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]

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. reported continued progress in evaluating assets for potential in-licensing and development in oncology and rare diseases, with optimism for a meaningful transaction in 2025 [2][5] - The company provided updates on the performance of APHEXDA under Ayrmid's stewardship, generating $1.4 million in sales and $0.3 million in royalty revenues for Q1 2025 [3][5] - The ongoing CheMo4METPANC Phase 2b trial of motixafortide in pancreatic ductal adenocarcinoma (PDAC) is set to present new data at the 2025 ASCO Annual Meeting [1][6] Financial Updates - For the quarter ended March 31, 2025, total revenues were $0.3 million, a significant decrease from $6.9 million in Q1 2024, primarily due to the one-time revenues from the out-licensing transaction in 2024 [9][16] - Research and development expenses decreased by 34.9% to $1.6 million compared to $2.5 million in Q1 2024, attributed to lower expenses related to motixafortide and reduced headcount [9][16] - Net income for Q1 2025 was $5.1 million, a substantial increase from a net loss of $0.7 million in Q1 2024 [9][16] Clinical Updates - The CheMo4METPANC Phase 2b trial has activated additional sites to enhance patient recruitment, with full enrollment expected by 2027 [6] - Key highlights from the trial include significant patient responses, with one patient achieving complete resolution of liver lesions and another showing a sustained partial response [6] - Enrollment is ongoing for a Phase 1 trial evaluating motixafortide for mobilization of CD34+ hematopoietic stem cells in sickle cell disease, sponsored by St. Jude Children's Research Hospital [9] Corporate Developments - The company completed financing in January 2025, raising gross proceeds of $10 million and successfully reduced operating expenses by over 70% [5] - BioLineRx's cash runway is reaffirmed through the second half of 2026, with cash and cash equivalents totaling $26.4 million as of March 31, 2025 [9][19]

Core Insights - BioLineRx Ltd. has made significant progress in evaluating assets for potential in-licensing and development in oncology and rare diseases [1] - The company executed a licensing agreement with Ayrmid Pharma Ltd. for APHEXDA® (motixafortide), which includes a $10 million upfront payment, up to $87 million in commercial milestones, and high double-digit royalties on net sales [1][5] - BioLineRx completed financings that raised a total of $19 million and reduced its operating expense run rate by 70%, extending its cash runway through the second half of 2026 [1][2] Corporate Updates - The CEO of BioLineRx highlighted a strategic shift with the exclusive licensing agreement with Ayrmid Ltd., which allows commercialization of APHEXDA® in non-solid tumor indications outside Asia [2] - The company has implemented cost efficiencies, including shutting down U.S. commercial operations, leading to a significant reduction in operating expenses [2] - BioLineRx is focused on in-licensing additional assets over the next year to advance through clinical proof-of-concept, funded by milestones and royalties from out-licensing transactions [2] Financial Updates - For the year ended December 31, 2024, BioLineRx reported revenues of $28.9 million, a 502.1% increase from $4.8 million in 2023, primarily due to licensing agreements and product sales [10] - The cost of revenues for 2024 was $9.3 million, up 151.4% from $3.7 million in 2023, reflecting amortization of intangible assets and royalties on net product sales [10] - Research and development expenses decreased by 26.4% to $9.2 million in 2024, while sales and marketing expenses decreased by 6.7% to $23.6 million [10] - The net loss for 2024 was $9.2 million, significantly reduced from $60.6 million in 2023 [10] Clinical Updates - The company activated additional trial sites for the CheMo4METPANC Phase 2b clinical trial for motixafortide, with full enrollment of 108 patients expected by 2027 [4] - The first patient was dosed in a Phase 1 clinical trial evaluating motixafortide for mobilization of CD34+ hematopoietic stem cells for gene therapies in Sickle Cell Disease [10]