Core Viewpoint - BioLineRx Ltd. has announced a change in the American Depositary Shares (ADS) ratio from 15 ordinary shares per ADS to 600 ordinary shares per ADS, effectively a 1-for-40 reverse stock split, aimed at compliance with Nasdaq listing standards [1][2][3] Group 1: ADS Ratio Change - The new ADS to ordinary share ratio of 1 for 600 will take effect before trading on January 30, 2025, reducing the number of outstanding ADSs from 142,340,133 to 3,558,503 [1][2] - The change is expected to increase the trading price of the ADSs by the same multiple, enhancing their suitability for trading on the Nasdaq Capital Market [2][3] Group 2: Financial Position - BioLineRx has $29.5 million in cash, providing a runway through the second half of 2026, with an annual operating burn of approximately $12 million [3] - The funds will support the ongoing development of motixafortide in pancreatic cancer and pipeline expansion activities [3] Group 3: Compliance and Strategy - The ratio change is designed to address Nasdaq's low-priced stock rule and ensure compliance with listing standards [3] - Maintaining the Nasdaq exchange listing is critical for the company's long-term strategy, which includes potential in-licensing of new assets [3] Group 4: Shareholder Impact - Holders of ordinary shares traded on the Tel Aviv Stock Exchange will not be affected by the new ADS ratio [3] - No fractional ADSs will be issued; instead, holders will receive cash payments for any fractional shares [4]

Core Points - BioLineRx Ltd. has entered into definitive agreements for the purchase of 50,000,000 American Depositary Shares (ADSs) and accompanying warrants at a price of $0.20 per ADS, with the offering expected to close around January 7, 2025 [1][3] - The gross proceeds from the offering are anticipated to be approximately $10 million, which will be used for research and development, expanding the drug pipeline, and general corporate purposes [3] - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2] Company Overview - BioLineRx is a biopharmaceutical company focused on developing therapies for oncology and rare diseases, with its first approved product being APHEXDA® for stem cell mobilization in multiple myeloma [6] - The company utilizes its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its innovative pipeline [6] Offering Details - The offering is made under a "shelf" registration statement filed with the SEC, and the securities will be offered only by means of a prospectus [4] - Each ADS represents fifteen ordinary shares of BioLineRx, with the warrants exercisable immediately upon issuance and expiring five years from the initial exercise date [1]

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $4.9 million, compared to no revenue in Q3 2023, reflecting $3.2 million from the Gloria Biosciences license and $1.7 million from APHEXDA product sales [35][41] - Net loss for Q3 2024 was $5.8 million, significantly reduced from a net loss of $16 million in Q3 2023 [40] - Cash, cash equivalents, and short-term bank deposits as of September 30, 2024, were $29.2 million, expected to be approximately $20 million post-transaction, sufficient to fund operations into 2026 [41] Business Line Data and Key Metrics Changes - APHEXDA achieved a 10% market share milestone in total CXCR4 inhibitor usage in the U.S. by the end of Q3 2024, capturing 10% of the market [29][30] - There was a 40% increase in the number of institutions ordering APHEXDA during Q3 compared to Q2 [28] Market Data and Key Metrics Changes - The agreement with Ayrmid Limited allows BioLineRx to focus on drug development while benefiting from APHEXDA's commercial potential, particularly in stem cell mobilization and sickle cell disease [7][10] - The company plans to evaluate early-stage clinical assets in oncology and rare diseases, leveraging its expertise in complex drug development [11] Company Strategy and Development Direction - The company is transitioning to a streamlined organization focused on clinical development in Israel, reducing annual cash burn by over 70% effective January 1, 2025 [17][18] - BioLineRx aims to add two new clinical assets in 2025 and 2026, focusing on oncology and rare diseases with low upfront payments [44][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PDAC program, highlighting strong scientific rationale for continued development despite the challenges of treating pancreatic cancer [21][26] - The company anticipates interim data from the ongoing Phase 2b study in 2026, which could lead to potential business development discussions [48][64] Other Important Information - The company received a $10 million upfront payment and is eligible for up to $87 million in potential commercial milestones from the licensing agreement with Ayrmid [8][15] - The restructuring of debt with BlackRock includes repayment of $16.5 million of outstanding debt, with favorable terms for the remaining balance [18] Q&A Session Summary Question: Pipeline growth and potential in-licensing - Management confirmed plans to in-license one asset in 2025 and another in 2026, with ongoing evaluations of potential candidates [47] Question: Mixing pancreatic program with additional solid tumor indications - Management views PDAC as a prototype for other solid tumors but plans to limit further investment in PDAC at this time [48] Question: Integration time within APHEXDA program and potential sales impact - Management expects a seamless transition with no significant lag in sales due to the transfer of employees and ongoing support [52] Question: Company's core competencies and future asset additions - Management highlighted the experienced development team and plans to focus on early-stage clinical assets in oncology and rare diseases [56][58] Question: Expected reduction in expenses for 2025 - Management indicated a 70% reduction in overall spending, including decreases in G&A expenses, while maintaining R&D commitments at a low cost [62][63] Question: Potential revenues from China - Management hopes for initial revenues from China in 2025, although control over the timeline is limited [67]

Core Points - BioLineRx has entered into a license agreement with Ayrmid Ltd. for its FDA-approved stem cell mobilization agent, motixafortide (APHEXDA), which includes a $10 million upfront payment and potential commercial milestones of up to $87 million, along with royalties on net sales ranging from 18% to 23% [1][3][4] - BioLineRx retains the rights to develop and commercialize motixafortide in solid tumors, including pancreatic ductal adenocarcinoma (PDAC) [1][7] - The agreement allows BioLineRx to significantly reduce its operational expenses and long-term debt, enabling a focus on high unmet needs in oncology and rare diseases [1][5][6] Financial Aspects - The $9 million equity investment from Highbridge Capital Management will support BioLineRx's pipeline and expansion efforts [1][6] - The combination of upfront payments, potential milestones, and royalties is expected to provide a strong financial foundation for BioLineRx to advance its therapeutic pipeline [6] Strategic Developments - Ayrmid will incorporate APHEXDA into its commercial portfolio, which includes Gamida Cell's OMISIRGE®, enhancing its capabilities in the stem cell transplant market [4][9] - BioLineRx plans to continue the development of motixafortide for PDAC through collaborations, including ongoing Phase 2b studies [7] Upcoming Events - BioLineRx will provide further updates during its Q3 results conference call scheduled for November 25, 2024 [1][12]

Core Points - BioLineRx Ltd. will release its unaudited financial results for Q3 2024 on November 25, 2024, before U.S. markets open [1] - A conference call will be held at 8:30 a.m. EST featuring remarks by CEO Philip Serlin [2] - The company is focused on developing therapies in oncology and rare diseases, with its first approved product being APHEXDA® for stem cell mobilization in multiple myeloma [4] Company Overview - BioLineRx Ltd. is a commercial stage biopharmaceutical company headquartered in Israel, with operations in the U.S. [4] - The company is advancing a pipeline of investigational medicines targeting sickle cell disease, pancreatic cancer, and other solid tumors [4] - BioLineRx aims to drive innovative therapeutics from development to commercialization, ensuring that discoveries reach patients effectively [4]

Core Insights - BioLineRx Ltd. announced promising results from a Phase 1 clinical trial of motixafortide for mobilizing CD34+ hematopoietic stem cells in sickle cell disease, indicating potential for improved gene therapy access [1][2][4] Group 1: Clinical Trial Findings - The trial demonstrated that motixafortide, both alone and in combination with natalizumab, was safe and well-tolerated, with common adverse events being transient [3][4] - A median of 198 CD34+ cells/μl was mobilized with motixafortide alone, projecting the collection of 13.9 million HSCs in a single apheresis session [4] - In combination with natalizumab, a median of 231 CD34+ cells/μl was mobilized, projecting the collection of 18.6 million HSCs in a single session [4] Group 2: Comparison with Current Standards - Current gene therapies for sickle cell disease require 16.5 million and 22 million total CD34+ HSCs, with plerixafor being the standard mobilization agent, which often requires multiple attempts [5] - Patients previously mobilized with plerixafor experienced 2.8-fold greater HSC mobilization with motixafortide alone and 3.2-fold greater with the combination therapy [6] Group 3: Future Presentation and Research - An oral presentation detailing these findings will occur at the ASH 2024 Annual Meeting on December 7, 2024, in San Diego, California [1][6] - The trial is part of ongoing research to enhance treatment options for patients with sickle cell disease, with continued collaboration with Washington University [2][8]

Patient survey currently underway in partnership with the HealthTree Foundation; data expected in Q1 2025 TEL AVIV, Israel and WALTHAM, Mass., Sept. 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the launch of Mobilization Matters, a digital resource for people with multiple myeloma who are preparing for stem cell collection for an autologous stem cell transplant ...

BioLineRx Ltd. (NASDAQ:BLRX) Q2 2024 Earnings Conference Call August 15, 2024 8:30 AM ET Company Participants John Lacey - Head of IR and Corporate Communications Phil Serlin - CEO Holly May - President of BioLineRx USA Mali Zeevi - CFO Ella Sorani - Chief Development Officer Conference Call Participants John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]. Following managem ...

Core Insights - BioLineRx Ltd. has successfully secured formulary placement for its APHEXDA® product among the top 80 transplant centers, representing approximately 37% of stem cell transplant procedures, exceeding its quarterly goal and aiming for 60% by the end of 2024 [1][2][4] - The company has doubled the number of centers ordering APHEXDA in the second quarter, indicating strong commercial momentum and recognition of its value compared to other mobilization agents [2][4] - BioLineRx has entered into a clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization in gene therapies for sickle cell disease [3][4] APHEXDA Launch Updates - The formulary placement at transplant centers has surpassed the company's goal, with a target of reaching 60% by year-end 2024 [1][4] - The number of centers ordering APHEXDA has doubled in the second quarter compared to the first quarter, contributing to a 100% quarter-over-quarter net revenue growth [4][6] - The ongoing clinical trial collaboration with St. Jude Children's Research Hospital aims to evaluate APHEXDA for stem cell mobilization in patients with sickle cell disease [3][4] Clinical Portfolio Updates - A Phase 1 clinical trial is being conducted at Washington University in St. Louis to evaluate motixafortide for stem cell mobilization in sickle cell disease, with initial data expected in 2025 [3][4] - Positive biopsy data from the CheMo4METPANC Phase 2b clinical trial for pancreatic cancer has shown a significant increase in CD8+ T-cell density [5] - The company anticipates the initiation of a pivotal clinical trial in China for motixafortide in combination with standard chemotherapy for metastatic pancreatic cancer in 2025 [5] Financial Results - Total revenue for the second quarter of 2024 was $5.4 million, a significant increase from no revenue recorded in the same period of 2023 [6] - The cost of revenue for the quarter was $0.9 million, primarily reflecting amortization of intangible assets and royalties on APHEXDA sales [6] - The company reported a net income of $0.5 million for the second quarter of 2024, compared to a net loss of $18.5 million in the same period of 2023 [6][15] Cash Position - As of June 30, 2024, BioLineRx had cash, cash equivalents, and short-term bank deposits totaling $40.1 million, which is expected to fund operations into 2025 [6][17]

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2024 Earnings Call Transcript May 28, 2024 8:30 AM ET Company Participants Conference Call Participants Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2024 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will be given for the question-and-answer session. I would now like to turn over the call to John Lacey, Head of Investor Relations and C ...