UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

(Mark One)

 

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2024

 

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of event requiring this shell company report

 

For the transition period from __________ to __________

 

Commission file number 001-35223

 

(Exact name of Registrant as specified in its charter)

 

Translation of Registrant’s name into English

 

 

Philip A. Serlin
+972 (8) 642-9100
+972 (8) 642-9101 (facsimile)
phils@biolinerx.com
2 HaMa’ayan Street
Modi’in 7177871, Israel

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

*Not for trading; only in connection with the registration of American Depositary Shares.

 

Securities registered or to be registered pursuant to Section 12(g) of the Act.

 

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

 

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of March 16, 2025: 2,232,601,990 ordinary shares

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

 

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

 

 

Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  ☐

 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. N/A

 

☐ Item 17       ☐ Item 18

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

TABLE OF CONTENTS
PART I.	1
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	1
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	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 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES	105
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	105
ITEM 15. CONTROLS AND PROCEDURES	105
ITEM 16. [RESERVED]	106
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERTS	106
ITEM 16B. CODE OF ETHICS	106
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES	107
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	107
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	107
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	107
ITEM 16G. CORPORATE GOVERNANCE	107
ITEM 16H. MINE SAFETY DISCLOSURE	108
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	108
ITEM 16J. INSIDER TRADING POLICIES	109
ITEM 16K. CYBERSECURITY	109
ITEM 17. FINANCIAL STATEMENTS	110
ITEM 18. FINANCIAL STATEMENTS	110
ITEM 19. EXHIBITS	110
SIGNATURES	113

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the clinical development, commercialization and market acceptance of our therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients;

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the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate development efforts;

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our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;

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whether the clinical trial results for APHEXDA will be predictive of real-world results;

	•	our receipt of regulatory approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals;
	•	whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors;
	•	our ability to establish, manage, and maintain corporate collaborations, as well as the ability of our collaborators to execute on their development and commercialization plans;

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our ability to integrate new therapeutic candidates and new personnel, as well as new collaborations;

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the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials;

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the implementation of our business model and strategic plans for our business and therapeutic candidates;

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the scope of protection that we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others;

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estimates of our expenses, future revenues, capital requirements and our need for and ability to access sufficient additional financing;

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risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;

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competitive companies, technologies and our industry;

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our ability to maintain the listing of our ADSs on Nasdaq;

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statements as to the impact of the political and security situation in Israel on our business, including the impact of Israel’s war with Hamas and other militant groups, which may exacerbate the magnitude of the factors discussed above; and

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those factors referred to in “Item 3.D. Risk Factors,” “Item 4. Information on the Company,” and “Item 5. Operating and Financial Review and Prospects”, as well as in this Annual Report on Form 20-F generally.

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We have incurred significant losses since inception and expect to incur additional losses in the future and may never be profitable.

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We cannot assure investors that our existing cash and investment balances will be sufficient to meet our future capital requirements.

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If we default under our secured loan agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital VII Aggregator SCSP), or BlackRock, all or a portion of our assets could be subject to forfeiture.

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We have earned limited commercialization revenues to date. We may never achieve profitability.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization, of APHEXDA. If we manufacture any therapeutic candidates in the future, we will be required to incur significant costs and devote significant efforts to establish and maintain manufacturing capabilities.

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Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by government authorities and third-party payors may adversely affect our business.

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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.

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Our business has a substantial risk of clinical trial and product liability claims. If we are unable to obtain and maintain appropriate levels of insurance, a claim could adversely affect our business.

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Significant disruptions of our information technology systems or breaches of our data security could adversely affect our business.

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We deal with hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business.

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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.

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Our access to most of the intellectual property associated with our therapeutic candidates results from in-license agreements with biotechnology companies and a university, the termination of which would prevent us from commercializing the associated therapeutic candidates.

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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.

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The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses by our investors.

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Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.

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Raising additional capital by issuing securities may cause dilution to existing shareholders.

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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.

	•	We conduct a substantial part of our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel and its region.
	•	Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.

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It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the United States, or to serve process on our officers and directors.

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Your rights and responsibilities as a shareholder will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. companies.

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Revenue sharing payments. These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third parties for further development and commercialization of our drug products. These payments are generally fixed at a percentage of the total revenues we earn from these sublicenses.

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Milestone payments. These payments are generally linked to the successful achievement of milestones in the development and approval of drugs, such Phases 1, 2 and 3 of clinical trials and approvals of NDAs, and achievement of sales milestones.

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Royalty payments. To the extent we elect to complete the development, licensing and marketing of a therapeutic candidate, we are generally required to pay our licensors royalties on the sales of the end drug product. These royalty payments are generally based on the net revenue from these sales. In certain instances, the rate of the royalty payments decreases upon the expiration of the drug’s underlying patent and its transition into a generic drug.

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Additional payments. In addition to the above payments, certain of our in-license agreements provide for a one-time or periodic payment that is not linked to milestones. Periodic payments may be paid until the commercialization of the product, either by direct sales or sublicenses to third parties. Other agreements provide for the continuation of these payments even following the commercialization of the licensed drug product.

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The motixafortide drug product composition of matter and methods of manufacturing thereof are covered by a granted U.S. patent and patent applications pending in the USA (two applications received notice of allowance). Israel, Europe, Japan, Canada, Australia, China, India, Mexico, Brazil, Hong-Kong and Korea. The patents, if granted, will expire in December 2041, not including any applicable patent term extension, which may add an additional term of up to five years for the U.S. patents. We also have an exclusive license to a patent family that covers motixafortide combined with a PD1 antagonist for the treatment of cancer. Patents of this family have been granted in the U.S., Israel, Australia, China, India, Mexico and Hong Kong; and member patent applications are pending in Australia, Hong Kong, Europe, China, Canada, India, Israel and Brazil. The granted U.S. patent and patents to issue in the future based on pending patent applications in this family will expire in 2036, not including any applicable patent term extension. In addition, we have an exclusive license to nineteen other patent families pending or granted worldwide directed to methods of synthesis of motixafortide and methods of use of motixafortide either alone or in combination with other drugs for the treatment of certain types of cancer and other indications. 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.

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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. Patents in this family have been granted in the U.S., Europe, Israel, Japan, China, Australia and New Zealand. The patents will expire in 2033-2034.

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preclinical laboratory tests, animal studies and formulation development;

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submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing;

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adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish the exposure levels;

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submission to the FDA of an application for marketing approval;

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and

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FDA review and approval of the drug and drug labeling for marketing.

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Consistent rules for conducting clinical trials throughout the EU;

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Making information on the authorization, conduct and results of each clinical trial carried out in the EU publicly available;

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Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states;

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Improved collaboration, information sharing and decision-making between and within member states;

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Increased transparency of information on clinical trials; and

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Higher standards of safety for all participants in EU clinical trials.

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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;

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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;

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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;

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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;

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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;

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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

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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.

Project	Status		Expected Near Term Milestones
motixafortide	1.	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. 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%. 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.	First patient dosed in December 2023 and initial data from the study released in November 2024. Final data planned in 2025*
	4.	Phase 1 study for gene therapies in SCD (with St. Jude Children’s Research Hospital, Inc.)**	4.	First patient dosed in February 2025, with data planned in 2025/2026*
	5.	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.	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.

***

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 addition, the planned studies of motixafortide in China under the Gloria License Agreement are currently not advancing according to schedule and it is unclear when such studies will be initiated, if at all. There can be no assurance that Gloria will meet its payment obligations or any other obligations under the Gloria License Agreement.

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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;

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the development stage of the therapeutic candidate; and

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the efficacy and safety profile of the therapeutic candidate.

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identify the contract with a customer;

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identify the performance obligations in the contract;

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determine the transaction price;

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allocate the transaction price to the performance obligations in the contract; and

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recognize revenue when (or as) the entity satisfies a performance obligation.

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the progress and costs of our preclinical studies, clinical trials and other research and development activities;

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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;

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the costs and timing of obtaining regulatory approval of our therapeutic candidates;

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our success in effecting out-licensing arrangements with third parties;

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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;

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the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

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the costs and timing of securing manufacturing arrangements for clinical or commercial production;

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the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;

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the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates;

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the magnitude of our general and administrative expenses;

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interest and principal payments on the loan from BlackRock;

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any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; and

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market conditions.

Name		Age		Position(s)
Philip A. 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)(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.
	(3)	A member of our compensation committee.
	(4)	A member of our investment monitoring committee

		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

Name and Position		Salary				Social Benefits(1)				Bonuses(2)				Value of Share-Based Compensation(3)				All Other Compensation(4)				Total
		(in thousands of U.S. dollars)
Philip A. Serlin Chief Executive Officer			296				109				74				265				20				764
Mali Zeevi Chief Financial Officer			195				59				49				32				22				357
Ella Sorani Chief Development Officer			221				54				-				32				20				328
Holly W. May Former President of BioLineRx USA, Inc.*			440				61				226				-				220				947

(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. May, does not include annual bonuses for 2024, which remain subject to the approval of the Company’s compensation committee and board of directors.
	(3)	Consists of amounts recognized as share-based compensation expense on the Company’s statement of comprehensive loss for the year ended December 31, 2024.

(4)

“All Other Compensation” includes automobile-related expenses pursuant to the Company’s automobile leasing program, telephone, basic health insurance and holiday presents, as well as termination benefits to Ms. May.

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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;

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the Class II directors, consisting of Dr. B.J. Bormann and Dr. Raphael Hofstein, will hold office until our annual general meeting of shareholders to be held in 2025; and

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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.

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oversight of the company’s independent registered public accounting firm and recommending the engagement, compensation or termination of engagement of our independent registered public accounting firm to our board of directors in accordance with Israeli law;

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recommending the engagement or termination of the office of our internal auditor; and

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reviewing and pre-approving the terms of audit and non-audit services provided by our independent auditors.

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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.  In addition, the compensation committee is required to periodically examine the implementation of the compensation policy; and

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to approve transactions relating to terms of office and employment of company office holders that require the approval of the compensation committee pursuant to the Companies Law (including determining whether the compensation terms of a candidate for chief executive officer of the company need not be brought to approval of the shareholders).

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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

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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.

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a person (or a relative of a person) who holds more than 5% of the company’s shares;

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a person (or a relative of a person) who has the power to appoint a director or the general manager of the company;

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an executive officer or director of the company (or a relative thereof); or

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a member of the company’s independent accounting firm.

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information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and

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all other important information pertaining to these actions.

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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;

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refrain from any activity that is competitive with the business of the company;

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refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others; and

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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.

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a transaction other than in the ordinary course of business;

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a transaction that is not on market terms; or

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a transaction that may have a material impact on the company’s profitability, assets or liabilities.

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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.  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  . 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.

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Chief Executive Officer.  The compensation of a chief executive officer in a public company generally requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority for Compensation. 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 . 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. 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.  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. 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.

•

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.

•

an amendment to the articles of association;

•

an increase in the company’s authorized share capital;

•

a merger; and

•

the approval of related party transactions and acts of office holders that require shareholder approval under the Companies Law.

•

monetary liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award approved by a court. 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.

•

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;

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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;

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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

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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.

•

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;

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a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

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an act or omission committed with intent to derive illegal personal benefit; or

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a fine, monetary sanction or forfeit levied against the office holder.

		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

●

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.

		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. 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. 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	%

(1)

Based on Schedule 13D filed with the SEC on October 26, 2023. 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. 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. 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. 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. 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. 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. 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. 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. 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. Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025.

(6)

Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025.

(7)

Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 1,937,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025.

(8)

Includes 2,366,400 ordinary shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 1,937,400 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. Does not include 1,712,400 ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 26, 2025.

(10)

Includes 171,600 ordinary shares and 15,994,800 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 6,006,000 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 26, 2025.

(11)

Includes 329,400 ordinary shares and 3,949,800 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 1,441,200 ordinary shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 26, 2025.

(12)

Includes 66,600 ordinary shares and 4,109,400 ordinary shares issuable upon exercise of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 26, 2025. Does not include 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.

•

amendments to our Articles of Association;

•

appointment, termination or the terms of service of our auditors;

•

appointment of external directors (if applicable);

•

approval of certain related party transactions;

•

increases or reductions of our authorized share capital;

•

a merger; and

•

the exercise of our board of directors’ powers by a general meeting, if our board of directors is unable to exercise its powers and the exercise of any of its powers is required for our proper management.

•

the excess distribution or gain would be allocated ratably over the Non-Electing U.S. Investor’s holding period for the ordinary shares or ADSs;

•

the amount allocated to the current taxable year and any year prior to us becoming a PFIC would be taxed as ordinary income; and

•

the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such other taxable year.

•

taxes and other governmental charges;

•

any applicable transfer or registration fees;

•

certain cable, telex and facsimile transmission charges as provided in the deposit agreement;

•

any expenses incurred in the conversion of foreign currency;

•

a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the deposit agreement terminates;

•

a fee of $.01 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;

•

a fee for the distribution of securities pursuant to the deposit agreement;

•

in addition to any fee charged for a cash distribution, a fee of $.01 or less per ADS (or portion thereof) per annum for depositary services;

•

a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and

•

any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the servicing of ordinary shares or other Deposited Securities.

a.	Disclosure Controls and Procedures

b.	Management’s Annual Report on Internal Control over Financial Reporting

c.	Attestation Report of Registered Public Accounting Firm

d.	Changes in Internal Control over Financial Reporting

		Year Ended December 31,
		2023				2024
Services Rendered		(in thousands of U.S. dollars)
Audit Fees(1)			130				160
Audit-Related Fees(2)			17				40
Tax Fees(3)			52				41
Total			199				211

	(1)	Audit fees consist of services that would normally be provided in connection with statutory and regulatory filings or engagements, including services that generally only the independent accountant can reasonably provide.
	(2)	Audit-related services relate to reports to the IIA and work regarding a public listing or offering.
	(3)	Tax fees relate to tax reports for BioLineRx USA, Inc., tax compliance, planning and advice.

•

Distribution of periodic reports to shareholders. Under Israeli law, a public company whose shares are traded on the TASE, is not required to distribute periodic reports directly to shareholders and the generally accepted business practice in Israel is not to distribute such reports to shareholders but to make such reports publicly available through a public website. We will only mail such reports to shareholders upon request. In addition, we make our audited financial statements available to our shareholders at our offices.

•

Quorum. While the Nasdaq Rules require that the quorum for purposes of any meeting of the holders of a listed company’s common voting stock, as specified in the company’s bylaws, be no less than 33 1/3% of the company’s outstanding common voting stock, as permitted under the Companies Law, our Articles of Association provide that a quorum of two or more shareholders holding at least 25% of the voting rights in person or by proxy is required for commencement of business at a general meeting (and, with respect to an adjourned meeting, a quorum consists of any number of shareholders present in person or by proxy).

•

Nomination of Directors. We follow Israeli corporate governance practices instead of the requirements of the Nasdaq Rules with regard to the nomination committee and director nomination procedures.  Israeli law and practice does not require director nominations to be made by a nominating committee of our board of directors consisting solely of independent directors, as required under the Nasdaq Rules.  In accordance with Israeli law and practice, directors are recommended by our board of directors for election by our shareholders (other than directors elected by our board of directors to fill a vacancy), and certain of our shareholders may nominate candidates for election as directors by the general meeting of shareholders in accordance with the Companies Law and our Articles of Association.

•

Compensation of Officers. We follow Israeli law and practice with respect to the approval of officer compensation, pursuant to which transactions with office holders regarding their terms of office and employment generally require the approval of the compensation committee, the board of directors and under certain circumstances (such as if the officer is a director or controlling shareholder) the shareholders, either in accordance with our compensation policy or, in special circumstances in deviation therefrom, taking into account certain considerations set forth in the Companies Law. See “Item 6.C— Directors, Senior Management and Employees — Board Practices — Compensation Committee” for information regarding the Compensation Committee, and “Item 6.C — Directors, Senior Management and Employees — Approval of Related Party Transactions under Israeli Law” for information regarding the approvals required with respect to approval of terms of office and employment of office holders, pursuant to the Companies Law.

•

Approval of Related Party Transactions.  We follow Israeli law and practice with respect to the approval of interested party acts and transactions, as set forth in sections 268 to 275 of the Companies Law, and the regulations promulgated thereunder, which generally require the approval of the audit committee, the board of directors and, under certain circumstances (such as if the transaction is with a controlling shareholder or another party in which the controlling shareholder has a personal interest) the shareholders, as may be applicable, for specified transactions. See “Item 6.C— Directors, Senior Management and Employees —Board Practices — Approval of Related Party Transactions under Israeli Law” for information regarding the approvals required with respect to approval of related party transactions pursuant to the Companies Law.

•

Shareholder Approval. We intend to seek shareholder approval for all corporate actions requiring such approval in accordance with the requirements of the Companies Law, which are different or in addition to the requirements for seeking shareholder approval under Nasdaq Listing Rule 5635, rather than seeking approval for corporation actions in accordance with such listing rules.

•

Equity Compensation Plans. We do not necessarily seek shareholder approval for the establishment of, and amendments to, stock option or equity compensation plans (as set forth in Nasdaq Listing Rule 5635(c)), as such matters are not subject to shareholder approval under Israeli law and practice.  However, any equity-based compensation arrangement with a director or the chief executive officer or the material amendment of such an arrangement must be approved by our Compensation Committee, board of directors and shareholders, in that order.