BioLineRx(BLRX)

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BioLineRx(BLRX) - 2023 Q3 - Earnings Call Transcript
2023-11-20 18:54
It does. I'd like to add something. Joe, IÂ'd like to add something -- I just I'm sorry, I sorry to interrupt you. I just wanted to add, first of all, hi, good to speak to you. But I do want to add, we mentioned the gene therapy in the sickle cell disease area. And Joe Pantginis Phil Serlin Of course, I'm not ruling out us potentially taking this forward ourselves depending on the situation. but it's likely in a very significant indication like this. And when we're talking about PDAC, we're not only talking ...
BioLineRx(BLRX) - 2023 Q2 - Earnings Call Transcript
2023-08-30 16:58
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2023 Earnings Conference Call August 30, 2023 7:30 PM ET Company Participants John Lacey - Head of Investor Relations and Corporate Communications Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2023 Financial Results Conference Ca ...
BioLineRx(BLRX) - 2023 Q1 - Earnings Call Transcript
2023-05-24 16:15
BioLineRx Ltd. (NASDAQ:BLRX) Q1 2023 Earnings Conference Call May 24, 2023 10:00 AM ET Company Participants John Lacey - Investor Relations Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Ella Sorani - Chief Development Officer Tami Rachmilewitz - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. ...
BioLineRx(BLRX) - 2022 Q4 - Earnings Call Transcript
2023-03-22 19:22
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Conference Call March 22, 2023 10:00 AM ET Company Participants John Lacey - Investor Relations Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Ella Sorani - Chief Development Officer Conference Call Participants Mark Breidenbach - Oppenheimer Joe Pantginis - Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx 2022 Financial Resul ...
BioLineRx(BLRX) - 2022 Q4 - Annual Report
2023-03-21 16:00
Drug Development and Clinical Trials - The company has two clinical-stage therapeutic candidates in its drug development pipeline, focusing on advancing them toward commercialization [257]. - Motixafortide has shown a 4.9-fold increase in the proportion of patients mobilizing ≥ 6 million CD34+ cells/kg after one administration, compared to the control arm [272]. - The Phase 3 trial for motixafortide demonstrated a treatment effect of 54.6% (95% CI 39.7-69.5%; p<0.0001) in mobilizing stem cells, with an odds-ratio of 12.9 [272]. - The median number of CD34+ cells collected on the first day of apheresis was approximately 11 million in the treatment arm, over five times higher than the control arm [272]. - The FDA accepted the NDA submission for motixafortide in November 2022, with a PDUFA target action date set for September 9, 2023 [272]. - The company entered a clinical collaboration in March 2023 to test motixafortide in combination with natalizumab for Sickle Cell Disease [273]. - AGI-134, acquired in March 2017, is in development for solid tumors and utilizes the body's anti-alpha-gal antibodies for a systemic anti-tumor response [278]. - The company plans to continue follow-up on GENESIS study patients for relapse-free and overall survival outcomes [272]. - The composite complete remission rate for motixafortide treatment was 38% in subjects receiving up to two cycles at doses of 1 mg/kg and higher, compared to a historical response rate of approximately 19% for high-risk AML patients treated with Ara-C alone [291]. - In the expansion phase of the motixafortide study, the response rate was 39% with a median overall survival of 10.7 months, significantly higher than the historical data of 6.1 months for HiDAC alone [291]. - The Phase 1b study for AGI-134 met its primary endpoint of safety and tolerability, with next steps to be determined in the first half of 2023 [363]. - The company plans to initiate a Phase 2b randomized clinical trial for motixafortide in first-line metastatic PDAC patients in 2023 [363]. - The Phase 3 registration study for motixafortide showed highly statistically significant results (p<0.0001) across all primary and secondary endpoints, demonstrating its safety and tolerability [363]. Financial Performance and Funding - The company did not generate significant revenues during the years included in the financial statements, with only immaterial amounts received from an outlicensing agreement signed in 2014 with Perrigo Company plc included in non-operating income [329]. - As of December 31, 2022, the company has not yet capitalized development expenses, indicating ongoing investment in research and development without immediate financial returns [326]. - The company held $51.1 million in cash, cash equivalents, and short-term bank deposits as of December 31, 2022, to fund operations [381]. - Future revenues are anticipated to primarily come from the independent commercialization of motixafortide, if approved, and from potential out-licensing agreements [382]. - The company expects to continue incurring substantial operating losses over the next several years as it expands its research and development activities [381]. - The company recognized net non-operating income of $5.7 million for the year ended December 31, 2022, compared to net non-operating expenses of $1.8 million for the year ended December 31, 2021 [416]. - The company entered into a loan agreement with Kreos Capital for up to $40 million in three tranches, with the initial tranche of $10 million drawn down in September 2022 [395]. - The company expects to require additional financing in the future to fund operations, despite current resources being sufficient into the first half of 2024 [396]. - The company incurred accumulated losses of $330 million through December 31, 2022 [395]. Regulatory and Compliance - The company is subject to various regulations governing clinical trials and commercial sales in multiple countries, which may affect the approval process and timelines [351]. - The company must comply with EU pharmacovigilance regulations, which have increased the financial and organizational burden on market authorization holders [345]. - The company is prohibited from manufacturing products developed with IIA grants outside of Israel without special approval, which could lead to increased royalty payments [353]. - The company’s marketing authorization holders must collect data on adverse events associated with the use of authorized products outside the scope of the authorization [345]. Corporate Governance and Compensation - The Board of Directors consists of seven members, including two external directors as required by the Companies Law [431]. - The Audit Committee is comprised of three directors, including all external directors, with Mr. Rami Dar serving as Chairperson [438]. - The company is required to have at least one director with financial and accounting expertise, currently held by Mr. Rami Dar and Dr. Michael J. Anghel [432]. - The Audit Committee oversees the independent registered public accounting firm and recommends engagement or termination of the auditor [439]. - The Compensation Committee must consist of at least three members, including all external directors, with a majority being external directors [441]. - The current Compensation Policy was approved by shareholders in 2022, establishing a framework for office holders' terms of employment and performance-based compensation [451]. - The company provides two types of variable compensation: short-term annual bonuses and long-term stock option plans [451]. - The Compensation Policy aims to discourage short-term risk-oriented behavior and promote long-term sustainability and value creation [451]. - The company analyzes overall market compensation trends to inform its compensation approach [451]. - The fixed component of compensation reflects the specific role, responsibilities, experience, and skills required for each position [451]. - The Board of Directors has the authority to approve changes in the incentive structure for executive officers, subject to formal approval by relevant parties [451]. Asset Management and Financial Risk - The company’s financial assets at amortized cost are included in other receivables and bank deposits in the consolidated statements of financial position, reflecting a conservative approach to asset management [311]. - Borrowings are initially recognized at fair value and subsequently measured at amortized cost, with adjustments recognized in profit or loss as financial income or expense [302]. - The company has no material credit losses reported in 2021 and 2022, indicating effective credit risk management [313]. - The company recognizes a loss allowance for expected credit losses on financial assets at amortized cost, reflecting a proactive approach to financial risk management [313]. - The company performs annual impairment reviews for its non-financial assets, ensuring that asset values are accurately reflected in the financial statements [310]. - Trade payables are classified as current liabilities if payment is due within one year, demonstrating the company's commitment to managing short-term obligations [318]. - Deferred tax assets are not recognized in the financial statements as the company is primarily engaged in development and regulatory activities [319].
BioLineRx(BLRX) - 2023 Q1 - Quarterly Report
2023-03-21 16:00
ERX BioLineRx Reports 2022 Financial Results and Recent Corporate and Portfolio Updates - Entered into Clinical Trial Collaboration with Washington University School of Medicine to Evaluate Motixafortide for Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease - • Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer • Finalized formation of the U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in st ...
BioLineRx(BLRX) - 2022 Q3 - Earnings Call Transcript
2022-11-15 20:11
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2022 Earnings Conference Call November 15, 2022 10:00 AM ET Company Participants John Lacey - IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2022 Results Confer ...
BioLineRx(BLRX) - 2022 Q2 - Earnings Call Transcript
2022-08-16 17:00
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2022 Earnings Conference Call August 16, 2022 10:00 AM ET Company Participants Tim McCarthy - IR, LifeSci Advisors Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second ...
BioLineRx(BLRX) - 2022 Q2 - Quarterly Report
2022-08-15 16:00
Exhibit 2 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 TABLE OF CONTENTS Page Condensed consolidated interim statements of financial position F-1 F-2 F-3 - F-4 F-5 - F-6 F-7 - F-9 | --- | |------------------------------------------------------------------| | | | | | Condensed consolidated interim statements of comprehensive | | Condensed consolidated interi ...
BioLineRx(BLRX) - 2022 Q1 - Earnings Call Transcript
2022-05-11 17:51
BioLineRx Ltd. (NASDAQ:BLRX) Q1 2022 Earnings Conference Call May 11, 2022 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - CEO Mali Zeevi - CFO Conference Call Participants Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 Conference Call. All participants are presently in a listen-only mode. Following management's formal presentation instructions will be given fo ...