Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $0.4 million, reflecting royalties from Ayrmid for APHEXDA commercialization, a significant decrease compared to the previous year due to the upfront payment received under the Gloria license agreement in 2024 [17][18] - Research and development expenses decreased to $1.7 million from $2.6 million in Q3 2024, primarily due to lower expenses related to metixafortide and a reduction in headcount [18][19] - Net loss for Q3 2025 was $1 million, a substantial decrease from a net loss of $5.8 million in Q3 2024 [19] Business Line Data and Key Metrics Changes - APHEXDA generated sales of $2.4 million in Q3 2025, resulting in $0.4 million of royalty revenue to the company [13][14] - The company continues to support the development of metixafortide in pancreatic cancer, with ongoing trials that could represent significant value inflection points [12][16] Market Data and Key Metrics Changes - The total addressable market for glioblastoma in the U.S. and Europe is estimated to exceed $3.7 billion, with an expected annual incidence of approximately 18,500 patients in the U.S. by 2030 [8][9] - The unmet need in glioblastoma treatment is significant, with current standard care established over 20 years ago and limited improvements since [7][8] Company Strategy and Development Direction - The company has established a joint venture with Hemispherian to develop GLIX1, a novel molecule targeting glioblastoma and other cancers, leveraging both companies' strengths [3][4] - The strategy includes expanding GLIX1's development into additional cancer indications once safety and dosing are established [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of GLIX1 and its unique mechanism of action, which could provide significant advancements in cancer treatment [9][10] - The company remains focused on creating long-term value for shareholders while addressing significant unmet medical needs in oncology [13][19] Other Important Information - The company ended Q3 2025 with cash and equivalents of approximately $25.2 million, sufficient to fund operations into the first half of 2027 [13][19] - A key patent for GLIX1 has been allowed, broadening its protection until at least 2040, with potential extensions [10][11] Q&A Session Summary Question: Insights on upcoming clinical study for GLIX1 and potential PD markers - Management confirmed plans to collect extensive pharmacokinetic data and mentioned challenges in obtaining pharmacodynamic markers due to the nature of the trial [22][23] Question: Intermediate manufacturing capacity needs for GLIX1 - The company stated that current manufacturing capacity is sufficient for Phase II-A trials, with no anticipated changes needed [25] Question: Timeline for preclinical data readouts for additional tumor indications - Management indicated that results from preclinical models are being performed, with plans to present findings at conferences next year [26] Question: Medium-term market penetration targets for APHEXDA - Management clarified that they cannot provide guidance on market penetration as they no longer own the asset in the territories held by Ayrmid [31] Question: Reasonable targets for overall survival improvement in GBM - Management noted that for newly diagnosed GBM, a median overall survival improvement of approximately two and a half months would be a benchmark for interest from established pharma [33] Question: Financial statement treatment of investments in the JV - Management confirmed that expenses related to the JV will be consolidated in their financial statements and reflected as R&D expenses [35][36]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $0.4 million, reflecting royalties from ARAMID for Effexta commercialization, a significant decrease compared to the previous year due to the absence of upfront payments and direct sales [17][18] - Research and development expenses decreased to $1.7 million from $2.6 million in Q3 2024, primarily due to lower expenses related to metixafortide and a reduction in headcount [18][19] - Net loss for Q3 2025 was $1 million, a substantial improvement from a net loss of $5.8 million in Q3 2024 [19] Business Line Data and Key Metrics Changes - Effexta generated sales of $2.4 million in Q3 2025, resulting in $0.4 million of royalty revenue to the company [13][14] - The company continues to support the development of metixafortide in pancreatic cancer, with a phase 2b clinical trial ongoing [12] Market Data and Key Metrics Changes - The total addressable market for glioblastoma in the U.S. and Europe is estimated to exceed $3.7 billion, with an expected annual incidence of approximately 18,500 patients in the U.S. by 2030 [8] Company Strategy and Development Direction - The company established a joint venture with Hemispherian to develop GLIX1, a novel treatment for glioblastoma, leveraging both companies' strengths in clinical and regulatory success [3][4] - The company plans to initiate a phase 1/2a trial for GLIX1 in the first quarter of next year, with data anticipated in the first half of 2027 [5][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of GLIX1 to address significant unmet needs in glioblastoma treatment, highlighting the poor prognosis and limited advancements in current therapies [7][8] - The company remains focused on creating long-term value for shareholders while advancing innovative cancer treatments [13] Other Important Information - The company ended Q3 2025 with cash and equivalents of approximately $25.2 million, sufficient to fund operations into the first half of 2027 [19] - A new patent for GLIX1 broadens its protection until 2040, with potential extensions, enhancing its competitive position in the market [10][11] Q&A Session Summary Question: What potential pharmacodynamic markers will be released during the GLIX1 clinical study? - Management plans to collect extensive pharmacokinetic data and will utilize biopsies if surgeries occur during the trial to gather pharmacodynamic markers [22][23] Question: What are the intermediate manufacturing needs for GLIX1? - The current manufacturer has sufficient capacity for the needs of the phase II-A trial, with no anticipated changes [25] Question: When might preclinical data for additional tumor indications be available? - Results from preclinical models are being performed, with plans to present findings at conferences next year [26] Question: What is the medium-term target for market penetration of Effexta? - Management indicated they cannot provide guidance on market penetration as they no longer own the asset in the territories held by ARAMID [31] Question: What improvement in overall survival for GBM would attract interest from established pharma? - For newly diagnosed GBM, an improvement of approximately two and a half months in median overall survival would be significant [33] Question: How will investments in the joint venture appear on financial statements? - The joint venture will be consolidated in the financial statements, with all expenses reflected as research and development expenses [35][36]

Corporate Updates Accessibility StatementSkip Navigation - 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, at 8:30 am EST - TEL AVIV, Israel, Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company ...

Management to Hold Conference Call at 8:30 a.m. EST Learn more about who we are, what we do, and how we do it atwww.biolinerx.com, or onLinkedIn. CONTACTS: United States Irina Koffler LifeSci Advisors, LLC [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] Logo: https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg , /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and ...

Accessibility StatementSkip Navigation Patent covers the use of GLIX1 for treating cancers in which cytidine deaminase (CDA) is not over-expressed (representing over 90% of cancers) Patent further broadens and strengthens GLIX1 patent protection until 2040, with a possible patent-term extension of up to five years TEL AVIV, Israel, Nov. 17, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and ...

GLIX1 Development - A joint venture with Hemispherian AS was established in September 2025 to develop GLIX1 for glioblastoma and other indications, with initial economic stakes of Hemispherian at 60% and BioLineRx at 40%, potentially increasing to 70% for BioLineRx [7, 8] - GLIX1 is set to begin Phase 1 development in H1 2026 and has received FDA IND clearance [8, 58] - GLIX1 enhances TET2 activity, leading to increased 5hmC levels and double-stranded DNA breaks in cancer cells, ultimately causing cell death [19, 24] - Preclinical data indicates GLIX1 shows efficacy in various cancer cell lines and addresses key challenges for GBM drug development, including good blood-brain barrier penetration [30, 44, 49] - A Phase 1/2a clinical trial for GLIX1 in recurrent and progressive GBM is expected to initiate in Q1 2026, with potential expansion cohorts for newly diagnosed GBM and combination therapy with PARPi [55, 57] Motixafortide and APHEXDA - APHEXDA (motixafortide) has been successfully developed and out-licensed for stem cell mobilization in multiple myeloma [4] - License agreements for APHEXDA include up to $87 million in commercial milestones and royalties on sales from 18%-23% in Asia, and up to $200 million in commercial milestones with tiered double-digit royalties on sales outside of Asia (excluding solid tumors) [5, 6] - In first-line PDAC, the Chemo4MetPanc pilot phase 2 clinical trial showed a 64% Overall Response Rate and a median PFS of 96 months [84, 89] - The Chemo4MetPanc randomized phase 2b clinical trial is ongoing, equally funded by Regeneron and BioLineRx, with full enrollment planned in 2027 [90, 94] Financial Status - The company reported cash of approximately $282 million as of June 30, 2025, with a cash runway into the first half of 2027 [96]

Core Insights - BioLineRx and Hemispherian AS have established a joint venture to develop GLIX1, a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers [1][2][3] - GLIX1 has shown potent anti-tumor activity, excellent blood-brain barrier penetration, and a favorable safety profile in preclinical studies [2][3] - The glioblastoma market opportunity is projected to exceed $3.8 billion annually across the US and EU5 by 2030 [1][7] Joint Venture Details - Hemispherian will contribute the global rights of GLIX1, while BioLineRx will manage and fund all development activities [4] - Hemispherian will hold 60% of the joint venture's share capital, with BioLineRx's stake potentially increasing to 70% based on continued investment [4] Clinical Development Plans - An Investigational New Drug (IND) application for GLIX1 was cleared by the FDA, with a Phase 1/2a study expected to start in Q1 2026 [1][2] - The Phase 1 trial will recruit up to 30 patients with recurrent GBM to establish a maximum tolerated dose and assess safety and preliminary efficacy [9] Market Opportunity - GBM is the most common and aggressive form of primary brain cancer, with a median overall survival of 12-18 months under current standard treatments [5][6] - The annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and 13,400 across the EU5 by 2030, with total addressable markets estimated at $2.5 billion in the U.S. and $1.3 billion in the EU5 [7]