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BIOLINERX BioLineRx Reports First Quarter 2021 Financial Results and Provides Corporate Update May 26 , 2021 - Phase 3 GENESIS study in stem - cell mobilization ( SCM ) demonstrated highly statistically significant positive results across all primary and secondary endpoints - - ~ 90 % of patients in treatment arm underwent transplantation following only one dose of Motixafortide and only one apheresis session ; potentially positions Motixafortide + G - CSF to become new standard of care in this indication - - - Company proceeding with activities in support of NDA submission targeted for H1 2022 - Management to hold conference call today , May 26 , at 10:00 am EST - TEL AVIV , Israel , May 26 , 2021 / PRNewswire / -- BioLineRx Ltd. ( NASDAQ : BLRX ) ( TASE : BLRX ) , a late clinical - stage biopharmaceutical company focused on oncology , today reports its financial results for the quarter ended March 31 , 2021 and provides a corporate update . Significant events and achievements during the first quarter 2021 and subsequent period : • Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem - cell mobilization ( SCM ) . The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance ( p < 0.0001 ) . • 88.3 % of patients receiving Motixafortide + G - CSF underwent transplantation after only ONE administration of Motixafortide and in only ONE apheresis session , compared to 10.8 % for G - CSF alone ; potentially supports Motixafortide on top of G - CSF as new standard - of - care mobilization agent in autologous bone - marrow transplantation . • The Company is proceeding with activities in support of an NDA submission in this indication anticipated in the first half of 2022 , including a pre - NDA meeting with the FDA planned for the second half of this year . • Presented data at the 2021 American Association for Cancer Research ( AACR ) Annual Meeting analyzing results by liver metastasis status from the Company's Phase 2a COMBAT / KEYNOTE - 202 triple combination study testing Motixafortide in metastatic pancreatic cancer . The analysis further strengthened the results reported from the study in December 2020 , since not only were substantially all patients initially diagnosed with stage 4 disease , but the vast majority ( ~ 80 % ) of the patients had liver metastases , emphasizing the extremely difficult patient population in this study . • Strengthened balance sheet with underwritten public offering resulting in gross proceeds of $ 34.5 million . " Subsequent to the end of the first quarter , we were extremely excited to announce positive topline results from our GENESIS Phase 3 trial of Motixafortide in stem - cell mobilization for autologous bone marrow transplantation in multiple myeloma patients , " stated Philip Serlin , Chief Executive Officer of BioLineRx . " The results demonstrated , with a high degree of statistical significance , a meaningful clinical benefit from adding Motixafortide to the current standard of care , G - CSF , for the mobilization of the targeted number of stem cells required for transplantation . While this was not a head - to - head study , our results compare very favorably to the registrational study of plerixafor . " Importantly , almost 90 % of patients in the treatment cohort underwent transplantation after only one administration of Motixafortide and in only one apheresis session , compared to 10.8 % for G - CSF alone . We believe this positions Motixafortide to become the new standard of care in this indication , with a clear clinical benefit of ' one dose , one apheresis , 90 % mobilization success rate . ' We are working diligently to submit a New Drug Application to the FDA in the first half of next year . If approved , this would be transformative for BioLineRx , and a huge milestone in the Company's history . " Regarding our PDAC program , the compelling liver metastases data that we recently presented at AACR further strengthen an already robust case for continued development in this very challenging indication . We continue to engage in discussions with potential partners regarding future development . " To support these and other initiatives , including continued advancement of our second clinical candidate , the anti - cancer vaccine AGI - 134 , we raised $ 34.5 million in January that we believe will finance the Company through multiple potentially value - creating milestones , " concluded Mr. Serlin . Upcoming Significant Expected Milestones : • Initial results from Part 2 of the Phase 1 / 2a trial of AGI - 134 in solid tumors in the second half of 2021 ; • Pre - NDA meeting with the FDA for SCM in the second half of 2021 ; • NDA submission for SCM in the first half of 2022 . Financial Results for the Quarter Ended March 31 , 2021 Research and development expenses for the quarter ended March 31 , 2021 were $ 4.3 million , a decrease of $ 1.1 million , or 21.1 % , compared to $ 5.4 million for the quarter ended March 31 , 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide COMBAT clinical trial , as well as lower expenses associated with the AGI - 134 study .