TABLE OF CONTENTS

 

 

 

 

 

 

	●	our ability to continue as a going concern;
	●	our history of losses and need for additional capital to fund our operations, and our ability to obtain additional capital on acceptable terms, or at all;

●

our dependence on the success of our initial product candidate, PRF-110;

●

the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;

●

our limited experience managing clinical trials;

●

our ability to retain key personnel and recruit additional employees;

●

our reliance on third parties for the conduct of clinical trials, product manufacturing and development;

●

the impact of competition and new technologies;

●

our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;

●

our ability to establish and maintain strategic partnerships and other corporate collaborations;

●

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

●

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

●

the overall global economic environment;

●

our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile;

●

statements as to the impact of the political and security situation in Israel on our business, including due to the current war between Israel and Hamas; and

●

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.

A.	[RESERVED]

B.	Capitalization and Indebtedness

C.	Reasons for the Offer and Use of Proceeds

D.	Risk Factors

●

The report of our independent registered public accounting firm contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern;

●

We have incurred significant losses and negative cash flows from operations since our inception and expect to incur losses for the foreseeable future. We may never achieve or maintain profitability;

●

Our limited operating history may make it difficult for you to assess our future viability. We have never generated revenues and may never be profitable;

●

We will need substantial additional funding, which may not be available to us on acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts; and

●

Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our product candidates.

●

We are dependent on the success of our initial product candidate, PRF-110, which is currently in a Phase 3 clinical trial, and future additional trials are currently planned. Our clinical trials of PRF-110 may not be successful. If we are unable to obtain approval for and commercialize PRF-110, or experience significant delays in doing so, our business will be materially harmed;

●

We have experienced delays in the manufacturing of our clinical trial batches and if we experience further delays, our business may be further harmed;

●

We are dependent on a single supplier from which we obtain some of our critical materials and components used in the manufacturing of PRF-110;

●

We have not yet commercialized any products or technologies, and we may never become profitable;

●

If we are unable to successfully complete our clinical trial programs for PRF-110, or if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected;

●

We have limited experience in conducting and managing clinical trials necessary to obtain regulatory approvals. If our drug candidates and technologies do not receive the necessary regulatory approvals, we will be unable to commercialize our products;

●

If third parties on which we will have to rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our products; and

●

If our competitors develop and market products that are less expensive or more effective than our product, our revenues and results may be harmed and our commercial opportunities may be reduced or eliminated;

●

If we are unable to maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to our product candidates, and our ability to successfully commercialize any product candidates we may develop, and our science may be adversely affected.

●

Conditions in the Middle East and in Israel may harm our operations.

●

Our international clinical trials may be delayed or otherwise adversely impacted by social, political and economic factors affecting the particular foreign country.

●

If we fail to regain compliance with the Nasdaq minimum listing requirements, our ordinary shares will be subject to delisting. Our ability to publicly or privately sell equity securities and the liquidity of our ordinary shares could be adversely affected if our ordinary shares are delisted;

●

We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine;

●

Because we are not subject to compliance with rules requiring the adoption of certain corporate governance measures, our shareholders have limited protections against interested director transactions, conflicts of interest and similar matters; and

●

If we are unable to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act as they apply to a foreign private issuer that is listed on a U.S. exchange, or our internal control over financial reporting is not effective, the reliability of our financial statements may be questioned and our share price may suffer.

●

initiate and manage clinical trials for PRF-110;

●

seek regulatory approvals;

●

implement internal systems and infrastructures;

●

hire management and other personnel; and

●

progress PRF-110 towards commercialization.

●

the costs, timing and outcome of manufacturing clinical trial and commercial quantities of PRF-110;

●

the scope, progress, results and costs of our current and future clinical trials of PRF-110 for our current targeted uses;

●

the costs, timing and outcome of regulatory review of PRF-110;

●

the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for PRF-110 on favorable terms, although we currently have no commitments or agreements to complete any such transactions;

●

the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time;

●

the amount of revenue, if any, received from commercial sales of PRF-110, should it receive marketing approval;

●

the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims;

●

our ability to establish strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

●

our headcount growth and associated costs as we expand our business operations and our research and development activities;

●

the costs of operating as a public company;

●

maintaining minimum shareholders’ equity requirements under the Nasdaq rules; and

●

the impact of the current wars between Israel and Hamas, and between Russian and Ukraine, which may exacerbate the magnitude of the factors discussed above.

●

establishing supply arrangements with third-party raw materials and components suppliers, and drug product manufacturers who can manufacture clinical trial and commercial quantities of PRF-110, and developing, validating and maintaining a commercially-viable manufacturing process that is compliant with current Good Manufacturing Practices, or cGMP, at a scale sufficient to meet anticipated demand, which will ultimately enable us to reduce our cost of manufacturing;

●

successfully initiating patient enrollment and completion of additional clinical trials on a timely basis;

●

our ability to demonstrate PRF-110’s safety, tolerability and efficacy to the FDA and any comparable foreign regulatory authority for marketing approval;

●

timely receipt of marketing approvals for PRF-110;

●

maintaining patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally;

●

successfully defending and enforcing our proprietary rights in our intellectual property portfolio;

●

avoiding and successfully defending against any claims that we have infringed, misappropriated or otherwise violated any intellectual property of any third party;

●

the performance of any future collaborations;

●

our ability to timely complete any post-marketing approval commitments required by the FDA or other applicable regulatory authorities;

●

establishing scaled production arrangements with third-party manufacturers to obtain finished products that are compliant with cGMP and appropriately packaged for commercialization;

●

successful launch of commercial sales following any marketing approval;

●

maintaining an acceptable safety profile following any marketing approval;

●

commercial acceptance by patients, the medical community and third-party payors;

●

the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities;

●

the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments; and

●

our ability to compete with other post-operative pain, or POP, treatments.

●

the timing of regulatory approvals in the requested countries, for the applications we seek;

●

competitive market environment;

●

the establishment and demonstration in the medical community of the safety and clinical efficacy of our products and their potential advantages over existing therapeutic products;

●

our ability to enter into strategic agreements with pharmaceutical and biotechnology companies with strong marketing and sales capabilities;

●

the adequacy and success of distribution and marketing efforts; and

●

the pricing and reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations and other plan administrators.

●

obtaining regulatory approvals (e.g., an Investigational New Drug, or IND, application) to commence a clinical trial;

●

reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

●

slower than expected rates of patient recruitment due to narrow screening requirements and competing clinical studies;

●

the inability of patients to meet protocol requirements imposed by the FDA or other regulatory authorities;

●

the need or desire to modify our manufacturing process;

●

delays, suspension, or termination of the clinical trials due to the institutional review board responsible for overseeing the study at a particular study site; and

●

governmental or regulatory delays or “clinical holds” requiring suspension or termination of the trials.

●

assist us in developing, testing and obtaining regulatory approval;

●

manufacture our drug candidates; and

●

market and distribute our products.

●

perceptions by members of the health care community, including physicians, of the safety and efficacy of our product;

●

the potential advantages that our product offers over existing treatment methods or other products that may be developed;

●

the cost-effectiveness of our product relative to competing products;

●

the availability of government or third-party pay or reimbursement for our products; and

●

the effectiveness of our or our partners’ sales, marketing and distribution efforts.

●

litigation involving patients taking our drug;

●

restrictions on such drugs, manufacturers or manufacturing processes;

●

restrictions on the labeling or marketing of a drug;

●

restrictions on drug distribution or use;

●

requirements to conduct post-marketing studies or clinical trials;

●

warning letters or untitled letters;

●

withdrawal of the drugs from the market;

●

refusal to approve pending applications or supplements to approved applications that we submit;

●

recall of drugs;

●

fines, restitution or disgorgement of profits or revenues;

●

suspension or withdrawal of marketing approvals;

●

damage to relationships with any potential collaborators;

●

exclusion from or restrictions on coverage by third-party payors;

●

unfavorable press coverage and damage to our reputation;

●

refusal to permit the import or export of drugs;

●

drug seizure; or

●

injunctions or the imposition of civil or criminal penalties.

●

decreased demand for a product;

●

damage to our reputation;

●

withdrawal of clinical trial volunteers; and

●

loss of revenues.

●

the potential disruption of our ongoing business;

●

the distraction of management away from the ongoing oversight of our existing business activities;

●

incurring additional indebtedness;

●

the anticipated benefits and cost savings of those transactions not being realized fully, or at all, or taking longer to realize than anticipated;

●

an increase in the scope and complexity of our operations; and

●

the loss or reduction of control over certain of our assets.

●

result in costly litigation;

●

divert management’s attention and resources;

●

cause product shipment delays; and

●

require us to enter into royalty or licensing agreements.  Such royalty or licensing agreements, if required, may not be available on terms acceptable to us, if at all.

●

others may be able to make products that are similar to our product candidates or utilize similar science or technology but that are not covered by the claims of the patents that we may own or license from our licensors or that incorporate certain research in our product candidates that is in the public domain;

●

we might not have been the first to file patent applications covering our inventions;

●

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

●

issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;

●

our competitors or other third parties might conduct research and development activities in countries where do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

●

the patents of others may harm our business if, for example, we are found to have infringed those patents or if those patents serve as prior art to our patents which could potentially invalidate our patents; and

●

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property, which could ultimately result in public disclosure of the intellectual property if the third party’s patent application is published or issues to a patent.

●

difficulty in establishing or managing relationships with clinical research organizations and physicians;

●

different standards for the conduct of clinical trials and/or health care reimbursement;

●

our inability to locate qualified local consultants, physicians, and partners;

●

the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical products and treatment; and

●

general geopolitical risks, such as political and economic instability, and changes in diplomatic and trade relations.

●

to elect or defeat the election of our directors;

●

amend or prevent amendment of our charter documents or by-laws;

●

effect or prevent a merger, sale of assets or other corporate transaction; and

●

to control the outcome of any other matter submitted to our shareholders for vote.

●

less liquid trading market for our securities;

●

more limited market quotations for our securities;

●

determination that our ordinary shares and/or warrants are a “penny stock” that requires brokers to adhere to more stringent rules and possibly resulting in a reduced level of trading activity in the secondary trading market for our securities;

●

more limited research coverage by stock analysts;

●

loss of reputation; and

●

more difficult and more expensive equity financings in the future.

●

changes or developments in laws or regulations governing our business;

●

announcements of regulatory approvals or the failure to obtain them, or specific label indications or patient populations for their use, or changes or delays in the regulatory review process;

●

unsatisfactory results of preclinical studies or clinical trials;

●

adverse actions taken by regulatory agencies with respect to our manufacturing supply chain or sales and marketing activities;

●

announcements of innovations or new products by us or our competitors;

●

any intellectual property infringement, misappropriation or other actions in which we may become involved;

●

any adverse changes to our relationships with manufacturers or suppliers;

●

announcements concerning our competitors;

●

achievement of expected product sales and profitability or our failure to meet expectations;

●

our commencement of, or involvement in, litigation; and

●

any changes in our board of directors or management.

ITEM 4.          INFORMATION ON THE COMPANY

A.	History and Development of the Company

B.	Business Overview

●

addressing unmet medical needs;

●

de-risked drug development by using long-established APIs and our patented, proprietary extended release drug-delivery system;

●

reduced development costs;

●

rapid preclinical and clinical testing;

●

well understood paths to approval: and

●

the potential to disrupt current practices.

●

PRF-110 is highly viscous and thus stays in place when placed into a surgical wound bed.

●

PRF-110 remains within the surgical site when the skin is closed, without being toxic or proinflammatory.

●

PRF-110 is easy to administer and its use is consistent with current surgical practice.

●

PRF-110 is highly uniform and resistant to degradation in the wound, resulting is sustained,/extended release of the analgesic.

●

Ropivacaine, the active drug used in PRF-110, is a safe and well-characterized local anesthetic.

●

The components that make up the remainder of the PRF-110 formulation are classified as GRAS (Generally Regarded As Safe) by the FDA.

●

We have amassed a human toxicology portfolio for PRF-110, demonstrating that there are no PRF-110-associated serious adverse events in either healthy controls or in surgical patients.

●

Based on extensive toxicology and pharmacokinetic studies, as well as positive Phase 2 results, the FDA has granted our company an IND for PRF-110 and approved the initiation of Phase 3 trials for the treatment of post-operative pain.

●

Unlike many drug trials that take months to years to complete and which are complex and whose endpoints are difficult to interpret, the planned trials are expected to last for 72 hours with a seven day and a one-month follow-up, with primary endpoint of pain measurement on the familiar scale of 0 (no pain) to 10 (worst imaginable pain).

●

Upon completion of the Phase 3 studies, if successful, we plan to apply for an NDA for the management of post-operative pain.

●

If and when approved for commercial sale, we intend to capitalize on the opportunity and carry out post-approval trials in a number of additional surgical indications, including breast augmentation/reduction, bariatric procedures, hysterectomy, cholecystectomy as well as orthopedic procedures including joint replacements and open fracture repair. We intend to capitalize on these opportunities to become the leader in opiate-free, long-acting local and regional analgesia.

●

Hospitals;

●

Free-standing surgical centers; and

●

Surgical offices.

●

Posimir by Durect (DRRX). A bupivacaine collagen matrix was recently approved by the FDA for only arthroscopic subacromial decompression (niche market ~600,000 annual procedures in the U.S.).

●

Xaracoll by Innocoll, a surgically implantable and bioresorbable bupivacaine-collagen matrix, FDA approved the product for only open inguinal hernia repair.

●

Allay Therapeutics ATX-101, a product based on bupivacaine is in development stage.

	●	TLC590, from the Taiwan Liposome Company, is a liposomal formulation of ropivacaine that completed Phase II trials in patients following hernia surgery.
	●	Cali Biosciences developing an injectable ropivacaine formulation CPL-01 which is currently in phase III for bunion and hernia; and
	●	Vertex pharmaceuticals, which completed phase III clinical studies in abdominoplasty and bunionectomy with VX-548, a selective NaV1.8 inhibitor.

●

completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;

●

submission to the FDA of an IND, which must take effect before human clinical trials begin;

●

approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;

●

performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug product for each proposed indication;

●

preparation and submission to the FDA of an NDA requesting marketing for one or more proposed indications;

●

review by an FDA advisory committee, where appropriate or if applicable;

●

satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;

●

satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;

●

payment of user fees and securing FDA approval of the NDA; and

●

compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies.

Phase 1:	The drug is initially introduced into healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage.
Phase 2:	The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
Phase 3:	The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.
Phase 4:	Post-approval studies, which are conducted following initial approval, are typically conducted to gain additional experience and data from treatment of patients in the intended therapeutic indication.

●

restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, complete withdrawal of the product from the market or product recalls;

●

fines, warning letters or holds on post-approval clinical trials;

●

refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;

●

product seizure or detention, or refusal to permit the import or export of products; or

●

injunctions or the imposition of civil or criminal penalties.

●

Compliance with the EU’s stringent pharmacovigilance and safety reporting rules, pursuant to which inter alia post-authorization studies and additional monitoring obligations can be imposed, has to be ensured.

●

The manufacturing of authorized drugs, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the EMA’s GMP requirements and comparable requirements of other regulatory bodies in the EU, which mandate the methods, facilities and controls used in manufacturing, processing and packing of drugs to assure their safety and identity.

●

The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs, cooperation with healthcare professionals and advertising of drugs directed to the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU member state laws.

C.	Organizational Structure

D.	Property, Plant and Equipment

ITEM 4A.      UNRESOLVED STAFF COMMENTS

ITEM 5.         OPERATING AND FINANCIAL REVIEW AND PROSPECTS

●

continue the ongoing and planned preclinical and clinical development of our drug candidates;

●

build a portfolio of drug candidates through the acquisition or in-license of drugs, drug candidates or technologies;

●

initiate preclinical studies and clinical trials for any additional drug candidates that we may pursue in the future;

●

seek marketing approvals for our current and future drug candidates that successfully complete clinical trials;

●

establish a sales, marketing and distribution infrastructure to commercialize any drug candidate for which we may obtain marketing approval;

●

develop, maintain, expand and protect our intellectual property portfolio;

●

implement operational, financial and management systems; and

●

attract, hire and retain additional administrative, clinical, regulatory and scientific personnel.

●

employee-related expenses, including salaries, benefits and stock-based compensation expense;

●

fees paid to consultants for services directly related to our drug development and regulatory effort;

●

expenses incurred under agreements with contract research organizations, as well as CMOs and consultants that conduct preclinical studies and clinical trials;

●

costs associated with preclinical activities and development activities; and

●

costs associated with technology and intellectual property licenses.

●

number of clinical trials required for approval and any requirement for extension trials;

●

per patient trial costs;

●

number of patients that participate in the clinical trials;

●

number of sites included in the clinical trials;

●

countries in which the clinical trial is conducted;

●

length of time required to enroll eligible patients;

●

potential additional safety monitoring or other studies requested by regulatory agencies; and

●

efficacy and safety profile of the drug candidate.

A.	Operating Results

		Year ended December 31,
		2023				2022				2021
Statements of comprehensive loss data:		(US$ thousands)
Research and development			6,035				4,422				2,860
General and administrative			3,549				4,447				4,348
Total operating loss			9,584				8,869				7,208
financial (income) expenses, net			(248	)			(86	)			32
Loss before taxes			9,336				8,783				7,240
Income tax expense			8				9				6
Net loss			9,344				8,792				7,246

JOBS Act Exemptions and Foreign Private Issuer Status

●

the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;

●

the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time;

●

the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events; and

●

Regulation FD, which regulates selective disclosures of material information by issuers.

B.	Liquidity and Capital Resources.

●

the costs, timing and outcome of manufacturing clinical trial and commercial quantities of PRF-110;

●

the scope, progress, results and costs of our current and future clinical trials of PRF-110 for our current targeted uses;

●

the costs, timing and outcome of regulatory review of PRF-110;

●

the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for PRF-110 on favorable terms, although we currently have no commitments or agreements to complete any such transactions;

●

the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time;

●

the amount of revenue, if any, received from commercial sales of PRF-110, should it receive marketing approval;

●

the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims;

●

our ability to establish strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

●

our headcount growth and associated costs as we expand our business operations and our research and development activities;

●

the costs of operating as a public company;

●

maintaining minimum shareholders’ equity requirements under the Nasdaq rules; and

●

the impact of the current wars between Israel and Hamas, and between Russian and Ukraine, which may exacerbate the magnitude of the factors discussed above.

		Payments due by period
		(US$ thousands)
		Less than 1 year				1-3 Years				3-5 Years				More than 5 years				Total
Obligations under master clinical research organization agreement(1)			2,192				—				—				—				2,192
Obligations under master clinical trial agreement(2)			6,991				—				—				—				6,991
Total		$	9,183				—				—				—			$	9,183

		Years ended December 31,
		(US$ thousands)
		2023				2022				2021
Net cash used in operating activities			(6,679	)			(6,459	)			(6,553	)
Net cash provided by (used in) investing activities			5,991				(6,006	)			(50	)
Net cash provided by financing activities			4,616				—				7,484
Effect of Exchange rate changes on cash, cash equivalents and restricted cash			2				—				—
(Decrease) Increase in cash and cash equivalents and restricted cash			3,930				(12,465	)			881
Cash and cash equivalents and restricted cash, at the beginning of the year			4,106				16,571				15,690
Cash and cash equivalents and restricted cash, at the end of the year			8,036				4,106				16,571

C.	Research and Development, Patents and Licenses

D.	Trend Information

ITEM 6.         DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A.	Directors and Senior Management

Name		Age		Position
Senior Management
Ilan Hadar		54		Chief Executive Officer and Chief Financial Officer
Prof. Eli Hazum		76		Chief Technology Officer and Director
Dr. Sigal Aviel		60		Chief Operating Officer
Rita Keynan		55		Vice President of Pharmaceutical Operations
Non-Employee Director
Dr. Ehud Geller		77		Chairman of the Board and Director
Efi Cohen-Arazi(1) (2) (3) (4)		69		Director
Dr. Ellen S. Baron(1) (2) (3)(4)		71		External Director
Augustine Lawlor(1) (2) (3)(4)		68		External Director

(1)	Member of the Compensation Committee
(2)	Member of the Audit Committee
(3)	Independent Director under Israeli Law
(4)	Independent Director under the Nasdaq Listing Rules

B.	Compensation

Salaries, fees, commissions, and bonuses

Pension, retirement and similar benefits

Value of Options Granted(1)

(in thousands of U.S. dollars)

(in thousands of U.S. dollars)

(in thousands of U.S. dollars)

All senior management and directors as a group, consisting of 8 persons

1,269

160

776

(1)	Consists of amounts recognized as share-based compensation expense for the year ended December 31, 2023. Assumptions and key variables used in the calculation of such amounts are discussed in Note 10 of our financial statements.

Name and Position(1)		Salary				Social Benefits(2)				Bonuses				Value of Options Granted (3)				All Other Compensation(4)				Total
		(in thousands of U.S. dollars)
Ehud Geller, Chairman			-				-				-				126				150				276
Ilan Hadar, Chief Executive  Officer			287				55				62				159				-				562
Eli Hazum Chief Technology Officer			-				-				-				126				144				270
Rita Keynan  Vice President of Pharmaceutical Operations			200				57				45				51				-				353
Sigal Aviel Chief Operating Officer			245				48				52				6				-				352

(1)	All executive officers listed in the table were employed on a full-time basis during 2023.
(2)	“Social Benefits” include payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds, vacation pay and recuperation pay as mandated by Israeli law.
(3)	Consists of amounts recognized as share-based compensation expense for the year ended December 31, 2023. Assumptions and key variables used in the calculation of such amounts are discussed in Note 10 of our financial statements.
(4)	“All Other Compensation” includes chairman of the board of directors' annual fee and directors’ consulting related fees.

C.	Board Practices

●

at least a majority of the shares of non-controlling shareholders or shareholders that do not have a personal interest in the approval voted at the meeting are voted in favor (disregarding abstentions); or

●

the total number of shares of non-controlling shareholders or shareholders that do not have a personal interest in the approval voted against the proposal does not exceed 2% of the aggregate voting rights in the company.

●

an employment relationship;

●

a business or professional relationship maintained on a regular basis;

●

control; and

●

service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such director was appointed as a director of the private company in order to serve as an external director following the initial public offering.

●

such majority includes at least a majority of the shares held by shareholders who are non-controlling shareholders and do not have a personal interest in the election of the external director (other than a personal interest not deriving from a relationship with a controlling shareholder) that are voted at the meeting, excluding abstentions, to which we refer as a disinterested majority; or

●

the total number of shares voted by non-controlling shareholders and by shareholders who do not have a personal interest in the election of the external director, against the election of the external director, does not exceed 2% of the aggregate voting rights in the company.

●

his or her service for each such additional term is recommended by one or more shareholders holding at least 1% of the company’s voting rights and is approved at a shareholders meeting by a disinterested majority, where the total number of shares held by non-controlling, disinterested shareholders voting for such reelection exceeds 2% of the aggregate voting rights in the company. In such event, the external director so reappointed may not be a Related or Competing Shareholder, as defined below, or a relative of such shareholder, at the time of the appointment, and is not and has not had any affiliation with a Related or Competing Shareholder, at such time or during the two years preceding such person’s reappointment to serve an additional term as external director. The term “Related or Competing Shareholder” means a shareholder proposing the reappointment or a shareholder holding 5% or more of the outstanding shares or voting rights of the company, provided, that at the time of the reappointment, such shareholder, the controlling shareholder of such shareholder, or a company controlled by such shareholder, have a business relationship with the company or are competitors of the company;

●

the external director proposed his or her own nomination, and such nomination was approved in accordance with the requirements described above;

●

his or her service for each such additional term is recommended by the board of directors and is approved at a shareholders meeting by the same majority required for the initial election of an external director (as described above).

●

he or she meets the qualifications for being appointed as an external director, except for the requirement that the director be an Israeli resident (which does not apply to companies whose securities have been offered outside of Israel or are listed outside of Israel); and

●

he or she has not served as a director of the company for a period exceeding nine consecutive years, provided that, for this purpose, a break of less than two years in service shall not be deemed to interrupt the continuation of the service.

●

retaining and terminating our independent auditors, subject to the ratification of the board of directors, and in the case of retention, to that of the shareholders;

●

pre-approving of audit and non-audit services and related fees and terms, to be provided by the independent auditors;

●

overseeing the accounting and financial reporting processes of the Company and audits of our financial statements, the effectiveness of our internal control over financial reporting and making such reports as may be required of an audit committee under the rules and regulations promulgated under the Exchange Act;

●

reviewing with management and our independent auditor our annual and quarterly financial statements prior to publication or filing (or submission, as the case may be) to the SEC;

●

recommending to the board of directors the retention and termination of the internal auditor, and the internal auditor’s engagement fees and terms, in accordance with the Companies Law as well as approving the yearly or periodic work plan proposed by the internal auditor;

●

reviewing with our general counsel and/or external counsel, as deem necessary, legal and regulatory matters that could have a material impact on the financial statements;

●

identifying irregularities in our business administration, inter alia, by consulting with the internal auditor or with the independent auditor, and suggesting corrective measures to the board of directors; and

●

reviewing policies and procedures with respect to transactions (other than transactions related to the compensation or terms of services) between the company and officers and directors, or affiliates of officers or directors, or transactions that are not in the ordinary course of the Company’s business and deciding whether to approve such acts and transactions if so required under the Companies Law.

●

determining whether there are deficiencies or irregularities in the business management practices of our company, including in consultation with our internal auditor or the independent auditor, and making recommendations to the board of directors to improve such practices;

●

determining the approval process for transactions with a controlling shareholder or in which a controlling shareholder has a personal interest;

●

determining whether to approve certain related party transactions (including transactions in which an office holder has a personal interest and whether such transaction is extraordinary or material under Companies Law) (see “— Approval of Related Party Transactions under Israeli Law”);

●

where the board of directors approves the working plan of the internal auditor, to examine such working plan before its submission to the board of directors and proposing amendments thereto;

●

examining our internal controls and internal auditor’s performance, including whether the internal auditor has sufficient resources and tools to dispose of its responsibilities;

●

examining the scope of our auditor’s work and compensation and submitting a recommendation with respect thereto to our board of directors or shareholders, depending on which of them is considering the appointment of our auditor; and

●

establishing procedures for the handling of employees’ complaints as to the management of our business and the protection to be provided to such employees.

●

Officers’ interests are as closely as possible aligned with our interests;

●

The correlation between pay and performance will be enhanced;

●

We will be able to recruit and retain top level executives capable of leading us to further business success, facing the challenges ahead;

●

Our officers will be motivated to achieve a high level of business performance without taking unreasonable risks. Therefore, the variable compensation component may not be based on extreme business performance goals which might potentially impose unreasonable risks on our officers; and

●

An appropriate balance between different compensation elements (e.g., fixed vs. variable, short-term vs. long-term and cash payments vs. equity-based compensation).

●

recommending whether a compensation policy should continue in effect, if the then-current policy has a term of greater than five years from the company’s initial public offering, or otherwise three years (approval of either a new compensation policy or the continuation of an existing compensation policy must in any case occur five years from the company’s initial public offering, or otherwise every three years);

●

recommending to the board of directors periodic updates to the compensation policy;

●

assessing implementation of the compensation policy;

●

determining whether to approve the terms of compensation of certain office holders which, according to the Companies Law, require the committee’s approval; and

●

determining whether the compensation terms of a candidate for the position of the chief executive officer of the company needs to be brought to approval of the shareholders according to the Companies Law.

●

the responsibilities set forth in the compensation policy;

●

reviewing and approving the granting of options and other incentive awards to the extent such authority is delegated by our board of directors; and

●

reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors.

●

overseeing our corporate governance functions on behalf of the board;

●

making recommendations to the board regarding corporate governance issues;

●

identifying and evaluating candidates to serve as our directors consistent with the criteria approved by the board;

●

reviewing and evaluating the performance of the board;

●

serving as a focal point for communication between director candidates, non-committee directors and our management; selecting or recommending to the board for selection candidates to the board; and

●

making other recommendations to the board regarding affairs relating to our directors.

●

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

●

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

●

an office holder or director (or a relative of an officer or director) of the company; or

●

a member of the company’s independent accounting firm, or anyone on its behalf.

●

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

●

all other important information pertaining to these actions.

●

refrain from any act involving a conflict of interest between the performance of his or her duties to the company and his or her other duties or personal affairs;

●

refrain from any activity that is competitive with the company;

●

refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and

●

disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.

●

a transaction other than in the ordinary course of business;

●

a transaction that is not on market terms; or

●

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

●

an amendment of the articles of association of the company;

●

an increase in the company’s authorized share capital;

●

a merger; or

●

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

●

financial 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 must 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 (a) no indictment was filed against such office holder as a result of such investigation or proceeding and (b) 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 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;

●

expenses associated with an administrative procedure, as defined in the Israeli Securities Law, conducted regarding an office holder, 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 care to the company or to a third party, including a breach arising out of the negligent conduct of the office holder;

●

a breach of fiduciary duty 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 monetary liability imposed on the office holder in favor of a third party; and

●

expenses incurred by an office holder in connection with an administrative procedure, including reasonable litigation expenses and reasonable attorneys’ fees.

●

a breach of fiduciary duty, except for indemnification and insurance for a breach of the fiduciary duty to the company and 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 or forfeit levied against the office holder.

D.	Employees.

E.	Share Ownership.

F.	Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation

ITEM 7.         MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A.	Major Shareholders

●

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.

		Ordinary Shares Beneficially Owned				Percentage Owned**
Senior Management and Directors
Ilan Hadar(1)			38,300				2.2	%
Dr. Ehud Geller(2)			347,228				19.9	%
Dr. Sigal Aviel(3)			15,273				*
Rita Keynan(4)			19,414				1.1	%
Prof. Eli Hazum(5)			33,388				1.9	%
Ellen S. Baron(6)			6,000				*	%
Augustine Lawlor(7)			6,000				*	%
Efi Cohen-Arazi(8)			18,000				*	%
All senior management and directors as a group (8 persons)			483,603				25.7	%
More than 5% Shareholders
Armistice Capital, LLC (9)			172,957	(10)			9.99	%(9)
XT Hi-Tech Investments (1992) Ltd. (11)			106,588				6.2	%
Medica III Investment group (2)			347,228				19.9	%

*	Less than 1%
**	Based on 1,728,347 ordinary shares outstanding.

(1)

Consists of options to purchase 38,300 ordinary shares exercisable at $5.70 per share and expiring on November 23, 2032. Does not include options to purchase 8,839 ordinary shares exercisable at $5.70 per share and expiring on November 23, 2032, that vest in more than 60 days from February 29, 2024.

(2)

Consists of 347,228 beneficially owned by the Medica III Investment group which includes Medica III Investments (International) L.P. which holds 111,275 ordinary shares, Medica III Investments (Israel) L.P. which holds 40,446 ordinary shares, Medica III Investments (S.F.) L.P. which holds 43,958 ordinary shares, Medica III Investments (P.F.) L.P. which holds 23,658 ordinary shares, Medica III Investments (Israel) (B) L.P. which holds 57,143 ordinary shares, and Poalim Medica III Investments L.P. which holds 52,748 ordinary shares and Dr. Ehud Geller who holds options to purchase 18,000 ordinary shares that are currently exercisable or will be exercisable within 60 days from February 29, 2024. The beneficial owners under Medica Group are: MCP Opportunity Secondary Program III L.P 10.57%, NYC Police Pension Fund 8.8%, Quantum Partners LDC 13.2%, Migdal Insurance Company Ltd 8.8%. None of which include individuals who hold more than 5% interest. Medica III Management L.P., an entity held 50% by Dr. Ehud Geller and 50% by Batsheva Elran, is the managing entity of Medica III Fund. The principal business address of Medica III Investment is 60C Medinat Hayehudim, Herzliya, 4676670, Israel. Does not include options to purchase 6,000 ordinary shares approved for issuance to Mr. Geller. Such options are exercisable at $5.90 per share and expiring on February 23, 2031, that vest in more than 60 days from February 29, 2024.

(3)

Consists of options to purchase 5,117 ordinary shares exercisable at a weighted average exercise price of $2.40 per share and expiring on May 23, 2029 and 10,156 ordinary shares exercisable at a weighted average exercise price of $5.70 expiring on November 23, 2032. Does not include options to purchase 2,344 ordinary shares exercisable at $5.70 per share and expiring on November 23, 2032, that vest in more than 60 days from February 29, 2024.

(4)

Consists of options to purchase 19,414 ordinary shares exercisable at $5.70 per share and expiring on November 23, 2032. Does not include options to purchase 4,481 ordinary shares exercisable at $5.70 per share and expiring on November 23, 2032, that vest in more than 60 days from February 29, 2024.

(5)

Consists of options to purchase 15,388 ordinary shares exercisable at $2.40 per share and expiring on April 2, 2024, options to purchase 6,000 ordinary shares exercisable at $45.00 per share and expiring on February 23, 2031 and options to purchase 12,000 ordinary shares exercisable at $5.90 per share and expiring on August 6, 2033. Does not include options to purchase 6,000 ordinary shares exercisable at $5.90 per share and expiring on August 6, 2033, that vest in more than 60 days from February 29, 2024

(6)	Consists of options to purchase 6,000 ordinary shares exercisable at $45.00 per share and expiring on February 23, 2031.

(11)

The following information is based on a Schedule 13G/A filed on January 23, 2024. XT Hi-Tech Investments (1992) Ltd., or XT Hi-Tech, is an indirect wholly owned subsidiary of XT Investments Ltd. (“XT Investments”), which is a direct wholly-owned subsidiary of XT Holdings, of which Orona Investments Ltd. (“Orona”) and Lynav Holdings Ltd. (“Lynav”) are each the direct owners of one-half of the outstanding ordinary shares. Orona is indirectly owned 56% by Mr. Udi Angel, who also indirectly owns 100% of the means of control of Orona. Lynav is held 95% by CIBC Bank and Trust Company (Cayman) Ltd. (“CIBC”)— as trustee of a discretionary trust established in the Cayman Islands. Udi Angel is member of the board of directors of XT Hi-Tech and has a casting vote with respect to various decisions taken by the board, including voting and disposition over the ordinary shares held by XT Hi-Tech. The principal business address XT Hi-Tech is 9 Andre Saharov Street, P.O. Box 15090, Haifa 31905, Israel.

B.	Related Party Transactions

C.	Interests of Experts and Counsel

ITEM 8.         FINANCIAL INFORMATION.

A.	Consolidated Statements and Other Financial Information.

B.	Significant Changes

ITEM 9.         THE OFFER AND LISTING

A.	Offer and Listing Details

B.	Plan of Distribution

C.

Markets

D.	Selling Shareholders

E.

Dilution

F.	Expenses of the Issue

ITEM 10.       ADDITIONAL INFORMATION

A.	Share Capital

B.	Memorandum and Articles of Association

C.	Material Contracts

D.	Exchange Controls

E.

Taxation.

●

amortization over an eight-year period of the cost of patents and rights to use a patent and know-how which were purchased in good faith and are used for the development or advancement of the Industrial Enterprise;

●

deduction over a three-year period of expenses incurred in connection with the issuance and listing of shares on a stock market; and

●

under certain conditions, an election to file tax returns with related Israeli Industrial Companies.

●

owns a Preferred Enterprise, which is defined as an “Industrial Enterprise” (as defined under the Investment Law) that is classified as either a “Competitive Enterprise” (as defined under the Investment Law) or a “Competitive Enterprise in the Field of Renewable Energy” (as defined under the Investment Law);

●

is controlled and managed from Israel;

●

is not a “Family Company,” a “Home Company,” or a “Kibbutz” (collective community) as defined under the Income Tax Ordinance;

●

keeps acceptable books of account and files reports in accordance with the provisions of the Investment Law and the Income Tax Ordinance; and

●

was not, and certain officers of which were not, convicted of certain crimes in the 10 years prior to the tax year with respect to which benefits are being claimed.

F.	Dividends and Paying Agents

G.	Statement by Experts

H.	Documents on Display

I.	Subsidiary Information.

J.	Annual Report to Security Holders.

ITEM 11.       QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 12.       DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

A.	Debt Securities.

B.	Warrants and rights.

C.	Other Securities.

D.	American Depositary Shares

ITEM 13.        DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

ITEM 14.       MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

ITEM 15.        CONTROLS AND PROCEDURES

ITEM 16A.     AUDIT COMMITTEE FINANCIAL EXPERT

ITEM 16B.     CODE OF ETHICS

ITEM 16C.     PRINCIPAL ACCOUNTANT FEES AND SERVICES

		Year Ended December 31,
		2023				2022
(USD in thousands)
Audit fees (1)			120				107
Audit-related fees(2)			122				5
Tax fees			-				-
All other fees			-				23
Total			242				135

(1)	The audit fees for the years ended December 31, 2023 and 2022 include professional services rendered in connection with the audit of our annual financial statements and the review of our interim financial statements, statutory audits of the Company.

(2)	Issuance of consents and assistance with review of documents filed with the SEC.

ITEM 16D.     EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

ITEM 16E.     PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

ITEM 16F.     CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT

ITEM 16G.    CORPORATE GOVERNANCE

●

Shareholder approval. We will seek shareholder approval for all corporate actions requiring such approval under the requirements of the Companies Law, rather than seeking approval for corporate actions in accordance with Nasdaq Listing Rule 5635. In particular, under this Nasdaq Listing Rule, shareholder approval is generally required for: (i) an acquisition of shares or assets of another company that involves the issuance of 20% or more of the acquirer’s shares or voting rights or if a director, officer or 5% shareholder has greater than a 5% interest in the target company or the consideration to be received; (ii) the issuance of shares leading to a change of control; (iii) adoption or amendment of equity compensation arrangements; and (iv) issuances of 20% or more of the shares or voting rights (including securities convertible into, or exercisable for, equity) of a listed company via a private placement (or via sales by directors, officers or 5% shareholders) if such equity is issued (or sold) at below the greater of the book or market value of shares. By contrast, under the Companies Law, shareholder approval is required (subject to certain limited exceptions) for, among other things: (a) transactions with directors concerning the terms of their service (including indemnification, exemption, and insurance for their service or for any other position that they may hold at a company), for which approvals of the compensation committee, board of directors, and shareholders are all required; (b) extraordinary transactions with controlling shareholders of publicly held companies, which require the special approval described below under “Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions;” (c) terms of office and employment or other engagement of our controlling shareholder, if any, or such controlling shareholder’s relative, which require the special approval described below under “Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions;” (d) approval of transactions with Company’s Chief Executive Officer with respect to his or hers compensation, whether in accordance with the approved compensation policy of the Company or not in accordance with the approved compensation policy of the Company, or transactions with officers of the Company not in accordance with the approved compensation policy; and (e) approval of the compensation policy of the Company for office holders. In addition, under the Companies Law, a merger requires approval of the shareholders of each of the merging companies.

●

Nomination of our directors. Israeli law and our amended articles of association do 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 Listing Rules of the Nasdaq Stock Market. We rely on the exemption available to foreign private issuers under the Nasdaq Listing Rules and follow Israeli law and practice with regard to the process of nominating directors, in accordance with which 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).

●

Quorum requirement. Under our amended and restated articles of association and as permitted under the Companies Law, a quorum for any meeting of shareholders shall be the presence of at least two shareholders present in person, by proxy or by a written ballot, who hold at least 25% of the voting power of our shares (or if a higher percentage is required by law, such higher percentage) instead of 33 1/3% of the issued share capital required under the Nasdaq Listing Rules. If within half an hour from the time designated for the meeting a quorum is not present, them will stand adjourned to the same day in the following week, at the same time and place. If a quorum is not present at the adjourned meeting within half hour from the time designated for its start, the meeting shall take place with any number of participants.

●

Periodic reports. As opposed to making periodic reports to shareholders and proxy solicitation materials available to shareholders in the manner specified by the Nasdaq Marketplace Rules, the Companies Law does not require us 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 available through a public website. We will only mail such reports to shareholders upon request; and

●

Compensation of officers. We follow Israeli law and practice with respect to the approval of officer compensation.  While our compensation committee currently complies with the provisions of the Nasdaq Listing Rules relating to composition requirements and Israeli law generally requires that the compensation of the chief executive officer and all other executive officers be approved, or recommended to the board for approval, by the compensation committee (and in certain instances, shareholder approval is required), Israeli law includes relief from compensation committee approval in certain instances. For details regarding the approvals required under the Israeli Companies Law and regulation promulgated thereunder for the approval of compensation of the chief executive officer, all other executive officers and directors, see Item 6C “Directors, Senior Management and Employees— Board Practices — Approval of Related Party Transactions under Israeli Law — Disclosure of Personal Interests of an Office Holder and Approval of Certain Transactions”).

ITEM 16H.   MINE SAFETY DISCLOSURE

ITEM 17.       FINANCIAL STATEMENTS

ITEM 18.       FINANCIAL STATEMENTS

ITEM 19.       EXHIBITS.