CMMB 20-F

Chemomab Therapeutics Ltd. (CMMB)

20-F 2024-03-28 For: 2023-12-31

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Added on April 08, 2026

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Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing twenty (20) ordinary shares, no par value per share	CMMB	Nasdaq Capital Market
Ordinary shares, no par-value*	NA	Nasdaq Capital Market

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS		2

PRESENTATION OF FINANCIAL AND OTHER INFORMATION		5

PART I		6

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS		6

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE		6

ITEM 3. KEY INFORMATION		6

A.	[Reserved.]	6

B.	Capitalization and Indebtedness	6

C.	Reasons for the Offer and Use of Proceeds	6

D.	Risk Factors	6

ITEM 4. INFORMATION ON THE COMPANY		38

A.	History and Development of the Company	38

B.	Business Overview	39

C.	Organizational Structure

D.	Property, Plants and Equipment

ITEM 4A. UNRESOLVED STAFF COMMENTS		91

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS		91

A.	Operating Results	92

B.	Liquidity and Capital Resources	98

C.	Research and Development, Patents and Licenses, Etc.	100

D.	Trend Information	100

E.	Critical Accounting Estimates	100

ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES		102

A.	Directors and Senior Management	102

B.	Compensation	104

C.	Board Practices	110

D.	Employees	120

E.	Share Ownership	120

F.	Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation	120

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS		121

A.	Major Shareholders	121

B.	Related Party Transactions	123

C.	Interests of Experts and Counsel	124

ITEM 8. FINANCIAL INFORMATION		124

A.	Consolidated Statements and Other Financial Information	124

B.	Significant Changes	124

ITEM 9. THE OFFER AND LISTING		125

A.	Offer and Listing Details	125

B.	Plan of Distribution	125

C.	Markets	125

D.	Selling Shareholders	125

E.	Dilution	125

F.	Expenses of the Issue	125

ITEM 10. ADDITIONAL INFORMATION		125

A.	Share Capital	125

B.	Memorandum and Articles of Association	125

C.	Material Contracts	125

D.	Exchange Controls	126

E.	Taxation	126

F.	Dividends and Paying Agents	137

G.	Statement by Experts	138

H.	Documents on Display	138

I.	Subsidiary Information	138

J.	Annual Report to Security Holders	138

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	138

ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	139

PART II	147

ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	147

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	147

ITEM 15. CONTROLS AND PROCEDURES	147

ITEM 16. [RESERVED]	148

ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT	148

ITEM 16B. CODE OF ETHICS	148

ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES	149

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	150

ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	150

ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	150

ITEM 16G. CORPORATE GOVERNANCE	150

ITEM 16H. MINE SAFETY DISCLOSURE	151

ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	151

ITEM 16J. INSIDER TRADING POLICY	151

ITEM 16K. CYBERSECURITY	151

PART III	152

ITEM 17. FINANCIAL STATEMENTS	152

ITEM 18. FINANCIAL STATEMENTS	153

ITEM 19. EXHIBITS	153

SIGNATURES	155

INDEX	F-1

•	we have incurred significant losses since inception and anticipate that we will continue to incur increasing levels of operating losses over the next several years and for the foreseeable future. We are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis;

•	we have a limited operating history and funding, which may make it difficult to evaluate our prospects and likelihood of success;

•	our business is highly dependent on the success of our lead product candidate, CM-101, and any other product candidates that we advance into clinical studies. All of our programs will require significant additional clinical development;

•	our central objective is to design and develop targeted treatments for inflammation and fibrosis with an initial focus on the antagonism of CCL24 signaling, which is known to regulate fibrotic and inflammatory processes. While several studies are currently underway, our approach in the area of fibrotic diseases is novel and unproven and may not result in marketable products;

•	the successful completion of clinical studies is a prerequisite to submitting a marketing application to the FDA and similar marketing applications to comparable foreign regulatory authorities, for each product candidate and, consequently, the ultimate approval and commercial marketing of any product candidates. We may experience negative or inconclusive results, which may result in us deciding, or regulators requiring us, to conduct additional clinical studies or trials or abandon some or all of our product development programs, which could have a material adverse effect on our business;

•	we may encounter difficulties enrolling patients in our clinical studies, including any public health emergencies and related clinical development activities could be delayed or otherwise adversely affected;

•	our ongoing and future clinical studies may reveal significant adverse events or immunogenicity-related responses and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of our product candidate;

•	the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for CM-101 or any other product candidates, our business will be substantially harmed;

•	if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed;

•	we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us;

•	we have been granted Orphan Drug Designation for CM-101 in connection with three indications and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates;

•	we expect to experience significant growth in the number of our employees over time and the scope of our operations, particularly in the areas of product candidate development, regulatory affairs and sales and marketing. We will therefore need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations;

•	if we are unable to protect our patents or other proprietary rights, or if we infringe the patents or other proprietary rights of others, our competitiveness and business prospects may be materially damaged. In addition, changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates;

•	risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations;

•	our principal executive offices are located in Israel and US and certain of our product candidates may be manufactured at third-party facilities located in Europe. In addition, our business strategy includes potentially expanding internationally if any of our product candidates receives regulatory approval. A variety of risks associated with operating internationally could materially adversely affect our business;

•	holders of ADSs are not treated as holders of our Ordinary Shares;

•	holders of ADSs may not have the same voting rights as the holders of our Ordinary Shares and may not receive voting materials in time to be able to exercise their right to vote;

•	holders of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying Ordinary Shares;

•	we are entitled to amend the deposit agreement and to change the rights of ADS holders under the terms of such agreement, or to terminate the deposit agreement, without the prior consent of the ADS holders;

•	ADSs holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action;

•	obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements;

•	the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for CM-101 or any other product candidates, our business will be substantially harmed;

•	obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions;

•	even if we obtain regulatory approval for CM-101 or any product candidate, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties;

•	disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder our ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business;

•	if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed;

•	we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us;

•	even if CM-101 or any other product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success;

•	we rely completely on third-party suppliers to manufacture our clinical drug supplies for our product candidates, and we intend to rely on third parties to produce preclinical, clinical, and commercial supplies of any future product candidates;

•	if we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing CM-101, if approved;

•	a variety of risks associated with operating internationally could materially adversely affect our business;

•	conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect our operations;

•	because a certain portion of our expenses are incurred in currencies other than the U.S. Dollar, our results of operations may be harmed by currency fluctuations and inflation;

•	we received Israeli government grants for certain of their research and development activities as detailed below. The terms of those grants require us to satisfy specified conditions in order to transfer outside of Israel the manufacture of products based on know-how funded by the Israel Innovation Authority or to transfer outside of Israel the know-how itself. If we fail to comply with the requirements of Israeli law in this regard, we may be required to pay penalties, and it may impair our ability to sell our technology outside of Israel;

•	we will need to raise additional capital to fund our operations, which may be unavailable to us on acceptable terms or at all, or may cause dilution or place significant restrictions on our ability to operate our business;

•	the trading price of the ADSs has been highly volatile, and is expected to continue to be volatile;

•	we have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to the value of the ADSs; and

•	if we fail to continue to meet all applicable Nasdaq requirements, Nasdaq may delist the ADSs, which could have an adverse impact on the liquidity and market price of the ADSs.

•	the costs and timing for potential additional clinical trials in order to gain possible regulatory approval for CM-101and our other product candidates;

•	the market price of our ADSs and the availability and cost of additional equity capital from existing and potential new investors;

•	our ability to retain the listing of our ADSs on the Nasdaq Capital Market;

•	general economic and industry conditions affecting the availability and cost of capital, including as a result of deteriorating market conditions due to investor concerns regarding inflation and continued hostilities between Israel and Hamas, and Russia and Ukraine;

•	our ability to control costs associated with our operations;

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

•	the terms and conditions of our existing collaborative and licensing agreements.

•	the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies;

•	obtaining regulatory authorizations to commence a trial or consensus with regulatory authorities on trial’s design;

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

•	obtaining IRB approval at each site, or Independent Ethics Committee, or IEC, approval at sites outside the United States;

•	imposition of a clinical hold by regulatory authorities, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols;

•	clinical studies may show the product candidates to be less effective than expected (e.g., a clinical study could fail to meet its primary endpoint(s)) or to have unacceptable side effects or toxicities;

•	failure to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful;

•	the occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

•	adding a sufficient number of clinical study sites;

•	manufacturing sufficient quantities of product candidate with sufficient quality for use in clinical studies;

•	having patients complete a trial or return for post-treatment follow-up;

•	recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers;

•	a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of current good manufacturing practice, or cGMP, regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;

•	third-party clinical investigators losing the licenses or permits necessary to perform our clinical studies, not performing our clinical studies on our anticipated schedule or consistent with the clinical study protocol, GCP, or other regulatory requirements;

•	third-party contractors not performing data collection or analysis in a timely or accurate manner;

•	manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make a product candidate uneconomical; or

•	the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized.

•	regulators, IRBs, or IECs may not authorize us or our investigators to commence a clinical study or conduct a clinical study at a prospective trial site;

•	the FDA or other comparable regulatory authorities may disagree with our clinical study design, including with respect to dosing levels administered in our planned clinical studies, which may delay or prevent us from initiating our clinical studies with our originally intended trial design;

•	we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•	the number of subjects required for clinical studies of any product candidates may be larger than we anticipate or subjects may drop out of these clinical studies or fail to return for post-treatment follow-up at a higher rate than we anticipate;

•	our third-party contractors may fail to comply with regulatory requirements or meet our contractual obligations to us in a timely manner, or at all, or may deviate from the clinical study protocol or drop out of the trial, which may require that we add new clinical study sites or investigators;

•	due to the impact of emerging public health threats, we may experience, delays and interruptions to clinical studies, we may experience delays or interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service providers on whom we rely;

•	additional delays and interruptions to our clinical studies could extend the duration of the trials and increase the overall costs to finish the trials as our fixed costs are not substantially reduced during delays;

•	we may elect to, or regulators, IRBs, Data Safety Monitoring Boards or ethics committees may require that us or its investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

•	we may not have the financial resources available to begin and complete the planned trials, or the cost of clinical studies of any product candidates may be greater than we anticipate; and

•	the supply or quality of our product candidates or other materials necessary to conduct clinical studies of our product candidates may be insufficient or inadequate to initiate or complete a given clinical study.

•	regulatory authorities may withdraw approvals of such product;

•	regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;

•	additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

•	we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a medication guide outlining the risks of such side effects for distribution to patients;

•	we could be sued and held liable for harm caused to patients;

•	the product may become less competitive; and

•	our reputation may suffer.

•	the patient eligibility and exclusion criteria defined in the protocol;

•	the need to receive study drug via an IV infusion;

•	the size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;

•	the willingness or availability of patients to participate in our trials (including due to fears of contracting COVID-19);

•	the proximity of patients to trial sites;

•	the design of the trial;

•	our ability to recruit clinical study investigators with the appropriate competencies and experience;

•	clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied with respect to other available therapies, including any new products that may be approved for the indications we are investigating;

•	the availability of competing commercially available therapies and other competing product candidates’ clinical studies;

•	our ability to obtain and maintain patient informed consents; and

•	the risk that patients enrolled in clinical studies will drop out of the trials before completion.

•	the diversion of healthcare resources away from the conduct of clinical study matters to focus on pandemic concerns, including the attention of infectious disease physicians serving as our clinical study investigators, hospitals serving as our clinical study sites and hospital staff supporting the conduct of our clinical studies;

•	the inability of patients to come to hospitals to participate in our trials, which may force us to conduct our trials in patients’ homes, rendering the trials more difficult and costly to conduct;

•	limitations on travel that interrupt key trial activities, such as clinical study site initiations and monitoring; and

•	employee furlough days that delay necessary interactions with local regulators, ethics committees and other important agencies and contractors.

•	the FDA or any foreign regulatory bodies can delay, limit or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including:

•	the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical studies;

•	we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

•	serious and unexpected drug-related side effects experienced by participants in our clinical studies or by individuals using drugs similar to our product candidates, or other products containing the active ingredient in our product candidates;

•	negative or ambiguous results from our clinical studies or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•	the population studied in the clinical study may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;

•	we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

•	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

•	the data collected from clinical studies of our product candidates may not be acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical studies;

•	the FDA’s or the applicable foreign regulatory agency’s disagreement regarding the formulation, labeling and/or the specifications of our product candidates;

•	the FDA or comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which our contracts for clinical and commercial supplies; and

•	the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

•	restrictions on manufacturing such products;

•	restrictions on the labeling or marketing of products;

•	restrictions on product manufacturing, distribution or use;

•	requirements to conduct post-marketing studies or clinical trials;

•	warning letters or untitled letters;

•	withdrawal of the products from the market;

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

•	recall of products;

•	fines, restitution or disgorgement of profits or revenues;

•	suspension or withdrawal of marketing approvals;

•	refusal to permit the import or export of our products;

•	product seizure; or

•	injunctions or the imposition of civil or criminal penalties.

•	our available capital resources or capital constraints we experience;

•	the rate of progress, costs and results of our clinical studies and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;

•	our ability to identify and enroll patients who meet clinical study eligibility criteria;

•	our receipt of authorizations by the FDA and comparable foreign regulatory authorities, and the timing thereof;

•	other actions, decisions or rules issued by regulators;

•	our ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates;

•	our ability to manufacture and supply clinical study materials to our clinical sites on a timely basis;

•	the efforts of our collaborators with respect to the commercialization of our products, if any; and

•	the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activities.

•	the efficacy and potential advantages compared to alternative treatments;

•	effectiveness of sales and marketing efforts;

•	the cost of treatment with respect to alternative treatments, including any similar generic treatments;

•	our ability to offer our products for sale at competitive prices;

•	the convenience and ease of administration compared to alternative treatments;

•	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•	the strength of marketing and distribution support;

•	the timing of market introduction of competitive products;

•	the availability of third-party coverage and adequate reimbursement;

•	product labeling or product insert requirements of the FDA, EMA or other regulatory authorities, including any limitations on warnings contained in a product’s approved labeling;

•	the prevalence and severity of any side effects; and

•	any restrictions on the use of our product together with other medications.

•	our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

•	the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe our products; and

•	unforeseen costs and expenses associated with creating an independent sales and marketing organization.

•	multiple, conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

•	failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;

•	additional potentially relevant third-party patent rights;

•	complexities and difficulties in obtaining protection and enforcing our intellectual property;

•	difficulties in staffing and managing foreign operations;

•	complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

•	limits in our ability to penetrate international markets;

•	financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

•	natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions;

•	certain expenses including, among others, expenses for travel, translation and insurance; and

•	regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the United States Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions.

•	CM-101 continued to appear well tolerated when administered subcutaneously

•	CM-101 administered subcutaneously demonstrated favorable pharmacokinetics and target engagement profiles

•	CM-101-treated patients showed greater improvements than the placebo group in a number of liver fibrosis-related biomarkers

•	A majority of CM-101-treated patients showed improvements in more than one liver fibrosis-related biomarker—almost 60% of CM-101-treated patients responded in at least three biomarkers at week 20, compared to no patients in the placebo group.

•	A higher proportion of patients in the CM-101-treated group showed improvement in a physiologic measure of liver stiffness as compared to placebo.

Preclinical findings		Observation
Ex vivo
Antibody dependent cell-cytotoxic (ADCC) and complement dependent cell-cytotoxic (CDC) activity was tested in PBMCs from healthy volunteers.		CM-101 did not have Fc-related effector functions such as ADCC and CDC.
Cytokine release was assessed in human whole blood from healthy volunteers.		CM-101 did not induce pro-inflammatory cytokine secretion.
Tissue cross reactivity was evaluated from healthy human tissues.		CM-101 does not bind non-specifically to healthy tissues, and therefore is expected to only bind to its target, circulating CCL24.
In vivo
GLP repeated dose 4-week toxicity study of CM-101 (IV) in mice.		1. No obvious treatment related adverse reactions. 2. No gross or microscopic pathological findings. 3. No cases of treatment related mortality were observed. 4. No significant elevation was seen in IL1β, IL2, IL4, IL5, IL10, GM-CSF, IFN and TNFα.

•	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 Investigational New Drug application, or IND, which must become effective before human clinical studies may begin;

•	approval by an Institutional Review Board, or IRB, at each clinical site before each study may be initiated;

•	performance of adequate and well-controlled human clinical studies in accordance with Good Clinical Practice, or GCP requirements to establish the safety and efficacy of the proposed drug product for each indication;

•	completion of all manufacturing requirements to ensure robust manufacturing process, and product quality and safety as per Good Manufacturing Practice, or cGMP guidelines;

•	completion of non-clinical reproductive studies, as applicable, prior to late stage clinical studies and NDA or Biologics License Application, or BLA, submission;

•	development of an appropriate pediatric plan for clinical testing or exclusion, pre- or post-approval, as applicable;

•	submission to the FDA of an NDA or BLA;

•	satisfactory completion of an FDA advisory committee review, if applicable;

•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

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

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

•	FDA review and approval of an NDA or BLA; and

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

•	Phase 1: The drug or biologic is initially introduced into healthy human subjects or 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. For some products for severe or life-threatening diseases, especially if the product may be too toxic to administer to healthy humans, the initial clinical trials may be conducted in individuals having a specific disease for which use the tested product is indicated.

•	Phase 2: The drug or biologic is administered 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 or biologic is administered to an expanded patient population, generally at geographically dispersed clinical study sites, in well-controlled clinical studies 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: Phase 4 clinical trials are studies required of, or agreed to by, a sponsor that are conducted after the FDA has approved a product for marketing. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication and to document a clinical benefit in the case of drugs approved under accelerated approval regulations. If the FDA approves a product while a company has ongoing clinical trials that were not necessary for approval, a company may be able to use the data from these clinical trials to meet all or part of any Phase 4 clinical trial requirement. Failure to promptly conduct Phase 4 clinical trials where necessary could result in withdrawal of approval for products approved under accelerated approval regulations.

	Year ended December 31,
	2023			2022			2021
	(in thousands)
Operating Expenses:
Research and development	$	18,381		$	16,977		$	6,334
General and administrative		7,078			11,556			6,033
Total operating expenses		25,459			28,533			12,367

Financing (income) expense, net		(1,238	)		(353	)		111
Loss before taxes		24,221			28,180			12,478
Taxes on income (benefit)		-			(534	)		-

Net loss	$	24,221		$	7,646		$	2,478

	Year ended December 31,												Increase/(decrease)
	2023			2022			2021						%
	(in thousands)
Net cash used in operating activities	$	(23,611	)	$	(20,370	)	$	(12,374	)	$	(3,241	)		16	%
Net cash provided by (used in) investing activities		15,879			19,533			(45,186	)		(3,654	)		(19)	%
Net cash provided by (used in) financing activities		3,504			(808	)		61,074			4,312			534	%
Net increase (decrease) in cash, cash equivalents and restricted cash	$	(4,228	)	$	(1,645	)	$	3,514		$	(2,584	)		157	%

Name	Age	Position
Executive Officers:
Adi Mor	42	Director, Chief Executive Officer and Chief Scientific Officer
Sigal Fattal	53	Chief Financial Officer
Matthew Frankel	55	Chief Medical Officer
Non-Employee Directors:
Nissim Darvish†(2)(3)	58	Chairman of the Board
Alan Moses†(1)	75	Director
Claude Nicaise†(1)	70	Director
Neil Cohen†(2)(3)	59	Director
Jill Quigley†(1)	48	Director

(1)	Member of Audit Committee

(2)	Member of Compensation Committee

(3)	Member of Corporate Governance and Nominating Committee

•	at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a personal interest in such matter, present and voting at such meeting, are voted in favor of the compensation package, excluding abstentions; or

•	the total number of shares of non-controlling shareholders and shareholders who do not have a personal interest in such matter voting against the compensation package does not exceed two percent (2%) of the aggregate voting rights in the Company.

•	Adi Mor, Chief Executive Officer, Chief Scientific Officer and Director. Compensation expenses recorded in 2023 were $0.33 million in salary expenses.

•	Dale Pfost, former Chief Executive Officer and Chairman of the Board (1). Compensation expenses recorded in 2023 were $0.7 million in salary expenses and $16 thousand in social benefits.
•	Donald Marvin, former Chief Financial Officer, Chief Operating Officer and Executive Vice President (2). Compensation expenses recorded in 2023 were $0.6 million in salary expenses and $32 thousand in social benefits.

•	Sigal Fattal, Chief Financial Officer. Compensation expenses recorded in 2023 were $0.3 million in salary expenses and $22 thousand in social benefits.

•	Matthew Frankel, Chief Medical Officer. Compensation expenses recorded in 2023 were $0.8 million in salary expenses and $50 thousand in social benefits. (1) Dale Pfost resigned from his positions as Chief Executive Officer and Chairman of the Board on June 1, 2023. The salary amount includes severance. (2) Donald Marvin resigned from his positions as Chief Financial Officer, Chief Operating Officer and Executive Vice President on June 1, 2023. The salary amount includes severance.

•	Class I consists of Nissim Darvish and Jill Quigley, each with a term expiring at the 2025 annual meeting of shareholders.
•	Class II consists of Neil Cohen and Claude Nicaise, each with a term expiring at the 2026 annual meeting of shareholders.
•	Class III consists of Adi Mor and Alan Moses, each with a term expiring at the 2024 annual meeting of shareholders.