Core Insights - BioLineRx Ltd. reported steady growth in the adoption of APHEXDA® in its first full quarter post-approval, with formulary placement secured at institutions representing approximately 26% of stem cell transplant procedures performed, on track to reach 35% by the end of Q2 2024 [1][2][6] - The company announced new data from its ongoing Phase 2b pancreatic cancer clinical trial collaboration with Columbia University, highlighting significant increases in CD8+ T-cell density in tumors from treated patients [3][8] - BioLineRx completed debt and equity financing totaling $26 million to support the U.S. commercialization of APHEXDA and advance lifecycle expansion activities [1][5] APHEXDA Launch Updates - Among the top 80 transplant centers, BioLineRx has secured formulary placement at institutions representing approximately 26% of stem cell transplant procedures, aiming for 35% by the end of Q2 and 60% by year-end 2024 [6] - The company received "pass through" status from the Centers for Medicare and Medicaid Services (CMS), ensuring separate reimbursement for APHEXDA when administered in the hospital outpatient setting [6] Clinical Portfolio Updates - In pancreatic cancer, BioLineRx is advancing its major pipeline program, with new data presented at the ASCO 2024 Annual Meeting showing promising results from the pilot phase of the Phase 2 PDAC trial [3][8] - The company is also pursuing motixafortide's potential in gene therapy for sickle cell disease, with initial data expected in the second half of 2024 from a collaboration with Washington University [4][8] Financial Results - For the first quarter ended March 31, 2024, total revenue was $6.9 million, reflecting a portion of the upfront payment and milestone payment from the Gloria Biosciences license agreement, along with $0.9 million from APHEXDA product sales [9] - The net loss for the quarter was $0.7 million, a significant reduction from $12.2 million in the same period of 2023, aided by $4.5 million in non-cash income related to warrant revaluation [10][9] - As of March 31, 2024, the company had cash, cash equivalents, and short-term bank deposits totaling $28.2 million, which is expected to fund operations into 2025 [10][9]
BioLineRx Reports First Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates