BioLineRx Reports Second Quarter 2025 Financial Results and Provides Corporate Update
- Reports continued progress in the evaluation of assets for potential pipeline expansion in the areas of oncology and rare disease; transaction targeted for 2025 -
- Provides updated and extended cash runway guidance into H1 2027 -
- Management to host conference call today,

"Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said
Financial Updates
- With
$28.2 million on its balance sheet as ofJune 30, 2025 ,BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company's previous cash runway guidance into the second half of 2026.
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
- Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by
Columbia University , and supported by both Regeneron andBioLineRx . The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel). - A prespecified interim analysis is 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 was presented at the 2025 ASCO Annual Meeting in May. Key highlights include:
- Four of 11 patients remained progression-free after more than one year.
- Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent 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
- Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by
Washington University School of Medicine inSt. Louis , and results are anticipated in the second half of 2025. - A second study, sponsored by
St. Jude Children's Research Hospital , continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD).
APHEXDA Performance Update
- APHEXDA generated sales of
$1.7 million in the second quarter of 2025, providing royalty revenue to the Company of$0.3 million .
Financial Results for the Quarter Ended
- Total revenues for the second quarter of 2025 were
$0.3 million , reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in theU.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales byBioLineRx prior to the Ayrmid transaction inNovember 2024 . - Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of
$0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales byBioLineRx prior to the Ayrmid transaction inNovember 2024 . - Research and development expenses for the second quarter of 2025 were
$2.3 million , compared to$2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study atColumbia University , offset by lower expenses related to motixafortide due to the out-licensing ofU.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 second quarter of 2025, compared to
$6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown ofU.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction. - General and administrative expenses for the second quarter of 2025 were
$0.2 million , compared to$1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses. - Net non-operating expenses for the second quarter of 2025 were
$1.9 million , compared to net non-operating income of$7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price - Net financial income for the second quarter of 2025 was
$0.2 million , compared to net financial expenses of$1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance inNovember 2024 , following the transaction with Ayrmid. - Net loss for the second quarter of 2025 was
$3.9 million , compared to net income of$0.5 million for the second quarter of 2024. - As of
June 30, 2025 , the Company had cash, cash equivalents, and short-term bank deposits of$28.2 million , sufficient to fund operations, as currently planned, into the first half of 2027.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the
event page
on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 16, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. 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
In addition,
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
Contacts:
Irina Koffler
IR@biolinerx.com
Moran Meir
moran@lifesciadvisors.com
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) |
||
|
|
|
|
|
|
|
2024 |
2025 |
|
in USD thousands |
|
Assets |
|
|
CURRENT ASSETS |
|
|
Cash and cash equivalents |
10,436 |
7,189 |
Short-term bank deposits |
9,126 |
20,970 |
Trade receivables |
2,476 |
78 |
Prepaid expenses |
443 |
572 |
Other receivables |
1,478 |
203 |
Inventory |
3,145 |
2,850 |
Total current assets |
27,104 |
31,862 |
|
|
|
NON-CURRENT ASSETS |
|
|
Property and equipment, net |
386 |
197 |
Right-of-use assets, net |
967 |
800 |
Intangible assets, net |
10,449 |
10,408 |
Total non-current assets |
11,802 |
11,405 |
Total assets |
38,906 |
43,267 |
|
|
|
Liabilities and equity |
|
|
CURRENT LIABILITIES |
|
|
Current maturities of long-term loan |
4,479 |
4,479 |
Accounts payable and accruals: |
|
|
Trade |
5,583 |
3,465 |
Other |
3,131 |
2,767 |
Current maturities of lease liabilities |
522 |
408 |
Warrants |
1,691 |
4,360 |
Total current liabilities |
15,406 |
15,479 |
|
|
|
NON-CURRENT LIABILITIES |
|
|
Long-term loan, net of current maturities |
8,958 |
6,718 |
Lease liabilities |
1,081 |
998 |
Total non-current liabilities |
10,039 |
7,716 |
COMMITMENTS AND CONTINGENT LIABILITIES |
|
|
Total liabilities |
25,445 |
23,195 |
|
|
|
EQUITY |
|
|
Ordinary shares |
38,097 |
71,819 |
Share premium |
353,693 |
327,475 |
Warrants |
5,367 |
3,686 |
Capital reserve |
17,547 |
17,148 |
Other comprehensive loss |
(1,416) |
(1,416) |
Accumulated deficit |
(399,827) |
(398,640) |
Total equity |
13,461 |
20,072 |
Total liabilities and equity |
38,906 |
43,267 |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) |
||||||
|
|
|
||||
|
Three months ended |
Six months ended |
||||
|
2024 |
2025 |
2024 |
2025 |
||
|
in USD thousands |
In USD thousands |
||||
REVENUES: |
|
|
|
|
||
License revenues |
3,550 |
304 |
9,481 |
559 |
||
Product sales, net |
1,843 |
- |
2,767 |
- |
||
Total revenues |
5,393 |
304 |
12,248 |
559 |
||
COST OF REVENUES |
(897) |
(72) |
(2,352) |
(106) |
||
GROSS PROFIT |
4,496 |
232 |
9,896 |
453 |
||
RESEARCH AND DEVELOPMENT EXPENSES |
(2,225) |
(2,326) |
(4,719) |
(3,949) |
||
SALES AND MARKETING EXPENSES |
(6,415) |
- |
(12,757) |
- |
||
GENERAL AND ADMINISTRATIVE EXPENSES |
(1,629) |
(209) |
(3,015) |
(1,198) |
||
OPERATING LOSS |
(5,773) |
(2,303) |
(10,595) |
(4,694) |
||
NON-OPERATING INCOME (EXPENSES), NET |
7,807 |
(1,851) |
12,297 |
5,793 |
||
FINANCIAL INCOME |
535 |
490 |
1,100 |
784 |
||
FINANCIAL EXPENSES |
(2,085) |
(276) |
(3,014) |
(696) |
||
NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) |
484 |
(3,940) |
(212) |
1,187 |
||
|
|
|
|
|
||
|
in USD |
In USD |
||||
EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED |
0.00 |
(0.00) |
(0.00) |
0.00 |
||
|
|
|
|
|
||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN |
1,197,582,901 |
2,369,687,536 |
1,142,221,033 |
2,294,127,662 |
||
|
|
|
|
|
||
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)
|
|||||||
|
|
|
|
|
|
|
|
|
Ordinary shares |
Share premium |
Warrants |
Capital reserve |
Other comprehensive loss |
Accumulated deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JUNE 30, 2024:
|
31,355 |
355,482 |
1,408 |
17,000 |
(1,416) |
(390,606) |
13,223 |
Issuance of share capital and warrants, net |
3,056 |
(3,056) |
- |
- |
- |
- |
- |
Employee stock options expired |
- |
- |
- |
(66) |
- |
- |
(66) |
Share-based compensation |
- |
- |
- |
1,036 |
- |
- |
1,036 |
Comprehensive loss for the period |
- |
- |
- |
- |
- |
(212) |
(212) |
BALANCE AT |
34,411 |
352,426 |
1,408 |
17,970 |
(1,416) |
(390,818) |
13,891 |
|
|
|
|
|
|
|
|
|
Ordinary shares |
Share premium |
Warrants |
Capital reserve |
Other comprehensive loss |
Accumulated deficit |
Total |
|
in USD thousands |
||||||
BALANCE AT JANUARY 1, 2025 CHANGES FOR SIX MONTHS ENDED
|
38,097 |
353,693 |
5,367 |
17,547 |
(1,416) |
(399,827) |
13,461 |
Issuance of share capital, pre-funded warrants and warrants, net |
25,664 |
(20,988) |
501 |
- |
- |
- |
5,177 |
Pre-funded warrants exercised |
8,058 |
(5,876) |
(2,182) |
- |
- |
- |
- |
Employee stock options expired |
- |
646 |
- |
(646) |
- |
- |
- |
Share-based compensation |
- |
- |
- |
247 |
- |
- |
247 |
Comprehensive income for the period |
- |
- |
- |
- |
- |
1,187 |
1,187 |
BALANCE AT |
71,819 |
327,475 |
3,686 |
17,148 |
(1,416) |
(398,640) |
20,072 |
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) |
||
|
|
|
|
Six months ended
|
|
|
2024 |
2025 |
|
in USD thousands |
|
|
|
|
CASH FLOWS - OPERATING ACTIVITIES |
|
|
Comprehensive income (loss) for the period |
(212) |
1,187 |
Adjustments required to reflect net cash used in operating activities (see appendix below) |
(25,226) |
(3,955) |
Net cash used in operating activities |
(25,438) |
(2,768) |
|
|
|
CASH FLOWS - INVESTING ACTIVITIES |
|
|
Investments in short-term deposits |
(20,559) |
(24,818) |
Maturities of short-term deposits |
28,660 |
12,926 |
Sale (purchase) of property and equipment |
(59) |
11 |
Net cash provided by (used in) investing activities |
8,042 |
(11,881) |
|
|
|
CASH FLOWS - FINANCING ACTIVITIES |
|
|
Issuance of share capital and warrants, net of issuance costs |
5,565 |
13,554 |
Net proceeds from loan |
19,223 |
- |
Repayments of loan |
(1,547) |
(2,240) |
Repayments of lease liabilities |
(256) |
(262) |
Net cash provided by financing activities |
22,985 |
11,052 |
|
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
5,589 |
(3,597) |
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD |
4,255 |
10,436 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
(221) |
350 |
|
|
|
CASH AND CASH EQUIVALENTS - END OF PERIOD |
9,623 |
7,189 |
|
|
|
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) |
|||
|
|||
|
Six months ended
|
||
|
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 |
1,373 |
341 |
|
Exchange differences on cash and cash equivalents |
221 |
(350) |
|
Fair value adjustments of warrants |
(12,845) |
(6,410) |
|
Warrant issuance costs |
642 |
702 |
|
Share-based compensation |
970 |
247 |
|
Interest on short-term deposits |
201 |
48 |
|
Interest on loan |
1,997 |
- |
|
Exchange differences on lease liabilities |
189 |
110 |
|
|
(7,252) |
(5,312) |
|
|
|
|
|
Changes in operating asset and liability items: |
|
|
|
Decrease (increase) in trade receivables |
(2,821) |
2,398 |
|
Decrease (increase) in prepaid expenses and other receivables |
(359) |
1,146 |
|
Decrease (increase) in inventory |
(1,681) |
295 |
|
Decrease in accounts payable and accruals |
(5,633) |
(2,482) |
|
Decrease in contract liabilities |
(7,480) |
- |
|
|
(17,974) |
1,357 |
|
|
(25,226) |
(3,955) |
|
|
|
|
|
|
|
|
|
Supplemental information on interest received in cash |
931 |
583 |
|
|
|
|
|
Supplemental information on interest paid in cash |
971 |
694 |
|
|
|
|
|
Supplemental information on non-cash transactions: |
|
|
|
Changes in right-of-use asset and lease liabilities |
58 |
45 |
|
Warrant issuance costs |
207 |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302530015.html
SOURCE