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 ...

Financial Data and Key Metrics Changes - Research and development expenses for the year ended December 31, 2020, were $18.2 million, a decrease of $5.2 million compared to $23.4 million for the comparable period in 2019 [18] - The company held $22.6 million of cash, cash equivalents, and short-term bank deposits as of December 31, 2020 [19] Business Line Data and Key Metrics Changes - Positive data sets were produced from two key programs: stem cell mobilization and metastatic pancreatic cancer (PDAC) [7] - The GENESIS Phase 3 study showed that motixafortide combined with G-CSF is superior in mobilizing stem cells compared to G-CSF alone [9] - The COMBAT/KEYNOTE-202 study demonstrated substantial improvements in overall survival and progression-free survival compared to historical data for PDAC [12][13] Market Data and Key Metrics Changes - The PDAC patient population has historically had poor prognosis, with five-year survival rates of just 9% overall [11] - The COMBAT/KEYNOTE study reported a median overall survival of 6.5 months compared to 4.7 months in historical data [13] Company Strategy and Development Direction - The company is targeting an NDA submission for stem cell mobilization in the first half of 2022 and is proceeding with activities in support of this submission [9][20] - The focus is on moving forward in the US with the FDA while contemplating discussions with regulatory authorities in Europe for potential commercialization [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the positive results from the GENESIS and COMBAT/KEYNOTE studies, indicating that motixafortide could enhance standards of care in multiple cancer types [20] - The company is focused on preparing for the NDA submission and is putting significant efforts into the necessary activities [30] Other Important Information - The company plans to announce top-line data from the GENESIS study in early Q2 of 2021 [9] - An interim analysis for the ongoing Phase 1b study of motixafortide in COVID-induced ARDS is planned after 10 patients have completed treatment [15] Q&A Session Summary Question: Can you shed some color on how the toxicity profile of the combination treatment being evaluated compared to the current standard of care? - The combination of motixafortide and chemotherapy has less toxicity in parameters like neutropenia and infection, indicating it is safe [23] Question: Do you plan on meeting regulators in any other regions globally with regards to potential commercialization? - The company is currently focused on the US and plans to discuss registration in Europe at a later stage [24] Question: What would be a bit of your wish list for this randomized control study in PDAC? - There is a possibility of an interim look for accelerated approval depending on the data robustness [26][27] Question: Can you describe a bit of the important behind-the-scenes activity in preparing for the NDA? - The entire CMC tests and NDA supporting activities are being prepared for submission [28][30]

Financial Performance - The company recorded net losses of $30.0 million in 2020, up from $25.4 million in 2019 and $23.0 million in 2018, with an accumulated deficit of $278 million as of December 31, 2020[60]. - The company’s operating loss was $22.9 million in 2020, compared to $28.1 million in 2019[30]. - The total assets of the company were $47.3 million as of December 31, 2020, down from $53.6 million in 2019[30]. - The company had total liabilities of $25.3 million as of December 31, 2020, compared to $20.2 million in 2019[30]. - The company expects to incur additional losses in the future and may never achieve profitability[60]. - The company anticipates that existing cash and investment balances will be sufficient to meet future capital requirements, excluding potential milestone and royalty payments[62]. - As of December 31, 2020, the company held cash and short-term investments totaling $22.6 million, which is expected to meet capital requirements into the second half of 2023[62]. - The company raised net proceeds of $31.4 million in an underwritten public offering in January 2021[62]. Research and Development - Research and development expenses were $18.2 million in 2020, a decrease from $23.4 million in 2019[30]. - The company has only one product, BL-5010, approved for marketing, while two clinical-stage candidates, motixafortide and AGI-134, are under development[71]. - The COVID-19 pandemic has caused an expected delay of approximately nine months in the phase 1/2a study for AGI-134 due to operational issues[68]. - Clinical trials are lengthy and expensive, with uncertain outcomes, and delays in securing clinical investigators or trial sites may occur[74]. - The company relies on third parties for conducting preclinical studies and clinical trials, which may lead to delays or substandard performance[83]. - The company seeks partnerships for the development and commercialization of motixafortide, facing competition from other companies, which may limit its ability to successfully develop and commercialize product candidates[95][96]. Regulatory and Compliance Risks - The company faces significant risks in obtaining regulatory approvals for its therapeutic candidates, which could materially affect future revenue generation[70]. - The ongoing regulatory review of approved products may result in restrictions or withdrawal from the market if compliance is not maintained[79]. - Modifications to therapeutic candidates may require new regulatory approvals, potentially leading to recalls or marketing suspensions, adversely affecting business operations[101][102]. - The company must comply with environmental, health, and safety laws regarding the use and disposal of hazardous materials, which can be costly and restrict business operations[136]. Market and Competitive Landscape - The company faces intense competition in the life sciences industry, with other companies developing products for similar indications, which could negatively impact its prospects[105]. - The company’s revenues and profits depend heavily on adequate reimbursement from governmental and third-party payors for its approved therapeutic candidates[127]. - The company is subject to significant pricing pressures due to healthcare reforms and changes in reimbursement policies from government and private payors[124]. - The company’s ability to market products and generate revenues may be adversely impacted by ongoing healthcare cost containment efforts by governments and payors[129]. Financial and Operational Risks - Access to additional financing may be challenging due to disruptions in capital and credit markets caused by the pandemic[68]. - The company may need to raise substantial future capital to complete clinical development and commercialize products, with future capital requirements depending on various factors including regulatory approval and commercial success[174]. - The company is responsible for costs related to patent applications and maintenance; failure to meet obligations could result in loss of proprietary technology rights, adversely affecting financial condition[92]. - The company may face substantial costs and uncertainties related to patent litigation or other proceedings, which could materially affect its ability to compete[154]. Intellectual Property and Licensing - The company has in-licensed rights for therapeutic candidates from various entities, with royalty rates ranging from 20% to 29.5% for sublicensing, and 10% of net sales for independently sold products from Biokine[91]. - As of February 22, 2021, the company owned or exclusively licensed 36 patent families containing over 105 issued patents, four allowed patent applications, and over 87 pending patent applications related to its therapeutic candidates[145]. - The company relies on a combination of patents, trade secrets, and regulatory exclusivity to maintain its competitive position, but enforcement of these rights can be costly and unpredictable[150]. Human Resources and Management - The company must attract and retain key personnel to ensure successful clinical trials and commercialization, facing competition for qualified candidates[111][113]. - The company lacks internal sales, marketing, and distribution capabilities, necessitating either the development of these functions or out-licensing arrangements to commercialize therapeutic candidates[108]. Currency and Economic Risks - A significant portion of the company's expenses and revenues are denominated in non-dollar currencies, exposing it to currency fluctuation risks[186]. - The company has engaged in currency hedging transactions to mitigate financial exposure from exchange rate fluctuations, although these measures may not fully protect against material adverse effects[186]. - Political, economic, and military instability in Israel may adversely affect the company's operations and ability to raise capital[180]. Insurance and Liability - The company carries life science liability insurance with an annual coverage amount of $30.0 million per occurrence and product liability and clinical trials coverage with an annual coverage amount of $30.0 million each claim and in the aggregate[132]. - The company’s insurance coverage may not be adequate to protect against potential liabilities arising from clinical trials and product liability claims[132]. Strategic Partnerships and Collaborations - The company has established collaborations with various institutions to enhance its drug development pipeline and increase the probability of therapeutic success[206]. - The acquisition of Agalimmune Ltd. included a development agreement that allows for a reversionary option for selling shareholders if certain conditions are not met, which could lead to loss of rights to proprietary technology[94].

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 ...

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 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 ...

BioLineRx Ltd. (NASDAQ:BLRX) Q4 2019 Earnings Conference Call March 12, 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 Conference Call Participants Mark Breidenbach - Oppenheimer Joe Pantginis - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx's Fourth Quarter and Full Year 2019 Confere ...

As filed with the U.S. Securities and Exchange Commission on March 12, 2020 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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY ...

Financial Data and Key Metrics Changes - Research and Development expenses for the nine months ended September 30, 2019, were $15.3 million, an increase of $0.7 million, or 5%, compared to $14.6 million for the same period in 2018 [33] - The company held $30.1 million of cash, cash equivalents, and short-term bank deposits as of September 30, 2019, sufficient to fund operations through significant clinical milestones [34] Business Line Data and Key Metrics Changes - The company is progressing its lead therapeutic candidates BL-8040 and AGI-134 for multiple cancer indications, with BL-8040 being evaluated in several phase 2 and phase 3 clinical trials [7] - BL-8040 has been granted FDA orphan drug designation for pancreatic cancer, acute myeloid leukemia (AML), and stem cell mobilization [9] - The GENESIS trial for stem cell mobilization is ongoing, with top-line results expected in the second half of 2020 [26] Market Data and Key Metrics Changes - The prognosis for pancreatic cancer patients remains poor, with low survival rates, highlighting the urgent need for better therapeutic options [12] - The company is collaborating with Genentech to evaluate BL-8040 in dual combinations for pancreatic and gastric cancers, with results expected in the first half of 2020 [21] Company Strategy and Development Direction - The company aims to partner out BL-8040 for all indications, with a focus on licensing opportunities following upcoming data releases [41] - The strategy includes leveraging data from ongoing trials to attract potential partners, particularly in the larger AML and pancreatic cancer markets [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts, particularly from the COMBAT/KEYNOTE-202 study, which could be transformational for treatment options in pancreatic cancer [11] - The company plans to provide updates on interim results from the AML study and top-line results from the GENESIS trial in 2020 [38] Other Important Information - The company has been invited to present at the European Society of Medical Oncology, highlighting the significance of the upcoming data [19] - AGI-134 is currently in a Phase 1/2a study, with initial efficacy results expected by the end of 2020 [31] Q&A Session Summary Question: Broader potential commercial profile for BL-8040 - Management is looking to partner out BL-8040 for all indications, with a focus on licensing opportunities following data releases in pancreatic cancer, AML, and stem cell mobilization [41] Question: Differences in patient populations for trials - The patient population in the triple combination study is more homogeneous, which is expected to yield more powerful data compared to earlier studies [48] Question: Inclusion of graphical data in presentations - Management confirmed that graphical representations, including spider plots, will be included in the upcoming presentation to illustrate treatment effects [50]

Financial Data and Key Metrics Changes - Research and development expenses for the six months ended June 30, 2019, were $9.7 million, an increase of $0.1 million, or 2%, compared to $9.6 million for the same period in 2018, primarily due to higher expenses associated with clinical trials [23] - The company held $35.2 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2019, compared to $30.2 million as of December 31, 2018 [24] Business Line Data and Key Metrics Changes - The company is advancing its lead therapeutic candidates, BL-8040 and AGI-134, for multiple cancer indications, with BL-8040 being evaluated in Phase 2 and Phase 3 clinical trials for pancreatic cancer, acute myeloid leukemia (AML), and stem cell mobilization [7][8] - In AML, data from a Phase 2a study showed a 39% overall response rate and a median overall survival of 10.7 months, compared to 6.1 months for historical data with cytarabine alone [15] Market Data and Key Metrics Changes - The company is collaborating with Merck on the COMBAT/KEYNOTE-202 study, which is evaluating BL-8040 in combination with KEYTRUDA and chemotherapy for pancreatic cancer [10] - The GENESIS trial for stem cell mobilization is ongoing, with expectations for top-line results in the second half of 2020 [19] Company Strategy and Development Direction - The company views BL-8040 as a broad platform molecule that can be combined with various therapies to treat a wide range of cancers [8] - The upcoming data readouts from clinical trials are seen as significant milestones that could open up additional opportunities for partnerships and further development [11][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the COMBAT/KEYNOTE-202 study, indicating that positive results could be transformational for the company [11] - The company plans to meet with regulators to discuss the optimal development path for AML indications based on ongoing studies [15] Other Important Information - The company completed a public offering in February 2019, raising gross proceeds of $15.4 million, which is expected to fund operations through significant clinical milestones into the first half of 2021 [24] Q&A Session Summary Question: What defines a successful outcome in the COMBAT/KEYNOTE-202 interim readout? - Management indicated that while PFS and OS data are significant, they hope to provide response data and some PFS and OS data on a subset of patients by the end of the year [28] Question: Will there be duration of response data in the top-line release? - Management confirmed that there will be duration of response data for some patients in addition to the response rate [30] Question: What are the expectations for the interim analysis of the BLAST trial? - Management emphasized the importance of the interim analysis for decision-making and indicated that they want robust data before proceeding to Phase 3 [32] Question: Will additional immune-related data be provided from the COMBAT trial? - Management stated that they have already proven the mechanism of action in the first part of the trial and will focus on biomarkers to predict patient responses in the future [35] Question: What other tumor types might be compelling for BL-8040 beyond pancreatic cancer? - Management noted that pancreatic cancer is just the beginning, and they see potential in other difficult-to-treat cancers like colorectal cancer and HCC [37]