ENTXW 10-K Fiscal year ended Dec. 31, 2024

Represents an amount less than one thousand U.S. dollars. 25% vest on the first anniversary of the date of grant and the remaining 75% of the options vest in twelve equal quarterly installments following the first anniversary of the grant date. 33.33% vest on the first anniversary of the date of grant and the remaining 66.67% of the options vest in eight equal quarterly installments following the first anniversary of the grant date. 00-0000000 0001638097 false FY 0001638097 2024-01-01 2024-12-31 0001638097 us-gaap:GovernmentMember 2024-01-01 2024-12-31 0001638097 entx:JointVentureAgreementMember entx:DnaBiomedicalSolutionsLtdAndOramedLtdMember 2024-01-01 2024-12-31 0001638097 entx:PatentTransferAgreementMember 2024-01-01 2024-12-31 0001638097 us-gaap:GovernmentMember 2024-12-31 0001638097 entx:JointVentureAgreementMember entx:DnaBiomedicalSolutionsLtdMember 2024-01-01 2024-12-31 0001638097 entx:OpkoBiologicsLtdMember 2024-01-01 2024-12-31 0001638097 2023-01-01 2023-12-31 0001638097 us-gaap:RetainedEarningsMember 2023-01-01 2023-12-31 0001638097 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-01-01 2023-12-31 0001638097 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-12-31 0001638097 us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001638097 us-gaap:RetainedEarningsMember 2024-01-01 2024-12-31 0001638097 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-01-01 2024-12-31 0001638097 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-12-31 0001638097 us-gaap:CommonStockMember 2024-01-01 2024-12-31 0001638097 2023-12-31 0001638097 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-12-31 0001638097 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001638097 us-gaap:CommonStockMember 2023-12-31 0001638097 2024-12-31 0001638097 us-gaap:RetainedEarningsMember 2024-12-31 0001638097 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-12-31 0001638097 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001638097 us-gaap:CommonStockMember 2024-12-31 0001638097 2022-12-31 0001638097 us-gaap:RetainedEarningsMember 2022-12-31 0001638097 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-12-31 0001638097 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001638097 us-gaap:CommonStockMember 2022-12-31 0001638097 us-gaap:RetainedEarningsMember 2023-12-31 0001638097 srt:MinimumMember 2023-01-01 2023-12-31 0001638097 srt:MaximumMember 2024-12-31 0001638097 srt:MaximumMember 2023-12-31 0001638097 srt:MaximumMember 2024-01-01 2024-12-31 0001638097 srt:MinimumMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointZeroTwoMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointZeroTwoMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointOneFourMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointOneFourMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointFiveSevenMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointFiveSevenMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointEightOneFiveMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointEightOneFiveMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointEightSixMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointEightSixMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareThreePointOneFiveMember 2024-12-31 0001638097 entx:ExercisePricePerShareThreePointOneFiveMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareThreePointSixOneMember 2024-12-31 0001638097 entx:ExercisePricePerShareThreePointSixOneMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareOnePointFourMember 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointFiveThreeMember 2024-12-31 0001638097 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-12-31 0001638097 us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-12-31 0001638097 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-12-31 0001638097 us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-12-31 0001638097 entx:ShareIncentivePlan2018Member 2024-12-31 0001638097 entx:ShareIncentivePlan2018Member 2018-07-02 0001638097 entx:ShareIncentivePlan2018Member 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareTwoPointFiveThreeMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareOnePointFourMember 2024-01-01 2024-12-31 0001638097 srt:MaximumMember 2023-01-01 2023-12-31 0001638097 us-gaap:CostOfSalesMember 2024-01-01 2024-12-31 0001638097 us-gaap:CostOfSalesMember 2023-01-01 2023-12-31 0001638097 srt:ChiefExecutiveOfficerMember 2021-01-01 2021-01-04 0001638097 entx:ExercisePricePerShareThreePointNineSevenMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareThreePointNineSevenMember 2024-12-31 0001638097 entx:ExercisePricePerShareSixPointThreeOneMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareSixPointThreeOneMember 2024-12-31 0001638097 entx:EmployeesAndExecutiveOfficersMember 2023-12-31 0001638097 entx:EmployeesAndExecutiveOfficersMember 2024-01-01 2024-12-31 0001638097 entx:EmployeesAndExecutiveOfficersMember 2024-12-31 0001638097 entx:ConsultantMember 2024-12-31 0001638097 srt:DirectorMember 2024-12-31 0001638097 srt:DirectorMember 2024-01-01 2024-12-31 0001638097 entx:ConsultantMember 2024-01-01 2024-12-31 0001638097 srt:DirectorMember 2023-12-31 0001638097 entx:DirectorsOneMember 2023-12-31 0001638097 entx:EmployeesAndExecutiveOfficersMember 2023-01-01 2023-12-31 0001638097 srt:DirectorMember 2023-01-01 2023-12-31 0001638097 entx:DirectorsOneMember 2023-01-01 2023-12-31 0001638097 entx:ExercisePricePerShareZeroSevenThreeMember 2024-12-31 0001638097 entx:ExercisePricePerShareZeroSevenNineMember 2024-12-31 0001638097 entx:ExercisePricePerShareZeroEightNineMember 2024-12-31 0001638097 entx:ExercisePricePerShareZeroSevenThreeMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareZeroSevenNineMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareZeroEightNineMember 2024-01-01 2024-12-31 0001638097 srt:MinimumMember 2024-12-31 0001638097 srt:MinimumMember 2023-12-31 0001638097 entx:ConsultantMember 2023-12-31 0001638097 entx:ConsultantMember 2023-01-01 2023-12-31 0001638097 entx:ExercisePricePerShareOnePointNineNineMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareOnePointNineNineMember 2024-12-31 0001638097 entx:ExercisePricePerShareZeroSixMember 2024-01-01 2024-12-31 0001638097 entx:ExercisePricePerShareZeroSixMember 2024-12-31 0001638097 us-gaap:RestrictedStockUnitsRSUMember 2024-01-30 2024-02-01 0001638097 entx:ConsultantMember us-gaap:RestrictedStockUnitsRSUMember 2024-08-01 2024-08-27 0001638097 entx:ConsultantMember us-gaap:RestrictedStockUnitsRSUMember 2024-08-01 2024-08-31 0001638097 entx:ConsultantMember us-gaap:RestrictedStockUnitsRSUMember 2024-09-01 2024-09-30 0001638097 entx:ConsultantMember us-gaap:RestrictedStockUnitsRSUMember 2024-10-01 2024-10-31 0001638097 entx:ConsultantMember us-gaap:RestrictedStockUnitsRSUMember 2024-11-01 2024-11-30 0001638097 entx:InvestorRelationsConsultingFirmMember us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-12-31 0001638097 us-gaap:RestrictedStockUnitsRSUMember 2024-02-02 2024-02-15 0001638097 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-12-31 0001638097 srt:ExecutiveOfficerMember us-gaap:RestrictedStockUnitsRSUMember 2024-04-01 2024-04-19 0001638097 srt:DirectorMember us-gaap:RestrictedStockUnitsRSUMember 2024-04-01 2024-04-19 0001638097 us-gaap:ShareBasedCompensationAwardTrancheOneMember 2024-01-01 2024-12-31 0001638097 us-gaap:ShareBasedCompensationAwardTrancheThreeMember 2024-01-01 2024-12-31 0001638097 us-gaap:ShareBasedCompensationAwardTrancheTwoMember 2024-01-01 2024-12-31 0001638097 entx:EnteraBioLtdMember 2024-01-01 2024-12-31 0001638097 entx:EnteraBioLtdMember 2023-01-01 2023-12-31 0001638097 srt:SubsidiariesMember 2023-01-01 2023-12-31 0001638097 srt:SubsidiariesMember 2024-01-01 2024-12-31 0001638097 us-gaap:ForeignCountryMember 2024-01-01 2024-12-31 0001638097 us-gaap:DomesticCountryMember 2024-01-01 2024-12-31 0001638097 2025-03-20 0001638097 2024-06-30 0001638097 srt:MinimumMember us-gaap:ComputerEquipmentMember 2024-12-31 0001638097 srt:MaximumMember us-gaap:ComputerEquipmentMember 2024-12-31 0001638097 us-gaap:OfficeEquipmentMember 2024-12-31 0001638097 srt:MinimumMember entx:LaboratoryEquipmentMember 2024-12-31 0001638097 srt:MaximumMember entx:LaboratoryEquipmentMember 2024-12-31 0001638097 entx:OperatingLeaseAgreementsForOfficeAndResearchAndDevelopmentSpaceMember 2024-12-31 0001638097 entx:OperatingLeaseAgreementsForOfficeAndResearchAndDevelopmentSpaceMember 2024-01-01 2024-12-31 0001638097 entx:OperatingLeaseAgreementsForVehiclesForEmployeesMember 2024-01-01 2024-12-31 0001638097 entx:FiveNonExecutiveBoardMembersMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-15 0001638097 entx:FiveNonexecutiveMembersMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-15 0001638097 us-gaap:WarrantMember 2025-01-02 2025-12-31 0001638097 2025-01-02 2025-12-31 0001638097 entx:LeerinkAtmProgramMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-03 0001638097 entx:LeerinkAtmProgramMember us-gaap:SubsequentEventMember 2025-01-01 2025-01-10 0001638097 entx:LeerinkAtmProgramMember us-gaap:SubsequentEventMember 2025-01-03 0001638097 us-gaap:SubsequentEventMember entx:OpkoBiologicsLtdMember entx:TwoZeroTwoFiveCollaborationAgreementMember 2025-03-01 2025-03-16 0001638097 us-gaap:SubsequentEventMember entx:OpkoBiologicsLtdMember entx:TwoZeroTwoFiveCollaborationAgreementMember 2025-03-16 0001638097 entx:AtmProgramMember us-gaap:CommonStockMember 2023-12-31 0001638097 entx:AtmProgramMember us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001638097 entx:AtmProgramMember entx:SvbSecuritiesLlcMember 2022-09-02 0001638097 us-gaap:WarrantMember us-gaap:InvestorMember 2023-12-22 0001638097 us-gaap:WarrantMember us-gaap:InvestorMember 2024-01-01 2024-12-31 0001638097 entx:BrokerWarrantsMember us-gaap:InvestorMember entx:PlacementAgencyAgreementWithBrokerDealerMember 2024-01-01 2024-12-31 0001638097 entx:BrokerWarrantsMember us-gaap:InvestorMember us-gaap:PrivatePlacementMember 2024-01-01 2024-12-31 0001638097 entx:BrokerWarrantsMember us-gaap:InvestorMember 2024-12-31 0001638097 entx:FinderAgreementWithPrivateFinderMember 2024-01-01 2024-12-31 0001638097 entx:FinderAgreementWithPrivateFinderMember 2024-12-31 0001638097 entx:BrokerWarrantsAndFinderWarrantsMember 2024-01-01 2024-12-31 0001638097 entx:BrokerWarrantsMember us-gaap:InvestorMember 2024-01-01 2024-12-31 0001638097 entx:PreFundedWarrantsMember us-gaap:InvestorMember 2023-12-22 0001638097 entx:InvestorsWarrantsMember us-gaap:InvestorMember 2023-12-22 0001638097 entx:PreFundedWarrantsMember us-gaap:InvestorMember 2023-12-01 2023-12-20 0001638097 us-gaap:InvestorMember us-gaap:PrivatePlacementMember 2023-12-20 0001638097 us-gaap:InvestorMember us-gaap:PrivatePlacementMember 2023-12-01 2023-12-20 0001638097 us-gaap:InvestorMember us-gaap:PrivatePlacementMember 2024-01-01 2024-12-31 0001638097 entx:AtmProgramMember us-gaap:CommonStockMember 2024-12-31 0001638097 entx:AtmProgramMember us-gaap:CommonStockMember 2024-01-01 2024-12-31 0001638097 us-gaap:WarrantMember us-gaap:CommonStockMember 2024-12-31 0001638097 entx:FormerEmployeeAndFormerNonexecutiveBoardMember 2024-01-01 2024-12-31 0001638097 entx:SevenNonexecutiveMembersMember us-gaap:CommonStockMember 2024-08-27 0001638097 us-gaap:CommonStockMember 2024-08-01 2024-08-27 0001638097 entx:FiveNonexecutiveMembersMember us-gaap:CommonStockMember 2024-10-02 0001638097 us-gaap:CommonStockMember 2024-10-01 2024-10-02 0001638097 us-gaap:WarrantMember us-gaap:CommonStockMember 2024-01-01 2024-12-31 iso4217:ILS xbrli:shares xbrli:pure iso4217:USD iso4217:USD xbrli:shares xbrli:shares

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

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

Israel	00-0000000
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)

Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Ordinary shares , par value NIS 0.0000769 per share		ENTX		Nasdaq Capital Market

Large accelerated filer	☐		Accelerated filer	☐
Non-accelerated filer	☒		Smaller reporting company	☒
			Emerging growth company	☐

		Page
PART I		7
Item 1.	Business	7
Item 1A.	Risk Factors	36
Item 1B.	Unresolved Staff Comments	76
Item 1C.	Cybersecurity	76
Item 2.	Properties	77
Item 3.	Legal Proceedings	77
Item 4.	Mine Safety Disclosures	77
PART II		78
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	78
Item 6.	[Reserved]	78
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	79
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	88
Item 8.	Financial Statements and Supplementary Data	89
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	117
Item 9A.	Controls and Procedures	117
Item 9B.	Other Information	117
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	117
PART III		118
Item 10.	Directors, Executive Officers and Corporate Governance	118
Item 11.	Executive Compensation	125
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	136
Item 13.	Certain Relationships and Related Transactions, and Director Independence	139
Item 14.	Principal Accounting Fees and Services	140
PART IV		141
Item 15.	Exhibits, Financial Statement Schedules	141
Item 16.	Form 10-K Summary	142

•

Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates;

•

The regulatory approval processes of the U.S. Food and Drug Administration (“FDA”) and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed;

•

Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all;

•

Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed or in later stage trials;

•

The scope, progress and costs of developing our product candidates such as EB613 for osteoporosis and EB612 or other oral peptides for hypoparathyroidism may alter over time based on various factors such as regulatory requirements, collaboration agreements, the competitive environment and new data from pre-clinical and clinical studies;

•

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

•

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

•

Our ability to raise additional funds or consummate strategic partnerships to offset additional required capital to pursue our business objectives, which may not be available on acceptable terms or at all. A failure to obtain this additional capital when needed, or failure to consummate strategic partnerships, could delay, limit or reduce our product development, and other operations;

•

Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success;

•

The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and third-party payors establish adequate coverage and reimbursement levels and pricing policies;

•

Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue;

•

If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected;

•

Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain;

•

Our reliance on third parties to conduct our clinical trials and on third-party suppliers to supply or produce our product candidates;

•

Our interpretation of FDA feedback and guidance and how such guidance may impact our clinical development plan;

•

Our ability to use and expand our drug delivery technology (“N-Tab™”) to additional product candidates;

•

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;

•

Our competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories we pursue;

•

Our ability to establish and maintain development and commercialization collaborations;

•

Our ability to manufacture and supply enough material to support our clinical trials and any potential future commercial requirements;

•

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

•

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;

•

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

•

Our ability to comply with laws and regulations that currently apply or become applicable to our business;

•

Our ability to manage growth; and

•

The duration and intensity of the ongoing Israel-Hamas War, and escalation of Hezbollah's conflict since October 2023 as well as the developing conflict with Iran and its proxies in the Middle East, such as the Houthis in Yemen and militias in Iraq and Syria, and their impact on our operations and workforce.

•

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

•

All of our product candidates, including EB613 and EB612, Oral GLP-1/Glucagon  and Oral GLP-2 are in preclinical or clinical development, and we have not yet successfully completed the development of any product candidate;

•

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;

•

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

•

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;

•

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;

•

Healthcare legislative changes may harm our business and future prospects;

•

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

•

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

•

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

•

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

•

Management has performed an analysis of our ability to continue as a going concern and our current cash resources should be sufficient to fund our operating expenses into the third quarter of 2026, 16 months after the date of this filing; Our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern;

•

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

•

Security, political and economic instability in the Middle East may harm our business, including the duration and intensity of the ongoing Israel-Hamas War and its impact on our operations and workforce.

	•	Advancing EB613, Potentially the First Daily Anabolic PTH(1-34) Tablet Treatment into Phase 3 for the Treatment of Post-Menopausal Women with Low Bone Mass and Osteoporosis : Our six-month placebo-controlled Phase 2 double-blind, dose-ranging trial of EB613 in 161 patients with low bone mass and osteoporosis met both primary and secondary endpoints was selected for oral presentation at the ASBMR annual conference in 2021 and published at JBMR in March 2024. Based on the outcomes of our FDA meetings, we believe that EB613 may be the first osteoporosis program to be permitted by FDA to pursue a placebo controlled, BMD endpoint registrational Phase 3 study to support an NDA. We view this potential outcome as testament to the treatment gap and unmet need for a viable alternative to treat the millions of osteoporosis patients who, despite current guidelines and availability of highly efficacious injectable anabolic agents, remain undertreated. We are preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which we currently expect to occur in 2025.

•

Advancing the First Daily PTH(1-34) Peptide Replacement Tablet Therapy for the Treatment of Hypoparathyroidism: In 2015, we successfully completed a Phase 2a four-month trial in 19 patients with hypoparathyroidism which demonstrated clinical benefit, including a statistically significant reduction in calcium supplementation, maintenance of calcium levels above the lower target level for Hypoparathyroidism patients (>7.5 mg/dL) throughout the study and statistically significant rapid decline in median serum phosphate levels two hours following the first dose, which was maintained for the duration of the study. The FDA and the European Medicines Agency (“EMA”) have granted EB612 orphan drug designation for the treatment of hypoparathyroidism. With respect to our EB612 program, we are currently testing new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens. In addition, we continue to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism.

•

Identifying and Developing Potentially High Value Oral Peptides in Collaboration with Strategic Partners such as our Oral GLP-2 and Oxyntomodulin (Oral GLP-1/Glucagon ) Programs with OPKO: We intend to leverage our N-Tab™ platform by applying it to the development of additional, currently approved injectable peptides and therapeutic proteins with known mechanisms of action and established safety profiles. We believe this will allow us to advance our product candidates more efficiently and predictably through the research and clinical development cycle. For example, in collaboration with OPKO, we are focusing on the development of the first oral OXM, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of metabolic disorders and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions, such as short bowel syndrome. Both these peptides have well characterized pre-clinical PK/PD and toxicology.

•

Establishing Select Global and Regional Development and Commercial Partnerships : Our N-Tab™ Technology platform and intellectual property are designed to generate a pipeline of product candidates across various therapeutic indications. We intend to explore opportunities to diversify and shorten the preclinical and clinical development of these candidates in a capital-efficient manner, including selectively pursuing research and clinical development partnerships with biopharmaceutical companies with specific domain expertise as well as with biopharmaceutical companies with proven commercial footprints to de-risk our late-stage programs.

Subject Mater	# Pending Applications	# Issued Patents	Geographical Scope	Nominal Patent Term
EB613	80	49	United States, Europe, Japan, China, Canada, Singapore, United Arab Emirates, Israel, Brazil, Mexico, South Africa, India, Australia, New Zealand, Russia, South Korea and Hong Kong	2029 - 2044
EB612	73	44	United States, Europe, Japan, China, Canada, Singapore, United Arab Emirates, Israel, Brazil, Mexico, South Africa, India, Australia, New Zealand, Russia, South Korea and Hong Kong	2029 - 2044
GLP1/Glucagon	58	8	United States, Europe, Japan, China, Canada, Singapore, United Arab Emirates, Israel, Brazil, Mexico, South Africa, India, Australia, New Zealand, Russia, South Korea and Hong Kong	2036 - 2044
GLP2	57	8	United States, Europe, Japan, China, Canada, Singapore, United Arab Emirates, Israel, Brazil, Mexico, South Africa, India, Australia, New Zealand, Russia, South Korea and Hong Kong	2036 - 2044
Platform (N-Tab™)	116	56	United States, Europe, Japan, China, Canada, Singapore, United Arab Emirates, Israel, Brazil, Mexico, South Africa, India, Australia, New Zealand, Russia, South Korea and Hong Kong	2029 - 2044

•

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

•

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

•

approval by an independent review board, or 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 for use and conducted in accordance with Good Clinical Practice, or 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 New Drug Application, or an NDA, or Biologics License Application, or BLA;

•

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 current Good Manufacturing Practice, or cGMP, standards 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 or BLA;

•

payment of user fees and securing FDA approval of the NDA or BLA 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. 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 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 regulatory agencies in EU member states, or 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 national authorities of a Marketing Authorisation 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 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 national authority of the MAA before any commercial marketing, sale or shipment of the product.

•

A streamlined application procedure via a single-entry point, known as the Clinical Trials Information System;

•

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 and different national authorities;

•

A harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts;

•

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.

•

the federal Anti-Kickback Statute prohibits, among other things, the knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under the Medicare, Medicaid or other governmental programs, or (iii) the purchase, lease or order or arranging or recommending purchasing, leasing or ordering of any item or service reimbursable under the Medicare, Medicaid or other governmental programs. 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, items or services resulting from a violation of the federal Anti-Kickback Statute may constitute 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;

•

the Health Insurance Portability and Accountability Act of 1996, or 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;

•

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 that is stored or transmitted electronically;

•

the Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which require 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.

		Employees
Area of Activity:
Research and Development			16
General and Administrative			2
Total			18

ITEM 1A.

RISK FACTORS

•

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

•

the costs, timing and outcome of seeking and obtaining approvals from the FDA, EMA or other regulatory agencies in relation to registrational strategies and potential NDA or BLA approvals for our product candidates;

•

the costs associated with manufacturing our product candidates and potentially establishing sales, marketing, and distribution capabilities in the absence of commercial partnerships;

•

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;

•

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

•

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;

•

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

•

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

•

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; and

•

our need to implement additional internal systems and infrastructure, including financial and reporting systems to support our current operations as a public company.

•

the completion of future development efforts for EB613, EB612 or other product candidates;

•

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

•

obtaining required regulatory and marketing approvals for the clinical development, manufacturing and commercialization of EB613, EB612 and any other product candidates we may develop;

•

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

•

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

•

continuing to build and maintain our intellectual property portfolio;

•

recruiting and retaining qualified executive management and other personnel;

•

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

•

gaining market acceptance for our product candidates;

•

developing and maintaining successful strategic relationships and collaborations;

•

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;

•

establishing sales, marketing, and distribution capabilities in the United States and the EU independently or in collaboration with strategic partners;

•

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

•

addressing any competing technological and market developments;

•

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

•

attracting, hiring and retaining qualified personnel.

•

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

•

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

•

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

•

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

•

sales of the product may decrease significantly;

•

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

•

our reputation may suffer.

•

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

•

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;

•

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;

•

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;

•

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;

•

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

•

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;

•

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;

•

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;

•

the FDA may require development of a REMS as a condition of approval; and

•

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.

•

future clinical trial results may show that our oral PTH is not effective, including if our platform 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;

•

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

•

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;

•

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;

•

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;

•

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

•

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.

•

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;

•

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;

•

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;

•

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

•

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

•

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

•

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;

•

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

•

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

•

the FDA or other regulatory authorities may impose a clinical hold, or we or our investigators, IRBs, or ethics committees may elect to suspend or terminate clinical research or trials;

•

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

•

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

•

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

•

failing to establish clinical endpoints acceptable to the FDA and other regulatory authorities;

•

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

•

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;

•

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

•

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.

•

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

•

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

•

suspend or withdraw marketing approval;

•

suspend any ongoing clinical trials;

•

refuse to approve pending applications or supplements to applications;

•

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

•

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

•

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

•

the federal Anti-Kickback Statute prohibits, among other things, the knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under the Medicare, Medicaid or other governmental programs, or (iii) the purchase, lease or order or arranging or recommending purchasing, leasing or ordering of any item or service reimbursable under the Medicare, Medicaid or other governmental programs. 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;

•

the federal Physician Self-Referral Law, or “Stark Law”, prohibits, among other things, a physician (defined to include a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor) from referring Medicare and Medicaid patients to certain types of entities with which the physician or any of the physician’s immediate family members have a financial relationship, unless an exception to the law’s prohibition is met. In addition, the government may assert that a claim including items or services resulting from a violation of the Stark Law 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 in order 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 Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require 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 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 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

•

regulation by the CMS and enforcement by the HHS Office of Inspector General or the U.S. Department of Justice.

•

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.

•

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.

•

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 the duration and intensity of the ongoing war in Israel, other geopolitical tensions such as the ongoing conflict between Russia and Ukraine, and numerous other factors.

•

We and our contract manufacturing organizations, or CMOs, must comply with applicable cGMP regulations and guidelines. We and our CMOs may encounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel. We and our CMOs 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.

•

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.

•

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.

•

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

•

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

•

limitations in the approved clinical indications for our product candidates;

•

demonstrated clinical safety and efficacy compared to other products;

•

lack of significant adverse side effects;

•

sales, marketing and distribution support;

•

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

•

timing of market introduction and perceived effectiveness of competitive products;

•

the degree of cost-effectiveness of our product candidates;

•

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

•

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

•

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;

•

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

•

convenience and ease of administration of our products; and

•

potential product liability claims.

•

a covered benefit under its health plan;

•

safe, effective and medically necessary;

•

appropriate for the specific patent;

•

cost-effective; and

•

neither experimental nor investigational.

•

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

•

injury to our reputation and significant negative media attention;

•

withdrawal of clinical trial participants or cancellation of clinical trials;

•

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

•

a diversion of management’s time and our resources;

•

substantial monetary awards to trial participants or patients;

•

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

•

loss of revenue; and

•

the inability to commercialize any products we develop.

•

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

•

Collaborators may not perform their obligations as expected;

•

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;

•

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;

•

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;

•

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;

•

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;

•

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;

•

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.

•

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;

•

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

•

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; and

•

Collaborations may be terminated for convenience by the collaborator and, if terminated, we may suffer from negative publicity and we may find it more difficult to attract new collaborators.

•

The Israel-Hamas War 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.

•

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

•

the possibility that the supply is inadequate or delayed;

•

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

•

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

•

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.

•

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

•

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

•

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

•

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

•

our entering into or terminating strategic relationships;

•

changes in laws or government regulation;

•

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

•

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

•

the departure of our key personnel;

•

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

•

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

•

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

•

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

•

market acceptance of our products;

•

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

•

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;

•

the publication of the results of preclinical or clinical trials for EB613, EB612 or any other oral peptide product candidates we may develop, including the oral GLP-2 and OXM programs we are developing with OPKO;

•

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

•

general economic and market conditions, including factors unrelated to our industry or operating performance, such as the duration and intensity of the ongoing Israel-Hamas War, and other geopolitical tensions.

We recognize the importance of assessing, identifying, and managing material risks associated with cybersecurity threats, as such term is defined in Item 106(a) of Regulation S-K. These risks include, among other things: operational risks, intellectual property theft, fraud, extortion, harm to employees or customers and violation of data privacy or security laws.

Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes. Cybersecurity risks related to our business, technical operations, privacy and compliance issues are identified and addressed through a multi-faceted approach including third party assessments, internal IT Audit, IT security, governance, risk and compliance reviews. Our IT policies, processes and practices are based on recognized frameworks established by our external IT service provider and other applicable industry standards. In general, we seek to address cybersecurity risks through a comprehensive, cross-functional approach that is focused on preserving the confidentiality, security and availability of the information that we collect and store by identifying, preventing and mitigating cybersecurity threats and effectively responding to cybersecurity incidents when they occur.

As part of the above processes, we regularly engage consultants to assess our internal cybersecurity programs and compliance with applicable practices and standards.

As part of our cybersecurity defense measures, we enforce the use of the following security systems:

•

EDR System (Endpoint Detection & Response)

•

Two-factor authentication for email (Office 365) and cloud-stored information

•

We protect our mail system against spam, phishing, spoofing, and malware using a (Mail Relay system).

Additionally, we enforce a real-time threat notification mechanism and activate alerts and reports for failures in our backup system.

76

---

We do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition. We also describe whether and how risks from identified cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, under the heading “We are increasingly dependent on information technology systems, infrastructure and data, and our internal computer systems, or those of our collaborators, third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.” included as part of our risk factor disclosures at Item 1A of this Annual Report.

Our Audit Committee of the Board of Directors (“the Audit Committee”), is responsible for overseeing cybersecurity risk and periodically updates our Board of Directors on such matters. The Audit Committee receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding any significant new cybersecurity threats or incidents.

Management is responsible for the operational oversight of company-wide cybersecurity strategy, policy, and standards across relevant departments to assess and help prepare us to address cybersecurity risks.

ITEM 3 .

LEGAL PROCEEDINGS

ITEM 4 .

MINE SAFETY DISCLOSURES.

ITEM 5 .

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

ITEM 6.

[Reserved]

ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

•

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.

		Year Ended
		December 31,								Increase (Decrease )
		2024				2023				$				%
		(In thousands, except for percentage information)
Revenues		$	181			$	-			$	181				100	%
Cost of revenues		$	172			$	-			$	172				100	%
Operating expenses:
Research and development expenses		$	4,499			$	4,510			$	(11	)			(0.2	)%
General and administrative expenses		$	5,095			$	4,430			$	665				15	%
Other income		$	-			$	(49	)		$	49				100	%
Operating loss		$	9,585			$	8,891			$	694				8	%
Financial income, net		$	(58	)		$	(31	)		$	(27	)			87	%
Income tax expenses		$	14			$	29			$	(15	)			(52	)%
Net loss		$	9,541			$	8,889			$	652				7	%

•

the costs, timing and outcome of clinical trials for, and regulatory review of our oral peptide programs, including EB613 and 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; and

•

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

		Year ended December 31,
		2024				2023
		(in thousands)
Net Cash used in operating activities		$	(6,818	)		$	(7,310	)
Net Cash used in investing activities			(3	)			(17	)
Net Cash provided by financing activities			4,476				6,036
Net decrease in cash and cash equivalents		$	(2,345	)		$	(1,291	)

		Year ended
		December 31,
		2024				2023
		(in thousands )
Cost of revenues		$	7			$	-
Research and development			839				424
General and administrative			1,710				1,265
Total		$	2,556			$	1,689

Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

	Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID 1309 )	90
CONSOLIDATED FINANCIAL STATEMENTS:
Consolidated Balance Sheets	92
Consolidated Statements of Operations	93
Consolidated Statements of Changes in Shareholders' Equity	94
Consolidated Statements of Cash Flows	95
Notes to the Consolidated Financial Statements	96

/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
March 28, 2025
We have served as the Company’s auditor since 2010.

		December 31
		2024				2023
A s s e t s
CURRENT ASSETS:
Cash and cash equivalents			8,660				11,019
Accounts receivable			126				-
Other current assets			186				238
TOTAL CURRENT ASSETS			8,972				11,257
NON-CURRENT ASSETS:
Property and equipment, net			57				100
Operating lease right-of-use assets			275				388
Deferred income taxes			-				14
Restricted deposit			80				-
Funds in respect of employee rights upon retirement			6				6
TOTAL NON-CURRENT ASSETS			418				508
TOTAL ASSETS			9,390				11,765
L i a b i l i t i e s and shareholder' equity
CURRENT LIABILITIES:
Accounts payable			132				83
Accrued expenses and other payables			874				874
Current maturities of operating lease			170				134
TOTAL CURRENT LIABILITIES			1,176				1,091
NON-CURRENT LIABILITIES :
Operating lease liabilities			102				256
Liability for employee rights upon retirement			32				32
TOTAL NON-CURRENT LIABILITIES			134				288
TOTAL LIABILITIES			1,310				1,379
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary Shares, NIS 0.0000769 par value: Authorized - as of December 31, 2024 and December 31, 2023, 140,010,000 shares; issued and outstanding as of December 31, 2024, and December 31, 2023, 38,837,220 and 35,476,341 shares, respectively			1				1
Additional paid-in capital			121,965				114,730
Accumulated other comprehensive income			41				41
Accumulated deficit			( 113,927	)			( 104,386	)
TOTAL SHAREHOLDERS' EQUITY			8,080				10,386
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY			9,390				11,765

		Year ended December 31
		2024				2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss			( 9,541	)			( 8,889	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation			46				56
Deferred income taxes			14				29
Share-based compensation			2,556				1,689
Finance income, net			( 5	)			-
Changes in operating asset and liabilities:
Decrease (increase) in accounts receivable			( 126	)			246
Decrease in other current assets			( 14	)			56
Increase in accounts payable			49				66
Decrease in accrued expenses and other payables			203				( 563	)
Net cash used in operating activities			( 6,818	)			( 7,310	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment			( 3	)			( 17	)
Net cash used in investing activities			( 3	)			( 17	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of shares through ATM programs,			3,960				5
Issuance of ordinary shares and warrants through to a private placement			-				6,611
Issuance costs			( 323	)			( 580	)
Exercise of warrants into ordinary shares			90				-
Exercise of options into ordinary shares			749				-
Net cash provided by financing activities			4,476				6,036
DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS			( 2,345	)			( 1,291	)
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE YEAR			11,085				12,376
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE YEAR			8,740				11,085
Reconciliation in amounts on consolidated balance sheets:
Cash and cash equivalents			8,660				11,019
Restricted deposits			80				66
Total cash and cash equivalents and restricted deposits			8,740				11,085
SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS:
Interest received			68				18
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Issuance costs			-				470
Operating lease right of use assets obtained in exchange for new operating lease liabilities			32				449

NOTE 8 - INCOME TAX

a)	Corporate tax rate

i.

Ordinary taxable income in Israel is subject to a corporate tax rate of 23 %.

	ii.	The Company’s subsidiary Entera Bio, Inc. is taxed separately under the U.S. tax laws at a tax rate of 29 % (federal and state tax)

b)	Losses for tax purposes carried forward to future years

The balance of carryforward losses of Entera Bio Ltd. as of December 31, 2024 and 2023 are approximately $ 83.5 million and $ 75.8 million , respectively.

Under Israeli tax law, tax loss carry-forwards have no expiration date.

c)	Tax assessments

The Company and its subsidiary have tax assessments that are considered to be final through tax year 2019.

d)	Loss (income) before income taxes is composed of the following:

		Year ended December 31
		2024				2023
Entera Bio Ltd.			9,479				8,868
Entera Bio Inc.			48				( 8	)
Total loss before taxes			9,527				8,860

e)	Income tax expense:

		Year ended December 31
Current:		2024				2023
Subsidiary:			-				-
Total current income tax			-				-
Deferred income taxes - subsidiary			14				29
Total deferred income taxes			14				29
Total income tax expense			14				29

114

---

ENTERA BIO LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(U.S. dollars in thousands, except share and per share amounts )

NOTE 8 - INCOME TAX (continued)

f)	Deferred income taxes:

		December 31,
		2024				2023
Deferred tax assets:
Net operating loss carry forward			19,208				17,427
Research and development			854				983
Share-based compensation			639				855
Other			172				220
Net deferred tax assets before valuation allowance			20,873				19,485
Valuation allowance			( 20,873	)			( 19,471	)
Net deferred tax assets			-				14

In assessing the likelihood of realizing deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences and carry forward losses become deductible. Based on the taxable loss in the Israel and in the United States, management believes it was more likely than not that the deferred tax assets will not be realized.

g)	Roll-forward of valuation allowance:

Balance at January 1, 2023			17,645
Additions			1,826
Balance at January 1, 2024			19,471
Additions			1,402
Balance at December 31, 2024			20,873

h)	Reconciliation of theoretical tax expenses to actual expenses:

The primary difference between the statutory tax rate of the Company and the effective rate results virtually from the changes in valuation allowance in respect of carry forward tax losses and research and development expenses due to the uncertainty of the realization of such tax benefits.

i)	Uncertain tax positions

As of December 31, 2024 and 2023, the Company did not have a provision for uncertain tax positions as existing uncertain tax positions as, based on the technical merits, given the existing tax positions are not more likely than not to be sustained.

ENTERA BIO LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION:

Balance sheets:

		December 31,
Accrued expenses and other payables:		2024				2023
Employees and employees related			161				159
Provision for vacation			178				215
Accrued expenses			535				500
			874				874

NOTE 10 - SUBSEQUENT EVENTS

a)	On January 3, 2025, the Company issued an aggregate of 2,700,000 ordinary shares pursuant to the Leerink ATM Program for net proceeds of $ 5,997 at a weighted average price of $ 2.29 per ordinary share.

b )	On January 10, 2025, the Company filed a supplement to the prospectus supplement relating to the Leerink ATM Program, which provides the Company the ability to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program

c)

On January 15, 2025, an aggregate of 142,545 options to purchase ordinary shares were granted to five non-executive board members with an exercise price of $ 2.28 per share. The options will vest over one year in four equal quarterly installments starting on January 1, 2025. This grant was approved by the shareholders of the Company on October 4, 2021.

d)

On January 15, 2025, the Company issued 40,993 ordinary shares to five non-executive members of the board of directors in lieu cash board fees for the fourth quarter of 2024, which was approved by the Company’s shareholders at a meeting of the Company’s shareholders held on July 31, 2024. The fair value of the ordinary shares at the grant date was $ 93 using the market price of the ordinary shares at the grant date.

e)	In January 2025, 149,700 warrants were exercised for an aggregate of 149,700 ordinary shares for a total consideration of $ 150 .

f)

On March 16, 2025, the Company entered into a collaboration and license agreement (the “2025 Collaboration Agreement”) with OPKO and its wholly owned subsidiary, OPKO Biologics Ltd., to collaborate with respect to the preclinical and clinical development and decision making related to the oral delivery of a dual agonist GLP-1/glucagon peptide in an oral dosage form using Entera’s N-Tab™ technology platform for the treatment of obesity, metabolic and fibrotic disorders in humans (the “Program”). The Program combines OPKO’s proprietary long-acting oxyntomodulin (OXM, dual targeted GLP-1/Glucagon agonist, OPK-88006) analog and Entera’s proprietary N-Tab™ technology.

Under the 2025 Collaboration Agreement, the Company granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of the company's intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/glucagon dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to the Company a non-exclusive, non-sublicensable and non-transferable license to certain of OPKO’s intellectual property and technology to the extent necessary for the Company to perform its obligations in relation to the Program, in each case subject to the exceptions contained therein.

Under the terms of the 2025 Collaboration Agreement, the Company and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively. Following the completion of the Phase 1 stage, the Company may continue to fund its 40% share of the Program to maintain its right to proceeds or to opt-out (the “Opt-Out”). If the Company exercises the Opt-Out, then the Company and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program.

In connection with the execution of the 2025 Collaboration Agreement, the Company issued and sold to OPKO an aggregate of 3,685,226 ordinary shares for a total purchase price of $ 8.0 million, representing a purchase price per share equal to approximately $ 2.17 , which was the volume weighted average price per share for the 30 trading days immediately preceding the date of the 2025 Collaboration Agreement.  OPKO has agreed to a customary lockup with respect to such shares, and may not sell or otherwise transfer them for a period of 12 months following the date of the 2025 Collaboration Agreement, and OPKO has additionally agreed to a customary “standstill” provision, pursuant to which, for a 24-month period following the date of the 2025 Collaboration Agreement, OPKO may not acquire additional equity in the Company or otherwise take certain other actions, in each case without our consent.

The Company has agreed to use the proceeds from the sale of the foregoing ordinary shares solely to fund its development cost obligations under the 2025 Collaboration Agreement, and has agreed to enter into an escrow arrangement, together with OPKO and an escrow agent, into which such proceeds will be deposited and subsequently disbursed to fund such development costs.  If the 2025 Collaboration Agreement expires or is terminated for any reason, any funds remaining in such escrow will be disbursed to the Company.