BioLineRx Ltd’s BLRX poster, which includes new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination trial, will be presented at the 2025 American Society of Clinical Oncology Annual Meeting.The CheMo4METPANC trial is evaluating motixafortide, cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).Updated results from the pilot phase indicat ...

BioLineRx (BLRX) Q1 2025 Earnings Call May 27, 2025 08:30 AM ET Company Participants Irina Koffler - Managing DirectorPhilip Serlin - Chief Executive OfficerMali Zeevi - Chief Financial OfficerJoe Pantginis - Managing DirectorElla Sorani - Chief Development Officer Conference Call Participants Justin Walsh - Director & Research AnalystJohn Vandermosten - Senior Analyst Operator Ladies and gentlemen, thank you for standing by. Welcome to BioLineRx First Quarter twenty twenty five Financial Results Conference ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $300,000, a significant decrease from $6,900,000 in Q1 2024, primarily due to the transition of Effexxa's commercialization to AIRMID [17][18] - Net income for Q1 2025 was $5,100,000, compared to a net loss of $700,000 in Q1 2024, driven by non-operating income related to the reevaluation of warrants [21] - Cash and cash equivalents as of March 31, 2025, stood at $26,400,000, providing a cash runway projected to fund operations through the second half of 2026 [21][9] Business Line Data and Key Metrics Changes - Effexxa generated sales of $1,400,000 in Q1 2025, resulting in $300,000 of royalty revenues to BioLineRx, with expectations of growth resuming after a transition period [15] - Research and development expenses decreased to $1,600,000 in Q1 2025 from $2,500,000 in Q1 2024, reflecting lower costs associated with motixafortide due to the out-licensing agreement [19] Market Data and Key Metrics Changes - The overall market for Effexxa is estimated at approximately $300,000,000, with expectations that BioLineRx could capture a substantial portion of this market, translating to potential revenues in the $100 million range [39][40] Company Strategy and Development Direction - The company is focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare diseases, leveraging expertise in drug development [6] - The strategic partnership with AIRMID is expected to provide significant commercial milestones and royalties, allowing the company to return to its roots in complex drug development [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing development of metixafortide in pancreatic cancer, highlighting strong scientific rationale for continued investment in this area [10][11] - The company aims to identify new assets for in-licensing and development to expand its pipeline and create additional value for shareholders [62] Other Important Information - The company has reduced its operating cash burn by over 70%, from over $40,000,000 annually to less than $12,000,000 as of 2025 [9] - The ongoing trials for sickle cell disease using metixafortide are expected to provide valuable data, with results from two phase one trials currently awaited [8] Q&A Session Summary Question: Does the cash runway include new asset development costs? - Yes, the cash runway includes potential costs associated with new assets, which may be offset by milestones and royalties [24] Question: Have the restructuring costs been fully accounted for in the P&L? - Yes, the restructuring costs were fully accrued by the end of 2024, with no further anticipated costs in 2025 [25] Question: What are the expectations for Effexxa's long-term opportunity? - The market for Effexxa is estimated at $300,000,000, with expectations of capturing a significant portion, leading to potential revenues exceeding $100 million [39][40] Question: What is the communication strategy for interim analysis results? - The communication strategy is aligned with Columbia University, which is leading the study, and data will be released following their publication [33] Question: What are the thoughts on the current trajectory of the cell and gene therapy fields? - There are headwinds in the gene therapy space, but the company views Effexxa as a long-term play with significant upside potential [42][45] Question: What is the visibility on future milestone payments? - Milestone payments are primarily commercial-based, with some geographic and regulatory milestones included in the agreements [51][55]

- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease - - New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting – - APHEXDA performing well under Ayrmid stewardship - - Management to host conference call today, May 27th, at 8:30 am EDT - TEL AVIV, Israel, May 27, 2025 /PRNewswire/ -- Bi ...

BioLineRx Ltd. (NASDAQ:BLRX) Q4 2024 Earnings Conference Call March 31, 2025 8:30 AM ET Company Participants Irina Koffler - IR, LifeSci Advisors Phil Serlin - CEO Mali Zeevi - CFO Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - HC Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2024 Financial Results Conference Call. All participants are present in listen-only mode. Foll ...

Financial Data and Key Metrics Changes - Total revenues for the year ended December 31, 2024, were $28.9 million, an increase of $24.1 million, or 502.1%, compared to $4.8 million for the year ended December 31, 2023 [30] - Net loss for the year ended December 31, 2024, was $9.2 million compared to a net loss of $60.6 million for the year ended December 31, 2023 [34] - Cash, cash equivalents, and short-term bank deposits as of December 31, 2024, were $19.6 million, with approximately $29 million on a pro forma basis after financing completed in early January 2025 [34] Business Line Data and Key Metrics Changes - APHEXDA achieved a 10% market share of total CXCR4 inhibitor usage in the U.S. within less than 11 months of being on the market [26] - Generated more than $6 million of net APHEXDA product revenue in the U.S. through the closing of the Ayrmid transaction on November 21 [27] Company Strategy and Development Direction - The company has shifted its strategy to focus on evaluating early clinical stage and late pre-clinical stage therapeutic assets in oncology and rare diseases [6][7] - The licensing agreement with Ayrmid Pharma Ltd. allows the company to return to its roots in complex drug development while leveraging expertise in drug development [6][9] - The company aims to help as many patients as possible while creating enduring value for shareholders [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about evaluating several promising candidates and the potential for definitive announcements within the year [8] - The company has reduced its ongoing operating cash burn by approximately 70%, from over $40 million annually to approximately $12 million annually [18] - The company believes it is well-positioned to advance motixafortide in solid tumor indications while evaluating additional assets in oncology and rare diseases [19] Other Important Information - The Ayrmid agreement generated $10 million in upfront payments and potential milestones of $87 million, along with double-digit sales royalties ranging from 18% to 23% [16] - The company has shut down its U.S. operations and implemented a headcount reduction in Israel, transitioning a substantial portion of its commercial team to Ayrmid [17] Q&A Session Summary Question: Any more color on meaningful progress in evaluating assets? - Management indicated that they are having meaningful discussions regarding early-stage clinical assets in oncology and rare diseases but could not provide a timeline for announcements [38] Question: How are internal programs looking, especially with WashU and sickle cell? - Management noted that a significant win would be mobilizing enough cells in one cycle for gene therapy, reducing the number of apheresis sessions required [43][44] Question: Commentary on increased traction of APHEXDA for multiple myeloma? - Management expressed confidence in Ayrmid's team and their marketing efforts, stating that the transition has gone smoothly [49] Question: How many assets have been looked at in the acquisition process? - Management stated that they have looked at thousands of molecules over the company's history, focusing on early clinical stage assets in oncology and rare diseases [56][58] Question: Allocation of expenses during the acquisition process? - Management confirmed that expenses would initially be higher during the search process but would shift towards R&D once assets are acquired [59] Question: Internal versus external efforts in the acquisition process? - Management indicated that the majority of the work is done in-house, with external consultants used as needed for specific expertise [64]

Financial Performance - The company recorded net losses of $60.6 million in 2023 and $9.2 million in 2024, with an accumulated deficit of $400 million as of December 31, 2024[39]. - The company expects to continue incurring significant expenses and net losses for the foreseeable future as it develops motixafortide for other indications[39]. - As of December 31, 2024, the company held $19.6 million in cash, cash equivalents, and short-term bank deposits, and completed a registered direct offering in January 2025 for net proceeds of $8.9 million[41]. - The company has begun generating product revenue from sales of APHEXDA, but there is no assurance of significant revenue generation in the future[39][40]. - The company has generated only limited commercialization revenues to date and may never achieve profitability[48]. Licensing and Partnerships - The company has out-licensed the rights to motixafortide for all indications in substantially all of Asia and globally (excluding Asia) for all indications except solid tumors[37]. - In October 2023, the company out-licensed motixafortide rights for all indications in substantially all of Asia to Gloria, and in November 2024, it out-licensed global rights (excluding Asia) to Ayrmid for all indications except solid tumors[48]. - The company retains rights to potentially meaningful milestones or royalty payments under the Gloria and Ayrmid License Agreements, but achieving these may take many years[51]. - The company entered into a license agreement with Ayrmid Pharma Ltd., receiving a non-refundable upfront payment of $10 million and potential commercial milestones of up to $87 million based on defined sales targets[200]. - The Gloria License Agreement includes a $15 million upfront payment and potential milestone payments totaling up to $246 million based on development and sales achievements in Asia[211]. Operational Challenges - The company has substantial doubt about its ability to continue as a going concern, as indicated by its independent registered public accounting firm's report[46]. - The company may face challenges in achieving market acceptance and reimbursement for APHEXDA, which could impact its revenue potential[40]. - The company faces risks in clinical trials, including the possibility of not demonstrating adequate efficacy and safety, which could adversely impact regulatory approval[70]. - Regulatory approvals are subject to ongoing review, and failure to comply with regulations could result in loss of approvals and significant harm to the business[71]. - The company may face adverse effects from unfavorable pricing regulations and reimbursement practices for newly approved drugs[94]. Development and Research - The company has shifted focus to the development of motixafortide in solid tumors for territories outside Asia, requiring additional costly development efforts[62]. - The company aims to in-license additional assets in oncology and rare diseases that address unmet medical needs, leveraging a systematic approach to identify and validate therapeutic candidates[196]. - Motixafortide has shown a direct anti-cancer effect and enhances T-cell activation in combination with immune checkpoint inhibitors[222]. - The company has retained rights to develop motixafortide across all solid tumor indications outside of Asia, with an ongoing Phase 2b trial for pancreatic cancer at minimal cost[195]. Financial Strategy and Capital Needs - The company is exploring alternative financing sources, including future securities offerings and government funding, to meet its capital requirements[41]. - The company expects to need substantial future capital to complete clinical development and commercialize its products, which may lead to dilution for existing shareholders[157]. - The company may need to relinquish valuable rights or grant unfavorable licensing terms if it raises additional funds through licensing arrangements[158]. - The company has a secured loan agreement with BlackRock for up to $40 million, with $30 million drawn down as of now, and a repayment plan established[43][44]. Market and Competitive Landscape - The company faces significant competition in the life sciences industry, particularly from generic versions of Mozobil, which may impact the commercialization of APHEXDA[89]. - The ability to commercialize therapeutic candidates depends on third-party payors providing adequate coverage and reimbursement, which is increasingly scrutinized for cost-effectiveness[95]. - Delays in obtaining coverage and reimbursement for newly approved drugs like APHEXDA may limit its market potential compared to similar products[97]. - Third-party payors are demanding higher evidence of clinical outcomes, which may affect the reimbursement rates for therapeutic candidates[98]. Legal and Compliance Risks - The company is currently involved in litigation that could negatively affect its business operations and financial condition[120]. - The company may face patent infringement claims that could be costly to defend and impact its ability to compete[135]. - The company may be subject to damages from claims related to the wrongful use of trade secrets by employees or contractors[140]. - The company is subject to environmental, health, and safety laws, which can be expensive and restrict business operations[117]. Geopolitical and Economic Factors - The company is exposed to currency fluctuation risks as a significant portion of its expenses is denominated in non-dollar currencies, which could adversely affect its results of operations[175]. - The ongoing geopolitical situation may lead to increased sanctions and negative measures against Israeli companies, potentially impacting the company's operating results and financial condition[173]. - The company has 24 full-time and 4 part-time employees, all located in Israel, which may expose it to risks from political and military instability in the region[168]. - Since the outbreak of the Israel-Hamas war on October 7, 2023, the company's operations have not been materially affected, and its manufacturing operations remain unaffected as they take place outside of Israel[170].

- Reports meaningful progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare diseases - - Executed license agreement with Ayrmid Pharma Ltd. for APHEXDA® (motixafortide) with $10 million upfront payment, up to $87 million in commercial milestones, and high double-digit royalties on net sales - - Completed financings raising combined gross proceeds of $19 million and reduced operating expense run rate by 70%, extending the Company's cash runway throug ...

Company Overview - BioLineRx Ltd. is a clinical-stage biopharmaceutical company focused on developing life-changing therapies in oncology and rare diseases [4] - The company's first approved product is APHEXDA® (motixafortide), indicated for stem cell mobilization for autologous transplantation in multiple myeloma [4] Financial Results Announcement - BioLineRx will release its audited financial results for the year ended December 31, 2024, on March 31, 2025, before U.S. markets open [1] - A conference call will be held at 8:30 a.m. EDT featuring remarks by CEO Philip Serlin [2] Conference Call Details - To access the conference call, dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally [3] - A live webcast and replay will be available on the company's website, with a replay accessible approximately two hours after the live call [3]

Core Viewpoint - BioLineRx Ltd. has outlined its strategic long-term vision and financial outlook following a significant licensing agreement for its product APHEXDA, aiming to maximize shareholder value while rebuilding its pipeline with new assets [2][10]. Licensing Agreements - The exclusive license agreement with Ayrmid Ltd. allows for the development and commercialization of APHEXDA outside Asia, with BioLineRx receiving a $10 million upfront payment and potential additional milestones of up to $87 million, plus royalties of 18% to 23% on net sales [4]. - The agreement with Guangzhou Gloria Biosciences Co., Ltd. grants rights for development and commercialization in Asia, with BioLineRx receiving a $15 million upfront payment and potential milestones of approximately $50 million for development and regulatory achievements, along with up to $200 million based on sales targets [5]. Financial Position - The company has strengthened its balance sheet with $29.5 million in cash and a reduced operating burn rate of approximately $12 million per year, providing a cash runway through the second half of 2026 [11][14]. - Recent equity financing of $10 million further supports the company's financial stability and operational goals [11]. Strategic Focus - BioLineRx is returning to its core competency as a lean drug development company, focusing on in-licensing additional assets in oncology and rare diseases over the next two years [6][8]. - The company aims to develop innovative assets while offsetting development costs through royalties and milestones from existing partnerships [10]. Clinical Development - BioLineRx retains rights to develop motixafortide for solid tumor indications outside Asia, with ongoing and planned Phase 2b trials at minimal cost to the company [7]. - The company is actively scouting for promising opportunities that can be acquired or licensed with modest upfront payments and affordable clinical development programs [9]. Nasdaq Compliance - To maintain compliance with Nasdaq's minimum bid price requirement, BioLineRx plans to implement a reverse stock split, changing the ratio of American Depositary Shares to ordinary shares from 15 to 600, effective January 30, 2025 [12][13].