10q10k10q10k.net
BioLineRx Ltd.

BioLineRx Ltd.BLRX決算レポート

Nasdaq · biotechnology

BioLineRx Ltd., or BioLine, is a publicly traded drug development company. Headquartered in Israel, its shares are traded on the NASDAQ Capital Market and on the Tel Aviv Stock Exchange.

What changed in BioLineRx Ltd.'s 20-F — 2024 vs 2025

Top changes in BioLineRx Ltd.'s 2025 20-F

321 paragraphs added · 460 removed · 219 edited across 4 sections

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

126 edited+89 added−91 removed222 unchanged
Unless a drug is exempt from the NDA process or the Biologics License Application, or BLA, process or subject to another regulatory procedure, the steps required before a drug may be marketed in the United States include: • preclinical laboratory tests, animal studies and formulation development; • submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing; • adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish the exposure levels; • submission to the FDA of an application for marketing approval; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and • FDA review and approval of the drug and drug labeling for marketing.
Unless a drug is exempt from the NDA process or the Biologics License Application, or BLA, process or subject to another regulatory procedure, the steps required before a drug may be marketed in the United States include: • completion of preclinical laboratory tests, animal studies and formulation development; • submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing; • completion of adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish the exposure levels; • submission to the FDA of an application for marketing approval; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and • FDA review and approval of the drug and drug labeling for marketing.
In any event, under our agreement with Biokine, we have a full right of offset for amounts payable to the IIA for the motixafortide program from any payments that we may owe to Biokine in the future.
In any event, under our agreement with Biokine, we have a full right of offset for amounts payable to the IIA for the motixafortide program from any payments that we may owe to Biokine in the future.
Out Licensing of Motixafortide in Asia On August 27, 2023, we entered into a License Agreement, or the Gloria License Agreement, with Hong Seng Technology Limited, or HST, and Gloria, and/or with HST, the Gloria Licensee, pursuant to which we granted HST an exclusive, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide in order to develop and commercialize motixafortide in Asia (other than Israel and certain other countries), or the Gloria Territory, and to engage and authorize Gloria to perform services under the Gloria License Agreement in the Territory.
Out Licensing of Motixafortide in Asia On August 27, 2023, we entered into the Gloria License Agreement, with Hong Seng Technology Limited, or HST, and Gloria, and/or with HST, the Gloria Licensee, pursuant to which we granted HST an exclusive, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide in order to develop and commercialize motixafortide in Asia (other than Israel and certain other countries), or the Gloria Territory, and to engage and authorize Gloria to perform services under the Gloria License Agreement in the Territory.
Orphan medicinal product designation provides regulatory and financial incentives for companies to develop and market therapies, including ten years of market exclusivity, protocol assistance, fee reductions and EU-funded research. BL-5010 Our commercialized, legacy therapeutic product, BL-5010, is a customized, proprietary pen-like applicator containing a novel, acidic, aqueous solution for the non-surgical removal of skin lesions.
Orphan medicinal product designation provides regulatory and financial incentives for companies to develop and market therapies, including ten years of market exclusivity, protocol assistance, fee reductions and EU-funded research. 41 BL-5010 Our commercialized, legacy therapeutic product, BL-5010, is a customized, proprietary pen-like applicator containing a novel, acidic, aqueous solution for the non-surgical removal of skin lesions.
Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not, however, a part of this Annual Report on Form 20-F. B. Business Overview We are a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases.
Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not, however, a part of this Annual Report on Form 20-F. B. Business Overview General We are a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases.
The operation of our facilities, however, entails risks in these areas. Significant expenditures could be required in the future if we are required to comply with new or more stringent environmental or health and safety laws, regulations or requirements. See “Business — Government Regulation and Funding — Israel Ministry of Environment — Toxin Permit.” C.
The operation of our facilities, however, entails risks in these areas. Significant expenditures could be required in the future if we are required to comply with new or more stringent environmental or health and safety laws, regulations or requirements. See “Business - Government Regulation and Funding - Israel Ministry of Environment - Toxin Permit.” 67 C.
Information contained on or accessible through our website is not a part of this Annual Report on Form 20-F, and the inclusion of our website address herein is an inactive textual reference only. We use our website ( http://www.biolinerx.com ) as a channel of distribution of Company information. The information we post through this channel may be deemed material.
Information contained on or accessible through our website is not a part of this Annual Report on Form 20-F, and the inclusion of our website address herein is an inactive textual reference only. 35 We use our website ( http://www.biolinerx.com ) as a channel of distribution of Company information. The information we post through this channel may be deemed material.
Foreign clinical trials may or may not be conducted under an IND. However, their safety assessments should be submitted annually. 48 We conduct clinical trials typically in three sequential phases (1-3), but the phases may overlap or be combined. An institutional review board, or IRB, must review and approve each trial before it can begin.
Foreign clinical trials may or may not be conducted under an IND. However, their safety assessments should be submitted annually. We conduct clinical trials typically in three sequential phases (1-3), but the phases may overlap or be combined. An institutional review board, or IRB, must review and approve each trial before it can begin.
Submission of an IND does not always result in the FDA allowing clinical trials to commence and the FDA may halt a clinical trial if unexpected safety issues surface or the study is not being conducted in compliance with applicable requirements. The FDA may refuse to accept an IND for review if applicable regulatory requirements are not met.
Submission of an IND does not always result in the FDA allowing clinical trials to commence and the FDA may halt a clinical trial if unexpected safety issues surface or the study is not being conducted in compliance with applicable requirements. 53 The FDA may refuse to accept an IND for review if applicable regulatory requirements are not met.
In recent years, there has been a trend towards shorter regulatory review times in the United States as well as certain European countries, despite increased regulation and higher quality, safety and efficacy standards. Historically, different requirements by different countries’ regulatory authorities have influenced the submission of applications.
In recent years, there has been a trend towards shorter regulatory review times in the United States as well as certain European countries, despite increased regulation and higher quality, safety and efficacy standards. 52 Historically, different requirements by different countries’ regulatory authorities have influenced the submission of applications.
In September 2023, we reported data from the pilot phase of the study. As of July 2023, of those 11 patients, seven patients (64%) experienced a partial response (PR), of which six (55%) are now confirmed PRs, with one patient experiencing resolution of the hepatic (liver) metastatic lesion.
In September 2023, we reported preliminary data from the pilot phase of the study. As of July 2023, of those 11 patients, seven patients (64%) experienced a partial response (PR), of which six (55%) are now confirmed PRs, with one patient experiencing resolution of the hepatic (liver) metastatic lesion.
Pursuant to the agreement, Biokine granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell certain technology relating to a short peptide that functions as a high-affinity antagonist for CXCR4 and the uses thereof. There were no upfront payments due under the agreement.
Pursuant to the agreement, Biokine granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell certain technology relating to a short peptide that functions as a high-affinity antagonist for CXCR4 and the uses thereof. 45 There were no upfront payments due under the agreement.
We may need to adapt our business and therapeutic candidates and products to changes that occur in the future. Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.
We may need to adapt our business and therapeutic candidates and products to changes that occur in the future. 62 Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.
We expect that additional foreign, federal and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures. 58 Israeli Government Programs Israel Innovation Authority Before we in-licensed motixafortide, Biokine had received $2.7 million in funding for the project from the IIA (formerly the OCS).
We expect that additional foreign, federal and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures. 66 Israeli Government Programs Israel Innovation Authority Before we in-licensed motixafortide, Biokine had received $2.7 million in funding for the project from the IIA (formerly the OCS).
In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy.
Pancreatic Cancer In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy.
Furthermore, we have Orphan Drug status for AML, pancreatic cancer and stem cell mobilization, as well as data exclusivity protection afforded to motixafortide as an NCE. 43 • With respect to BL-5010, we have an exclusive license to a patent family directed to a novel applicator uniquely configured for applying the BL-5010 composition to targeted skin tissue safely and effectively.
Furthermore, we have Orphan Drug status for AML, pancreatic cancer and stem cell mobilization, as well as data exclusivity protection afforded to motixafortide as an NCE. 47 • With respect to BL-5010, we have an exclusive license to a patent family directed to a novel applicator uniquely configured for applying the BL-5010 composition to targeted skin tissue safely and effectively.
Fast Track and Breakthrough Therapy designations may be requested during development, while Accelerated Approval and Priority Review relate to the marketing approval stage. 50 European Union/European Economic Area Clinical Trials Within the European Union (EU) and the European Economic Area (EEA), which is composed of the 27 member states of the EU plus Norway, Iceland and Liechtenstein, the authorization of clinical trials occurs at member state level.
Fast Track and Breakthrough Therapy designations may be requested during development, while Accelerated Approval and Priority Review relate to the marketing approval stage. 56 European Union/European Economic Area Clinical Trials Within the European Union (EU) and the European Economic Area (EEA), which is composed of the 27 member states of the EU plus Norway, Iceland and Liechtenstein, the authorization of clinical trials occurs at member state level.
Mutual Recognition Procedure (MRP) The mutual recognition procedure (Art. 28 Directive 2004/27/EC) should be used if a medicinal product already has a marketing authorization in one EEA member state, and the authorization holder would like to extend the authorization to other member states. An application for mutual recognition may be addressed to one or more EEA countries.
Mutual Recognition Procedure (MRP) The mutual recognition procedure (Art. 28 Directive 2004/27/EC) can be used if a medicinal product already has a marketing authorization in one EEA member state, and the authorization holder would like to extend the authorization to other member states. An application for mutual recognition may be addressed to one or more EEA countries.
Our first approved product, APHEXDA® (motixafortide), a novel peptide for the treatment of stem-cell mobilization and solid tumors, with an indication in the United States for stem cell mobilization for autologous transplantation in multiple myeloma, is being developed and commercialized by Ayrmid (globally, excluding Asia) and Gloria (in Asia).
Our first approved product, APHEXDA® (motixafortide), a novel peptide for the treatment of stem-cell mobilization and solid tumors, with an indication in the United States for stem cell mobilization for autologous transplantation in multiple myeloma, is being developed and commercialized by Ayrmid Pharma Ltd. (globally, excluding Asia) and Gloria, (in Asia).
Louis to advance a Phase 1 clinical trial in which motixafortide will be evaluated as a monotherapy and in combination with natalizumab (VLA-4 inhibitor), as novel regimens to mobilize CD34+ hematopoietic stem cells (HSC) for gene therapies in Sickle Cell Disease.
Louis to advance a Phase 1 clinical trial in which motixafortide would be evaluated as a monotherapy and in combination with natalizumab (VLA-4 inhibitor), as novel regimens to mobilize CD34+ hematopoietic stem cells (HSC) for gene therapies in Sickle Cell Disease.
We have also been advancing plans in collaboration with Gloria, our Asia partner, for a Phase 2b randomized study assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. IND submission and protocol finalization was planned for the first half of 2025, with study initiation expected during 2025.
We have also been advancing plans in collaboration with Gloria, our Asia partner, for a Phase 2b randomized study assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. IND submission and protocol finalization was planned for the first half of 2025.
The amended Phase 2b study is evaluating the combination of motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone. The trial's primary endpoint is progression free survival, and a pre-specified interim futility analysis will be conducted when 40% of progression free survival events are observed, which is expected in 2026.
The amended Phase 2b study is evaluating the combination of motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone. The trial's primary endpoint is progression free survival, and a pre-specified interim futility analysis will be conducted when 40% of progression free survival events are observed, which is planned for 2026.
The patent positions for our three therapeutic candidates are described below and include both issued patents and pending patent applications we exclusively license.
The patent positions for our three therapeutic candidates are described below and include both issued patents and pending patent applications we own or exclusively license.
Recent Developments Out Licensing of Motixafortide in All Territories Except Asia On November 20, 2024, we entered into a license agreement, or the Ayrmid License Agreement, with Ayrmid Pharma Ltd., or Ayrmid, pursuant to which we granted to Ayrmid an exclusive, transferable, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide, in order to commercialize motixafortide across all indications, except solid tumor indications, in all territories other than Asia, or collectively, the Ayrmid Territory. 31 Pursuant to the terms of the Ayrmid License Agreement, Ayrmid paid a non-refundable $10 million upfront payment and we are entitled to up to $87 million of certain commercial and sales milestones based on defined sales targets of motixafortide in the Ayrmid Territory.
Out-Licensing Agreements Out Licensing of Motixafortide in All Territories Except Asia On November 20, 2024, we entered into a license agreement, or the Ayrmid License Agreement with Ayrmid pursuant to which we granted to Ayrmid an exclusive, transferable, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide, in order to commercialize motixafortide across all indications, except solid tumor indications, in all territories other than Asia, or collectively, the Ayrmid Territory. 42 Pursuant to the terms of the Ayrmid License Agreement, Ayrmid paid a non-refundable $10 million upfront payment and we are entitled to up to $87 million of certain commercial and sales milestones based on defined sales targets of motixafortide in the Ayrmid Territory.
Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. In February 2024, the first patient was dosed, with full enrollment projected for 2027.
Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. In February 2024, the first patient was dosed, with full enrollment planned in 2027.
As of December 31, 2024, $1.1 million in aggregate royalties had been paid to the IIA on account of the motixafortide program and there was a contingent liability to the IIA (including interest) of $2.7 million (without taking into account the potential repayment requirement of up to six times the amount as detailed above).
As of December 31, 2025, $1.3 million in aggregate royalties had been paid to the IIA on account of the motixafortide program and there was a contingent liability to the IIA (including interest) of $2.5 million (without taking into account the potential repayment requirement of up to six times the amount as detailed above).
In addition, motixafortide has demonstrated a direct anti-cancer effect by inducing apoptosis (cell death) and inhibiting proliferation in various cancer cell models (multiple myeloma, non-Hodgkin’s lymphoma, leukemia, non-small-cell lung carcinoma, neuroblastoma and melanoma). 34 In the field of immuno-oncology, motixafortide mediates infiltration of T-cells while reducing immune regulatory cells in the tumor microenvironment, or TME.
In addition, motixafortide has demonstrated a direct anti-cancer effect by inducing apoptosis (cell death) and inhibiting proliferation in various cancer cell models (multiple myeloma, non-Hodgkin’s lymphoma, leukemia, non-small-cell lung carcinoma, neuroblastoma and melanoma). In the field of immuno-oncology, motixafortide mediates infiltration of effector T-cells while reducing immune suppressor cells (Tregs and MDSCs) in the tumor microenvironment, or TME.
As of March 16, 2025, we have registered textual trademarks for “APHEXDA” in Israel, Australia, Brazil, Canada, China, EU, UK, Japan, Republic of Korea and the USA, as well as registered logo marks for “APHEXDA” in Israel, Australia, Brazil, China, EU, UK, Japan, Republic of Korea and the USA. We also have the same pending logo trademark in Canada.
As of March 8, 2026, we have registered textual trademarks for “APHEXDA” in Israel, Australia, Brazil, Canada, China, EU, UK, Japan, Republic of Korea and the USA, as well as registered logo marks for “APHEXDA” in Israel, Australia, Brazil, China, EU, UK, Japan, Republic of Korea and the USA. We also have the same pending logo trademark in Canada.
The assessment time is 180 days plus 30 days. 52 Decentralized Procedure (DCP) The decentralized procedure (introduced by Directive 2004/27/EU) is used in cases where the medicinal product has not received a marketing authorization in the EU at the time of application. It allows the common assessment of an application submitted simultaneously to several member states.
Decentralized Procedure (DCP) The decentralized procedure (introduced by Directive 2004/27/EU) is used in cases where the medicinal product has not received a marketing authorization in the EU at the time of application. It allows the common assessment of an application submitted simultaneously to several member states.
Such restrictions under applicable federal and state healthcare laws and regulations include the following: • the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; • the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 56 • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing, or attempting to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits, items, or services; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf; • the Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; • the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or collectively the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, within HHS, information related to payments and other transfers of value to certain healthcare providers and teaching hospitals and information regarding ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
Such restrictions under applicable federal and state healthcare laws and regulations include the following: • the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; • the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing, or attempting to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits, items, or services; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf; • the Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; the Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal health care program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, or offering or transferring remuneration to a federal health care beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; 64 • the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or collectively the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, within HHS, information related to payments and other transfers of value to certain healthcare providers and teaching hospitals and information regarding ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
Monthly rent is NIS 128,300 (approximately $35,000), including maintenance fees and parking. The initial term of the lease expired in June 2020, and we exercised our options to extend the lease through June 30, 2028. We have the option to extend the lease for one additional period of two years, at a 5% increase to the preceding lease payment amount.
Monthly rent is NIS 137,000 (approximately $39,700), including maintenance fees and parking. The initial term of the lease expired in June 2020, and we exercised our options to extend the lease through June 30, 2028. We have the option to extend the lease for one additional period of two years, at a 5% increase to the preceding lease payment amount.
The CTR provides inter alia: • Consistent rules for conducting clinical trials throughout the EU; • Making information on the authorization, conduct and results of each clinical trial carried out in the EU publicly available; • Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states; • Improved collaboration, information sharing and decision-making between and within member states; • Increased transparency of information on clinical trials; and • Higher standards of safety for all participants in EU clinical trials.
The CTR provides inter alia: • Consistent rules for conducting clinical trials throughout the EU; • Making information on the authorization, conduct and results of each clinical trial carried out in the EU publicly available; • Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states; • Improved collaboration, information sharing and decision-making between and within member states; • Increased transparency of information on clinical trials; and • Higher standards of safety for all participants in EU clinical trials, also ensured through compliance with Good Clinical Practice (GCP).
Under U.S. federal law, the submission of NDAs is generally subject to substantial application user fees, and the manufacturer and/or sponsor under an NDA approved by the FDA is also subject to annual product and establishment user fees. These fees are typically increased annually.
Under U.S. federal law, the submission of NDAs is generally subject to substantial application user fees, and the manufacturer and/or sponsor under an NDA approved by the FDA is also subject to annual product and establishment user fees.
Failure to comply with statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreements to resolve allegations of non-compliance with these laws, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and individual imprisonments.
Failure to comply with statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreements to resolve allegations of non-compliance with these laws, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and individual imprisonments. 49 Contract Research Organizations We outsource certain preclinical and clinical development activities to CROs, which meet FDA or European Medicines Agency regulatory standards.
To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on any of our future commercial products are unknown.
To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on any of our future commercial products are unknown. 65 In August 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.
Competition The life science industry is intensely competitive. We face potential competition from both large and small pharmaceutical and biotechnology companies, academic institutions, governmental and public and private research institutions. Many of these organizations have substantially greater financial, technical, manufacturing and marketing resources than we do.
We face potential competition from both large and small pharmaceutical and biotechnology companies, academic institutions, governmental and public and private research institutions. Many of these organizations have substantially greater financial, technical, manufacturing and marketing resources than we do.
Under U.S. federal law, the FDA has agreed to certain performance goals in the review of NDAs/BLAs. Most such applications for non-priority drug products are to be reviewed within 10 months following acceptance of the application for filing.
Once the submission is accepted for filing, the FDA begins an in-depth review of the submitted application. Under U.S. federal law, the FDA has agreed to certain performance goals in the review of NDAs/BLAs. Most such applications for non-priority drug products are to be reviewed within 10 months following acceptance of the application for filing.
Our current toxin permit will remain in effect until August 2031. 54 Clinical Testing in Israel In order to conduct clinical testing on humans in Israel, special authorization must first be obtained from the ethics committee and the head of the medical center in which the clinical studies are planned to be conducted, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation.
Clinical Testing in Israel In order to conduct clinical testing on humans in Israel, special authorization must first be obtained from the ethics committee and the head of the medical center in which the clinical studies are planned to be conducted, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation.
Directive 2017/1572/EU has replaced Directive 2003/94/EC. Directive 2003/94/EC will still be applicable to clinical trials conducted in accordance with the former regime under transitional provisions. Furthermore, distribution of medicinal products in the EU is subject to Directive 2001/83/EC and current guidance on good distribution practice, or GDP.
Directive 2017/1572/EU has replaced Directive 2003/94/EC. Directive 2003/94/EC will still be applicable to clinical trials conducted in accordance with the former regime under transitional provisions. Furthermore, distribution of medicinal products in the EU is subject to Directive 2001/83/EC and current guidance on good distribution practice, or GDP. Additionally, an official manufacturing license is required before production can commence.
The regulations frequently operate within a criminal law framework, and failure to comply with the requirements may not only affect the authorization, but also can lead to financial and other sanctions levied on the company in question and responsible officers.
These obligations also include reporting side effects via EudraVigilance. The regulations frequently operate within a criminal law framework, and failure to comply with the requirements may not only affect the authorization, but also can lead to financial and other sanctions levied on the company in question and responsible officers.
To this end, the marketing authorization holder shall request the Reference Member State either to prepare an assessment report on the product or, if necessary, to update any existing assessment report.
To this end, the marketing authorization holder shall request the Reference Member State either to prepare an assessment report on the product or, if necessary, to update any existing assessment report. The assessment time is 180 days plus 30 days.
The proof-of-concept investigator-initiated study plans to enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial’s primary objective is to assess the safety and tolerability of motixafortide alone and in combination with natalizumab in SCD patients, defined by dose-limiting toxicities.
The proof-of-concept investigator-initiated study planned to enroll ten adults with a diagnosis of SCD that were receiving automated red blood cell exchanges via apheresis. The trial’s primary objective was to assess the safety and tolerability of motixafortide alone and in combination with natalizumab in SCD patients, defined by dose-limiting toxicities.
Organizational Structure Our corporate structure consists of BioLineRx Ltd., one wholly owned subsidiary, BioLineRx USA, Inc., and a substantially wholly owned, inactive U.K. subsidiary, Agalimmune Ltd. 59 D. Property, Plant and Equipment We are headquartered in Modi’in, Israel. We entered into a lease agreement in August 2014, for an aggregate of 1,663 square meters (approximately 17,900 square feet) of space.
Organizational Structure Our corporate structure consists of BioLineRx Ltd., one wholly owned subsidiary, BioLineRx USA, Inc. and we own 40% of the shares of Tetragon. D. Property, Plant and Equipment We are headquartered in Modi’in, Israel. We entered into a lease agreement in August 2014, for an aggregate of 1,663 square meters (approximately 17,900 square feet) of space.
Regulations also cover research, development, manufacturing and reporting procedures, both pre- and post-approval. In many markets, especially in Europe, marketing and pricing strategies are subject to national legislation or administrative practices that include requirements to demonstrate not only the quality, safety and efficacy of a new product, but also its cost-effectiveness relating to other treatment options.
In many markets, especially in Europe, marketing and pricing strategies are subject to national legislation or administrative practices that include requirements to demonstrate not only the quality, safety and efficacy of a new product, but also its cost-effectiveness relating to other treatment options.
The competitive development pipeline in stem cell mobilization is currently very scarce, but we are aware of GPCR Therapeutic’s burixafor +propranolol combination under clinical investigation for stem cell mobilization in multiple myeloma, which may compete with motixafortide in the future.
The competitive development pipeline in stem cell mobilization is currently limited, but we are aware of Exicure’s burixafor in combination with propranolol and G-CSF, which is under clinical investigation for stem cell mobilization in multiple myeloma and may compete with motixafortide in the future.
Either party may terminate the agreement for material breach if the breach is not cured within 30 days after written notice from the non-breaching party.
We may terminate the license agreement for any reason on 30 days’ prior written notice. Either party may terminate the agreement for material breach if the breach is not cured within 30 days after written notice from the non-breaching party.
EU pharmacovigilance legislation has been significantly modified by the Pharmacovigilance Directive, Directive 2010/84/EU (as amended on January 20, 2011) which amended the legal framework of pharmacovigilance for medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized medicinal products and in Directive 2001/83/EC with respect to nationally authorized medicinal products (including those authorized through the mutual recognition and decentralized systems).
As an example, the mandatory designation of a Qualified Person for Pharmacovigilance (QPPV) constitutes a requirement whose breach can be subject to sanctions, EU pharmacovigilance legislation has been significantly modified by the Pharmacovigilance Directive, Directive 2010/84/EU (as amended on January 20, 2011) which amended the legal framework of pharmacovigilance for medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized medicinal products and in Directive 2001/83/EC with respect to nationally authorized medicinal products (including those authorized through the mutual recognition and decentralized systems).
Our current capital expenditures involve acquisitions of laboratory equipment, computers and communications equipment. 30 The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers like BioLineRx that file electronically with the SEC. The address of that site is www.sec.gov . We maintain a corporate website at www.biolinerx.com .
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers like BioLineRx that file electronically with the SEC. The address of that site is www.sec.gov . We maintain a corporate website at www.biolinerx.com .
The results of studies such as these are presented from time to time at relevant professional conferences. 39 Orphan Drug Designations Motixafortide has been granted three Orphan Drug Designations by the FDA: for use to mobilize HSCs from the bone marrow to peripheral blood for collection in autologous or allogeneic transplantation (granted in July 2012); for the treatment of AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February 2019).
Orphan Drug Designations Motixafortide has been granted three Orphan Drug Designations by the FDA: for use to mobilize HSCs from the bone marrow to peripheral blood for collection in autologous or allogeneic transplantation (granted in July 2012); for the treatment of AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February 2019).
The adoption of the Common Technical Document format by the ICH has greatly facilitated use of a single regulatory submission for seeking approval in the ICH regions and many other countries worldwide.
The adoption of the Common Technical Document format by the ICH has greatly facilitated use of a single regulatory submission for seeking approval in the ICH regions and many other countries worldwide. Summaries of the United States, EU, United Kingdom and Israeli regulatory processes follow below.
Clinical trials in the EU are regulated under Regulation (EU) 536/2014 (CTR), as amended on April 5, 2022. As opposed to the previous Directive 2001/20/EC (CTD), which as an EU directive was not directly applicable in the member states, the CTR has immediate effect for the whole EU and did not have to be transposed into national law.
As opposed to the previous Directive 2001/20/EC (CTD), which as an EU directive was not directly applicable in the member states, the CTR (as an EU regulation) has immediate effect for the whole EU and did not have to be transposed into national law.
Federal Food, Drug and Cosmetic Act, or FDCA, and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, record-keeping, packaging, labeling, adverse event reporting, advertising, promotion, marketing, distribution and import and export of pharmaceutical products.
United States In the United States, drugs are subject to rigorous regulation by the FDA. The U.S. Federal Food, Drug and Cosmetic Act, or FDCA, and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, record-keeping, packaging, labeling, adverse event reporting, advertising, promotion, marketing, distribution and import and export of pharmaceutical products.
Competitors and other companies could adopt similar marks or try to prevent us from using our marks, consequently impeding our ability to build brand identity and possibly leading to customer confusion. 44 Manufacturing We rely on contract manufacturers to produce motixafortide for clinical trials and commercial sales.
Competitors and other companies could adopt similar marks or try to prevent us from using our marks, consequently impeding our ability to build brand identity and possibly leading to customer confusion. 48 Manufacturing With respect to GLIX1, we rely on contract manufacturers for clinical and pre-clinical development.
Patents As of March 16, 2025, we owned or exclusively licensed for use within our field of business 20 patent families that collectively contain 70 granted patents, 6 allowed patent applications and 73 pending patent applications relating to the two candidates listed below. We are also pursuing patent protection for other drug candidates in our pipeline.
Patents As of March 8, 2026, we owned or exclusively licensed for use within our field of business 21 patent families that collectively contain 141 granted patents, 3 allowed patent applications and 97 pending patent applications relating to the three candidates listed below. We are also pursuing patent protection for other drug candidates in our pipeline.
Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication. 55 In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic, health outcome studies in order to demonstrate the medical necessity, quality of life benefits, and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals.
In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic, health outcome studies in order to demonstrate the medical necessity, quality of life benefits, and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals.
We completed our initial public offering in Israel in February 2007 and our ordinary shares are traded on the TASE under the symbol “BLRX.” In July 2011, we listed our ADSs on Nasdaq and they are traded under the symbol “BLRX.” In March 2017, we acquired Agalimmune a private U.K.-based company and intend to either transfer ownership of Agalimmune to a third party or liquidate it during 2025.
We completed our initial public offering in Israel in February 2007 and our ordinary shares are traded on the TASE under the symbol “BLRX.” In July 2011, we listed our ADSs on Nasdaq and they are traded under the symbol “BLRX.” In March 2017, we acquired Agalimmune a private U.K.-based company and in June 2025, we sold Agalimmune, to a third party for future potential royalty consideration.
Because we utilize toxic materials in the course of operation of our laboratories, we were required to apply for a permit to use these materials.
Because we utilize toxic materials in the course of operation of our laboratories, we were required to apply for a permit to use these materials. Our current toxin permit will remain in effect until August 2031.
These studies serve to potentially further elucidate the mechanism of action for motixafortide, generate data about motixafortide’s potential use in other indications, and inform the life-cycle management process of motixafortide.
These studies serve to potentially further elucidate the mechanism of action for motixafortide, generate data about motixafortide’s potential use in other indications, and inform the life-cycle management process of motixafortide. The results of studies such as these are presented from time to time at relevant professional conferences.
Motixafortide in combination with natalizumab mobilized a median of 231 CD34+ cells/μl (range 117-408), with median 4.64x10 6 CD34+ cells/kg collected as part of a single blood volume collection, projecting the collection of 18.6x10 6 CD34+ HSCs in a single day four blood volume apheresis collection session.
Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/μl (range 117-447) at 14 hours post motixafortide administration, with median 4.89x10 6 CD34+ cells/kg collected as part of a single blood volume collection, projecting the collection of 19.6x10 6 CD34+ HSCs in a single-day four-blood -volume apheresis collection session.
The FDA has 60 days from its receipt of an NDA/BLA to determine whether the application will be accepted for filing based on the FDA threshold determination that the application is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review of the submitted application.
These fees are typically increased annually. 54 The FDA has 60 days from its receipt of an NDA/BLA to determine whether the application will be accepted for filing based on the FDA threshold determination that the application is sufficiently complete to permit substantive review.
These payments are generally linked to the successful achievement of milestones in the development and approval of drugs, such Phases 1, 2 and 3 of clinical trials and approvals of NDAs, and achievement of sales milestones. • Royalty payments.
These payments are generally fixed at a percentage of the total revenues we earn from these sublicenses. • Milestone payments. These payments are generally linked to the successful achievement of milestones in the development and approval of drugs, such Phases 1, 2 and 3 of clinical trials and approvals of NDAs, and achievement of sales milestones. • Royalty payments.
Motixafortide alone mobilized a median of 198 CD34+ cells/μl (range 77-690) to PB with median 3.49x10 6 CD34+ cells/kg as part of a single blood volume collection, projecting the collection of 13.9x10 6 HSCs in a normal, single-day four-blood-volume apheresis collection session.
Motixafortide alone mobilized a median of 189 CD34+ cells/μl (range 77-690) to the PB at 10-14 hours post motixafortide administration, with a median 4.22x10 6 CD34+ cells/kg as part of a single blood volume collection, projecting the collection of 16.9x10 6 HSCs in a normal, single-day four-blood-volume apheresis collection session.
Our longer-term vision is to develop innovative assets with significant potential value whose development costs have been offset by the royalties and milestones from our existing motixafortide partnerships. We aim to continue pursuing new partnerships on these programs to create additional value for our shareholders.
Our longer-term vision is to develop innovative assets with significant potential value whose development costs have been offset by the royalties and milestones from our existing motixafortide partnerships.
If the breach is not susceptible to cure within the stated period and the breaching party uses diligent, good faith efforts to cure such breach, the stated period will be extended by an additional 30 days.
If the breach is not susceptible to cure within the stated period and the breaching party uses diligent, good faith efforts to cure such breach, the stated period will be extended by an additional 30 days. In addition, either party may terminate the agreement upon the occurrence of certain bankruptcy events.
If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities and entered into the first set of agreements with pharmaceutical manufacturers to conduct price negotiations in October 2023.
If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities and entered into the first set of agreements with pharmaceutical manufacturers for negotiated prices of 10 products, which became applicable for payment year 2026.
In the case of self-commercialization, we are obligated to make royalty payments of 10% of net sales, subject to certain limitations. 41 Before we in-licensed motixafortide, Biokine had received funding for the project from the IIA, and as a condition to IIA giving its consent to our in-licensing of motixafortide, we were required to agree to abide by any obligations resulting from such funding.
Before we in-licensed motixafortide, Biokine had received funding for the project from the IIA, and as a condition to IIA giving its consent to our in-licensing of motixafortide, we were required to agree to abide by any obligations resulting from such funding.
Our capital expenditures for the year ended December 31, 2024 were immaterial and were $0.3 million for each of the years ended December 31, 2022 and 2023.
Our capital expenditures for each of the years ended December 31, 2024 and 2025 were immaterial and were $0.3 million for the year ended December 31, 2023. Our current capital expenditures involve acquisitions of laboratory equipment, computers and communications equipment.
We also have the right to grant sublicenses for the licensed technology and are required to pay IPC a payment, within our standard range of sublicense receipt consideration, based on the revenues we receive as consideration in connection with any sublicensing, development, manufacture, marketing, distribution or sale of the licensed technology.
We also have the right to grant sublicenses for the licensed technology and are required to pay IPC a payment, within our standard range of sublicense receipt consideration, based on the revenues we receive as consideration in connection with any sublicensing, development, manufacture, marketing, distribution or sale of the licensed technology. 46 The license agreement remains in effect until the expiration of all of our license, royalty and sublicense revenue obligations to IPC, determined on a product-by-product and country-by-country basis, unless we terminate the license agreement earlier.
We further have registered textual trademarks for “BioLineRx” in the USA and registered logo marks for “BioLineRx” in Israel and the USA. We also claim common law protections for other marks we use in our business.
We further have registered textual trademarks for “BioLineRx” in the USA and registered logo marks for “BioLineRx” in Israel and the USA, and a pending national application for the textual trademark “BioLineRx” in the USA (subject to approval of a transformation request). We also claim common law protections for other marks we use in our business.
In addition, the planned studies of motixafortide in China under the Gloria License Agreement are currently not advancing according to schedule and it is unclear when such studies will be initiated, if at all. There can be no assurance that Gloria will meet its payment obligations or any other obligations under the Gloria License Agreement.
However, Gloria is not currently advancing this study according to schedule and it is unclear when such study will be initiated, if at all. There can be no assurance that Gloria will meet its obligations under the Gloria License Agreement.
Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the pharmacokinetics of CD34+ HSPCs mobilization to peripheral blood in response to motixafortide alone and motixafortide plus natalizumab in SCD patients. As anticipated, the study began enrolling in 2023, with first patient dosed in December 2023, and is ongoing.
Secondary objectives included determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the pharmacokinetics of CD34+ HSPCs mobilization to peripheral blood in response to motixafortide alone and motixafortide plus natalizumab in SCD patients. The study began in 2023 and was completed during 2025.
In August 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA. The IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.
The IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.
We are continuing to advance the development of motixafortide for patients with pancreatic cancer and other solid tumors. 33 In addition, as part of our growth strategy, we are actively pursuing in-licensing opportunities to expand and diversify our product pipeline.
We are continuing to advance the development of motixafortide for patients with pancreatic cancer and other solid tumors. In addition, as part of our future growth strategy, we intend to pursue additional in-licensing opportunities as well as other strategic transactions such as co-development agreements, acquisitions, and technology partnerships, to expand and diversify our product pipeline.
In certain cases, our competitors may also be able to use alternative technologies that do not infringe upon our patents to formulate the active materials in our therapeutic candidates.
In certain cases, our competitors may also be able to use alternative technologies that do not infringe upon our patents to formulate the active materials in our therapeutic candidates. They may, therefore, bring to market products that are able to compete with our candidates, or other products that we may develop in the future.
These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third parties for further development and commercialization of our drug products. These payments are generally fixed at a percentage of the total revenues we earn from these sublicenses. • Milestone payments.
Our in-licensing agreements generally provide for the following types of payments: • Revenue sharing payments. These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third parties for further development and commercialization of our drug products.
Depending on the nature of the medicinal product, several different legal frameworks of the EU and the member states may be relevant for the market clearance. 51 Centralized Procedure (CP) The Centralized Procedure according to Regulation 726/2004/EC (as amended on January 28, 2022) allows a marketing authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the entire EEA on the basis of a single marketing authorization, granted by the European Commission, acting in its capacity as the European Licensing Authority on the advice of the EMA.
Centralized Procedure (CP) The Centralized Procedure according to Regulation 726/2004/EC (as amended on January 28, 2022) allows a marketing authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the entire EEA on the basis of a single marketing authorization, granted by the European Commission based on the opinion of the Committee for Medicinal Products for Human Use (CHMP), which is responsible for the scientific assessment, acting in its capacity as the European Licensing Authority on the advice of the EMA.
Even with submission of additional information for a new review cycle, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. 49 The Pediatric Research Equity Act, or PREA, requires NDAs and BLAs (or supplements) for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration to contain results assessing the safety and efficacy for the claimed indication in all relevant pediatric subpopulations.
The Pediatric Research Equity Act, or PREA, requires NDAs and BLAs (or supplements) for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration to contain results assessing the safety and efficacy for the claimed indication in all relevant pediatric subpopulations.
Other Healthcare Laws and Regulation Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted regulatory approval. Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business and/or financial arrangements.
Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business and/or financial arrangements.
Another relevant aspect in the EU regulatory framework is the “sunset clause”: a provision leading to the cessation of the validity of any marketing authorization if it is not followed by marketing within three years or, if marketing is interrupted for a period of three consecutive years.
This ensures that safety‑relevant information is collected more quickly and that risks can be identified and managed at an early stage. 60 Another relevant aspect in the EU regulatory framework is the “sunset clause”: a provision leading to the cessation of the validity of any marketing authorization if it is not followed by marketing within three years or, if marketing is interrupted for a period of three consecutive years.
They may, therefore, bring to market products that are able to compete with our candidates, or other products that we may develop in the future. 45 Any therapeutic candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.
Any therapeutic candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

… 226 more changes not shown on this page.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

0 edited+2 added−137 removed0 unchanged
Removed
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report on Form 20-F. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.
Added
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 68 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 79 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 101 ITEM 8. FINANCIAL INFORMATION 104 ITEM 9. THE OFFER AND LISTING 105 ITEM 10. ADDITIONAL INFORMATION 106 ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK 118 ITEM 12.
Removed
Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 20-F, particularly those in “Item 3.
Added
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 118 ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES 121
Removed
Key Information — Risk Factors.” Our discussion and analysis for the year ended December 31, 2023 can be found in Item 5. “Operating and Financial Review and Prospects” of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with the SEC on March 26, 2024, as amended on March 26, 2024 (File No. 001-35223).
Removed
We are a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases.
Removed
Our first approved product is APHEXDA (motixafortide), a novel peptide for the treatment of stem-cell mobilization and solid tumors which, on September 8, 2023, was approved by the FDA for use in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
Removed
In October 2023, we out-licensed the rights to motixafortide for all indications in substantially all of Asia to Gloria, and in November 2024, we out-licensed the global rights (other than in Asia) to motixafortide for all indications, other than solid tumors, to Ayrmid.
Removed
As a result of the November 2024 transaction, we shut down our independent commercialization activities in the United States and refocused our operations on development activities in Israel in the fields of oncology (including solid tumors) and rare diseases, at a significantly reduced annual cash burn rate.
Removed
We have retained the rights to develop motixafortide across all solid tumor indications, in all territories other than Asia, including in PDAC, for which an investigator-initiated Phase 2b trial, sponsored by Columbia University, and supported equally by us and Regeneron, is ongoing at a relatively minimal cost to BioLineRx.
Removed
We expect this program to continue to advance without any significant expense to us. A key component of our strategy moving forward is to in-license additional assets in oncology and/or rare diseases that exhibit distinct advantages over currently available therapies or address unmet medical needs that we can advance through clinical development.
Removed
We have generated our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic candidates that we believe exhibit a high probability of therapeutic and commercial success.
Removed
We have substantial experience in scouting and assessing assets in transactions with back-ended, success-based consideration, which can be acquired or licensed for a modest upfront payment, and with relatively modest and affordable clinical development programs.
Removed
We are actively working on this initiative and are being presented with many promising opportunities that meet these criteria. 60 Our longer-term vision is to develop innovative assets with significant potential value whose development costs have been offset by the royalties and milestones from our existing motixafortide partnerships.
Removed
We aim to continue pursuing new partnerships on these programs to create additional value for our shareholders. A. Operating Results History of Losses Since our inception in 2003, we have generated significant losses in connection with our research and development, and more recently, our commercialization activities (prior to the Ayrmid License Agreement in November 2024).
Removed
As of December 31, 2024, we had an accumulated deficit of $400 million. We expect to continue to generate losses in connection with our research and development activities relating to our pipeline of therapeutic candidates until we reach commercial profitability, if ever.
Removed
Such research and development activities are budgeted to expand over time and will require further resources if we are to be successful. As a result, we expect to continue to incur operating losses and we expect to need to obtain additional funds to further pursue our research and development programs.
Removed
We have funded our operations primarily through the sale of equity securities (both in public and private offerings), payments received under our strategic licensing and collaboration arrangements, funding previously received from the IIA, and interest earned on investments.
Removed
We expect to continue to fund our operations over the next several years through our existing cash resources, potential future milestone and royalty payments that we may receive from our existing out-licensing agreements, primarily royalties from the commercialization of APHEXDA by Ayrmid, potential future upfront, milestone or royalty payments that we may receive from Gloria and any other out-licensing transaction, interest earned on our investments, and additional capital to be raised through public or private equity offerings or debt financings.
Removed
As of December 31, 2024, we had $19.6 million of cash, cash equivalents and short-term bank deposits. Revenues Our revenues to date have been generated primarily from upfront and milestone payments under out-licensing agreements and between the fourth quarter of 2023 and November 2024, revenues from product sales of APHEXDA.
Removed
We expect our revenues, if any, for the next several years to be derived primarily from future royalties on product sales, primarily royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. and potential milestone payments from the license agreements with Ayrmid and Gloria.
Removed
Cost of Revenues Our cost of revenues to date have consisted of sub-license payments to the licensors in respect of upfront and milestone payments associated with out-licensing agreements and costs associated with the manufacture of APHEXDA and royalty payments to the licensor with respect to direct product sales of APHEXDA.
Removed
Prior to receiving FDA approval for APHEXDA in September 2023, we expensed all manufacturing and material costs as research and development expenses.
Removed
We expect our cost of revenues, if any, for the next several years to be derived primarily from sub-license payments to the licensors in respect of out-licensing agreements and other potential collaboration arrangements, including future royalties on product sales from such out-licensing agreements.
Removed
Research and Development Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to external service providers, up-front and milestone payments under our license agreements, patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory supplies and costs for facilities and equipment.
Removed
We primarily use external service providers to manufacture our therapeutic candidates for clinical trials and for the majority of our preclinical and clinical development work. We charge all research and development expenses to operations as they are incurred.
Removed
We expect our research and development expenses to remain one of our primary expenses in the near future as we continue to develop motixafortide and additional assets we may in license. 61 The following table identifies our current major research and development projects: Project Status Expected Near Term Milestones motixafortide 1.
Removed
FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients. 1. Out-licensed to Ayrmid in November 2024; five-year long-term follow-up of GENESIS patients ongoing 2. Reported data from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC.
Removed
Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 6 (55%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%) experienced stable disease, resulting in a disease control rate of 91%.
Removed
Based on these encouraging results, study was substantially revised to a multi-institution, randomized Phase 2b trial of 108 patients 2. First patient dosed in February 2024. Interim data expected in 2026 and full enrollment projected for 2027* 3. Phase 1 study for gene therapies in SCD (with Washington University School of Medicine in St. Louis)** 3.
Removed
First patient dosed in December 2023 and initial data from the study released in November 2024. Final data planned in 2025* 4. Phase 1 study for gene therapies in SCD (with St. Jude Children’s Research Hospital, Inc.)** 4. First patient dosed in February 2025, with data planned in 2025/2026* 5.
Removed
IND approved in China for initiation of pivotal bridging study in SCM under license agreement with Gloria 5. Initiation of the study is currently delayed*** 6. Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria 6.
Removed
IND submission and protocol finalization is currently delayed*** * These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent investigators and are subject to change. ** Study to be continued under the Ayrmid License Agreement *** Under the Gloria License Agreement, Gloria is late in the payment of $2.4 million to us for the achievement of a specific milestone under the Gloria License Agreement and for certain product supply, which was due during 2024.
Removed
In addition, the planned studies of motixafortide in China under the Gloria License Agreement are currently not advancing according to schedule and it is unclear when such studies will be initiated, if at all. There can be no assurance that Gloria will meet its payment obligations or any other obligations under the Gloria License Agreement.
Removed
We expect that a large percentage of our research and development expenses in the future will be incurred in support of our current and future preclinical and clinical development projects.
Removed
Due to the inherently unpredictable nature of preclinical and clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of motixafortide in our pipeline for commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations.
Removed
We expect to continue to test motixafortide and any other therapeutic candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each such candidate.
Removed
If we are not able to enter into an out-licensing arrangement with respect to any therapeutic candidate prior to the commencement of later stage clinical trials, we may fund the trials for the therapeutic candidate ourselves.
Removed
Our future research and development expenses will depend on the clinical success of motixafortide in solid tumor indications and on other potential therapeutic candidates, as well as ongoing assessments of each therapeutic candidate’s commercial potential.
Removed
In addition, we cannot forecast with any degree of certainty which therapeutic candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. 62 As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain therapeutic candidates or projects in order to focus our resources on more promising therapeutic candidates or projects.
Removed
Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a therapeutic candidate.
Removed
The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others: • the number of sites included in the clinical trials; • the length of time required to enroll suitable patients; • the number of patients that participate, and are eligible to participate, in the clinical trials; • the duration of patient follow-up; • whether the patients require hospitalization or can be treated on an outpatient basis; • the development stage of the therapeutic candidate; and • the efficacy and safety profile of the therapeutic candidate.
Removed
The lengthy process of completing clinical trials and seeking regulatory approval for our therapeutic candidates requires expenditure of substantial resources.
Removed
Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations.
Removed
Due to the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects. Sales and Marketing Expenses Sales and marketing expenses consist primarily of compensation for employees in commercialization, marketing and business development functions.
Removed
Other significant costs include marketing and communication materials, market access activities, professional fees for outside market research and consulting, and legal services related to compliance and to potential business development transactions.
Removed
We expect our sales and marketing expenses to be reduced significantly following the license agreement with Ayrmid and the termination of our commercialization activities in the U.S., and to be primarily related to business development General and Administrative Expenses General and administrative expenses consist primarily of compensation for employees in executive and operational functions, including accounting, finance, legal, investor relations, information technology and human resources.
Removed
Other significant general and administration costs include facilities costs, professional fees for outside accounting and legal services, travel costs, insurance premiums and depreciation. 63 Non-Operating Expense and Income Non-operating expense and income includes fair-value adjustments of liabilities on account of the warrants issued in equity financings we carried out in February 2019, September 2022 April 2024, November 2024 and January 2025.
Removed
These fair-value adjustments are highly influenced by our share price at each period end (revaluation date). Non-operating expense and income also includes issuance expenses under the “at-the-market” offering agreement, or ATM Agreement, between us and HCW entered into in September 2021, and the pro-rata share of issuance expenses from the placements related to the warrants.
Removed
Sales-based royalties from the license agreement with Perrigo have also been included as part of non-operating income, as the out-licensed product is not an integral part of our strategy, and the amounts are not material.
Removed
Financial Expense and Income Financial expense and income consist of interest earned on our cash, cash equivalents and short-term bank deposits; interest expense related to our loans from BlackRock, bank fees and other transactional costs.
Removed
In addition, it may also include gains/losses on foreign exchange hedging transactions, which we carry out from time to time to protect against a portion of our NIS-denominated expenses (primarily compensation) in relation to the dollar. Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in conformity with IFRS, as issued by the IASB.
Removed
In preparing our consolidated financial statements, we make judgements, estimates and assumptions about the application of our accounting policies which affect the reported amounts of assets, liabilities, revenue and expenses. Our critical accounting judgements and sources of estimation uncertainty are described in Note 4 to our consolidated financial statements, which are included elsewhere in this Annual Report on Form 20-F.
Removed
Revenue Recognition We account for contract revenues in accordance with International Financial Reporting Standards No. 15, or IFRS 15. IFRS 15, “Revenue from Contracts with Customers”.
Removed
IFRS 15 introduces a five-step model for recognizing revenue from contracts with customers, as follows: • identify the contract with a customer; • identify the performance obligations in the contract; • determine the transaction price; • allocate the transaction price to the performance obligations in the contract; and • recognize revenue when (or as) the entity satisfies a performance obligation.
Removed
Accrued Expenses We are required to estimate accrued expenses as part of our process of preparing financial statements. This process involves estimating the level of service performed on our behalf and the associated cost incurred in instances where we have not been invoiced or otherwise notified of actual costs.
Removed
Examples of areas in which subjective judgments may be required include costs associated with services provided by contract organizations for commercialization, clinical trials, and preclinical development. We account for expenses associated with these external services by determining the total cost of a given study based on the terms of the related contract.
Removed
We accrue for costs incurred as the services are being provided by monitoring the status of the trials and the invoices received from our external service providers.
Removed
In the case of clinical trials, the estimated cost normally relates to the projected costs of treating the patients in our trials, which we recognize over the estimated term of the trial according to the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment.
Removed
As actual costs become known to us, we adjust our accruals. 64 Investments in Financial Assets The primary objective of our investment activities is to preserve principal while maximizing the income that we receive from our investments without significantly increasing risk and loss.
Removed
Our investments are exposed to market risk due to fluctuations in interest rates, which may affect our interest income and the fair market value of our investments. We manage this exposure by performing ongoing evaluations of our investments. Due to the short-term maturities of our investments to date, their carrying value has always approximated their fair value.
Removed
A financial asset is classified in this category if our management has designated it as a financial asset upon initial recognition, because it is managed, and its performance is evaluated, on a fair-value basis in accordance with a documented risk management or investment strategy.
Removed
Our investment policy with regard to excess cash, as adopted by our board of directors, is composed of the following objectives: (i) preserving investment principal; (ii) providing liquidity; and (iii) providing optimum yields pursuant to the policy guidelines and market conditions.
Removed
The policy provides detailed guidelines as to the securities and other financial instruments in which we are allowed to invest. In addition, in order to maintain liquidity, investments are structured to provide flexibility to liquidate at least 50% of all investments within 15 business days.
Removed
Information about these assets, including details of the portfolio and income earned, is provided internally on a quarterly basis to our key management personnel and on a semi-annual basis to the Investment Monitoring Committee of our board of directors. Any divergence from this investment policy requires approval from our board of directors.
Removed
Share-based Compensation We account for share-based compensation arrangements in accordance with the provisions of IFRS 2. IFRS 2 requires companies to recognize share compensation expense for awards of equity instruments based on the grant-date fair value of those awards (with limited exceptions).
Removed
The cost is recognized as compensation expense over the life of the instruments, based upon the grant-date fair value of the equity or liability instruments issued.
Removed
The fair value of our share-based compensation grants is computed as of the grant date based on the Black-Scholes model, using the standard parameters established in that model including estimates relating to volatility of our shares/ADSs, risk-free interest rates, estimated life of the equity instruments issued and the market price of our shares/ADSs.
Removed
As our ordinary shares/ADSs are publicly traded on the TASE or Nasdaq, we do not need to estimate their fair market value. Rather, we use the actual closing market price of our ordinary shares/ADSs on the date of grant, as reported by the TASE or Nasdaq.
Removed
Warrants In connection with a loan transaction entered into with BlackRock in October 2018, we issued a warrant to purchase 1,596 ADSs at an exercise price of $564.00 per ADS. The warrant is exercisable for a period of ten years from the date of issuance.
Removed
Since the exercise price was not deemed to be fixed, the warrant is not qualified for classification as an equity instrument and has therefore been classified as a non-current financial liability. In connection with an underwritten public offering we completed in January 2021, we issued warrants to purchase 17,989 ADSs at an exercise price of $120.00 per ADS.
Removed
The warrants are exercisable for a period of five years from the date of issuance. The warrants have been classified as shareholder’s equity. In connection with a registered direct offering we completed in September 2022, we issued warrants to purchase 340,909 ADSs at an exercise price of $46.00 per ADS, of which warrants to purchase 63,637 have been exercised.
Removed
The warrants are exercisable for a period of five years from the date of issuance. Since the exercise price of those warrants were not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been classified as a non-current financial liability.
Removed
We also issued warrants to purchase 17,045 ADSs at an exercise price of $55.00 per ADS. The warrants are exercisable for a period of five years from the date of issuance and have been classified as shareholder’s equity.
Removed
In connection with a registered direct offering we completed in April 2024, we issued warrants to purchase 187,500 ADSs at an exercise price of $32.00 per ADS, of which none of these warrants have been exercised to date. The warrants are exercisable for a period of five years from the date of issuance.
Removed
Since the exercise price of those warrants were not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been classified as a non-current financial liability.
Removed
In connection with a registered direct offering we completed in November 2024, we issued warrants to purchase 205,893 ADSs at an exercise price of $23.60 per ADS, of which none of these warrants have been exercised to date, and pre-funded warrants to purchase 308,749 ADSs at an exercise price of $0.004 per ADS, of which warrants to purchase 124,982 have been exercised.
Removed
The warrants are exercisable for a period of four years from the date of issuance and the pre-funded warrants will not expire until exercised in full. Since the exercise price of the warrants were not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been classified as a non-current financial liability.
Removed
The pre-funded warrants have been classified as equity instruments. 65 In connection with a registered direct offering we completed in January 2025, we issued warrants to purchase 1,250,000 ADSs at an exercise price of $8.00 per ADS, of which none of these warrants have been exercised to date, and pre-funded warrants to purchase 391,697 ADSs at an exercise price of $7.996 per ADS, of which all of the warrants had been exercised.
Removed
The warrants are exercisable for a period of five years from the date of issuance and the pre-funded warrants will not expire until exercised in full. We also issued placement agent warrants to purchase 62,500 ADSs at an exercise price of $10.00 per ADS. The warrants are exercisable for a period of five years from the date of issuance.

… 59 more changes not shown on this page.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

68 edited+11 added−9 removed130 unchanged
The compensation of a chief executive officer in a public company generally requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority for Compensation.
Chief Executive Officer . The compensation of a chief executive officer in a public company generally requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority for Compensation.
The compensation policy must be approved at least once every three years by the board of directors, after considering the recommendations of the compensation committee, and subject to limited exceptions, by the shareholders of the company by a majority vote of the shares present and voting at a shareholder meeting on the matter, subject to a certain special majority requirement, or the Special Majority for Compensation, as set forth in the Companies Law, pursuant to which one of the following must be met: • the majority of the votes voted in favor includes at least a majority of all the votes of shareholders who are not controlling shareholders of the company and shareholders who do not have a personal interest in the compensation policy, present and voting on the matter (excluding abstentions); or • the total of opposing votes from among the shareholders who are non-controlling shareholders and shareholders who do not have a personal interest in the matter does not exceed 2% of all the voting rights in the company.
The compensation policy must be approved at least once every three years by the board of directors, after considering the recommendations of the compensation committee, and subject to limited exceptions, by the shareholders of the company by a majority vote of the shares present and voting at a shareholder meeting on the matter, subject to a certain special majority requirement, or the Special Majority for Compensation, as set forth in the Companies Law, pursuant to which one of the following must be met: • the majority of the votes voted in favor includes at least a majority of all the votes of shareholders who are not controlling shareholders of the company and shareholders who do not have a personal interest in the compensation policy, present and voting on the matter (excluding abstentions); or 88 • the total of opposing votes from among the shareholders who are non-controlling shareholders and shareholders who do not have a personal interest in the matter does not exceed 2% of all the voting rights in the company.
Furthermore, in order to create a ceiling for the variable compensation: (1) the aggregate value of annual grants to any one office holder (based on the Black Scholes calculation as of the date of grant) will be no more than the higher of 2% of our market capitalization at the end of the measurement period or $1.5 million; and (2) it is our intention that the maximum outstanding equity awards under its share incentive plan will not exceed 12% of our total fully-diluted share capital.
Furthermore, in order to create a ceiling for the variable compensation: (1) the aggregate value of annual grants to any one office holder (based on the Black Scholes calculation as of the date of grant) will be no more than the higher of 2% of our market capitalization at the end of the measurement period or $1.5 million; and (2) it is our intention that the maximum outstanding equity awards under our share incentive plan will not exceed 12% of our total fully-diluted share capital.
Duties of shareholders Under the Companies Law, a shareholder has a duty to act in good faith and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders, and must refrain from abusing its power in the company, including, among other things, voting at general meetings of shareholders on the following matters: • an amendment to the articles of association; • an increase in the company’s authorized share capital; • a merger; and • the approval of related party transactions and acts of office holders that require shareholder approval under the Companies Law.
Duties of Shareholders Under the Companies Law, a shareholder has a duty to act in good faith and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders, and must refrain from abusing its power in the company, including, among other things, voting at general meetings of shareholders on the following matters: • an amendment to the articles of association; 95 • an increase in the company’s authorized share capital; • a merger; and • the approval of related party transactions and acts of office holders that require shareholder approval under the Companies Law.
However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria; 84 • reasonable litigation expenses, including attorneys’ fees, incurred by the office holder (i) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (1) no indictment was filed against such office holder as a result of such investigation or proceeding; and (2) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability (such as a criminal penalty) was imposed, it was imposed with respect to an offense that does not require proof of criminal intent and (ii) in connection with a monetary sanction; • a monetary liability imposed on an office holder in favor of an injured party at an Administrative Procedure (as defined below) pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; • expenses incurred by an office holder or certain compensation payments made to an injured party that were instituted against an office holder in connection with an Administrative Procedure under the Israeli Securities Law, including reasonable litigation expenses and reasonable attorneys’ fees; and • reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the office holder was acquitted or as a result of a conviction for an offense that does not require proof of criminal intent.
However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria; 96 • reasonable litigation expenses, including attorneys’ fees, incurred by the office holder (i) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (1) no indictment was filed against such office holder as a result of such investigation or proceeding; and (2) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability (such as a criminal penalty) was imposed, it was imposed with respect to an offense that does not require proof of criminal intent and (ii) in connection with a monetary sanction; • a monetary liability imposed on an office holder in favor of an injured party at an Administrative Procedure (as defined below) pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; • expenses incurred by an office holder or certain compensation payments made to an injured party that were instituted against an office holder in connection with an Administrative Procedure under the Israeli Securities Law, including reasonable litigation expenses and reasonable attorneys’ fees; and • reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the office holder was acquitted or as a result of a conviction for an offense that does not require proof of criminal intent.
In addition, the compensation committee may exempt from shareholder approval the compensation terms of a candidate for the office of chief executive officer where such officer has no prior business relationship with the controlling shareholder or the company, if it has found, based on detailed reasons, that bringing the compensation to the approval of the shareholders would impede the employment of such candidate by the company, provided that the terms of office and employment are in accordance with the company’s compensation policy. • Directors .
In addition, the compensation committee may exempt from shareholder approval the compensation terms of a candidate for the office of chief executive officer where such officer has no prior business relationship with the controlling shareholder or the company, if it has found, based on detailed reasons, that bringing the compensation to the approval of the shareholders would impede the employment of such candidate by the company, provided that the terms of office and employment are in accordance with the company’s compensation policy. 93 Directors .
However, if the shareholders do not approve a compensation arrangement with an executive officer that is inconsistent with the company’s compensation policy, a company’s compensation committee and board of directors, may, in special circumstances approve the compensation despite shareholder objection, provided that the compensation committee and thereafter the board of directors have determined to approve the compensation based on detailed reasoning, after each having re- discussed the terms of compensation, and after examining the objection of the shareholders. • Chief Executive Officer .
However, if the shareholders do not approve a compensation arrangement with an executive officer that is inconsistent with the company’s compensation policy, a company’s compensation committee and board of directors, may, in special circumstances approve the compensation despite shareholder objection, provided that the compensation committee and thereafter the board of directors have determined to approve the compensation based on detailed reasoning, after each having re- discussed the terms of compensation, and after examining the objection of the shareholders.
Zeevi also served as a certified public accountant at Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited. Ms. Zeevi is a certified public accountant and holds a B.A. degree in business and accountancy from the College of Management Academic Studies in Israel. Ella Sorani, Ph.D., has served as our Chief Development Officer since January 2021.
Zeevi also served as a certified public accountant at Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited. Ms. Zeevi is a certified public accountant and holds a B.A. degree in business and accountancy from the College of Management Academic Studies in Israel. 80 Ella Sorani, Ph.D., has served as our Chief Development Officer since January 2021.
Molcho holds an M.D. from Tel Aviv University School of Medicine and an MBA degree from Tel-Aviv University Recanati Business School. 72 Sandra Panem, Ph.D., has served on our board of directors since February 2014 and on our Investment Monitoring Committee since 2010. Dr. Panem served as a managing partner at Cross Atlantic Partners, from 2000 2023. Dr.
Molcho holds an M.D. from Tel Aviv University School of Medicine and an MBA degree from Tel-Aviv University Recanati Business School. Sandra Panem, Ph.D., has served on our board of directors since February 2014 and on our Investment Monitoring Committee since 2010. Dr. Panem served as a managing partner at Cross Atlantic Partners, from 2000 2023. Dr.
See “— Approval of Related Party Transactions under Israeli Law.” Compensation Committee In accordance with the Relief Regulations described above, on March 25, 2024, our board of directors elected to “opt out” from the Companies Law requirement to appoint external directors and related rules concerning the composition of the audit committee and compensation committee, effective immediately.
See “- Approval of Related Party Transactions under Israeli Law.” 87 Compensation Committee In accordance with the Relief Regulations described above, on March 25, 2024, our board of directors elected to “opt out” from the Companies Law requirement to appoint external directors and related rules concerning the composition of the audit committee and compensation committee, effective immediately.
Sorani led the development of one of Teva’s leading innovative late-stage compounds. Dr. Sorani holds a B.Sc. degree in chemistry and an M.Sc. degree and Ph.D. in pharmacology, all from Tel Aviv University. 71 Aharon Schwartz, Ph.D., has served as the Chairman of our board of directors since 2004. Dr.
Sorani led the development of one of Teva’s leading innovative late-stage compounds. Dr. Sorani holds a B.Sc. degree in chemistry and an M.Sc. degree and Ph.D. in pharmacology, all from Tel Aviv University. Aharon Schwartz, Ph.D., has served as the Chairman of our board of directors since 2004. Dr.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is good. 86 E. Share Ownership See “Item 7.A. Major Shareholders” below. Equity Compensation Plan 2003 Amended and Restated Share Incentive Plan In 2003, we adopted the BioLineRx Ltd. 2003 Share Incentive Plan, or the Plan.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is good. E. Share Ownership See “Item 7.A. Major Shareholders” below. Equity Compensation Plan 2003 Amended and Restated Share Incentive Plan In 2003, we adopted the BioLineRx Ltd. 2003 Share Incentive Plan, or the Plan.
Dr. Hofstein has served as the President and Chief Executive Officer of MaRS Innovation (a commercialization company for 15 of Toronto’s universities, institutions and research institutes plus the MaRS Discovery District) from June 2009 to March 2020. From 2000 through June 2009, Dr.
Dr. Hofstein served as the President and Chief Executive Officer of MaRS Innovation (a commercialization company for 15 of Toronto’s universities, institutions and research institutes plus the MaRS Discovery District) from June 2009 to March 2020. From 2000 through June 2009, Dr.
Major Shareholders and Related Party Transactions - Related Party Transactions - Gloria License Agreement and Securities Purchase Agreement.” Gal Cohen, MBA, has served on our board of directors since December 2023. Mr.
Major Shareholders and Related Party Transactions - Related Party Transactions - Gloria License Agreement and Securities Purchase Agreement.” 82 Gal Cohen, MBA, has served on our board of directors since December 2023. Mr.
In addition to the foregoing, our board of directors has approved the inclusion in the option agreements of the Company’s officers of a provision for accelerated vesting of options if both a change of control of the Company occurs and, following such change of control, the officer’s employment is terminated or there is a significant demotion in the officer’s new job or position. 87 F.
In addition to the foregoing, our board of directors has approved the inclusion in the option agreements of the Company’s officers of a provision for accelerated vesting of options if both a change of control of the Company occurs and, following such change of control, the officer’s employment is terminated or there is a significant demotion in the officer’s new job or position.
Schwartz. 74 For information concerning our equity compensation plan, see “— Beneficial Ownership of Executive Officers and Directors — Equity Compensation Plan . ” There are currently no arrangements or understandings between us, on the one hand, and any of our directors, on the other hand, providing for benefits upon termination of their service as directors of our Company. C.
Schwartz. 84 For information concerning our equity compensation plan, see “- Beneficial Ownership of Executive Officers and Directors - Equity Compensation Plan . ” There are currently no arrangements or understandings between us, on the one hand, and any of our directors, on the other hand, providing for benefits upon termination of their service as directors of our Company. C.
See “Item 6.C — Directors, Senior Management and Employees — Board Practices — Exculpation, insurance and indemnification of office holders.” Compensation of Directors and Senior Management The following table presents in the aggregate all compensation we paid to all of our directors and senior management as a group for the year ended December 31, 2024.
See “Item 6.C - Directors, Senior Management and Employees - Board Practices - Exculpation, insurance and indemnification of office holders.” Compensation of Directors and Senior Management The following table presents in the aggregate all compensation we paid to all of our directors and senior management as a group for the year ended December 31, 2025.
Raphael Hofstein, will hold office until our annual general meeting of shareholders to be held in 2025; and • the Class III directors, consisting of Dr. Sandra Panem, Dr. Aharon Schwartz and Dr. Shaoyu Yan, will hold office until our annual general meeting of shareholders to be held in 2026.
Raphael Hofstein, will hold office until our annual general meeting of shareholders to be held in 2028; and • the Class III directors, consisting of Dr. Sandra Panem, Dr. Aharon Schwartz and Dr. Shaoyu Yan, will hold office until our annual general meeting of shareholders to be held in 2026.
All amounts reported reflect the cost to the Company as recognized in our financial statements for the year ended December 31, 2024. Name and Position Salary Social Benefits (1) Bonuses (2) Value of Share-Based Compensation (3) All Other Compensation (4) Total (in thousands of U.S. dollars) Philip A.
All amounts reported reflect the cost to the Company as recognized in our financial statements for the year ended December 31, 2025. Name and Position Salary (1) Social Benefits (2) Bonuses (3) Value of Share-Based Compensation (4) All Other Compensation (5) Total (in thousands of U.S. dollars) Philip A.
Molcho served as the Chief Executive Officer and Chairman of Neovasc Medical, a privately-held Israeli medical device company. From 2006 until 2019, Dr. Molcho was a venture partner at Forbion Capital Partners, a Dutch life sciences venture capital firm. From 2001 through 2006, Dr.
Molcho served as Ayana’s Chief Executive Officer and director until 2019. From 2006 through 2008, Dr. Molcho served as the Chief Executive Officer and Chairman of Neovasc Medical, a privately-held Israeli medical device company. From 2006 until 2019, Dr. Molcho was a venture partner at Forbion Capital Partners, a Dutch life sciences venture capital firm. From 2001 through 2006, Dr.
The Nasdaq Rules require us to establish an audit committee comprised of at least three members, all of whom must be independent directors under the respective “independence” requirements of the SEC and Nasdaq, each of whom is financially literate and one of whom has accounting or related financial management expertise at senior levels within a company. 76 Our Audit Committee is currently comprised of Mr.
The Nasdaq Rules require us to establish an audit committee comprised of at least three members, all of whom must be independent directors under the respective “independence” requirements of the SEC and Nasdaq, each of whom is financially literate and one of whom has accounting or related financial management expertise at senior levels within a company.
Rami Dar, Dr. Avraham Molcho and Dr. Raphael Hofstein. Mr. Rami Dar serves as the Chairperson of the Audit Committee. Our board of directors has determined that Mr. Rami Dar (Chairperson) qualifies as an audit committee financial expert as defined by the rules of the SEC and Nasdaq.
Our Audit Committee is currently comprised of Mr. Rami Dar, Dr. Avraham Molcho and Dr. Raphael Hofstein. Mr. Rami Dar serves as the Chairperson of the Audit Committee. Our board of directors has determined that Mr. Rami Dar (Chairperson) qualifies as an audit committee financial expert as defined by the rules of the SEC and Nasdaq.
The terms of such agreements are consistent with the provisions of our Compensation Policy that was approved by our shareholders in July 2022. However, in the opinion of the SEC, indemnification of office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.
The terms of such agreements are consistent with the provisions of our Compensation Policy that was approved by our shareholders in June 2025. However, in the opinion of the SEC, indemnification of office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Executive Officers and Directors The following table sets forth information for our executive officers and directors as of March 16, 2025. Unless otherwise stated, the address for our directors and officers is c/o BioLineRx Ltd., 2 HaMa’ayan Street, Modi’in 7177871, Israel. Name Age Position(s) Philip A.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Executive Officers and Directors The following table sets forth information for our executive officers and directors as of March 8, 2026. Unless otherwise stated, the address for our directors and officers is c/o BioLineRx Ltd., 2 HaMa’ayan Street, Modi’in 7177871, Israel. 79 Name Age Position(s) Philip A.
Disclosure of a registrant’s action to recover erroneously awarded compensation. There was no erroneously awarded compensation that was required to be recovered pursuant to the BioLineRx Ltd. Executive Officer Clawback Policy during the fiscal year ended December 31, 2024.
F. Disclosure of a registrant’s action to recover erroneously awarded compensation. There was no erroneously awarded compensation that was required to be recovered pursuant to the BioLineRx Ltd. Executive Officer Clawback Policy during the fiscal year ended December 31, 2025. 100
If a majority of the directors have a personal interest in the matter, such matter also requires approval of the shareholders of the company. 81 Approval of transactions with officer holders Under the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder or with a third party in which the office holder has a personal interest that is not an extraordinary transaction and an action of an office holder that would otherwise be deemed a breach of duty of loyalty that may have a material impact on a company’s profitability, assets or liabilities, requires approval by the board of directors.
Approval of transactions with officer holders Under the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder or with a third party in which the office holder has a personal interest that is not an extraordinary transaction and an action of an office holder that would otherwise be deemed a breach of duty of loyalty that may have a material impact on a company’s profitability, assets or liabilities, requires approval by the board of directors.
Our office holders are currently covered by a directors’ and officers’ liability insurance policy. The terms of such directors’ and officers’ insurance are consistent with the provisions of our current Compensation Policy that was approved by our shareholders in July 2022.
Our office holders are currently covered by a directors’ and officers’ liability insurance policy. The terms of such directors’ and officers’ insurance are consistent with the provisions of our current Compensation Policy that was approved by our shareholders in June 2025.
December 31, 2022 2023 2024 Management and administration 12 12 8 Research and development 29 29 19 Commercialization and business development 8 38 1 Total 49 79 28 While none of our employees are party to any collective bargaining agreements, in Israel we are subject to certain labor statutes and national labor court precedent rulings, as well as to certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations and/or the Industrialists’ Association which are applicable to our employees by virtue of expansion orders issued in accordance with relevant labor laws by the Israel Ministry of Labor and Welfare, and which apply such agreement provisions to our employees even though they are not directly part of a union that has signed a collective bargaining agreement.
Of our employees, 10 hold M.D. or Ph.D. degrees. 98 December 31, 2023 2024 2025 Management and administration 12 8 7 Research and development 29 19 17 Commercialization and business development 38 1 - Total 79 28 24 While none of our employees are party to any collective bargaining agreements, in Israel we are subject to certain labor statutes and national labor court precedent rulings, as well as to certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations and/or the Industrialists’ Association which are applicable to our employees by virtue of expansion orders issued in accordance with relevant labor laws by the Israel Ministry of Labor and Welfare, and which apply such agreement provisions to our employees even though they are not directly part of a union that has signed a collective bargaining agreement.
Compensation Directors and Officer Agreements We have entered into written employment agreements with each of our executive officers, the terms of which are consistent with the provisions of our Compensation Policy for Executives and Directors, or Compensation Policy, which was approved by our shareholders in July 2022.
Compensation Directors and Officer Agreements We have entered into written employment agreements with each of our executive officers, the terms of which are consistent with the provisions of our Compensation Policy for Executives and Directors, or Compensation Policy, which was approved most recently by our shareholders in June 2025.
However, the enforceability of the noncompetition provisions may be limited under applicable law. 73 In addition, we have entered into agreements with each executive officer and director exculpating them, to the fullest extent permitted by law, from liability to us for damages caused to us as a result of a breach of duty of care, and undertaking to indemnify each of them to the fullest extent permitted by law, to the extent that these liabilities are not covered by directors’ and officers’ liability insurance.
In addition, we have entered into agreements with each executive officer and director exculpating them, to the fullest extent permitted by law, from liability to us for damages caused to us as a result of a breach of duty of care, and undertaking to indemnify each of them to the fullest extent permitted by law, to the extent that these liabilities are not covered by directors’ and officers’ liability insurance.
(LLB, LLM), a director at Deloitte Israel. Fiduciary Duties and Approval of Related Party Transactions under Israeli Law Fiduciary duties of office holders The Companies Law imposes a duty of care and a duty of loyalty on all office holders of a company.
Fiduciary Duties and Approval of Related Party Transactions under Israeli Law Fiduciary duties of office holders The Companies Law imposes a duty of care and a duty of loyalty on all office holders of a company.
(1)(2)(3) 75 Class II Director Avraham Molcho, M.D. (1)(2)(3) 67 Class I Director Sandra Panem, Ph.D. (1)(4) 78 Class III Director Shaoyu Yan, Ph.D. 60 Class III Director Gal Cohen (1) 52 Class I Director (1) Independent director under applicable Nasdaq Capital Market, as affirmatively determined by our board of directors. (2) A member of our audit committee.
(1)(2)(3) 76 Class II Director Avraham Molcho, M.D. (1)(2)(3) 68 Class I Director Sandra Panem, Ph.D. (1)(4) 79 Class III Director Shaoyu Yan, Ph.D. 61 Class III Director Gal Cohen (1) 53 Class I Director (1) Independent director under applicable Nasdaq Capital Market, as affirmatively determined by our board of directors. (2) A member of our audit committee.
Pursuant to regulations promulgated under the Israeli Companies Law, certain transactions, including with respect to compensation, with a controlling shareholder or his or her relative, or with directors or other office holders, that would otherwise require approval of a company’s shareholders may be exempt from shareholder approval under certain conditions. 83 Approval of Significant Private Placements Under the Companies Law, a significant private placement of securities requires approval by the board of directors and the shareholders by a simple majority.
Pursuant to regulations promulgated under the Israeli Companies Law, certain transactions, including with respect to compensation, with a controlling shareholder or his or her relative, or with directors or other office holders, that would otherwise require approval of a company’s shareholders may be exempt from shareholder approval under certain conditions.
A director who has a personal interest in a matter that is considered at a meeting of the board of directors or the audit committee may generally not be present at the meeting or vote on the matter unless a majority of the directors or members of the audit committee have a personal interest in the matter, or, unless the chairman of the audit committee or board of directors (as applicable) determines that he or she should be present to present the transaction that is subject to approval.
However, a company may not approve a transaction or action that is adverse to the company’s interest or that is not performed by the office holder in good faith. 92 A director who has a personal interest in a matter that is considered at a meeting of the board of directors or the audit committee may generally not be present at the meeting or vote on the matter unless a majority of the directors or members of the audit committee have a personal interest in the matter, or, unless the chairman of the audit committee or board of directors (as applicable) determines that he or she should be present to present the transaction that is subject to approval.
The shareholder approval must meet one of the following requirements: • at least a majority of the shares held by shareholders who have no personal interest in the matter who are present and voting at the meeting must be voted in favor of approving the transaction, excluding abstentions; or • the shares voted by shareholders who have no personal interest in the matter who are present and vote against the transaction represent no more than 2% of the voting rights in the company.
The shareholder approval must meet one of the following requirements: • at least a majority of the shares held by shareholders who have no personal interest in the matter who are present and voting at the meeting must be voted in favor of approving the transaction, excluding abstentions; or • the shares voted by shareholders who have no personal interest in the matter who are present and vote against the transaction represent no more than 2% of the voting rights in the company. 94 The terms of service and employment of a controlling shareholder approved by the compensation committee and board of directors shall be in accordance with the compensation policy of the company.
Under the Relief Regulations, the exemption from such Companies Law requirements will continue to be available to us so long as: (i) we do not have a “controlling shareholder” (as such term is defined under the Companies Law), (ii) our shares are traded on an exchange outside Israel or dual listed on the TASE and certain foreign stock exchanges, including the Nasdaq, and (iii) we comply with the director independence requirements and the audit committee and compensation committee composition requirements under U.S. laws (including applicable Nasdaq Rules) applicable to U.S. domestic issuers.
Under the Relief Regulations, the exemption from such Companies Law requirements will continue to be available to us so long as: (i) we do not have a “controlling shareholder” (as such term is defined under the Companies Law), (ii) our shares are traded on an exchange outside Israel or dual listed on the TASE and certain foreign stock exchanges, including the Nasdaq, and (iii) we comply with the director independence requirements and the audit committee and compensation committee composition requirements under U.S. laws (including applicable Nasdaq Rules) applicable to U.S. domestic issuers. 86 Audit Committee In accordance with the Relief Regulations described above, on March 25, 2024, our board of directors elected to “opt out” from the Companies Law requirement to appoint external directors and related rules concerning the composition of the audit committee and compensation committee, effective immediately.
An Israeli company may insure an office holder against the following liabilities incurred for acts performed as an office holder if and to the extent provided in the company’s articles of association: • a breach of duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; • a breach of duty of care to the company or to a third party, including a breach arising out of the negligent (but not intentional or reckless) conduct of the office holder; • a financial liability imposed on the office holder in favor of a third party; • a monetary liability imposed on the office holder in favor of an injured party in an Administrative Procedure pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; and • expenses, including reasonable litigation expenses and reasonable attorneys’ fees, incurred by an office holder in connection with an Administrative Procedure instituted against him or her pursuant to certain provisions of the Israeli Securities Law.
An Israeli company may insure an office holder against the following liabilities incurred for acts performed as an office holder if and to the extent provided in the company’s articles of association: • a breach of duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; • a breach of duty of care to the company or to a third party, including a breach arising out of the negligent (but not intentional or reckless) conduct of the office holder; • a financial liability imposed on the office holder in favor of a third party; • a monetary liability imposed on the office holder in favor of an injured party in an Administrative Procedure pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; and • expenses, including reasonable litigation expenses and reasonable attorneys’ fees, incurred by an office holder in connection with an Administrative Procedure instituted against him or her pursuant to certain provisions of the Israeli Securities Law. 97 An Israeli company may not indemnify, exculpate or insure an office holder against any of the following, and any provision in a company’s articles of association which allows for any of the following is invalid: • a breach of duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; • a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder; • an act or omission committed with intent to derive illegal personal benefit; or • a fine, monetary sanction or forfeit levied against the office holder.
Serlin, CPA, MBA 64 Chief Executive Officer Mali Zeevi, CPA 49 Chief Financial Officer Ella Sorani, Ph.D. 57 Chief Development Officer Aharon Schwartz, Ph.D. (1) 82 Chairman of the Board of Directors, Class III Director Rami Dar, MBA (1)(2)(3)(4) 68 Class I Director B.J. Bormann, Ph.D. (1)(3) 66 Class II Director Raphael Hofstein, Ph.D.
Serlin, CPA, MBA 65 Chief Executive Officer Mali Zeevi, CPA 50 Chief Financial Officer Ella Sorani, Ph.D. 58 Chief Development Officer Aharon Schwartz, Ph.D. (1) 83 Chairman of the Board of Directors, Class III Director Rami Dar, MBA (1)(2)(3)(4) 69 Class I Director B.J. Bormann, Ph.D. (1)(3) 67 Class II Director Raphael Hofstein, Ph.D.
The role of the internal auditor is to examine, among other things, our compliance with applicable law and orderly business procedures. The audit committee is required to oversee the activities and to assess the performance of the internal auditor as well as to approve the internal auditor’s work plan. Our internal auditor is Tali Yaron Adv.
The role of the internal auditor is to examine, among other things, our compliance with applicable law and orderly business procedures. The audit committee is required to oversee the activities and to assess the performance of the internal auditor as well as to approve the internal auditor’s work plan. Our internal auditor is Dana Gottesman-Erlich, a partner at BDO Israel.
The board of directors’ satisfaction with the officer’s performance will also affect the bonus amount. Annual bonus payments are subject to the limitations set out in the Compensation Policy and are also subject to the discretion of our Compensation Committee and approval by the board of directors.
Annual bonus payments are subject to the limitations set out in the Compensation Policy and are also subject to the discretion of our Compensation Committee and approval by the board of directors.
Our board of directors has determined that each member of our compensation committee is independent under the Nasdaq Rules, including the additional independence requirements applicable to the members of a compensation committee. 77 The responsibilities of the compensation committee include the following: • to make recommendations to the board of directors for its approval of (i) a compensation policy for office holders, (ii) once every three years whether to extend the then current compensation policy (approval of either a new compensation policy or the continuation of an existing compensation policy must, in any case, occur every three years); and (iii) periodic updates to the compensation policy which may be required from time to time.
The responsibilities of the compensation committee include the following: • to make recommendations to the board of directors for its approval of (i) a compensation policy for office holders, (ii) once every three years whether to extend the then current compensation policy (approval of either a new compensation policy or the continuation of an existing compensation policy must, in any case, occur every three years); and (iii) periodic updates to the compensation policy which may be required from time to time.
The duty of care includes a duty to use reasonable means, in light of the circumstances, to obtain: • information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and • all other important information pertaining to these actions. 80 The duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes the duty to: • refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or personal affairs; • refrain from any activity that is competitive with the business of the company; • refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others; and • disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
The duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes the duty to: • refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or personal affairs; • refrain from any activity that is competitive with the business of the company; • refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others; and • disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
Hofstein received his Ph.D. and M.Sc. degree from the Weizmann Institute of Science, and his B.Sc. degree in chemistry and physics from the Hebrew University of Jerusalem. Dr. Hofstein completed postdoctoral training at Harvard Medical School in both the departments of biological chemistry and neurobiology.
Hofstein received his Ph.D. and M.Sc. degree from the Weizmann Institute of Science, and his B.Sc. degree in chemistry and physics from the Hebrew University of Jerusalem. Dr.
In all events, the weight of all the variable components (out of the total compensation amount which is to be granted for any year) will not be greater than 80% for each office holder and may vary from one office holder to the other. 79 According to the Companies Law, our Compensation Policy provides that in the event of an accounting restatement, we shall be entitled to recover from office holders’ bonus compensation granted, earned or vested based on a pre-accounting restatement of our financial results in the amount of the excess over what would have been paid under the accounting restatement, with a three-year look-back period.
According to the Companies Law, our Compensation Policy provides that in the event of an accounting restatement, we shall be entitled to recover from office holders’ bonus compensation granted, earned or vested based on a pre-accounting restatement of our financial results in the amount of the excess over what would have been paid under the accounting restatement, with a three-year look-back period.
Avraham Molcho, M.D., has served on our board of directors since 2010 (as an external director, within the meaning of the Companies Law, until March 25, 2024) and on our Audit Committee since 2010. In addition, Dr. Molcho has served on our Compensation Committee since 2012. Dr.
Hofstein completed postdoctoral training at Harvard Medical School in both the departments of biological chemistry and neurobiology. 81 Avraham Molcho, M.D., has served on our board of directors since 2010 (as an external director, within the meaning of the Companies Law, until March 25, 2024) and on our Audit Committee since 2010. In addition, Dr.
Approval of terms of the compensation of directors of a company which do not comply with the compensation policy may nonetheless be approved, in special circumstances, subject to two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect to a compensation policy and (ii) the shareholders of the company have approved the terms by means of the Special Majority for Compensation. 82 With respect to compensation of an officer (including a chief executive officer) or director who is also a controlling shareholder, see “— Disclosure of personal interests of a controlling shareholder and approval of transactions .” Disclosure of personal interests of a controlling shareholder and approval of certain transactions Under the Companies Law, the disclosure requirements that apply to an office holder also apply to a controlling shareholder of a public company.
Approval of terms of the compensation of directors of a company which do not comply with the compensation policy may nonetheless be approved, in special circumstances, subject to two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect to a compensation policy and (ii) the shareholders of the company have approved the terms by means of the Special Majority for Compensation.
Molcho is the co-founder of Biolojic Design Ltd., a technology platform that encourages human antibody discovery. In 2012, Dr. Molcho became the co-founder of Ayana Pharma Ltd. (formerly DoxoCure), a privately-held company engaged in the manufacturing of liposome-based therapeutics. Dr. Molcho served as Ayana’s Chief Executive Officer and director until 2019. From 2006 through 2008, Dr.
Molcho has served on our Compensation Committee since 2012. Dr. Molcho is the co-founder of Biolojic Design Ltd., a technology platform that encourages human antibody discovery. In 2012, Dr. Molcho became the co-founder of Ayana Pharma Ltd. (formerly DoxoCure), a privately-held company engaged in the manufacturing of liposome-based therapeutics. Dr.
At the company level, we analyze the overall compensation trends of the market in order to make informed decisions about our compensation approach. 78 According to the Compensation Policy, the fixed components of our office holder compensation will be examined at least every two years and compared to the market.
According to the Compensation Policy, the fixed components of our office holder compensation will be examined at least every two years and compared to the market.
All of these agreements contain customary provisions regarding noncompetition, confidentiality of information and assignment of inventions.
All of these agreements contain customary provisions regarding noncompetition, confidentiality of information and assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable law.
Salaries, fees, commissions and bonuses Pension, retirement, options and other similar benefits (in thousands of U.S. dollars) All directors and senior management as a group, consisting of 13 persons 1,912 899 The following table presents information regarding the compensation costs of our four executive officers in the year ended December 31, 2024.
The table does not include any amounts we paid to reimburse any such persons for costs incurred in providing us with services during this period. 83 Salaries, fees, commissions and bonuses Pension, retirement, options and other similar benefits (in thousands of U.S. dollars) All directors and senior management as a group, consisting of 13 persons 1,295 577 The following table presents information regarding the compensation costs of our three executive officers in the year ended December 31, 2025.
To strengthen the alignment of shareholder interests and the interests of management and employees, performance measurements reflect our actual results overall, as well as that of the individual office holder. To support the aforementioned principles, we provide two types of variable compensation: short-term - annual bonuses; and long-term - equity compensation.
To strengthen the alignment of shareholder interests and the interests of management and employees, performance measurements reflect our actual results overall, as well as that of the individual office holder.
In addition, our board of directors may appoint directors (other than external directors) to fill vacancies on our board of directors, including if the number of directors is below the maximum number of directors who may serve as provided in our Articles of Association, for a term of office equal to the remaining period of the term of office of the director(s) whose office(s) has been vacated, or in case of a vacancy due to the number of directors serving being less than the maximum number stated in our Articles of Association, until the next annual general meeting of our shareholders for the class he or she has been assigned by our board of directors. 75 Under the Companies Law, our board of directors must determine the minimum number of directors who are required to have financial and accounting expertise.
In accordance with the exemption available to foreign private issuers under applicable Nasdaq Rules, we do not follow the requirements of the Nasdaq Rules with regard to the process of nominating directors, and instead follow Israeli law and practice, in accordance with which our board of directors is authorized to recommend to our shareholders director nominees for election, and, in some circumstances, our shareholders may nominate candidates for election as directors by the shareholders’ general meeting. 85 In addition, our board of directors may appoint directors (other than external directors) to fill vacancies on our board of directors, including if the number of directors is below the maximum number of directors who may serve as provided in our Articles of Association, for a term of office equal to the remaining period of the term of office of the director(s) whose office(s) has been vacated, or in case of a vacancy due to the number of directors serving being less than the maximum number stated in our Articles of Association, until the next annual general meeting of our shareholders for the class he or she has been assigned by our board of directors.
Investment Monitoring Committee Our board of directors has established an Investment Monitoring Committee which currently consists of the following three members: our directors Dr. Sandra Panem (Chairperson) and Mr. Rami Dar; Ms. Mali Zeevi, our Chief Financial Officer; and Mr. Raziel Fried, our Treasurer and Budgetary Control Director.
Sandra Panem (Chairperson) and Mr. Rami Dar; Ms. Mali Zeevi, our Chief Financial Officer; and Mr. Raziel Fried, our Treasurer and Budgetary Control Director. The role of the Investment Monitoring Committee includes providing recommendations to our board of directors regarding investment guidelines and performing an on-going review of the fulfillment of established investment guidelines.
Consequently, our Compensation Committee and board of directors should be able to judge the suitability of a bonus payment by deliberating retrospectively at year end and comparing actual performance and target achievements against the forecasted operating plan. The annual bonus mechanism will be directly tied to meeting objectives - both our business objectives and the office holder’s personal objectives.
The operating plan encompasses all aspects of our activities and as such sets the business targets for each member of the management team. Consequently, our Compensation Committee and board of directors should be able to judge the suitability of a bonus payment by deliberating retrospectively at year end and comparing actual performance and target achievements against the forecasted operating plan.
Compensation is considered performance-based to the extent that a direct link is maintained between compensation and performance and that rewards are consistent with long-term stakeholder value creation.
Compensation is considered performance-based to the extent that a direct link is maintained between compensation and performance and that rewards are consistent with long-term stakeholder value creation. At the company level, we analyze the overall compensation trends of the market in order to make informed decisions about our compensation approach.
The Plan provides for equity grants to be made at the determination of our board of directors in accordance with applicable law. As of March 16, 2025, options to purchase 107,746,200 ordinary shares or 179,577 ADSs, an aggregate 13,832,400 PSUs or 23,054 ADSs and an aggregate of 9,588,600 RSUs or 15,981 ADSs were outstanding under the Plan.
The Plan provides for equity grants to be made at the determination of our board of directors in accordance with applicable law. As of March 8, 2026, options to purchase 264,303,600 ordinary shares or 440,506 ADSs, an aggregate 29,366,400 PSUs or 48,944 ADSs and an aggregate of 32,623,200 RSUs or 54,372 ADSs were outstanding under the Plan.
D. Employees As of March 16, 2025, we had 24 full-time employees and 4 part-time employees, all of whom are employed in Israel. Of our employees, 11 hold M.D. or Ph.D. degrees.
D. Employees As of March 8, 2026, we had 20 full-time employees and 4 part-time employees, all of whom are employed in Israel.
From time to time, our board of directors has approved an increase in the number of shares reserved for the purpose of equity grants pursuant to the Plan. As of March 16, 2025, 68.9 million ordinary shares, or 0.1 million ADSs, were reserved for future issuance under the Plan.
From time to time, our board of directors has approved an increase in the number of shares reserved for the purpose of equity grants pursuant to the Plan.
The Plan is administered by our board of directors for the purposes of making equity grants and approving the terms of those grants, including, exercise price (in the case of options), vesting schedule, acceleration of vesting and the other matters necessary in the administration of the Plan.
As of March 8, 2026, 233,830,200 million ordinary shares, which may be represented by 0.4 million ADSs, were reserved for future issuance under the Plan. 99 The Plan is administered by our board of directors for the purposes of making equity grants and approving the terms of those grants, including, exercise price (in the case of options), vesting schedule, acceleration of vesting and the other matters necessary in the administration of the Plan.
However, the compensation recovery will not be triggered in the event of a financial restatement required due to changes in applicable financial reporting standards. In addition, in November 2023 we adopted an Executive Officer Clawback Policy in accordance with the rules of the SEC and Nasdaq.
However, the compensation recovery will not be triggered in the event of a financial restatement required due to changes in applicable financial reporting standards.
Our current Compensation Policy was approved at the annual general meeting of our shareholders held in 2022.
Our current Compensation Policy was approved at the annual general meeting of our shareholders held in June 2025, and may be in effect for up to three years.
Internal Auditor Under the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor recommended by the audit committee and nominated by the board of directors.
The Investment Monitoring Committee convenes for meetings in accordance with our needs, but in any event at least twice per year. Internal Auditor Under the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor recommended by the audit committee and nominated by the board of directors.
All compensation arrangements of office holders are to be approved in the manner prescribed by applicable law. Our Compensation Committee will review the Compensation Policy on an annual basis, and monitor its implementation, and recommend to our board of directors and shareholders to amend the Compensation Policy as it deems necessary from time to time.
Our Compensation Committee will review the Compensation Policy on an annual basis, and monitor its implementation, and recommend to our board of directors and shareholders to amend the Compensation Policy as it deems necessary from time to time. 90 Investment Monitoring Committee Our board of directors has established an Investment Monitoring Committee which currently consists of the following four members: our directors Dr.
Annual bonuses are based on achievement of the business goals set out in our annual operating plan approved by the board of directors at the beginning of each year. The operating plan encompasses all aspects of our activities and as such sets the business targets for each member of the management team.
To support the aforementioned principles, we provide two types of variable compensation: short-term - annual bonuses; and long-term - equity compensation. 89 Annual bonuses are based on achievement of the business goals set out in our annual operating plan approved by the board of directors at the beginning of each year.
(4) “All Other Compensation” includes automobile-related expenses pursuant to the Company’s automobile leasing program, telephone, basic health insurance and holiday presents, as well as termination benefits to Ms. May.
(4) Consists of amounts recognized as share-based compensation expense on the Company’s statement of comprehensive loss for the year ended December 31, 2025. (5) “All Other Compensation” includes automobile-related expenses pursuant to the Company’s automobile leasing program, telephone, basic health insurance and holiday presents.
This duty of care requires an office holder to act with the degree of care with which a reasonable office holder in the same position would have acted under the same circumstances.
This duty of care requires an office holder to act with the degree of care with which a reasonable office holder in the same position would have acted under the same circumstances. 91 The duty of care includes a duty to use reasonable means, in light of the circumstances, to obtain: • information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and • all other important information pertaining to these actions.
May ceased to serve as President of BioLineRx USA, Inc. on December 31, 2024. (1) “Social Benefits” include payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds, vacation pay and recuperation pay as mandated by Israeli law. (2) With the exception of Ms.
(2) “Social Benefits” include payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds, vacation pay and recuperation pay as mandated by Israeli law. (3) Does not include annual bonuses for 2025, which remain subject to the approval of the Company’s compensation committee and board of directors.
For the year ended December 31, 2024, we recorded $62,300 on account of cash compensation paid to the Chairman of our Board of Directors, Dr. Aharon Schwartz, and a $6,400 equity-based compensation expense for equity-based compensation granted to Dr.
During the first three quarters of 2025, directors’ fees were reduced by 25% at the directors’ initiative; the directors’ fees were reinstated to their prior levels effective as of the fourth quarter of 2025. For the year ended December 31, 2025, we recorded $45,000 on account of cash compensation paid to the Chairman of our Board of Directors, Dr.
Removed
The table does not include any amounts we paid to reimburse any such persons for costs incurred in providing us with services during this period.
Added
Serlin Chief Executive Officer 296 93 148 81 23 641 Mali Zeevi Chief Financial Officer 195 57 73 12 23 360 Ella Sorani Chief Development Officer 221 59 83 12 23 397 (1) Amounts shown for 2025 reflect a 10% base salary reduction agreed to by management during the first three quarters of 2025; base salaries were reinstated to their prior levels effective as of the fourth quarter of 2025.
Removed
Serlin Chief Executive Officer 296 109 74 265 20 764 Mali Zeevi Chief Financial Officer 195 59 49 32 22 357 Ella Sorani Chief Development Officer 221 54 - 32 20 328 Holly W. May Former President of BioLineRx USA, Inc.* 440 61 226 - 220 947 * Ms.
Added
Aharon Schwartz, and a $98,000 equity-based compensation expense for equity-based compensation granted to Dr.
Removed
May, does not include annual bonuses for 2024, which remain subject to the approval of the Company’s compensation committee and board of directors. (3) Consists of amounts recognized as share-based compensation expense on the Company’s statement of comprehensive loss for the year ended December 31, 2024.
Added
Under the Companies Law, our board of directors must determine the minimum number of directors who are required to have financial and accounting expertise.
Removed
In accordance with the exemption available to foreign private issuers under applicable Nasdaq Rules, we do not follow the requirements of the Nasdaq Rules with regard to the process of nominating directors, and instead follow Israeli law and practice, in accordance with which our board of directors is authorized to recommend to our shareholders director nominees for election, and, in some circumstances, our shareholders may nominate candidates for election as directors by the shareholders’ general meeting.
Added
Our board of directors has determined that each member of our compensation committee is independent under the Nasdaq Rules, including the additional independence requirements applicable to the members of a compensation committee.
Removed
Audit Committee In accordance with the Relief Regulations described above, on March 25, 2024, our board of directors elected to “opt out” from the Companies Law requirement to appoint external directors and related rules concerning the composition of the audit committee and compensation committee, effective immediately.
Added
The annual bonus mechanism will be directly tied to meeting objectives - both our business objectives and the office holder’s personal objectives. The board of directors’ satisfaction with the officer’s performance will also affect the bonus amount.
Removed
The role of the Investment Monitoring Committee includes providing recommendations to our board of directors regarding investment guidelines and performing an on-going review of the fulfillment of established investment guidelines. The Investment Monitoring Committee convenes for meetings in accordance with our needs, but in any event at least twice per year.
Added
In all events, the weight of all the variable components (out of the total compensation amount which is to be granted for any year) will not be greater than 80% for each office holder and may vary from one office holder to the other.

… 8 more changes not shown on this page.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

25 edited+0 added−4 removed11 unchanged
C — Directors, Senior Management and Employees — Board Practices — Exculpation, insurance and indemnification of office holders.” 90 Gloria License Agreement and Securities Purchase Agreement On August 27, 2023, we entered into the Gloria License Agreement with HST and Gloria, collectively, the Purchaser Party, pursuant to which we granted HST an exclusive, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide in order to develop and commercialize motixafortide in Asia (other than Israel and certain other countries) and to engage and authorize Gloria to perform services under the Gloria License Agreement in such territory.
C - Directors, Senior Management and Employees - Board Practices - Exculpation, insurance and indemnification of office holders.” Gloria License Agreement and Securities Purchase Agreement On August 27, 2023, we entered into the Gloria License Agreement with HST and Gloria, collectively, the Purchaser Party, pursuant to which we granted HST an exclusive, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide in order to develop and commercialize motixafortide in Asia (other than Israel and certain other countries) and to engage and authorize Gloria to perform services under the Gloria License Agreement in such territory.
Such shares are also deemed outstanding for purposes of computing the percentage ownership of the person holding the option or PSU. They are not, however, deemed to be outstanding and beneficially owned for the purpose of computing the percentage ownership of any other shareholder.
Such shares are also deemed outstanding for purposes of computing the percentage ownership of the person holding the option, RSU or PSU. They are not, however, deemed to be outstanding and beneficially owned for the purpose of computing the percentage ownership of any other shareholder.
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report on Form 20-F, there has been no significant change in the percentage ownership held by any major shareholder since January 1, 2022. None of our shareholders has different voting rights from other shareholders.
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report on Form 20-F, there has been no significant change in the percentage ownership held by any major shareholder since January 1, 2023. None of our shareholders has different voting rights from other shareholders.
Related Party Transactions The following is a description of the material terms of those transactions with related parties to which we, or our subsidiaries, have been a party since January 1, 2024. Agreements with Directors and Officers Employment Agreements We have entered into employment agreements with each of our executive officers. See “Item 6.B.
Related Party Transactions The following is a description of the material terms of those transactions with related parties to which we, or our subsidiaries, have been a party since January 1, 2025. 103 Agreements with Directors and Officers Employment Agreements We have entered into employment agreements with each of our executive officers. See “Item 6.B.
Directors, Senior Management and Employees — Compensation.” Options and Restricted Share Units. We have granted, from time to time, options to purchase our ordinary shares, RSUs and PSUs to our executive officers and directors. We describe our share incentive plan under “Item 6.E.
Directors, Senior Management and Employees - Compensation.” Options, Restricted Share Units and Performance Share Units We have granted, from time to time, options to purchase our ordinary shares, RSUs and PSUs, to our executive officers and directors. We describe our share incentive plan under “Item 6.E. Directors, Senior Management and Employees-Share Ownership-Equity Compensation Plan.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 16, 2025 by: ● each of our directors and senior management; ● all of our directors and senior management as a group; and ● each person (or group of affiliated persons) known by us to be the beneficial owner of 5% or more of the outstanding ordinary shares.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 8, 2026 by: ● each of our directors and senior management; ● all of our directors and senior management as a group; and ● each person (or group of affiliated persons) known by us to be the beneficial owner of 5% or more of the outstanding ordinary shares.
All ordinary shares subject to options currently exercisable or exercisable into ordinary shares within 60 days of March 26, 2025, and underlying restricted stock units, or RSUs, and performance stock units, or PSUs, that shall vest within 60 days of March 26, 2025, are deemed to be outstanding and beneficially owned by the shareholder holding such options or PSUs for the purpose of computing the number of shares beneficially owned by such shareholder.
All ordinary shares subject to options currently exercisable or exercisable into ordinary shares within 60 days of March 18, 2026, and underlying RSUs and PSUs that shall vest within 60 days of March 18, 2026, are deemed to be outstanding and beneficially owned by the shareholder holding such options, RSUs or PSUs for the purpose of computing the number of shares beneficially owned by such shareholder.
Directors, Senior Management and Employees—Share Ownership—Equity Compensation Plan.” Exculpation, Insurance and Indemnification Our Articles of Association and Compensation Policy approved by our shareholders permit us to exculpate, indemnify and insure our directors and office holders to the fullest extent permitted by law.
Exculpation, Insurance and Indemnification Our Articles of Association and Compensation Policy approved by our shareholders permit us to exculpate, indemnify and insure our directors and office holders to the fullest extent permitted by law.
The following table sets forth information regarding the beneficial ownership of our outstanding ordinary shares as of March 16, 2025 of each of our current directors and executive officers individually and as a group. The percentages shown are based on 2,232,601,990 ordinary shares issued and outstanding as of March 26, 2025.
The following table sets forth information regarding the beneficial ownership of our outstanding ordinary shares as of March 18, 2026 of each of our current directors and executive officers individually and as a group. The percentages shown are based on 2,610,814,390 ordinary shares issued and outstanding as of March 18, 2026.
Lepu Medical Technology (Beijing) Co., Ltd. holds 99.95% equity interest of Lepu Medical (Europe) Cooperatief U.A. Lepu Medical Technology (Beijing) Co., Ltd. is a company publicly listed on Shenzhen Stock Exchange in the PRC (300003.SZ). (2) Based on Schedule 13G filed with the SEC on January 10, 2025.
Lepu Medical Technology (Beijing) Co., Ltd. holds 99.95% equity interest of Lepu Medical (Europe) Cooperatief U.A. Lepu Medical Technology (Beijing) Co., Ltd. is a company publicly listed on Shenzhen Stock Exchange in the PRC (300003.SZ).
Number of Ordinary Shares Beneficially Percent of Held Class 5% or Greater Shareholder Hong Seng Technology Limited (1) 102,437,055 4.6 % Intracoastal Capital LLC (2) 102,236,115 4.6 % Directors Aharon Schwartz (3) 6,071,400 * B.J.
Number of Ordinary Shares Beneficially Percent of Held Class 5% or Greater Shareholder Hong Seng Technology Limited (1) 102,437,055 3.9 % Directors Aharon Schwartz (2) 6,981,600 * B.J.
Bormann (4) 2,366,400 * Rami Dar (5) 1,917,600 * Raphael Hofstein (6) 2,366,400 * Avraham Molcho (7) 2,366,400 * Sandra Panem (8) 2,366,400 * Shaoyu Yan - Gal Cohen (9) 342,600 * Executive officers Philip A.
Bormann (3) 3,276,600 * Rami Dar (4) 2,827,800 * Raphael Hofstein (5) 3,276,600 * Avraham Molcho (6) 3,276,600 * Sandra Panem (7) 3,267,600 * Shaoyu Yan - Gal Cohen (8) 1,027,800 * Executive officers Philip A.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (4) Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
(4) Includes 2,827,800 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026. Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (8) Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026. (8) Includes 1,027,800 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026.
As of March 16, 2025, BNY held 1,670,120,400 ordinary shares representing 74.8% of our issued share capital held at that date. Certain of these ordinary shares were held by brokers or other nominees.
As of March 8, 2026, BNY held 1,920,795,000 ordinary shares representing 73.6% of our issued share capital held at that date. Certain of these ordinary shares were held by brokers or other nominees.
Does not include 1,441,200 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 26, 2025. (12) Includes 66,600 ordinary shares and 4,109,400 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 24,570,600 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 18, 2026. (11) Includes 66,600 ordinary shares and 4,631,400 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 18, 2026.
Does not include 1,441,200 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 26, 2025. (13) See footnotes (3)-(12) for certain information regarding beneficial ownership.
Does not include 24,569,400 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 18, 2026. (12) See footnotes (2)-(11) for certain information regarding beneficial ownership.
Serlin (10) 16,166,400 * Mali Zeevi (11) 4,279,200 * Ella Sorani (12) 4,176,000 * All directors and executive officers as a group (11 persons) (13) 42,418,800 1.1 % * Less than 1.0%. 88 (1) Based on Schedule 13D filed with the SEC on October 26, 2023.
Serlin (9) 18,226,800 * Mali Zeevi (10) 4,746,000 * Ella Sorani (11) 4,697,400 * All directors and executive officers as a group (11 persons) (12) 51,613,800 1.94 % * Less than 1.0%. 101 (1) Based on Schedule 13D filed with the SEC on October 26, 2023.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (5) Includes 1,917,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
(3) Includes 3,276,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026. Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026.
Does not include 1,712,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (10) Includes 171,600 ordinary shares and 15,994,800 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026. (9) Includes 171,600 ordinary shares and 18,055,200 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 18, 2026.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (7) Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026. (7) Includes 3,276,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (6) Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026. 102 (6) Includes 3,276,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026.
Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025. (9) Includes 342,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
(2) Includes 3,705,000 ordinary shares and 3,276,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026. Does not include 1,027,200 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 18, 2026.
Does not include 6,006,000 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 26, 2025. 89 (11) Includes 329,400 ordinary shares and 3,949,800 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025.
Does not include 1,123,800 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 18, 2026. (10) Includes 328,200 ordinary shares and 4,417,800 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 18, 2026.
The principal business office of Intracoastal is 245 Palm Trail, Delray Beach, FL 33483. (3) Includes 3,705,000 ordinary shares and 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025.
(5) Includes 3,276,600 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 18, 2026.
Removed
According to the Schedule 13G, includes (i) 3,125 ADSs representing 1,875,000 ordinary shares and (ii) 45,394 ADSs representing 27,236,115 ordinary shares issuable upon exercise of a warrant issued in January 2025. Mitchell P. Kopin and Daniel B.
Removed
Asher, each of whom are managers of Intracoastal Capital LLC, or Intracoastal, have shared voting control and investment discretion over the securities reported herein that are held by Intracoastal. As a result, each of Mr. Kopin and Mr.
Removed
Asher may be deemed to have beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities reported herein that are held by Intracoastal.
Removed
The warrant is subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the shareholder from exercising that portion of the warrant that would result in the shareholder and its affiliates owning, after exercise, a number of shares in excess of the beneficial ownership limitation.

Other BLRX 10-K year-over-year comparisons