Entera Bio Ltd.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1 - DESCRIPTION OF BUSINESS

Entera is focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. The Company leverages its N-Tab™ platform, which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream. The Company concentrates on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.

Entera’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. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets in 161 post-menopausal women with low BMD and osteoporosis met primary and secondary endpoints. On July 28, 2025, the Company announced that in a written response to a Type A meeting request, the FDA agreed that the NDA filing for EB613 (oral PTH (1-34), teriparatide) would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24-month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint.

The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism.

In addition, Entera is developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes pursuant to a 2025 collaboration and license agreement (the “2025 Collaboration Agreement”) with OPKO Health, Inc. (“OPKO”); and the first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome, pursuant to a 2023 research collaboration agreement with OPKO.

NOTE 1 - DESCRIPTION OF BUSINESS (Cont.)

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

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES

These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of September 30, 2025, the consolidated results of operations and statements of changes in shareholders' equity for the three and nine-month periods ended September 30, 2025 and 2024, and cash flows for the nine-month periods ended September 30, 2025 and 2024.

The consolidated results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025.

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (Cont.)

These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company as of and for the year ended December 31, 2024, as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 28, 2025.

Basic loss per share is computed on the basis of net loss for the period divided by the weighted average number of outstanding ordinary shares and pre-funded warrants during the period. Each outstanding pre-funded warrant has no expiration and is exercisable at a price of NIS 0.0000769 per ordinary share.

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 restricted share units (“RSUs”), which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include options, warrants and RSUs exercisable into 17,016,053 and 17,136,035 ordinary shares for the nine months ended September 30, 2025 and 2024, respectively, and 17,806,128 and 17,276,113 ordinary shares for the three months ended September 30, 2025 and 2024, respectively, because the effect would have been anti-dilutive.

Recently issued accounting pronouncements not yet adopted

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. 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. Based on the Company’s evaluation of this guidance, no material impact is expected on its consolidated financial statement disclosures.

In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated financial statements disclosures.

NOTE 3 - EQUITY AND SHARE-BASED COMPENSATION

Changes in Share Capital:

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.

During the nine months ended September 30, 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.

NOTE 3 - EQUITY AND SHARE-BASED COMPENSATION (Cont.)

Share-based Compensation:

These options vest over three years from the date of grant;33.33% vest on the first anniversary of the date of grant and the remaining 66.67% of the options will vest in eight equal quarterly installments following the first anniversary of the grant date.

In addition, the board of directors approved the grant of 259,650 RSUs to executive officers, of which grant 233,334 RSUs were subject to shareholder approval, which was obtained at a meeting of the Company’s shareholders held on July 16, 2025. The RSUs vest in four equal quarterly installments over a one-year period that started on April 28, 2025. The fair value of the RSUs at the grant date was $536 with a share price ranging from $2.04 to $2.28 per share.

NOTE 3 - EQUITY AND SHARE-BASED COMPENSATION (Cont.)

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

NOTE 4 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Balance sheets:

NOTE 5 - COLLABORATION AND RESEARCH AGREEMENTS

For the three and nine months ended September 30, 2025, the Company recognized $0 and $42 in revenues, respectively, from this agreement.

NOTE 5 - COLLABORATION AND RESEARCH AGREEMENTS (Cont.)

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 condensed consolidated balance sheet, and will be 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.

NOTE 5 - COLLABORATION AND RESEARCH AGREEMENTS (Cont.)

The Company determined that the 2025 Collaboration Agreement is a collaboration agreement 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 2025 Collaboration Agreement date. 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 nine months ended September 30, 2025, the Company recognized net expenses of $190 relating to the 2025 Collaboration Agreement.

NOTE 6 - SEGMENT INFORMATION

• 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.

NOTE 7 - SUBSEQUENT EVENTS

In October and November 2025,192,736 warrants were exercised for an aggregate of 192,736 ordinary shares for total consideration of $155,249.

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