What changed in this filing

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Item 9A. Controls and Procedures

2026-03-27 compared with 2025-03-28 · 153 added, 174 removed, 613 unchanged (35% of the section changed)

24 unchanged sentences

Miranda Toledano

Chief Executive Officer and Director

Chief Executive Officer, Director

Gregory Burshtein

5 unchanged sentences

Non-Employee Directors

Gerald Lieberman (1)

Director, Chairman of the Board of Directors

Rubin (1)(2)(3)

Director, Chairman of the Audit Committee

Sean Ellis (1)(3)(4)

3 unchanged sentences

Director, Chairman of the Compensation Committee

Ostrov (1) (2) (3)

Director, Chairman of the Audit Committee

Independent in accordance with SEC regulations and Nasdaq rules requirements applicable to us.

2 unchanged sentences

Member of the Nominating and Corporate Governance Committee.

(5) Member of the Scientific Advisory Committee.

Executive Officers

Miranda Toledano has served as a member of our Board since 2018, as prior Chair of the Audit Committee as of 2018 and as Member of the Scientific Advisory Committee since February 2022.

Toledano has served as the Company's Chief Executive Officer, or CEO, since July 2022.Ms.

Miranda Toledano has served as the Company’s Chief Executive Officer since July 2022 and as member of our Board of Directors since September 2018.

Toledano has over 25 years of C-level leadership, principal investment and Wall Street/capital market experience in the biotech sector.

1 unchanged sentence

CMPX) in June 2021.

At TRIGR, Miranda oversaw the clinical development of lead asset TR009 (now CTX-009) and led strategic execution, including a $117 million China License Transaction and TRIGR’s 2021 acquisition by CMPX.

At TRIGR, Miranda oversaw the clinical development of lead asset TR009 (now tovecimig) and led strategic execution, including a $117 million China License Transaction and TRIGR’s 2021 acquisition by CMPX.

Previously, Ms.

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Gregory Burshtein, PhD has led research and development at the Company since he joined Entera in September 2012, as Director of Pharmaceutical R&D, and since May 2024, as our Chief of Research and Development.

Burshtein is a leader in the field of oral delivery of peptides, has published in peer-reviewed journal articles holds 25 issued patents and has 113 pending patent applications related to development, formulation, and delivery of oral large molecules.

Burshtein is a leader in the field of oral delivery of peptides, has published in peer-reviewed journal articles and holds 25 issued patents and has 113 pending patent applications related to development, formulation, and delivery of oral large molecules.

Burshtein holds over 20 years of experience in the field of drug delivery, pharmacology and biopharmaceutics, with a primary focus on the challenging area of oral delivery of therapeutic peptides.

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Pharm degree from the Institute for Drug Research, Faculty of Medicine of the Hebrew University of Jerusalem.

Dana Yaacov-Garbeli has served as our Chief Financial Officer since July 2022.

Prior that, Ms.

Yaacov-Garbeli served as our Israel-based Chief Financial Officer from June 2019 through July 2022.

Dana Yaacov-Garbeli has served as our Chief Financial Officer since June 2019.

Yaacov-Garbeli has over 17 years of finance and accounting experience.

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She has significant experience in financial planning, operations management, external and internal audit for public multinational companies under US GAAP, IFRS and PCAOB standards.

Yaacov-Garbeli is also a partner at A2Z-Finance, a company that provides financial and accounting services.

Yaacov-Garbeli holds a B.A in accounting and business management and an MBA in financial management from The College of Management and Academic studies.

10 unchanged sentences

Non-Employee Directors

Gerald Lieberman has served as a member of our Board since April 2014 and became our Chairman in July 2019.

Lieberman is also a member of the Board of Directors of Teva Pharmaceutical Industries Ltd.

(NYSE and TASE:

He serves on the Board of Directors of DosentRx, Ltd., and is a special advisor at Reverence Capital Partners, a private investment firm focused on the middle-market financial services industry.

From 2000 to 2009, Mr.

Lieberman was an executive at AllianceBernstein L.P.

primarily as the President and Chief Operating Officer when he also served as a Board Member.

From 1998 to 2000, he was Senior Vice President, Finance and Administration at Sanford C.

Bernstein & Co Inc., until it was acquired by Alliance Capital in 2000.

Prior to that, he served in various executive positions over six years at Fidelity Investments including Chief Financial Officer and Chief of Administration.

Prior to Fidelity he was in various senior positions over fourteen years at Citicorp including serving as a member of the Policy Committee.

Prior to joining Citicorp, he was a certified public accountant with Arthur Andersen.

Lieberman received a B.S.

Beta Gamma Sigma with honors in business from the University of Connecticut.

Our Board believes that Mr.

Lieberman is qualified to serve as director based upon his experience on boards of other pharmaceutical and health care companies and his years of experience working with listed public companies and private companies.

Germano is a 35-year veteran of the pharmaceutical and life sciences industry with extensive experience in development and commercialization of a broad range of medicines across most therapeutic categories.

Most recently, from August 2018 to June 2024, Mr.

Germano served as President and Chief Executive Officer and a board member of Elucida Oncology, Inc., a biotechnology company.

He previously served as President of Intrexon Corporation, or Intrexon, a leader in engineering and industrialization of biology, from June 2016 to March 2017.

Prior to joining Intrexon, from 2014 to February 2016, Mr.

Germano was Group President of the Global Innovative Pharma Business of Pfizer, where he led a growing global $14 billion business with market-leading medicines and an extensive portfolio of late-stage development candidates in several therapeutic areas.

Germano was also Co-Chair of the Portfolio Strategy and Investment Committee at Pfizer from 2013 to February 2016.

Previously, from 2009 through 2013, Mr.

Germano served as President and General Manager of Pfizer’s Specialty Care and Oncology business units where he led commercial, medical, and post proof-of-concept pipeline strategy and development across global markets.

Additionally, Mr.

Germano has served on the board of directors of Precision Biosciences, Inc., a clinical stage biotechnology company, since March 2020.

In the past five years, Mr.

Germano served on the boards of directors of Sage Therapeutics (from 2016 until the company was acquired in 2025), Orbital Therapeutics, a private pre-clinical stage biotechnology company (from March 2025 until the company was acquired in December 2025), Bioverativ Inc.

(acquired by Sanofi S.A.

in March 2018) and The Medicines Company (acquired by Novartis AG in January 2020).

Germano received his B.S.

in Pharmacy from Albany College of Pharmacy.

Rubin has served as OPKO Health’s Executive Vice President – Administration since May 2007 and as a director since February 2007.

He has extensive experience as a practicing lawyer, and as general counsel and board member to multiple public companies.

Rubin currently serves on the board of directors of the following companies:

Niagen Bioscience, Inc.

NAGE), a bioscience company developing NAD+ products to support cellular health;

Cocrystal Pharma, Inc.

(NASDAQ:COCP), a biotechnology company developing new treatments for viral diseases;

Eloxx Pharmaceuticals (NASDAQ:

ELOX), a biotechnology company engaged in ribosomal RNA targeted genetic therapies for rare diseases;

and Red Violet, Inc., (NASDAQ:

RDVT) a leading analytics and information solutions provider.

Rubin previously served as the Senior Vice President, General Counsel and Secretary of IVAX from August 2001 until September 2006.

Rubin previously served as a director of the following companies:

Neovasc, Inc.

(NASDAQ:NVCN), a company developing and marketing medical specialty vascular devices;

Non-Invasive Monitoring Systems, Inc.

(OTCBB:NIMU), a medical device company;

Castle Brands, Inc.

(NYSE:ROX), a developer and marketer of premium brand spirits;

Kidville, Inc.

(OTCBB:KVIL), an operator of large, upscale facilities, catering to newborns through five-year-old children and their families and offers a wide range of developmental classes for newborns to five-year-olds;

VBI Vaccines Inc.

VBIV), a commercial-stage biopharmaceutical company developing a next generation of vaccines;

DRJ), a vertically integrated sports licensing and products company;

Safestitch Medical, Inc.

prior to its merger with TransEnterix, Inc.;

and, PROLOR Biotech, Inc.;

and Cognit, Inc.

(NASDAQ:COGT), a data and analytics company providing cloud-based mission-critical information and performance marketing solutions.

Rubin holds a B.A.

degree from Tulane University and a Juris Doctor from University of Florida.

Sean Ellis has served as a member of our Board since June 2019.

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Taitel has over 30 years of global C-level biopharma commercial and strategic executive experience.

She currently serves as the Head of Sanofi’s Global Transplant Franchise where she is responsible for increasing franchise growth and profitability.

She currently serves as the Head of Sanofi’s Strategic Partnership and Portfolio Planning where she is responsible for increasing franchise growth and profitability.

Prior to her role at Sanofi, Ms.

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Malca is qualified to serve as a director based upon his pharmaceutical industry experience as an executive as well as his experience on boards of multiple pharmaceutical companies.

Ostrov has served as a member of our Board since January 2019.

Ostrov consults and invests in new technologies in the medical device and consumer products fields.

Ostrov currently serves on the board of directors of several privately held companies, including Synergio, Addon Optics, and Nuvo Group Ltd.

From 2008 to 2010, he served as Chairman and CEO of Bausch & Lomb.

Ostrov led the stabilization, streamlining and pipeline building of Bausch & Lomb following its going-private transaction.

From 1998 until 2006, Mr.

Ostrov very successfully served as Company Group Chairman for Johnson & Johnson's Worldwide Vision Care businesses.

From 1991 to 1998, Mr.

Ostrov worked for Johnson & Johnson and quickly rose to serve as Company Group Chairman of the Consumer and Personal Care businesses in North America.

From 1982 to 1991, he served as President of CIBA Consumer Pharmaceuticals Company.

From 1976 to 1982, he worked for the Health Care Division of Johnson & Johnson.

From 1973 to 1976, Mr.

Ostrov worked at Procter & Gamble.

Ostrov holds a B.S.

from Cornell and an M.B.A.

from Harvard.

Our Board believes that Mr.

Ostrov is qualified to serve as a director based upon his years as an investor in healthcare related companies.

Family Relationships

15 unchanged sentences

the Class II director is Haya Taitel;

the Class III directors are Gerald Lieberman, Gerald M.

Ostrov and Sean Ellis.

the Class III directors are Steven D.

Rubin, Geno J.

Germano and Sean Ellis.

At each annual meeting of shareholders, directors will be elected to succeed the class of directors whose term has expired.

13 unchanged sentences

Sean Ellis, Mr.

Ostrov and Mr.

Rubin and Mr.

Yonatan Malca each have financial and accounting expertise as defined in the regulations promulgated under the Companies Law.

12 unchanged sentences

The Board has affirmatively determined that the following Directors are “independent” as of the date of this Annual Report, as defined in the listing standards of Nasdaq:

Gerald Lieberman, Gerald M.

Ostrov, Sean Ellis, Yonatan Malca, and Haya Taitel.

Germano, Steven D.

Rubin, Sean Ellis, Yonatan Malca, and Haya Taitel.

In making these determinations, our Board considered the current and prior relationships that each non-employee director has or had with our Company and all other facts and circumstances our Board deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director, and the transactions involving them described in the section titled “Item 13.

12 unchanged sentences

Under the Nasdaq rules and SEC regulations, we are required to maintain an Audit Committee consisting of at least three independent directors, each of whom is financially literate and one of whom has accounting or related financial management expertise and would qualify as an “audit committee financial expert” as such term is defined in Item 407(d)(5) of Regulation S-K.

Our Audit Committee consists of Gerald M.

Ostrov, who also serves as chairman of the committee, Yonatan Malca, and Sean Ellis.

Our Audit Committee consists of Steven D.

Rubin, who also serves as chairman of the committee, Yonatan Malca, and Sean Ellis.

The Board has determined that each of the members of our Audit Committee is an independent director and additionally satisfies the heightened standards for audit committee service under applicable SEC and Nasdaq rules.

All designated members of our Audit Committee meet the requirements for financial literacy under the applicable Nasdaq rules and SEC regulations.

Our Board has determined that Gerald M.

Ostrov is an audit committee financial expert.

Our Board has determined that Steven D.

Rubin is an audit committee financial expert.

Roles, Responsibilities and Procedures

17 unchanged sentences

Compensation Committee

We have a Compensation Committee, the members of which are Yonatan Malca, who also serves as chairman of the committee, Gerald M.

Ostrov and Haya Taitel.

We have a Compensation Committee, the members of which are Yonatan Malca, who also serves as chairman of the committee, Steven D.

Rubin and Haya Taitel.

Each member of our Compensation Committee is independent under Nasdaq rules.

24 unchanged sentences

Under the Companies Law, we must obtain Compensation Committee, Board and shareholder approval every three years for either the continuation of our existing compensation policy or adoption of a new compensation policy.

Our compensation policy was last approved by our shareholders on July 31, 2024, after having been recommended by our Compensation Committee and approved by our Board.

Our Compensation Committee may conduct or authorize investigations into, or studies of, matters within its scope of responsibilities, and may retain or obtain the advice of a compensation consultant, legal counsel or other advisor in its sole discretion.

1 unchanged sentence

The Compensation Committee may select, or receive advice from, a compensation consultant, legal counsel or other advisor to the Compensation Committee, other than in-house legal counsel, only after conducting an assessment of, and determining, the advisor’s independence, including whether the advisor’s work has raised any questions of independence or conflicts of interest, taking into consideration the Exchange Act, the factors set forth in Nasdaq rules and any other factors that the committee deems relevant.

In 2021 and 2023, in determining the compensation of certain non-executive directors and in determining our compensation policy, the Compensation Committee retained the services of a compensation consultant, Brightman Almagor Zohar & co., a firm in the Deloitte Touche Tohmatsu Limited network, to conduct a comparative survey of the compensation of such Office Holders.

In 2023 and 2025, in determining the compensation of certain executive officers and in determining our compensation policy, the Compensation Committee retained the services of a compensation consultant, Brightman Almagor Zohar & co., a firm in the Deloitte Touche Tohmatsu Limited network, to conduct a comparative survey of the compensation of such Office Holders.

The 2023 and 2025 comparative studies consisted of:

1 unchanged sentence

On May 27, 2024, the Compensation Committee and the Board voted to approve, and on July 31, 2024, the shareholders of the Company ratified and confirmed, the revised compensation terms of the Company’s non-executive directors, retroactively effective as of January 1, 2024, which includes (i) a quarterly grant of fully vested Ordinary shares, in lieu of each non-executive director’s respective quarterly cash compensation and (ii) an annual option grant.

On July 16, 2025, following the recommendation of the Compensation Committee and the Board’s approval and recommendation, the Shareholders of the Company voted to approve an Amended Compensation Policy, which is substantially similar to the Company’s prior policy, subject to certain updated thresholds to align with market standards and to attract prospective management members, such that the policy would be effective for the next three years, or such longer period as permitted and in accordance with the Israeli Companies Law.

Nominating and Corporate Governance Committee

6 unchanged sentences

The Nominating and Corporate Governance Committee believes that candidates for director should have certain minimum qualifications, including sufficient scientific and/or medical expertise to review and evaluate appropriately the Company’s clinical programs, research and development programs and licensing opportunities.

Scientific Advisory Committee

Our Scientific Advisory Committee consists of Miranda Toledano who also serves as chairwoman of the committee, along with Yonatan Malca and Haya Taitel.

Our Board has adopted a Scientific Advisory Committee Charter that sets forth the responsibilities of the Scientific Advisory Committee, including (a) reviewing, evaluating and reporting to the Board regarding strategy, plans and goals, as well as progress and performance, of the Company’s clinical programs, licensing activities, and research and development activities, (b) meeting with the Company’s R&D and licensing teams to evaluate the plans, goals and performance of the Company’s clinical programs and research and development projects, and make recommendations to the Board as appropriate in the opinion of the committee to fulfill the company strategic goals, (c) identifying and discussing significant emerging regulatory, research and scientific issues and trends and competitive activity, including their potential impacts on any Company programs, plans, or policies relating to its licensing opportunities, clinical programs and research and development activities.

(d) evaluating the performance of the committee, including a review of the committee’s compliance with its charter, and review and reassess the charter and submit any recommended changes to the Board for its consideration and approval, (e) forming external consulting panels to assist the committee in review of specific R&D programs either current or planned and (f) such other duties and responsibilities as may be assigned to the committee, from time to time, by the Board.

A copy of the Scientific Advisory Committee Charter is available on our website at www.enterabio.com.

Section 16(a) Beneficial Ownership Reporting Compliance

1 unchanged sentence

Delinquent Section 16(a) Reports

Based solely upon our review of copies of filings or written representations from the reporting persons, we believe that all reporting persons timely filed all reports required by them under Section 16(a) of the Exchange Act with respect to the year ended December 31, 2024.

Based solely upon our review of copies of filings or written representations from the reporting persons, other than as noted below, we believe that all reporting persons timely filed all reports required by them under Section 16(a) of the Exchange Act with respect to the year ended December 31, 2025.

On May 20, 2025, Leslie Velka Gautam, a former executive officer of the Company, filed an untimely Form 3 due to delays in obtaining such reporting person’s EDGAR codes from the SEC.

EXECUTIVE COMPENSATION

Compensation Policy

Our compensation policy was last ratified by our shareholders on July 31, 2024, after having been recommended by our Compensation Committee and approved by our Board, and will therefore, under the Companies Law, will need to be either re-approved, amended, or replaced by a new policy no later than 2027, and every three years thereafter.

Our compensation policy was last approved by our shareholders on July 16, 2025, after having been recommended by our Compensation Committee and approved by our Board, and will therefore, under the Companies Law, will need to be either re-approved, amended, or replaced by a new policy no later than 2028, and every three years thereafter.

The compensation policy includes, among other matters prescribed by the Companies Law, a framework for establishing the terms of office and employment of the directors and officers and guidelines with respect to the structure of the variable pay of officers.

79 unchanged sentences

Hillel Galitzer

Chief Operating

Dana Yaacov-Garbeli

Chief Finance Officer

Chief Operating Officer

Gregory Burshtein

Chief of Research and Development

Reflects the associated annual expense recorded in our financial statements based on the grant date fair value of the share-based compensation granted in exchange for the directors’ and officers’ services computed in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718, Compensation - Stock Compensation (“ASC Topic 718”).

6 unchanged sentences

Number of Securities

Unexercised Options

Unexercised Options and Unvested RSUs

Unexercisable

5 unchanged sentences

Chief Operating Officer

Dana Yaacov-Garbeli

Chief Finance Officer

The 187,500 unexercisable options as of December 31, 2024 will vest in six equal quarterly installments beginning on February 16, 2025.

The 262,500 unexercisable options as of December 31, 2024 will vest in seven equal quarterly installments beginning on January 15, 2025.

The 218,750 unexercisable options as of December 31, 2024 will vest in ten equal quarterly installments beginning on January 24, 2025.

Of the 500,000 unexercisable options as of December 31, 2024, 25% vest on April 19, 2025, the first anniversary of the grant date, and the remaining 75% vesting in 8 equal quarterly installments over the following two years.

The 62,061 unexercisable RSUs as of December 31, 2024 will vest in two equal quarterly installments beginning on January 19, 2025.

The 6,375 unexercisable options as of December 31, 2024 will vest in two equal quarterly installments beginning on January 7, 2025.

The 62,500 unexercisable options as of December 31, 2025 will vest in two equal quarterly installments beginning on February 16, 2026.

The 112,500 unexercisable options as of December 31, 2025 will vest in three equal quarterly installments beginning on January 15, 2026.

The 131,250 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning on January 24, 2026.

The 40,625 unexercisable options as of December 31, 2024 will vest in ten equal quarterly installments beginning on January 24, 2025.

The 250,000 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning on January 19, 2026.

Of the 500,000 unexercisable options as of December 31, 2025, 33.33% vest on April 28, 2026, the first anniversary of the grant date, and the remaining 66.67% vesting in 8 equal quarterly installments over the following two years.

The 12,563 unexercisable RSUs as of December 31, 2024 will vest in two equal quarterly installments beginning on January 19, 2025.

The 90,351 unvested RSUs as of December 31, 2025 will vest in two equal quarterly installments beginning on January 28, 2026.

The 5,625 unexercisable options as of December 31, 2025 will vest in two equal quarterly installments beginning on January 28, 2026.

The 18,750 unexercisable options as of December 31, 2024 will vest in five equal quarterly installments beginning on March 31, 2025.

The 131,250 unexercisable options as of December 31, 2024 will vest in ten equal quarterly installments beginning January 24, 2025.

The 24,375 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning on January 24, 2026.

The 75,000 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning on January 19, 2026.

Of the 200,000 unexercisable options as of December 31, 2025, 33.33% vest on April 28, 2026, the first anniversary of the grant date, and the remaining 66.67% vesting in 8 equal quarterly installments over the following two years.

The 15,076 unexercisable RSUs as of December 31, 2024 will vest in two equal quarterly installments beginning on January 19, 2025.

The 15,000 unexercisable options as of December 31, 2024 will vest in two equal quarterly installments beginning on January 16, 2025.

The 10,938 unexercisable options as of December 31, 2024 will vest in five equal quarterly installments beginning on March 31, 2025.

The 118,750 unexercisable options as of December 31, 2024 will vest in ten equal quarterly installments beginning January 24, 2025.

The 13,158 unvested RSUs as of December 31, 2025 will vest in two equal quarterly installments beginning on January 28, 2026.

The 3,750 unexercisable options as of December 31, 2025 will vest in one installments on March 31, 2026.

The 78,750 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning on March 31, 2026.

The 65,000 unexercisable options as of December 31, 2025 will vest in six equal quarterly installments beginning January 19, 2026.

Of the 100,000 unexercisable options as of December 31, 2024, 33.33% vest on April 28, 2026, the first anniversary of the grant date, and the remaining 66.67% vesting in 8 equal quarterly installments over the following two years.

The 15,076 unexercisable RSUs as of December 31, 2024 will vest in two equal quarterly installments beginning on January 19, 2025.

The 13,158 unvested RSUs as of December 31, 2025 will vest in two equal quarterly installments beginning on January 28, 2026.

Director Compensation Table

4 unchanged sentences

Under this arrangement, each non-executive director receives a quarterly grant of fully vested Ordinary Shares.

Such quarterly grants for the fiscal year ended December 31, 2025 were granted in a single aggregate grant on January 1, 2026.

The value of these shares is equivalent to their respective cash compensation for board and committee services, calculated based on the average daily closing share price of the Ordinary Shares during the applicable fiscal quarter.

2 unchanged sentences

Yonatan Malca

Ron Mayron (3)

1 unchanged sentence

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).

Reflects the associated annual expenses for fully vested Ordinary Shares granted in lieu of cash fees during 2024, based on the grant date market value.

Former board member whose term expired at the 2024 Annual Meeting of Shareholders.

Reflects the associated annual expenses for Ordinary Shares granted in January 2026 in lieu of cash fees earned for services rendered during 2025, based on the grant date market value.

Former board member that resigned as a director of the Company in February 2026.

The table below sets forth the aggregate number of share options of each non-employee director outstanding as of December 31, 2025:

13 unchanged sentences

In connection with Ms.

Toledano’s appointment Chief Business Officer, Chief Financial Officer and Head of Corporate Strategy in May 2022, Ms.

Toledano’s appointment as Chief Business Officer, Chief Financial Officer and Head of Corporate Strategy in May 2022, Ms.

Toledano entered into an employment agreement (the “Original Employment Agreement”) with the Company, providing for an annual employer cost of $350,000 inclusive of base salary, pension payments, severance and disability benefits as required under Israeli law.

23 unchanged sentences

Toledano’s employment agreement in January 2024, under the terms of which the salary increase became effective on January 1, 2024.

On April 14, 2024, and April 19, 2024, the Compensation Committee and the Board, respectively, voted to approve, and on July 31, 2024, the shareholders of the Company ratified and confirmed, a one-time grant to Ms.

Toledano of (i) options to purchase 500,000 Ordinary Shares (the "Miranda's 2024 Options"), at an exercise price of $1.99 per Ordinary Share, under the 2018 Plan, and (ii) a one-time grant of 124,121 RSUs in place of the annual cash bonus for 2023 (the "Miranda's 2024 RSUs”) under the 2018 Plan.

Provided that Ms.

Toledano has not undergone a Termination of Service (as defined in the 2018 Plan) prior to the applicable vesting date, Miranda's 2024 Options shall vest over a three (3) year period, with a third of Miranda's 2024 Options vesting at the end of a 12-month period following April 19, 2024, and the remaining two-thirds of Miranda's 2024 Options shall vest in eight substantially equal portions over the next two (2) year period thereafter, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Miranda's 2024 Options that vest in the installment shall be such that Ms.

Toledano will be fully vested in the total number of Miranda's 2024 Options listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Miranda's 2024 Options shall become fully vested on April 19, 2027);

provided further, however, that in the event of a Change in Control (as defined in the 2018 Plan) in which Ms.

Toledano continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Miranda's 2024 Options at the time of the consummation of such Change in Control shall become fully vested and exercisable.

The expiration date of Miranda's 2024 Options shall be April 19, 2034, or such earlier date in accordance with the 2018 Plan or the Company's option agreement.

Provided that Ms.

Toledano has not undergone a Termination of Service (as defined in the 2018 Plan) prior to the applicable vesting date, Miranda's 2024 RSUs shall vest over a one (1) year period, with 100% of Miranda's 2024 RSUs vesting in four substantially equal portions over the 12 month period following April 19, 2024, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Miranda's 2024 RSUs that vest in the installment shall be such that Ms.

Toledano will be fully vested in the total number of Miranda's 2024 RSUs listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Miranda's 2024 RSUs shall become fully vested on April 19, 2025);

provided further, however, that in the event of the Change in Control in which Ms.

Toledano continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Miranda's 2024 RSUs at the time of the consummation of such Change in Control shall become fully vested.

On April 23, 2025 and April 28, 2025, the Compensation Committee and the Board, respectively, voted to approve, and on July 16, 2025, the shareholders of the Company ratified and confirmed for Ms.

(i) a salary increase for Ms.

Toledano, according to which her annual employer cost would be increased to $600,000, as of April 1, 2025 (while with respect to the 12-month period beginning April 1, 2025, in order to preserve Company cash, Ms.

Toledano is entitled to receive a one-time grant of 43,860 RSUs in place of $100,000 of her Updated Salary in lieu of cash payment for such one (1) year period (the “2025 Salary RSUs”), under the 2018 Plan and subject to the requirements of applicable laws and regulations.

the 2025 Salary RSUs shall vest over a one (1) year period, with 100% of the 2025 Salary RSUs vesting in four substantially equal portions over the 12 month period and (ii) a one-time grant of options to purchase an additional 500,000 Ordinary Shares (the “2025 Options”), at an exercise price of $2.28 per Ordinary Share, under the 2018 Plan, and subject to the requirements of applicable laws and regulations.

Hillel Galitzer

5 unchanged sentences

Galitzer’s annual salary, and he is currently entitled to an annual gross base salary of $246,000.

The Board approved an increase to Mr.

Galitzer’s annual salary, effective April 1, 2025, and he is currently entitled to an annual gross base salary of $254,000.

Additionally, pursuant to the terms of his employment agreement, Mr.

7 unchanged sentences

Galitzer also agreed to customary non-disclosure and non-competition covenants.

On April 14, 2024, and April 19, 2024, the Compensation Committee and the Board, respectively, voted to approve a one-time grant to Mr.

Galitzer of (i) options to purchase 130,000 Ordinary Shares (the “Galitzer's 2024 Options”), at an exercise price of $1.99 per Ordinary Share, under the 2018 Plan, and (ii) a one-time grant of 30,151 RSUs in place of the annual cash bonus for 2023 (the “Galitzer's 2024 RSUs”) under the 2018 Plan.

Galitzer's 2024 Options shall vest over a three (3) year period, with a third of the Galitzer's 2024 Options vesting at the end of a 12-month period following April 19, 2024, and the remaining two-thirds of Galitzer's 2024 Options shall vest in eight substantially equal portions over the next two (2) year period thereafter, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Galitzer's 2024 Options that vest in the installment shall be such that Mr.

Galitzer will be fully vested in the total number of Galitzer's 2024 Options listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Galitzer's 2024 Options shall become fully vested on April 19, 2027);

provided further, however, that in the event of a Change in Control (as defined in the 2018 Plan) in which Mr.

Galitzer continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Galitzer's 2024 Options at the time of the consummation of such Change in Control shall become fully vested and exercisable.

The expiration date of Galitzer's 2024 Options shall be April 19, 2034, or such earlier date in accordance with the 2018 Plan or the Company's option agreement.

Galitzer's 2024 RSUs shall vest over a one (1) year period, with 100% of Galitzer's 2024 RSUs vesting in four substantially equal portions over the 12 month period following April 19, 2024, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Galitzer's 2024 RSUs that vest in the installment shall be such that Dr.

Galitzer will be fully vested in the total number of Galitzer's 2024 RSUs listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Galitzer's 2024 RSUs shall become fully vested on April 19, 2025);

provided further, however, that in the event of the Change in Control in which Dr.

Galitzer continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Galitzer's 2024 RSUs at the time of the consummation of such Change in Control shall become fully vested.

Dana Yaacov-Garbeli

In June 2019, we entered into a consulting agreement with A2Z Finance Ltd.

(“A2Z”), in connection with the appointment of Ms.

Yaacov-Garbeli as our Chief Financial Officer, which was further amended in June 2020, October 2021 and April 2023 (as amended, the “consulting agreement”).

Under the terms of the consulting agreement, both parties may terminate the agreement for any reason upon 30 days’ notice.

In addition, the Company has the ability to terminate the agreement immediately upon the occurrence of certain limited circumstances, such as breach of contract.

In 2022 and 2023, pursuant to the terms of the consulting agreement, Ms.

Yaacov-Garbeli was entitled to an annual payment of $193,200.

Yaacov-Garbeli's annual payment was raised to $225,000 for fiscal year 2024.

In addition, Ms.

Yaacov-Garbeli is reimbursed for reasonable out of pocket expenses which were pre-approved in writing in connection with her duties as Chief Financial Officer.

Pursuant to the terms the consulting agreement, Ms.

Yaacov-Garbeli also agreed to customary non-disclosure and non-competition covenants.

On April 14, 2024, and April 19, 2024, the Compensation Committee and the Board, respectively, voted to approve a one-time grant to Ms.

Yaacov-Garbeli of (i) options to purchase 130,000 Ordinary Shares (the “Dana's 2024 Options”), at an exercise price of $1.99 per Ordinary Share, under the 2018 Plan, and (ii) a one-time grant of 30,151 RSUs in place of the annual cash bonus for 2023 (the “Dana's 2024 RSUs”) under the 2018 Plan.

Dana's 2024 Options shall vest over a three (3) year period, with a third of the Dana's 2024 Options vesting at the end of a 12-month period following April 19, 2024, and the remaining two-thirds of Dana's 2024 Options shall vest in eight substantially equal portions over the next two (2) year period thereafter, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Dana's 2024 Options that vest in the installment shall be such that Ms.

Yaacov-Garbeli will be fully vested in the total number of Dana's 2024 Options listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Dana's 2024 Options shall become fully vested on April 19, 2027);

provided further, however, that in the event of a Change in Control (as defined in the 2018 Plan) in which Ms.

Yaacov-Garbeli continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Dana's 2024 Options at the time of the consummation of such Change in Control shall become fully vested and exercisable.

The expiration date of Dana's 2024 Options shall be April 19, 2034, or such earlier date in accordance with the 2018 Plan or the Company's option agreement.

Dana's 2024 RSUs shall vest over a one (1) year period, with 100% of Dana's 2024 RSUs vesting in four substantially equal portions over the 12 month period following April 19, 2024, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Dana's 2024 RSUs that vest in the installment shall be such that Ms.

Yaacov-Garbeli will be fully vested in the total number of Dana's 2024 RSUs listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Dana's 2024 RSUs shall become fully vested on April 19, 2025);

provided further, however, that in the event of the Change in Control in which Ms.

Yaacov-Garbeli continues to provide services to the Company on the date of consummation of such Change in Control, 100% of any unvested Dana's 2024 RSUs at the time of the consummation of such Change in Control shall become fully vested.

Gregory Burshtein

Burshtein currently serves as the Company's Chief of Research and Development.

Pursuant to the terms of his employment, and within the discretion granted to the Board, Dr.

Burshtein was entitled to an annual gross base salary of $157,000 for 2024, increasing to $200,000 effective as of April 1, 2025.

Additionally, pursuant to the terms of his employment agreement, Mr.

Burshtein is eligible to participate in the Company's standard full-time employment benefits that are offered by the Company from time to time, which currently include pension fund benefits.

Burshtein is also generally entitled to reimbursement for travel and other business expenses and other benefits, including, vacation, holidays, travel expenses and sick leave.

Subject to applicable law, Mr.

Burshtein is also covered by our D&O insurance policy.

Pursuant to the terms of his employment agreement, Mr.

Burshtein also agreed to customary non-disclosure and non-competition covenants.

On April 28, 2025, the Board voted to approve revised compensation terms and a one-time grant of compensation for Dr.

Burshtein, including (i) options to purchase 200,000 Ordinary Shares (the "Gregory's 2025 Options"), at an exercise price of $2.28 per Ordinary Share, under the 2018 Plan, and (ii) a one-time grant of 26,316 RSUs in lieu of a cash bonus for 2024 (the "Gregory's 2025 RSUs") under the 2018 Plan.

Gregory's 2025 Options shall vest over a three (3) year period, with a third of the Gregory's 2025 Options vesting at the end of a 12-month period following April 28, 2025, and the remaining two-thirds of Gregory's 2025 Options shall vest in eight substantially equal portions over the next two (2) year period thereafter, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Gregory's 2025 Options that vest in the installment shall be such that Dr.

Burshtein will be fully vested in the total number of Gregory's 2025 Options listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Gregory's 2025 Options shall become fully vested on April 28, 2028).

Gregory's 2025 RSUs shall vest over a one (1) year period, with 100% of Gregory's 2025 RSUs vesting in four substantially equal portions over the 12 month period following April 28, 2025, on a quarterly basis, rounded down to the nearest whole share, provided, that with respect to the last such quarterly installment, the number of Gregory's 2025 RSUs that vest in the installment shall be such that Dr.

Burshtein will be fully vested in the total number of Gregory's 2025 RSUs listed above as of such applicable quarterly anniversary (i.e., such that one hundred percent (100%) of Gregory's 2025 RSUs shall become fully vested on April 28, 2026) .

Employee Equity Incentive Plans

12 unchanged sentences

In our shareholders meeting held July 31, 2024, our shareholders approved an amendment to the 2018 Plan to increase the number of Ordinary Shares issuable under the 2018 Plan by a one-time additional amount of 1,788,515 Ordinary Shares.

As of December 31, 2024, a total of 2,068,226 Ordinary Shares representing 5.3% of the total outstanding shares as of that date remained available for issuance under the 2018 Plan.

On January 1, 2025, pursuant to the annual evergreen provision and following the approval of our Board, an additional 1,941,859 Ordinary Shares, equal to 5% of the total outstanding shares as of January 1, 2025, became available for issuance under the 2018 Plan.

As of December 31, 2025, a total of 2,052,375 Ordinary Shares representing 4.4% of the total outstanding shares remained available for issuance under the 2018 Plan.

On January 1, 2026, pursuant to the annual evergreen provision and following the approval of our Board, an additional 2,308,931 Ordinary Shares, equal to 5% of the total outstanding shares as of January 1, 2026, became available for issuance under the 2018 Plan.

Equity incentive awards may be granted to our employees, non-employee directors, consultants or other advisors, as well as holders of equity compensation awards granted by a company that may be acquired by us in the future.

27 unchanged sentences

Except where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the Ordinary Shares listed below have sole investment and voting power with respect to such shares.

Unless otherwise noted below, each shareholder’s address is c/o Entera Bio Ltd., Kiryat Hadassah, Minrav Building - Fifth Floor, Jerusalem, Israel.

Unless otherwise noted below, each person’s address is c/o Entera Bio Ltd., Kiryat Hadassah, Minrav Building - Fifth Floor, Jerusalem, Israel.

Number and Percentage of

2 unchanged sentences

Gakasa Holdings LLC (1)

D.N.A Biomedical Solutions Ltd.

Israel Canada Hotels Ltd.

OPKO Health Inc.

Point72 Asset Management, L.P (4)

Centillion Fund (4)

1 unchanged sentence

Miranda Toledano (5)

Gerald Lieberman (7)

Hillel Galitzer (6)

Sean Ellis (7)

Yonatan Malca (10)

Dana Yaacov-Garbeli (8)

Yonatan Malca (9)

Gregory Burshtein (10)

4 unchanged sentences

This consists of:

(i) 5,534,275 Ordinary Shares, (ii) 347,604 Ordinary Shares underlying Pre-Funded Warrants (iii) 1,197,604 Ordinary Shares underlying warrant to acquire Ordinary Shares.

5,534,275 Ordinary Shares, The holder also owns (i) 347,604 Pre-Funded Warrants and (ii) purchase warrants to acquire 1,197,604 Ordinary Shares.

Such warrants include a 9.99% ownership blocker and, as a result, are not included in the ownership amount.

Gasaka Holdings LLC’s address is at 201 S.

Biscayne Blvd suite 800, Miami, FL 33131.

D.N.A Biomedical Solutions Ltd.’s holdings consisted of 3,762,960 Ordinary Shares.

Israel Canada Hotels Ltd.

D.N.A Biomedical Solutions Ltd.) holdings consists of 3,732,540 Ordinary Shares.

D.N.A’s address is at Shimon Hatarsi 43 St., Tel Aviv, Israel.

Pursuant to the Schedule 13G filed with the SEC on January 6, 2025 regarding Point72 Asset Management, L.P.’s holdings.

Beneficial ownership includes 2,701,560 Ordinary Shares.

Point72 Asset Management, L.P's address is at 72 Cumming point road, Stamford, CT 06902.

OPKO Health Inc.

holdings consisted of 3,865,226 Ordinary Shares.

Pursuant to Schedule 13G filed with the SEC on April 2, 2025 regarding OPKO Health, Inc.

holdings which consists of 3,685,226 Ordinary Shares.

OPKO Health, Inc.’s address is at 4400 Biscayne Blvd., Miami, FL 33137.

Pursuant to the Schedule 13G/A filed by Centillion Fund Inc.

8 unchanged sentences

Centillion Fund Inc’s address is 10 Manoel Street, Castries, Saint Lucia LC04 101.

Consists of (i) 110,752 Ordinary Shares and (ii) 23,952 Ordinary Shares underlying warrants to acquire Ordinary Shares (iii) 124,121Ordinary Shares underlying RSUs to acquire Ordinary Shares (iv) 1,306,214 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 301,008 Ordinary Shares and (ii) 23,952 Ordinary Shares underlying warrants to acquire Ordinary Shares (iii) 381,548 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 34,106 Ordinary Shares and (ii) 30,151 Ordinary Shares underlying RSUs to acquire Ordinary Shares (iii) 493,333 Ordinary Shares underlying options to acquire Ordinary Shares (9)Consists of (i) 134,727 Ordinary Shares and (ii) 381,548 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 47,259 Ordinary Shares and (ii) 381,548 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 381,399 Ordinary Shares, (ii) 23.952 Ordinary Shares underlying warrants to acquire Ordinary Shares, (iii) 45,176 Ordinary Shares underlying RSUs to acquire Ordinary Shares, and (iv) 2,002,047 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 83,994 Ordinary Shares, (ii) 6,579 Ordinary Shares underlying RSUs to acquire Ordinary Shares and (iii) 637,500 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 188,098 Ordinary Shares, (ii) 411,306 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 106,468 Ordinary Shares, (ii) 6,579 Ordinary Shares underlying RSUs to acquire Ordinary Shares and (iii) 462,500 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 77,416 Ordinary Shares and (ii) 411,306 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 79,191 Ordinary Shares and (ii) 7,538 Ordinary Shares underlying RSUs to acquire Ordinary Shares (iii) 319,583 Ordinary Shares underlying options to acquire Ordinary Shares..

Consists of 231,276 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 94,863 Ordinary Shares, (ii) 6,579 Ordinary Shares underlying RSUs to acquire Ordinary Shares and (iii) 350,317 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 98,479 Ordinary Shares, (ii) 176,053 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of (i) 818,629 Ordinary Shares (ii) 47,904 Ordinary Shares underlying warrant to acquire Ordinary Shares and (iii) 186,936 RSUs to acquire Ordinary Shares (iv) 3,986.554 Ordinary Shares underlying options to acquire Ordinary Shares.

Consists of 40,000 Ordinary Shares.

Consists of 15,000 Ordinary Shares.

Consists of (i) 1,085,717 Ordinary Shares, (ii) 23,952 Ordinary Shares underlying warrant to acquire Ordinary Shares, (iii) 64,913 RSUs to acquire Ordinary Shares and (iv) 4,451,029 Ordinary Shares underlying options to acquire Ordinary Shares.

Securities Authorized for Issuance under Equity Compensation Plans

31 unchanged sentences

The Board has affirmatively determined that the following Directors are “independent” as of the date of this Annual Report as defined in the listing standards of Nasdaq:

Gerald Lieberman, Gerald M.

Ostrov, Sean Ellis, Yonatan Malca and Haya Taitel.

Germano, Steven D.

Rubin, Sean Ellis, Yonatan Malca and Haya Taitel.

In making these determinations, our Board considered the current and prior relationships that each non-employee director has with our Company and all other facts and circumstances our Board deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director, and the transactions involving them described in this Item 13.

10 unchanged sentences

EXHIBITS, FINANCIAL STATEMENT SCHEDULES.

Documents filed as part of this report:

(a) Documents filed as part of this report:

(1) Financial statements

1 unchanged sentence

(2) Financial Statement Schedules

(3) Exhibits:

Amended and Restated Articles of Association of Entera Bio Ltd.

11 unchanged sentences

and SVB Securities LLC (incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on September 2, 2022)

Amendment No.

1 to Sales Agreement, dated June 5, 2025, between Entera Bio Ltd.

and Leerink Partners LLC (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed with the SEC on August 8, 2025)

Securities Purchase Agreement, dated as of December 20, 2023, by and among Entera Bio Ltd.

11 unchanged sentences

001-38556) filed with the SEC on March 28, 2019)

Form of Restricted Stock Award Agreement under the 2018 Equity Incentive Plan

Amended and Restated Employment Agreement, dated July 15, 2022, by and between Entera Bio Ltd.

7 unchanged sentences

(incorporated by reference to Exhibit 10.12 to the Form 10-K filed with the SEC on December March 8, 2024)

Employment Agreement, dated as of July 16, 2025 , between Entera Bio Ltd.

and Gregory Burshtein

Amended and Restated Collaboration and License Agreement, dated February 3, 2026, by and among Entera Bio Ltd., OPKO Health, Inc.

and OPKO Biologics Ltd.

(incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on February 4, 2026)

Entera Bio Ltd.

12 unchanged sentences

Executive Officer Clawback Policy, effective as of November 30, 2023 (incorporated by reference to Exhibit 97 to the Form 10-K filed with the SEC on March 8, 2024)

Inline XBRL Instance Document

Inline XBRL Taxonomy Extension Schema Document

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Inline XBRL Taxonomy Extension Definition Linkbase Document

Inline XBRL Taxonomy Extension Label Linkbase Document

Inline XBRL Taxonomy Extension Presentation Linkbase Document

Inline XBRL for the cover page of this Annual Report, included in the Exhibit 101 Inline XBRL Document Set.

____________________

† Management contract or compensatory plan or arrangement.

+ Pursuant to Item 601(a)(5) of Regulation S-K, schedules and similar attachments to this exhibit have been omitted because they do not contain information material to an investment or voting decision and such information is not otherwise disclosed in such exhibit.

The Company will supplementally provide a copy of any omitted schedule or similar attachment to the U.S.

Securities and Exchange Commission or its staff upon request.

* Filed herewith.

20 unchanged sentences

(Principal Financial and Accounting Officer)

/s/ Gerald Lieberman

March 27, 2026

Gerald Lieberman

/s/ Yonatan Malca

3 unchanged sentences

March 27, 2026

/s/ Gerald M.

/s/ Steven D.

March 27, 2026

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures