What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2026-03-27 compared with 2025-03-28 · 236 added, 222 removed, 434 unchanged (51% of the section changed)

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The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty .

This matter is also described in the “Critical Audit Matters” section of our report.

Basis for Opinion

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Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.

We determined there are no critical audit matters.

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

The Company’s ability to continue as a going concern

As described above and in Note 1c to the consolidated financial statements, the Company has an accumulated deficit and cash outflows from operating activities.

The Company's ability to continue its operations relies on securing the necessary funding to support its future research and clinical development activities.

These conditions and events raise substantial doubt about the Company's ability to continue as a going concern.

The principal considerations for our determination that performing procedures related to the Company’s ability to continue as a going concern is a critical audit matter are the estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions in estimating these cash flows to conclude the Company would not have sufficient liquidity to fund its operations for at least one year from the date of issuance of the consolidated financial statements.

This in turn led to a high degree of auditor subjectivity and judgment to evaluate the audit evidence supporting the liquidity conclusions.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with our overall opinion on the consolidated financial statements.

Our audit procedures to evaluate the significant judgments and assumptions made by management included, among others, inquiries with management, testing the reasonableness of the forecasted inflows and operating expenses and the underlying management assumptions.

We assessed the adequacy of the Company’s going concern disclosures included in Note 1c to the consolidated financial statements.

/s/ Kesselman & Kesselman

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Accounts receivable

Restricted cash

Other current assets

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Operating lease right-of-use assets

Deferred income taxes

Restricted deposit

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TOTAL NON-CURRENT ASSETS

L i a b i l i t i e s and shareholder' equity

Liabilities and shareholders' equity

CURRENT LIABILITIES:

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Operating lease liabilities

Other long-term liability

Liability for employee rights upon retirement

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Ordinary Shares, NIS 0.0000769 par value:

Authorized - as of December 31, 2024 and December 31, 2023, 140,010,000

issued and outstanding as of December 31, 2024, and December 31, 2023, 38,837,220 and 35,476,341

shares, respectively

Authorized - as of December 31, 2025 and December 31, 2024, 140,010,000 shares;

issued and outstanding as of December 31, 2025, and December 31, 2024, 46,178,630 and 38,837,220 shares, respectively

Additional paid-in capital

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OPERATING EXPENSES:

Research and development

Research and development, net

General and administrative

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Ordinary shares

shares issued

paid-in capital

Number of shares issued

Additional paid-in capital

Accumulated other Comprehensive income

Accumulated deficit

BALANCE AT JANUARY 1, 2024

Issuance of ordinary shares, warrants and pre-funded

warrants in a private placement, net of issuance costs

Issuance of shares under the ATM program, net of issuance costs

Exercise of warrants to ordinary shares

Exercise of options to ordinary shares

Issuance of ordinary shares under the ATM program, net of issuance costs

Vested restricted share units

Share-based compensation

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Exercise of options to ordinary shares

Issuance of shares under the ATM program, net of issuance costs

Issuance of ordinary shares under the ATM program, net of issuance costs

Issuance of ordinary shares under collaboration agreement, net

Vested restricted share units

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Finance income, net

Changes in operating asset and liabilities:

Changes in operating assets and liabilities:

Decrease (increase) in accounts receivable

Decrease in other current assets

Increase in other current assets

Increase in accounts payable

Decrease in accrued expenses and other payables

Increase in accrued expenses and other payables and other long-term liability

Net cash used in operating activities

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CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of shares through ATM programs,

Issuance of ordinary shares and warrants through to a private placement

Proceeds from ordinary issuance of shares through ATM programs

Issuance of ordinary shares, under collaboration agreement

Issuance costs

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Net cash provided by financing activities

DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS

EFFECT OF EXCHANGE RATE CHANGE ON CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS

CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE YEAR

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Cash and cash equivalents

Restricted deposits

Total cash and cash equivalents and restricted deposits

Restricted cash

Restricted deposit

Total cash and cash equivalents, restricted cash and restricted deposit

SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS:

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SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:

Issuance costs

Operating lease right of use assets obtained in exchange for new operating lease liabilities

Operating lease right of use assets obtained in exchange for operating lease liabilities

The accompanying notes are an integral part of the consolidated financial statements.

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The Company focuses on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.

The Company’s most advanced product candidate, EB613, oral PTH (1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis with no prior fracture.

The Company is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint.

The Company’s most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis without prior fracture.

The Company is also developing a next-generation formulation of EB613 utilizing its proprietary N-Tab ® platform, which is expected to provide significant advantages in administration, commercialization, and strategic partnering.

The Company is preparing to submit final protocol to the FDA and initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint.

The Company’s product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism.

Additionally, the Company intends to license its N-Tab™ technology to biopharmaceutical companies for use with their proprietary compounds.

In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 5) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc.

(“OPKO”), to advance the first oral long-acting PTH analog (“LA-PTH”) as a once-daily tablet for patients with hypoparathyroidism.

In addition, EB618 is being developed pursuant to the Company’s collaboration with OPKO, pursuant to which the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment and as a weekly subcutaneous injection for patients with obesity, metabolic and fibrotic disorders.

The oral program combines OPKO’s proprietary long-acting oxyntomodulin (“OXM”) analog (OPK-88006) and the Company’s proprietary N-Tab ® platform.

In addition to its internal product development programs, the Company intends to license its proprietary N-Tab ® platform to biopharmaceutical companies for use with their proprietary compounds.

The Company's ordinary shares, NIS 0.0000769 par value per share (“ordinary shares”), are listed on the Nasdaq Capital Market under the symbol “ENTX”.

Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred an accumulated deficit in the amount of $ 113.9 million as of December 31, 2024 and negative cash flows from operating activities.

The Company's management is of the opinion that its available funds as of December 31, 2024 will be sufficient to support the Company’s operations under its current plans into the third quarter of 2026, excluding the initiation of Phase 3 of EB613 in Osteoporosis.

This assumes the use of the Company’s capital to fund its ongoing operations, including regulatory expenses and optimization related to the preparation of the EB613 phase 3 study in osteoporosis, research and development, the completion of an additional Phase 1 PK study related to the Company’s new generation platform and the GLP-2/OXM collaborative research the Company is conducting with OPKO Biologics, Inc., a subsidiary of OPKO Health Inc ("OPKO").

The Company’s current capital resources do not include the capital required to fund the Company's proposed Phase 3 study for EB613 in osteoporosis.

These factors raise substantial doubt as to the Company's ability to continue as a going concern.

Management continually evaluates various financing alternatives in the public and private equity markets, debt financing and strategic collaborations, as the Company will need to finance future research and development activities, general and administrative expenses and working capital through capital raising.

However, there is no certainty that the Company will be able to obtain such funding.

These consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.

Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred negative cash flows from operating activities.

The Company has incurred an accumulated deficit in the amount of $ 125.4 million as of December 31, 2025.

The Company's management is of the opinion that its available funds as of December 31, 2025 will be sufficient to support the Company’s ongoing operations under its current plans through the middle of the third quarter of 2026.

ENTERA BIO LTD.

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NOTE 1 - DESCRIPTION OF BUSINESS (continued)

The Company’s current capital resources do not include the capital required to fund the Company's proposed Phase 3 program for EB613 in osteoporosis.

These factors raise substantial doubt as to the Company's ability to continue as a going concern.

Management continually evaluates various financing alternatives and strategic collaborations, as the Company will need to finance future research and clinical development with additional capital.

However, there is no certainty that the Company will be able to obtain such funding.

These consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.

In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war.

Since the commencement of these events, there have been additional active hostilities, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran.

In January 2025, a ceasefire with Hamas was declared.

As of the date of these consolidated financial statements, the war is ongoing and continues to evolve.

The Company's headquarters and its R&D operations are located in Israel.

Currently, such activities in Israel remain largely unaffected.

During the years ended December 31, 2024 and December 31, 2023, the impact of this war on the Company’s results of operations and financial condition was immaterial.

Since the commencement of these events, there have been additional active hostilities, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and Iran.

In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders.

On June 21, 2025, U.S.

President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran.

On October 9, 2025, a ceasefire had been reached.

Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas.

On February 28, 2026, the United States and Israel conducted preemptive strikes targeting Iranian military infrastructure.

Iran retaliated with extensive ballistic missile and drone attacks against Israel.

On March 2, 2026, Hezbollah resumed hostilities by launching projectiles into northern Israel, ending the November 2024 ceasefire.

Israel responded with airstrikes on Lebanon and ground operations in Southern Lebanon, marking a significant escalation in the regional conflict.

How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region become is unknown at this time and any continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict.

The Company’s research personnel and certain management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel.

Currently, the Company’s activities in Israel remain largely unaffected by the foregoing events.

During the years ended December 31, 2025 and December 31, 2024, the impact of such events on the Company’s results of operations and financial condition was immaterial.

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES

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The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Use of estimates in the preparation of financial statements

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Currency transaction gains and losses are presented in financial income, net, as appropriate.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Principles of consolidation

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Bank deposits with original maturity dates of more than three months but less than one year are included in short-term deposits.

Such short-term deposits bore interest at an average annual rate of approximately 5% for the year ended December 31, 2024.

Such short-term deposits bore interest at an average annual rate of approximately 1-4% for the years ended December 31, 2025 and 2024.

Bank deposits with maturity of more than one year are considered long-term.

Restricted cash

Restricted cash deposited in an interest-bearing saving account which is used as a security for the Company's office rent and credit card.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Restricted cash and deposits

Restricted deposits are placed in an interest-bearing savings account and serve as security for the Company's office rent and credit card obligations.

Restricted cash is designated specifically to fund the development costs under the 2025 Collaboration Agreement.

Concentrations of credit risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents.

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and restricted cash.

The Company maintains cash held in checking accounts and deposits at financial institutions in major Israeli and U.S.

Management believes the Company is not exposed to significant credit risk with respect to its cash and cash equivalent deposits at its current financial institutions, but will continue to monitor regularly and adjust, if needed, to mitigate risk.

Management believes the Company is not exposed to significant credit risk with respect to its cash and cash equivalent deposits and restricted cash at its current financial institutions, but will continue to monitor regularly and adjust, if needed, to mitigate risk.

The Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity.

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The Company expects to contribute to insurance companies approximately $ 181 for the year ending December 31, 2026 in connection with its expected severance liabilities for that year.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

The Company determines if an arrangement is a lease at inception.

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Lease expense for lease payments is recognized on a straight-line basis over the lease term.

Sublease income is recognized on a straight-line basis over the expected lease term and is included in other income in our consolidated statements of operations.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Property and equipment

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Leasehold improvements are amortized by the straight-line method over the shorter of (i) the expected lease term and (ii) the estimated useful life of the improvements.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Share-based compensation

The Company grants share options and restricted share units (“RSUs”) (together “Share-Based Compensation”) to its employees, directors and non-employees in consideration for services rendered.

The Company accounts for Share-Based Compensation awards classified as equity awards, including share-based option awards and RSUs, using grant-date fair value.

The Company recognizes the value of the award as an expense over the requisite service period.

The Company classifies Share-Based Compensation as equity awards and accounts for such compensation using grant-date fair value.

The Company recognizes the value of the Share-Based Compensation awards as an expense over the requisite service period.

The Company calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model.

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The Company has elected to account for forfeitures as they occur.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Research and development expenses

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Revenues attributed to the research services agreement are recognized over the duration of the research services agreement.

Collaborative Arrangement

The Company records the elements of a collaboration agreement that represent joint operating activities in accordance with ASC 808, Collaborative Arrangements (“ASC 808”).

Accordingly, the elements of a collaboration agreement that represent activities in which both parties are active participants, and to which both parties are exposed to the significant risks and rewards that are dependent on the commercial success of the collaborative activities, are recorded as a collaborative arrangement.

Generally, the classification of a transaction under a collaborative arrangement is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants.

ENTERA BIO LTD.

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Loss per share

Basic loss per share is computed on the basis of the net loss for the period, divided by the weighted average number of outstanding ordinary shares and pre-funded warrants during the period.

Basic loss per share is computed on the basis of the net loss for the period, divided by the weighted average number of outstanding ordinary shares, vested RSUs and pre-funded warrants during the period.

Diluted loss per share is based upon the weighted average number of ordinary shares and ordinary share equivalents outstanding when dilutive.

Ordinary share equivalents include outstanding stock options, warrants and RSUs, which are included under the treasury stock method when dilutive.

The calculation of diluted loss per share does not include options and warrants exercisable into 16,790,842 ordinary shares and 7,458,542 ordinary shares for the years ended December 31, 2024 and 2023, respectively, because the effect would have been anti-dilutive.

The calculation of diluted loss per share does not include options, warrants and RSUs exercisable into 17,351,501 ordinary shares and 16,790,842 ordinary shares for the years ended December 31, 2025 and 2024, respectively, because the effect would have been anti-dilutive.

Legal and other contingencies

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Legal costs incurred in connection with loss contingencies are expensed as incurred.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

When the Company issues freestanding instruments, it first analyzes the provisions of ASC 480, “Distinguishing Liabilities From Equity” (“ASC 480”) in order to determine whether the instrument should be classified as a liability, with subsequent changes in fair value recognized in the consolidated statements of operations in each period.

If the instrument is not within the scope of ASC 480, the Company further analyzes the provisions of ASC 815-10 in order to determine whether the instrument is considered indexed to the entity’s own stock and qualifies for classification within equity.

To determine whether the freestanding equity instrument qualifies for classification within equity, the Company also considers the equity classification conditions in accordance with ASC 815-40.

All warrants issued by the Company have been classified within stockholders’ equity as “Additional paid-in capital”.

Segment Information

Operating segments are components of an enterprise for which separate financial information is available and is provided regularly by the Company’s chief operating decision maker ("CODM") in deciding how to allocate resources and assessing performance.

The Company’s CODM is its Chief Executive Officer.

The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development of products related to pharmaceuticals.

Accordingly, the consolidated financial statements and accompanying notes contained herein include the measure of profit or loss, categories of expenses and other financial information that is evaluated by the Company’s Chief Executive Officer.

Newly issued and recently adopted accounting pronouncements:

Recently adopted accounting pronouncements

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting:

Improvements to Reportable Segment Disclosures”.

This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable.

The Company adopted this standard in the current period.

The adoption of this ASU did not have a material impact on the Company’s financial statements.

ENTERA BIO LTD.

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NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued)

Recently issued accounting pronouncements, not yet adopted

Newly issued and recently adopted accounting pronouncements:

Recently adopted accounting pronouncements

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740):

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and in foreign jurisdictions.

ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis.

The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

ASU 2023-09 became effective for fiscal years beginning after December 15, 2024 and may be applied either retrospectively or prospectively, at the Company’s discretion.

The Company adopted this standard retrospectively.

Recently issued accounting pronouncements, not yet adopted

In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

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The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

In December 2025, the FASB issued ASU 2025-10 “Government Grants (Topic 832)“ to establish authoritative guidance on the accounting for government grants received by business entities.

This update is effective beginning with the Company’s 2029 fiscal year annual reporting period, with early adoption permitted.

The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements.

NOTE 3 - OPERATING LEASES

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As of December 31, 2025, the Company provided bank guarantees of approximately $ 60 , in the aggregate, to secure the fulfillment of its obligations under the lease agreements.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 3 - OPERATING LEASES (continued)

The Company has entered into operating lease agreements for vehicles used by its employees.

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The annual lease consideration is a total of $ 44 .

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 3 - OPERATING LEASES (continued)

The lease cost was as follows:

Year ended December 31, 2025

Year ended December 31, 2024

Operating lease cost

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Weighted-average discount rate

As of December 31, 2024, the maturity of lease liabilities under our non-cancelable operating leases were $ 272 to be paid in 2025- 2027.

As of December 31, 2025, the maturity of lease liabilities under our non-cancelable operating leases were as follows:

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Commitment to pay royalties to the government of Israel

The Company is committed to pay royalties to the Israel Innovation Authority (the “IIA”) on proceeds from sales of products for which the government provided grants with respect to the research and development underlying such products.

At the time the grants were received, successful development of the related project was not assumed.

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Biomedical Solutions Ltd.

("D.N.A.") and Oramed Ltd., ("Oramed") entered into a joint venture agreement, (the "Joint Venture Agreement") for the establishment of Entera Bio Ltd.

According to the Joint Venture Agreement each of D.N.A.

("D.N.A.") and Oramed Ltd., ("Oramed") entered into a joint venture agreement for the establishment of Entera Bio Ltd.

According to such agreement, each of D.N.A.

and Oramed acquired 50 % of the Company's ordinary shares.

D.N.A invested $ 600 in the Company, and Oramed and the Company entered into a patent license agreement pursuant to which Oramed licensed to the Company one of Oramed’s patents (the “IPR&D”).

On February 22, 2011, Oramed and the Company entered into a patent transfer agreement, that superseded the patent license agreement, whereby Oramed assigned to the Company all of its rights, title and interest to its patent that Oramed licensed to the Company in 2010, under certain conditions.

D.N.A invested $ 600 in the Company, and Oramed and the Company entered into a patent license agreement pursuant to which Oramed licensed to the Company one of Oramed’s patents.

On February 22, 2011, Oramed and the Company entered into a patent transfer agreement, which superseded the patent license agreement, whereby Oramed assigned to the Company all of its rights, title and interest to its patent that Oramed licensed to the Company in 2010, under certain conditions.

Under this agreement, the Company is obligated to pay Oramed royalties equal to 3 % of its net revenues (as defined in the patent transfer agreement).

In September 2023, the Company entered into a research collaboration agreement with OPKO Biologics, Inc., a subsidiary of OPKO.

Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using the Company’s proprietary oral delivery technology.

The Company and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

For the Year ended December 31, 2024, the Company recognized total expenses of $ 71 from this agreement.

Additionally, in March 2025, the Company entered into a license and collaboration agreement with OPKO 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 our N-Tab™ technology platform for the treatment of obesity, metabolic and fibrotic disorders in humans.

For additional information, see note 10(f).

ENTERA BIO LTD.

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dollars in thousands, except share and per share amounts)

NOTE 5 - REVENUE RECOGNITION

In April 2024, the Company entered into a material transfer and research project agreement (the “research services agreement”) with a third party.

Pursuant to the agreement, the third party has agreed to pay the Company a monthly payment for research services, as well as reimbursement for external expenses based on an agreed budget.

The Company concluded that, because the research services provided under the research services agreement have no alternative use (because, in nature, these services are unique to each customer), and the Company has the right to receive payment for performance completed to date, the Company recognizes revenue over the contract term using the input model method, which is labor hours expended and time lapsed.

For the year ended December 31, 2024, the Company recognized total revenues of $ 181 from this agreement.

NOTE 5 - COLLABORATION AND RESEARCH AGREEMENTS

In April 2024, the Company entered into a material transfer and research project agreement with a third party.

According to the agreement, the third party will pay the Company a monthly payment for certain research services, as well as reimbursement for external expenses based on an agreed budget.

During the first quarter of 2025, the Company completed the first stage of the research services under this agreement.

For years ended December 31, 2025 and 2024, the Company recognized revenues of $ 42 and $ 181 , respectively, from this agreement.

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 the Company’s N-Tab ® 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 the Company’s proprietary N-Tab ® platform.

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 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 the Company’s 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 entered into an escrow arrangement, together with OPKO and an escrow agent, into which such proceeds in an amount of $ 8,000 have been deposited.

Such proceeds are presented under restricted cash in the consolidated balance sheet, and 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.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 5 - COLLABORATION AND RESEARCH AGREEMENTS (Cont.)

The Company determined that the agreement is a collaboration arrangement under the scope of ASC 808, as the parties are active participants and exposed to the risks and rewards of the collaborative activity.

The consideration received was allocated to the collaboration component and the equity component.

The Company recognized as equity the fair value of the ordinary shares issued to OPKO net of issuance costs (issuance costs of $ 75 ) based on the fair value of the ordinary shares, which was the Nasdaq closing share price as of the date of the 2025 Collaboration Agreement.

The remaining consideration was allocated to the agreement and presented under current other payables (an amount of $ 295 ) and Other long-term liabilities (an amount of $ 515 ) in the balance sheet and will be recognized as the program is performed.

For the year ended December 31, 2025, the Company recognized net expenses of $ 437 relating to the 2025 Collaboration Agreement.

See Note 11 for a discussion of the A&R Collaboration Agreement.

NOTE 6 - SHARE CAPITAL

1 unchanged sentence

Each ordinary share is entitled to one vote .

The holder of an ordinary shares is also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors.

The holder of an ordinary share is also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors.

A holder of an ordinary share also has the right to receive upon liquidation of the Company, a sum equal to the nominal value of such share, and if a surplus per share remains, to receive such surplus, subject to the rights conferred on any class of shares which may be issued in the future.

1 unchanged sentence

Changes in share capital:

On September 2, 2022, the Company entered into a sales agreement with Leerink Partners LLC (formerly known as SVB Securities LLC), as sales agent, to implement an ATM program under which the Company may from time to time offer and sell up to 5,000,000 Ordinary Shares (the “Leerink ATM Program”).

During the year ended December 31, 2023, the Company issued 4,030 ordinary shares pursuant to the Leerink ATM Program for net proceeds of $ 5 at a weighted average price of $ 1.16 per ordinary share.

On September 2, 2022, the Company entered into a sales agreement with Leerink Partners LLC (formerly known as SVB Securities LLC), as sales agent, to implement an ATM program under which the Company had originally been able from time to time offer and sell up to 5,000,000 ordinary shares (the “Leerink ATM Program”).

On January 10, 2025, the Company filed Supplement No.

1 to the prospectus supplement relating to the Leerink ATM Program, which provides the Company with the ability to sell up to an additional 30,000,000 ordinary shares under the Leerink ATM Program.

In June 2025, following the filing a new Registration Statement on Form S-3 to replace the Company’s prior expiring Registration Statement on Form S-3, the Company filed a new prospectus supplement that provides the Company with the ability, but not the obligation, to continue to sell up to 30,000,000 ordinary shares under the Leerink ATM Program.

During the year ended December 31, 2025, the Company issued an aggregate of 2,731,574 ordinary shares pursuant to the Leerink ATM Program for net proceeds of $ 6,067 at a weighted average price of $ 2.29 per ordinary share.

See additional information in note 10(a).

ENTERA BIO LTD.

2 unchanged sentences

NOTE 6 - SHARE CAPITAL (continued)

On December 20, 2023, the Company entered into a securities purchase agreement in connection with a private offering (the " 2023 PIPE " ) with certain existing and new investors, including the Company's Chairman of the Board and the Chief Executive Officer (collectively, the "Investors") for the private placement of 7,916,879 units at a purchase price of $ 0.835 per unit, each unit consisting of (i) one ordinary share and (ii) one warrant to purchase one ordinary share (each an “ Investor Warrant”).

The Company received aggregate proceeds of approximately $ 6.6 million before expenses.

Certain Investors elected to receive pre-funded warrants (the “Pre-Funded Warrants”) in lieu of ordinary shares, as such warrants may not be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof would exceed 4.99 % or 9.99 %, as applicable, immediately after exercise thereof.

The 2023 PIPE closed on December 22, 2023, and the Company issued 6,662,389 ordinary shares, 1,254,490 Pre-Funded Warrants and 7,916,879 Investors Warrants.

Each Pre-Funded Warrant has an exercise price of NIS 0.0000769 per ordinary share, is immediately exercisable and may be exercised at any time and has no expiration date and is subject to customary adjustments.

Each Investor Warrant has an exercise price of $ 1.00 per share, is immediately exercisable, and expires five years from the date of issuance, and is subject to customary adjustments.

The Company accounted for the Investors Warrant as a component of permanent equity, as part of Additional Paid in Capital.

The Investor Warrants are considered a separate instrument and they are indexed to the entity’s own stock based on the provision of ASC 815.

The Chairman of the Board and the Chief Executive Officer participated in the 2023 PIPE on the same terms and subject to the same conditions as all other Investors.

In connection therewith, the Company entered into a placement agency agreement with a registered U.S.

broker-dealer (the “Broker”), pursuant to which the Broker was entitled to the following consideration:

A cash fee equal to 10 % of the total proceeds paid by subscribers introduced by the Broker.

A cash fee equal to 5 % of the total proceeds paid by other subscribers that participated in the private placement.

Five-year warrants to purchase 487,496 ordinary shares, representing 10% of the ordinary shares issued to subscribers introduced by the Broker, at a per share exercise price of $ 0.71 (the “Broker Warrants”).

In addition, the Company entered into a finder agreement with a private non-U.S.

finder (the “Finder”), pursuant to which the Finder was entitled to a cash fee equal to 5 % of total proceeds paid by subscribers introduced by the Finder, as well as five-year warrants to purchase 179,640 ordinary shares, representing 10% of the ordinary shares issued to the subscribers introduced by the Finder, at a per share exercise price of $ 0.71 (the “Finder Warrants”).

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 6 - SHARE CAPITAL (continued)

The Pre-Funded Warrants and Investors Warrants (collectively, the “Warrants”) were classified as a component of permanent equity and recorded as part of the Additional Paid in Capital based on the provision of ASC 815.

The Warrants are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the Investor to receive a fixed number of shares of common stock upon exercise.

The Company had transaction costs of approximately $ 1,000 , of which $ 267 were stock-based compensation deducted from equity due to issuance of Broker Warrants and Finder Warrants.

During the year ended December 31, 2024, warrants were exercised for an aggregate of 89,820 ordinary shares for a total consideration of $ 90 .

For additional information see note 10(e).

During the year ended December 31, 2024, a former employee and former non-executive board members of the Company exercised options for an aggregate of 733,704 ordinary shares for total consideration of $ 749 .

On August 27, 2024, the Company issued 143,049 ordinary shares to seven non-executive members of the Board in lieu cash board fees for the first two quarters 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 $ 263 using the market price of the ordinary shares at the grant date.

On October 2, 2024, the Company issued 43,104 ordinary shares to five non-executive members of the board of directors in lieu cash board fees for the third 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 $ 80 using the market price of the ordinary shares at the grant date.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

As of December 31, 2025, approximately $ 29.95 million of ordinary shares remained available for sale under the Leerink ATM Program.

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.

In March 2025, in connection with the execution the 2025 Collaboration Agreement with OPKO, 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.

For additional information, see Note 5b.

During year ended December 31, 2025, 546,028 warrants were exercised for an aggregate of 546,028 ordinary shares for a total consideration of $ 508 .

During the year ended December 31, 2025, two employees exercised options for an aggregate of 26,448 ordinary shares for total consideration of $ 20 .

NOTE 7 - SHARE-BASED COMPENSATION

10 unchanged sentences

According to these provisions, the Company will not be allowed to claim as an expense for tax purposes the amounts credited to the employees as a capital gain benefit in respect of the options granted.

2018 Plan Options granted to related parties or non-employees of the Company are governed by Section 3(i) of the Ordinance or Non-Qualified Share Options ("NSO").

The 2018 Plan Options granted to related parties or non-employees of the Company are governed by Section 3(i) of the Ordinance or Non-Qualified Share Options ("NSO").

The Company will be allowed to claim as an expense for tax purposes in the year in which the related parties or non-employees exercised the options into shares.

As of December 31, 2024, 2,068,226 ordinary shares remained available for future grants under the 2018 Plan.

On January 1, 2025, the Company’s Board of Directors approved an increase of 1,941,859 ordinary shares that may be issued under the Company’s 2018 Plan pursuant of the terms of the 2018 Plan.

ENTERA BIO LTD.

2 unchanged sentences

NOTE 7 - SHARE-BASED COMPENSATION (continued)

As of December 31, 2025, 2,052,375 ordinary shares remained available for future grants under the 2018 Plan.

On January 1, 2026, the Company’s Board of Directors approved an increase of 2,308,931 ordinary shares that may be issued under the Company’s 2018 Plan pursuant of the evergreen provision contained in f the 2018 Plan.

Options grants to employees, directors and consultants:

The below table summarizes the options grants to employees and directors during the years ended December 31, 2024 and 2023:

The following tables summarizes information concerning outstanding and exercisable options as of December 31, 2025, in terms of ordinary shares for which the options may be exercised:

Number of options

Exercise price

Vesting period

Fair value at the grant date

Expiration period

For the year ended December 31, 2024

Employees and Executive Officers

Quarterly over a period of one year

For the year ended December 31, 2023

Employees and Executive Officers

Quarterly over a period of one year

Quarterly over a period of three years

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.

Upon the occurrence of a Triggering Event (as defined below) and subject to the approval of the Board of Directors, the Company's CEO will be granted additional options to purchases 200,000 ordinary shares.

The exercise price will be determined at the time of the Board of Directors’ approval.

"Triggering Event" means the earlier of the following events:

(i) the execution by the Company of a binding strategic or partnership agreement with a strategic partner to fund the Company's Phase III FDA Trial;

and (b) raising sufficient funding to complete the Company's Phase III FDA Trial, in each case as such event is approved by the Board of Directors.

As of December 31, 2024, neither of these events had occurred.

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts )

NOTE 7 - SHARE-BASED COMPENSATION (continued)

The fair value of each option granted is estimated at the date of grant using the Black-Scholes option-pricing model, with the following weighted average assumptions:

Weighted average exercise price

Outstanding at beginning of the year

Outstanding at end of the year

Exercisable at end of the year

As of December 31, 2025, the weighted-average remaining contractual life of exercisable options was 6.82 years.

The total intrinsic value of options exercised during 2025 and 2024 was approximately $ 35 thousand and $ 651 thousand, respectively.

As of December 31, 2025, the Company had 2,989,046 unvested options outstanding.

The total unrecognized compensation cost of employee options as of December 31, 2025 is $ 1,735 thousand which is expected to be recognized over a weighted average period of 0.9 years.

The fair value of each option granted is estimated at the date of grant using the Black-Scholes option-pricing model, with the following assumptions:

Exercise price

$ 0.60 -$ 1.99

$ 0.73 -$ 0.89

Dividend yield

2 unchanged sentences

Risk-free interest rate

3.93 %- 4.66 %

3.58 %- 4.37 %

Expected life - in years

The following tables summarizes information concerning outstanding and exercisable options as of December 31, 2024, in terms of ordinary shares for which the options may be exercised:

Weighted average exercise price

Outstanding at beginning of the year

Outstanding at end of the year

Exercisable at end of the year

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 7 - SHARE-BASED COMPENSATION (continued)

The total fair value of options granted during the year ended December 31, 2025 and 2024 was $ 2,943 and $ 2,059 , respectively.

December 31, 2025

1 unchanged sentence

Options exercisable

The aggregate intrinsic value of the total of the outstanding and exercisable options as of December 31, 2024 was $ 3,632 and $ 2,255 , respectively.

The aggregate intrinsic value of the outstanding and exercisable options as of December 31, 2025 was $ 3,121 and $ 3,632 , respectively.

Restricted shares units grants to employees and consultants:

The following tables summarize information concerning RSUs as of December 31, 2025:

Year ended December 31

Outstanding at beginning of year

Changes during the year:

Outstanding at end of year

ENTERA BIO LTD.

2 unchanged sentences

NOTE 7 - SHARE-BASED COMPENSATION (continued)

RSUs grants to employees and consultants:

On February 1, 2024, the Company entered into a consulting agreement with an investor relations consulting firm.

Under the terms of the agreement, the Company agreed to pay a monthly fee of $ 5 and issued to the consultant 25,000 RSUs.

The RSUs vested in five equal monthly installments over a five-month period that began on February 1, 2024.

On August 27, 2024, the Company entered into an amendment to the consulting agreement and granted an additional 25,000 RSUs to the foregoing investor relations consulting firm.

The RSUs vested in four installments as follows:

10,000 on August 31,2024, 5,000 on September 30, 2024, 5,000 on October 31, 2024, and 5,000 on November 30, 2024.

As of December 31, 2024, all 50,000 RSUs granted to this investor relations consulting firm had vested.

The total fair value of the RSUs on the date of grants was $ 65 .

On February 15, 2024, the Company entered into a consulting agreement with an additional investor relations firm.

Under the terms of the agreement, the Company agreed to issue the consultant 50,000 RSUs.

The RSUs vested in five equal monthly installments over a five-month period that started on February 15, 2024.

As of December 31, 2024, all 50,000 RSUs had vested.

The fair value of the RSUs on the date of grant was $ 53 .

On April 19, 2024, the board of directors approved the grant of 209,548 RSUs to executive officers in lieu of an annual cash bonus, of which 124,121 RSUs were granted to the CEO and were subject to shareholder approval, which was obtained at a meeting of the Company’s shareholders held on July 31, 2024.

The RSUs vest in four equal quarterly installments over a one-year period that started on April 19, 2024.

As of December 31, 2024, 104,774 RSUs had vested.

The fair value of the RSUs was $ 370 using the fair value of the RSUs on the date on board of directors' approval.

As of December 31, 2025, the Company had 142,981 unvested RSUs.

The total unrecognized compensation cost of employee RSUs as of December 31, 2025 was $ 57 , which is expected to be recognized over a weighted average period of 0.33 years.

The total vesting-date value of equity classified RSUs that vested during 2025 was $ 676 .

The following table illustrates the effect of share-based compensation on the statements of operations:

Year ended December 31, 2025

Year ended December 31, 2024

Cost of revenues

1 unchanged sentence

General and administrative

NOTE 8 - SEGMENT INFORMATION

The Company operates in Israel as a single operating segment.

The Company’s Chief Executive Officer is the chief operating decision marker (the “CODM”).

The CODM makes decisions on resource allocation, assesses performance of the business and monitors budget versus actual results on a consolidated basis.

Segment information:

Year ended December 31

Research and development, net:

Sub-contractors and consulting expense (EB613)

Net expenses related to 2025 Collaboration Agreement

Payroll and related expenses

Share-based compensation

Rent and related expenses

Other development expenses*

Other segment expenses**

Segment net loss

* Other development expenses include materials and productions and others.

** Other segment expenses include payroll and related expenses, share-based compensation, legal and audit and related fees and others.

Long lived assets are located in Israel.

ENTERA BIO LTD.

9 unchanged sentences

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.

as of December 31, 2025 and 2024 was approximately $ 91.8 million and $ 83.5 million, respectively.

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

The balance of carryforward losses of Entera Bio Inc.

as of December 31, 2025 and 2024 was each approximately $ 0.15 million.

Tax assessments

The Company and its subsidiary have tax assessments that are considered to be final through tax year 2020.

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

Loss before income taxes is composed of the following:

Year ended December 31

Entera Bio Ltd.

Entera Bio Inc.

Entera Bio Ltd.(domestic)

Entera Bio Inc.(foreign)

Total loss before taxes

2 unchanged sentences

Total current income tax

Deferred income taxes - subsidiary

Deferred income taxes – subsidiary (foreign)

Total deferred income taxes

19 unchanged sentences

Balance at December 31, 2025

ENTERA BIO LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

dollars in thousands, except share and per share amounts)

NOTE 9 - INCOME TAX (continued)

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.

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.

Following is a reconciliation of the theoretical provision for income tax, assuming all income is taxed at the statutory corporate tax rate applicable to Israeli corporations, and the actual tax on income:

Year Ended December 31, 2025

Year Ended December 31, 2024

Statutory corporate tax rate

Foreign tax effects

United States

Non-taxable or non-deductible items:

Share-based compensation

Change in valuation allowance

Effective tax rate

ENTERA BIO LTD.

3 unchanged sentences

Balance sheets:

Other current assets:

Prepaid expenses

Receivable in respect of collaborative arrangement (See Note 5b)

Accrued expenses and other payables:

2 unchanged sentences

Accrued expenses

Other payables (See Note 5b)

NOTE 11 - SUBSEQUENT EVENTS

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.

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

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.

On January 1, 2026, an aggregate of 167,525 options to purchase ordinary shares was granted to five non-executive board members with an exercise price of $ 1.94 per share.

The options will vest over one year in four equal quarterly installments starting on January 1, 2026.

This grant was approved by the shareholders of the Company on October 4, 2021.

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.

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

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.

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”).

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.

On January 1, 2026, the Company issued 148,872 ordinary shares to five non-executive members of the board of directors in lieu cash board fees for fiscal year 2025, 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 on the grant date was $ 289 using the market price of the ordinary shares on the grant date.

On February 3, 2026, the Company and OPKO entered into an amended and restated collaboration and license agreement (the “A&R Collaboration Agreement”), which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily LA-PTH tablets for the treatment of hypoparathyroidism and other indications in addition to the original oral dual agonist GLP-1/glucagon peptide program.

Development costs incurred by the parties with respect to the development of the LA-PTH program will be shared equally between the Company and OPKO.

Except for the forgoing, the material terms of the 2025 Collaboration Agreement remain unchanged and in full force and effect.

On February, 2026, two former non-executive board members exercised options for an aggregate of 216,666 ordinary shares for a total consideration of $ 130 .

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

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 8. Financial Statements and Supplementary Data