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INTRODUCTION	i
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	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. 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
ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES	96
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	96
ITEM 15. CONTROLS AND PROCEDURES	96
ITEM 16. [RESERVED]	97
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERTS	97
ITEM 16B. CODE OF ETHICS	97
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES	97
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	97
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	97
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	98
ITEM 16G. CORPORATE GOVERNANCE	98
ITEM 16H. MINE SAFETY DISCLOSURE	99
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	99
ITEM 16J. INSIDER TRADING POLICIES	99
ITEM 16K. CYBERSECURITY	99
ITEM 17. FINANCIAL STATEMENTS	100
ITEM 18. FINANCIAL STATEMENTS	100
ITEM 19. EXHIBITS	100
SIGNATURES	103

 

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references to “BioLineRx,” the “Company,” “us,” “we” and “our” refer to BioLineRx Ltd., an Israeli company, and its consolidated subsidiaries;

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references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, NIS 0.10 nominal (par) value per share;

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references to “ADS” or “ADSs” refer to the Company’s American Depositary Shares;

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references to “dollars,” “U.S. dollars” and “$” are to United States Dollars;

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references to “shekels” and “NIS” are to New Israeli Shekels, the Israeli currency;

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references to the “Companies Law” are to Israel’s Companies Law, 5759-1999, as amended;

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and references to the “SEC” are to the U.S. Securities and Exchange Commission.

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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, including any unexpected costs or delays in the ongoing commercialization of APHEXDA;

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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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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 Kreos, all or a portion of our assets could be subject to forfeiture.

  

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Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental 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.

	•	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 patent applications pending in Israel, USA, Europe, Japan, Canada, Australia, China, India, Mexico, Brazil, Hong-Kong and Korea. Corresponding 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 and Hong Kong; and member patent applications are pending in Australia, Hong Kong, Europe, Japan, China, Canada, India, Korea, Mexico 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;

•	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

•	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.	Commercialization 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 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%.  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.	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.	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

•

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 Kreos Capital;

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payments to the IIA; and

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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.

		Total				Less than 1 year				1-3 years				4-5 years				More than 5 years
		(in thousands of U.S. dollars)
Car leasing obligations			300				161				139				-				-
Premises leasing obligations			2,231				575				584				613				459
Purchase commitments			6,911				6,578				308				25				-
Total			9,442				7,314				1,031				638				459

(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 14 persons			2,483				1,259

Name and Position		Salary				Social Benefits(1)				Bonuses				Value of Options Granted(2)				All Other Compensation(3)				Total
		(in thousands of U.S. dollars)
Philip A. Serlin Chief Executive Officer			280				81				215				354				22				952
Mali Zeevi
Chief Financial Officer			182				53				119				69				20				443
Ella Sorani Chief Development Officer			206				70				156				68				20				520
Holly W. May President BioLineRx USA, Inc.			420				130				160				304				-				1,014
Tami Rachmilewitz
Chief Medical Officer *			157				54				-				-				15				226

(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)	Consists of amounts recognized as share-based compensation expense on the Company’s statement of comprehensive loss for the year ended December 31, 2023.

(3)	“All Other Compensation” includes automobile-related expenses pursuant to the Company’s automobile leasing program, telephone, basic health insurance and holiday presents.

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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 2024;

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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.

Country of Principal Executive Offices	Israel
Foreign Private Issuer	Yes
Disclosure Prohibited under Home Country Law	No
Total Number of directors	8
Part I: Gender Identity		Female		Male		Non-Binary		Did Not Disclose  Gender
directors		2		6		0		0
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction		0
LGBTQ+		0
Did Not Disclose Demographic Background		0

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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 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.  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.  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 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. 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.

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Chief Executive Officer.  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. 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. 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. 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.

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Directors.  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. 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. In addition, pursuant to a relief provided under the Israeli Companies Regulations (Relief in Interested Party Transactions), 2000, the terms of office and engagement of a non-executive director are exempt from shareholder approval if the compensation committee and board of directors determined that (i) such terms of office are only for the benefit of the company, or (ii) the compensation terms of the director do not exceed the maximum compensation paid to external directors pursuant to the applicable regulations.

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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.

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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;

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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;

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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;

•

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.

•

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.

		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

		Number of
		Ordinary Shares
		Beneficially				Percent of
		Held				Class
Directors
Aharon Schwartz(1)			4,784,970				*
B.J. Bormann(2)			1,079,970				*
Rami Dar(3)			630,000				*
Raphael Hofstein(4)			1,079,970				*
Avraham Molcho(5)			1,079,970				*
Sandra Panem(6)			1,079,970				*
Shaoyu Yan			-
Gal Cohen			-
Executive officers
Philip A. Serlin(7)			12,120,645				1.1	%
Mali Zeevi(8)			3,348,030				*
Ella Sorani(9)			3,195,930				*
Holly May (10)			3,567,645				*
All directors and executive officers as a group (12 persons)(11)			31,967,100				2.9	%

(1)

Includes 3,705,000 Ordinary Shares and 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024.

(2)	Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024.

(3)	Includes 630,000 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024.

(4)	Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024.

(5)	Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024.

(6)	Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options that are not exercisable within 60 days 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. 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. 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).

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amendments to our Articles of Association;

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

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appointment of external directors (if applicable);

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approval of certain related party transactions;

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increases or reductions of our authorized share capital;

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a merger; and

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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.

 

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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;

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

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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.

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taxes and other governmental charges;

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any applicable transfer or registration fees;

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

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any expenses incurred in the conversion of foreign currency;

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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;

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a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;

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

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in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;

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

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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,
		2022				2023
Services Rendered		(in thousands of U.S. dollars)
Audit Fees(1)			130				130
Audit-Related Fees(2)			4				17
Tax Fees(3)			18				52
All Other Fees			-				-
Total			152				199

(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 compliance, planning and advice.

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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.

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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).

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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.

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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, and a transaction with a controlling shareholder in a company regarding his or her employment and/or his or her terms of office with the company, 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.

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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 officer holder is a controlling shareholder) 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.

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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.

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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.

Exhibit Number		Exhibit Description
2.1		Articles of Association, as amended August 7, 2023
2.2 *		Description of Securities Registered under Section 12
2.3(2)		Deposit Agreement dated as of July 21, 2011 among the Registrant, The Bank of New York Mellon, as Depositary, and all Owners and Holders from time to time of American Depositary Shares issued thereunder
2.4(2)		Form of American Depositary Receipt; the Form is Exhibit A of the deposit agreement which is Exhibit 2.2 above.
4.1(3)		Employment Agreement with Philip Serlin, dated May 24, 2009
4.2(1)		Amendment to Employment Agreement between BioLineRx Ltd. and Philip Serlin, dated September 24, 2020
4.3(3)		Employment Agreement with Mali Zeevi, dated September 16, 2009
4.4(1)		Amendment to Employment Agreement between BioLineRx Ltd and Mali Zeevi, dated September 24, 2020
4.5(2)		Employment Agreement with Ella Sorani, dated January 11, 2017
4.6(1)		Amendment to Employment Agreement between BioLineRx Ltd and Ella Sorani, dated September 24, 2020
4.7†(4)		License Agreement entered into as of November 25, 2007 between BioLine Innovations Jerusalem L.P. and Innovative Pharmaceutical Concepts, Inc.
4.8(5)		BioLineRx Ltd. Amended and Restated 2003 Share Incentive Plan
4.9(6)		License Agreement entered into as of September 2, 2012 by and between the Registrant and Biokine Therapeutics Ltd.
4.10(7)†		Amendment Agreement entered into as of October 2, 2018 by and between the Registrant and Biokine Therapeutics Ltd.

4.11(7)		Warrant issued to Kreos Capital V dated October 2, 2018
4.12(8)		Compensation Policy for Executives and directors, as amended
4.13(10)		Lease Agreement entered into as of August 7, 2014 between S.M.L. Solomon Industrial Buildings Ltd. and Infrastructure Management and Development Established by C.P.M. Ltd. as Lessor and the Registrant as Lessee, as amended (English summary of the Hebrew original)
4.14(11)†		License Agreement entered into as of December 22, 2014 between the Registrant and Wartner Europe BV
4.15†		Amendment No. 2 to Clinical Trial Collaboration and Supply Agreement entered into as of July 24, 2018 between the Registrant and Merck Sharp & Dohme B.V.
4.16(3)†		Amended and Restated Exclusive License Agreement entered into as of April 30, 2013 between the University of Massachusetts and Agalimmune Ltd.
4.17†		Patent and Know-how License Agreement entered into as of September 19, 2017 between Kode Biotech Limited and Agalimmune Ltd.
4.18†		Second Amendment Agreement entered into as of October 16, 2018 between the University of Massachusetts and Agalimmune Ltd.
4.19†		Amendment No. 1 to License Agreement entered into as of June 18, 2018 between the Registrant and Wartner Europe BV
4.20(9)		First Addendum to License Agreement entered into as of October 16, 2019 by and between the Registrant and Biokine Therapeutics Ltd., as amended.

4.21(12)		Form of Warrant issued February 7, 2019
4.22(13)		Form of Underwriter Warrant to be issued by BioLineRx Ltd. on January 22, 2021
4.23(14)		At-the-Market Sales Agreement, dated September 3, 2021, between BioLineRx Ltd. and H.C. Wainwright & Co., LLC
4.24(15)		Agreement for the Provision of a Loan Facility entered into as of September 14, 2022, by and between the Registrant and Kreos Capital VII Aggregator SCSP
4.25(16)		Form of Securities Purchase Agreement dated as of September 18, 2022 between the Registrant and the investors listed therein
4.26(16)		Form of Warrant issued by the Registrant on September 21, 2022
4.2716)		Form of Placement Agent Warrant issued by the Registrant on September 21, 2022
4.28(18)†		License Agreement dated as of August 27, 2023 between the BioLineRx Ltd., Guangzhou Gloria Biosciences Co., Ltd. and Hong Seng Technology Limited
4.29(18)†		Securities Purchase Agreement dated as of August 27, 2023 between the BioLineRx Ltd., Hong Seng Technology Limited and Guangzhou Gloria Biosciences Co., Ltd.
8.1(17)		List of Subsidiaries of BioLineRx Ltd.
12.1*		Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
12.2*		Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
13.1*		Certification by Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
13.2*		Certification by Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
15.1*		Consent of Kesselman & Kesselman, Certified Public Accountant (Isr.), a member of PricewaterhouseCoopers International Limited, independent registered public accounting firm for the Registrant
97.1*		BioLineRx Ltd. Executive Officer Clawback Policy
101		The following financial information from BioLineRx Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023 formatted in Inline XBRL (Extensible Business Reporting Language): (i) Consolidated Statements of Financial Position at December 31, 2023 and 2022; (ii) Consolidated Statements of Comprehensive Loss for the years ended December 31, 2023, 2022 and 2021; (iii) Statements of Changes in Equity for the years ended December 31, 2023, 2022 and 2021; (iv) Consolidated Cash Flow Statements for the years ended December 31, 2023, 2022 and 2021; and (v) Notes to the Consolidated Financial Statements.

*	Filed herewith.

†	Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

(1)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on February 23, 2021.

(2)	Incorporated by reference to Exhibit 1 of the Registration Statement on Form F-6EF (No. 333-218969) filed by the Bank of New York Mellon on June 26, 2017 with respect to the Registrant’s American Depositary Shares.

(3)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2017.

(4)	Incorporated by reference to the Registrant’s Registration Statement on Form 20-F (No. 001-35223) filed on July 1, 2011.

(5)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 10, 2016.

(6)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on May 31, 2016.

(7)	Incorporated by reference to the Registrant’s Form 6-K filed on October 3, 2018.

(8)	Incorporated by reference to the Registrant’s Form 6-K filed on May 27, 2022.

(9)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 12, 2020.

(10)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2015.

(11)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on September 22, 2015.

(12)	Incorporated by reference to the Registrant’s Form 6-K filed on February 7, 2019.

(13)	Incorporated by reference to the Registrant’s Form 6-K filed on January 21, 2021.

(14)	Incorporated by reference to the Registrant’s Form 6-K filed on September 3, 2021.

(15)	Incorporated by reference to the Registrant’s Form 6-K filed on September 15, 2022.

(16)	Incorporated by reference to the Registrant’s Form 6-K filed on September 21, 2022.

(17)	Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 16, 2022.

(18)	Incorporated by reference to the Registrant’s Form 6-K filed on August 30, 2023.

	BIOLINERX LTD.
	By:	/s/ Philip A. Serlin
		Philip A. Serlin
		Chief Executive Officer