BioLineRx(BLRX)
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BioLineRx(BLRX) - 2021 Q4 - Annual Report
2022-03-15 16:00
Exhibit 99.1 INEEX For Immediate Release BioLineRx Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update - Commercial assessment commissioned indicating US stem-cell mobilization opportunity of ~$360m - - Successful pre-NDA meeting with FDA; NDA submission anticipated in mid-2022 - - Announced highly positive results from additional pharmacoeconomic study indirectly comparing Motixafortide plus G-CSF versus plerixafor plus G-CSF - - Cash and cash equivalents at December 31, 2021 of $57 ...
BioLineRx(BLRX) - 2021 Q4 - Annual Report
2022-03-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) of the Securities Exchange Act of 19 ...
BioLineRx(BLRX) - 2021 Q3 - Earnings Call Transcript
2021-11-18 19:25
Financial Data and Key Metrics Changes - 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 comparable period in 2020 [34] - The company held $62.2 million in cash, cash equivalents, and short-term bank deposits as of September 30, 2021, indicating strong financial positioning to achieve multiple value-creating milestones [35] Business Line Data and Key Metrics Changes - The GENESIS Phase 3 study reported that 89% of patients receiving Motixafortide in combination with G-CSF mobilized the optimal number of cells after only one administration and one apheresis session, compared to 10% for G-CSF alone [10][12] - The median number of cells collected in one apheresis session was 11 million for the Motixafortide G-CSF arm, significantly higher than the 2 million cells collected with G-CSF alone [11][22] Market Data and Key Metrics Changes - The global estimated market for autologous stem cell transplantation is approximately $500 million, with over 45,000 procedures performed annually in the U.S. and Europe [24] - The first-generation CXCR4 inhibitor, plerixafor, generates annual sales exceeding $250 million, primarily used as a rescue therapy [24] Company Strategy and Development Direction - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2022, following a pre-NDA meeting scheduled for mid-December [25][37] - Future plans include evaluating lifecycle management potential in other autologous stem cell mobilization indications and exploring partnerships for commercialization rather than self-commercialization [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive results from the GENESIS study and the pharmacoeconomic study, viewing them as significant milestones for the company [38][56] - The company anticipates a catalyst-rich 2022, with meaningful clinical benefits for patients and considerable value creation for shareholders [56][57] Other Important Information - The pharmacoeconomic study indicated a net cost savings of approximately $17,000 per patient when using Motixafortide in combination with G-CSF compared to the current standard-of-care [20][21] - The company has a notable presence at the upcoming American Society of Hematology Annual Meeting, with four abstracts accepted for presentation [29][30] Q&A Session Summary Question: Key components for the upcoming pre-NDA meeting with the FDA - Management aims to align with the FDA on the overall content of the NDA submission [40][41] Question: Next steps for AGI-134 and potential randomized studies - Future steps will depend on the data from the current study, with considerations for patient populations and combination therapies [42][44] Question: Update on the timing of the first data for the academic sponsored trial - Recruitment is ongoing for the investigator-initiated trial, but specific timelines cannot be provided [46][47] Question: Delay in AGI-134 data and presentation at conferences - Recruitment delays were primarily due to COVID-19, but completion is expected by the end of the year, with data anticipated in the first half of next year [48][49] Question: Commercialization strategy for Motixafortide - The company is exploring collaboration options for commercialization rather than self-commercialization due to operational and financial risks [52] Question: Applicability of pharmacoeconomic study results in Europe - The cost structure in Europe differs from the U.S., and while the model can be adapted, the company believes similar significant benefits could be observed [54]
BioLineRx(BLRX) - 2021 Q2 - Earnings Call Transcript
2021-08-18 16:10
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2021 Earnings Conference Call August 18, 2021 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Abi Vainstein-Haras - Chief Medical Officer Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - HC Wainwright Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2021 Results Con ...
BioLineRx(BLRX) - 2021 Q1 - Earnings Call Transcript
2021-05-26 16:01
BioLineRx Ltd. (NASDAQ:BLRX) Q1 2021 Earnings Conference Call May 26, 2021 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Avi Vainstein - Chief Medical Officer Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2021 Results Conference Ca ...
BioLineRx(BLRX) - 2020 Q4 - Earnings Call Transcript
2021-02-23 17:06
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2020 Earnings Conference Call February 23, 2021 10:00 AM ET Company Participants Timothy McCarthy - LifeSci Advisors Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Avi Vainstein - Chief Medical Officer Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - HC Wainwright Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx Fourth Quarter and Full Year 2020 Results Conference Call. All par ...
BioLineRx(BLRX) - 2020 Q4 - Annual Report
2021-02-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) of the Securities Exchange Act of 19 ...
BioLineRx(BLRX) - 2020 Q3 - Earnings Call Transcript
2020-11-23 17:48
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2020 Earnings Conference Call November 23, 2020 10:00 AM ET Company Participants Timothy McCarthy - IR, LifeSci Advisors, LLC Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Abi Vainstein - Vice President-Clinical Development Conference Call Participants Joe Pantginis - HC Wainwright Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2020 Results Conference Call. All partic ...
BioLineRx(BLRX) - 2020 Q2 - Earnings Call Transcript
2020-08-07 03:27
BioLine RX Ltd (NASDAQ:BLRX) Q2 2020 Earnings Conference Call August 6, 2020 10:00 AM ET Company Participants Timothy McCarthy - LifeSci Advisors Philip Serlin - CEO Mali Zeevi - CFO Abi Vainstein - VP, Clinical Development Conference Call Participants Joseph Pantginis - H.C. Wainwright & Co. Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2020 Results Conference Call. [Operator Instructions]. I would now like to turn the call ...
BioLineRx(BLRX) - 2020 Q1 - Earnings Call Transcript
2020-05-20 16:17
BioLineRx Ltd. (NASDAQ:BLRX) Q1 2020 Earnings Conference Call May 20, 2020 10:00 AM ET Company Participants Timothy McCarthy - Investor Relations, LifeSci Advisors Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Abi Vainstein - Vice President, Clinical Development Ella Sorani - Vice President, Research and Development Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the ...