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BioLineRx Ltd.

BioLineRx Ltd.BLRXEarnings & Financial Report

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 — 2023 vs 2024

Top changes in BioLineRx Ltd.'s 2024 20-F

661 paragraphs added · 621 removed · 449 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

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ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3 . KEY INFORMATION 1 ITEM 4. INFORMATION ON THE COMPANY 28 ITEM 4A UNRESOLVED STAFF COMMENTS 51 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 51 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 60 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 79 ITEM 8. FINANCIAL INFORMATION 81 ITEM 9.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3 . KEY INFORMATION 1 ITEM 4. INFORMATION ON THE COMPANY 30 ITEM 4A UNRESOLVED STAFF COMMENTS 60 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 60 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 71 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 88 ITEM 8. FINANCIAL INFORMATION 91 ITEM 9.
THE OFFER AND LISTING 81 ITEM 10. ADDITIONAL INFORMATION 82 ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK 93 ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 94
THE OFFER AND LISTING 92 ITEM 10. ADDITIONAL INFORMATION 93 ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK 103 ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 104

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Later discovery of previously unknown problems with any product, manufacturer or manufacturing process, or failure to comply with regulatory requirements, may result in actions such as: • restrictions on such product, manufacturer or manufacturing process; • warning letters from the FDA or other regulatory authorities; • withdrawal of the product from the market; • suspension or withdrawal of regulatory approvals; 9 • refusal to approve pending applications or supplements to approved applications that we or our licensees submit; • voluntary or mandatory recall; • fines; • refusal to permit the import or export of our products; • product seizure or detentions; • injunctions or the imposition of civil or criminal penalties; or • adverse publicity.
Later discovery of previously unknown problems with any product, manufacturer or manufacturing process, or failure to comply with regulatory requirements, may result in actions such as: • restrictions on such product, manufacturer or manufacturing process; 9 • warning letters from the FDA or other regulatory authorities; • withdrawal of the product from the market; • suspension or withdrawal of regulatory approvals; • refusal to approve pending applications or supplements to approved applications that we or our licensees submit; • voluntary or mandatory recall; • fines; • refusal to permit the import or export of our products; • product seizure or detentions; • injunctions or the imposition of civil or criminal penalties; or • adverse publicity.
Dependence on out-licensing arrangements subjects us to a number of risks, including the risk that: • we have limited control over the amount and timing of resources that a licensee devotes to our therapeutic candidate; • a licensee may experience financial difficulties; 10 • a licensee may fail to secure adequate commercial supplies of our therapeutic candidate upon marketing approval, if at all; • our future revenues depend heavily on the efforts of a licensee; • business combinations or significant changes in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete its obligations under any arrangement with us; • a licensee could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including our competitors; and • out-licensing arrangements are often terminated or allowed to expire, which would delay the development and may increase the development costs of our therapeutic candidates.
Dependence on out-licensing arrangements subjects us to a number of risks, including the risk that: • we have limited control over the amount and timing of resources that a licensee devotes to our therapeutic candidate; 10 • a licensee may experience financial difficulties; • a licensee may fail to secure adequate commercial supplies of our therapeutic candidate upon marketing approval, if at all; • our future revenues depend heavily on the efforts of a licensee; • business combinations or significant changes in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete its obligations under any arrangement with us; • a licensee could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including our competitors; and • out-licensing arrangements are often terminated or allowed to expire, which would delay the development and may increase the development costs of our therapeutic candidates.
If our competitors develop and market products that are more effective, safer or less expensive than our current or future therapeutic candidates, our prospects will be negatively impacted.
If competitors develop and market products that are more effective, safer or less expensive than our current or future therapeutic candidates, our prospects will be negatively impacted.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured therapeutic candidates ourselves, including: • reliance on the third party for regulatory compliance and quality assurance; • limitations on supply availability resulting from capacity and scheduling constraints of the third parties; 14 • impact on our reputation in the marketplace if manufacturers of our products, once commercialized, fail to meet customer demands; • the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and • the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured therapeutic candidates ourselves, including: • reliance on the third party for regulatory compliance and quality assurance; • limitations on supply availability resulting from capacity and scheduling constraints of the third parties; • impact on our reputation in the marketplace if manufacturers of our products, once commercialized, fail to meet customer demands; • the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and • the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.
The degree of market acceptance of APHEXDA, or any other therapeutic candidate that may be approved in the future, will depend on a number of factors, including: • the advantages of the treatment compared to competitive therapies; • the number of competitors approved for similar uses; • the relative promotional effort and marketing success of us as compared with our competitors; • how the product is positioned in physician treatment guidelines and pathways; • the prevalence and severity of any side effects; • the efficacy and safety of the product; • our ability to offer the product for sale at competitive prices; • the product’s tolerability, convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try, and of physicians to prescribe, the product; • limitations or warnings, including use restrictions, contained in the product’s approved labeling; • the strength of sales, marketing and distribution support; • the timing of market introduction of our approved products as well as competitive products; • adverse publicity about the product or favorable publicity about competitive products; • potential product liability claims; • changes in the standard of care for the targeted indications of the product; and • availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.
The degree of market acceptance of APHEXDA, or any other therapeutic candidate that may be approved in the future, will depend on a number of factors, including: • the advantages of the treatment compared to competitive therapies; • the number of competitors approved for similar uses; • the relative promotional effort and marketing success of us as compared with our competitors; • how the product is positioned in physician treatment guidelines and pathways; • the prevalence and severity of any side effects; • the efficacy and safety of the product; • our ability to offer the product for sale at competitive reimbursement; • the product’s tolerability, convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try, and of physicians to prescribe, the product; • limitations or warnings, including use restrictions, contained in the product’s approved labeling; • the strength of sales, marketing and distribution support; • the timing of market introduction of our approved products as well as competitive products; • adverse publicity about the product or favorable publicity about competitive products; • potential product liability claims; 6 • changes in the standard of care for the targeted indications of the product; and • availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.
The market price of our ordinary shares and ADSs are and will be subject to a number of factors, including: • announcements of technological innovations or new products by us or others; • announcements by us of significant acquisitions, strategic partnerships, in-licensing, out-licensing, joint ventures or capital commitments; • expiration or terminations of licenses, research contracts or other collaboration agreements; • public concern as to the safety of drugs we, our licensees or others develop; • general market conditions; • the volatility of market prices for shares of biotechnology companies generally; 22 • success of research and development projects; • departure of key personnel; • developments concerning intellectual property rights or regulatory approvals; • variations in our and our competitors’ results of operations; • changes in earnings estimates or recommendations by securities analysts, if our ordinary shares or ADSs are covered by analysts; • statements about the Company made in the financial media or by bloggers on the Internet; • statements made about drug pricing and other industry-related issues by government officials; • changes in government regulations or patent decisions; • developments by our licensees; and • general market conditions and other factors, including factors unrelated to our operating performance.
The market price of our ordinary shares and ADSs are and will be subject to a number of factors, including: • announcements of technological innovations or new products by us or others; • announcements by us of significant acquisitions, strategic partnerships, in-licensing, out-licensing, joint ventures or capital commitments; • expiration or terminations of licenses, research contracts or other collaboration agreements; • public concern as to the safety of drugs we, our licensees or others develop; 23 • general market conditions; • the volatility of market prices for shares of biotechnology companies generally; • success of research and development projects; • departure of key personnel; • developments concerning intellectual property rights or regulatory approvals; • variations in our and our competitors’ results of operations; • changes in earnings estimates or recommendations by securities analysts, if our ordinary shares or ADSs are covered by analysts; • statements about the Company made in the financial media or by bloggers on the Internet; • statements made about drug pricing and other industry-related issues by government officials; • changes in government regulations or patent decisions; • developments by our licensees; and • general market conditions and other factors, including factors unrelated to our operating performance.
These efforts could have an adverse impact on our ability to market products and generate revenues in the United States and foreign countries. 16 If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.
These efforts could have an adverse impact on our ability to market products and generate revenues in the United States and foreign countries. If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • a collaboration partner may shift its priorities and resources away from our therapeutic candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing; • a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration; • a collaboration partner may not devote sufficient capital or resources towards our therapeutic candidates; • a collaboration partner may change the success criteria for a therapeutic candidate thereby delaying or ceasing development of such candidate; • a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; • a collaboration partner could develop a product that competes, either directly or indirectly, with our therapeutic candidate; • a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product; • a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements; • a partner may exercise a contractual right to terminate a strategic alliance; • a dispute may arise between us and a partner concerning the research, development or commercialization of a therapeutic candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and • a partner may use our products or technology in such a way as to invite litigation from a third party. 12 Any collaborative partners may in the future shift their priorities and resources away from our therapeutic candidates or seek to renegotiate or terminate their relationships with us.
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • a collaboration partner may shift its priorities and resources away from our therapeutic candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing; • a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration; • a collaboration partner may not devote sufficient capital or resources towards our therapeutic candidates; 12 • a collaboration partner may change the success criteria for a therapeutic candidate, thereby delaying or ceasing development of such candidate; • a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; • a collaboration partner could develop a product that competes, either directly or indirectly, with our therapeutic candidate; • a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product; • a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements; • a partner may exercise a contractual right to terminate a strategic alliance; • a dispute may arise between us and a partner concerning the research, development or commercialization of a therapeutic candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and • a partner may use our products or technology in such a way as to invite litigation from a third party.
Such failure could also result in product liability claims, product recalls, product seizures or withdrawals, delays or failures in testing or delivery, cost overruns or other problems, which would have a material adverse effect on our business, financial condition and results of operations. Our contract manufacturers are, and will be, subject to FDA and other comparable agency regulations.
Such failure could also result in product liability claims, product recalls, product seizures or withdrawals, delays or failures in testing or delivery, cost overruns or other problems, which would have a material adverse effect on our business, financial condition and results of operations. 15 Our contract manufacturers are, and will be, subject to FDA and other comparable agency regulations.
Adverse pricing limitations may hinder our ability to recoup our or their investment in one or more therapeutic candidates, even if our therapeutic candidates obtain marketing approval. 13 Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
Adverse pricing limitations may hinder our ability to recoup our or their investment in one or more therapeutic candidates, even if our therapeutic candidates obtain marketing approval. Patients who are provided with medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
In addition, if we develop a manufacturing capacity, we may incur substantial costs to comply with environmental regulations and would be subject to the risk of accidental contamination or injury from the use of hazardous materials in our manufacturing process. In the event of an accident, government authorities may curtail our use of these materials and interrupt our business operations.
In addition, if we develop a manufacturing capacity, we may incur substantial costs to comply with environmental regulations and would be subject to the risk of accidental contamination or injury from the use of hazardous materials in our manufacturing process. 18 In the event of an accident, government authorities may curtail our use of these materials and interrupt our business operations.
Furthermore, whether or not we are ultimately successful in defending any claims, we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result. 17 Significant disruptions of our information technology systems or breaches of our data security could adversely affect our business.
Furthermore, whether or not we are ultimately successful in defending any claims, we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result. Significant disruptions of our information technology systems or breaches of our data security could adversely affect our business.
Failure to license or otherwise acquire necessary technologies could materially and adversely affect our business, financial condition and results of operations. If we cannot meet requirements under our in-license agreements, we could lose the rights to any of our therapeutic candidates, which could have a material adverse effect on our business.
Failure to license or otherwise acquire necessary technologies could materially and adversely affect our business, financial condition and results of operations. 11 If we cannot meet requirements under our in-license agreements, we could lose the rights to any of our therapeutic candidates, which could have a material adverse effect on our business.
Our competitors may also obtain FDA or other regulatory approval for their therapeutic candidates more rapidly than we may be able to do so for any existing or new therapeutic candidates of ours, which could result in their establishing a strong market position before we are able to enter the market.
Competitors may also obtain FDA or other regulatory approval for their therapeutic candidates more rapidly than we or our licensees may be able to do so for any existing or new therapeutic candidates of ours, which could result in their establishing a strong market position before we are able to enter the market.
If a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such person may be treated as a “United States shareholder” with respect to each “controlled foreign corporation” in our group (if any).
If a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such person may be treated as a “United States shareholder” with respect to each “controlled foreign corporation”, or CFC, in our group (if any).
If, we, or others, discover that a product is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following adverse events could occur: • regulatory authorities may withdraw their approval of the product or seize the product; • we, or any of our collaborators, may be required to recall the product, change the way the product is administered or conduct additional clinical trials; • additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product; • we, or any of our collaborators, may be subject to fines, injunctions or the imposition of civil or criminal penalties; • regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; • we, or any of our collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients; • we could be sued and held liable for harm caused to patients; • physicians and patients may stop using our product; and • our reputation may suffer.
If we, or others, discover that a product is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following adverse events could occur: • regulatory authorities may withdraw their approval of the product or seize the product; • we, or any of our collaborators, may be required to recall the product, change the way the product is administered or conduct additional clinical trials; • additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product; • we, or any of our collaborators, may be subject to fines, injunctions or the imposition of civil or criminal penalties; • regulatory authorities may require the addition of labeling or warning statements, such as a “black box” warning or a contraindication; • we, or any of our collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to physicians, health care professionals and patients; • we could be sued and held liable for harm caused to patients; • physicians and patients may stop using our product; and • our reputation may suffer.
There can be no assurance that we will be able to continue to retain and attract such personnel. Our growth and success also depend on our ability to attract and retain additional highly qualified scientific, technical, sales, managerial and finance personnel.
There can be no assurance that we will be able to continue to retain and attract such personnel. Our growth and success also depend on our ability to attract and retain highly qualified scientific, technical, sales, managerial and finance personnel.
Risks Related to Our Industry • Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental authorities and third-party payors may adversely affect our business. • If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase. • Our business has a substantial risk of clinical trial and product liability claims.
Risks Related to Our Industry • Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by government authorities and third-party payors may adversely affect our business. • If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase. • Our business has a substantial risk of clinical trial and product liability claims.
If our cash reserves, cash flows and capital resources are insufficient to fund our debt obligations to Kreos Capital, we may be required to seek additional capital, restructure or refinance our indebtedness, or delay or abandon our research and development projects or other capital expenditures, which could have a material adverse effect on our business, financial condition, prospects or results of operations.
If our cash reserves, cash flows and capital resources are insufficient to fund our debt obligations to BlackRock, we may be required to seek additional capital, restructure or refinance our indebtedness, or delay or abandon our research and development projects or other capital expenditures, which could have a material adverse effect on our business, financial condition, prospects or results of operations.
These payors may not view APHEXDA as cost-effective, and coverage and reimbursement may not be available to our customers or may not be sufficient to allow our products to be marketed on a competitive basis. Cost-control initiatives could cause us or our collaborators to decrease the price we might establish, which could result in lower than anticipated product revenues.
These payors may not view APHEXDA as cost-effective, and coverage and reimbursement may not be available to customers or may not be sufficient to allow our products to be marketed on a competitive basis. Cost-control initiatives could cause us or our licensees to decrease the price we might establish, which could result in lower than anticipated product revenues.
Because PFIC status is determined annually and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with certainty whether we will be characterized as a PFIC for the 2024 taxable year until after the close of the year, and there can be no assurance that we will not be classified as a PFIC in any future year.
Because PFIC status is determined annually and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with certainty whether we will be characterized as a PFIC for the 2025 taxable year until after the close of the year, and there can be no assurance that we will not be classified as a PFIC in any future year.
Any of these events could harm our business and operations and could negatively impact the market price of our ordinary shares and/or ADSs. 7 If we or our collaborators are unable to obtain and/or maintain U.S. and/or foreign regulatory approval for our therapeutic candidates in a timely manner or at all, we will be unable to commercialize our therapeutic candidates.
Any of these events could harm our business and operations and could negatively impact the market price of our ordinary shares and/or ADSs. 7 If we or our licensees are unable to obtain and/or maintain U.S. and/or foreign regulatory approval for our therapeutic candidates in a timely manner or at all, we will be unable to commercialize our therapeutic candidates.
Any government-adopted reform measures, such as the IRA, could cause significant pressure on the pricing of healthcare products and services, including those biopharmaceuticals currently being developed by us or our licensees, in the United States and internationally, as well as the amount of reimbursement available from governmental agencies or other third-party payors.
Any government-adopted reform measures could cause significant pressure on the pricing of healthcare products and services, including those biopharmaceuticals currently being developed by us or our licensees, in the United States and internationally, as well as the amount of reimbursement available from governmental agencies or other third-party payors.
Any infringement by us of the proprietary rights of third parties may have a material adverse effect on our business, financial condition and results of operations. 19 If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
Any infringement by us of the proprietary rights of third parties may have a material adverse effect on our business, financial condition and results of operations. 20 If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
As a result, we or our collaborators might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country.
As a result, we or our licensees might obtain marketing approval for a product in a particular country but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country.
If we are a PFIC for our taxable year ending December 31, 2023, or any subsequent year, and a U.S. Investor (as defined below) does not make an election to treat us as a “qualified electing fund,” or QEF, or make a “mark-to-market” election, then “excess distributions” to a U.S.
If we are a PFIC for our taxable year ending December 31, 2024, or any subsequent year, and a U.S. Investor (as defined below) does not make an election to treat us as a “qualified electing fund,” or QEF, or make a “mark-to-market” election, then “excess distributions” to a U.S.
The life sciences industry is highly competitive, and we face significant competition from many pharmaceutical, biopharmaceutical and biotechnology companies that are researching and marketing products designed to address the indications for which we are currently developing motixafortide or for which we may develop therapeutic candidates in the future.
The life sciences industry is highly competitive, and we and our licensees face significant competition from many pharmaceutical, biopharmaceutical and biotechnology companies that are researching and marketing products designed to address the indications for which we are currently developing motixafortide or for which we may develop therapeutic candidates in the future.
Therefore, our ability, and the ability of any collaborators, to successfully commercialize any of our therapeutic candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors. Third-party payors decide which medications they will cover and establish reimbursement levels.
Therefore, our ability, and the ability of any licensees to successfully commercialize any of our therapeutic candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors. Third-party payors decide which medications they will cover and establish reimbursement levels.
If the FDA requires additional studies or data, we would incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available. In addition, the FDA may not consider any additional information to be complete or sufficient to support approval.
If the FDA requires additional studies or data, we will incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available. In addition, the FDA may not consider any additional information to be complete or sufficient to support approval.
Due to a significant portion of our expenses and revenues being denominated in non-dollar currencies, our results of operations may be harmed by currency fluctuations. Our reporting and functional currency is the dollar. However, we pay a significant portion of our expenses in NIS and in Euro, and we expect this to continue.
Due to a significant portion of our expenses and revenues being denominated in non-dollar currencies, our results of operations may be harmed by currency fluctuations. Our reporting and functional currency is the U.S. dollar. However, we pay a significant portion of our expenses in NIS and in Euro, and we expect this to continue.
Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional testing requirements for our therapeutic candidates. We may not obtain additional marketing approvals for motixafortide in other indications or initial approval for any other therapeutic candidates we may develop in the future.
Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional testing requirements for our therapeutic candidates. We and our licensees may not obtain additional marketing approvals for motixafortide or initial approval for any other therapeutic candidates we may develop in the future.
Opposition procedures may be costly, and there is a risk that we may not prevail. 20 We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
Opposition procedures may be costly, and there is a risk that we may not prevail. 21 We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
Depending on the extent of these or any other required trials or studies, approval of any application that we submit may be delayed by several years, or may require us or our collaborator to expend more resources than we or they have available.
Depending on the extent of these or any other required trials or studies, approval of any application that we submit may be delayed by several years, or may require us or our licensee to expend more resources than we or they have available.
Our APHEXDA sales will suffer or our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize products that are safer or more effective, have fewer or less severe side effects, or are more convenient or less expensive than any products that we may develop.
APHEXDA sales will suffer, or the commercial opportunity may be reduced or eliminated if competitors develop and commercialize products that are safer or more effective, have fewer or less severe side effects, or are more convenient or less expensive than any products that we may develop.
See also “— Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.” 24 As a foreign private issuer, we follow certain home country corporate governance practices instead of applicable SEC and Nasdaq requirements, which may result in less protection than is accorded to investors under rules applicable to domestic issuers.
See also “— Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.” 25 As a foreign private issuer, we follow certain home country corporate governance practices instead of applicable Nasdaq requirements, which may result in less protection than is accorded to investors under rules applicable to domestic issuers.
Our ability to make the scheduled payments under the Loan Agreement or to refinance our debt obligations with Kreos Capital depends on numerous factors including, but not limited to, the amount of our cash reserves, our capital requirements and our ability to raise additional capital.
Our ability to make the scheduled payments under the Loan Agreement or to refinance our debt obligations with BlackRock depends on numerous factors including, but not limited to, the amount of our cash reserves, our capital requirements and our ability to raise additional capital.
Any delay in obtaining, or an inability to obtain, marketing approvals would prevent us or our collaborators from commercializing motixafortide in other jurisdictions and indications or any other therapeutic candidate that we may develop in the future and generating revenues.
Any delay in obtaining, or an inability to obtain, marketing approvals would prevent us or our licensees from commercializing motixafortide in other jurisdictions and indications or any other therapeutic candidate that we may develop in the future and generating revenues.
APHEXDA, or any other therapeutic candidate that we or our collaborators are able to commercialize, may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business.
APHEXDA, or any other therapeutic candidate that we or our licensees are able to commercialize, may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business.
If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as damages awards beyond the coverage of our insurance policies resulting from a claim brought successfully against us.
If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as damage awards beyond the coverage of our insurance policies resulting from a claim brought successfully against us.
Although we have not determined whether we will be a PFIC for our taxable year ending December 31, 2024, or in any subsequent year, our operating results for any such years may cause us to be a PFIC.
Although we have not determined whether we will be a PFIC for our taxable year ending December 31, 2025, or in any subsequent year, our operating results for any such years may cause us to be a PFIC.
We are currently part to, and may in the future, become subject to litigation or claims arising in or outside the ordinary course of business that could negatively affect our business operations and financial condition.
We are currently party to, and may in the future, become subject to litigation or claims arising in or outside the ordinary course of business that could negatively affect our business operations and financial condition.
APHEXDA, or any other therapeutic candidate that may receive marketing approval in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for APHEXDA or any other therapeutic candidate may be smaller than our estimates.
APHEXDA, or any other therapeutic candidate that may receive approval to sell the product in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for APHEXDA or any other therapeutic candidate may be smaller than our estimates.
If any of these outcomes occur, we would not be eligible for certain milestone and royalty revenue under our partnership agreements, our collaborators could terminate our partnership agreements and we may be forced to abandon our development efforts, any of which could significantly harm our business. 8 Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
If any of these outcomes occur, we would not be eligible for certain milestone and royalty revenue under our license agreements, our licensees could terminate our license agreements and we may be forced to abandon our development efforts, any of which could significantly harm our business. 8 Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
A United States investor should consult its tax advisors regarding the potential application of these rules to its investment in the shares. 21 Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.
A United States investor should consult its tax advisors regarding the potential application of these rules to its investment in our ordinary shares or ADSs. 22 Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.
Raising additional capital by issuing securities may cause dilution to existing shareholders. We may need to raise substantial future capital to continue to complete clinical development and commercialize our products and therapeutic candidates and to conduct the research and development and clinical and regulatory activities necessary to bring our therapeutic candidates to market.
Raising additional capital by issuing securities may cause dilution to existing shareholders. We expect that we will need to raise substantial future capital to continue to complete clinical development and commercialize our products and therapeutic candidates and to conduct the research and development and clinical and regulatory activities necessary to bring our therapeutic candidates to market.
It is possible that the FDA or comparable foreign regulatory agencies may refuse to accept for substantive review any future application that we or a collaborator may submit to market and sell our therapeutic candidates, or that any such agency may conclude after review of our or our collaborator’s data that such application is insufficient to obtain marketing approval of our therapeutic candidate.
It is possible that the FDA or comparable foreign regulatory agencies may refuse to accept for substantive review any future application that we or a licensee may submit to market and sell our therapeutic candidates, or that any such agency may conclude after review of our or our licensee’s data that such application is insufficient to obtain marketing approval of our therapeutic candidate.
Under the license agreement for motixafortide, we are obligated to make commercially reasonable, good faith efforts to sublicense or commercialize motixafortide for fair consideration. In 2007, we in-licensed the rights to BL-5010 under a license agreement with IPC.
In 2012, we in-licensed the rights to motixafortide under a license agreement from Biokine. Under the license agreement for motixafortide, we are obligated to make commercially reasonable, good faith efforts to sublicense or commercialize motixafortide for fair consideration. In 2007, we in-licensed the rights to BL-5010 under a license agreement with IPC.
Further, our Articles of Association, as amended at our annual general meeting of shareholder held in August 2023, provide that our directors (other than external directors, if any) are elected on a staggered basis, such that a potential acquirer cannot readily replace our entire board of directors at a single annual general shareholder meeting; rather, at least two annual meetings of shareholders will generally be required to effect a change in a majority of our board of directors.
Further, our Articles of Association, as currently in effect, provide that our directors (other than external directors, if any) are elected on a staggered basis, such that a potential acquirer cannot readily replace our entire board of directors at a single annual general shareholder meeting; rather, at least two annual meetings of shareholders will generally be required to effect a change in a majority of our board of directors.
There are numerous examples of unsuccessful product launches and failures to meet expectations of market potential, including by pharmaceutical companies with more experience and resources than us. Successful commercialization will depend upon our ability to achieve sufficient market acceptance, reimbursement from third-party payers and adequate market share for APHEXDA.
Successful commercialization is subject to many risks. There are numerous examples of unsuccessful product launches and failures to meet expectations of market potential, including by pharmaceutical companies with more experience and resources than us. Successful commercialization will depend upon our licensees’ ability to achieve sufficient market acceptance, reimbursement from third-party payers and adequate market share for APHEXDA.
We expect to also continue to seek to finance our operations through other sources, including commercialization in the United States for APHEXDA, out-licensing arrangements for the development and commercialization of our therapeutic candidates or other partnerships or joint ventures, as well as grants from government agencies and foundations.
We expect to also continue to seek to finance our operations through other sources, including out-licensing arrangements for the development and commercialization of our therapeutic candidates or other partnerships or joint ventures, as well as grants from government agencies and foundations.
For example, despite the recent FDA marketing approval of APHEXDA in the United States, we, or others, may discover that APHEXDA is less effective or tolerable than previously believed.
For example, despite the recent FDA marketing approval of APHEXDA in the United States, we, or others, including our licensees, may discover that APHEXDA is less effective or tolerable than previously believed.
We and any collaborators may never succeed in these activities and, even if we do, or any collaborators do, we may never generate revenues that are large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
We and any licensees may never succeed in these activities and, even if we do, or any licensee does, we may never generate revenues that are large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
If we are not able to compete effectively, our business will not grow and our financial condition and operations will suffer.
If we or our licensees are not able to compete effectively, our business will not grow and our financial condition and operations will suffer.
The adequacy of our available funds to meet our operating and capital requirements will depend on many factors, including: the costs of commercializing APHEXDA, the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our therapeutic candidates; the terms and conditions of in-licensing and out-licensing therapeutic candidates; and costs incurred in enforcing and defending our patent claims and other intellectual property rights While we expect to continue to explore alternative financing sources, including the possibility of future securities offerings and government funding, we cannot be certain that in the future these liquidity sources will be available when needed on commercially reasonable terms or at all, or that our actual cash requirements will not be greater than anticipated.
The adequacy of our available funds to meet our operating and capital requirements will depend on many factors, including: milestone payments from our license agreements with Ayrmid and Gloria, the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our therapeutic candidates; the terms and conditions of in-licensing and out-licensing therapeutic candidates; and costs incurred in enforcing and defending our patent claims and other intellectual property rights While we expect to continue to explore alternative financing sources, including the possibility of future securities offerings and government funding, we cannot be certain that in the future these liquidity sources will be available when needed on commercially reasonable terms or at all, or that our actual cash requirements will not be greater than anticipated.
We do not currently have any long-term agreements with third-party manufacturers that guarantee the supply of product and we rely on single source suppliers.
We do not currently have any long-term agreements with third-party manufacturers that guarantee the supply of therapeutic supplies and we rely on single source suppliers.
Since this is our first independently marketed therapeutic, the timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and sustain commercial success for APHEXDA. • APHEXDA, or any other therapeutic candidate that may receive marketing approval in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for APHEXDA or any other therapeutic candidate may be smaller than our estimates. • If we or our collaborators are unable to obtain and/or maintain U.S. and/or foreign regulatory approval for our therapeutic candidates, in a timely manner or at all, we will be unable to commercialize our therapeutic candidates. • We may not obtain additional marketing approvals for motixafortide in other indications or initial approval for any other therapeutic candidates we may develop in the future. 1 • Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. • Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review and if we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business would be seriously harmed. • We generally rely on third parties to conduct our preclinical studies and clinical trials and to provide other services, and those third parties may not perform satisfactorily, including by failing to meet established deadlines for the completion of such services. • We have in the past and may depend in the future on out-licensing arrangements for late-stage development, marketing and commercialization of our therapeutic candidates. • If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic candidates, which could have a material adverse effect on our business. • We have partnered with and may seek to partner with third-party collaborators with respect to the development and commercialization of motixafortide, and we may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our therapeutic candidates successfully, if at all. • If our competitors develop and market therapeutics that are more effective, safer or less expensive than our current or future therapeutic candidates, our prospects will be negatively impacted. • APHEXDA, or any other therapeutic candidate that we or our collaborators are able to commercialize, may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business. • We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization, of APHEXDA.
We may never achieve profitability. • APHEXDA, or any other therapeutic candidate that may receive marketing approval in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for APHEXDA or any other therapeutic candidate may be smaller than our estimates. • If we or our collaborators are unable to obtain and/or maintain U.S. and/or foreign regulatory approval for our therapeutic candidates, in a timely manner or at all, we will be unable to commercialize our therapeutic candidates. • We and our collaborators may not obtain additional marketing approvals for motixafortide in other indications or initial approval for any other therapeutic candidates we may develop in the future. 1 • Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. • Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review and if we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business would be seriously harmed. • We generally rely on third parties to conduct our preclinical studies and clinical trials and to provide other services, and those third parties may not perform satisfactorily, including by failing to meet established deadlines for the completion of such services. • We recently entered into and may in the future rely on out-licensing arrangements for late-stage development, marketing or commercialization of our therapeutic candidates. • If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic candidates, which could have a material adverse effect on our business. • We have partnered with and may seek to partner with third-party collaborators with respect to the development and commercialization of motixafortide, and we may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our therapeutic candidates successfully, if at all. • If competitors develop and market therapeutics that are more effective, safer or less expensive than our current or future therapeutic candidates, our prospects will be negatively impacted. • APHEXDA, or any other therapeutic candidate that we or our licensees are able to commercialize, may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business. • We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization, of APHEXDA.
In addition, a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company.
In addition, a controlling shareholder and a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company or has other powers toward the company, has a duty of fairness toward the company.
In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account. We believe that we are a PFIC for the year ended December 31, 2023.
In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account. We believe that we may have been a PFIC for the year ended December 31, 2024.
Additionally, increases in inflation, along with the uncertainties surrounding any resurgence of COVID-19, geopolitical developments and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly or dilutive for us to secure additional financing.
Additionally, increases in inflation, along with the uncertainties geopolitical developments and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly or dilutive for us to secure additional financing.
Therefore, a judgment obtained against us or any of our executive officers and directors in the United States, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be enforced by an Israeli court.
Therefore, a judgment obtained against us or any of our executive officers and directors in the United States, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States.
In particular, a shareholder of an Israeli company has a duty to act in good faith toward the company and other shareholders, and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and interested party transactions requiring shareholder approval, as well as a general duty to refrain from discriminating against other shareholders.
In particular, pursuant to the Companies Law, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner toward the company and other shareholders, and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting of shareholders on amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and interested party transactions requiring shareholder approval under the Companies Law, as well as a general duty to refrain from discriminating against other shareholders.
We may not obtain additional marketing approvals for motixafortide or any other therapeutic candidate that we may develop in the future.
We and our licensees may not obtain additional marketing approvals for motixafortide or any other therapeutic candidate that we may develop in the future.
An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for therapeutic candidate for which we obtain regulatory approval could significantly harm our operating results and our overall financial condition. We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization, of APHEXDA.
An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any therapeutic candidate for which we obtain regulatory approval could significantly harm our operating results and our overall financial condition. We rely upon third-party manufacturers to produce therapeutic supplies of motixafortide.
We may terminate the BL-5010 in-licensing agreement upon 30 days’ prior written notice to IPC.
We may terminate the motixafortide in-licensing agreement upon 90 days’ prior written notice to Biokine. We may terminate the BL-5010 in-licensing agreement upon 30 days’ prior written notice to IPC.
There is no assurance that we would be able to take any of such actions, or that such actions would permit us meet our scheduled debt obligations under the Kreos Capital loan agreements.
There is no assurance that we would be able to take any of such actions, or that such actions would permit us meet our scheduled debt obligations under the BlackRock loan agreement.
We have incurred losses since inception, principally as a result of research and development and general administrative expenses and more recently sales and marketing in support of our operations. We recorded net losses of $27.1 million in 2021, $25.0 million in 2022 and $60.6 million in 2023. As of December 31, 2023, we had an accumulated deficit of $391 million.
We have incurred losses since inception, principally as a result of research and development and general administrative expenses and more recently sales and marketing in support of our operations. We recorded net losses of $25.0 million in 2022, $60.6 million in 2023 and $9.2 million in 2024. As of December 31, 2024, we had an accumulated deficit of $400 million.
The termination of any in-license or our inability to enforce our rights under any in-license would materially and adversely affect our ability to commercialize certain of our therapeutic candidates. We currently have in-licensing agreements relating to our therapeutic candidates that are in development or being commercialized. In 2012, we in-licensed the rights to motixafortide under a license agreement from Biokine.
The termination of any in-license or our inability to enforce our rights under any in-license would materially and adversely affect our ability to commercialize certain of our therapeutic candidates. We currently have in-licensing agreements relating to our therapeutic candidates that are in development or are being commercialized.
Actual or perceived political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.
Actual or perceived political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and ability to raise capital.
Such securities litigation or any additional securities litigation could have a substantial cost and divert resources and attention of management from our business, even if we are successful. Our ordinary shares are traded on the TASE and our ADSs are listed on Nasdaq.
See “Item 8.A—Financial Information—Legal Proceedings” for additional information. Such securities litigation or any additional securities litigation could have a substantial cost and divert resources and attention of management from our business, even if we are successful. Our ordinary shares are traded on the TASE and our ADSs are listed on Nasdaq.
If the conditions in the global economies remain uncertain or continue to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Russia and Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely affected.
Our business depends on the economic health of the global economies. If the conditions in the global economies remain uncertain or continue to be volatile, or if they deteriorate, including as a result of the impact of military conflict, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely affected.
Risks Related to our Ordinary Shares and ADSs • Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. • The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses by our investors. • Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs. • Raising additional capital by issuing securities may cause dilution to existing shareholders.
Risks Related to our Ordinary Shares and ADSs • Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. • The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses by our investors. • Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs. • Raising additional capital by issuing securities may cause dilution to existing shareholders. • If we fail to comply with the continued listing requirements of the Nasdaq, our ADSs may be delisted and the price of our ADSs and our ability to access the capital markets could be negatively impacted.
Most of our executive officers and the majority of our directors reside outside of the United States, and a significant portion of our assets and most of the assets of such executive officers and directors are located outside of the United States.
We are incorporated in Israel. All of our executive officers and the majority of our directors reside outside of the United States, and a significant portion of our assets and most of the assets of such executive officers and directors are located outside of the United States.
The failure of these third parties to carry out their obligations would materially adversely affect our ability to develop and market new products and implement our strategies. We have in the past and may in the future rely on out-licensing arrangements for late-stage development, marketing and commercialization.
The failure of these third parties to carry out their obligations would materially adversely affect our ability to develop and market new products and implement our strategies. We recently entered into out-licensing arrangements with Gloria and Ayrmid and may in the future rely on additional out-licensing arrangements for late-stage development, marketing or commercialization.
On September 3, 2021, the Original HCW Offering Agreement was terminated. 23 On September 3, 2021, we entered into a new offering agreement, or the New HCW Offering Agreement, with HCW, pursuant to which we may offer and sell, at our option, up to $25.0 million of our ADSs through an “at-the-market” equity program under which HCW agreed to act as sales agent.
On September 3, 2021, we entered into an offering agreement, or the HCW Offering Agreement, with H.C. Wainwright & Co., LLC, or HCW, pursuant to which we may offer and sell, at our option, up to $25.0 million of our ADSs through an “at-the-market” equity program under which HCW agreed to act as sales agent.
In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts.
In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.
Investors with information needed in order to complete IRS Form 8621 (which form would be required to be filed with the IRS on an annual basis by the U.S. Investor) and to make and maintain a valid QEF election for any year in which we or any of our subsidiaries are a PFIC. See also “Item 10. Additional Information—E. Taxation—U.S.
Investors with information needed in order to complete IRS Form 8621 (which form would be required to be filed with the IRS on an annual basis by the U.S. Investor) and to make and maintain a valid QEF election for any year in which we are a PFIC.
It also may be difficult for you to effect service of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel.
It also may be difficult for you to effect service of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel or obtain a judgment based on the civil liability provisions of U.S. federal securities laws.
Under the Loan Agreement, Kreos Capital will provide the Company with access to term loans in an aggregate principal amount of up to $40 million in three tranches as follows: (a) a loan in the aggregate principal amount of up to $10 million, (b) a loan in the aggregate principal amount of up to $20 million, available for drawdown upon achievement of certain milestones and until April 1, 2024, and (c) a loan in the aggregate principal amount of up to $10 million, available for drawdown upon achievement of certain milestones and until October 1, 2024.
In September 2022, we entered into a secured loan agreement, or the Loan Agreement, with BlackRock, under which BlackRock agreed to provide the Company with access to term loans in an aggregate principal amount of up to $40 million in three tranches as follows: (a) a loan in the aggregate principal amount of up to $10 million, (b) a loan in the aggregate principal amount of up to $20 million, available for drawdown upon achievement of certain milestones and until April 1, 2024, and (c) a loan in the aggregate principal amount of up to $10 million, available for drawdown upon achievement of certain milestones and until October 1, 2024.
We have a full right of offset for amounts payable to the IIA for motixafortide from 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.
Successful commercialization of APHEXDA will in part require that we are able to overcome competition from Mozobil and its generic versions, where average selling price reimbursement is currently favoring the generic market. Any therapeutic candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.
Successful commercialization of APHEXDA will in part require that our licensees are able to overcome competition from Mozobil and its generic versions. 13 Any therapeutic candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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While our bioanalytical laboratory complies with these regulations, the chemistry and formulation, as well as the analytical laboratories, are limited in manufacturing scale and resources and therefore are intended to support our projects for research and development activities only. These laboratories are not compliant with current good manufacturing practices, or cGMP.
While our bioanalytical laboratory complies with these regulations, the chemistry and formulation laboratories, as well as the analytical laboratories, are limited in manufacturing scale and resources and therefore are intended to support our projects for research and development activities only. These laboratories are not compliant with current good manufacturing practices, or cGMP.
The EMA’s Committee for Advanced Therapies (CAT) is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMP). ATMP include gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products.
The EMA’s Committee for Advanced Therapies (CAT) is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMP). ATMP include gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered medicinal products.
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 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; 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.
Additionally, we are eligible to receive tiered, double-digit royalties (ranging from 10-20%), on aggregate net sales of motixafortide in the Territory payable on a country-by-country basis until the longer of (i) fifteen years from the date of the first sale of motixafortide by Licensee, (ii) the last to expire valid claim of any licensed patents with respect to motixafortide in such country and (iii) the expiration of motixafortide’s orphan drug status in such country.
Additionally, we are eligible to receive tiered, double-digit royalties (ranging from 10-20%), on aggregate net sales of motixafortide in the Gloria Territory payable on a country-by-country basis until the longer of (i) fifteen years from the date of the first sale of motixafortide by Licensee, (ii) the last to expire valid claim of any licensed patents with respect to motixafortide in such country and (iii) the expiration of motixafortide’s orphan drug status in such country.
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 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). 34 In the field of immuno-oncology, motixafortide mediates infiltration of T-cells while reducing immune regulatory cells in the tumor microenvironment, or TME.
While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections. ASCT is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma.
While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections. 35 ASCT is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma.
These include requirements relating to provision of a risk management plan and provision of annual periodic safety update reports, carrying out of post-authorization efficacy studies and/or post-authorization safety studies, maintenance of a pharmacovigilance system master file, adverse event reporting, signal detection and management and other pharmacovigilance activities conducted under an established quality system, advertising, packaging and labelling, patient package leaflets, and distribution.
These may include requirements relating to provision of a risk management plan and provision of annual periodic safety update reports, carrying out of post-authorization efficacy studies and/or post-authorization safety studies, maintenance of a pharmacovigilance system master file, adverse event reporting, signal detection and management and other pharmacovigilance activities conducted under an established quality system, advertising, packaging and labelling, patient package leaflets, and distribution.
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. • 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. 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.
In addition, Orphan Drug Designation enables sponsors to apply for certain federal grants and tax credits for clinical trials and provides an exemption from the Prescription Drug User Fee so long, as the sponsor’s annual revenue is below $50,000,000. 34 In January 2020, the EMA granted an Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
In addition, Orphan Drug Designation enables sponsors to apply for certain federal grants and tax credits for clinical trials and provides an exemption from the Prescription Drug User Fee so long, as the sponsor’s annual revenue is below $50,000,000. In January 2020, the EMA granted an Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
The royalties payable by Licensee to us are to be reduced by 50% following the end of the initial royalty term and to also be reduced upon the occurrence of certain events, including, on a country-by-country basis, the entry of a generic product in such country.
The royalties payable by Gloria Licensee to us are to be reduced by 50% following the end of the initial royalty term and are also to be reduced upon the occurrence of certain events, including, on a country-by-country basis, the entry of a generic product in such country.
The authorization of a clinical trial (Phase 1-3) in an EU member state requires the submission of a clinical trial application (CTA) via the EU Portal. The application will be reviewed by the competent authorities of the member states where the trial is supposed to take place.
The authorization of a clinical trial (Phase 1-3) in an EU member state requires the submission of a clinical trial application (CTA) via the EU Portal, CTIS. The application will be reviewed by the competent authorities of the member states where the trial is supposed to take place.
Where the product is no longer covered by a patent or supplementary protection certificate, the applicant may make a separate application for a Pediatric Use Marketing Authorization, or PUMA, which, on approval, will provide eight years’ protection for data and 10 years’ marketing protection for the pediatric results. 45 Post-authorization Obligations An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post-authorization regulations relating to the marketing and other activities of authorization holders.
Where the product is no longer covered by a patent or supplementary protection certificate, the applicant may make a separate application for a Pediatric Use Marketing Authorization, or PUMA, which, on approval, will provide eight years’ protection for data and 10 years’ marketing protection for the pediatric results. 53 Post-authorization Obligations An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post-authorization regulations relating to the marketing and other activities of authorization holders.
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. 42 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.
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.
We are entitled to up to $49 million based on the achievement of certain development and regulatory milestones in China and Japan, and up to $197 million in sales milestones based on defined sales targets of motixafortide in the Territory.
We are entitled to up to $49 million based on the achievement of certain development and regulatory milestones in China and Japan, and up to $197 million in sales milestones based on defined sales targets of motixafortide in the Gloria Territory.
Organizational Structure Our corporate structure consists of BioLineRx Ltd., one wholly owned subsidiary, BioLineRx USA, Inc., and a substantially wholly owned U.K. subsidiary, Agalimmune Ltd. 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 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.
Top-line results announced in May 2021 showed highly statistically significant evidence across all primary and secondary endpoints favoring motixafortide in combination with G-CSF (p During 2023, we completed the build-out of the infrastructure for commercial operations in the U.S. designed to support the commercialization of APHEXDA.
Top-line results announced in May 2021 showed highly statistically significant evidence across all primary and secondary endpoints favoring motixafortide in combination with G-CSF (p During 2023, we completed the build-out of the infrastructure for commercial operations in the U.S. designed to support the commercialization of APHEXDA and launched the product in the U.S.
Foreign clinical trials may or may not be conducted under an IND. However, their safety assessments should be submitted annually. 41 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. 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.
The FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA plus G-CSF compared to placebo plus G-CSF, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.
The FDA approval of APHEXDA was based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA plus G-CSF compared to placebo plus G-CSF, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.
Hence, we cannot independently manufacture drug substances or drug products for our current clinical trials or for commercial distribution. Our current and any future third-party manufacturers, their facilities and all lots of drug substance and drug products used in our clinical trials and commercial sales are required to be in compliance with cGMPs.
Hence, we cannot independently manufacture drug substances or drug products for our current clinical trials or for commercial distribution. Our current and any future third-party manufacturers, their facilities and all lots of drug substance and drug products used in our clinical trials and commercial sales are required to be in compliance with cGMP.
Under the Research Law and the terms of the grants, royalties on the revenues derived from sales of products (and associated services) developed with the support of the IIA are payable to the Israeli government, generally at the rate of 3% (and at an increased rate under certain circumstances, as described below).
Under the Research Law and the terms of IIA grants, royalties on the revenues derived from sales of products (and associated services) developed with IIA funding are payable to the Israeli government, generally at the rate of 3% (and at an increased rate under certain circumstances, as described below).
The scope of payments we are required to make under our in-licensing agreements is comprised of various components that are paid commensurate with the progressive development and commercialization of our drug products. 35 Our in-licensing agreements generally provide for the following types of payments: • Revenue sharing payments.
The scope of payments we are required to make under our in-licensing agreements is comprised of various components that are paid commensurate with the progressive development and commercialization of our drug products. 40 Our in-licensing agreements generally provide for the following types of payments: • Revenue sharing payments.
More recently, 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.
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.
AGI-134 In March 2017, we acquired substantially all of the outstanding shares of Agalimmune and entered into the Agalimmune Development Agreement with the selling shareholders. The compound is a synthetic alpha-gal immunotherapy in development for solid tumors.
AGI-134 In March 2017, we acquired substantially all of the outstanding shares of Agalimmune and entered into a development agreement with Agalimmune and its selling shareholders, or the Agalimmune Development Agreement. The compound is a synthetic alpha-gal immunotherapy in development for solid tumors.
Today, it is estimated that approximately two-thirds, i.e., 65-70% of patients undergoing autologous transplantation in the U.S. receive plerixafor on top of G-CSF. Based on our internal assessment, we estimate the value of the U.S. stem cell mobilization market at approximately $300 million in 2023. Multiple myeloma is the second most-common hematologic malignancy.
It is estimated that approximately two-thirds, i.e., 60-70% of patients undergoing autologous transplantation in the U.S. receive plerixafor on top of G-CSF. Based on our internal assessment, we estimate the value of the U.S. stem cell mobilization market at approximately $300 million in 2023. Multiple myeloma is the second most-common hematologic malignancy.
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, 92/25/EEC 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.
Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers (“PBMs”) and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.
Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers, or PBMs, and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.
With headquarters and development operations in Israel, and commercialization operations in the U.S., we are driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside. We use “APHEXDA” when referring to our FDA approved drug and “motixafortide” when referring to our development of APHEXDA for additional indications.
With headquarters and development operations in Israel, we are driving innovative therapeutics with end-to-end expertise in development, ensuring life-changing discoveries move beyond the bench to the bedside. We use “APHEXDA” when referring to our FDA approved drug and “motixafortide” when referring to our development of APHEXDA for additional indications.
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. Manufacturing We rely on contract manufacturers to produce motixafortide for clinical trials and for commercial sale.
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.
Following this approval, we commenced commercialization of motixafortide in the U.S. independently, as planned, in order to accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate.
Following this approval, we commenced commercialization of motixafortide in the U.S. independently in order to accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate.
Summaries of the United States, EU, United Kingdom and Israeli regulatory processes follow below. 40 United States In the United States, drugs are subject to rigorous regulation by the FDA. The U.S.
Summaries of the United States, EU, United Kingdom and Israeli regulatory processes follow below. 47 United States In the United States, drugs are subject to rigorous regulation by the FDA. The U.S.
Stem cells are mobilized from the bone marrow of the patient (i.e., autologous transplant) or donor (i.e., allogeneic transplant) using granulocyte-colony stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after intensive myeloablation (chemo/radiotherapy). In 2019, approximately 45,000 autologous transplants were conducted in the U.S. and EU.
Stem cells are mobilized from the bone marrow of the patient (i.e., autologous transplant) or donor (i.e., allogeneic transplant) using granulocyte-colony stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after intensive myeloablation (chemo/radiotherapy). In 2021, approximately 40,000 autologous transplants were conducted in the U.S. and EU.
EU pharmacovigilance legislation has been significantly modified by the Pharmacovigilance Directive, Directive 2010/84/EU 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).
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).
In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 495,000 people were diagnosed with the disease in 2020.
In the United States in 2024, an estimated 67,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 8% of all cancer deaths. Worldwide, an estimated 495,000 people were diagnosed with the disease in 2020.
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.
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.
Mutual Recognition Procedure (MRP) The mutual recognition procedure (Art. 28 et seq. Directive 2001/83/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) 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.
In December 2019, we announced that preliminary data from the study indicated that the triple combination therapy showed a high level of disease control, including seven partial responders and 10 patients with stable disease out of 22 evaluable patients.
We initiated this arm of the trial in December 2018. In December 2019, we announced that preliminary data from the study indicated that the triple combination therapy showed a high level of disease control, including seven partial responders and 10 patients with stable disease out of 22 evaluable patients.
Our wholly owned subsidiary, BioLineRx USA, Inc., was incorporated in Delaware on January 4, 2008, and is located at 77 Fourth Ave, Waltham, Massachusetts 02451, and its telephone number is (617) 859-6409. We were founded in 2003 by leading institutions in the Israeli life sciences industry.
Our wholly owned subsidiary, BioLineRx USA, Inc., was incorporated in Delaware on January 4, 2008, and is located at 77 Fourth Ave, Waltham, Massachusetts 02451. We were founded in 2003 by leading institutions in the Israeli life sciences industry.
Before “motixafortide” was approved by the World Health Organization, or WHO, in 2019 as an International Nonproprietary Name, this therapeutic candidate was known as “BL-8040”. In October 2021, we received WHO approval of the United States Adopted Name, or USAN, “motixafortide”.
Before “motixafortide” was approved by the World Health Organization, or WHO, in 2019 as an International Nonproprietary Name, this therapeutic candidate was known as “BL-8040”. In October 2021, we received WHO approval of the United States Adopted Name, or USAN, “motixafortide”. The FDA-approved trade or brand name of motixafortide is APHEXDA.
We recently determined to terminate development of AGI-134 and provided notice of our intent to terminate the Agalimmune Development Agreement effective March 15, 2024.
In December 2023, we determined to terminate development of AGI-134 and provided notice of our intent to terminate the Agalimmune Development Agreement effective March 15, 2024.
The European Medicines Agency, or EMA, plays a key role in ensuring that GCP standards are applied across the European Economic Area, or EEA in cooperation with the member states. It also manages a database of clinical trials carried out in the EU. 43 Clinical trials in the EU are regulated under Regulation (EU) 536/2014 (CTR).
The European Medicines Agency, or EMA, plays a key role in ensuring that GCP standards are applied across the European Economic Area, or EEA, in cooperation with the member states. It also manages a database of clinical trials carried out in the EU.
We also have the same pending logo trademarks in Canada, Korea and the USA and the same pending textual trademarks in Canada and Korea. We further have pending textual and 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. We also claim common law protections for other marks we use in our business.
For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; and established the Center for Medicare & Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending. 48 We expect that future changes or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States.
For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; and established the Center for Medicare & Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
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.
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.
Certain medicinal products (e.g., products derived from biotechnology, orphan medicinal products and medicinal products for human use, which contain an active substance authorized in the Union after 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes) must be authorized centrally.
Certain medicinal products (e.g., products derived from biotechnology, advanced-therapy medicinal products, orphan medicinal products and medicinal products for human use, which contain an active substance authorized in the European Union after May 20, 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune diseases and other immune dysfunctions or viral diseases) must be authorized centrally.
Pancreatic Cancer Novel, emerging therapeutic approaches for targeting solid tumors in oncology are being developed and tested. Combinational therapies of immune checkpoint inhibitors with immuno-oncology supporting agents, with or without chemotherapy, are among the most promising experimental treatments for solid malignancies. Pancreatic cancer has a low rate of early diagnosis, a high mortality rate and a poor five-year survival prognosis.
Combinational therapies of immune checkpoint inhibitors with immuno-oncology supporting agents, with or without chemotherapy, are among the most promising experimental treatments for solid malignancies. Pancreatic cancer has a low rate of early diagnosis, a high mortality rate and a poor five-year survival prognosis.
Reddy’s Laboratories Ltd, Teva Pharmaceuticals USA Inc, Zydus Pharmaceuticals USA Inc, MSN Laboratories Private Ltd, Eugia Pharma Specialities Ltd, Amneal EU Ltd and Kindos Pharmaceuticals Co Ltd.
Reddy’s Laboratories Ltd, Teva Pharmaceuticals USA Inc, Zydus Pharmaceuticals USA Inc, MSN Laboratories Private Ltd, Eugia Pharma Specialities Ltd, Amneal EU Ltd, Gland Pharma Ltd. and Meitheal Pharmaceuticals Inc.
Out Licensing of Motixafortide in Asia On August 27, 2023, we entered into a License Agreement, or the License Agreement, with Hong Seng Technology Limited, or HST, and Guangzhou Gloria Biosciences Co., Ltd., or Gloria, and/or with HST, the 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 Territory, and to engage and authorize Gloria to perform services under the License Agreement in the Territory. 29 Pursuant to the terms of the License Agreement, the Licensee made a $15 million upfront payment in October 2023, upon the closing of the transaction.
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.
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.
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.
Furthermore, EU good pharmacovigilance practice (GVP) rules apply. With the amended pharmacovigilance requirements, the financial and organizational burden on market authorization holders increased significantly, such as the obligation to maintain a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.
With the amended pharmacovigilance requirements, the financial and organizational burden on market authorization holders increased significantly, such as the obligation to maintain a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC (as amended on January 1, 2025) or Regulation (EC) No 726/2004 (as amended on January 28, 2022).
The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function.
The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.
A marketing authorization may either be granted in a national procedure, or in a coordinated procedure of several member states pursuant to Directive 2001/83/EC, as amended, or under the centralized EU procedure in accordance with Regulation (EC) No. 726/2004, as amended, or its predecessor, Regulation 2309/93.
A marketing authorization may either be granted in a national procedure, or in a coordinated procedure of several member states pursuant to Directive 2001/83/EC, as amended on January 1, 2025, or under the centralized EU procedure in accordance with Regulation (EC) No. 726/2004, as amended on January 28, 2022.
We are also 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 is expected later in 2024 and study initiation in 2025. See “Item 4.B.
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 a full right of offset for amounts payable to the IIA for motixafortide from 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.
In March 2023, we entered into a clinical collaboration with Washington University School of Medicine in St. 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 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.
In addition, any sublicense of ours will terminate provided that, upon such termination and at the request of the sublicensee, Biokine will be required to enter into a separate license agreement with the sublicensee on substantially the same terms as those contained in the applicable sublicense agreement. 36 BL-5010 In November 2007, we in-licensed the rights to develop and commercialize BL-5010 under a license agreement with IPC.
In addition, any sublicense of ours will terminate provided that, upon such termination and at the request of the sublicensee, Biokine will be required to enter into a separate license agreement with the sublicensee on substantially the same terms as those contained in the applicable sublicense agreement.
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 .
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 private placement closed in October 2023. No warrants were issued in the transaction. The License Agreement includes various development obligations for the Licensee pursuant to an agreed-upon development plan, including the execution of a registrational study in stem-cell mobilization and the execution of a randomized Phase 2b study in first-line pancreatic adenocarcinoma.
The Gloria License Agreement includes various development obligations for the Gloria Licensee pursuant to an agreed-upon development plan, including the execution of a registrational study in stem-cell mobilization and the execution of a randomized Phase 2b study in first-line pancreatic adenocarcinoma.
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 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).
One of the member states will take the lead in evaluating the application as Reference Member State. The Reference Member State should prepare an assessment report that is then used to facilitate agreement with the Concerned Member States and the grant of a national marketing authorization in all of these member states.
One of the member states will take the lead in evaluating the application as Reference Member State to facilitate agreement with the Concerned Member States and the grant of a national marketing authorization in all of these member states.
Under the agreement, IPC granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell certain technology relating to an acid-based formulation for the non-surgical removal of skin lesions and the uses thereof.
BL-5010 In November 2007, we in-licensed the rights to develop and commercialize BL-5010 under a license agreement with IPC. Under the agreement, IPC granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell certain technology relating to an acid-based formulation for the non-surgical removal of skin lesions and the uses thereof.
The Agalimmune Development Agreement provides the selling shareholders with a reversionary option, in the event of certain triggering events, including termination by us, that permits the selling shareholders to re-acquire our equity interests in Agalimmune for nominal consideration. We are currently awaiting Agalimmune’s founders’ decision whether to exercise its reversionary option right.
The Agalimmune Development Agreement provides the selling shareholders with a reversionary option, in the event of certain triggering events, including termination by us, that permits the selling shareholders to re-acquire our equity interests in Agalimmune for nominal consideration.
Our Product Pipeline The table below summarizes key information about our products and our clinical programs: Motixafortide Motixafortide, is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which we are developing for the treatment of stem cell mobilization and solid tumors.
Information on the Company — In-Licensing Agreements.” Our Product Pipeline The table below summarizes key information about our products and our clinical programs: Motixafortide Motixafortide is a novel, short peptide that functions as a high-affinity antagonist of CXCR4, used in the treatment of stem cell mobilization and solid tumors.
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 Ltd., a private U.K.-based company.
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.
Our resources are focused on advancing our therapeutic candidates through development and toward commercialization. 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.
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.
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.
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.
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 February 2025.
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.
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.
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.
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.
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.
The country in which the national marketing authorization has been granted acts as the Reference Member State, and the other countries concerned (Concerned Member States) can, upon successful completion of the procedure, recognize the marketing authorization. The assessment time is 180 days plus 30 days.
The country in which the national marketing authorization has been granted acts as the “Reference Member State,” and the other countries concerned (Concerned Member States) can, upon successful completion of the procedure, recognize the marketing authorization.
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.
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.
We are also pursuing patent protection for other drug candidates in our pipeline. Patents related to our therapeutic candidates may provide future competitive advantages by providing exclusivity related to the composition of matter, formulation, and method of administration of the applicable compounds and could materially improve the value of our therapeutic candidates.
Patents related to our therapeutic candidates may provide future competitive advantages by providing exclusivity related to the composition of matter, formulation, and method of administration of the applicable compounds and could materially improve the value of our therapeutic candidates.
In October 2020, we announced positive results from the interim analysis. Based on the statistically significant evidence favoring treatment with motixafortide, the study’s independent DMC issued a recommendation to us that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.
Based on the statistically significant evidence favoring treatment with motixafortide, the study’s independent DMC issued a recommendation to us that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s recommendation, study enrollment was completed at 122 patients.
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 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.
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.
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.
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.
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.
Our capital expenditures for the year ended December 31, 2021 were immaterial and were $0.3 million for each of the years ended December 31, 2022 and 2023. Our current capital expenditures involve acquisitions of laboratory equipment, computers and communications equipment.
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.
Centralized Procedure (CP) The Centralized Procedure according to Regulation 726/2004/EC 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.
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.
In February 2024, Ipsen’s Onivyde® obtained approval in first line PDAC in the NALIRIFOX regimen based on phase III NAPOLI -3. Oncologists have limited options of existing therapies for second-line metastatic patients. The only FDA-approved second-line treatment is Onivyde ® in combination with 5FU and LV for gemcitabine-treated patients.
In the first line setting, Gemcitabine in combination with Abraxane® or FOLFIRINOX regimen are the current standard of care. In February 2024, Ipsen’s Onivyde® obtained approval in first line PDAC in the NALIRIFOX regimen based on phase III NAPOLI -3. Oncologists have limited options of existing therapies for second-line metastatic patients.
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.
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.
The trial's primary endpoint is progression free survival. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. In February 2024, the first patient was dosed.
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.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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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; 53 • the development stage of the therapeutic candidate; and • the efficacy and safety profile of the therapeutic candidate.
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.
All of our in-licensing agreements are terminable at-will by us upon prior written notice of 30 to 90 days. We are unable at this time to estimate the actual amount or timing of the costs we will incur in the future under these agreements. See “Item 4. Information on the Company — Business Overview — In-Licensing Agreements.” 59 C.
All of our in-licensing agreements are terminable at-will by us upon prior written notice of 30 to 90 days. We are unable at this time to estimate the actual amount or timing of the costs we will incur in the future under these agreements. See “Item 4. Information on the Company — Business Overview — In-Licensing Agreements.” C.
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, risk-free interest rates, estimated life of the equity instruments issued and the market price of our shares.
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.
Therefore, our cash flow projections are subject to various risks and uncertainties concerning their fulfilment, and these factors and the risk inherent in our operations, which management has concluded indicate that a material uncertainty exists, may cast significant doubt on our ability to continue as a going concern.
Our cash flow projections are subject to various risks and uncertainties concerning their fulfilment, and these factors and the risk inherent in our operations, which management has concluded indicate that a material uncertainty exists, may cast significant doubt on our ability to continue as a going concern.
As actual costs become known to us, we adjust our accruals. 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.
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.
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 received from the IIA, and interest earned on investments.
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.
The transaction closed in September 2022. In September 2021, we entered into the ATM Agreement with HCW pursuant to which we may offer and sell, at our option, up to $25.0 million of our ADSs through an at-the-market equity program under which HCW agreed to act as sales agent.
In September 2021, we entered into the ATM Agreement with HCW pursuant to which we may offer and sell, at our option, up to $25.0 million of our ADSs through an at-the-market equity program under which HCW agreed to act as sales agent.
The revenues in 2023 (all of which were recorded in the fourth quarter of 2023) primarily reflect a portion of the up-front payment received by us for the License Agreement, of which $4.6 million was recognized in 2023, as well as $0.2 million of revenues from product sales of APHEXDA in the U.S.
The revenues in 2023 (all of which were recorded in the fourth quarter of 2023) primarily reflect a portion of the up-front payment received by us for the Gloria License Agreement, of $4.6 million, as well as $0.2 million of revenues from product sales of APHEXDA in the U.S.
Similarly, our independent registered public accounting firm included a “going concern” explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2023. Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.
Similarly, our independent registered public accounting firm included a “going concern” explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2024. Developing drugs and conducting clinical trials is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.
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.
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.
Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 5 (45%) 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%.
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%.
Net cash provided by investing activities was $1.4 million for the year ended December 31, 2023, compared to net cash provided by investing activities of $4.0 million for the year ended December 31, 2022. The changes in cash flows from investing activities relate primarily to investments in, and maturities of short-term bank deposits.
Net cash provided by investing activities was $29.4 million for the year ended December 31, 2024, compared to net cash provided by investing activities of $1.4 million for the year ended December 31, 2023. The changes in cash flows from investing activities relate primarily to investments in, and maturities of short-term bank deposits.
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 Kreos Capital; bank fees and other transactional costs.
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.
We expect to continue to fund our operations over the next several years through our existing cash resources, the commercialization of APHEXDA, potential future milestone and royalty payments that we may receive from our existing out-licensing agreement, potential future upfront, milestone or royalty payments that we may receive from 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.
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.
We are a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases.
We are a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases.
Our primary commercialization pipeline consists of 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.
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.
Key Information — Risk Factors.” Our discussion and analysis for the year ended December 31, 2021 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, 2022, filed with the SEC on March 22, 2023 (File No. 001-35223).
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).
Liquidity and Capital Resources Since our inception, we have funded our operations primarily through public and private offerings of our equity securities, payments received under our strategic licensing and collaboration arrangements, interest earned on investments and funding from the IIA. As of December 31, 2023, we held $43.0 million of cash, cash equivalents and short-term bank deposits.
B. Liquidity and Capital Resources Since our inception, we have funded our operations primarily through public and private offerings of our equity securities, payments received under our strategic licensing and collaboration arrangements, interest earned on investments and funding previously received from the IIA. As of December 31, 2024, we held $19.6 million of cash, cash equivalents and short-term bank deposits.
Net cash provided by financing activities was $15.1 million for the year ended December 31, 2023, compared to net cash provided by financing activities of $20.4 million for the year ended December 31, 2022.
Net cash provided by financing activities was $20.7 million for the year ended December 31, 2024, compared to net cash provided by financing activities of $15.1 million for the year ended December 31, 2023.
Our future capital requirements will depend on many factors, including: • the progress and costs of our preclinical studies, clinical trials and other research and development activities; • the scope, prioritization and number of our clinical trials and other research and development programs; • the amount of revenues we receive, if any, under our collaboration or licensing arrangements; • the costs of the development and expansion of our operational infrastructure; • the costs and timing of obtaining regulatory approval of our therapeutic candidates; • our success in effecting out-licensing arrangements with third parties; 58 • the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing agreements; • the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; • the costs and timing of securing manufacturing arrangements for clinical or commercial production; • the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us; • the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates; • the magnitude of our general and administrative expenses; • interest and principal payments on the loan from Kreos Capital; • any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; • market conditions; • payments to the IIA; and • the impact of any resurgence of the COVID-19 pandemic, the Russian invasion of Ukraine, and the military campaigns by Israel against Hamas and other terrorist organizations (including the declaration of war by Israel against Hamas), which may exacerbate the magnitude of the factors discussed above.
Our future capital requirements will depend on many factors, including: • the progress and costs of our preclinical studies, clinical trials and other research and development activities; • the scope, prioritization and number of our clinical trials and other research and development programs; • the amount of revenues we receive, if any, under our collaboration or licensing arrangements; • the costs of the development and expansion of our operational infrastructure; • the costs and timing of obtaining regulatory approval of our therapeutic candidates; • our success in effecting out-licensing arrangements with third parties; • the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing agreements; • the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; • the costs and timing of securing manufacturing arrangements for clinical or commercial production; • the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us; • the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates; • the magnitude of our general and administrative expenses; • interest and principal payments on the loan from BlackRock; • any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; and • market conditions.
We expect to also continue to seek to finance our operations through other sources, including commercialization in the United States for APHEXDA, out-licensing arrangements for the development and commercialization of our therapeutic candidates or other partnerships or joint ventures, as well as grants from government agencies and foundations.
We expect to also continue to seek to finance our operations through other sources, including out-licensing arrangements for the development and commercialization of our therapeutic candidates or other partnerships or joint ventures, public and private offerings of our equity securities, as well as grants from government agencies and foundations.
We expect our revenues, if any, for the next several years to be derived primarily from the independent commercialization of APHEXDA in stem cell mobilization in the U.S. and milestone payments from the license agreement with HST and Gloria, including future royalties on product sales from such out-licensing agreements.
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.
The warrant is exercisable for a period of ten years from the date of issuance. 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.
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.
Non-operating income for the year ended December 31, 2022 primarily relates to non-cash, fair-value adjustments of warrant liabilities on our balance sheet, offset by warrant offering expenses.
Non-operating income for the year ended December 31, 2024 primarily relates to non-cash fair-value adjustments of warrant liabilities on our balance sheet, as a result of changes in our share price, offset by warrant offering expenses. Non-operating expenses for the year ended December 31, 2023 primarily relates to non-cash, fair-value adjustments of warrant liabilities on our balance sheet.
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. We also issued warrants to purchase 681,818 ADSs at an exercise price of $1.375 per ADS.
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.
We expect our cost of revenues, if any, for the next several years to be derived primarily from the costs associated with the manufacture of APHEXDA, royalties payable to the licensors stemming from direct product sales related to the independent commercialization as set forth above, as well as 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.
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.
Based on our current projected cash requirements, we believe that our existing cash and investment balances and other sources of liquidity, including net product revenues from product sales of APHEXDA and milestone payments from the License Agreement, will be sufficient to meet our capital requirements into 2025.
Based on our current projected cash requirements, we believe that our existing cash and investment balances and other sources of liquidity, including royalties received from Ayrmid from product sales of APHEXDA and milestone payments from our license agreements with Ayrmid and Gloria, will be sufficient to meet our capital requirements through the second half of 2026.
As of December 31, 2023, we held $43.0 million of cash, cash equivalents and short-term bank deposits. Revenues Our revenues to date have been generated primarily from milestone payments under out-licensing agreements and more recently, revenues from product sales of APHEXDA.
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.
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.
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.
In connection with an underwritten public offering we completed in January 2021, we issued warrants to purchase 718,750 ADSs at an exercise price of $3.00 per ADS. The warrants are exercisable for a period of five years from the date of issuance. The warrants have been classified as shareholder’s equity.
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.
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.
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.
Research and development expenses Research and development expenses for the year ended December 31, 2023 were $12.5 million a decrease of $5.1 million, or 29.0% compared to $17.6 million for the year ended December 31, 2022.
Research and development expenses Research and development expenses for the year ended December 31, 2024 were $9.2 million, a decrease of $3.3 million, or 26.4% compared to $12.5 million for the year ended December 31, 2023.
Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in conformity with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. 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.
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.
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. The warrants expired in February 2024.
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. The pre-funded warrants have been classified as equity instruments.
In connection with a registered direct offering we completed in September 2022, we issued warrants to purchase 13,636,365 ADSs at an exercise price of $1.15 per ADS, of which warrants to purchase 2,545,455 have been exercised. The warrants were exercisable for a period of five years from the date of issuance.
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.
As of the issuance date of this report, we have sold 2,109,858 of our ADSs for total gross proceeds of approximately $4.4 million under the ATM program.
As of the issuance date of this Annual Report on Form 20-F, we have sold 141,910 of our ADSs for total gross proceeds of approximately $19.0 million under the ATM program.
We expect our research and development expenses to remain one of our primary expenses in the near future as we continue to develop motixafortide. 52 The following table identifies our current major research and development projects: Project Status Expected Near Term Milestones motixafortide 1. FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients. 1.
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.
If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts.
If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. 69 Contractual Obligations We are party to contractual obligations involving commitments to make payments to third parties. Our contractual obligations primarily consist of lease payments and purchase order obligations.
As our ordinary shares are publicly traded on the TASE, we do not need to estimate their fair market value.
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.
Cost of revenues Cost of revenues for the year ended December 31, 2023 was $3.7 million. We did not record any cost of revenues for the year ended December 31, 2022. The cost of revenues in 2023 primarily reflects Biokine’s share of the up-front payment received by us for the License Agreement and of the net sales.
The cost of revenues in 2023 primarily reflects Biokine’s share of the up-front payment received by us for the Gloria License Agreement and of the net sales.
Non-operating expense and income also includes issuance expenses of an “at-the-market” offering agreement, or ATM Agreement, between us and H.C. Wainwright & Co., LLC, or HCW, entered into in September 2021, and the pro-rata share of issuance expenses from the placements related to the warrants.
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.
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. Our strategy includes commercializing our therapeutic candidates by way of out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on a case-by-case basis, the commercialization of our therapeutic candidates independently.
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.
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 and commercialization plans.
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.
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. The warrants expired in November 2022.
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.
Net cash used in operating activities was $22.6 million for the year ended December 31, 2023, compared with net cash used in operating activities of $26.2 million for the year ended December 31, 2022.
The Company has also granted BlackRock certain information rights. Cash Flows Net cash used in operating activities was $43.9 million for the year ended December 31, 2024, compared with net cash used in operating activities of $22.6 million for the year ended December 31, 2023.
While we are currently focused on the U.S. commercialization of motixafortide, and a life-cycle expansion and management program for other therapeutic indications for motixafortide, our future research and development expenses will depend on the clinical success of motixafortide in these other indications, and of each therapeutic candidate, as well as ongoing assessments of each therapeutic candidate’s commercial potential.
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.
Management monitors rolling forecasts of our liquidity reserves on the basis of anticipated cash flows and maintains liquidity balances at levels that are sufficient to meet its needs. The execution of an independent commercialization plan for motixafortide in the United States implies an increased level of expenses prior to and following launch of the product.
In this regard, management monitors rolling forecasts of our liquidity reserves on the basis of anticipated cash flows and seeks to maintain liquidity balances at levels that are sufficient to meet its needs.
Non-operating income (expense), net We recognized net non-operating expenses of $10.8 million for the year ended December 31, 2023 compared to net non-operating income of $5.7 million for the year ended December 31, 2022. Non-operating expenses for the year ended December 31, 2023 primarily relates to non-cash, fair-value adjustments of warrant liabilities on our balance sheet.
Non-operating income (expense), net We recognized net non-operating income of $18.4 million for the year ended December 31, 2024 compared to net non-operating expenses of $10.8 million for the year ended December 31, 2023.
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 more recently, costs associated with the manufacture of APHEXDA. Prior to receiving FDA approval for APHEXDA in September 2023, we expensed such manufacturing and material costs as research and development expenses.
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.
In connection with a public offering we completed in February 2019, we issued warrants to purchase 1,866,667 ADSs at an exercise price of $11.25 per ADS. The warrants were exercisable for a period of five years from the date of issuance.
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.
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. The warrants expired in November 2022.
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.
Under our in-licensing agreements, we are obligated to make certain payments to our licensors upon the achievement of agreed-upon milestones.
In addition, under our in-licensing agreements, we are obligated to make certain payments to our licensors upon the achievement of agreed-upon milestones and receipt of royalties. We are unable at this time to estimate the actual amount or timing of the costs we will incur in the future under these agreements.
We expect to continue to generate losses in connection with our research and development activities relating to our pipeline of therapeutic candidates and commercialization of APHEXDA until we reach commercial profitability, if ever. Such research and development and commercialization activities are budgeted to expand over time and will require further resources if we are to be successful.
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.
We did not record any impairment of intangible assets for the year ended December 31, 2022. This non-cash expense in 2023 reflects the impairment of the intellectual property related to AGI-134 resulting from our decision to terminate its development.
This non-cash expenses in 2024 reflects the impairment of the remaining rights related to motixafortide in solid tumor indications. This non-cash expenses in 2023 reflects the impairment of the intellectual property related to AGI-134 resulting from our decision to terminate its development.
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. 54 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”.
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”.
Financial income (expense), net We recognized net financial expenses of $0.1 million for the year ended December 31, 2023 compared to net financial expenses of $1.5 million for the year ended December 31, 2022. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on our bank deposits. B.
Financial income (expense), net We recognized net financial expenses of $7.3 million for the year ended December 31, 2024 compared to net financial expenses of $0.1 million for the year ended December 31, 2023.
The $3.6 million decrease in net cash used in operating activities in 2023 was primarily the result of increases in contract liabilities as well as accounts payable and accruals, partially offset by an increase in sales and marketing expenses.
The $21.3 million increase in net cash used in operating activities in 2024 was primarily the result of a decrease in contract liabilities resulting from deferred revenues as of December 31, 2023 that were recognized during 2024, a decrease in accounts payable and accruals, and a decrease in research and development expenses as described above.
Based on these encouraging results, study was substantially revised to a multi-institution, randomized trial of 108 patients 2. First patient dosed in February 2024 and currently enrolling* 3. Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections 3. Data from the study is anticipated in 2024* 4.
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.
Phase 1 study for gene therapies in SCD 4. First patient does in December 2023 and data from the study is expected in the second half of 2024* 5. Pivotal bridging study in SCM in China under license agreement with Gloria 5. Initiation of the study is expected in second half of 2024 6.
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.
The increase resulted primarily from the ramp-up of pre-commercialization and commercialization activities related to motixafortide. General and administrative expenses General and administrative expenses for the year ended December 31, 2023 were $6.3 million, an increase of $1.2 million, or 24.6% compared to $5.1 million for the year ended December 31, 2022.
General and administrative expenses General and administrative expenses for the year ended December 31, 2024 were $6.3 million, similar to the year ended December 31, 2023. 66 Impairment of intangible assets Impairment of intangible assets expenses for the year ended December 31, 2024 were $1.0 compared to impairment of intangible assets expenses of $6.7 million for the year ended December 31, 2023.
Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria 6. IND submission and protocol finalization expected in 2024 and study initiation in 2025 *These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent investigators and are subject to change.
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.
In connection with a registered direct offering we completed in June 2020, we issued warrants to purchase 2,510,286 ADSs at an exercise price of $2.25 per ADS and also issued warrants to purchase 125,514 ADSs at an exercise price of $2.1875 per ADS. The warrants were exercisable for a period of two and one-half years from the date of issuance.
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.
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. As of December 31, 2023, we had an accumulated deficit of $391 million.
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).
In connection with a registered direct offering we completed in May 2020, we issued warrants to purchase 5,142,859 ADSs at an exercise price of $2.25 per ADS and also issued warrants to purchase 257,143 ADSs at an exercise price of $2.1875 per ADS. The warrants were exercisable for a period of two and one-half years from the date of issuance.
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.
The cash flows in 2023 primarily reflect the private placement of ADSs to HST and Gloria, warrant exercises and net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital and the repayments of lease liabilities.
The cash provided by financing activities in 2023 primarily reflects the private placement of ADSs to HST and Gloria, warrant exercises, and net proceeds from the ATM facility, offset in part by repayments of the loan from BlackRock and the repayments of lease liabilities. 68 Funding Requirements We have incurred accumulated losses in the amount of $400 million through December 31, 2024, and we expect to continue incurring losses and negative cash flows from operations until the cash flows from our strategic partnerships reach a level to offset our ongoing development costs.
The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide, as well as lower expenses associated with the completion of the AGI-134 study. 56 Sales and marketing expenses Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million, an increase of $18.8 million, or 291.1% compared to $6.5 million for the year ended December 31, 2022.
Sales and marketing expenses Sales and marketing expenses for the year ended December 31, 2024 were $23.6 million, a decrease of $1.7 million, or 6.7% compared to $25.3 million for the year ended December 31, 2023. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid License Agreement.
Commercialization ongoing 2. Reported data from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC.
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.
The warrants are exercisable for a period of five years from the date of issuance and have been classified as shareholder’s equity. Results of Operations – Overview Comparison of the Year Ended December 31, 2023 to the Year Ended December 31, 2022 Revenues Revenues for the year ended December 31, 2023 were $4.8 million.
Results of Operations – Overview Comparison of the Year Ended December 31, 2024 to the Year Ended December 31, 2023 Revenues Revenues for the year ended December 31, 2024 were $28.9 million, an increase of $24.1 million, or 502.1% compared to $4.8 million for the year ended December 31, 2023.
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, May-June 2020 and September 2022. These fair-value adjustments are highly influenced by our share price at each period end (revaluation date).
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.
General and Administrative Expenses General and administrative expenses consist primarily of compensation for employees in executive and operational functions, including accounting, finance, legal, compliance, investor relations, information technology and human resources. Other significant general and administration costs include facilities costs, professional fees for outside accounting and legal services, travel costs, insurance premiums and depreciation.
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.
Under the Loan Agreement, Kreos Capital will provide the Company with access to term loans in an aggregate principal amount of up to $40 million in three tranches as follows: (a) a loan in the aggregate principal amount of up to $10 million, available for drawdown upon closing of the Loan Agreement and until April 1, 2023, (b) a loan in the aggregate principal amount of up to $20 million, available for drawdown upon achievement of certain milestones and until April 1, 2024, and (c) a loan in the aggregate principal amount of up to $10 million, available for drawdown upon achievement of certain milestones and until October 1, 2024.
Loan Agreements with BlackRock In September 2022, we entered into a secured Loan Agreement with BlackRock, under which BlackRock agreed to provide us with access to term loans in an aggregate principal amount of up to $40 million in three tranches, or the Loans.
We seek to develop and commercialize a pipeline of promising therapeutic candidates that exhibit distinct advantages over currently available therapies or address unmet medical needs. Our resources are focused on advancing our therapeutic candidates through development and toward commercialization.
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.
The cash flows in 2022 primarily reflect the underwritten public offering of our ADSs in September 2022 and the net proceeds of a loan from Kreos Capital, offset by repayment of a previous loan from Kreos Capital.
The cash provided by financing activities in 2024 primarily reflects the net proceeds of the loan from BlackRock and the net proceeds of registered direct offerings of our ADSs in April 2024 and in November 2024, offset by repayments of the loan from BlackRock and the repayments of lease liabilities.
Removed
We are also advancing the development of motixafortide for patients with sickle cell disease, pancreatic cancer and other solid tumors. In addition, we have an off-strategy, legacy therapeutic product called BL-5010 for the treatment of skin lesions.
Added
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
In this regard, we are currently executing on an independent commercialization plan for APHEXDA in stem cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.
Added
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
With headquarters and development operations in Israel, and commercialization operations in the U.S., we are driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside. 51 A.
Added
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
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.

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Item 6. [Reserved]

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

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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 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.
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 also subject to the discretion of our Compensation Committee and approval by the board of directors.
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.
Equity grants made under the Plan to eligible employees and office holders who are Israeli residents are made under Section 102 of the Israeli Income Tax Ordinance [New Version], 5721-1961, or the Income Tax Ordinance, pursuant to which the securities granted must be allocated or issued to a trustee and be held in trust for two years from the date of grant.
Equity grants made under the Plan to eligible employees and office holders who are Israeli residents are made under Section 102 of the Israeli Income Tax Ordinance [New Version], 5721-1961, or the Israeli Tax Ordinance, pursuant to which the securities granted must be allocated or issued to a trustee and be held in trust for two years from the date of grant.
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; • 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; 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.
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; 74 • 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.
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 transaction 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 transaction 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.
See “— Approval of Related Party Transactions under Israeli Law.” 66 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.” 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.
Furthermore, a person who is directly or indirectly subordinate to a chief executive officer of a company may not serve as the chairperson of the board of directors of that company and the chairperson of the board of directors may not otherwise serve in any other capacity in a company or in a subsidiary of that company other than as a director or the chairperson of the board of directors of such a subsidiary.
Furthermore, a person who is directly or indirectly subordinate to a chief executive officer of a public company may not serve as the chairperson of the board of directors of that company and the chairperson of the board of directors of a public company may not otherwise serve in any other capacity in that company or a subsidiary of that company other than as a director or the chairperson of the board of directors of such a subsidiary.
Compensation Employment 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 by our shareholders in July 2022.
(LLB, LLM), a director at Deloitte Israel. 69 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.
(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.
As of the date of this Annual Report on Form 20-F, except as disclosed in Item 8.A below, no claims have been filed under our directors’ and officers’ liability insurance policy, there is no pending litigation or proceeding against any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer. 75 D.
As of the date of this Annual Report on Form 20-F, except as disclosed in Item 8.A below, no claims have been filed under our directors’ and officers’ liability insurance policy, there is no pending litigation or proceeding against any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.
Transactions concerning the terms of engagement of a controlling shareholder or a controlling shareholder’s relative, whether as an office holder or an employee, require the approval of the compensation committee, the board of directors and the shareholders, in that order.
Transactions concerning the compensation terms of a controlling shareholder or a controlling shareholder’s relative, whether as an office holder or an employee, require the approval of the compensation committee, the board of directors and the shareholders, in that order.
Major Shareholders and Related Party Transactions - Related Party Transactions - Gloria License Agreement and Securities Purchase Agreement.” 62 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.” Gal Cohen, MBA, has served on our board of directors since December 2023. Mr.
The table does not include any amounts we paid to reimburse any of such persons for costs incurred in providing us with services during this period.
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.
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.
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.
Our directors are divided among three classes as follows: • the Class I directors, consisting of Dr. Avraham Molcho, Mr. Rami Dar and Gal Cohen, will hold office until our annual general meeting of shareholders to be held in 2024; • the Class II directors, consisting of Dr. B.J. Bormann and Dr.
Our directors are divided among three classes as follows: • the Class I directors, consisting of Dr. Avraham Molcho, Mr. Rami Dar and Gal Cohen, will hold office until our annual general meeting of shareholders to be held in 2027; • the Class II directors, consisting of Dr. B.J. Bormann and Dr.
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, 2023.
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.
From January 2008 to August 2008, Mr. Serlin served as the Chief Financial Officer and Chief Operating Officer of Kayote Networks Inc. From January 2006 to December 2007, Mr. Serlin served as the Chief Financial Officer of Tescom Software Systems Testing Ltd., an IT services company publicly traded in both Tel Aviv and London. Mr.
Serlin served as the Chief Financial Officer and Chief Operating Officer of Kayote Networks Inc. From January 2006 to December 2007, Mr. Serlin served as the Chief Financial Officer of Tescom Software Systems Testing Ltd., an IT services company publicly traded in both Tel Aviv and London. Mr.
References below to the “Plan” refer to the Plan as amended in August 2013, January 2016 and November 2023. The Plan provides for the granting of options, ordinary shares, RSUs and PSUs to our directors, employees, consultants and service providers, and to the directors, employees, consultants and service providers of our subsidiaries and affiliates.
References below to the “Plan” refer to the Plan as amended in August 2013, January 2016, November 2023 and May 2024. The Plan provides for the granting of options, ordinary shares, RSUs and PSUs to our directors, employees, consultants and service providers, and to the directors, employees, consultants and service providers of our subsidiaries and affiliates.
According to our Articles of Association, our board of directors must consist of at least five and not more than 10 directors, including external directors under Israeli law (if any). Currently, our board of directors consists of nine directors. Our board of directors has determined that each of our directors other than Mr.
According to our Articles of Association, our board of directors must consist of at least five and not more than 10 directors, including external directors under Israeli law (if any). Currently, our board of directors consists of eight directors. Our board of directors has determined that each of our directors other than Mr.
Disclosure of personal interests of an office holder and approval of acts and transactions The Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may have and all related material information or documents relating to any existing or proposed transaction by the company, and in any event no later than the first meeting of the board of directors at which the transaction is considered.
Disclosure of personal interests of an office holder The Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may have and all related material information or documents relating to any existing or proposed transaction by the company, and in any event no later than the first meeting of the board of directors at which the transaction is considered.
For additional 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. 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.
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.
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.
December 31, 2021 2022 2023 Management and administration 9 12 12 Research and development 27 29 29 Commercialization and business development 2 8 38 Total 38 49 79 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.
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.
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.
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.
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 25, 2024. 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 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.
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.
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.
Approval of terms of office and employment for the chief executive officer which do not comply with the compensation policy may nonetheless be approved 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 Requirements, as detailed above.
Approval of the compensation terms of a chief executive officer 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 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. 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. 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.
Approval of terms of office and employment for directors of a company which do not comply with the compensation policy may nonetheless be approved 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 Requirements, as detailed above.
Approval of terms of office and employment for such officers 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 a compensation policy, and (ii) the shareholders of the company have approved the terms by the Special Majority for Compensation .
Cohen has served since April 2020 as Chairman of the board of directors and Chief Executive Officer of Quark Pharmaceuticals, Inc., and also serves on the boards of directors of Ayana Pharma Ltd. and Silver Castle Holdings Ltd (TASE: SLCL). From November 2006 to May 2019, Mr.
Cohen serves on the boards of directors of Ayana Pharma Ltd. and Silver Castle Holdings Ltd (TASE: SLCL) and from April 2020 to February 2024, served as Chairman of the board of directors and Chief Executive Officer of Quark Pharmaceuticals, Inc. From November 2006 to May 2019, Mr.
Investment Monitoring Committee Our board of directors has established an Investment Monitoring Committee which currently consists of the following three members: Mr. Rami Dar; a director, Ms. Mali Zeevi, our Chief Financial Officer; and Mr. Raziel Fried, our Treasurer and Budgetary Control Director.
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.
Our board of directors may change the amount of the fixed components for one or more of our executives after receiving a recommendation for such from our Compensation Committee, provided such change is within the limits determined by the Compensation Policy.
Our board of directors may change the amount of the fixed components for one or more of our executives after receiving a recommendation for such from our Compensation Committee, provided such change is within the limits determined by the Compensation Policy and subject to applicable law.
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 Ld. Executive Officer Clawback Policy during the fiscal year ended December 31, 2023.
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.
However, pursuant to the Relief Regulations, the foregoing shareholder approval requirements shall not apply to a company whose shares are listed on a foreign exchange referenced in the second or third addendum to the Israeli Securities Law, 5728-1968, or the Israeli Securities Law, (which include, among others, the NASDAQ Capital Market), if the law of the foreign jurisdiction sets forth requirements regarding the approval of private placements and the company complies with such requirements as they apply to companies incorporated in such foreign jurisdiction.
However, pursuant to the Relief Regulations, the foregoing shareholder approval requirements shall not apply to a company whose shares are listed on an exchange outside Israel or dual listed on the TASE and a foreign exchange referenced in the second or third addendum to the Israeli Securities Law (which include, among others, the Nasdaq), if the law of the foreign jurisdiction sets forth requirements regarding the approval of private placements and the company complies with such requirements as they apply to companies incorporated in such foreign jurisdiction.
Options generally expire 10 years from the grant date. If we terminate an employee’s employment or service for cause, all of the grantee’s vested and unvested equity awards expire immediately from the time of delivery of the notice of discharge, unless determined otherwise by the compensation committee or the board of directors.
If we terminate an employee’s employment or service for cause, all of the grantee’s vested and unvested equity awards expire immediately from the time of delivery of the notice of discharge, unless determined otherwise by the compensation committee or the board of directors.
However, a company’s compensation committee and board of directors, may, in special circumstances approve a transaction with a chief executive officer (who is not a director) that is not approved by shareholders despite shareholder rejection, provided that the company’s compensation committee and thereafter the board of directors have determined to approve the transaction, based on detailed reasoning, after each having re-discussed the terms of office and employment, and taken the shareholder rejection into consideration.
However, a company’s compensation committee and board of directors, may, in special circumstances approve the compensation of a chief executive officer (who is not a director) that is not approved by shareholders despite shareholder objection, provided that the company’s 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 office and employment, and after examining the objection of the shareholders.
Nonetheless, even if the shareholders of the company do not approve the compensation policy, the board of directors of a company may still approve the compensation policy, provided that the compensation committee and, thereafter, the board of directors determine, based on detailed, documented, reasons and after further discussion of the compensation policy, that the approval of the compensation policy in the best interest of the company.
Nonetheless, even if the shareholders of the company do not approve the compensation policy, the board of directors may still approve the compensation policy, provided that the compensation committee and, thereafter, the board of directors determine, based on detailed, documented, reasons and after further discussion of the compensation policy, that despite the objection of shareholders, the approval of the compensation policy is in the best interests of the company.
In addition, the compensation committee may exempt from shareholder approval the terms of office and employment of a candidate for the office of chief executive officer where such officer has no relationship with the controlling shareholder or the company, if it has found, based on detailed reasons, that bringing the transaction to the approval of the shareholders meeting shall prevent 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. 71 • 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. • Directors .
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 certain U.S. stock exchanges, including the Nasdaq Capital Market, 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.
(2) A member of our audit committee. (3) A member of our compensation committee. (4) A member of our investment monitoring committee 60 Philip A. Serlin, CPA, MBA, has served as our Chief Executive Officer since October 2016. From May 2009 to October 2016, Mr. Serlin served as our Chief Financial and Operating Officer.
(3) A member of our compensation committee. (4) A member of our investment monitoring committee Philip A. Serlin, CPA, MBA, has served as our Chief Executive Officer since October 2016. From May 2009 to October 2016, Mr. Serlin served as our Chief Financial and Operating Officer. From January 2008 to August 2008, Mr.
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.
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.
Under Section 102 of the Income Tax Ordinance, any tax payable by an employee from the grant of securities or the exercise of options or vesting of RSUs or PSUs is deferred until the transfer of the securities (or ordinary shares issued upon the exercise of options or the vesting of RSUs or PSUs) by the trustee to the employee or upon the sale of the securities or ordinary shares, as the case may be, and gains may qualify to be taxed as capital gains at a rate equal to 25%, subject to compliance with specified conditions. 78 Options and RSUs granted under the Plan generally vest over four years.
Under Section 102 of the Israeli Tax Ordinance, any tax payable by an employee from the grant of securities or the exercise of options or vesting of RSUs or PSUs is deferred until the transfer of the securities (or ordinary shares issued upon the exercise of options or the vesting of RSUs or PSUs) by the trustee to the employee or upon the sale of the securities or ordinary shares, as the case may be, and gains may qualify to be taxed as capital gains at a rate equal to 25%, subject to compliance with specified conditions.
Cohen holds a B.Sc. degree in Industrial Engineering and Management ( cum laude ) from the Technion-Israel Institute of Technology and an M.B.A. degree ( cum laude ) from Tel Aviv University. On March 25, 2024, Dr.
Cohen holds a B.Sc. degree in Industrial Engineering and Management ( cum laude ) from the Technion-Israel Institute of Technology and an M.B.A. degree ( cum laude ) from Tel Aviv University. B.
In addition, under 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.
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 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.
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.
Shaoyu Yan, will hold office until our annual general meeting of shareholders to be held in 2026. 64 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.
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.
The final adoption of the compensation policy is subject to the approval of the shareholders of the company by a majority vote of the shares present and voting at a shareholders meeting on the matter, subject to a certain special majority requirement, 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 • 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.
Nonetheless, the compensation committee and the board of directors may, in special circumstances, approve terms of office and compensation of a controlling shareholder that do not comply with the company’s compensation policy, provided that the compensation committee and, thereafter, the board of directors approve such terms, based on, among other things, the considerations and mandatory requirements with respect to a compensation policy set forth in the Companies Law.
Nonetheless, the compensation committee and the board of directors may, in special circumstances, approve a compensation arrangement of a controlling shareholder that does not comply with the company’s compensation policy, provided that (i) the compensation committee and, thereafter, the board of directors approve such terms, based on, among other things, the considerations and mandatory requirements with respect to a compensation policy set forth in the Companies Law and (ii) the shareholders have approved the terms by means of the Special Majority for Compensation.
Our board of directors has determined that Rami Dar has such financial and accounting expertise. Chairperson of the Board. Under the Companies Law, a person cannot hold the role of both chairperson of the board of directors and chief executive officer of a company, without shareholder approval by special majority and for periods of time not exceeding three years each.
Under the Companies Law, a person cannot hold the role of both chairperson of the board of directors and chief executive officer of a public company, without shareholder approval by a special majority and for periods of time not exceeding three years each.
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.
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. 85 Under the Companies Law and the regulations promulgated thereunder, exculpation, indemnification and insurance of office holders must be approved by the compensation committee and the board of directors and, with respect to the chief executive officer and a director, also by the shareholders.
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 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.
In January 2016, our board of directors approved amendments to the Plan in order to permit the granting of restricted share units, or RSUs, and PSUs to eligible grantees. In November 2023, our board of directors approved the extension of the term of the Plan for an additional six-month period, until May 2024.
In January 2016, our board of directors approved amendments to the Plan in order to permit the granting RSUs and PSUs to eligible grantees. In November 2023, our board of directors approved a six-month extension of the term of the Plan until May 2024 and, in May 2024, our board of directors approved a further extension until May 2044.
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 15, 2024, 17.7 million ordinary shares 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. As of March 16, 2025, 68.9 million ordinary shares, or 0.1 million ADSs, were reserved for future issuance under the Plan.
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 officer 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.
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 Companies Law does not describe the substance of this duty of fairness except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position in the company into account. 73 Exculpation, insurance and indemnification of office holders Under the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty.
The Companies Law does not describe the substance of this duty of fairness except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position in the company into account.
Bormann completed postdoctoral training at Yale Medical School in the department of pathology. 61 Raphael Hofstein, Ph.D., has served on our board of directors since 2003, our Audit Committee since 2007 and our Compensation Committee since 2012. Dr.
Bormann received her Ph.D. in biomedical science from the University of Connecticut Health Center and her B.Sc. degree from Fairfield University in biology. Dr. Bormann completed postdoctoral training at Yale Medical School in the department of pathology. Raphael Hofstein, Ph.D., has served on our board of directors since 2003, our Audit Committee since 2007 and our Compensation Committee since 2012.
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.
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.
A transaction with an office holder in a public company who is neither a director nor the chief executive officer regarding his or her terms of office and employment requires approval by the (i) compensation committee; and (ii) the board of directors.
Approval of compensation of office holders • Executive officers other than the Chief Executive Officer . The compensation of an office holder in a public company who is neither a director nor the chief executive officer generally requires approval by the (i) compensation committee; and (ii) the board of directors.
A transaction with the chief executive officer in a public company regarding his or her terms of office and employment requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority Requirements.
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.
Following such approval by the compensation committee and board of directors, shareholder approval would be required by the special majority described above. 72 To the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval, in the same manner described above, is required once every three years, unless, with respect to extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, the audit committee determines that the duration of the transaction is reasonable given the related circumstances related.
To the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval, in the same manner described above, is required once every three years, unless, with respect to transactions not involving the receipt of services or compensation can be approved for a longer term, the audit committee determines that the duration of the transaction for such longer term is reasonable given the related circumstances.
However, a company’s compensation committee and board of directors, may, in special circumstances approve a transaction despite shareholder rejection, provided that the compensation committee and thereafter the board of directors have determined to approve the transaction based on detailed reasoning, after each having re- discussed the terms of office and employment, and taken the shareholder rejection into consideration. • 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. • Chief Executive Officer .
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 14 persons 2,483 1,259 63 The following table presents information regarding compensation actually received or accrued by our five most highly compensated executive officers during the year ended December 31, 2023.
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.
Serlin, CPA, MBA 64 Chief Executive Officer Mali Zeevi, CPA 48 Chief Financial Officer Ella Sorani, Ph.D. 56 Chief Development Officer Holly W. May, MBA 62 U.S. President Aharon Schwartz, Ph.D. (1) 81 Chairman of the Board of Directors, Class III Director Rami Dar, MBA (1)(2)(3)(4) 67 Class I Director B.J. Bormann, Ph.D.
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.
(1)(3) 65 Class II Director Raphael Hofstein, Ph.D. (1)(2)(3) 74 Class II Director Avraham Molcho, M.D. (1)(2)(3) 66 Class I Director Sandra Panem, Ph.D. (1) 77 Class III Director Shaoyu Yan, Ph.D. 59 Class III Director Gal Cohen (1) 51 Class I Director (1) Independent director under applicable Nasdaq Capital Market, as affirmatively determined by our board of directors.
(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.
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. Holly W. May, MBA , has served as our U.S. president since September 2022. From June 2022 to August 2022, Ms.
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.
A personal interest includes the personal interest of a person for whom the office holder holds a voting proxy and the personal interest of the office holder voting as a proxy, even if the shareholder granting the proxy has no personal interest in the approval of the matter. 70 Under the Companies Law, an extraordinary transaction is defined as any of the following: • a transaction other than in the ordinary course of business; • a transaction that is not on market terms; or • a transaction that may have a material impact on the company’s profitability, assets or liabilities.
Under the Companies Law, an extraordinary transaction is defined as any of the following: • a transaction other than in the ordinary course of business; • a transaction that is not on market terms; or • a transaction that may have a material impact on the company’s profitability, assets or liabilities.
Panem served on numerous boards of public and private companies, including Martek Biosciences (Nasdaq:MATK), IBAH Pharmaceuticals (Nasdaq:IBAH), Confluent Surgical, Molecular Informatics and Labcyte, Inc. Dr. Panem received a B.S. degree in biochemistry and a Ph.D. in microbiology from the University of Chicago. Shaoyu Yan, Ph.D., has served on our board of directors since November 2023. Dr.
Panem received a B.S. degree in biochemistry and a Ph.D. in microbiology from the University of Chicago. Shaoyu Yan, Ph.D., has served on our board of directors since November 2023. Dr.
Pursuant to the Israeli Companies Regulations (Relief for Companies the Shares of which are Registered for Trading Outside of Israel) – 2000, or the Relief Regulations, companies that do not have a controlling shareholder (within the meaning of the Companies Law) with shares traded on certain U.S. stock exchanges, including the Nasdaq Capital Market, may, subject to certain conditions, “opt out” from the Companies Law requirements to appoint external directors and related Companies Law rules concerning the composition of the audit committee and compensation committee of the board of directors (other than the gender diversification rule under the Companies Law, which requires the appointment of a director from the other gender if at the time of appointment of a director all members of the board of directors are of the same gender). 65 On March 25, 2024, in accordance with the Relief Regulations, our board of directors elected to “opt out” from the Companies Law requirement to appoint external directors and related Companies Law rules concerning the composition of the audit committee and compensation committee of the board of directors, effective immediately.
However, pursuant to the Israeli Companies Regulations (Relief for Companies whose Securities are Listed for Trading Outside of Israel) – 2000, or the Relief Regulations, companies that do not have a controlling shareholder (within the meaning of the Companies Law), whose shares are listed on an exchange outside Israel or are dual listed on the TASE and a foreign exchange referenced in the second or third addendum to the Israeli Securities Law, 5728-1968, or the Israeli Securities Law (which include, among others, the Nasdaq), such as us, may, subject to certain conditions, “opt out” from the Companies Law requirements to appoint external directors and related Companies Law rules concerning the composition of the audit committee and compensation committee of the board of directors (other than the gender diversification rule under the Companies Law, which requires the appointment of a director from the other gender if at the time of appointment of a director all members of the board of directors are of the same gender).
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.
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.
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.
All of these agreements contain customary provisions regarding noncompetition, confidentiality of information and assignment of inventions.
Panem was also a Science and Public Policy Fellow in economic studies at the Brookings Institution, and an Assistant Professor of Pathology at the University of Chicago. Dr. Panem currently serves on the board of directors of Acorda Therapeutics, Inc. (Nasdaq:ACOR). Previously, Dr.
Panem was also a Science and Public Policy Fellow in economic studies at the Brookings Institution, and an Assistant Professor of Pathology at the University of Chicago. Previously, Dr. Panem served on numerous boards of public and private companies, including Acorda Therapeutics, Inc. (Nasdaq:ACOR). Martek Biosciences (Nasdaq:MATK), IBAH Pharmaceuticals (Nasdaq:IBAH), Confluent Surgical, Molecular Informatics and Labcyte, Inc. Dr.
If such transaction concerns the terms of office and employment of such controlling shareholder, in his capacity as an office holder or an employee of the company, such terms of office and employment approved by the compensation committee and board of directors shall be in accordance with the compensation policy of the company.
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.
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.
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.
A transaction with a director who is not the chief executive officer of a public company regarding his or her terms of office and engagement requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company.
The compensation of a director (who is not the chief executive officer) of a public company generally requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) unless exempted under regulations promulgated under the Companies Law, the shareholders of the company.
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 15, 2024, options to purchase 119,786,490 ordinary shares and an aggregate 32,412,375 PSUs 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 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.
In order to maintain some measure of flexibility, after calculating the compensation amount, the board of directors may exercise discretion about the final amount of the bonus but may not increase the recommended bonus amount by more than 25%. 68 Equity-based compensation may be granted in any form permitted under our share incentive plan in effect from time to time and shall be made in accordance with the terms of such share incentive plan.
In order to maintain some measure of flexibility, after calculating the compensation amount, the board of directors may exercise discretion about the final amount of the bonus but may not increase the recommended bonus amount by more than 25%.
In addition, our Compensation Committee makes recommendations to the board of directors regarding equity compensation issues (with the board also approving the compensation of our executive officers) and administers our share incentive plan. 67 Compensation Policy Under the Companies Law, the board of directors of a publicly traded company is required, after considering the recommendations of the compensation committee, to adopt a compensation policy according to which the compensation of the company’s office holders will be determined.
Compensation Policy Under the Companies Law, the board of directors of a publicly traded company is required to adopt a compensation policy according to which the compensation of the company’s office holders will be determined.
May President BioLineRx USA, Inc. 420 130 160 304 - 1,014 Tami Rachmilewitz Chief Medical Officer * 157 54 - - 15 226 *Until October 31, 2023 (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.
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.
Approval of terms of office and employment for such officers which do not comply with the compensation policy may nonetheless be approved 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 a compensation policy, and (ii) the shareholders of the company have approved the terms by means of the following special majority requirements, or the Special Majority Requirements, as set forth in the Companies Law, pursuant to which the shareholder approval must either include at least a majority of the shares held by non-controlling shareholders and disinterested shareholders who are present and vote on the matter (excluding abstentions), or, alternatively, the total shareholdings of the non-controlling shareholders and disinterested shareholders who vote against the transaction must not represent more than 2% of the voting rights in the 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. 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.

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Item 7. Management's Discussion & Analysis

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

11 edited+25 added−4 removed4 unchanged
We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company. 79 Record Holders Bank of New York Mellon, or BNY, is the holder of record for the Company’s American Depositary Receipt program, pursuant to which each ADS represents 15 ordinary shares.
We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company. Record Holders Bank of New York Mellon, or BNY, is the holder of record for the Company’s American Depositary Receipt program, pursuant to which each ADS represents 600 ordinary shares.
In connection with the License Agreement, on August 27, 2023, we also entered into a securities purchase agreement with HST and Gloria pursuant to which we agreed to sell and issue to HST, in a private placement, an aggregate of 6,829,137 of our ADSs. Aggregate gross proceeds from the sale were approximately $14.6 million.
In connection with the Gloria License Agreement, on August 27, 2023, we also entered into a securities purchase agreement with HST and Gloria pursuant to which we agreed to sell and issue to HST, in a private placement, an aggregate of 170,728 of our ADSs. Aggregate gross proceeds from the sale were approximately $14.6 million.
C. Interests of Experts and Counsel Not applicable. 80
C. Interests of Experts and Counsel Not applicable.
According to the Schedule 13D, includes 6,829,137 ADS, representing 102,437,055 ordinary shares held by Hong Seng Technology Limited. Lepu (Hong Kong) Co., Limited holds 66.67% equity interest of Hong Seng Technology Limited. Lepu Holdings Limited holds 99.5% equity interest of Lepu (Hong Kong) Co., Limited. Lepu Medical (Europe) Cooperatief U.A. holds 100% equity interest of Lepu Holdings Limited.
According to the Schedule 13D, includes 170,728 ADS, representing 102,437,055 ordinary shares held by Hong Seng Technology Limited. Lepu (Hong Kong) Co., Limited holds 66.67% equity interest of Hong Seng Technology Limited. Lepu Holdings Limited holds 99.5% equity interest of Lepu (Hong Kong) Co., Limited. Lepu Medical (Europe) Cooperatief U.A. holds 100% equity interest of Lepu Holdings Limited.
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report, there has been no significant change in the percentage ownership held by any major shareholder since January 1, 2021. 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, 2022. None of our shareholders has different voting rights from other shareholders.
Directors, Senior Management and Employees — Compensation — Compensation of Directors and Senior Management.” Indemnification Agreements 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.
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.
Gloria License Agreement and Securities Purchase Agreement On August 27, 2023, we entered into the 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 License Agreement in such territory.
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.
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).
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.
As of March 15, 2024, BNY held 993,504,176 ordinary shares representing 91% of our issued share capital held at that date. Certain of these ordinary shares were held by brokers or other nominees.
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.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. Major Shareholders The following table sets forth information with respect to the beneficial ownership of our shares as of March 15, 2024, by each person or entity known by us to own beneficially more than 5% of our ordinary shares.
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.
As a result, the number of holders of record or registered holders in the United States is not representative of the number of beneficial holders or of the residence of beneficial holders. B. Related Party Transactions Agreements with Directors and Officers Employment Agreements We have entered into employment agreements with each of our executive officers. See “Item 6.
As a result, the number of holders of record or registered holders in the United States is not representative of the number of beneficial holders or of the residence of beneficial holders. B.
Removed
The percentages shown are based on 1,086,589,165 ordinary shares issued and outstanding as of March 15, 2024. Name Number of Ordinary Shares Beneficially Held Percent of Class Hong Seng Technology Limited (1) 102,437,055 9.4 % (1) Based on Schedule 13D filed with the SEC on October 26, 2023.
Added
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A.
Removed
C — Directors, Senior Management and Employees — Board Practices — Exculpation, insurance and indemnification of office holders.” GSAP Agreement On February 9, 2023, we entered into an agreement with GSAP Biomed Ltd., or GSAP, pursuant to which GSAP undertook to provide ongoing quality assurance support services to us. This agreement was terminated effective January 1, 2024.
Added
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.
Removed
Rami Dar, one of our directors (who formerly served as an external director, within the meaning of the Companies Law), who serves as the chairman of our audit committee and as a member of our compensation committee and investment monitoring committee, is a non-executive chairman of Novolog Ltd., which is the parent company of GSAP.
Added
Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting power or investment power with respect to securities.
Removed
During 2023, we paid GSAP NIS 408,000 (approximately $110,000) as compensation for the services provided thereunder.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.

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