cash and cash equivalents | 10,436 | 9,036 | |
Short-term bank deposits | 9,126 | 17,333 | |
Trade receivables | 2,476 | 1,469 | |
Prepaid expenses | 443 | 312 | |
Other receivables | 1,478 | 452 | |
Inventory | 3,145 | 3,315 | |
Total current assets | 27,104 | 31,917 | |
NON-CURRENT ASSETS | |||
Property and equipment, net | 386 | 299 | |
Right-of-use assets, net | 967 | 863 | |
Intangible assets, net | 10,449 | 10,431 | |
Total non-current assets | 11,802 | 11,593 | |
Total assets | 38,906 | 43,510 | |
Liabilities and equity | |||
CURRENT LIABILITIES | |||
Current maturities of long-term loan | 4,479 | 4,684 | |
Accounts payable and accruals: | |||
Trade | 5,583 | 4,693 | |
Other | 3,131 | 1,751 | |
Current maturities of lease liabilities | 522 | 440 | |
Warrants | 1,691 | 2,462 | |
Total current liabilities | 15,406 | 14,030 | |
NON-CURRENT LIABILITIES | |||
Long-term loan, net of current maturities | 8,958 | 7,633 | |
Lease liabilities | 1,081 | 985 | |
Total non-current liabilities | 10,039 | 8,618 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |||
Total liabilities | 25,445 | 22,648 | |
EQUITY | |||
Ordinary shares | 38,097 | 62,570 | |
Share premium | 353,693 | 333,627 | |
Warrants | 5,367 | 3,686 | |
Capital reserve | 17,547 | 17,095 | |
Other comprehensive loss | (1,416) | (1,416) | |
Accumulated deficit | (399,827) | (394,700) | |
Total equity | 13,461 | 20,862 | |
Total liabilities and equity | 38,906 | 43,510 | |
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) | |||
Three months ended March 31, | |||
2024 | 2025 | ||
in USD thousands | |||
REVENUES: | |||
License revenues | 5,931 | 255 | |
Product sales, net | 924 | - | |
Total revenues | 6,855 | 255 | |
COST OF REVENUES | (1,455) | (34) | |
GROSS PROFIT | 5,400 | 221 | |
RESEARCH AND DEVELOPMENT EXPENSES | (2,494) | (1,623) | |
SALES AND MARKETING EXPENSES | (6,342) | - | |
GENERAL AND ADMINISTRATIVE EXPENSES | (1,386) | (989) | |
OPERATING LOSS | (4,822) | (2,391) | |
NON-OPERATING INCOME (EXPENSES), NET | 4,490 | 7,644 | |
FINANCIAL INCOME | 565 | 294 | |
FINANCIAL EXPENSES | (929) | (420) | |
NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) | (696) | 5,127 | |
in USD | |||
EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED | (0.00) | 0.00 | |
WEIGHTED AVERAGE NUMBER OF SHARES USED IN | 1,086,589,165 | 2,217,728,234 | |
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) | |||||||||||||
Ordinary shares |
Share pre-mium |
Warrants |
Capital re-serve | Other compre-hensive loss | Accumulated deficit |
Total | |||||||
in USD thousands | |||||||||||||
BALANCE AT JANUARY 1, 2024 | 31,355 | 355,482 | 1,408 | 17,000 | (1,416) | (390,606) | 13,223 | ||||||
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024: | |||||||||||||
Share-based compensation | - | - | - | 533 | - | - | 533 | ||||||
Comprehensive loss for the period | - | - | - | - | - | (696) | (696) | ||||||
BALANCE AT MARCH 31, 2024 | 31,355 | 355,482 | 1,408 | 17,533 | (1,416) | (391,302) | 13,060 | ||||||
Ordinary shares |
Share pre-mium |
Warrants |
Capital re-serve | Other compre- |
Accumulated deficit |
Total | |||||||
in USD thousands | |||||||||||||
BALANCE AT JANUARY 1, 2025 | 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 | 16,415 | (14,836) | 501 | - | - | - | 2,080 | ||||||
Pre-funded warrants exercised | 8,058 | (5,876) | (2,182) | - | - | - | - | ||||||
Employee stock options expired | - | 646 | - | (646) | - | - | - | ||||||
Share-based compensation | - | - | - | 194 | - | - | 194 | ||||||
Comprehensive income for the period | - | - | - | - | - | 5,127 | 5,127 | ||||||
BALANCE AT MARCH 31, 2025 | 62,570 | 333,627 | 3,686 | 17,095 | (1,416) | (394,700) | 20,862 | ||||||
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) | |||
Three months ended | |||
2024 | 2025 | ||
in USD thousands | |||
CASH FLOWS - OPERATING ACTIVITIES | |||
Comprehensive income (loss) for the period | (696) | 5,127 | |
Adjustments required to reflect net cash used in operating activities (see appendix below) | (13,413) | (7,718) | |
Net cash used in operating activities | (14,109) | (2,591) | |
CASH FLOWS - INVESTING ACTIVITIES | |||
Investments in short-term deposits | - | (12,307) | |
Maturities of short-term deposits | 16,719 | 4,130 | |
Purchase of property and equipment | (32) | - | |
Net cash provided by (used in) investing activities | 16,687 | (8,177) | |
CASH FLOWS - FINANCING ACTIVITIES | |||
Issuance of share capital, pre-funded warrants and warrants, net of issuance costs | - | 10,697 | |
Repayments of loan | (765) | (1,120) | |
Repayments of lease liabilities | (129) | (127) | |
Net cash provided by (used in) financing activities | (894) | 9,450 | |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 1,684 | (1,318) | |
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD | 4,255 | 10,436 | |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 51 | (82) | |
CASH AND CASH EQUIVALENTS - END OF PERIOD | 5,990 | 9,036 | |
BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) | ||||
Three months ended March 31, | ||||
2024 | 2025 | |||
in USD thousands | ||||
Adjustments required to reflect net cash used in operating activities: | ||||
Income and expenses not involving cash flows: | ||||
Depreciation and amortization | 897 | 165 | ||
Exchange differences on cash and cash equivalents | (51) | 82 | ||
Fair value adjustments of warrants | (4,444) | (8,311) | ||
Warrant issuance costs | - | 702 | ||
Share-based compensation | 533 | 194 | ||
Interest on short-term deposits | (163) | (30) | ||
Interest on loan | 610 | - | ||
Exchange differences on lease liabilities | (25) | (7) | ||
(2,643) | (7,205) | |||
Changes in operating asset and liability items: | ||||
Decrease (increase) in trade receivables | (2,474) | 1,007 | ||
Increase in inventory | (936) | (170) | ||
Decrease in prepaid expenses and other receivables | 81 | 1,157 | ||
Decrease in accounts payable and accruals | (3,511) | (2,507) | ||
Decrease in contract liabilities | (3,930) | - | ||
(10,770) | (513) | |||
(13,413) | (7,718) | |||
Supplemental information on interest received in cash | 357 | 236 | ||
Supplemental information on interest paid in cash | 255 | 361 | ||
Supplemental information on non-cash transactions: | ||||
Changes in right-of-use asset and lease liabilities | 32 | 44 | ||
Warrant issuance costs | - | 237 | ||
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Contacts:
Irina Koffler
LifeSci Advisors, LLC
IR@biolinerx.com
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
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SOURCE BioLineRx Ltd.
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