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

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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020

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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from  ___ to ___ .

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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report ___

Title of each class	Trading Symbol	Name of each exchange on which registered
Ordinary Shares, par value of NIS 0.0000769	ENTX	NASDAQ Capital Market
Warrants, each warrant exercisable for 0.5 shares of Ordinary Shares at an exercise price of $5.85 per Ordinary Share.	ENTXW	NASDAQ Capital Market

Large Accelerated Filer ☐	Accelerated Filer ☐	Non-Accelerated Filer ☒
		Emerging growth company ☒

U.S. GAAP ☐

International Financial Reporting Standards as issued by the International Accounting Standards Board ☒

Other ☐

Item Number	Title	Page
PART ONE
Item 1	Identity of Directors, Senior Management and Advisers	7
Item 2	Offer Statistics and Expected Timetable	7
Item 3	Key Information	7
Item 4	Information on the Company	55
Item 4A	Unresolved Staff Comments	93
Item 5	Operating and Financial Review and Prospects	93
Item 6	Directors, Senior Management and Employees	106
Item 7	Major Shareholders and Related Party Transactions	123
Item 8	Financial Information	129
Item 9	The Offer and Listing	129
Item 10	Additional Information	130
Item 11	Quantitative and Qualitative Disclosures About Market Risk	144
Item 12	Description of Securities Other than Equity Securities	144
PART TWO
Item 13	Defaults, Dividend Arrearages and Delinquencies	145
Item 14	Material Modifications to the Rights of Security Holders and Use of Proceeds	145
Item 15	Controls and Procedures	145
Item 16A	Audit Committee Financial Expert	146
Item 16B	Code of Ethics	146
Item 16C	Principal Accountant Fees and Services	146
Item 16D	Exemptions from the Listing Standards for Audit Committees	147
Item 16E	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	147
Item 16F	Change in Registrant’s Certifying Accountant	147
Item 16G	Corporate Governance	147
Item 16H	Mine Safety Disclosure	151
PART THREE
Item 17	Financial Statements	152
Item 18	Financial Statements	152
Item 19	Exhibits	153

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the scope, progress and costs of developing our product candidates such as EB613 for Osteoporosis and EB612 for Hypoparathyroidism, including without limitation any changes to the design of the ongoing Phase 2 clinical trial of EB613 or the need for additional clinical trials or development work based on further analysis of the interim data from the ongoing EB613 Phase 2 clinical trial;

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the accuracy of our estimates regarding expenses, capital requirements, the sufficiency of our cash resources and the need for additional financing;

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our ability to raise additional funds on commercially reasonable terms, including via our At The Market, or ATM, Program (as defined below in Item 10.C “Material Contracts”);

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our ability to develop, advance product candidates into, and successfully complete, clinical studies such as our ongoing Phase 2 clinical trial of EB613 in osteoporosis;

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our interpretation of FDA feedback and guidance and how such guidance may impact our clinical development plans, specifically our ability to utilize the 505(b)(2) pathway for the development and potential approval of EB613 and any other product candidates we may develop;

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our ability to use and expand our drug delivery technology to additional product candidates;

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our operation as a development stage company with limited operating history and a history of operating losses and our ability to fund our operations going forward;

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our ability to continue as a going concern absent access to sources of liquidity;

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our ability to obtain and maintain regulatory approval for any of our product candidates;

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our competitive position, especially with respect to Forteo® and other products on the market or in development for the treatment of osteoporosis;

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our ability to establish and maintain development and commercialization collaborations;

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any potential commercial launch of current or future product candidates, and the timing, cost or other aspects of such commercialization;

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our ability to manufacture and supply sufficient amounts of material to support our clinical trials and any potential future commercial requirements;

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the safety and efficacy of therapeutics marketed by competitors that are targeted toward indications for which we are developing product candidates;

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the size of any market we may target and the adoption of our product candidates, if approved, by physicians and patients;

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our ability to obtain, maintain and protect our intellectual property and operate our business without infringing misappropriating or otherwise violating any intellectual property rights of others;

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our ability to retain key personnel and recruit additional qualified personnel;

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the possibility that competing products or technologies may make any product candidates we may develop and commercialize or our oral delivery technology obsolete;

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the pricing and reimbursement of our product candidates, if approved;

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our ability to develop a sales, marketing and distribution infrastructure, if any;

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the duration and severity of the coronavirus (COVID-19) outbreak, the actions that may be required to contain the Coronavirus or treat its impact, and its impact on our operations and workforce, including our research and development and clinical trials.

​		Year Ended December 31,
​		2020				2019				2018				2017				2016
​		(In thousands, except shares and per share data)
Consolidated statements of comprehensive loss:										​				​
Revenue		$	365			$	236			$	500				-				-
Cost of revenue			209				210				-				-				-
Research and development expenses, net		$	6,398			$	7,199			$	8,518			$	2,768			$	2,648
General and administrative expenses			4,891				4,281				2,843				8,575				2,719
Total operating loss			11,133				11,454				10,861				11,343				5,367
Financial income:										​				​				​
Income from change in fair value of financial liabilities at fair value through profit or loss			(1,237	)			(743	)			(523	)			(251	)			(4,311	)
Other financial expenses (income), net			67				84				(34	)			105				143
Financial income, net			(1,170	)			(659	)			(557	)			(146	)			(4,168	)
Loss before taxes		$	9,963			$	10,795			$	10,304			$	11,197			$	1,199
Taxes on income			20
Net comprehensive loss		$	9,983			$	10,795			$	10,304			$	11,197			$	1,199
Loss per ordinary share(1)										​				​				​
Basic		$	0.54			$	0.89			$	1.30			$	2.49			$	0.27
Diluted		$	0.55			$	0.89			$	1.31			$	2.49			$	0.78
Weighted average number of Ordinary Shares used in computing basic loss per ordinary share(1)			18,417,093				12,146,729				7,955,447				4,490,720				4,473,170
Weighted average number of Ordinary Shares used in computing diluted loss per ordinary share(1)			18,563,675				12,146,729				7,983,402				4,490,720				6, 756,360

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We have incurred significant losses since our inception and anticipate that we will continue to incur substantial losses for the next several years;

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Management has performed an analysis of our ability to continue as a going concern and our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern;

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All of our product candidates, including EB613 and EB612, are in preclinical or clinical development and we have not yet successfully completed the development of any product candidates;

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If serious adverse, undesirable or unacceptable side effects are identified during the development of our product candidates, marketing approval may be delayed or we may need to abandon our development of such product candidates, and if such side effects are identified following regulatory approval, any approved product label may be limited or we may be subject to other significant negative consequences;

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The outbreak of COVID-19 in the United States, Israel and elsewhere has created significant business disruptions  and could adversely affect our business;

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The commencement and completion of clinical trials can be delayed or prevented for a number of reasons;

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The results of previous clinical trials may not be predictive of future results, our progress in trials for one product candidate may not be indicative of progress in trials for other product candidates, and our trials may not be designed so as to support regulatory approval;

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Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation. If we fail to comply with applicable current and future laws and government regulations, it could delay or prevent the promotion, marketing or sale of our products;

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Healthcare legislative changes may harm our business and future prospects;

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We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products;

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We are highly dependent upon our ability to enter into agreements with collaborators to develop, commercialize and market our products;

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We may fail to establish, maintain, defend and enforce intellectual property rights with respect to our technology;

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The price of our Ordinary Shares and IPO Warrants may be volatile, and holders of our Ordinary Shares and IPO Warrants could lose all or part of their investment; and

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Security, political and economic instability in the Middle East may harm our business.

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the number and characteristics of product candidates that we pursue;

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the scope, progress, timing, cost and results of research, preclinical development, and clinical trials;

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the costs, timing and outcome of seeking and obtaining approvals from the FDA, EMA or other regulatory agencies;

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the costs associated with manufacturing our product candidates and establishing sales, marketing, and distribution capabilities;

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the costs associated with obtaining, maintaining, expanding, defending and enforcing the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights;

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the extent to which we acquire or in-license other products or technologies;

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the economic and other terms, timing of and success of any collaboration, licensing, or other arrangements into which we entered or may enter in the future, including the timing of achievement of milestones and receipt of any milestone or royalty payments under these agreements;

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our need and ability to hire additional management, scientific, and medical personnel;

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the effect of competing products that may limit market penetration of our product candidates;

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the amount and timing of revenues, if any, we receive from commercial sales of any product candidates for which we receive marketing approval in the future;

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the impact of COVID-19, once known, on our clinical trials, regulatory timelines, business operations and financial stability.

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the completion of our ongoing Phase 2 dose-ranging clinical trial for EB613 and any future development efforts for EB613 or other product candidates;

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securing additional funding as may be needed to continue the development of EB613 or any other product candidates;

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obtaining required regulatory and marketing approvals for the manufacturing and commercialization of EB613 and any other product candidates we may develop, including a new Oral GLP-2 analog research program ;

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obtaining adequate reimbursement from third-party payors for any product that may be commercialized, if approved;

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managing our spending as costs and expenses increase due to the preparation of regulatory filings, potential regulatory approvals, manufacturing scale-up and potential commercialization;

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continuing to build and maintain our intellectual property portfolio;

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recruiting and retaining qualified executive management and other personnel;

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building and maintaining appropriate research and development, clinical, sales, manufacturing, financial reporting, distribution and marketing capabilities on our own or through third parties;

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gaining market acceptance for our product candidates;

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developing and maintaining successful strategic relationships and collaborations;

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developing a sustainable and scalable manufacturing process for any approved product candidates and maintaining supply and manufacturing relationships with third parties that can support clinical development and market demand for our product candidates, if approved;

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establishing sales, marketing, and distribution capabilities in the United States;

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obtaining market acceptance for any of our product candidates that receive marketing approval, if any, as viable treatment options;

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addressing any competing technological and market developments;

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negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; and

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attracting, hiring and retaining qualified personnel.

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regulatory authorities may require us to take these products off the market;

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regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;

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we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

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we may be subject to limitations on how we may promote the product;

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sales of the product may decrease significantly;

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we may be subject to litigation or product liability claims; and

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our reputation may suffer.

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such authorities may disagree with the number, design, size, conduct or implementation of our clinical trials or any of our collaborators’ clinical trials;

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we or any of our development partners may be unable to demonstrate to the satisfaction of the FDA or other regulatory authorities that a product candidate is safe and effective for any indication;

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the results of clinical trials may not meet the level of statistical significance or clinical significance required by the FDA, EMA or other regulatory agencies for approval;

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such authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that authority’s jurisdiction;

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the data collected from non-clinical studies and clinical trials of our product candidates may not be sufficient to support the submission of an application for regulatory approval;

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the results of clinical trials may not demonstrate the safety or efficacy required by such authorities for approval;

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we or any of our future development partners may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

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such authorities may disagree with our interpretation of data from preclinical studies or clinical trials or the use of results from studies that served as precursors to our current or future product candidates;

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such authorities may find deficiencies in our manufacturing processes or facilities or those of third-party manufacturers with which we or any of our future development partners contract for clinical and commercial supplies;

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the FDA may require development of a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval; and

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the approval policies or regulations of such authorities may significantly change in a manner rendering our or any of our future development partners’ clinical data insufficient for approval.

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future clinical trial results may show that our oral PTH is not effective, including if our drug delivery technology is not effective, our product candidates are not effective, our clinical trial designs are flawed, or clinical trial investigators or subjects do not comply with trial protocols;

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our product candidates may not be well tolerated or may cause negative side effects;

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our ability to complete the development and commercialization of our oral PTH for our intended uses may be significantly dependent upon our ability to obtain and maintain experienced and committed collaborators to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, our oral PTH;

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even if our oral PTH is shown to be safe and effective for its intended purposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities at reasonable prices, or at all;

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even if our oral PTH is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that there will be market acceptance;

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even if our oral PTH is successfully developed, commercially produced and receives all necessary regulatory approvals for the treatment of Osteoporosis, there is no guarantee that we will successfully develop and commercialize it for other indications, including hypoparathyroidism and delayed union fractures; and

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our competitors may develop therapeutics or other treatments that are superior to or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues.

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difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;

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

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failure of our third-party contractors, such as CROs and contract manufacturing organizations, or our investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner;

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insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;

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difficulties obtaining institutional review board, or IRB, or ethics committee approval to conduct a clinical trial at a prospective site;

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the FDA, EMA or other regulatory authority may require changes to any of our trial designs, our pre-clinical strategy or our manufacturing plans;

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various challenges recruiting and enrolling subjects to participate in clinical trials, including size and nature of subject population, proximity of subjects to clinical sites, eligibility criteria for the trial, budgetary limitations, nature of trial protocol, the patient referral practices of physicians, changes in the readiness of subjects to volunteer for a trial, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications;

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difficulties in maintaining contact with subjects who withdraw from the trial, resulting in incomplete data;

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governmental or regulatory delays and changes in regulatory requirements, policy and guidelines;

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varying interpretations of data by the FDA and foreign regulatory agencies; and

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inaccurate interpretations by us of the FDA’s guidance for the clinical and regulatory path for our product candidates.

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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

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findings of an inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;

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unforeseen issues, including serious adverse events associated with a product candidate, or lack of effectiveness or any determination that a clinical trial presents unacceptable health risks;

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lack of adequate funding to continue the clinical trial due to unforeseen costs or other business decisions; and

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upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future collaborators that have responsibility for the clinical development of any of our product candidates.

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issue warning letters or untitled letters or take similar enforcement actions;

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seek an injunction or impose civil or criminal penalties or monetary fines;

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suspend or withdraw marketing approval;

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suspend any ongoing clinical trials;

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refuse to approve pending applications or supplements to applications;

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suspend or impose restrictions on operations, including costly new manufacturing requirements;

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seize or detain products, refuse to permit the import or export of products, exclude products from federal healthcare programs, or request that we initiate a product recall; or

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refuse to allow us to enter into supply contracts, including government contracts.

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the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal health care program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

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the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

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HIPAA imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

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the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services;

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the federal transparency requirements under the ACA requires certain manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and the ownership and investment interests of such physicians or their family members;

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the Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which requires specified manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other “transfers of value” made to physicians. All such reported information is publicly available;

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analogous state and non-U.S. laws and regulations, such as certain state anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and

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regulation by the Centers for Medicare and Medicaid Services and enforcement by the U.S. Department of Health and Human Services (Office of Inspector General) or the U.S. Department of Justice.

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We do not have experience in manufacturing our product candidates at commercial scale. We may not succeed in the scaling up of our final manufacturing process. We may need a larger-scale manufacturing process for our oral PTH than what we have planned, depending on the dose and regimen that will be determined in future studies. Any changes in our manufacturing processes as a result of scaling up may result in the need to obtain additional regulatory approvals. Difficulties in achieving commercial-scale production or the need for additional regulatory approvals as a result of scaling up could delay the development and regulatory approval of our product candidates and ultimately affect our success. Contract manufacturers may not have sufficient expertise to manufacture a dry oral formulation with a large molecule API, in which case we may have to establish our own commercial manufacturing capabilities, which could be expensive and delay launch of product candidates.

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The manufacturing process for large molecules is more complex and subject to greater regulation than that of other drugs. The process of manufacturing large molecules, such as our product candidates, is extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

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The manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures, outbreaks of an infectious disease such as COVID-19 and numerous other factors.

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We must comply with applicable current cGMP, regulations and guidelines. We may encounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel. We are subject to inspections by the FDA and comparable agencies in other jurisdictions to confirm compliance with applicable regulatory requirements. Any failure to follow cGMP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our product candidates as a result of a failure of our facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our product candidates, including leading to significant delays in the availability of drug product for our clinical trials or the termination or hold on a clinical trial, or the delay or prevention of a filing or approval of marketing applications for our product candidates. Significant noncompliance could also result in the imposition of sanctions, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could damage our reputation. If we are not able to maintain regulatory compliance, we may not be permitted to market our product candidates and/or may be subject to product recalls, seizures, injunctions, or criminal prosecution.

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Any adverse developments affecting manufacturing operations for our product candidates, if any are approved, may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our products. We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives.

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Our product candidates that have been produced and are stored for later use may degrade, become contaminated or suffer other quality defects, which may cause the affected product candidates to no longer be suitable for their intended use in clinical trials or other development activities. If the defective product candidates cannot be replaced in a timely fashion, we may incur significant delays in our development programs that could adversely affect the value of such product candidates.

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limitations or warnings contained in the approved labeling for a product candidate;

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changes in the standard of care for the targeted indications for any of our product candidates;

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limitations in the approved clinical indications for our product candidates;

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demonstrated clinical safety and efficacy compared to other products;

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lack of significant adverse side effects;

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sales, marketing and distribution support;

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availability and extent of coverage and reimbursement from managed care plans and other third-party payors;

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timing of market introduction and perceived effectiveness of competitive products;

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the degree of cost-effectiveness of our product candidates;

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availability of alternative therapies at similar or lower cost, including generic and over-the-counter products;

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the extent to which the product candidate is approved for inclusion on formularies of hospitals and third-party payors, including managed care organizations;

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whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular diseases;

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adverse publicity about our product candidates or favorable publicity about competitive products;

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convenience and ease of administration of our products; and

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potential product liability claims.

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a covered benefit under its health plan;

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safe, effective and medically necessary;

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appropriate for the specific patient;

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cost-effective; and

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neither experimental nor investigational.

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decreased demand for any of our product candidates or products we develop;

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injury to our reputation and significant negative media attention;

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withdrawal of clinical trial participants or cancellation of clinical trials;

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costs to defend the related litigation, which may be only partially recoverable even in the event of successful defense;

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a diversion of management’s time and our resources;

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substantial monetary awards to trial participants or patients;

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regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

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loss of revenues; and

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the inability to commercialize any products we develop.

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Collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

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Collaborators may not perform their obligations as expected;

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Collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

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Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

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Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

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Product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;

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A collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;

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Disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

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Collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity and enforceability of our intellectual property. For example, Amgen has the first right to enforce or defend certain of our intellectual property rights under our research collaboration and license agreement, and although we may have the right to assume the enforcement and defense of such intellectual property rights if Amgen does not, our ability to do so may be compromised by Amgen’s actions;

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Collaborators may own or co-own intellectual property covering our product candidates or research programs that results from our collaboration with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property or such product candidates or research programs;

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Collaborators may infringe, misappropriate or otherwise violate the intellectual property rights of third parties, which may expose us to litigation and potential liability;

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Collaborators may fail to comply with applicable laws, rules or regulations when performing services for us, which may expose us to legal proceedings and potential liability;

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The outbreak of COVID-19 may cause us to fail to meet contractually obligated deadlines with our collaboration partners or otherwise strain our relationships with current collaborators or other business partners.

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the possibility of a breach of the manufacturing agreements by the third parties because of factors beyond our control;

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the possibility that the supply is inadequate or delayed;

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the risk that the third party may enter the field and seek to compete and may no longer be willing to continue supplying;

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the possibility of termination or nonrenewal of the agreements by the third parties before we are able to arrange for a qualified replacement third-party manufacturer; and

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the possibility that we may not be able to secure a manufacturer or manufacturing capacity in a timely manner and on satisfactory terms in order to meet our manufacturing needs.

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our clinical trial results and the timing of the release of such results;

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the amount of our cash resources and our ability to obtain additional funding;

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the announcement of research activities, business developments, technological innovations or new products, or acquisitions or expansion plans by us or our competitors;

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the success or failure of our research and development projects or those of our competitors;

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our entering into or terminating strategic relationships;

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changes in laws or government regulation;

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actual or anticipated fluctuations in our and our competitors’ results of operations and financial condition;

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regulatory developments and the decisions of regulatory authorities as to the approval or rejection of new or modified products;

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the departure of our key personnel;

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disputes related to intellectual property and proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies;

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our sale, or the sale by our significant shareholders, of Ordinary Shares, IPO Warrants or other securities in the future;

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public concern regarding the safety, efficacy or other aspects of the products or methodologies we are developing;

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market conditions in our industry and changes in estimates of the future size and growth rate of our markets;

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market acceptance of our products;

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the mix of products that we sell and related services that we provide;

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the success or failure of our licensees to develop, obtain approval for and commercialize our licensed products, for which we are entitled to contingent payments and royalties;

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the publication of the results of preclinical or clinical trials for EB613, EB612 or any other product candidates we may develop, including a new Oral GLP-2 analog research program;

•

the failure by us to achieve a publicly announced milestone;

•

delays between our expenditures to develop and market new or enhanced products and the generation of sales from those products;

•

changes in the amounts that we spend to develop, acquire or license new products, technologies or businesses;

•

changes in our expenditures to promote our products;

•

variances in our financial performance from the expectations of market analysts;

•

the limited trading volume of our Ordinary Shares and IPO Warrants; and

•

general economic and market conditions, including factors unrelated to our industry or operating performance.

•

Advance EB613 into a Phase 3 clinical trial for the treatment of osteoporosis: We are currently conducting a dose ranging Phase 2 clinical trial of EB613 for the treatment of osteoporosis and expect to report final BMD data from this trial in the second quarter of 2021.Based on FDA guidance received at our pre-IND meeting in November 2018, we intend to further develop EB613 and conduct the required non-clinical and clinical trials independently or with a partner in order to attain regulatory approval. We intend to conduct a single Phase 3, multicenter trial with a BMD endpoint comparing oral PTH with Forteo. We believe this Phase 3 trial could be initiated 2022, based on the successful outcome of the ongoing Phase 2 trial and the availability of  sufficient financial resources.

•

Advance EB612 through clinical development for the treatment of hypoparathyroidism: To date we have completed two Phase 2 clinical trials of EB612 for the treatment of hypoparathyroidism. We reported positive results from the first trial in the third quarter of 2015, and then conducted a Phase 2PK/PD trial in 2019 to evaluate the profile of various EB612 dose regimens. After the completion of additional formulation and development activities to determine our final formulations, and subject to available funds, we expect to initiate a Phase 2b/3 clinical trial of EB612 for the treatment of hypoparathyroidism. The FDA and the EMA have granted EB612 orphan drug designation for the treatment of hypoparathyroidism.

•

Establish global and regional commercial partnerships, or selectively develop commercial capabilities for our lead oral PTH product candidates: For our oral PTH product candidates that target orphan indications, we may determine to retain commercialization rights within key territories, including the United States, because of the ability to commercialize efficiently with a small sales and marketing organization. For product candidates that target indications with larger patient populations such as Osteoporosis, we may choose to partner with larger biopharmaceutical companies ahead of late stage development and commercialization, or to license our technology to third parties for additional indications, pending our Phase 2 trial results and the potential impact of COVID-19 on those results or on our discussions with potential collaboration or other business partners. We are building a corporate and business development capability to determine the appropriate development and commercial strategies for our current and future product candidates.

•

Leverage our technology to develop more effective novel large molecule therapeutics through collaborations with other biotechnology or pharmaceutical companies: Oral drug delivery lowers the treatment burden on patients relative to injectable drugs, leading to higher patient and physician acceptance and compliance, and at a lower cost to patients. However, certain peptides, proteins and other large molecule therapeutics can currently only be delivered via injections and other non-oral pathways because oral administration leads to negligible absorption into the blood stream as well as enzymatic degradation within the gastrointestinal tract. In December 2018, we entered into a research collaboration and license agreement with Amgen and we intend to explore additional collaborations to further validate our technology and potentially generate value through funding from such collaborations. COVID-19 may impact our ability to conduct research and development activities or to develop data that may lead to potential future collaborations (see “Risk Factors—The outbreak of COVID-19 in the United States, Israel and elsewhere has created significant business disruptions and will adversely affect our business”).

•

Identify and develop additional products based on FDA-approved injectable large molecule therapeutics: We intend to leverage our technology platform by applying it to the development of known large molecule therapeutics and believe we can reduce the development and regulatory risks by working on FDA-approved large molecule therapeutic agents with known mechanisms of action. We believe this will allow us to advance our product candidates efficiently and predictably through the development cycle thereby offering us the option either to develop these products on our own or to collaborate with the innovator companies. For example, In February 2021, we announced that we initiated a new research program for an oral glucagon-like peptide-2 (GLP-2) analog based on the Company’s platform technology.

•

having the appropriate size, as measured by molecular weight, and other chemical/physical characteristics;

•

having a mechanism of action that favors delivery through the gastrointestinal tract rather than through injections, and;

•

having a dosing schedule that requires dosing one or more times per day for at least three months.

						Stage of
Program		Indication		Description		Development		Status
EB613		Osteoporosis		Oral PTH (1-34)		Phase 2	Pre-IND meeting conducted in Q4 2018; IND opened in Dec 2020
							Phase 2 dose ranging clinical trial final BMD results expected in Q2 2021 Phase 3 initiation expected in 2022
EB612		Hypoparathyroidism		Oral PTH (1-34)		Phase 2	Phase 2a successfully completed (results reported 2015)
							Phase 2b PK/PD clinical trial head to head with Natpara in hypoparathyroid patients results reported in Q3 2019
							Final formulation(s) to be selected in 2021 subject to sufficient funding

Company/Technology	​	Molecule	​	API MW (g/mole)	​	Bioavailability (F)
Entera Bio	​	PTH (1-34)	​	4118	​	1.5%
Novartis/Emisphere (Eligen - CNAC) (1)	​	PTH (1-34)	​	4118	​	0.2 - 0.5%
Enteris Biopharma - Unigen (Peptelligence) (2)	​	PTH (1-31)	​	3719	​	0.52%
Multiple manufacturers(3)	​	Desmopressin	​	1069	​	0.16%
Chiasma (TPE)(4)	​	Octreotide	​	1019 (Cyclic peptide)	​	0.67%
Proxima Concepts (AXCESS)(5)	​	Insulin	​	5733	​	0.7%

(1)	Source: The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women Sibylle P. Hämmerle, et al. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25.

(2)	Source: Pharmacokinetics of oral recombinant human parathyroid hormone rhPTH (1-31)NH2 in postmenopausal women with osteoporosis. Sturmer A1 et el. Clin Pharmacokinet. 2013 Nov;52(11):995-1004. doi: 10.1007/s40262-013-0083-4.

(3)	Source: Public Assessment Report, Desmopressin Acetate 100 Microgram Tablet PL 24668/0177 and Desmopressin Acetate 200 Microgram Tablet PL 24668/0178. Medicines and Healthcare Products Regulatory Agency.

(4)

Source: Pharmacokinetic Modeling of Oral Octreotide (Octreolin™) in Healthy Volunteers and Dosing Regimen Optimization for Acromegaly Patients. Shmuel Tuvia et al. Endocrine Society’s 94th Annual Meeting June 2012, OR29-6-OR29-6. Source: The glucose lowering effect of an oral insulin (Capsulin) during an isoglycaemic clamp study in persons with type 2 diabetes S. D. Luzio et al. Diabetes Obes Metab. 2010 Jan;12(1):82-7. doi: 10.1111/ j.1463-1326.2009.01146.x. Epub 2009 Sep 25.

	N	Mean	Median
Age	161	61	61
Weight (Kg)	161	67	66
BMI	161	26	26

•

A significant increase in P1NP from baseline versus placebo at month 3 (P <0.04) as well as significant increases at months 1 (P <0.0001) and 2 (P <0.003);

•

A significant increase in Osteocalcin from baseline versus placebo at month 3 (P<0.006) as well as significant increases at months 1 (P<0.0001) and 2 (P<0.0001);

•

A significant decrease in CTX from baseline versus placebo at month 3 (P <0.015) as well as a significant decrease at month 1 (P <0.001)

•

EB612 is designed to be dosed multiple times a day. Studies performed by the NIH have shown that dosing PTH multiple times per day significantly increases the efficacy of therapy and would be more effective for treating hypoparathyroidism. These studies found that the total daily PTH dose required to maintain serum calcium in the normal or near-normal range was reduced by 50% with twice-daily PTH (1-34) and also demonstrated that twice-daily dosing achieved better control over serum calcium and urinary calcium excretion as compared to once-daily dosing.

•

EB612 is designed to be dosed according to patient needs. The hypoparathyroid population is heterogeneous and patients have highly variable responsiveness to PTH. Therefore, the ability to customize PTH dosing throughout the day with an oral tablet is an advantage over a once-daily preset injection pen.

•

EB612 is expected to have fewer adverse events of hypercalcemia. Our planned treatment regimen would be increased gradually and in parallel to increases in serum calcium. As a result, calcium supplements and active vitamin D metabolites (e.g., calcitriol) would be reduced gradually, while maintaining a relatively stable level of serum calcium. This is in contrast with Natpara’s initial high dose, which requires an immediate reduction in supplements in anticipation of a rapid increase in serum calcium levels. Furthermore, this immediate and prolonged increase in serum calcium increases the risk of prolonged hypercalcemia compared to EB612. Moreover, the target serum calcium level would be the lower end of the normal range. If serum calcium were at, or greater than, the middle of the normal range, calcium supplements, active vitamin D metabolites and oral PTH dose would be reduced.

•

EB612 can be administered in a more convenient manner. Natpara is administered by subcutaneous injection, must be stored under restrictive conditions (refrigeration required with no freezing or shaking) and has a multi-step preparation that must be performed every two weeks. EB612 will not require such additional preparations and will have no significant storage restrictions.

•

A significant reduction of 42% (p=0.001) from baseline in median calcium supplement use;

•

Maintenance of median ACa levels above the lower target level for HypoPT patients (>7.5 mg/dL) throughout the study;

•

A rapid decline of 23% (p=0.0003) in median serum phosphate levels 2 hours following the first dose that was maintained within the normal range for the duration of the study;

•

A notable median decrease of 21% (p=0.07) in 24-hour urine calcium excretion between the first and last treatment days; and

•

An increase in quality of life score of 5% (p=0.03) from baseline by the end of the treatment period.

•

preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s Good Laboratory Practice regulations;

•

submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin;

•

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

•

performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product candidate for each proposed indication and conducted in accordance with GCP requirements;

•

submission of data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labeling;

•

preparation and submission to the FDA of a NDA;

•

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

•

satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with 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 any FDA audits of the non-clinical and clinical trial sites to assure compliance with GCP requirements and the integrity of clinical data in support of the NDA;

•

payment of user fees and securing FDA approval of the NDA for the proposed indication; and

•

compliance with any post-approval requirements, including risk evaluation and mitigation strategies, or REMS, and any post-approval studies required by the FDA.

•

Phase 1 clinical trials are initially conducted in a limited population to test the product candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics in healthy humans or, on occasion, in patients, such as cancer patients.

•

Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, evaluate the efficacy of the product candidate for specific targeted indications and determine dose tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more costly Phase 3 clinical trials.

•

Phase 3 clinical trials proceed if the Phase 2 clinical trials demonstrate that a dose range of the product candidate is potentially effective and has an acceptable safety profile. Phase 3 clinical trials are undertaken to further evaluate, in a larger number of patients, dosage, provide substantial evidence of clinical efficacy and further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites. A well-controlled, statistically robust Phase 3 trial may be designed to deliver the data that regulatory authorities will use to decide whether or not to approve, and, if approved, how to appropriately label a drug: such Phase 3 studies are referred to as “pivotal.”

•

restrictions on the marketing or manufacturing of the product, 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.

•

preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations;

•

submission to the relevant national authorities of a clinical trial application, or CTA, for each clinical trial, which must be approved before human clinical trials may begin;

•

performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;

•

submission to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labeling;

•

satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMP;

•

potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and

•

review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.

•

A streamlined application procedure via a single entry point, the EU portal;

•

A single set of documents to be prepared and submitted for the application as well as simplified reporting procedures which will spare sponsors from submitting broadly identical information separately to various bodies and different Member States;

•

A harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is jointly assessed by all Member States concerned. Part II is assessed by each Member State concerned separately;

•

Strictly defined deadlines for the assessment of clinical trial application; and

•

The involvement of the ethics committees in the assessment procedure in accordance with the national law of the Member State concerned but within the overall timelines defined by the Regulation (EU) No 536/2014.

•

medicinal products developed by means of one of the following biotechnological processes:

•

recombinant DNA technology;

•

controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;

•

hybridoma and monoclonal antibody methods;

•

advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 on advanced therapy medicinal products;

•

medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorized in the EU, for which the therapeutic indication is the treatment of any of the following diseases:

•

acquired immune deficiency syndrome;

•

cancer;

•

neurodegenerative disorder;

•

diabetes;

•

auto-immune diseases and other immune dysfunctions;

•

viral diseases; and

•

medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.

•

The decentralized procedure allows applicants to file identical applications to several EU member states and receive simultaneous national approvals based on the recognition by EU member states of an assessment by a reference member state.

•

The national procedure is only available for products intended to be authorized in a single EU member state.

•

A mutual recognition procedure similar to the decentralized procedure is available when a marketing authorization has already been obtained in at least one EU member state.

•

the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal health care program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

•

the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

•

HIPAA imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•

the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services;

•

the federal transparency requirements under the ACA require certain manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and the ownership and investment interests of such physicians and their immediate family members;

•

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

•

the Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which requires specified manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other “transfers of value” made to physicians. All such reported information is publicly available;

•

analogous state and non-U.S. laws and regulations, such as state anti-kickback and false claims laws which may apply to items or services reimbursed by any payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require pharmaceutical manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and

•

regulation by the Centers for Medicare and Medicaid Services and enforcement by the U.S. Department of Health and Human Services (Office of Inspector General) or the U.S. Department of Justice.

1.

Identification of the contract, or contracts, with a customer.

2.

Identification of the performance obligations in the contract.

3.

Determination of the transaction price.

4.

Allocation of the transaction price to the performance obligations in the contract.

5.

Recognition of revenue.

•

The subsequent sale or usage occurs; and

•

The performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).

•

employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function;

•

expenses incurred in operating our laboratories including our small-scale manufacturing facility;

•

expenses incurred under agreements with CROs, and investigative sites that conduct our clinical trials;

•

expenses related to outsourced and contracted services, such as external laboratories, consulting and advisory services;

•

supply, development and manufacturing costs relating to clinical trial materials; and

•

other costs associated with pre-clinical and clinical activities.

•

the uncertainty of the scope, rate of progress, results and cost of our clinical trials, nonclinical testing and other related activities;

•

the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop;

•

the number and characteristics of product candidates that we pursue;

•

the cost, timing and outcomes of regulatory approvals;

•

the cost and timing of establishing any sales, marketing, and distribution capabilities; and

•

the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder.

(2)

The resignation of Mr. Gridley, our Former CEO, took effect on September 7, 2020. According to the terms of Mr. Gridley’s options, options which had yet to fully vest expired, therefore 553,942 options expired and were recognized in the consolidated statement of comprehensive loss as a reverse of expense under the General and administrative line item in the amount of $0.3 million.

​		​December 31, 2020				​December 31, 2019				July 2, 2018
Price per share*			$1.08				$1.84-$2.07				865
Volatility			66%				62%-63%				62%
Risk free rate			0.1%-0.13%				1.63%-1.71%				N/A
Probability for IPO/shares registration			N/A				N/A				100%

⁎	The price per share as of July 2, 2018 was based on the quoted price on Nasdaq prior to the share split. ​

​		Year Ended December 31,								Increase (Decrease)
​		2020				2019				$					%
​		(In thousands, except for percentage information)
Revenues		$	365			$	236			$	129				54.6	%
Cost of revenues			209				210				(1	)			(0.01	)%
Operating expenses:						​
Research and development expenses, net		$	6,398			$	7,199			$	(801	)			(11.1	)%
General and administrative expenses			4,891				4,281				610				14.2	%
Operating loss			11,133				11,454				(321	)			(0.03	)%
Financial income, net			(1,170	)			(659	)			(511	)			77.5	%
Taxes on income			20				-				20				100	%
Net loss		$	9,983			$	10,795			$	(812	)			(0.08	)%

•

the costs, timing and outcome of clinical trials for, and regulatory review of, EB613, EB612 and any other product candidates we may develop;

•

the costs of development activities for any other product candidates we may pursue;

•

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

•

the impact of COVID-19, once known, on our clinical trials, regulatory timelines, business operations and financial stability; and

•

our ability to establish collaborations on favorable terms, if at all.

​		(audited) Year ended December 31,
​		2020				2019
​		(in thousands)
Cash used in operating activities		$	(10,423	)		$	(8,919	)
Cash (used in) provided by investing activities			(86	)			3,946
Cash provided by financing activities			3,917				12,652
Net (decrease) increase in cash and cash equivalents		$	(6,592	)		$	7,679

​		Payments due by period
Contractual Obligations		Total				Less than 1 year				1 - 3 years				3 - 5 years				More than 5 years
​		(In thousands)
Operating leases for facility and vehicles		$	510			$	205			$	305			$	-			$	-
Total		$	510			$	205			$	305			$	-			$	-

•

a commitment to pay royalties to the IIA. See “Item 4.B.—Business Overview—Patent Transfer, Licensing Agreement and Grant Funding.”

Name		Age		Position
Executive Officers
Dr. Spiros Jamas		60		Chief Executive Officer and Director
Jonathan Lieber		51		U.S.-based Chief Financial Officer
Dana Yaacov-Garbeli		37		Israel-based Chief Financial Officer
Dr. Phillip Schwartz		59		President of Research and Development and Director
Dr. Hillel Galitzer		42		Chief Operating Officer
Dr. Arthur Santora		70		Chief Medical Officer
Non-Employee Directors
Gerald Lieberman(2)		74		Director, Chairman of the Board of Directors
Dr. Roger J. Garceau		67		Director, Chief Development Advisor
Zeev Bronfeld		69		Director
Yonatan Malca		54		Director
Faith L. Charles(1) (2) (3) (4)		59		Director, Chairman of the Compensation Committee
Miranda J. Toledano(1) (2) (3) (4)		44		Director, Chairman of the Audit Committee
Gerald M. Ostrov(2) (3) (4)		71		Director
Sean Ellis		46		Director

⁽¹⁾ External Director under Israeli law.

Name		Position		Annual 2020 Compensation
				Base Salary and Related Benefits ($) (1)				Bonus ($)				Retirement, Service Fees and Other Similar Benefits ($)				Share Based Compensation ($) (2)				Total ($)
Dr. Phillip Schwartz (3)		President of Research and development and Director			384				30				27			$	169				610
Mr. Adam Gridley (4)		Former Chief Executive Officer and Director			380				110				32			$	19				541
Dr. Hillel Galitzer (5)		Chief Operating Officer			292				50				17			$	168				527
Dr. Arthur Santora (6)		Chief Medical Officer			355				-				-			$	34				389
Mr. Jonathan Lieber (7)		U.S based Chief Financial Officer			240				-				-				45				285

(1)	Includes base salary, social benefits and car allowances. The amounts shown in this column represent expenses recorded or to be recorded by the Company, calculated using the average monthly exchange rates of the relevant month in which the salary was recorded.

(2)

Reflects the associated annual expense recorded in our financial statements for the year ended December 31, 2020, based on the grant date fair value of the share-based compensation granted in exchange for the directors’ and officers’ services. The fair value amount is recognized as an expense over the course of the vesting period of the options (subject to any applicable accounting adjustments during that period).

(3)

Dr. Schwartz, who previously served as the Chief Executive Officer from inception through August 4, 2019, has served in his current position, since August 5, 2019.  In November 2017, Dr. Schwartz was granted options to purchase 357,500 Ordinary Shares (with an exercise price of $6.31 per share) under our 2013 Equity Incentive Plan, of which 290,469 were vested as of March 16, 2021. The fair value of these options as of the grant date was $1,442,474.

(4)

Mr. Gridley was appointed as our Chief Executive Officer on August 5, 2019 and resigned on August 7, 2020 with effect as of September 7, 2020. In connection with his appointment, Mr. Gridley was granted options to purchase 696,587 Ordinary Shares (with an exercise price of $2.75 per share) under our 2018 Equity Incentive Plan, or the 2018 Plan. The options will expire within 10 years from the grant date. This grant was ratified by our shareholders on October 3, 2019. The fair value of these options as of the grant date was $1,074,186. In April 2020 he was granted an additional 31,502 options to purchase 31,502 Ordinary Shares (with an exercise price of $1.98 per share) under our 2018 Plan, none of which were vested as of March 16, 2021. The options will expire within 10 years from the grant date. This grant was ratified by our shareholders on June 25, 2020. The fair value of these options as of the grant date was $37,176. Due to the termination of his employment, 553,942 of his options have yet to fully vest, and have therefore expired. and 174,147 of his option that were fully vested have been expired in December 2020.

(5)

In November 2017, Dr. Galitzer was granted options to purchase 143,000 Ordinary Shares (with an exercise price of $6.31 per share) under our 2013 Equity Incentive Plan, of which 116,188 were vested as of March 16, 2021. The options will expire within 10 years from the grant date. The fair value of these options as of the grant date was $547,002. In March 2020, Dr. Galitzer was further granted options to purchase 175,000 Ordinary Shares (with an exercise price of $2.14 per share) under our 2018 Plan, of which 43,750 were vested as of March 16, 2021. The options will expire within 10 years from the grant date. The fair value of these options as of the grant date was $229,631.

(6)

In January 2019, Dr. Santora was granted options to purchase 25,000 Ordinary Shares (with an exercise price of $3.97 per share) under our 2018 Plan, of which 18,750 were vested as of March 16, 2021. The options will expire within 10 years from the grant date. This grant was ratified by our shareholders on May 20, 2019. The fair value of these options as of the grant date was $67,078. In March 2020, Dr. Santora was further granted options to purchase 40,000 Ordinary Shares (with an exercise price of $2.14 per share) under our 2018 Plan,of which 10,000 were vested as of March16, 2021. The options will expire within 10 years from the grant date. This grant was ratified by our shareholders on June 25 2020. The fair value of these options as of the grant date was $46,067.

(7)

In November 2019, Mr. Lieber was granted options to purchase 30,385 Ordinary Shares (with an exercise price of $2.53 per share) under our 2018 Plan, of which 18,991 were vested as of March 16, 2021. The options will expire within 10 years from the grant date. This grant was ratified by our shareholders on February 18, 2020. The fair value of these options as of the grant date was $59,797.

•

the Class I directors are Zeev Bronfeld and Roger Garceau;

•

the Class II directors are Phillip Schwartz and Yonatan Malca; and

•

the Class III directors are Gerald Lieberman, Gerald M. Ostrov and Mr. Sean Ellis.