Plerixafor

- Establishes joint venture with Hemispherian AS to advance GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers - - Phase 1/2a clinical trial of GLIX1 expected to commence in Q1 2026 - - Management to host conference call today, November 24 th, at 8:30 am EST - TEL AVIV, Israel , Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended September 30, 2025 , and provided a corporate update. "The clear highlight of the third quarter was our announcement in September that we established a joint venture with Hemispherian, expanding our development pipeline into additional high-need cancer indications, leading with glioblastoma, in addition to our ongoing PDAC program," stated Philip Serlin , Chief Executive Officer of BioLineRx . "Hemispherian's lead asset, GLIX1, is a versatile molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models. Importantly, the development path is straightforward and efficient, and we are eager to initiate a Phase 1/2a first-in-human study in the first quarter of next year while also advancing pre-clinical activities in support of future potential trials of GLIX1 in other cancers." "At the same time, the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide in metastatic pancreatic cancer, which is being led by Columbia University and supported by both Regeneron and BioLineRx , continues to progress, giving us a second opportunity to leverage our drug development expertise to bring true innovation to patients with difficult-to-treat cancers," Mr. Serlin concluded. Corporate Updates Announced formation of a joint venture to advance privately held Hemispherian's small molecule cancer therapeutic, GLIX1 GLIX1, a Phase 1-ready candidate that is being developed as a potential treatment for glioblastoma, estimated to be a greater than $3.7 billion global addressable market by 2030 that has seen little innovation since the current standard of care was developed in 2005. The compound is also expected to be evaluated in other cancers, with preclinical work beginning in 2026. Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. GLIX1, a Phase 1-ready candidate that is being developed as a potential treatment for glioblastoma, estimated to be a greater than $3.7 billion global addressable market by 2030 that has seen little innovation since the current standard of care was developed in 2005. The compound is also expected to be evaluated in other cancers, with preclinical work beginning in 2026. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. Financial Updates With $25.2 million on its balance sheet as of September 30, 2025 , BioLineRx is maintaining its cash runway guidance into the first half of 2027. Clinical Updates GLIX1 Continued to advance preparations for initiation of a Phase 1/2a clinical trial of GLIX1 in recurrent and newly diagnosed glioblastoma in the first quarter of 2026. World leading investigators in the field of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University , will serve as principal investigators for the study. The Phase 1 part of the trial aims to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 on top of standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study, with biopsies before and after treatment for PD assessment), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors. Pre-clinical activities in support of potential clinical trials of GLIX1 in additional cancers are ongoing. World leading investigators in the field of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University , will serve as principal investigators for the study. The Phase 1 part of the trial aims to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 on top of standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study, with biopsies before and after treatment for PD assessment), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors. Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment continues 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. Sickle Cell Disease (SCD) & Gene Therapy Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was accepted for presentation at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 6-9, 2025 , in Orlando, FL. The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine , demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. Common adverse events were transient and included Grade 1-2 injection site and systemic reactions. No Grade 4 adverse events, dose limiting toxicities or complicated vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab resulted in robust CD34+ HSC mobilization. Motixafortide alone mobilized a median of 189 CD34+ cells/μl (range 77-690) to the peripheral blood (PB), with a median yield of 4.22x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 16.9x106 cells/kg in a four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/μl (range 117-447) to the PB, with a median yield of 4.89x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 19.6x106 CD34+ cells/kg in a four-blood-volume apheresis collection session. The collection yields of motixafortide alone and in combination with natalizumab are encouraging given that hematopoietic stem cell-based gene therapy for sickle cell disease requires sufficient HSCs (16.5-20x106 CD34+ cells/kg) to generate a product. In two subjects with prior plerixafor mobilization, motixafortide alone, and in combination with natalizumab, led to 2.7-2.8 fold higher CD34+ cells/μl mobilization to PB and 2.8-3.2 fold higher CD34+ cells/kg collection yield, respectively, than plerixafor. A second SCD 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+ HSCs used in the development of gene therapies for patients with SCD. The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine , demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. Common adverse events were transient and included Grade 1-2 injection site and systemic reactions. No Grade 4 adverse events, dose limiting toxicities or complicated vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab resulted in robust CD34+ HSC mobilization. Motixafortide alone mobilized a median of 189 CD34+ cells/μl (range 77-690) to the peripheral blood (PB), with a median yield of 4.22x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 16.9x106 cells/kg in a four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/μl (range 117-447) to the PB, with a median yield of 4.89x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 19.6x106 CD34+ cells/kg in a four-blood-volume apheresis collection session. The collection yields of motixafortide alone and in combination with natalizumab are encouraging given that hematopoietic stem cell-based gene therapy for sickle cell disease requires sufficient HSCs (16.5-20x106 CD34+ cells/kg) to generate a product. In two subjects with prior plerixafor mobilization, motixafortide alone, and in combination with natalizumab, led to 2.7-2.8 fold higher CD34+ cells/μl mobilization to PB and 2.8-3.2 fold higher CD34+ cells/kg collection yield, respectively, than plerixafor. APHEXDA Performance Update APHEXDA generated sales of $2.4 million in the third quarter of 2025, providing royalty revenue to the Company of $0.4 million . Financial Results for the Quarter Ended September 30, 2025 Total revenues for the third quarter of 2025 were $0.4 million , reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included a portion of the upfront payment from Gloria Biosciences ( $3.2 million ) as well as direct commercial sales by BioLineRx ( $1.7 million ) prior to the Ayrmid transaction in November 2024 . Cost of revenues for the third quarter of 2025 was immaterial, compared to cost of revenues of $0.8 million for the third quarter of 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the third quarter of 2025 were $1.7 million , a decrease of $0.8 million , or 33.0%, compared to $2.6 million for the third quarter of 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of 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 third quarter of 2025, compared to $5.5 million for the third quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the third quarter of 2025 were $0.8 million , a decrease of $0.6 million , or 40.2%, compared to $1.4 million for the third quarter of 2024. The decrease resulted primarily from lower 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. Non-operating income (expenses) for the third quarters of 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses. Net financial income for the third quarter of 2025 was $0.1 million , compared to net financial expenses of $1.2 million for the third 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 against the US dollar during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024 , following the transaction with Ayrmid. Net loss for the third quarter of 2025 was $1.0 million , compared to net loss of $5.8 million for the third quarter of 2024. As of September 30, 2025 , the Company had cash, cash equivalents, and short-term bank deposits of $25.2 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 November 26, 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 Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC) and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. In addition, BioLineRx has established a joint venture with Hemispherian AS to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is planned to be initiated in the first quarter of 2026. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on X 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 commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide and GLIX1, 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 the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025 . In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United States Irina Koffler LifeSci Advisors, LLC IR@biolinerx.com Israel Moran Meir LifeSci Advisors, LLC moran@lifesciadvisors.com BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) December 31 , September 30 , 2024 2025 in USD thousands Assets CURRENT ASSETS Cash and cash equivalents 10,436 7,914 Short-term bank deposits 9,126 17,298 Trade receivables 2,476 - Prepaid expenses 443 432 Other receivables 1,478 699 Inventory 3,145 2,181 Total current assets 27,104 28,524 NON-CURRENT ASSETS Property and equipment, net 386 168 Right-of-use assets, net 967 724 Intangible assets, net 10,449 10,388 Total non-current assets 11,802 11,280 Total assets 38,906 39,804 Liabilities and equity CURRENT LIABILITIES Current maturities of long-term loan 4,479 4,479 Accounts payable and accruals: Trade 5,583 3,537 Other 3,131 2,127 Current maturities of lease liabilities 522 297 Warrants 1,691 3,229 Total current liabilities 15,406 13,669 NON-CURRENT LIABILITIES Long-term loan, net of current maturities 8,958 5,599 Lease liabilities 1,081 1,003 Total non-current liabilities 10,039 6,602 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 25,445 20,271 EQUITY Ordinary shares 38,097 73,428 Share premium 353,693 327,257 Warrants 5,367 3,686 Capital reserve 17,547 16,195 Other comprehensive loss (1,416) (1,416) Accumulated deficit (399,827) (399,617) Total equity 13,461 19,533 Total liabilities and equity 38,906 39,804 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three months ended September 30 , Nine months ended September 30 , 2024 2025 2024 2025 in USD thousands in USD thousands REVENUES: License revenues 3,221 427 12,702 986 Product sales, net 1,722 - 4,489 - Total revenues 4,943 427 17,191 986 COST OF REVENUES (822) (84) (3,174) (190) GROSS PROFIT 4,121 343 14,017 796 RESEARCH AND DEVELOPMENT EXPENSES (2,565) (1,719) (7,284) (5,668) SALES AND MARKETING EXPENSES (5,553) - (18,310) - GENERAL AND ADMINISTRATIVE EXPENSES (1,390) (831) (4,405) (2,029) OPERATING LOSS (5,387) (2,207) (15,982) (6,901) NON-OPERATING INCOME (EXPENSES), NET 756 1,157 13,053 6,950 FINANCIAL INCOME 434 377 1,534 1,161 FINANCIAL EXPENSES (1,625) (304) (4,639) (1,000) NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) (5,822) (977) (6,034) 210 in USD in USD EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED (0.00) (0.00) (0.01) 0.00 WEIGHTED AVERAGE NUMBER OF SHARES USED INCALCULATION OF BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE 1,199,485,845 2,607,025,540 1,161,448,634 2,399,573,101 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 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223 CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2024: Issuance of share capital, net 3,056 (3,056) - - - - - Employee stock options exercised 19 56 - (48) - - 27 Employee stock options expired - 523 - (523) - - - Share-based compensation - - - 1,289 - - 1,289 Comprehensive loss for the period - - - - - (6,034) (6,034) BALANCE AT SEPTEMBER 30, 2024 34,430 353,005 1,408 17,718 (1,416) (396,640) 8,505 Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss 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 NINE MONTHS ENDED SEPTEMBER 30, 2025 : Issuance of share capital, pre-funded warrants and warrants, net 27,273 (22,260) 501 - - - 5,514 Pre-funded warrants exercised 8,058 (5,876) (2,182) - - - - Employee stock options expired - 1,700 - (1,700) - - - Share-based compensation - - - 348 - - 348 Comprehensive income for the period - - - - - 210 210 BALANCE AT SEPTEMBER 30, 2025 73,428 327,257 3,686 16,195 (1,416) (399,617) 19,533 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Nine months ended September 30 , 2024 2025 in USD thousands CASH FLOWS - OPERATING ACTIVITIES Comprehensive income (loss) for the period (6,034) 210 Adjustments required to reflect net cash used in operating activities (see appendix below) (29,229) (5,084) Net cash used in operating activities (35,263) (4,874) CASH FLOWS - INVESTING ACTIVITIES Investments in short-term deposits (26,350) (29,027) Maturities of short-term deposits 44,626 20,819 Purchase of property and equipment (59) - Net cash provided by (used in) investing activities 18,217 (8,208) CASH FLOWS - FINANCING ACTIVITIES Issuance of share capital, pre-funded warrants and warrants, net of issuance costs 5,358 13,894 Employee stock options exercised 27 - Net proceeds from loan 19,223 - Repayments of loan (2,461) (3,359) Repayments of lease liabilities (380) (399) Net cash provided by financing activities 21,767 10,136 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 4,721 (2,946) CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD 4,255 10,436 EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (140) 424 CASH AND CASH EQUIVALENTS - END OF PERIOD 8,836 7,914 BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Nine months ended September 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 2,213 460 Exchange differences on cash and cash equivalents 140 (424) Fair value adjustments of warrants (13,567) (7,544) Share-based compensation 1,289 348 Interest on short-term deposits 126 36 Interest on loan 1,269 - Exchange differences on lease liabilities 67 158 Warrant issuance costs 642 702 (7,821) (6,264) Changes in operating asset and liability items: Decrease (increase) in trade receivables (3,253) 2,476 Decrease in prepaid expenses and other receivables 357 790 Decrease (increase) in inventory (1,591) 964 Decrease in accounts payable and accruals (6,219) (3,050) Decrease in contract liabilities (10,702) - (21,408) 1,180 (29,229) (5,084) Supplemental information on interest received in cash 1,644 874 Supplemental information on interest paid in cash 1,586 1,126 Supplemental information on non-cash transactions: Changes in right-of-use asset and lease liabilities 305 62 Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302624413.html SOURCE BioLineRx Ltd. +972-8-6429100