BioLineRx Reports Second Quarter 2025 Financial Results and Provides Corporate Update
BioLineRx (NASDAQ: BLRX) has reported its Q2 2025 financial results and provided corporate updates. The company recorded $0.3 million in revenues from APHEXDA royalties and reported a net loss of $3.9 million. The company's cash position stands at $28.2 million, extending their runway into H1 2027.
Clinical progress includes continued enrollment in the CheMo4METPANC Phase 2b trial for pancreatic cancer, with promising interim data showing 4 out of 11 patients remaining progression-free after one year. Two Phase 1 trials evaluating motixafortide for stem cell mobilization in sickle cell disease are progressing, with results expected in H2 2025.
The company is actively pursuing pipeline expansion opportunities in oncology and rare diseases, targeting a potential transaction in 2025.
BioLineRx (NASDAQ: BLRX) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti aziendali. Ha registrato 0,3 milioni di dollari di ricavi derivanti dalle royalty di APHEXDA e un perdita netta di 3,9 milioni di dollari. La liquidità disponibile è di 28,2 milioni di dollari, sufficiente a coprire le attività fino alla prima metà del 2027.
Sul fronte clinico prosegue l'arruolamento nello studio CheMo4METPANC di fase 2b per il cancro al pancreas; dati provvisori promettenti mostrano che 4 su 11 pazienti sono rimasti liberi da progressione dopo un anno. Proseguono inoltre due studi di fase 1 che valutano motixafortide per la mobilizzazione delle cellule staminali nella sindrome della falciforme, con risultati attesi nella seconda metà del 2025.
L'azienda sta attivamente cercando opportunità per ampliare la pipeline in oncologia e malattie rare, mirando a una possibile operazione nel 2025.
BioLineRx (NASDAQ: BLRX) ha dado a conocer sus resultados financieros del 2T 2025 y actualizaciones corporativas. Registró 0,3 millones de dólares en ingresos por royalties de APHEXDA y una pérdida neta de 3,9 millones de dólares. La posición de caja es de 28,2 millones de dólares, lo que extiende su liquidez hasta el primer semestre de 2027.
En el ámbito clínico, continúa el reclutamiento en el ensayo CheMo4METPANC fase 2b para cáncer de páncreas; datos provisionales alentadores muestran que 4 de 11 pacientes permanecen libres de progresión después de un año. Avanzan también dos ensayos de fase 1 que evalúan motixafortide para la movilización de células madre en la enfermedad de células falciformes, con resultados previstos en la segunda mitad de 2025.
La compañía busca activamente oportunidades para ampliar su pipeline en oncología y enfermedades raras, con la mira puesta en una posible transacción en 2025.
BioLineRx (NASDAQ: BLRX)가 2025년 2분기 실적 및 기업 업데이트를 발표했습니다. 회사는 APHEXDA 로열티로 미화 30만 달러(0.3백만 달러)의 매출을 기록했으며, 순손실 390만 달러(3.9백만 달러)를 보고했습니다. 현금 잔액은 미화 2,820만 달러(28.2백만 달러)로, 2027년 상반기까지 자금 운용이 가능할 것으로 보입니다.
임상 측면에서는 췌장암 대상 CheMo4METPANC 2b상에 대한 환자 등록이 계속 진행되고 있으며, 예비 데이터에서 11명 중 4명이 1년 후에도 무진행 상태인 것으로 나타나는 등 유망한 신호가 확인되었습니다. 또한, 낫형 겸상적혈구병에서 조혈모세포 동원을 평가하는 두 건의 1상 시험이 진행 중이며, 결과는 2025년 하반기에 예상됩니다.
회사는 항암 및 희귀질환 분야에서 파이프라인 확장 기회를 적극적으로 모색하고 있으며, 2025년 내 잠재적 거래를 목표로 하고 있습니다.
BioLineRx (NASDAQ: BLRX) a publié ses résultats financiers du deuxième trimestre 2025 et des informations d'entreprise. La société a enregistré 0,3 million de dollars de revenus issus des redevances d'APHEXDA et affiché une perte nette de 3,9 millions de dollars. La trésorerie s'élève à 28,2 millions de dollars, assurant une visibilité financière jusqu'au premier semestre 2027.
Sur le plan clinique, l'enrôlement se poursuit dans l'essai de phase 2b CheMo4METPANC pour le cancer du pancréas ; des données intermédiaires prometteuses montrent que 4 des 11 patients sont restés sans progression après un an. Deux essais de phase 1 évaluant motixafortide pour la mobilisation des cellules souches dans la drépanocytose sont en cours, avec des résultats attendus au second semestre 2025.
La société recherche activement des opportunités pour élargir sa pipeline en oncologie et maladies rares, visant une transaction potentielle en 2025.
BioLineRx (NASDAQ: BLRX) hat seine Finanzergebnisse für das 2. Quartal 2025 und unternehmensbezogene Neuigkeiten veröffentlicht. Das Unternehmen erzielte 0,3 Millionen US-Dollar Umsatz aus APHEXDA-Royaltys und wies einen Nettoverlust von 3,9 Millionen US-Dollar aus. Der Kassenbestand beträgt 28,2 Millionen US-Dollar und sichert die Finanzierung bis ins erste Halbjahr 2027.
Klinisch läuft weiterhin die Rekrutierung für die Phase-2b-Studie CheMo4METPANC bei Bauchspeicheldrüsenkrebs; Zwischenanalysen sind vielversprechend und zeigen, dass 4 von 11 Patienten nach einem Jahr progressionsfrei sind. Zwei Phase-1-Studien zur Prüfung von Motixafortide zur Stammzellmobilisierung bei Sichelzellenanämie laufen ebenfalls, Ergebnisse werden für das 2. Halbjahr 2025 erwartet.
Das Unternehmen verfolgt aktiv Möglichkeiten zur Erweiterung der Pipeline in Onkologie und bei seltenen Erkrankungen und peilt eine mögliche Transaktion im Jahr 2025 an.
- Extended cash runway guidance into H1 2027, improved from previous H2 2026 guidance
- Strong cash position of $28.2 million as of June 30, 2025
- Promising clinical data with 36% of PDAC patients progression-free after one year
- Significant reduction in operating expenses due to organizational restructuring
- APHEXDA generating royalty revenue of $0.3 million in Q2 2025
- Net loss of $3.9 million in Q2 2025, compared to net income of $0.5 million in Q2 2024
- Revenues declined to $0.3 million from previous quarters due to transition to royalty-based model
- Non-operating expenses of $1.9 million primarily due to warrant liability adjustments
Insights
BioLineRx reports strong cash position with extended runway while pursuing strategic pipeline expansion; operational metrics show improved financial discipline.
BioLineRx's Q2 2025 results demonstrate a company in transition that has significantly improved its financial position. The $28.2 million cash balance now provides runway into H1 2027, extending beyond previous guidance of H2 2026. This extension suggests successful cost containment measures and efficient capital management after the Ayrmid transaction.
The company reported $0.3 million in revenue from APHEXDA royalties, while dramatically reducing expenses. General and administrative costs fell to just $0.2 million from $1.6 million in Q2 2024, aided by recovery of a previously doubtful account from Gloria. Sales and marketing expenses were eliminated entirely (from $6.4 million), reflecting the successful transition to a royalty-based model following the Ayrmid deal.
The $3.9 million net loss includes $1.9 million in non-operating expenses primarily from warrant liability adjustments. However, financial expenses improved substantially due to the BlackRock loan paydown in November 2024.
The clinical pipeline shows continued progress with the CheMo4METPANC Phase 2b trial for motixafortide in pancreatic cancer, with encouraging early signals including complete responses in some patients and increased CD8+ T-cell infiltration across all treated patients. Additionally, two Phase 1 trials for motixafortide in sickle cell disease gene therapy applications continue to advance.
Most significantly, management indicates they're actively pursuing pipeline expansion opportunities in oncology and rare diseases, with a potential transaction targeted before year-end. Given their lean structure and strong cash position, this strategic move could create new value catalysts while maintaining an extended operational runway.
- 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, August 14th, at 8:30 am EDT -
"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 Philip Serlin, Chief Executive Officer of BioLineRx. "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria - most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation."
Financial Updates
- With
$28.2 million
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 and BioLineRx. 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 in
St. 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 $0.3 million
Financial Results for the Quarter Ended June 30, 2025
- Total revenues for the second quarter of 2025 were
$0.3 million U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024. - Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of
$0.9 million - Research and development expenses for the second quarter of 2025 were
$2.3 million $2.2 million Columbia 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 U.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 $1.6 million - Net non-operating expenses for the second quarter of 2025 were
$1.9 million $7.8 million - Net financial income for the second quarter of 2025 was
$0.2 million $1.6 million - Net loss for the second quarter of 2025 was
$3.9 million $0.5 million - As of June 30, 2025, the Company had cash, cash equivalents, and short-term bank deposits of
$28.2 million
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
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, BioLineRx is in discussions to expand its pipeline in the areas of oncology and/or rare diseases, where the Company can utilize its end-to-end expertise in drug development, regulatory affairs and manufacturing to bring life-changing innovation from bench to bedside.
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, expectations regarding pipeline expansion, 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
Contacts:
Irina Koffler
LifeSci Advisors, LLC
IR@biolinerx.com
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
| BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) | ||
December 31, | June 30, | |
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 |
| BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) | ||||||
Three months ended June 30, | Six months ended June 30, | |||||
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 | ||
| BioLineRx Ltd. 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 JANUARY 1, 2024 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 JUNE 30, 2024 | 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 JUNE 30, 2025:
| 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 JUNE 30, 2025 | 71,819 | 327,475 | 3,686 | 17,148 | (1,416) | (398,640) | 20,072 |
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) | ||
Six months ended June 30, | ||
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 |
BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) | |||
Six months ended June 30, | |||
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 | - | |
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SOURCE BioLineRx Ltd.
FAQ
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