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BIOLINERX BioLineRx Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 18 , 2021 - Company actively preparing for an NDA submission for Motixafortide in stem cell mobilization targeted for H1 2022 - - Cash and cash equivalents of $ 66 million at June 30 , 2021 - Management to hold conference call today , August 18 , at 10:00 am EDT - TEL AVIV , Israel , Aug. 18 , 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 June 30 , 2021 and provides a corporate update . Significant events and achievements during the second 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 ) , including approximately 90 % of patients who mobilized enough cells for transplantation with only one administration of Motixafortide and in only one apheresis session . • Based on the positive results from the GENESIS study , the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization anticipated in the first half of 2022 , including a pre - NDA meeting with the FDA planned for the second half of this year . This is consistent with prior guidance . • Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard - of - care mobilization agent ( in combination with G - CSF ) . The aim of the study is to demonstrate the cost benefits related to the use of Motixafortide , due to a reduction in the number of doses of G - CSF and apheresis sessions required , a reduction in the number of rescue therapies required , higher rates of transplantation , and quality - of - life benefits in Motixafortide - treated patients ; initial data on track to be announced in the second half of this year . • Ended the second quarter on a solid financial footing , with cash and cash equivalents of $ 66 million . " Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem - cell mobilization that we announced in May , we are working vigorously to submit an NDA in the first half of next year , " stated Philip Serlin , Chief Executive Officer of BioLineRx . " If approved , this would be transformative for BioLineRx as we would have a commercial - stage molecule in stem cell mobilization for transplantation in multiple myeloma , the standard of treatment for this disease , along with significant potential clinical utility in other cancer indications , most notably pancreatic cancer . " Mr. Serlin continued , " GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem cells necessary for transplantation - in approximately 90 % of cases with only one dose of Motixafortide and in one apheresis session - potentially resulting in significant clinical benefits for patients and cost savings for payers . We believe there is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard - of - care for all multiple myeloma patients . To that end , we are advancing a pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new SCM treatment paradigm . " In parallel with these activities , the versatility of Motixafortide demonstrated in studies to date has attracted interest from potential partners , and we continue to engage in productive discussions . " We are very well financed with $ 66 million of cash , sufficient to bring Motixafortide through potential FDA approval in stem - cell mobilization , while continuing to advance our other clinical programs , including our second asset , AGI - 134 , a novel agent in immunotherapy currently being investigated in a Phase 1 / 2a study , with initial results expected by the end of this year , " concluded Mr. Serlin . Upcoming Significant Expected Milestones : • Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021 ; • Pre - NDA meeting with the FDA for SCM in the second half of 2021 ; • Initial results from Part 2 of the Phase 1 / 2a trial of AGI - 134 in solid tumors in the second half of 2021 ; • NDA submission for SCM in the first half of 2022 ; • Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined . Financial Results for the Quarter Ended June 30 , 2021 Research and development expenses for the three months ended June 30 , 2021 were $ 5.1 million , an increase of $ 0.5 million , or 10.8 % , compared to $ 4.6 million for the three months ended June 30 , 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide , an increase in payroll and related - expenses due to a company - wide salary reduction in connection with the COVID - 19 pandemic in the 2020 comparable period , and an increase in expenses associated with the AGI - 134 study ; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide , and a timing difference related to a tax credit received in respect of AGI - 134 . Research and development expenses for the six months ended June 30 , 2021 were $ 9.4 million , a decrease of $ 0.6 million , or 6.4 % , compared to $ 10.1 million for the six months ended June 30 , 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials