Entera Bio Ltd. 10-K

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA ENTERA BIO LTD. CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2024 TABLE OF CONTENTS Page REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID 1309 ) 90 CONSOLIDATED FINANCIAL STATEMENTS: Consolidated Balance Sheets 92 Consolidated Statements of Operations 93 Consolidated Statements of Changes in Shareholders' Equity 94 Consolidated Statements of Cash Flows 95 Notes to the Consolidated Financial Statements 96 89 Report of Independent Registered Public Accounting Firm To the Board of Directors and Shareholders of Entera Bio Ltd. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Entera Bio Ltd. and its subsidiary (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, changes in shareholders' equity and cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America. Substantial Doubt About the Company’s Ability to Continue as a Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in note 1c to the consolidated financial statements, the Company has suffered recurring losses from operations and has cash outflows from operating activities that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in note 1c. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty . Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. 90 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. /s/ Kesselman & Kesselman Certified Public Accountants (Isr.) A member firm of PricewaterhouseCoopers International Limited Tel-Aviv, Israel March 28, 2025 We have served as the Company’s auditor since 2010. 91 ENTERA BIO LTD. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share data) December 31 2024 2023 A s s e t s CURRENT ASSETS: Cash and cash equivalents 8,660 11,019 Accounts receivable 126 - Other current assets 186 238 TOTAL CURRENT ASSETS 8,972 11,257 NON-CURRENT ASSETS: Property and equipment, net 57 100 Operating lease right-of-use assets 275 388 Deferred income taxes - 14 Restricted deposit 80 - Funds in respect of employee rights upon retirement 6 6 TOTAL NON-CURRENT ASSETS 418 508 TOTAL ASSETS 9,390 11,765 L i a b i l i t i e s and shareholder' equity CURRENT LIABILITIES: Accounts payable 132 83 Accrued expenses and other payables 874 874 Current maturities of operating lease 170 134 TOTAL CURRENT LIABILITIES 1,176 1,091 NON-CURRENT LIABILITIES : Operating lease liabilities 102 256 Liability for employee rights upon retirement 32 32 TOTAL NON-CURRENT LIABILITIES 134 288 TOTAL LIABILITIES 1,310 1,379 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Ordinary Shares, NIS 0.0000769 par value: Authorized - as of December 31, 2024 and December 31, 2023, 140,010,000 shares; issued and outstanding as of December 31, 2024, and December 31, 2023, 38,837,220 and 35,476,341 shares, respectively 1 1 Additional paid-in capital 121,965 114,730 Accumulated other comprehensive income 41 41 Accumulated deficit ( 113,927 ) ( 104,386 ) TOTAL SHAREHOLDERS' EQUITY 8,080 10,386 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 9,390 11,765 The accompanying notes are an integral part of the consolidated financial statements. 92 ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) Year ended December 31 2024 2023 REVENUES 181 - COST OF REVENUES 172 - GROSS PROFIT 9 - OPERATING EXPENSES: Research and development 4,499 4,510 General and administrative 5,095 4,430 Other income - ( 49 ) TOTAL OPERATING EXPENSES 9,594 8,891 OPERATING LOSS 9,585 8,891 FINANCIAL INCOME, NET ( 58 ) ( 31 ) LOSS BEFORE INCOME TAX 9,527 8,860 INCOME TAX EXPENSES 14 29 NET LOSS 9,541 8,889 LOSS PER SHARE BASIC AND DILUTED 0.25 0.31 WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 37,650,179 29,007,794 The accompanying notes are an integral part of the consolidated financial statements. 93 ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (U.S. dollars in thousands, except share and per share data) Ordinary shares Number of shares issued Amounts Additional paid-in capital Accumulated other Comprehensive income Accumulated deficit Total BALANCE AT JANUARY 1, 2023 28,809,922 * 107,210 41 ( 95,497 ) 11,754 Net loss - - - - ( 8,889 ) ( 8,889 ) Issuance of ordinary shares, warrants and pre-funded warrants in a private placement, net of issuance costs 6,662,389 1 5,826 - - 5,827 Issuance of shares under the ATM program, net of issuance costs 4,030 * 5 - - 5 Share-based compensation - - 1,689 - - 1,689 BALANCE AT DECEMBER 31, 2023 35,476,341 1 114,730 41 ( 104,386 ) 10,386 Net loss - - - - ( 9,541 ) ( 9,541 ) Exercise of warrants to ordinary shares 89,820 * 90 - - 90 Exercise of options to ordinary shares 733,704 * 749 - - 749 Issuance of shares under the ATM program, net of issuance costs 2,236,126 * 3,840 - - 3,840 Vested restricted share units 301,229 * ( * ) - - - Share-based compensation - - 2,556 - - 2,556 BALANCE AT DECEMBER 31, 2024 38,837,220 1 121,965 41 ( 113,927 ) 8,080 * Represents an amount less than one thousand U.S. dollars. The accompanying notes are an integral part of these consolidated financial statements. 94 ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in thousands) Year ended December 31 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss ( 9,541 ) ( 8,889 ) Adjustments required to reconcile net loss to net cash used in operating activities: Depreciation 46 56 Deferred income taxes 14 29 Share-based compensation 2,556 1,689 Finance income, net ( 5 ) - Changes in operating asset and liabilities: Decrease (increase) in accounts receivable ( 126 ) 246 Decrease in other current assets ( 14 ) 56 Increase in accounts payable 49 66 Decrease in accrued expenses and other payables 203 ( 563 ) Net cash used in operating activities ( 6,818 ) ( 7,310 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment ( 3 ) ( 17 ) Net cash used in investing activities ( 3 ) ( 17 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of shares through ATM programs, 3,960 5 Issuance of ordinary shares and warrants through to a private placement - 6,611 Issuance costs ( 323 ) ( 580 ) Exercise of warrants into ordinary shares 90 - Exercise of options into ordinary shares 749 - Net cash provided by financing activities 4,476 6,036 DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS ( 2,345 ) ( 1,291 ) CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE YEAR 11,085 12,376 CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE YEAR 8,740 11,085 Reconciliation in amounts on consolidated balance sheets: Cash and cash equivalents 8,660 11,019 Restricted deposits 80 66 Total cash and cash equivalents and restricted deposits 8,740 11,085 SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS: Interest received 68 18 SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: Issuance costs - 470 Operating lease right of use assets obtained in exchange for new operating lease liabilities 32 449 The accompanying notes are an integral part of the consolidated financial statements. 95 ENTERA BIO LTD . NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts) NOTE 1 - DESCRIPTION OF BUSINESS a) Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 and commenced operation on June 1, 2010. On January 8, 2018, the Company incorporated its wholly owned subsidiary, Entera Bio Inc., in Delaware, United States. The Company is focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. 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 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. b) 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”. c) 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. 96 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 1 - DESCRIPTION OF BUSINESS (continued) d) 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. NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation of the financial statements The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). b. Use of estimates in the preparation of financial statements The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. c. Functional currency 1) Functional and presentation currency Items included in the financial statements of the Company are measured using the currency of the primary economic environment in which the Company operates (the “functional currency”). The U.S. dollar is the currency of the primary economic environment in which the operations of the Company are conducted. The consolidated financial statements are presented in U.S. dollars. The functional currency of the subsidiary is the U.S. dollar. 2) Transactions and balances Transactions and balances originally denominated in U.S. dollars are presented at their original amounts. Balances in non-U.S. dollar currencies are translated into U.S. dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-U.S. dollar transactions and other items in the statements of income (indicated below), the following exchange rates are used: (i) for transactions – exchange rates at transaction dates or average exchange rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization) – historical exchange rates. Currency transaction gains and losses are presented in financial income, net, as appropriate. 97 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) d. Principles of consolidation The consolidated financial statements include the accounts of the Company and its subsidiary Entera Bio Inc. All inter-company transactions and balances have been eliminated in consolidation. e. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. f. Bank deposits 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. Bank deposits with maturity of more than one year are considered long-term. g. 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. h. Concentrations of credit risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains cash held in checking accounts and deposits at financial institutions in major Israeli and U.S. banks. 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. The Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. To date, the Company has not experienced any losses associated with this credit risk and continues to believe that this exposure is not significant. i. Fair value measurement The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. 98 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) j. Employee severance benefits Under the Israeli Severance Pay Law, 1963, the Company is required to make severance payments upon dismissal of an Israeli employee or upon termination of employment in certain other circumstances. The severance payment liability to the employees located in Israel (based upon length of service and the latest monthly salary - one month’s salary for each year employed) is recorded on the Company’s balance sheet under “Liability for employee rights upon retirement.” The liability is recorded as if it had been payable at each balance sheet date on an undiscounted basis. For periods prior to December 2013, the liability was funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the balance sheets under “Funds in respect of employee rights upon retirement”. These policies are the Company’s assets. In accordance with Section 14 of the Israeli Severance Pay Law, 1963, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s retirement benefit obligation. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company’s balance sheet, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plan”). The amounts of severance payment expenses were $ 144 and $ 128 for the years ended December 31, 2024 and 2023, respectively. The Company expects to contribute to insurance companies approximately $ 144 for the year ending December 31, 2025 in connection with its expected severance liabilities for that year. 99 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) k. Leases The Company determines if an arrangement is a lease at inception. Balances related to operating leases are included in operating lease right-of-use (“ROU”) assets and current and non-current operating lease liabilities in the consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized as of the commencement date based on the present value of lease payments over the lease term. Lease terms will include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate the lease. The discount rate for the lease is the rate implicit in the lease unless that rate cannot be readily determined. As the Company’s leases do not provide an implicit rate, the Company’s uses its estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. 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. l. Property and equipment 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The Company’s property and equipment are depreciated using the straight-line method, which approximates the pattern of usage, over the term of the estimated useful life, as follows: Years Computer equipment 3 - 5 Office furniture 10 Laboratory equipment 7 - 10 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. 100 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) m. 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 calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected share price volatility and the expected option term. The computation of expected volatility is based on the historical volatility of the Company’s ordinary shares. The expected option term is calculated using the simplified method, as the Company has concluded that its historical share option exercise experience does not provide a reasonable basis to estimate expected option terms. The interest rate for periods within the expected term of an award is based on the U.S. Treasury yield curve in effect at the time of grant. The Company’s expected dividend rate is zero because the Company does not currently pay cash dividends on its shares and does not anticipate doing so in the foreseeable future. The Company elected to recognize compensation costs for awards granted to employees and directors conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. The Company has elected to account for forfeitures as they occur. n. Research and development expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and development are expensed as incurred. o. Revenue recognition The Company recognizes revenues according to ASC 606, "Revenues from Contracts with Customers”. ASC 606 Revenue from Contracts with Customer introduces a five-step model for recognizing revenue from contracts with customers, as follows: 1. Identify the contract with a customer. 2. Identify the performance obligations in the contract. 3. Determine the transaction price. 4. Allocate the transaction price to the performance obligations in the contract. 5. Recognize revenue when (or as) the entity satisfies a performance obligation. Revenues attributed to the research services agreement are recognized over the duration of the research services agreement. 101 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) p. Income taxes 1) Deferred taxes Deferred income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future. 2) Uncertainty in income taxes The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. q. 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. 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. r. Legal and other contingencies Management applies the guidance in ASC 450-20, “Loss Contingencies” when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability is recorded as accrued expenses in the Company’s consolidated financial statements. Legal costs incurred in connection with loss contingencies are expensed as incurred. 102 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) s. Warrants 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. All warrants issued by the Company have been classified within stockholders’ equity as “Additional paid-in capital”. t. 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. u. 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. 103 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued) Recently issued accounting pronouncements, not yet adopted 1) 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 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. 2) 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 consolidated financial statements disclosures. NOTE 3 - OPERATING LEASES 1) The Company leases office and research and development space under several agreements. The annual lease consideration is a total of $ 172 and is linked to the Israeli consumer price index. In April 2023, the Company extended the period of the lease agreement for an additional five years, expiring on June 30, 2028, with two options for early termination by the Company subject to a notice period. The Company recorded the related asset and obligation at the present value of lease payments over the expected terms, discounted using the lessee’s incremental borrowing rate, which was 13.84 %. The Company lease agreements do not provide a readily determinable implicit rate. Therefore, the Company estimated the incremental borrowing rate to discount the lease payments based on information available at lease commencement. As of December 31, 2024, the Company provided bank guarantees of approximately $ 52 , in the aggregate, to secure the fulfillment of its obligations under the lease agreements. 104 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 3 - OPERATING LEASES (continued) 2) The Company has entered into operating lease agreements for vehicles used by its employees. The lease periods are generally for three years, and the payments are linked to the Israeli consumer price index. To secure the terms of the lease agreement, the Company has made certain deposits to the leasing company, representing approximately three months of lease payments. The annual lease consideration is a total of $ 26 . The lease cost was as follows: Year ended December 31, 2024 Year ended December 31, 2023 Operating lease cost 198 196 Supplemental cash flow information related to leases was as follows: Year ended December 31, 2024 Year ended December 31, 2023 Operating cash flows from operating leases 198 196 Supplemental balance sheet information related to operating leases was as follows: December 31, 2024 December 31, 2023 Operating Leases Operating lease right-of-use assets 275 388 Current lease liabilities 170 134 Non-current lease liabilities 102 256 Total lease liabilities 272 390 Weighted-average remaining lease term (in years) 1.54 2.5 Weighted-average discount rate 14 % 14 % 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, 2024, the maturity of lease liabilities under our non-cancelable operating leases were as follows: 2025 198 2026 101 2027 2 Total future minimum lease payments 301 Less: interest ( 29 ) Present value of operating lease liabilities 272 105 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 4 - COMMITMENTS AND CONTINGENCIES a . 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. In the case of failure of the project that was partly financed by the IIA, the Company is not obligated to pay any such royalties. Under the terms of the Company’s funding from the IIA, royalties are payable on sales of products developed from IIA funded projects in the amount of 3 % of sales during the first three years following commencement of revenues, 4 % during the subsequent three years and 5 % commencing the seventh year up to 100% of the amount of the grant received by the Company (dollar linked) plus annual interest based on SOFR. The amount that must be repaid may be increased to three times the amount of the grant received, and the rate of royalties may be accelerated, if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. In addition, if the Company undergoes a change of control or otherwise transfers the technology “know-how” (as defined under the Research Law) in or outside of Israel, the amount that must be repaid will be increased up to six times. As of December 31, 2024, the total royalty amount that would be payable by the Company to the IIA, before interest and potential increases as described above, was approximately $ 460 . These grants were allocated to research and development in prior periods. Following the signing of a former collaboration agreement in 2018, the IIA determined that the Company was required to pay 5.38 % of each payment received by the Company from the counterparty under such agreement in an amount up to six times the grant received. As of December 31, 2024, the Company had paid a total of $ 96 to the IIA. b. On June 1, 2010, D.N.A. 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. 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. 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). c. 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). 106 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. 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 6 - SHARE CAPITAL 1) Rights of the Company’s ordinary shares 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. 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. Since its inception, the Company has not declared any dividends. 2) Changes in share capital: a. 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. During the year ended December 31, 2024, the Company issued an aggregate of 2,236,126 ordinary shares pursuant to the Leerink ATM Program for net proceeds of $ 3,840 at a weighted average price of $ 1.77 per ordinary share. See additional information in note 10(a). 107 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 6 - SHARE CAPITAL (continued) b. 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: 1. A cash fee equal to 10 % of the total proceeds paid by subscribers introduced by the Broker. 2. A cash fee equal to 5 % of the total proceeds paid by other subscribers that participated in the private placement. 3. 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”). 108 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. 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). c. 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 . d. 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. f. 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. 109 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 7 - SHARE-BASED COMPENSATION 1) Share-based compensation plan On March 17, 2013, the Company's Board of Directors approved a Share Incentive Plan (the “2013 Plan”). Under the 2013 Plan, the Company reserves specified number of ordinary shares for allocation to stock options (each, an “Option”), RSUs, restricted share awards and performance-based awards, that are awarded to employees and non-employees under the 2013 Plan. Each Option is exercisable for one ordinary share. Any Option granted under the 2013 Plan that is not exercised within six years from the date upon which it becomes exercisable will expire. Since adopting the 2018 Plan (as defined below), the Company has not granted any awards under the 2013 Plan. On July 2, 2018, the Company's Board of Directors and shareholders of the Company approved a new Share Incentive Plan (the “2018 Plan”) and reserved 1,371,398 ordinary shares for allocation to stock options (each, a "2018 Plan Option"), RSUs, restricted share awards and performance-based awards, to employees and non-employees for issuance under the 2018 Plan. Each 2018 Plan Option is exercisable for one ordinary share. Any 2018 Plan Option that is not exercised within 10 years from the date of grant will expire. The 2018 Plan Options granted to employees are subject to the terms stipulated by section 102(b)(2) of the Israeli Income Tax Ordinance (the “Ordinance”). 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 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. 110 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 7 - SHARE-BASED COMPENSATION (continued) 2) Options grants to employees, directors and consultants: a) The below table summarizes the options grants to employees and directors during the years ended December 31, 2024 and 2023: Period Grantee 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 1,268,000 $ 1.99 (2) $ 1,640 10 years Directors 758,331 $ 0.6 Quarterly over a period of one year $ 295 10 years Consultants 90,000 $ 1.99 Immediate $ 124 10 years For the year ended December 31, 2023 Employees and Executive Officers 1,201,000 $ 0.80 (1) $ 629 10 years Directors 534,246 $ 0.73 Quarterly over a period of one year $ 253 10 years Directors 33,638 $ 0.89 Quarterly over a period of three years $ 15 10 years Consultant 30,000 $ 0.80 Immediate $ 17 10 years (1) 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. (2) 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. b) 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. 111 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. 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: 2024 2023 Exercise price $ 0.60 -$ 1.99 $ 0.73 -$ 0.89 Dividend yield - - Expected volatility 74.28 %- 84.5 % 74 %- 76 % Risk-free interest rate 3.93 %- 4.66 % 3.58 %- 4.37 % Expected life - in years 5.3 - 5.9 5.3 - 6.11 c) 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: 2024 2023 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding at beginning of the year 7,105,414 $ 2.57 5,733,087 $ 3.30 Granted 2,116,331 1.49 1,798,884 0.78 Exercised ( 733,704 ) 1.02 - - Forfeited ( 149,184 ) 1.14 ( 34,313 ) 2.27 Expired ( 686,203 ) 4.00 ( 392,244 ) 4.97 Outstanding at end of the year 7,652,654 $ 2.32 7,105,414 $ 2.57 Exercisable at end of the year 4,884,830 $ 2.67 4,208,325 $ 3.26 December 31, 2024 Options outstanding Options exercisable Number of Weighted Number of Weighted options Average options Average Exercise outstanding Remaining exercisable Remaining prices per at end of Contractual at end of contractual share (USD) Year Life year Life 0.6 541,665 9.01 541,665 9.01 0.73 356,164 8.01 356,164 8.01 0.79 1,218,000 8.32 475,813 8.32 0.89 33,638 8.43 16,819 8.43 1.40 600,000 7.54 337,500 7.54 1.99 1,358,000 9.3 90,000 9.3 2.02 500,000 7.37 312,500 7.37 2.14 379,900 5.26 379,900 5.26 2.53 33,638 4.89 33,638 4.89 2.57 187,500 7.33 115,437 7.33 2.815 717,045 7.01 672,230 7.01 2.86 135,000 7.25 85,937 7.25 3.15 345,000 6.30 245,625 6.30 3.61 204,000 6.27 178,500 6.27 3.97 232,554 4.05 232,552 4.05 6.31 810,550 2.95 810,550 2.95 7,652,654 4,884,830 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. 112 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 7 - SHARE-BASED COMPENSATION (continued) 3) RSUs grants to employees and consultants: a) 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 . b) 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 . c) 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. The following table illustrates the effect of share-based compensation on the statements of operations: Year ended December 31, 2024 Year ended December 31, 2023 Cost of revenues 7 - Research and development expenses 839 424 General and administrative 1,710 1,265 2,556 1,689 113 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 8 - INCOME TAX a) Corporate tax rate i. Ordinary taxable income in Israel is subject to a corporate tax rate of 23 %. ii. The Company’s subsidiary Entera Bio, Inc. is taxed separately under the U.S. tax laws at a tax rate of 29 % (federal and state tax) b) Losses for tax purposes carried forward to future years The balance of carryforward losses of Entera Bio Ltd. as of December 31, 2024 and 2023 are approximately $ 83.5 million and $ 75.8 million , respectively. Under Israeli tax law, tax loss carry-forwards have no expiration date. c) Tax assessments The Company and its subsidiary have tax assessments that are considered to be final through tax year 2019. d) Loss (income) before income taxes is composed of the following: Year ended December 31 2024 2023 Entera Bio Ltd. 9,479 8,868 Entera Bio Inc. 48 ( 8 ) Total loss before taxes 9,527 8,860 e) Income tax expense: Year ended December 31 Current: 2024 2023 Subsidiary: - - Total current income tax - - Deferred income taxes - subsidiary 14 29 Total deferred income taxes 14 29 Total income tax expense 14 29 114 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 8 - INCOME TAX (continued) f) Deferred income taxes: December 31, 2024 2023 Deferred tax assets: Net operating loss carry forward 19,208 17,427 Research and development 854 983 Share-based compensation 639 855 Other 172 220 Net deferred tax assets before valuation allowance 20,873 19,485 Valuation allowance ( 20,873 ) ( 19,471 ) Net deferred tax assets - 14 In assessing the likelihood of realizing deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences and carry forward losses become deductible. Based on the taxable loss in the Israel and in the United States, management believes it was more likely than not that the deferred tax assets will not be realized. g) Roll-forward of valuation allowance: Balance at January 1, 2023 17,645 Additions 1,826 Balance at January 1, 2024 19,471 Additions 1,402 Balance at December 31, 2024 20,873 h) Reconciliation of theoretical tax expenses to actual expenses: The primary difference between the statutory tax rate of the Company and the effective rate results virtually from the changes in valuation allowance in respect of carry forward tax losses and research and development expenses due to the uncertainty of the realization of such tax benefits. i) Uncertain tax positions As of December 31, 2024 and 2023, the Company did not have a provision for uncertain tax positions as existing uncertain tax positions as, based on the technical merits, given the existing tax positions are not more likely than not to be sustained. 115 ENTERA BIO LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (U.S. dollars in thousands, except share and per share amounts ) NOTE 9 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: December 31, Accrued expenses and other payables: 2024 2023 Employees and employees related 161 159 Provision for vacation 178 215 Accrued expenses 535 500 874 874 NOTE 10 - SUBSEQUENT EVENTS a) On January 3, 2025, the Company issued an aggregate of 2,700,000 ordinary shares pursuant to the Leerink ATM Program for net proceeds of $ 5,997 at a weighted average price of $ 2.29 per ordinary share. b ) On January 10, 2025, the Company filed a supplement to the prospectus supplement relating to the Leerink ATM Program, which provides the Company the ability to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program c) On January 15, 2025, an aggregate of 142,545 options to purchase ordinary shares were granted to five non-executive board members with an exercise price of $ 2.28 per share. The options will vest over one year in four equal quarterly installments starting on January 1, 2025. This grant was approved by the shareholders of the Company on October 4, 2021. d) On January 15, 2025, the Company issued 40,993 ordinary shares to five non-executive members of the board of directors in lieu cash board fees for the fourth quarter of 2024, which was approved by the Company’s shareholders at a meeting of the Company’s shareholders held on July 31, 2024. The fair value of the ordinary shares at the grant date was $ 93 using the market price of the ordinary shares at the grant date. e) In January 2025, 149,700 warrants were exercised for an aggregate of 149,700 ordinary shares for a total consideration of $ 150 . f) On March 16, 2025, the Company entered into a collaboration and license agreement (the “2025 Collaboration Agreement”) with OPKO and its wholly owned subsidiary, OPKO Biologics Ltd., to collaborate with respect to the preclinical and clinical development and decision making related to the oral delivery of a dual agonist GLP-1/glucagon peptide in an oral dosage form using Entera’s N-Tab™ technology platform for the treatment of obesity, metabolic and fibrotic disorders in humans (the “Program”). The Program combines OPKO’s proprietary long-acting oxyntomodulin (OXM, dual targeted GLP-1/Glucagon agonist, OPK-88006) analog and Entera’s proprietary N-Tab™ technology. Under the 2025 Collaboration Agreement, the Company granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of the company's intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/glucagon dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to the Company a non-exclusive, non-sublicensable and non-transferable license to certain of OPKO’s intellectual property and technology to the extent necessary for the Company to perform its obligations in relation to the Program, in each case subject to the exceptions contained therein. Under the terms of the 2025 Collaboration Agreement, the Company and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively. Following the completion of the Phase 1 stage, the Company may continue to fund its 40% share of the Program to maintain its right to proceeds or to opt-out (the “Opt-Out”). If the Company exercises the Opt-Out, then the Company and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program. In connection with the execution of the 2025 Collaboration Agreement, the Company issued and sold to OPKO an aggregate of 3,685,226 ordinary shares for a total purchase price of $ 8.0 million, representing a purchase price per share equal to approximately $ 2.17 , which was the volume weighted average price per share for the 30 trading days immediately preceding the date of the 2025 Collaboration Agreement. OPKO has agreed to a customary lockup with respect to such shares, and may not sell or otherwise transfer them for a period of 12 months following the date of the 2025 Collaboration Agreement, and OPKO has additionally agreed to a customary “standstill” provision, pursuant to which, for a 24-month period following the date of the 2025 Collaboration Agreement, OPKO may not acquire additional equity in the Company or otherwise take certain other actions, in each case without our consent. The Company has agreed to use the proceeds from the sale of the foregoing ordinary shares solely to fund its development cost obligations under the 2025 Collaboration Agreement, and has agreed to enter into an escrow arrangement, together with OPKO and an escrow agent, into which such proceeds will be deposited and subsequently disbursed to fund such development costs. If the 2025 Collaboration Agreement expires or is terminated for any reason, any funds remaining in such escrow will be disbursed to the Company. 116 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.