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BIOLINERX BioLineRx Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 18 , 2021 - Positive results from pharmacoeconomic cost effectiveness study of Motixafortide in stem cell mobilization support its use as standard of care in combination with G - CSF- - Pre - NDA meeting with FDA set for mid - December ; NDA submission planned for H1 2022 - - Cash and cash equivalents at September 30 , 2021 of $ 62.2 million - - Management to hold conference call today , November 18 , at 10:00 am EST - TEL AVIV , Israel , Nov. 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 September 30 , 2021 and provides a corporate update . Significant events and achievements during the third quarter 2021 and subsequent period : • Announced statistically significant positive results from a pharmacoeconomic cost effectiveness study supporting Motixafortide's use as the new standard - of - care and primary mobilization agent ( in combination with G - CSF ) in stem cell mobilization ( SCM ) . The study demonstrated substantial clinical benefits and cost savings in favor of Motixafortide from a significantly higher number of mobilized cells , reduced numbers of apheresis sessions and reduced doses of G - CSF ; • Announced acceptance of an oral presentation , as well as three poster presentations , at the 63rd American Society of Hematology ( ASH ) Annual Meeting & Exposition , which is taking place December 11-14 . The presentations , which include an oral presentation describing the highly significant and clinically meaningful results from the Company's GENESIS Phase 3 clinical trial in stem cell mobilization ( SCM ) , reflect the versatility of Motixafortide as the backbone of promising new treatments for both hematological and solid tumor cancers ; • Finalized preparations for a pre - NDA meeting with FDA , which is set for mid - December ; • Proceeded with activities in support of a New Drug Application ( NDA ) submission in stem cell mobilization planned for the first half of 2022 ; • Ended the third quarter on a solid financial footing , with cash and cash equivalents of $ 62.2 million . " The key highlight since our last quarterly update was the statistically significant positive results from a pharmacoeconomic study of Motixafortide in stem cell mobilization for multiple myeloma patients , " stated Philip Serlin , Chief Executive Officer of BioLineRx . " The study demonstrated that use of Motixafortide on top of G - CSF resulted in a net cost savings of $ 17,000 per patient , not including the cost of Motixafortide , driven by fewer doses of G - CSF and a reduction in the number of apheresis sessions and related costs , versus G - CSF alone . These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter , if approved . " These results , together with the overwhelmingly positive results from our GENESIS Phase 3 study , which showed that almost 90 % of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session , strongly support our view that Motixafortide , in combination with G - CSF , can become the new standard of care in SCM as an upfront , or primary , therapy for all multiple myeloma patients . If approved , this represents a significant advancement in SCM to the benefit of patients and payers alike and , to that end , we plan to submit an NDA to the FDA in the first half of next year . " Our significant progress in SCM , together with the encouraging results we have seen in trials to date in metastatic pancreatic cancer , reflect the versatility of Motixafortide in both hematological and solid tumor cancers , which we have an opportunity to highlight at this year's ASH meeting next month . Our notable presence at such an important medical conference reflects the excellent progress that we have made to date across these core programs and underscores the momentum that we have entering 2022 . " With over $ 62 million in cash , we believe we are well financed to achieve our upcoming important and potentially value creating milestones , " Mr. Serlin concluded . Upcoming Expected Milestones : • Complete pre - NDA meeting with the FDA for SCM , scheduled for mid - December 2021 ; • Complete recruitment of part 2 of ongoing Phase 1 / 2a trial of AGI - 134 in solid tumors by end of 2021 ; • Announce initial results for Part 2 of Phase 1 / 2a trial of AGI - 134 in solid tumors in first half of 2022 ; • Submit NDA for Motixafortide in SCM in first half of 2022 . Financial Results for the Quarter Ended September 30 , 2021 Research and development expenses for the three months ended September 30 , 2021 were $ 4.9 million , an increase of $ 1.4 million , or 41.3 % , compared to $ 3.5 million for the three months ended September 30 , 2020. The increase resulted primarily from an increase in expenses associated with the AGI - 134 study and a timing difference related to a tax credit received in respect of AGI - 134 , as well as an increase in payroll and related- expenses due to a company - wide salary reduction related to the COVID - 19 pandemic in the comparable 2020 period . Research and development expenses for the nine months ended September 30 , 2021 were $ 14.3 million , an increase of $ 0.8 million , or 5.9 % , compared to $ 13.5 million for the nine months ended September 30 , 2020. The increase resulted primarily from an increase in expenses associated with the AGI - 134 study , as well as an increase in payroll and related - expenses due to a company - wide salary reduction related to the COVID - 19 pandemic in the comparable 2020