Core Viewpoint - BioLineRx and Hemispherian have established a joint venture, which was announced in a press release and is available in the Investor Relations section of BioLineRx's website [2]. Group 1 - The announcement was made during a conference call led by Irina Koffler, Head of Investor Relations and Corporate Communications at BioLineRx [2]. - The company has filed the announcement as a 6-K with the U.S. Securities and Exchange Commission [2][3]. - Forward-looking statements were made during the call, indicating that actual results may differ from these projections due to various risks and uncertainties [2][3].

Core Points - BioLineRx and Hemispherian have established a joint venture [2] - The announcement was made during a conference call and a press release was issued [2] - The press release is available in the Investor Relations section of BioLineRx's website and was filed as a 6-K [2] Company Overview - Irina Koffler serves as the Head of Investor Relations and Corporate Communications at BioLineRx [2] - Philip Serlin is the Chief Executive Officer of BioLineRx [3]

Summary of BioLineRx Update Conference Call Company and Industry Overview - **Company**: BioLineRx - **Industry**: Biotechnology, specifically focused on cancer therapeutics Key Points and Arguments 1. **Joint Venture Announcement**: BioLineRx has established a joint venture with Hemispherian AS to develop GLYCS1, a novel molecule targeting glioblastoma and other cancers [4][6][19] 2. **Focus on GLYCS1**: GLYCS1 is an oral small molecule that targets DNA damage response, showing promise in treating glioblastoma, an aggressive brain tumor with limited treatment options [6][8][10] 3. **Clinical Development Plans**: A phase 1-2A clinical trial for GLYCS1 is planned to start in Q1 2026, with the phase 1 part focusing on safety and tolerability in recurrent GBM patients [9][17][20] 4. **Market Opportunity**: The annual incidence of glioblastoma is projected to be around 18,500 patients in the U.S. and 13,400 in the EU5 by 2030, representing a combined addressable market of approximately $3.8 billion [10][11] 5. **Mechanism of Action**: GLYCS1 restores TET2 activity, leading to DNA breaks in cancer cells while sparing healthy cells, which is expected to enhance its efficacy [14][15] 6. **Preclinical Success**: GLYCS1 has demonstrated potent anti-tumor activity in preclinical models, including complete prevention of tumor growth in glioblastoma models [16][17] 7. **Intellectual Property**: GLYCS1 is protected by patents valid until at least 2040, with potential extensions, covering its use in various cancers [11][12][13] 8. **Financial Position**: BioLineRx has a cash runway extending into the first half of 2027, supported by royalties and milestone payments from existing partnerships [20][23] 9. **JV Structure**: Hemispherian holds 60% of the joint venture, with BioLineRx holding 40%, which can increase to 70% based on further investments [19] 10. **Future Pipeline**: The joint venture will also have the first look at other molecules in Hemispherian's pipeline, focusing on DNA repair [11][19] Additional Important Information - **Current Standard of Care**: The existing treatment for glioblastoma includes surgery, radiotherapy, and temozolomide, which only benefits 25% to 50% of patients [10] - **Patient Advocacy**: Hemispherian is building relationships with patient advocacy groups to facilitate clinical trial enrollment [21] - **Safety Profile**: GLYCS1 has shown excellent safety results in preclinical studies, indicating a favorable profile for human trials [31] - **Potential Combinations**: There is significant potential for GLYCS1 to be used in combination with PARP inhibitors, which may enhance treatment efficacy in various cancers [18][33] This summary encapsulates the critical insights from the BioLineRx update conference call, highlighting the company's strategic direction, clinical development plans, and market potential for GLYCS1.

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]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $300,000, reflecting royalties from Aramid for the commercialization of Effexxa, compared to $900,000 in 2024 [17] - Net loss for Q2 2025 was $3,900,000, a significant decrease from a net income of $500,000 in 2024 [20] - Cash and equivalents at the end of Q2 2025 were approximately $28,200,000, sufficient to fund operations into 2027, extending the cash runway compared to previous guidance [13][20] Business Line Data and Key Metrics Changes - Effexxa generated sales of $1,700,000 in Q2 2025, resulting in $300,000 of royalty revenues to BioLineRx [15] - Research and development expenses for Q2 2025 were $2,300,000, slightly up from $2,200,000 in 2024, primarily due to one-time costs associated with the PEDEX study [18] - Sales and marketing expenses were eliminated in 2025, down from $6,400,000 in 2024, due to the shutdown of U.S. commercial operations [19] Market Data and Key Metrics Changes - The company is focusing on early-stage assets in oncology and rare diseases, with ongoing evaluations of promising candidates [5][12] - The ongoing randomized Phase 2b PDAC trial is evaluating metixafortide in combination with standard chemotherapy, with interim analysis planned [8] Company Strategy and Development Direction - The company aims to expand its pipeline by targeting early clinical and late preclinical stage assets, leveraging its expertise in drug development [5][12] - A transformational exclusive out-licensing agreement with Aramid Pharma for Effexxa has been established, allowing the company to focus on other therapeutic areas [5][14] - The company has undergone a restructuring, resulting in a 70% reduction in operating cash burn, positioning it to seize new opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Effexxa in the treatment of multiple myeloma and sickle cell disease, anticipating meaningful growth as treatment protocols evolve [15] - The management team is focused on identifying new assets for in-licensing and development, with a target for a definitive announcement this year [12][50] Other Important Information - The company has retained rights to metixafortide in pancreatic cancer, continuing its development in this indication [7] - The interim analysis of the ongoing PDAC trial could represent a significant value inflection point if results are positive [8] Q&A Session Summary Question: Does Regeneron have any options or rights regarding the chemo for METPANK study? - No, Regeneron does not have any options or rights; it is a clinical collaboration [23] Question: Will the interim analysis release data or be a continuous announcement? - The interim analysis is pre-specified, and publication timing will depend on discussions with Columbia University [24][26] Question: What key metrics should be looked for in the sickle cell study? - Key metrics include safety, mobilization data, and collection yields from sickle cell disease patients [30][31] Question: What sources are being identified for pipeline candidates? - The company is looking at smaller private and public companies as the best source for early clinical stage projects [41][45] Question: How does the current funding environment affect negotiations? - The company is in a better position now due to its validated development history, making it easier to negotiate for assets [47]

Core Insights - BioLineRx Ltd. is making progress in evaluating assets for potential pipeline expansion in oncology and rare diseases, with a targeted transaction for 2025 [1][2] - The company has a strong balance sheet with $28.2 million in cash as of June 30, 2025, extending its cash runway into the first half of 2027 [3] - The CEO expressed confidence in executing a transaction this year to expand the pipeline and create long-term value [2] Financial Updates - Total revenues for Q2 2025 were $0.3 million, primarily from royalties related to APHEXDA, compared to $5.4 million in Q2 2024 [14][21] - Research and development expenses for Q2 2025 were $2.3 million, slightly up from $2.2 million in Q2 2024 [14][21] - The net loss for Q2 2025 was $3.9 million, a significant decline from a net income of $0.5 million in Q2 2024 [14][21] Clinical Updates - The ongoing CheMo4METPANC Phase 2b clinical trial is evaluating motixafortide in combination with cemiplimab and standard chemotherapy, with promising interim results [9] - In the treatment of metastatic pancreatic cancer, two patients showed significant responses, including one with complete resolution of liver lesions [4][5] - A Phase 1 clinical trial for motixafortide in sickle cell disease is progressing, with results expected in the second half of 2025 [10] Product Performance - APHEXDA generated sales of $1.7 million in Q2 2025, contributing $0.3 million in royalty revenue to BioLineRx [11] - The company has retained rights to develop motixafortide for metastatic pancreatic cancer, with a Phase 2b trial ongoing in collaboration with Columbia University [15][16]

Management to Hold Conference Call at 8:30 a.m. EDT 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 is APHEXDA® (motixafortide), with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia). BioLineRx is utili ...

Core Insights - BioLineRx Ltd is presenting new data from the CheMo4METPANC Phase 2 trial at the 2025 American Society of Clinical Oncology Annual Meeting, which evaluates a combination of motixafortide, cemiplimab, and standard chemotherapies for first-line pancreatic cancer [1] Group 1: Clinical Trial Results - The pilot phase of the trial showed that four out of eleven patients remained progression-free after more than one year [2] - The overall response rate (ORR) was 64% (7 out of 11), and the disease control rate (DCR) was 91% (10 out of 11), significantly higher than historical rates of 23% and 48% for gemcitabine and nab-paclitaxel [5] - The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies, with full enrollment expected by 2027 [6] Group 2: Patient Outcomes - Two patients with metastatic pancreatic cancer (mPDAC) underwent definitive treatment, with one achieving complete resolution of liver lesions and the other showing a sustained partial response [3] - An increase in CD8+ T-cell tumor infiltration was observed across all eleven patients treated with the motixafortide combination, indicating a potential immune response [4] Group 3: Company Financials and Market Response - BioLineRx has reduced its operating expense run rate by over 70% starting January 1, 2025, due to the transfer of the APHEXDA program and the shutdown of U.S. commercial operations [7] - The company raised gross proceeds of $10 million in financing and reaffirmed its cash runway through the second half of 2026 [7] - Following these developments, Jones Trading upgraded BioLineRx from Hold to Buy with a price target of $12, and the stock price increased by 42.7% to $5.41 [8]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $300,000, a significant decrease from $6,900,000 in Q1 2024, primarily due to the transition of Effexxa's commercialization to AIRMET [18][19] - Net income for Q1 2025 was $5,100,000, compared to a net loss of $700,000 in Q1 2024, driven by non-operating income from the reevaluation of warrants [22][23] - Cash and cash equivalents as of March 31, 2025, were $26,400,000, providing a runway projected to fund operations through the second half of 2026 [10][23] Business Line Data and Key Metrics Changes - Effexxa generated sales of $1,400,000 in Q1 2025, resulting in $300,000 of royalty revenues to BioLineRx, indicating a return to growth after a transition period [17] - Research and development expenses decreased to $1,600,000 in Q1 2025 from $2,500,000 in Q1 2024, reflecting lower costs related to motixafortide due to the out-licensing agreement [20][21] Market Data and Key Metrics Changes - The overall market for Effexxa is estimated at approximately $300,000,000, with expectations that BioLineRx could capture a substantial portion of this market [43][44] - The company is focused on expanding its pipeline in oncology and rare diseases, leveraging expertise in drug development [7][8] Company Strategy and Development Direction - The company has shifted focus to evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare diseases, aiming to leverage its drug development expertise [7][8] - The out-licensing agreement with AIRMET allows BioLineRx to return to its roots as an innovative company in complex drug development [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing development of metixafortide in treating pancreatic cancer, highlighting strong scientific rationale for continued investment in this area [11][12] - The company is actively seeking new assets for in-licensing and development to expand its pipeline and create additional value for shareholders [68] Other Important Information - The company has reduced its operating cash burn by over 70%, from over $40,000,000 annually to less than $12,000,000 as of 2025 [10] - The ongoing development of metixafortide in sickle cell disease is supported by two phase one trials, with promising initial results [9][12] Q&A Session Summary Question: Does the cash runway include new asset development costs? - Yes, it does [27] Question: Have the costs from the November restructuring impacted the P&L? - Those costs were fully accrued by the end of 2024, with no further anticipated costs in 2025 [28] Question: What is the long-term opportunity for Effexxa? - The market is estimated at $300,000,000, with potential revenues in the $100 million range for BioLineRx [43][44] Question: What is the communication strategy for interim analysis results? - The company is limited by Columbia University's communication strategy and will release data once published by them [36] Question: What are the chances of regulatory approval based on the current study? - Regulatory approval is unlikely based on the current study, as it primarily measures progression-free survival [37] Question: What is the visibility on future milestone payments? - Milestones are primarily commercial-based, with some geographic and regulatory milestones included in the agreements [56][60] Question: What type of assets is the company looking for? - The company is looking for assets with a short clinical development pathway and lean programs to reach value-creating events [64][65]