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]

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 from Gloria Biosciences [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] - 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 BioLineRx [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 is estimated to exceed $3.7 billion in the U.S. and Europe, with an expected annual incidence of approximately 18,500 patients in the U.S. by 2030 [8][9] Company Strategy and Development Direction - The establishment of a joint venture with Hemispherian aims to develop GlyxOne, a novel treatment for glioblastoma and other cancers, leveraging both companies' strengths [4][5] - The company plans to initiate a phase 1/2a glioblastoma trial in Q1 2026, with data anticipated in the first half of 2027 [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about GlyxOne's potential to address significant unmet needs in glioblastoma treatment, highlighting the poor prognosis and limited advancements in current therapies [6][7] - 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] - GlyxOne has received a notice of allowance for a key patent, broadening its protection until at least 2040 [10][11] Q&A Session Summary Question: Insights on upcoming clinical study for GlyxOne - Management confirmed plans to collect extensive pharmacokinetic data and mentioned challenges in obtaining pharmacodynamic markers due to the nature of the study [22][23] Question: Medium-term market penetration targets for Effexta - Management stated they cannot provide guidance on market penetration as they no longer own the asset in the territories held by ARAMID [30] Question: Reasonable targets for overall survival improvement in GBM - Management indicated that for newly diagnosed GBM, a median overall survival improvement of approximately two and a half months would be a sufficient benchmark [31][32] Question: Financial statement treatment of JV investments - Management clarified that expenses related to the JV will be consolidated in their financial statements and reflected as R&D expenses [33][34]