Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 01, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Entity Public Float | $ 142.1 | ||
Entity Registrant Name | Entera Bio Ltd. | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity Central Index Key | 0001638097 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Amendment Flag | false | ||
Entity Current Reporting Status | Yes | ||
Entity Common Stock, Shares Outstanding | 28,804,411 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Interactive Data Current | Yes | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Incorporation, State or Country Code | L3 | ||
Entity Address, Address Line One | Kiryat Hadassah | ||
Entity Address, Address Line Two | Minrav Building – Fifth Floor | ||
Entity Address, City or Town | Jerusalem | ||
Entity Address, Postal Zip Code | 9112002 | ||
Entity Address, Country | IL | ||
City Area Code | 972 | ||
Local Phone Number | 2-532-7151 | ||
Document Transition Report | false | ||
Entity File Number | 001-38556 | ||
Entity Tax Identification Number | 00-0000000 | ||
Trading Symbol | ENTX | ||
Security Exchange Name | NASDAQ | ||
Title of 12(b) Security | Ordinary shares, | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Document Annual Report | true | ||
Auditor Name | Kesselman & Kesselman | ||
Auditor Location | Tel-Aviv, Israel | ||
Auditor Firm ID | 1309 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 24,892 | $ 8,593 | |
Accounts receivable | 183 | 255 | |
Other current assets | 254 | 261 | |
TOTAL CURRENT ASSETS | 25,329 | 9,109 | |
NON-CURRENT ASSETS: | |||
Property and equipment, net | 156 | 192 | |
Operating lease right-of-use assets | 239 | 374 | |
Deferred income taxes | 217 | 0 | |
Funds in respect of employee rights upon retirement | 46 | 47 | |
TOTAL NON-CURRENT ASSETS | 658 | 613 | |
TOTAL ASSETS | 25,987 | 9,722 | |
CURRENT LIABILITIES: | |||
Accounts payable | 166 | 164 | |
Accrued expenses and other payables | 2,801 | 1,330 | |
Current maturities of operating lease | 179 | 189 | |
Contract liabilities | 15 | 158 | |
TOTAL CURRENT LIABILITIES | 3,161 | 1,841 | |
NON-CURRENT LIABILITIES: | |||
Operating lease liabilities | 123 | 243 | |
Liability for employee rights upon retirement | 138 | 128 | |
TOTAL NON-CURRENT LIABILITIES | 261 | 371 | |
TOTAL LIABILITIES | 3,422 | 2,212 | |
COMMITMENTS AND CONTINGENCIES | |||
SHAREHOLDERS' EQUITY: | |||
Ordinary Shares, NIS 0.0000769 par value: Authorized - as of December 31, 2021 and December 31, 2020, 140,010,000 shares; issued and outstanding: - as of December 31, 2021, and December 31, 2020 28,804,411 and 21,057,922 shares, respectively | [1] | ||
Additional paid-in capital | 104,950 | 77,708 | |
Accumulated other comprehensive income | 41 | 41 | |
Accumulated deficit | (82,426) | (70,239) | |
TOTAL SHAREHOLDERS' EQUITY | 22,565 | 7,510 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 25,987 | $ 9,722 | |
[1] | Represents an amount less than one thousand US dollars |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - ₪ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Ordinary share, par value | ₪ 0.0000769 | ₪ 0.0000769 |
Ordinary shares, authorized | 140,010,000 | 140,010,000 |
Ordinary shares, issued | 28,804,411 | 21,057,922 |
Ordinary shares, outstanding | 28,804,411 | 21,057,922 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
REVENUES | $ 571 | $ 365 |
COST OF REVENUES | 373 | 300 |
GROSS PROFIT | 198 | 65 |
OPERATING EXPENSES: | ||
Research and development | 6,771 | 6,382 |
General and administrative | 5,690 | 4,851 |
Other income | (46) | 0 |
TOTAL OPERATING EXPENSES | 12,415 | 11,233 |
OPERATING LOSS | 12,217 | 11,168 |
FINANCIAL EXPENSES, net | 29 | 28 |
LOSS BEFORE INCOME TAX | 12,246 | 11,196 |
INCOME TAX (BENEFIT) EXPENSE | (59) | 20 |
NET LOSS | $ 12,187 | $ 11,216 |
LOSS PER SHARE BASIC AND DILUTED | $ 0.47 | $ 0.67 |
WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 26,133,770 | 18,417,093 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary shares [Member] | Additional paid-in capital [Member] | Accumulated other Comprehensive income [Member] | Accumulated deficit [Member] | Total | |
Balance at Dec. 31, 2019 | [1] | $ 72,756 | $ 41 | $ (59,023) | $ 13,774 | |
BALANCE (in shares) at Dec. 31, 2019 | 17,864,684 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (11,216) | (11,216) | |
Issuance of ordinary shares and warrants due to a private placement net of issuance costs | $ 0 | 796 | 0 | 0 | 796 | |
Issuance of ordinary shares and warrants due to a private placement net of issuance costs (in shares) | 337,553 | |||||
Issuance of shares due to the ATM program, net of issuance costs | $ 0 | 3,187 | 0 | 0 | 3,187 | |
Issuance of shares due to the ATM program, net of issuance costs (in shares) | 2,802,731 | |||||
Exercise of options to ordinary shares | $ 0 | 68 | 0 | 0 | $ 68 | |
Exercise of options to ordinary shares (in shares) | 31,954 | 31,954 | ||||
Share-based compensation | $ 0 | 901 | 0 | 0 | $ 901 | |
Vested restricted share units | $ 0 | 0 | 0 | 0 | 0 | |
Vested restricted share units (in shares) | 21,000 | |||||
BALANCE (in shares) at Dec. 31, 2020 | 21,057,922 | |||||
Balance at Dec. 31, 2020 | [1] | 77,708 | 41 | (70,239) | 7,510 | |
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | 0 | 0 | 0 | (12,187) | (12,187) | |
Issuance of shares due to the ATM program, net of issuance costs | [1] | 21,805 | 0 | 0 | 21,805 | |
Issuance of shares due to the ATM program, net of issuance costs (in shares) | 4,386,728 | |||||
Exercise of options to ordinary shares | $ 0 | 418 | 0 | 0 | $ 418 | |
Exercise of options to ordinary shares (in shares) | 177,711 | 177,710 | ||||
Exercise of warrants to ordinary shares | $ 0 | 3,158 | 0 | 0 | $ 3,158 | |
Exercise of warrants to ordinary shares (in shares) | 3,175,050 | |||||
Share-based compensation | $ 0 | 1,861 | 0 | 0 | 1,861 | |
Vested restricted share units | $ 0 | 0 | 0 | 0 | 0 | |
Vested restricted share units (in shares) | 7,000 | |||||
BALANCE (in shares) at Dec. 31, 2021 | 28,804,411 | |||||
Balance at Dec. 31, 2021 | [1] | $ 104,950 | $ 41 | $ (82,426) | $ 22,565 | |
[1] | Represents an amount less than one thousand US dollars. |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (12,187) | $ (11,216) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 53 | 63 |
Deferred income taxes | (217) | 0 |
Share-based compensation | 1,861 | 901 |
Finance expenses (income), net | 18 | 46 |
Changes in operating asset and liabilities: | ||
Decrease in accounts receivable | 72 | 23 |
Decrease (increase) in other current assets | 7 | (55) |
Increase (decrease) in accounts payable | 2 | (170) |
Increase (decrease) in accrued expenses and other payables | 1,471 | (40) |
Increase (decrease) in contract liabilities | (143) | (109) |
Net cash used in operating activities | (9,063) | (10,557) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (17) | (53) |
Net cash used in investing activities | (17) | (53) |
Cash flows from financing activities: | ||
Proceeds from issuance of shares and warrants, net of issuance costs | 0 | 796 |
Proceeds from issuance of shares through ATM programs, net of issuance costs | 21,805 | 3,187 |
Exercise of options and warrants into shares | 3,576 | 68 |
Net cash provided by financing activities | 25,381 | 4,051 |
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 16,301 | (6,559) |
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE YEAR | 8,663 | 15,222 |
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE YEAR | 24,964 | 8,663 |
Reconciliation in amounts on consolidated balance sheets: | ||
Cash and cash equivalents | 24,892 | 8,593 |
Restricted deposits included in other current assets | 72 | 70 |
Total cash and cash equivalents and restricted cash | 24,964 | 8,663 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW TRANSACTIONS: | ||
Income taxes paid in cash during the year | 2 | 89 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
Cashless exercise of warrants | ||
Operating lease right of use assets obtained in exchange for new operating lease liabilities | $ 31 | $ 258 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GENERAL | NOTE 1 - GENERAL a. Entera as incorporated on September 30, 2009 and commenced operation on June 1, 2010. On January 8, 2018 the Company incorporated Entera Bio Inc., a wholly owned subsidiary incorporated in Delaware USA. The Company is a leader in the development and commercialization of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism, are based on its proprietary technology platform and are both in Phase 2 clinical development. The Company also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has completed one such agreement with Amgen Inc . b. The Company's securities have been listed for trading on the Nasdaq Capital Market since the Company’s initial public offering in July 2018, where a total of 1,400,000 ordinary shares and 1,400,000 warrants (the “IPO warrants”) to purchase up to 700,000 ordinary shares were issued in consideration of net proceeds of $9.6 million, after deducting offering expenses . The public offering price was $8.00 per unit c. On . The . d. Since . |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation of the financial statements The . 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 entity operates (“the functional currency”). The U.S. dollar is the currency of the primary economic environment in which the operations of the Company is conducted. The consolidated financial statements are presented in U.S. dollars. 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 (expenses), as appropriate . The functional currency of the subsidiary is the U.S. dollar. d. Principles of consolidation The consolidated financial statements include the accounts of the Company and 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. Restricted Restricted cash deposited in an interest-bearing saving account which is used as a security for the Company's office rent, and credit card. g. Fair value measurement The Level Level Level h. Employee severance benefits Under In With The The i. Leases On ROU The . 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 . j. Property and equipment 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The : 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. k. Impairment of long-lived assets The . l. Share-based compensation The . The . The . The . The . m. Research and development expenses Research . Grants . n. Revenue recognition The Company recognized revenue from the Amgen Agreement which was signed in December 2018 according to ASC 606, "Revenues from Contracts with Customers”. Prior to the signing of the Amgen Agreement in 2018, the Company did not have revenue transactions. 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. According to ASC 606, a performance obligation is a promise to provide a distinct good or service or a series of distinct goods or services. Goods and services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created. A good or service promised to a customer is distinct if the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Options granted to the customer that do not provide a material right to the customer that it would not receive without entering into the contract do not give rise to performance obligations. On December 10, 2018, the Company entered into the Amgen Agreement in inflammatory disease and other serious illnesses. As part of the agreement, the Company received non-refundable and non-creditable initial access payment of $725 from Amgen in January 2019. The Company identified two performance obligations in the agreement: 1) License to use the Company's proprietary drug delivery platform and 2) pre-clinical research and development services (“pre-clinical R&D services”). The preclinical R&D services include discovery, research and design preclinical activities relating to the programs selected by Amgen. The . Revenues attributed to the preclinical R&Ds services are recognized during the period of the pre-clinical R&D services, over time according to the input model method on a cost-to-cost basis, since the customer benefits from the research and development services as the entity performs the service. The Company evaluated the standalone selling price of the pre-clinical R&D services at $225 and the right to use the intellectual property at $500. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements) . Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events of development and commercial progress, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained. Variable consideration is included in the transaction price if, in the Company’s judgment, it is highly probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. A s of December 31, 2021, the Company did not recognize any revenues from any potential milestone payments. An entity should recognize revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property only when (or as) the later of the following events occurs: a) The subsequent sale or usage occurs; and b) The performance obligation to which some or all of the sales based or usage-based royalty has been allocated has been satisfied (or partially satisfied). As . o. Income taxes 1) Deferred taxes Deferred . 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. p. Loss per share Basic . Diluted 6,517,102 shares and 7,218,966 q. Legal and other contingencies Certain . Management . Legal costs incurred in connection with loss contingencies are expensed as incurred . r. Derivatives Freestanding . If . s. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements, not yet adopted 1) In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. 2) In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. 3) In June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. |
COVID-19
COVID-19 | 12 Months Ended |
Dec. 31, 2021 | |
Unusual or Infrequent Items, or Both [Abstract] | |
COVID-19 | NOTE 3 - COVID-19 In March 2020, the World Health Organization declared the outbreak of COVID-19 to be a pandemic. The COVID-19 pandemic is having widespread, rapidly evolving, and unpredictable impacts on global society, economies, financial markets, and business practices. During 2021, there was a broad distribution of several vaccinations and medicines to overcome the pandemic. The Company has shifted its operations to co-exist along the pandemic with encouragement of vaccinations to all of its employees. Though the Company sees great progress to overcome the COVID-19 pandemic, still the COVID-19 pandemic may continue to impact the Company’s business operations, with outbursts of new variants of the COVID-19 from time to time, and there is uncertainty in the nature and degree of its continued effects over time. |
OPERATING LEASES
OPERATING LEASES | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
OPERATING LEASES | NOTE 4 - OPERATING LEASES 1) The Company leases office and research and development space under several agreements. The annual lease consideration is a total of $ 192 and is linked to the Israeli CPI. The lease agreement will expire on June 30, 2023. As of December 31, 2021, the Company provided bank guarantees of approximately $42, in the aggregate, to secure the fulfillment of its obligations under the lease agreements. 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 CPI. To secure the terms of the lease agreements, the Company has made certain prepayments to the leasing company, representing approximately three months of lease payments. The annual lease consideration is a total of $ 36 The lease cost was as follows: Year ended December 31, 2021 Year ended December 31, 2020 Operating lease cost 216 180 Supplemental cash flow information related to leases was as follows: Year ended December 31, 2021 Year ended December 31, 2020 Operating cash flows from operating leases 216 180 Supplemental balance sheet information related to operating leases was as follows: December 31, 2021 December 31, 2020 Operating Leases Operating lease right-of-use assets 239 374 Current lease liabilities 179 189 Non-current lease liabilities 123 243 Total lease liabilities 302 432 Weighted-average remaining lease term (in years) 1.53 2.53 Weighted-average discount rate 16 % 16 % As of December 31, 2021, the maturity of lease liabilities under our non-cancelable operating leases were as follows: 2022 224 2023 117 Total future minimum lease payments 341 Less: interest (39 ) Present value of operating lease liabilities 302 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 5 - COMMITMENTS AND CONTINGENCIES a. Commitment to pay royalties to the government of Israel The . Under the terms of the Company’s funding from the IIA, royalties are payable on sales of products developed from projects so funded of 3% during the first three years, from 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) with the addition of annual interest based on LIBOR. 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. As $460. Following 5.38% of $79 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 certain of Oramed's patent (the “IPR&D”). On February 22, 2011, Oramed and the Company entered into a patent transfer agreement, (the "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). |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL | NOTE 6 - SHARE CAPITAL 1) Rights of the Company’s ordinary shares Each ordinary share is entitled to one vote. The holder of the ordinary shares is also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. The right to receive upon liquidation of the Company a sum equal to the nominal value of the share, and if a surplus 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. IPO warrants As described in note 1b, in July 2018 the Company issued 1,400,000 IPO warrants to purchase 700,000 ordinary shares of the Company, these warrants have been listed for trading on the Nasdaq Capital Market and trading began on August 12, 2018. The IPO warrants are exercisable immediately at an initial exercise price of $8.40 per ordinary share for a period of five years, unless earlier repurchased by the Company under "Fundamental Transactions” as described in the warrant agreement or early expired as described in the warrant agreement. The exercise price and number of ordinary shares issuable upon exercise of each warrant are subject to standard adjustments. In addition, the exercise price is subject to reduction if, within two years of the date of original issuance of the warrants which ended in July 2020, the Company sells or grants any warrant or option (except in certain circumstances as described in the warrant agreement) at an effective price per share less than $8.00 per share (as adjusted in proportion with any adjustments made from time to time), which reduction will be based on a weighted average, as described in the agreement. As described in note 6(2)b below, the Company completed financing round in a price per share lower than the $8.00, therefore, the adjusted exercise price is $5.85. At the IPO completion date, both of the instruments (warrants and shares) were classified as equity instruments as the warrants are considered indexed to the entity's own stock based on the provision of ASC 815. As of the December 31, 2021 there are 1,395,500 traded warrants to purchase 697,750 ordinary shares of the Company with an exercise price of $5.85. b. On December 11, 2019 and December 18, 2019 (“the first and second closing”), the Company entered into subscription agreements with a selected group of accredited investors, including certain board members and their affiliates for the private placement of 5,710,153 ordinary shares for aggregate subscription proceeds to the Company of $13.5 million at a price of $2.37 per share. In addition, the Company granted 2,855,095 warrants, exercisable over a three-years period from the date of issuance, to purchase 2,855,095 ordinary shares at a per share exercise price of $2.96. In addition, the exercise price is subject to reduction if, within one years of the date of original issuance of the warrants which ended in December 2020 the Company will issue ordinary shares at an effective price per share less than $2.96. In addition, on December 13, 2019, D.N.A Biomedical Solutions Ltd. (“DNA”), an existing shareholder of the Company, subscribed to the Private Placement (the “DNA Private Placement”) to purchase 337,553 ordinary shares for aggregate consideration of $800. In connection with the transaction, the Company granted DNA warrants, exercisable over a three-year period from the date of issuance, to purchase 168,776 ordinary shares at a per share exercise price of $2.96. This investment was approved by the shareholders of the Company on February 18, 2020. The 168,776 warrants issued in connection with the DNA Private Placement together with the 2,855,095 warrants issued in connection with the Private Placement are the “Investors Warrants” In connection therewith, the Company entered into Placement Agency agreement with GP Numenkari Inc., a broker-dealer (“the Broker”). Based on the agreement, the Broker was entitled to the following consideration: 1. A cash fee equal to 10% of the total proceeds paid by subscribers invested through the Broker. 2. Three-years warrants to purchase ordinary shares in the amount equal to 10% of the number of shares issued to subscribers invested through the Broker at a per share exercise price of $2.37 (“Broker Warrants Type 1”). 3. Three-years warrants to purchase ordinary share in the amount equal to 5% of number of shares issued to subscribers invested through the Broker at a per share exercise price of $2.96 (“Broker Warrants Type 2”), together with the Broker Warrants Type 1 (the “Broker Warrants”). Following the first and second closing of the offering, the Company issued 184,515 Broker Warrants type 1 and 92,257 Broker Warrants type 2 at per share exercise price of $2.37 to $2.96, respectively The Company had transaction costs of approximately $1.2 million, out of which $205 are Stock-Based Compensation due to issuance of the Broker Warrants. At the transaction date, both of the instruments (shares and warrants) were classified as equity instruments as the warrants are considered indexed to the entity's own stock based on the provision of ASC 815. During 2020, upon issuance of shares through the Company’s At-the-market equity program at a price per share lower than the exercise price, the exercise price adjusted to $1.05. See note 6(2)e. On April 21, 2021, upon satisfaction of the sale price condition pursuant to the subscription agreement signed in December 2019, the Company’s Board of Directors decided to accelerate the termination date of the Investors and Broker warrants issued in December 2019 and February 2020. In accordance with the terms of the agreement, as of the notice date and until June 23, 2021 (the “Early Termination Exercise Period”), the holders may exercise their warrants and following such Early Termination Exercise Period, these warrants shall be deemed terminated. Through June 23, 2021, all warrants holders, including the company's Chairman of the board and DNA, exercised 3,300,645 warrants into 3,172,800 ordinary shares through cash or cashless mechanism. The total consideration from the exercise of these warrants was $3,145 at an exercise price of $1.05. As of December 31, 2021, all Investors and Broker warrants were exercised. c. On June 13, 2020, 687,960 warrants to purchase 687,960 ordinary shares for a purchase price of $6.99 per share in accordance with the Series B preferred share purchase agreement signed in 2016 and its following amendments expired. d. In July 2020, 340,210 warrants to purchase 340,210 ordinary shares for a purchase price of $3.69 per share in accordance with the Series A preferred share purchase agreement expired. e. On July 4, 2020, the Company established a primary registration statement under form F-3 and at-the-market equity program (the " 2020 ATM Program") that allows the Company to issue up to $13.9 million of ordinary shares, at the Company's discretion. Distributions of the ordinary shares through 2020 ATM Program were made pursuant to the terms of an equity distribution agreement dated July 13, 2020 among the Company and Canaccord Genuity LLC (the "Agent"). In February and March 2021, the Company issued additional 2,546,265 ordinary shares for net proceeds of $9.9 million at a weighted average price of $3.99 per ordinary share through 2020 ATM Program. f. On May 7, 2021, the Company entered into a new At-the-market equity program (the "2021 ATM Program") that allows the Company to issue up to additional 5 million ordinary shares, at the Company's discretion. Distributions of the ordinary shares through the 2021 ATM Program were made pursuant to the terms of an equity distribution agreement dated May 7, 2021 among the Company and B. Riley Securities, Inc. In June and July 2021, the Company issued 1,840,463 ordinary shares for net proceeds of $12.1 million at a weighted average price of $6.74 per ordinary share through the Company’s 2021 ATM Program. g. During the twelve months ended December 31, 2021, several employees and service providers exercised 177,711 options into 177,711 ordinary shares of the Company for a total consideration of $418 at a weighted average price of $2.54 per ordinary share. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | 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 shall reserve sufficient number of ordinary shares, NIS 0.000769 par value, of the Company for allocation of stock options, restricted share units, restricted share awards and performance-based awards (the "Option"), to employees and non-employees. 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. 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 of the Company for allocation of stock options, restricted share units, restricted share awards and performance-based awards (the "Option"), to employees and non-employees for issuance under the 2018 Plan. Each Option is exercisable for one ordinary share NIS 0.0000769 par value. Any option granted under 2018 Plan that is not exercised within 10 years from the date upon which it becomes exercisable will expire. The 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. 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, 2021, 289,638 ordinary shares remain available for future grants under the Plan. On January 1, 2022 the Company’s Board of Directors approved an increase of 1,440,220 ordinary shares that may be issued under the Company’s Plan. 2) share-based compensation grants to employees and directors: a) On March 16, 2020, the Company’s Board of Directors approved the following option grants, with an exercise price of $2.14 per share: 1. 250,000 options to purchase ordinary shares were granted to certain executive officers. 2. 201,600 options to purchase ordinary shares were granted to certain employees. 3. 7,500 options to purchase ordinary shares was granted to a service provider. The options vest over 4 years from the date of grant; 25% vest on the first anniversary of the date of grant and the remaining 75% vest in twelve equal quarterly installments following the first anniversary of the applicable grant date. The fair value of the options at the date of grant was $590. b) On April 20, 2020 options to purchase 31,502 ordinary shares granted to the former CEO with an exercise price of $1.98 per share. The options vest over 4 years from the date of grant; 25% vest on the first anniversary of the date of grant and the remaining 75% vest in twelve equal quarterly installments following the first anniversary of the applicable grant date. The fair value of the options at the date of grant was $37. Effective September 7, 2020, due to termination of the employment agreement with the former CEO, these options are forfeited and recognized as a reverse of expense under the General and Administrative line. c) In April 2020, the Company entered into an investor relations services agreement. Under the terms of the agreement, the Company agreed to pay a monthly fee of $5 and to issue the consultant 28,000 Restricted Share Units (“RSU”), of which the first 7,000 shares vested on the signing date and the remaining 21,000 shares will vest in three equal installments until January 8, 2021. As of December 31, 2020, 21,000 shares were fully vested. The fair value of the RSU was $53 using the fair value of the shares at the grant date. d) In November 2020, the Company entered into an amendment to business development services agreement with the business development consultant. Under the terms of the agreement, the Company agreed to pay a monthly fee of $5 and to issue the consultant 79,760 options with an exercise price of $1.06 per share. The options vests over 6 months in six equal installments from October 1, 2020. The fair value of the options at the date of grant was $35. e) On January 4, 2021 options to purchase 1,314,218 ordinary shares were granted to the Chief Executive Officer of the Company, with an exercise price of $1.24. The options vest over 4 years from the date of grant; 25% vest on the first anniversary of the date of grant and the remaining 75% of the option will vest in twelve equal quarterly installments following the first anniversary of the grant date. The grant was subject to the approval by the shareholders of the Company, which approved the grant in March 2021. The fair value of the options at the date of grant was $1,320. f) On April 7, 2021, the Company’s Board of Directors approved the following option grants: i. Options grants to purchase 213,000 ordinary shares to certain employees and 70,000 options granted to service providers, with an exercise price of $3.61 per share. The options vest over 4 years from the date of grant; 25% vest on the first anniversary of the date of grant and the remaining 75% of the option will vest in twelve equal quarterly installments following the first anniversary of the grant date. The fair value of the options at the date of grant was $646. ii. Options grant to purchase 33,368 ordinary shares to a non-executive director of the Company, with an exercise price of $3.61. The options will vest over 3 years in twelve equal quarterly instalments starting on the vesting commencement date. These options were subject to the approval of the shareholders of the Company, which was approved on October 4, 2021. The fair value of the options at the shareholders' approval date was $104. g) On April 21, 2021, options to purchase 345,000 ordinary shares were granted to several executive officers of the Company, with an exercise price of $3.15. The options vest over 4 years from the date of grant; 25% vest on the first anniversary of the date of grant and the remaining 75% of the option will vest in twelve equal quarterly installments following the first anniversary of the grant date. These options were subject to the approval of the shareholders of the Company, which was approved on October 4, 2021. The fair value of the options at the shareholders' approval date was $1,140. h) On August 23. 2021, the Company’s Board of Directors approved the following option grants which were approved by the shareholders of the Company on October 4, 2021. i. Grants of options to purchase ordinary shares with a total fair value 0f $195 for each of the seven non-executive board member on January 1, 2022. The options will vest over 3 years in twelve equal quarterly instalments starting on January 1, 2022 the vesting commencement date. On January 1, 2022, which is considered the awards grant date, the Company granted 752,899 ordinary shares to non-executive directors with an exercise price of $2.815 per share. ii. Grants of options to purchase ordinary shares with a total fair value 0f $65 for each of the seven non-executive board member on January 1, 2022. The options will vest over 1 year in four equal quarterly instalments starting on January 1, 2022 the vesting commencement date. On January 1, 2022, which is considered the awards grant date, the Company granted 250,964 ordinary shares to non-executive directors with an exercise price of $2.815 per share. 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: 2021 2020 Exercise price $ 1.24-$3.61 $ 1.06-$2.14 Dividend yield - - Expected volatility 68%-71 % 66.35%-71 % Risk-free interest rate 1.11%-0.94 % 0.16%-0.58 % Expected life - in years 6.1-5.8 2.75-6.1 2021 2020 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding at beginning of year 2,570,109 $ 4.85 2,847,600 $ 4.74 Granted 1,975,586 1.95 570,362 $ 1.98 Exercised (177,710 ) 2.37 (31,954 ) 2.11 Forfeited (16,660 ) 2.37 (589,793 ) 2.7 Expired (34,466 ) 4.00 (226,106 ) 2.68 Outstanding at end of year 4,316,859 $ 3.63 2,570,109 $ 4.85 Exercisable at end of year 2,068,067 $ 5.39 1,791,687 $ 5.49 The following tables summarizes information concerning outstanding and exercisable options as of December 31, 2021, in terms of ordinary shares: December 31, 2021 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 - 4,680 0.78 4,680 0.78 1.06 14,760 3.85 14,760 3.85 1.24 1,314,218 9.02 - - 2.14 422,300 8.26 184,756 8.26 2.53 33,638 7.89 28,031 7.89 3.15 345,000 9.30 - - 3.61 316,368 9.27 5,561 9.27 3.68 185,640 0.32 185,640 0.32 3.97 287,565 7.05 251,949 7.05 6.31 1,245,400 4.08 1,245,400 4.08 7.54 147,290 1.26 147,290 1.26 4,316,859 2,068,067 The aggregate intrinsic value of the total of the outstanding and exercisable options as of December 31, 2021, is $2,378 and $146, respectively. The following table illustrates the effect of share-based compensation on the statements of operations: 2021 2020 Cost of revenues 102 51 Research and development expenses 661 514 General and administrative 1,098 336 1,861 901 |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAX | NOTE 8 - INCOME TAX A. Corporate tax rate 1) Ordinary taxable income in Israel is subject to a corporate tax rate of 23%. 2) 29%. B. Losses for tax purposes carried forward to future years The balance of carryforward losses as of December 31, 2021 and 2020 are approximately $56.1 million and $44.2 million, respectively. Under Israeli tax law, tax loss carry forward have no expiration date. C. Tax assessments The Company and its subsidiary have tax assessments that are considered to be final through tax year 2016. D. Loss (income) before income taxes is composed of the following Year ended December 31 2021 2020 Entera Bio Ltd 12,362 11,283 Entera Bio Inc (116 ) (87 ) Total loss before taxes 12,246 11,196 E. Tax expenses: Year ended December 31 2021 2020 Current: Subsidiary 158 20 Total current income tax 158 20 Deferred: Subsidiary (217 ) - Total tax on income (59 ) 20 F. Deferred income taxes December 31, 2021 2020 Deferred tax assets: Net operating loss carry forward 12,895 10,176 Research and development 1,319 1,316 Share-based compensation 876 688 Other 152 240 Net deferred tax assets before valuation allowance 15,242 12,420 valuation allowance (15,025 ) (12,420 ) Net deferred tax assets 217 - Realization of deferred tax assets is contingent upon sufficient future taxable income during the period that deductible temporary differences and carry forward losses are expected to be available to reduce taxable income. G. Rollforward of valuation allowance: Balance at January 1, 2020 9,718 Additions 2,702 Balance at January 1, 2021 12,420 Additions 2,605 Balance at December 31, 2021 15,025 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, 2021 and 2020, the Company does not have a provision for uncertain tax positions. |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
Supplementary Financial Statement Information [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 9 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: December 31, 2021 2020 U.S. dollars in thousands b. Accounts payable - other: Employees and employees related 147 144 Income tax 134 - Provision for vacation 308 263 Accrued expenses 2,212 923 2,801 1,330 |
REVENUE FROM COLLABORATION AND
REVENUE FROM COLLABORATION AND LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE FROM COLLABORATION AND LICENSE AGREEMENT | NOTE 10 - REVENUE FROM COLLABORATION AND LICENSE AGREEMENT On December 10, 2018, the Company entered into a research collaboration and license agreement (the “Amgen Agreement”) with Amgen Inc. (“Amgen”) in inflammatory disease and other serious illnesses. Pursuant to the Amgen Agreement, the Company and Amgen will use the Company’s proprietary drug delivery platform to develop oral formulations for one preclinical large molecule program that Amgen has selected. Amgen also has options to select up to two additional programs to include in the collaboration. Amgen is responsible for the clinical development, regulatory approval, manufacturing and worldwide commercialization of the programs. The Company granted Amgen an exclusive, worldwide, sublicensable license under certain of its intellectual property relating to its drug delivery technology to develop, manufacture and commercialize the applicable products. The Company will retain all intellectual property rights to its drug delivery technology, and Amgen will retain all rights to its large molecules and any subsequent improvements, and ownership of certain intellectual property developed through the performance of the collaboration is to be determined by U.S. patent law. Pursuant to the terms of the Amgen Agreement, Amgen is required to make aggregate payments of up to $270 million upon achievement of various clinical and commercial milestones or its exercise of options to select additional two programs to include in the collaboration, as well as tiered royalty payments ranging from the low to mid-single digits based on the level of Amgen’s net sales of the applicable products. Amgen is required to pay for the initial program $450 for the second year of preclinical R&D services to be provided by the Company and must reimburse the Company for further expenses as shall be agreed between the parties. Preclinical R&D services includes time spent by the Company's employees performing the Company's activities under the work plan of collaboration program. Amgen’s obligation to pay royalties with respect to a product in a particular country commences upon the first commercial sale of such product in such country and expires on a country-by-country and product-by-product basis on the later of (a) the date on which the sale of the product is no longer covered by a valid claim of a patent licensed to Amgen under the Amgen Agreement, and (b) the tenth anniversary of the first commercial sale of such product in such country. The term of the Amgen Agreement commenced on December 10, 2018, and unless earlier terminated, shall continue in full force and effect, on a product-by-product basis, until expiration of the last-to-expire royalty term with respect to such product. In January 2019, as required by the Amgen Agreement, Amgen paid the Company a non-refundable and non-creditable initial technology access fee of $725. The Company evaluated the selling price of the preclinical R&D services at $225 and the right to use the intellectual property (“License fees”) at $500. In December 2018, the Company recognized $500 in revenues for the right to use the intellectual property. During the second quarter of 2021, the Company extended the agreement, pursuant to the terms, Amgen is required to pay for the third year of preclinical R&D services to be provided by the Company for a total consideration of $450. Revenues attributed to the preclinical R&D services are recognized during the period of the pre-clinical R&D services according to the input model method on a cost-to-cost basis. During 2021 the Company received the second installment for the second year and the first installment for the third year for the pre-clinical R&D services in the amount of $450. In 2021 and 2020, the Company recorded revenues of $502 and $365 related to services provided under the Amgen Agreement. In addition, as of December 31, 2021 and 2020 the Company recorded a contract liability of $15 and $158, respectively. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation of the financial statements | a. Basis of presentation of the financial statements The . |
Use of estimates in the preparation of financial statements | 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. |
Functional currency | 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 entity operates (“the functional currency”). The U.S. dollar is the currency of the primary economic environment in which the operations of the Company is conducted. The consolidated financial statements are presented in U.S. dollars. 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 (expenses), as appropriate . The functional currency of the subsidiary is the U.S. dollar. |
Principles of consolidation | d. Principles of consolidation The consolidated financial statements include the accounts of the Company and Entera Bio Inc. All inter-company transactions and balances have been eliminated in consolidation. |
Cash and cash equivalents | 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. |
Restricted | f. Restricted Restricted cash deposited in an interest-bearing saving account which is used as a security for the Company's office rent, and credit card. |
Fair value measurement | g. Fair value measurement The Level Level Level |
Employee severance benefits | h. Employee severance benefits Under In With The The |
Leases | i. Leases On ROU The . 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 . |
Property and equipment | j. Property and equipment 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The : 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. |
Impairment of long-lived assets | k. Impairment of long-lived assets The . |
Share-based compensation | l. Share-based compensation The . The . The . The . The . |
Research and development expenses | m. Research and development expenses Research . Grants . |
Revenue recognition | n. Revenue recognition The Company recognized revenue from the Amgen Agreement which was signed in December 2018 according to ASC 606, "Revenues from Contracts with Customers”. Prior to the signing of the Amgen Agreement in 2018, the Company did not have revenue transactions. 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. According to ASC 606, a performance obligation is a promise to provide a distinct good or service or a series of distinct goods or services. Goods and services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created. A good or service promised to a customer is distinct if the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Options granted to the customer that do not provide a material right to the customer that it would not receive without entering into the contract do not give rise to performance obligations. On December 10, 2018, the Company entered into the Amgen Agreement in inflammatory disease and other serious illnesses. As part of the agreement, the Company received non-refundable and non-creditable initial access payment of $725 from Amgen in January 2019. The Company identified two performance obligations in the agreement: 1) License to use the Company's proprietary drug delivery platform and 2) pre-clinical research and development services (“pre-clinical R&D services”). The preclinical R&D services include discovery, research and design preclinical activities relating to the programs selected by Amgen. The . Revenues attributed to the preclinical R&Ds services are recognized during the period of the pre-clinical R&D services, over time according to the input model method on a cost-to-cost basis, since the customer benefits from the research and development services as the entity performs the service. The Company evaluated the standalone selling price of the pre-clinical R&D services at $225 and the right to use the intellectual property at $500. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements) . Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events of development and commercial progress, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained. Variable consideration is included in the transaction price if, in the Company’s judgment, it is highly probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably available. A s of December 31, 2021, the Company did not recognize any revenues from any potential milestone payments. An entity should recognize revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property only when (or as) the later of the following events occurs: a) The subsequent sale or usage occurs; and b) The performance obligation to which some or all of the sales based or usage-based royalty has been allocated has been satisfied (or partially satisfied). As . |
Income taxes | o. Income taxes 1) Deferred taxes Deferred . 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. |
Loss per share | p. Loss per share Basic . Diluted 6,517,102 shares and 7,218,966 |
Legal and other contingencies | q. Legal and other contingencies Certain . Management . Legal costs incurred in connection with loss contingencies are expensed as incurred . |
Derivatives | r. Derivatives Freestanding . If . |
Newly issued and recently adopted accounting pronouncements | s. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements, not yet adopted 1) In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. 2) In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. 3) In June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of estimated useful life | Years Computer equipment 3-5 Office furniture 10 Laboratory equipment 7-10 |
OPERATING LEASES (Tables)
OPERATING LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of lease cost | Year ended December 31, 2021 Year ended December 31, 2020 Operating lease cost 216 180 |
Schedule of operating lease cashflow information | Year ended December 31, 2021 Year ended December 31, 2020 Operating cash flows from operating leases 216 180 |
Schedule of operating lease liability and operating lease right-of-use asset | December 31, 2021 December 31, 2020 Operating Leases Operating lease right-of-use assets 239 374 Current lease liabilities 179 189 Non-current lease liabilities 123 243 Total lease liabilities 302 432 Weighted-average remaining lease term (in years) 1.53 2.53 Weighted-average discount rate 16 % 16 % |
Schedule of maturities of undiscounted lease liabilities | 2022 224 2023 117 Total future minimum lease payments 341 Less: interest (39 ) Present value of operating lease liabilities 302 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value assumptions of option granted using Black-Scholes option-pricing model | 2021 2020 Exercise price $ 1.24-$3.61 $ 1.06-$2.14 Dividend yield - - Expected volatility 68%-71 % 66.35%-71 % Risk-free interest rate 1.11%-0.94 % 0.16%-0.58 % Expected life - in years 6.1-5.8 2.75-6.1 |
Schedule of option activity | 2021 2020 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding at beginning of year 2,570,109 $ 4.85 2,847,600 $ 4.74 Granted 1,975,586 1.95 570,362 $ 1.98 Exercised (177,710 ) 2.37 (31,954 ) 2.11 Forfeited (16,660 ) 2.37 (589,793 ) 2.7 Expired (34,466 ) 4.00 (226,106 ) 2.68 Outstanding at end of year 4,316,859 $ 3.63 2,570,109 $ 4.85 Exercisable at end of year 2,068,067 $ 5.39 1,791,687 $ 5.49 |
Schedule of outstanding and exercisable options of ordinary shares | December 31, 2021 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 - 4,680 0.78 4,680 0.78 1.06 14,760 3.85 14,760 3.85 1.24 1,314,218 9.02 - - 2.14 422,300 8.26 184,756 8.26 2.53 33,638 7.89 28,031 7.89 3.15 345,000 9.30 - - 3.61 316,368 9.27 5,561 9.27 3.68 185,640 0.32 185,640 0.32 3.97 287,565 7.05 251,949 7.05 6.31 1,245,400 4.08 1,245,400 4.08 7.54 147,290 1.26 147,290 1.26 4,316,859 2,068,067 The aggregate intrinsic value of the total of the outstanding and exercisable options as of December 31, 2021, is $2,378 and $146, respectively. |
Schedule of of share-based compensation on statements of operations | 2021 2020 Cost of revenues 102 51 Research and development expenses 661 514 General and administrative 1,098 336 1,861 901 |
INCOME TAX (Tables)
INCOME TAX (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of loss (income) before income taxes | Year ended December 31 2021 2020 Entera Bio Ltd 12,362 11,283 Entera Bio Inc (116 ) (87 ) Total loss before taxes 12,246 11,196 |
Schedule of tax expenses | Year ended December 31 2021 2020 Current: Subsidiary 158 20 Total current income tax 158 20 Deferred: Subsidiary (217 ) - Total tax on income (59 ) 20 |
Schedule of deferred income taxes | December 31, 2021 2020 Deferred tax assets: Net operating loss carry forward 12,895 10,176 Research and development 1,319 1,316 Share-based compensation 876 688 Other 152 240 Net deferred tax assets before valuation allowance 15,242 12,420 valuation allowance (15,025 ) (12,420 ) Net deferred tax assets 217 - |
Schedule of rollforward of valuation allowance | Balance at January 1, 2020 9,718 Additions 2,702 Balance at January 1, 2021 12,420 Additions 2,605 Balance at December 31, 2021 15,025 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Supplementary Financial Statement Information [Abstract] | |
Schedule of accounts payable - other | December 31, 2021 2020 U.S. dollars in thousands b. Accounts payable - other: Employees and employees related 147 144 Income tax 134 - Provision for vacation 308 263 Accrued expenses 2,212 923 2,801 1,330 |
GENERAL (Detail Textuals)
GENERAL (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | |
General [Line Items] | |||
Number of warrants issued | 1,395,500 | ||
Number of ordinary shares will be purchased by exercising warrants | 697,750 | ||
Accumulated deficit | $ (82,426) | $ (70,239) | |
IPO [Member] | Ordinary shares [Member] | |||
General [Line Items] | |||
Number of shares issued | 1,400,000 | ||
Number of ordinary shares will be purchased by exercising warrants | 700,000 | ||
Net proceeds from share issuance | $ 9,600 | ||
Warrant to purchase ordinary share | $ 0.5 | ||
Price of shares issued under private placement | $ 8 | ||
IPO [Member] | Warrant [Member] | |||
General [Line Items] | |||
Number of warrants issued | 1,400,000 | 4,500 | |
Number of ordinary shares will be purchased by exercising warrants | 700,000 | 2,250 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Computer equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Office furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 10 years |
Laboratory equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Laboratory equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 10 years |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Detail Textuals) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Significant Accounting Policies [Line Items] | ||||
Severance payment expenses | $ 137 | $ 125 | ||
Severance expenses | $ 142 | |||
Number of antidilutive securities excluded from computation of earnings per share | 6,517,102 | 7,218,966 | ||
Amgen Inc [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Non-refundable and non-creditable initial technology access fee payment, including payment for the first year of preclinical services | $ 725 | |||
Additional amount paid for services to be recognized upon commencement of the pre-clinical Research and Development services | $ 225 | |||
Right to use intellectual property | $ 500 |
OPERATING LEASE (Details)
OPERATING LEASE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Operating lease cost | $ 216 | $ 180 |
OPERATING LEASE (Details 1)
OPERATING LEASE (Details 1) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Operating cash flows from operating leases | $ 216 | $ 180 |
OPERATING LEASES (Details 2)
OPERATING LEASES (Details 2) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Leases | ||
Operating lease right-of-use assets | $ 239 | $ 374 |
Current lease liabilities | 179 | 189 |
Non-current lease liabilities | 123 | 243 |
Total lease liabilities | $ 302 | $ 432 |
Weighted-average remaining lease term (in years) | 1 year 6 months 10 days | 2 years 6 months 10 days |
Weighted-average discount rate | 16.00% | 16.00% |
OPERATING LEASES (Details 3)
OPERATING LEASES (Details 3) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 224 | |
2023 | 117 | |
Total future minimum lease payments | 341 | |
Less: interest | (39) | |
Present value of operating lease liabilities | $ 302 | $ 432 |
OPERATING LEASES (Detail Textua
OPERATING LEASES (Detail Textuals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | ||
Operating leases cost for rental space and vehicles | $ 216 | $ 180 |
Operating lease agreements for office and research and development space [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Annual lease consideration | 192 | |
Value of bank guarantees provided | 42 | |
Operating lease agreements for vehicles for employees [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Annual lease consideration | $ 36 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Detail Textuals) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Patent Transfer Agreement [Member] | |
Commitments [Line Items] | |
Percentage of net revenues | 3.00% |
D.N.A Biomedical Solutions Ltd [Member] | Joint Venture Agreement [Member] | |
Commitments [Line Items] | |
Amount of investment in entity | $ 600 |
D. N. A Biomedical Solutions Ltd And Oramed Ltd [Member] | Joint Venture Agreement [Member] | |
Commitments [Line Items] | |
Percentage of ownership of entity acquired | 50.00% |
Government of Israel [Member] | |
Commitments [Line Items] | |
Percentage sales of products developed from projects in first three years, from commencement of revenues | 3.00% |
Percentage sales of products developed from projects subsequent three years | 4.00% |
Percentage sales of products developed from projects commencing the seventh year | 5.00% |
Total royalty amount payable | $ 460 |
Percentage of each payment received from Amgen | 5.38% |
Royalty amount paid | $ 79 |
SHARE CAPITAL (Detail Textuals)
SHARE CAPITAL (Detail Textuals) | Dec. 13, 2019USD ($)$ / sharesshares | Jun. 23, 2021USD ($)$ / sharesshares | Feb. 18, 2020shares | Jul. 31, 2021USD ($)$ / sharesshares | Mar. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2021₪ / shares | Dec. 31, 2021USD ($)$ / sharesshares | May 07, 2021shares | Jul. 31, 2020$ / sharesshares | Jul. 04, 2020USD ($) | Jun. 13, 2020$ / sharesshares | |
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 1,395,500 | ||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 697,750 | ||||||||||||||
Exercise price of warrants issued | ₪ / shares | ₪ 5.85 | ||||||||||||||
Transaction costs | $ | $ 1,200,000 | ||||||||||||||
Stock-based compensation expenses | $ | 1,861,000 | $ 901,000 | |||||||||||||
Value of shares issued | $ | [1] | ||||||||||||||
Proceeds from issuance of shares through ATM programs, net of issuance costs | $ | $ 21,805,000 | $ 3,187,000 | |||||||||||||
Number of options exercised | 177,710 | 31,954 | |||||||||||||
Exercise of options to ordinary shares | $ | $ 418,000 | $ 68,000 | |||||||||||||
Weighted average exercise rice of options exercised | $ / shares | $ 2.37 | $ 2.11 | |||||||||||||
ATM Equity Program 2020 [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Adjusted exercise price under At-the-market equity program | $ / shares | $ 1.05 | ||||||||||||||
Several employees and service providers [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of options exercised | 177,711 | ||||||||||||||
Private Placement [Member] | Accredited investors, including certain board members and their affiliates [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 2,855,095 | ||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 2,855,095 | ||||||||||||||
Exercise price of warrants issued | $ / shares | $ 2.96 | ||||||||||||||
Term of warrants issued | 3 years | ||||||||||||||
Number of shares issued under private placement | 5,710,153 | ||||||||||||||
Proceeds from private placement | $ | $ 13,500,000 | ||||||||||||||
Price of shares issued under private placement | $ / shares | $ 2.37 | ||||||||||||||
Private Placement [Member] | D.N.A Biomedical Solutions Ltd [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 168,776 | ||||||||||||||
Term of warrants issued | 3 years | ||||||||||||||
Number of shares issued under private placement | 337,553 | ||||||||||||||
Proceeds from private placement | $ | $ 800 | ||||||||||||||
Private Placement [Member] | Chairman of the board and DNA [Member] | Series B Preferred Stock [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 687,960 | ||||||||||||||
Exercise price of warrants issued | $ / shares | $ 6.99 | ||||||||||||||
Private Placement [Member] | Chairman of the board and DNA [Member] | Series A Preferred Stock [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 340,210 | ||||||||||||||
Exercise price of warrants issued | $ / shares | $ 3.69 | ||||||||||||||
Placement Agency agreement with GP Numenkari Inc [Member] | D.N.A Biomedical Solutions Ltd [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Cash fees in percentage of total proceeds paid by subscribers invested through the Broker | 10.00% | ||||||||||||||
Ordinary shares [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Voting rights of ordinary share | one vote | ||||||||||||||
Number of options exercised | 177,711 | 31,954 | |||||||||||||
Exercise of options to ordinary shares | $ | $ 0 | $ 0 | |||||||||||||
Ordinary shares [Member] | ATM Equity Program 2020 [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Value of shares issued | $ | $ 13,900,000 | ||||||||||||||
Effect of down round trigger amount | $ | 1,042,000,000 | ||||||||||||||
Proceeds from issuance of shares through ATM programs, net of issuance costs | $ | $ 3,500,000 | ||||||||||||||
Weighted average price of share issued | $ / shares | $ 3.99 | $ 1.27 | |||||||||||||
Net proceeds from share issuance | $ | $ 9,900,000 | $ 3,200,000 | |||||||||||||
Number of shares issued | 2,546,265 | 2,802,731 | |||||||||||||
Ordinary shares [Member] | ATM Equity Program 2021 [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Weighted average price of share issued | $ / shares | $ 6.74 | ||||||||||||||
Net proceeds from share issuance | $ | $ 12,100,000 | ||||||||||||||
Number of shares issued | 1,840,463 | 5,000,000 | |||||||||||||
Ordinary shares [Member] | Several employees and service providers [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of shares issued on options exercised | 177,711 | ||||||||||||||
Weighted average exercise rice of options exercised | $ / shares | $ 2.54 | ||||||||||||||
Ordinary shares [Member] | IPO [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 700,000 | ||||||||||||||
Price of shares issued under private placement | $ / shares | $ 8 | ||||||||||||||
Net proceeds from share issuance | $ | $ 9,600,000 | ||||||||||||||
Number of shares issued | 1,400,000 | ||||||||||||||
Ordinary shares [Member] | Private Placement [Member] | Chairman of the board and DNA [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 3,172,800 | ||||||||||||||
Warrant [Member] | IPO [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 4,500 | 1,400,000 | |||||||||||||
Number of ordinary shares will be purchased by exercising warrants | 2,250 | 700,000 | |||||||||||||
Exercise price of warrants issued | $ / shares | $ 5.85 | $ 8.4 | |||||||||||||
Term of warrants issued | 5 years | ||||||||||||||
Threshold limit of period for reduction in exercise price | 2 years | ||||||||||||||
Threshold limit of reduction in exercise price | $ / shares | $ 8 | ||||||||||||||
Reduced exercise price | $ / shares | $ 5.85 | ||||||||||||||
Proceeds from exercise of warrants | $ | $ 13,000 | ||||||||||||||
Warrant [Member] | Private Placement [Member] | Chairman of the board and DNA [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 3,300,645 | 340,210 | 687,960 | ||||||||||||
Exercise price of warrants issued | $ / shares | $ 1.05 | ||||||||||||||
Proceeds from exercise of warrants | $ | $ 3,145,000 | ||||||||||||||
Broker Warrants Type 1 [Member] | Placement Agency agreement with GP Numenkari Inc [Member] | D.N.A Biomedical Solutions Ltd [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 184,515 | ||||||||||||||
Exercise price of warrants issued | $ / shares | $ 2.37 | ||||||||||||||
Term of warrants issued | 3 years | ||||||||||||||
Shares granted in percentage | 10.00% | ||||||||||||||
Broker Warrants Type 2 [Member] | Placement Agency agreement with GP Numenkari Inc [Member] | D.N.A Biomedical Solutions Ltd [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Number of warrants issued | 92,257 | ||||||||||||||
Exercise price of warrants issued | $ / shares | $ 2.96 | ||||||||||||||
Term of warrants issued | 3 years | ||||||||||||||
Shares granted in percentage | 5.00% | ||||||||||||||
Broker Warrants [Member] | Placement Agency agreement with GP Numenkari Inc [Member] | D.N.A Biomedical Solutions Ltd [Member] | |||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||
Stock-based compensation expenses | $ | $ 205,000 | ||||||||||||||
[1] | Represents an amount less than one thousand US dollars |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price | $ 1.24 | $ 1.06 | |
Expected volatility | 68.00% | 66.35% | |
Risk-free interest rate | 1.11% | 0.16% | |
Expected life - in years | 6 years 1 month 6 days | 2 years 9 months | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price | $ 3.61 | $ 2.14 | |
Expected volatility | 71.00% | 71.00% | |
Risk-free interest rate | 0.94% | 0.58% | |
Expected life - in years | 5 years 9 months 18 days | 6 years 1 month 6 days |
SHARE-BASED COMPENSATION (Det_2
SHARE-BASED COMPENSATION (Details 1) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of options | ||
Outstanding at beginning of year | 2,570,109 | 2,847,600 |
Granted | 1,975,586 | 570,362 |
Exercised | (177,710) | (31,954) |
Forfeited | (16,660) | (589,793) |
Expired | (34,466) | (226,106) |
Outstanding at end of year | 4,316,859 | 2,570,109 |
Exercisable at end of year | 2,068,067 | 1,791,687 |
Weighted Average exercise price | ||
Outstanding at beginning of year | $ 4.85 | $ 4.74 |
Granted | 1.95 | 1.98 |
Exercised | 2.37 | 2.11 |
Forfeited | 2.37 | 2.7 |
Expired | 4 | 2.68 |
Outstanding at end of year | 3.63 | 4.85 |
Exercisable at end of year | $ 5.39 | $ 5.49 |
SHARE-BASED COMPENSATION (Det_3
SHARE-BASED COMPENSATION (Details 2) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 3.63 | $ 4.85 | $ 4.74 |
Number of options outstanding at end of year | 4,316,859 | 2,570,109 | 2,847,600 |
Number of options exercisable at end of year | 2,068,067 | 1,791,687 | |
Exercise Price Per Share - Zero | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 0 | ||
Number of options outstanding at end of year | 4,680 | ||
Options outstanding, Weighted Average Remaining contractual Life | 9 months 10 days | ||
Number of options exercisable at end of year | 4,680 | ||
Options exercisable, Weighted Average Remaining contractual Life | 9 months 10 days | ||
Exercise Price Per Share - 1.06 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 1.06 | ||
Number of options outstanding at end of year | 14,760 | ||
Options outstanding, Weighted Average Remaining contractual Life | 3 years 10 months 6 days | ||
Number of options exercisable at end of year | 14,760 | ||
Options exercisable, Weighted Average Remaining contractual Life | 3 years 10 months 6 days | ||
Exercise Price Per Share - 1.24 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 1.24 | ||
Number of options outstanding at end of year | 1,314,218 | ||
Options outstanding, Weighted Average Remaining contractual Life | 9 years 7 days | ||
Number of options exercisable at end of year | 0 | ||
Exercise Price Per Share - 2.14 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 2.14 | ||
Number of options outstanding at end of year | 422,300 | ||
Options outstanding, Weighted Average Remaining contractual Life | 8 years 3 months 3 days | ||
Number of options exercisable at end of year | 184,756 | ||
Options exercisable, Weighted Average Remaining contractual Life | 8 years 3 months 3 days | ||
Exercise Price Per Share - 2.53 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 2.53 | ||
Number of options outstanding at end of year | 33,638 | ||
Options outstanding, Weighted Average Remaining contractual Life | 7 years 10 months 20 days | ||
Number of options exercisable at end of year | 28,031 | ||
Options exercisable, Weighted Average Remaining contractual Life | 7 years 10 months 20 days | ||
Exercise Price Per Share - 3.15 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 3.15 | ||
Number of options outstanding at end of year | 345,000 | ||
Options outstanding, Weighted Average Remaining contractual Life | 9 years 3 months 18 days | ||
Number of options exercisable at end of year | 0 | ||
Exercise Price Per Share - 3.61 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 3.61 | ||
Number of options outstanding at end of year | 316,368 | ||
Options outstanding, Weighted Average Remaining contractual Life | 9 years 3 months 7 days | ||
Number of options exercisable at end of year | 5,561 | ||
Options exercisable, Weighted Average Remaining contractual Life | 9 years 3 months 7 days | ||
Exercise Price Per Share - 3.68 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 3.68 | ||
Number of options outstanding at end of year | 185,640 | ||
Options outstanding, Weighted Average Remaining contractual Life | 3 months 25 days | ||
Number of options exercisable at end of year | 185,640 | ||
Options exercisable, Weighted Average Remaining contractual Life | 3 months 25 days | ||
Exercise Price Per Share - 3.97 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 3.97 | ||
Number of options outstanding at end of year | 287,565 | ||
Options outstanding, Weighted Average Remaining contractual Life | 7 years 18 days | ||
Number of options exercisable at end of year | 251,949 | ||
Options exercisable, Weighted Average Remaining contractual Life | 7 years 18 days | ||
Exercise Price Per Share - 6.31 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 6.31 | ||
Number of options outstanding at end of year | 1,245,400 | ||
Options outstanding, Weighted Average Remaining contractual Life | 4 years 29 days | ||
Number of options exercisable at end of year | 1,245,400 | ||
Options exercisable, Weighted Average Remaining contractual Life | 4 years 29 days | ||
Exercise Price Per Share - 7.54 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price Per Share | $ 7.54 | ||
Number of options outstanding at end of year | 147,290 | ||
Options outstanding, Weighted Average Remaining contractual Life | 1 year 3 months 3 days | ||
Number of options exercisable at end of year | 147,290 | ||
Options exercisable, Weighted Average Remaining contractual Life | 1 year 3 months 3 days |
SHARE-BASED COMPENSATION (Det_4
SHARE-BASED COMPENSATION (Details 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | $ 1,861 | $ 901 |
Cost of revenues | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | 102 | 51 |
Research and development expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | 661 | 514 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | $ 1,098 | $ 336 |
SHARE-BASED COMPENSATION (Det_5
SHARE-BASED COMPENSATION (Detail Textuals) | Apr. 07, 2021USD ($)$ / sharesshares | Jan. 04, 2021USD ($)$ / sharesshares | Aug. 23, 2021USD ($)$ / sharesshares | Apr. 21, 2021USD ($)$ / sharesshares | Nov. 30, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($)shares | Apr. 20, 2020USD ($)$ / sharesshares | Mar. 16, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2021₪ / shares | Dec. 31, 2021USD ($)shares | Dec. 31, 2020₪ / shares | Jul. 02, 2018₪ / sharesshares | Mar. 17, 2013₪ / shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Ordinary share, par value | ₪ / shares | ₪ 0.0000769 | ₪ 0.0000769 | |||||||||||||
Ordinary shares available for future grant | 289,638 | ||||||||||||||
Number of additional ordinary shares authorized | 1,440,220 | ||||||||||||||
Number of options to purchase ordinary shares | 1,975,586 | 570,362 | |||||||||||||
Exercise price of options granted | $ / shares | $ 1.95 | $ 1.98 | |||||||||||||
Aggregate intrinsic value of outstanding options | $ | $ 2,378,000 | ||||||||||||||
Aggregate intrinsic value of exercisable options | $ | $ 146,000 | ||||||||||||||
Stock-based compensation expenses | $ | $ 1,861,000 | $ 901,000 | |||||||||||||
Investor relations services agreement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Restricted Share Units vested | 21,000 | ||||||||||||||
Investor relations services agreement | Restricted Stock Units (RSUs) | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Fair value of options at the date of grant | $ | $ 53 | ||||||||||||||
Certain employees | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 213,000 | 201,600 | |||||||||||||
Exercise price of options granted | $ / shares | $ 3.61 | $ 2.14 | |||||||||||||
Vestion period | 4 years | 4 years | |||||||||||||
Fair value of options at the date of grant | $ | $ 646,000 | $ 590 | |||||||||||||
Certain employees | Vest on the first anniversary of the date of grant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 25.00% | 25.00% | |||||||||||||
Certain employees | Vest in twelve equal quarterly installments following the first anniversary of the applicable grant date | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 75.00% | 75.00% | |||||||||||||
Service Provider | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 70,000 | 7,500 | |||||||||||||
Exercise price of options granted | $ / shares | $ 3.61 | $ 2.14 | |||||||||||||
Vestion period | 4 years | 4 years | |||||||||||||
Fair value of options at the date of grant | $ | $ 646,000 | $ 590 | |||||||||||||
Service Provider | Vest on the first anniversary of the date of grant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 25.00% | 25.00% | |||||||||||||
Service Provider | Vest in twelve equal quarterly installments following the first anniversary of the applicable grant date | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 75.00% | 75.00% | |||||||||||||
Executive Officer | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 345,000 | 250,000 | |||||||||||||
Exercise price of options granted | $ / shares | $ 3.15 | $ 2.14 | |||||||||||||
Vestion period | 4 years | 4 years | |||||||||||||
Fair value of options at the date of grant | $ | $ 1,140,000 | $ 590 | |||||||||||||
Executive Officer | Vest on the first anniversary of the date of grant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 25.00% | 25.00% | |||||||||||||
Executive Officer | Vest in twelve equal quarterly installments following the first anniversary of the applicable grant date | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 75.00% | 75.00% | |||||||||||||
Former CEO | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 31,502 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 1.98 | ||||||||||||||
Vestion period | 4 years | ||||||||||||||
Fair value of options at the date of grant | $ | $ 37 | ||||||||||||||
Former CEO | Vest on the first anniversary of the date of grant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 25.00% | ||||||||||||||
Former CEO | Vest in twelve equal quarterly installments following the first anniversary of the applicable grant date | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 75.00% | ||||||||||||||
Consultant | Investor relations services agreement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Monthly fee | $ | $ 5 | ||||||||||||||
Consultant | Investor relations services agreement | Restricted Stock Units (RSUs) | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Restricted Share Units granted | 28,000 | ||||||||||||||
Consultant | Amendment to business development services agreement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 79,760 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 1.06 | ||||||||||||||
Fair value of options at the date of grant | $ | $ 35 | ||||||||||||||
Monthly fee | $ | $ 5 | ||||||||||||||
Consultant | Shares vested on the signing date | Investor relations services agreement | Restricted Stock Units (RSUs) | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Restricted Share Units vested | 7,000 | ||||||||||||||
Consultant | Vest in three equal installments until January 8, 2021 | Investor relations services agreement | Restricted Stock Units (RSUs) | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Restricted Share Units vested | 21,000 | ||||||||||||||
Chief Executive Officer | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 1,314,218 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 1.24 | ||||||||||||||
Fair value of options at the date of grant | $ | $ 1,320,000 | ||||||||||||||
Chief Executive Officer | Vest on the first anniversary of the date of grant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 25.00% | ||||||||||||||
Chief Executive Officer | Vest in twelve equal quarterly installments following the first anniversary of the applicable grant date | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Vesting percentage | 75.00% | ||||||||||||||
Non-executive director | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 33,368 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 3.61 | ||||||||||||||
Vestion period | 3 years | ||||||||||||||
Fair value of options at the date of grant | $ | $ 104,000 | ||||||||||||||
Non-executive director | Vest over twelve equal quarterly instalments starting on January 1, 2022 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 752,899 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 2.815 | ||||||||||||||
Vestion period | 3 years | ||||||||||||||
Fair value of options at the date of grant | $ | $ 195,000 | ||||||||||||||
Non-executive director | Vest over four equal quarterly instalments starting on January 1, 2022 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Number of options to purchase ordinary shares | 250,964 | ||||||||||||||
Exercise price of options granted | $ / shares | $ 2.815 | ||||||||||||||
Vestion period | 1 year | ||||||||||||||
Fair value of options at the date of grant | $ | $ 65,000 | ||||||||||||||
2013 Plan | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Ordinary share, par value | ₪ / shares | ₪ 0.000769 | ||||||||||||||
2018 Plan | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Ordinary share, par value | ₪ / shares | ₪ 0.0000769 | ||||||||||||||
Number of ordinary shares authorized | 1,371,398 |
INCOME TAX (Details)
INCOME TAX (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Loss (income) before income taxes | $ 12,246 | $ 11,196 |
Entera Bio Ltd | ||
Operating Loss Carryforwards [Line Items] | ||
Loss (income) before income taxes | 12,362 | 11,283 |
Entera Bio Inc | ||
Operating Loss Carryforwards [Line Items] | ||
Loss (income) before income taxes | $ (116) | $ (87) |
INCOME TAX (Details 1)
INCOME TAX (Details 1) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
Total current income tax | $ 158 | $ 20 |
Deferred: | ||
Total deferred income tax | 217 | 0 |
Total tax on income | (59) | 20 |
Subsidiary | ||
Current: | ||
Total current income tax | 158 | 20 |
Deferred: | ||
Total deferred income tax | $ (217) | $ 0 |
INCOME TAX (Details 2)
INCOME TAX (Details 2) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | |||
Net operating loss carry forward | $ 12,895 | $ 10,176 | |
Research and development | 1,319 | 1,316 | |
Share-based compensation | 876 | 688 | |
Other | 152 | 240 | |
Net deferred tax assets before valuation allowance | 15,242 | 12,420 | |
valuation allowance | (15,025) | (12,420) | $ (9,718) |
Net deferred tax assets | $ 217 | $ 0 |
INCOME TAX (Details 3)
INCOME TAX (Details 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Opening balance | $ 12,420 | $ 9,718 |
Additions | 2,605 | 2,702 |
Closing balance | $ 15,025 | $ 12,420 |
INCOME TAX (Detail Textuals)
INCOME TAX (Detail Textuals) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Carryforward losses | $ 56.1 | $ 44.2 |
Israeli tax rate [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Income tax rate | 23.00% | |
Foreign Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Income tax rate | 29.00% |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accounts payable - other: | ||
Employees and employees related | $ 147 | $ 144 |
Income tax | 134 | 0 |
Provision for vacation | 308 | 263 |
Accrued expenses | 2,212 | 923 |
Accrued Liabilities and Other Liabilities, Total | $ 2,801 | $ 1,330 |
REVENUE FROM COLLABORATION AN_2
REVENUE FROM COLLABORATION AND LICENSE AGREEMENT (Detail Textuals) - USD ($) $ in Thousands | Dec. 10, 2018 | Jan. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Disaggregation of Revenue [Line Items] | ||||||
Revenues | $ 571 | $ 365 | ||||
Amgen Inc [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Milestone payments | $ 270,000 | |||||
Amount to be paid for preclinical services | $ 450 | 450 | ||||
Non-refundable and non-creditable initial technology access fee payment | $ 725 | |||||
Selling price of preclinical R&D services | 225 | |||||
Right to use intellectual property | $ 500 | |||||
Research and development service expense | $ 450 | |||||
Contract liabilities | 15 | 158 | ||||
Amgen Inc [Member] | Intellectual Property [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Revenues | $ 500 | |||||
Service [Member] | Amgen Inc [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Revenues | $ 502 | $ 365 |