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]

BioLineRx Ltd. (NASDAQ:BLRX) Q2 2019 Results Conference Call August 6, 2019 10:00 AM ET Company Participants Timothy McCarthy - IR, LifeSci Advisors Phil Serlin - CEO Mali Zeevi - CFO Abi Vainstein - VP, Clinical and Medical Affairs Conference Call Participants Mark Breidenbach - Oppenheimer Joe Pantginis - HC Wainwright Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2019 Conference Call. All participants are at present in a listen-only mode. Following mana ...

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2019 Results Earnings Conference Call May 14, 2019 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Phil Serlin - CEO Mali Zeevi - CFO Abi Vainstein - VP, Clinical Development Ella Sorani - VP, Research and Development Conference Call Participants Joe Pantginis - HC Wainwright Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2019 Conference Call. [Operator Instructions] I would now like to turn the call over ...

Financial Data and Key Metrics Changes - Research and development expenses in 2018 were $19.8 million, an increase of $0.3 million or 1.5% compared to $19.5 million for 2017, primarily due to an increase in share-based compensation [33] - The company held $30.2 million in cash, cash equivalents, and short-term bank deposits as of December 31, 2018, and completed a public offering in February 2019 with gross proceeds of $15.4 million, providing a runway of almost two and a half years to fund operations through significant clinical milestones [34] Business Line Data and Key Metrics Changes - The company is advancing therapeutic candidates BL-8040 and AGI134 for multiple cancer indications, with BL-8040 being evaluated in eight Phase 2 or Phase 3 clinical trials [7][8] - BL-8040 has demonstrated robust mobilization of target cells and the ability to induce infiltration of T-cells into tumors while maintaining a favorable safety profile [10] - The company revised its license agreement with Biokine Therapeutics to increase its economic stake in BL-8040 to 80% from 60% [11] Market Data and Key Metrics Changes - The ongoing collaboration with Merck and Genentech validates the platform and provides confidence in BL-8040's mechanism of action [9] - The disease control rate for pancreatic cancer patients in a trial was 34.5%, with an overall survival of 3.3 months for all patients and 7.5 months for second-line patients [17] Company Strategy and Development Direction - The company aims to position BL-8040 as a potential game changer in stem cell mobilization, adding clinical and pharmacoeconomic value [14] - The focus is on advancing BL-8040 in multiple myeloma and pancreatic cancer, with plans to meet with regulatory authorities to discuss clinical development pathways [22] - The company is also developing AGI-134 for solid tumors, with a Phase 1/2a study initiated to assess safety and tolerability [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for additional partnerships to complement current programs [30] - The company is collecting pharmacoeconomic data in parallel with clinical studies to support future reimbursement discussions [52] Other Important Information - The company was granted FDA orphan drug designation for BL-8040 for the treatment of pancreatic cancer, adding significant value to the program [19] - The company expects interim results from the Phase 2 AML consolidation study and initial safety results from the AGI-134 trial in the second half of 2019 [36] Q&A Session Summary Question: Can you review the multiple myeloma treatment paradigm and where BL-8040 fits? - Management clarified that bone marrow transplantation remains the standard of care and that BL-8040 aims to reduce patient burden without competing with new therapies [39][40] Question: What are the market dynamics regarding HSCTs in multiple myeloma? - Management indicated that approximately 70% to 75% of transplants are performed at around 50 major centers in the U.S. [43] Question: Can you elaborate on AGI-134's mechanism of action and its synergy with checkpoint inhibitors? - Management explained that AGI-134 has shown synergistic effects in preclinical models when combined with checkpoint inhibitors [46][47] Question: What pharmacoeconomic work is being done for the stem cell program? - Management confirmed that extensive work has been done to map cost elements for the Phase 3 study, which will aid in economic justification for payers [51][52] Question: What can you tell us about the pending interim readout from the BLAST study? - Management stated that the timing for the interim analysis is being carefully considered to ensure robust data is available for reporting [55][56] Question: Are there plans for label expansions beyond multiple myeloma? - Management indicated interest in expanding the label into non-Hodgkin lymphoma and other indications but emphasized the current focus on multiple myeloma [62]

[PART I](index=7&type=section&id=PART%20I) [Key Information](index=7&type=section&id=ITEM%203.%20Key%20Information) This section presents selected consolidated financial data for the past five years, highlighting consistent operating losses and an accumulated deficit, along with a comprehensive list of risk factors [Selected Financial Data](index=7&type=section&id=A.%20Selected%20Financial%20Data) The company presents selected consolidated financial data for the five years ended December 31, 2018, showing consistent operating and net losses primarily driven by research and development expenses Selected Consolidated Financial Data (2014-2018) | Financial Metric | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | **Research and development expenses** | ($11.2 million) | ($19.5 million) | ($19.8 million) | | **Operating loss** | ($16.5 million) | ($25.2 million) | ($25.6 million) | | **Net loss** | ($15.8 million) | ($24.4 million) | ($23.0 million) | | **Total assets (at year-end)** | $38.9 million | $61.0 million | $56.2 million | | **Total shareholders' equity (at year-end)** | $35.0 million | $52.9 million | $41.3 million | *All figures in millions of U.S. dollars.* [Risk Factors](index=9&type=section&id=D.%20Risk%20Factors) The company identifies numerous material risks that could adversely affect its business, including financial, operational, and geopolitical factors - The company is a clinical-stage biopharmaceutical firm with a history of operating losses, recording net losses of **$15.8 million in 2016**, **$24.4 million in 2017**, and **$23.0 million in 2018**, with an accumulated deficit of **$222.5 million** as of December 31, 2018[41](index=41&type=chunk) - Existing cash balances, including proceeds from a February 2019 offering, are expected to be sufficient to meet capital requirements into **2021**, excluding potential milestone payments[43](index=43&type=chunk) - The company received a deficiency letter from Nasdaq on December 3, 2018, for failing to meet the minimum bid price requirement of **$1.00 per share**, with a compliance deadline of June 3, 2019[146](index=146&type=chunk)[147](index=147&type=chunk) - Operations are conducted in Israel, exposing the company to risks from political, economic, and military instability in the region[159](index=159&type=chunk)[160](index=160&type=chunk) [Information on the Company](index=30&type=section&id=ITEM%204.%20Information%20on%20the%20Company) This section details the company's history, business overview, and strategic focus on oncology, including its clinical-stage therapeutic candidates and key collaboration agreements [History and Development of the Company](index=30&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) BioLineRx Ltd. was founded in Israel in 2003, with its shares listed on the TASE since 2007 and ADSs on Nasdaq since 2011, and it acquired Agalimmune Ltd. in 2017 - The company was founded in **2003**, listed on the TASE in **2007** (BLRX), and listed ADSs on Nasdaq in **2011** (BLRX)[182](index=182&type=chunk) - In March **2017**, BioLineRx acquired Agalimmune Ltd., a private UK-based company, expanding its pipeline[182](index=182&type=chunk) [Business Overview](index=30&type=section&id=B.%20Business%20Overview) BioLineRx is a clinical-stage biopharmaceutical company focused on oncology, with lead candidates BL-8040 and AGI-134, and strategic collaborations with MSD and Genentech - The company's strategic focus is on oncology, with two main clinical-stage candidates: **BL-8040** and **AGI-134**[184](index=184&type=chunk) - BL-8040 is a CXCR4 antagonist being developed for solid tumors, AML, and stem cell mobilization, having received Orphan Drug Designation from the FDA for AML, stem cell mobilization, and pancreatic cancer[187](index=187&type=chunk)[190](index=190&type=chunk) - AGI-134 is a synthetic alpha-Gal glycolipid immunotherapy for solid tumors, with a Phase 1/2a clinical study initiated in **August 2018**[204](index=204&type=chunk) - The company has active collaborations with **MSD (Merck)** and **Genentech (Roche)** to evaluate BL-8040 in combination with their respective checkpoint inhibitors, KEYTRUDA® and TECENTRIQ®[186](index=186&type=chunk) [Operating and Financial Review and Prospects](index=67&type=section&id=ITEM%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section provides management's discussion and analysis of the company's financial condition and results of operations, highlighting significant losses, funding sources, and future capital requirements - The company has a history of significant losses, with an accumulated deficit of **$222.5 million** as of December 31, 2018, primarily funded through equity sales and collaboration payments[414](index=414&type=chunk)[415](index=415&type=chunk) Comparison of Operating Expenses (in millions USD) | Expense Category | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Research & Development | $11.2 | $19.5 | $19.8 | | Sales & Marketing | $1.4 | $1.7 | $1.4 | | General & Administrative | $4.0 | $4.0 | $4.4 | - Net cash used in operating activities increased to **$24.2 million in 2018**, up from **$20.5 million in 2017** and **$14.5 million in 2016**, primarily due to increased R&D activities[465](index=465&type=chunk) - The company believes its existing cash resources, including proceeds from a February 2019 public offering, are sufficient to fund operations into **2021**, but substantial additional funds will be required thereafter[462](index=462&type=chunk)[468](index=468&type=chunk) [Directors, Senior Management and Employees](index=78&type=section&id=ITEM%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section provides information on the company's executive officers and directors, their compensation, board practices, and employee data Employee Headcount by Function | Function | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Management and administration | 11 | 11 | 10 | | Research and development | 28 | 36 | 34 | | Sales and marketing | 4 | 4 | 4 | | **Total** | **43** | **51** | **48** | - As of March 25, 2019, all directors and executive officers as a group (12 persons) beneficially owned **2.65 million ordinary shares**, representing **1.8%** of the class[604](index=604&type=chunk) - The Board of Directors consists of **seven members**, including two external directors as required by Israeli law, and has an Audit Committee, a Compensation Committee, and an Investment Monitoring Committee[504](index=504&type=chunk)[525](index=525&type=chunk)[543](index=543&type=chunk)[560](index=560&type=chunk) 2018 Compensation for Top 5 Executive Officers (in thousands USD) | Name and Position | Salary | Social Benefits | Bonuses | Value of Options Granted | All Other Compensation | Total | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Philip A. Serlin, CEO | $0.25 million | $0.07 million | $0.12 million | $0.38 million | $0.02 million | $0.85 million | | Mali Zeevi, CFO | $0.15 million | $0.04 million | $0.06 million | $0.19 million | $0.02 million | $0.45 million | | Hillit Mannor Shachar, VP Business Dev. | $0.13 million | $0.03 million | $0 | $0.09 million | $0.01 million | $0.26 million | | Abi Vainstein-Haras, VP Clinical Dev. | $0.17 million | $0.05 million | $0.04 million | $0.22 million | $0.02 million | $0.50 million | | Ella Sorani, VP R&D | $0.17 million | $0.05 million | $0.04 million | $0.16 million | $0.02 million | $0.45 million | [Major Shareholders and Related Party Transactions](index=102&type=section&id=ITEM%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies the company's major shareholders and describes related party transactions, primarily limited to employment and indemnification agreements Major Shareholders (as of March 25, 2019) | Shareholder | Percent of Class | | :--- | :--- | | BVF Partners L.P. | 21.2% | | Senvest Management, LLC | 5.1% | - Related party transactions consist of employment agreements and indemnification agreements with the company's directors and executive officers[630](index=630&type=chunk)[631](index=631&type=chunk) [Financial Information](index=103&type=section&id=ITEM%208.%20Financial%20Information) This section refers to the full consolidated financial statements in Item 18 and confirms the absence of material legal proceedings or cash dividend payments - The company is not involved in any material legal proceedings[632](index=632&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the near future, planning to reinvest any future earnings[633](index=633&type=chunk) [The Offer and Listing](index=104&type=section&id=ITEM%209.%20The%20Offer%20and%20Listing) This section provides details on the trading markets for the company's securities, with ADSs on Nasdaq and ordinary shares on the TASE - The company's ADSs trade on Nasdaq and its ordinary shares trade on the TASE, both under the ticker symbol "**BLRX**"[636](index=636&type=chunk) [Additional Information](index=104&type=section&id=ITEM%2010.%20Additional%20Information) This section covers supplementary corporate information, including details from the Articles of Association, material contracts, and Israeli and U.S. federal income tax considerations - Material contracts include a clinical trial collaboration with **MSD** for a Phase 2 study of BL-8040 with KEYTRUDA®, a combination study agreement with **Genentech** for BL-8040 with TECENTRIQ®, and a **$10 million** loan agreement with Kreos Capital[679](index=679&type=chunk)[682](index=682&type=chunk)[684](index=684&type=chunk) - The company is subject to Israeli corporate tax but may be eligible for tax benefits as a "Benefited Enterprise" or "Preferred Enterprise" under Israeli law, which could significantly reduce its tax rate on future income[689](index=689&type=chunk)[690](index=690&type=chunk) - The company believes it was a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes for several prior years, including **2014 through 2018**, which has significant tax implications for U.S. investors[724](index=724&type=chunk) [Quantitative and Qualitative Disclosure on Market Risk](index=119&type=section&id=ITEM%2011.%20Quantitative%20and%20Qualitative%20Disclosure%20on%20Market%20Risk) The company's primary market risks are interest rate fluctuations and foreign currency exchange risk, with the latter arising from expenses paid in NIS and euros - The company's main market risks are interest rate fluctuations on its cash and deposits, and foreign currency exchange risk[755](index=755&type=chunk) - Foreign currency risk stems from paying a significant portion of expenses in NIS and euros, while the functional currency is the U.S. dollar, and the company occasionally engages in currency hedging[757](index=757&type=chunk)[758](index=758&type=chunk) [Description of Securities Other Than Equity Securities](index=119&type=section&id=ITEM%2012.%20Description%20of%20Securities%20Other%20Than%20Equity%20Securities) This section describes the company's American Depositary Shares (ADSs), each representing one ordinary share, and outlines associated fees charged by the depositary - Each American Depositary Share (ADS) represents **one ordinary share** of the company[764](index=764&type=chunk) - The depositary, The Bank of New York Mellon, charges fees to ADS holders for various services, including a fee of **$5.00 or less per 100 ADSs** for issuance/surrender and a fee of **$0.05 or less per ADS** for cash distributions[766](index=766&type=chunk) [PART II](index=121&type=section&id=PART%20II) [Controls and Procedures](index=121&type=section&id=ITEM%2015.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2018 - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[774](index=774&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2018[777](index=777&type=chunk) [Corporate Governance and Other Information](index=122&type=section&id=ITEM%2016.%20Corporate%20Governance%20and%20Other%20Information) This section covers corporate governance topics, including the audit committee financial expert, the Code of Business Conduct and Ethics, principal accountant fees, and differences from Nasdaq listing standards - The Board of Directors has determined that **Ms. Nurit Benjamini** is the audit committee financial expert[780](index=780&type=chunk) Principal Accountant Fees (in thousands USD) | Fee Type | 2017 | 2018 | | :--- | :--- | :--- | | Audit Fees | $0.11 million | $0.11 million | | Audit-Related Fees | $0.03 million | $0 | | Tax Fees | $0.03 million | $0.01 million | | **Total** | **$0.17 million** | **$0.13 million** | - As a foreign private issuer, the company follows certain home country (Israeli) corporate governance practices in lieu of Nasdaq rules, particularly regarding quorum for shareholder meetings, director nominations, and shareholder approval requirements for equity compensation plans and related party transactions[790](index=790&type=chunk)[792](index=792&type=chunk)[795](index=795&type=chunk)[798](index=798&type=chunk)[799](index=799&type=chunk) [PART III](index=125&type=section&id=PART%20III) [Financial Statements](index=125&type=section&id=ITEM%2018.%20Financial%20Statements) This section contains the company's audited consolidated financial statements for the fiscal year ended December 31, 2018, prepared under IFRS, including the independent auditor's report and detailed financial statements - The independent auditor, Kesselman & Kesselman (PwC), issued an unqualified opinion, stating that the financial statements present fairly the financial position and that the company maintained effective internal control over financial reporting as of December 31, 2018[824](index=824&type=chunk) Consolidated Statement of Financial Position Highlights (as of Dec 31, in thousands USD) | Account | 2017 | 2018 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term deposits | $49.5 million | $30.2 million | | Total Assets | $61.0 million | $56.2 million | | Total Liabilities | $8.1 million | $14.9 million | | Total Equity | $52.9 million | $41.3 million | Consolidated Statement of Comprehensive Loss (Year ended Dec 31, in thousands USD) | Account | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Operating Loss | ($16.5 million) | ($25.2 million) | ($25.6 million) | | Net Loss and Comprehensive Loss | ($15.8 million) | ($24.4 million) | ($23.0 million) | | Loss Per Share (Basic and Diluted) | ($0.28) | ($0.27) | ($0.21) | [Exhibits](index=126&type=section&id=ITEM%2019.%20Exhibits) This section lists all exhibits filed as part of the annual report, including corporate documents, material contracts, and executive certifications - The report includes a comprehensive list of exhibits, including foundational corporate documents, material contracts, and executive certifications[805](index=805&type=chunk)