BioLineRx Ltd. (NASDAQ: BLRX) reported its financial results for the third quarter ended September 30th, 2020. The company reported positive results from a preplanned interim analysis of GENSIS Phase 3 trial of motixafortide for stem cell mobilization in numerous myeloma patients. The study enrollment was completed at 122 patients instead of the originally planned 177. “With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we’ve had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.
“Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year’s ESMO IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA®, together with chemotherapy, will prove beneficial to survival as well.
“The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers,” Mr. Serlin concluded.
The company reported an operating loss of USD 4.6 Million compared to USD 6.6 Million in the comparable period in 2019. Net financial expenses amounted to USD 0.3 Million compared to net financial expenses of USD 0.4 Million in the comparable period in 2019. BioLine held USD 20.8 Million in cash, cash equivalents and short term bank deposits at the end of the quarter.