Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2022 shares | |
Cover [Abstract] | |
Entity Registrant Name | ENTERA BIO LTD. |
Document Type | 10-Q |
Document Period End Date | Jun. 30, 2022 |
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 | 28,809,922 |
Document Fiscal Year Focus | 2022 |
Document Fiscal Period Focus | Q2 |
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 Quarterly Report | true |
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 |
CONDENCED CONSOLIDATED BALANCE
CONDENCED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 17,279 | $ 24,892 | |
Accounts receivable | 225 | 183 | |
Other current assets | 922 | 254 | |
TOTAL CURRENT ASSETS | 18,426 | 25,329 | |
NON-CURRENT ASSETS: | |||
Property and equipment, net | 166 | 156 | |
Operating lease right-of-use assets | 170 | 239 | |
Deferred income taxes | 280 | 217 | |
Funds in respect of employee rights upon retirement | 46 | 46 | |
TOTAL NON-CURRENT ASSETS | 662 | 658 | |
TOTAL ASSETS | 19,088 | 25,987 | |
CURRENT LIABILITIES: | |||
Accounts payable | 109 | 166 | |
Accrued expenses and other payables | 1,411 | 2,801 | |
Current maturities of operating lease | 172 | 179 | |
Contract liabilities | 0 | 15 | |
TOTAL CURRENT LIABILITIES | 1,692 | 3,161 | |
NON-CURRENT LIABILITIES: | |||
Operating lease liabilities | 5 | 123 | |
Liability for employee rights upon retirement | 122 | 138 | |
TOTAL NON-CURRENT LIABILITIES | 127 | 261 | |
TOTAL LIABILITIES | 1,819 | 3,422 | |
COMMITMENTS AND CONTINGENCIES | |||
SHAREHOLDERS' EQUITY: | |||
Ordinary Shares, NIS 0.0000769 par value: Authorized - as of June 30, 2022 and December 31, 2021, 140,010,000 shares; issued and outstanding: - as of June 30, 2022 and December 31, 2021, 28,809,922 and 28,804,411 shares, respectively | [1] | ||
Additional paid-in capital | 106,623 | 104,950 | |
Accumulated other comprehensive income | 41 | 41 | |
Accumulated deficit | (89,395) | (82,426) | |
TOTAL SHAREHOLDERS' EQUITY | 17,269 | 22,565 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 19,088 | $ 25,987 | |
[1]Represents an amount less than one thousand US dollars |
CONDENCED CONSOLIDATED BALANC_2
CONDENCED CONSOLIDATED BALANCE SHEETS (Parentheticals) (Unaudited) - ₪ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 28,809,922 | 28,804,411 |
Ordinary shares, outstanding | 28,809,922 | 28,804,411 |
CONDENCED CONSOLIDATED STATEMEN
CONDENCED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
REVENUES | $ 44 | $ 109 | $ 112 | $ 266 |
COST OF REVENUES | 33 | 99 | 87 | 172 |
GROSS PROFIT | 11 | 10 | 25 | 94 |
OPERATING EXPENSES: | ||||
Research and development | 1,394 | 1,227 | 3,084 | 2,351 |
General and administrative | 1,880 | 1,364 | 4,052 | 2,674 |
Other income | (14) | (11) | (27) | (22) |
TOTAL OPERATING EXPENSES | 3,260 | 2,580 | 7,109 | 5,003 |
OPERATING LOSS | 3,249 | 2,570 | 7,084 | 4,909 |
FINANCIAL (INCOME) LOSS ,NET | (60) | 24 | (104) | (5) |
LOSS BEFORE INCOME TAX | 3,189 | 2,594 | 6,980 | 4,904 |
INCOME TAX BENEFIT | (4) | (17) | (11) | (31) |
NET LOSS | $ 3,185 | $ 2,577 | $ 6,969 | $ 4,873 |
LOSS PER SHARE BASIC | $ 0.11 | $ 0.1 | $ 0.24 | $ 0.21 |
LOSS PER SHARE DILUTED | $ 0.11 | $ 0.1 | $ 0.24 | $ 0.21 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC LOSS PER SHARE | 28,808,023 | 24,716,608 | 28,806,217 | 23,377,668 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF DILUTED LOSS PER SHARE | 28,808,023 | 24,716,608 | 28,806,217 | 23,377,668 |
CONDENCED CONSOLIDATED STATEM_2
CONDENCED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Ordinary shares [Member] | Additional paid-in capital [Member] | Accumulated other Comprehensive income [Member] | Accumulated deficit [Member] | Total | |
Balance at Dec. 31, 2020 | [1] | $ 77,708 | $ 41 | $ (70,239) | $ 7,510 | |
BALANCE (in shares) at Dec. 31, 2020 | 21,057,922 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (4,873) | (4,873) | |
Issuance of shares due to the ATM program, net of issuance costs | [1] | 19,342 | 0 | 0 | 19,342 | |
Issuance of shares due to the ATM program, net of issuance costs (in shares) | 3,946,265 | |||||
Exercise of options to ordinary shares | [1] | 275 | 0 | 0 | 275 | |
Exercise of options to ordinary shares (in shares) | 99,974 | |||||
Exercise of warrants to ordinary shares | [1] | 3,158 | 0 | 0 | 3,158 | |
Exercise of warrants to ordinary shares (in shares) | 3,175,050 | |||||
Share-based compensation | $ 0 | 865 | 0 | 0 | 865 | |
Vested restricted share units | $ 0 | 0 | 0 | 0 | 0 | |
Vested restricted share units (in shares) | 7,000 | |||||
BALANCE (in shares) at Jun. 30, 2021 | 28,286,211 | |||||
Balance at Jun. 30, 2021 | [1] | 101,348 | 41 | (75,112) | 26,277 | |
Balance at Mar. 31, 2021 | [1] | 88,144 | 41 | (72,535) | 15,650 | |
BALANCE (in shares) at Mar. 31, 2021 | 23,776,785 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (2,577) | (2,577) | |
Issuance of shares due to the ATM program, net of issuance costs | [1] | 9,484 | 0 | 0 | 9,484 | |
Issuance of shares due to the ATM program, net of issuance costs (in shares) | 1,400,000 | |||||
Exercise of options to ordinary shares | [1] | 48 | 0 | 0 | 48 | |
Exercise of options to ordinary shares (in shares) | 28,594 | |||||
Exercise of warrants to ordinary shares | [1] | 3,134 | 0 | 0 | 3,134 | |
Exercise of warrants to ordinary shares (in shares) | 3,080,832 | |||||
Share-based compensation | $ 0 | 538 | 0 | 0 | 538 | |
BALANCE (in shares) at Jun. 30, 2021 | 28,286,211 | |||||
Balance at Jun. 30, 2021 | [1] | 101,348 | 41 | (75,112) | 26,277 | |
Balance at Dec. 31, 2021 | [1] | 104,950 | 41 | (82,426) | 22,565 | |
BALANCE (in shares) at Dec. 31, 2021 | 28,804,411 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (6,969) | (6,969) | |
Exercise of options to ordinary shares | [1] | 13 | 0 | 0 | 13 | |
Exercise of options to ordinary shares (in shares) | 5,511 | |||||
Share-based compensation | $ 0 | 1,660 | 0 | 0 | 1,660 | |
BALANCE (in shares) at Jun. 30, 2022 | 28,809,922 | |||||
Balance at Jun. 30, 2022 | [1] | 106,623 | 41 | (89,395) | 17,269 | |
Balance at Mar. 31, 2022 | [1] | 105,914 | 41 | (86,210) | 19,745 | |
BALANCE (in shares) at Mar. 31, 2022 | 28,804,411 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (3,185) | (3,185) | |
Exercise of options to ordinary shares | [1] | 13 | 0 | 0 | 13 | |
Exercise of options to ordinary shares (in shares) | 5,511 | |||||
Share-based compensation | $ 0 | 696 | 0 | 0 | 696 | |
BALANCE (in shares) at Jun. 30, 2022 | 28,809,922 | |||||
Balance at Jun. 30, 2022 | [1] | $ 106,623 | $ 41 | $ (89,395) | $ 17,269 | |
[1]Represents an amount less than one thousand US dollars. |
CONDENCED CONSOLIDATED STATEM_3
CONDENCED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||
Net loss | $ (3,185) | $ (2,577) | $ (6,969) | $ (4,873) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||
Depreciation | 32 | 24 | ||
Deferred income taxes | (63) | (109) | ||
Share-based compensation | 1,660 | 865 | ||
Finance income, net | (71) | (4) | ||
Changes in operating asset and liabilities: | ||||
Decrease (increase) in accounts receivable | (42) | 139 | ||
Increase in other current assets | (704) | (602) | ||
Increase (decrease) in accounts payable | (57) | 125 | ||
Increase (decrease) in accrued expenses and other payables | (1,390) | 143 | ||
Decrease in contract liabilities | (15) | (150) | ||
Net cash used in operating activities | (7,619) | (4,442) | ||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||
Purchase of property and equipment | (42) | 0 | ||
Net cash used in investing activities | (42) | 0 | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||
Proceeds from issuance of shares through ATM programs, net of issuance costs | 0 | 19,342 | ||
Exercise of options and warrants into shares | 13 | 3,433 | ||
Net cash provided by financing activities | 13 | 22,775 | ||
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (7,648) | 18,333 | ||
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE PERIOD | 24,964 | 8,663 | ||
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE PERIOD | 17,316 | 26,996 | 17,316 | 26,996 |
Reconciliation in amounts on consolidated balance sheets: | ||||
Cash and cash equivalents | 17,279 | 26,926 | 17,279 | 26,926 |
Restricted deposits included in other current assets | 37 | 70 | 37 | 70 |
Total cash and cash equivalents and restricted cash | $ 17,316 | $ 26,996 | 17,316 | 26,996 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||||
Operating lease right of use assets obtained in exchange for new operating lease liabilities | $ 0 | $ 31 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 - DESCRIPTION OF BUSINESS: a. Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 under the laws of the State of Israel and commenced operation on June 1, 2010. On January 8, 2018 the Company incorporated Entera Bio Inc., a wholly owned subsidiary incorporated in Delaware, United States.The Company is a leader in the development of orally delivered macromolecule therapeutics, including peptides and other therapeutic proteins. The Company applies its platform 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 clinical development. Additionally, the Company intends to license its oral delivery technology to biopharmaceutical companies for use with their proprietary compounds. Entera established such a collaboration with Amgen Inc. (“Amgen”) in December 2018, for the use of the Company’s oral delivery platform in the field of inflammatory diseases. b. The Company's ordinary shares, NIS 0.0000769 par value per share (“ordinary shares”), have been listed for trading on the Nasdaq Capital Market since the Company’s initial public offering in July 2018, in which total of 1,400,000 ordinary shares and 1,400,000 warrants to purchase up to 700,000 ordinary shares were issued in consideration for net proceeds of $9.6 million, after deducting offering expenses. c. On December 10, 2018, the Company entered into a research collaboration and license agreement (the “Amgen Agreement”) with Amgen for the use of the Company’s oral delivery platform in the field of inflammatory disease and other serious illnesses. Pursuant to the Amgen Agreement, the Company and Amgen have agreed to 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 Amgen Agreement. 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 has retained all intellectual property rights to its drug delivery technology, and Amgen has retained all rights to its large molecules and any subsequent improvements, and ownership of certain intellectual property developed through the performance of the agreement is to be determined by U.S. patent law. d. Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred accumulated losses in the amount of $89.4 million through June 30, 2022 and negative cash flows from operating activities. The Company's management is of the opinion that its available funds as of June 30, 2022 will allow the Company to operate under its current plans through the second quarter of 2023. These factors raise substantial doubt as to the Company's ability to continue as a going concern. Management is in the process of evaluating various financing alternatives in the public or private equity markets or through the license of the Company's technology 1 e. 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 adjusted its operations to co-exist with the pandemic and has encouraged its employees to get vaccinated against COVID-19. Though the Company sees great progress to overcome the COVID-19 pandemic, 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. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Basis of presentation of the financial statements These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2022, the consolidated results of operations, statements of changes in shareholders' equity for the three and six-month periods ended June 30, 2022 and 2021 and cash flows for the six-month periods ended June 30, 2022 and 2021. The consolidated results for the three and six-month periods ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2021 as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 8, 2022. The comparative balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for annual financial statements. b. Loss per share Basic loss per share is computed on the basis of the net loss for the period, divided by the weighted average number of outstanding ordinary shares during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include options and warrants, exercisable into 6,326,180 shares and 7,804,106 shares for the six months ended June 30, 2022 and 2021, respectively and 6,473,863 shares and 7,718,887 shares for the three months ended June 30, 2022 and 2021, respectively, because the effect would be anti-dilutive. c. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements 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 adoption of this guidance did not have material impact on the Company’s 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 adoption of this guidance did not have material impact on the Company’s consolidated financial statements. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 3 - SHARE-BASED COMPENSATION: a. 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 members 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 members 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. b. On March 31, 2022, the Company’s Board of Directors approved option grants to purchase 115,000 ordinary shares to certain executive officers and 20,000 options granted to a service provider, in each case with an exercise price of $2.86 per share. The options vest over four 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 $147. Of these options, 55,000 are subject to the approval of the shareholders of the Company and as such, are not included as part of the fair value. c. On April 28, 2022, the Company’s Board of Directors approved options grants to purchase 220,000 ordinary shares to employees with an exercise price of $2.57 per share. The options vest over four 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 $364. d. On May 11, 2022, the Company’s Board of Directors approved a grant of options to purchase 500,000 ordinary shares to the Company’s Chief Financial Officer, who has since been appointed the Company’s Chief Executive Officer. These options have an exercise price of $2.02 per share and vest over four 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 are subject to the approval of the shareholders of the Company. 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: Six months ended June 30, 2022 Exercise price $2.57-$2.86 Dividend yield - Expected volatility 69%-70% Risk-free interest rate 1.35%-2.87% Expected life - in years 5.5-6.5 e. On June 15, 2022 the Company signed on a separation agreement with Dr. Phillip Schwartz, the Company’s former President of R&D, under which he agreed to continue to provide services to the Company until July 21, 2022 (the “Separation Date”). Pursuant to the terms of the separation agreement and subject to approval of the Company’s shareholders, Dr. Schwartz is entitled to receive a full acceleration of the options to purchase 100,000 ordinary shares granted in April 2021, such that 68,750 outstanding options to acquire ordinary shares that not already vested will be deemed to have vested as of the Separation date. These options, together with 357,500 options to purchase ordinary shares, granted in 2017 will remain exercisable, consistent with the original exercise periods. In addition, the separation agreement provides for the following payments to Dr. Schwartz, all of which would have otherwise been payable in accordance with either Israeli law or pursuant to his existing employment agreement: a one-time cash separation payment in an amount equal to NIS 537,600 (approximately $155,900) and additional payments of approximately NIS 737,771 (approximately $213,952) in respect of all other ongoing accrued benefits, subject to any mandatory deductions. The foregoing payments were recognized in the research and development expenses. |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 6 Months Ended |
Jun. 30, 2022 | |
Supplementary Financial Statement Information [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 4 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: June 30, December 31, Accrued expenses and other payables: 2022 2021 Employees and employees related 182 147 Income tax 20 134 Provision for vacation 260 308 Accrued expenses 949 2,212 1,411 2,801 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 5 - SUBSEQUENT EVENTS: a. On July 15, 2022, the Company’s Board of Directors appointed Ms. Miranda Toledano as the Company’s new CEO and approved a grant of additional (see also note 3d) options to purchase 600,000 ordinary shares at an exercise price of $1.40 per share. The options vest over four 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 applicable grant date. In addition, upon the occurrence of a Triggering Event (as defined below), the Board of Directors will grant Ms. Toledano options to purchase 200,000 ordinary shares. "Triggering Event" shall mean the earlier of the following events: (i) the execution by the Company of a binding strategic or partnership agreement with a strategic partner to fund the Company's Phase III FDA Trial; or (b) raising sufficient funding to complete the Company's Phase III FDA Trial, in each case as such event was approved by the Board of Directors. The foregoing option grants are subject to the Company’s shareholders' approval. b. On July 15, 2022, the Company entered into a mutual separation agreement with Dr. Spiros Jamas, the Company’s former CEO. Pursuant to the separation agreement, Dr. Jamas received the following benefits: (i) a one-time lump sum payment of his annual base salary for a period of 13 months, for a total gross amount equal to $411,666.67; and (ii) an extension of the exercise period for the vested portion of the options granted to Dr. Jamas on January 4, 2021, representing collectively 492,832 ordinary shares, through the end of a two-year period commencing on July 15, 2022. All of Dr. Jamas’ remaining unvested options, totaling 821,386 options, were forfeited. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation of the financial statements | a. Basis of presentation of the financial statements These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2022, the consolidated results of operations, statements of changes in shareholders' equity for the three and six-month periods ended June 30, 2022 and 2021 and cash flows for the six-month periods ended June 30, 2022 and 2021. The consolidated results for the three and six-month periods ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2021 as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 8, 2022. The comparative balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for annual financial statements. |
Loss per share | b. Loss per share Basic loss per share is computed on the basis of the net loss for the period, divided by the weighted average number of outstanding ordinary shares during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include options and warrants, exercisable into 6,326,180 shares and 7,804,106 shares for the six months ended June 30, 2022 and 2021, respectively and 6,473,863 shares and 7,718,887 shares for the three months ended June 30, 2022 and 2021, respectively, because the effect would be anti-dilutive. |
Newly issued and recently adopted accounting pronouncements | c. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements 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 adoption of this guidance did not have material impact on the Company’s 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 adoption of this guidance did not have material impact on the Company’s consolidated financial statements. |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value assumptions of option granted using Black-Scholes option-pricing model | Six months ended June 30, 2022 Exercise price $2.57-$2.86 Dividend yield - Expected volatility 69%-70% Risk-free interest rate 1.35%-2.87% Expected life - in years 5.5-6.5 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Table) | 6 Months Ended |
Jun. 30, 2022 | |
Supplementary Financial Statement Information [Abstract] | |
Schedule of accounts payable and accrued liabilities | June 30, December 31, Accrued expenses and other payables: 2022 2021 Employees and employees related 182 147 Income tax 20 134 Provision for vacation 260 308 Accrued expenses 949 2,212 1,411 2,801 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Detail Textuals) $ in Thousands | 6 Months Ended | ||||
Jun. 30, 2022 USD ($) | Jun. 30, 2022 ₪ / shares | Jun. 30, 2022 USD ($) shares | Dec. 31, 2021 ₪ / shares | Dec. 31, 2021 USD ($) | |
General [Line Items] | |||||
Ordinary share, par value | ₪ / shares | ₪ 0.0000769 | ₪ 0.0000769 | |||
Number of warrants issued | 1,400,000 | ||||
Number of ordinary shares will be purchased by exercising warrants | 700,000 | ||||
Net proceeds from share issuance | $ | $ 9,600 | ||||
Accumulated deficit | $ | $ (89,395) | $ (82,426) | |||
Ordinary shares [Member] | |||||
General [Line Items] | |||||
Number of shares issued | 1,400,000 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Detail Textuals) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Significant Accounting Policies [Line Items] | ||||
Number of antidilutive securities excluded from computation of earnings per share | 6,473,863 | 7,718,887 | 6,326,180 | 7,804,106 |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Details) | 6 Months Ended |
Jun. 30, 2022 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ 2.57 |
Expected volatility | 69% |
Risk-free interest rate | 1.35% |
Expected life - in years | 5 years 6 months |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ 2.86 |
Expected volatility | 70% |
Risk-free interest rate | 2.87% |
Expected life - in years | 6 years 6 months |
SHARE-BASED COMPENSATION (Det_2
SHARE-BASED COMPENSATION (Detail Textuals) $ / shares in Units, ₪ in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
May 11, 2022 $ / shares shares | Jun. 15, 2022 ILS (₪) shares | Jun. 15, 2022 USD ($) shares | Apr. 28, 2022 USD ($) $ / shares shares | Aug. 23, 2021 USD ($) $ / shares shares | Apr. 30, 2021 shares | Mar. 31, 2022 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Ordinary shares available for future grant | 55,000 | ||||||
Description of terms of share-based payment arrangement | The options vest over four 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 $147. | ||||||
Vestion period | 4 years | ||||||
Fair value of options at the date of grant | $ | $ 147 | ||||||
Service Provider [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted to purchase ordinary shares | 20,000 | ||||||
Exercise price of options granted | $ / shares | $ 2.86 | ||||||
Executive Officer [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted to purchase ordinary shares | 115,000 | ||||||
Exercise price of options granted | $ / shares | $ 2.86 | ||||||
Non-executive director [Member] | Vest over twelve equal quarterly instalments starting on January 1, 2022 [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted 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 | ||||||
Non-executive director [Member] | Vest over four equal quarterly instalments starting on January 1, 2022 [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted 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 | ||||||
Employee [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Description of terms of share-based payment arrangement | The options vest over four 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. | ||||||
Number of additional options granted to purchase ordinary shares | 220,000 | ||||||
Exercise price of options granted | $ / shares | $ 2.57 | ||||||
Vestion period | 4 years | ||||||
Fair value of options at the date of grant | $ | $ 364 | ||||||
Chief Financial Officer [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Description of terms of share-based payment arrangement | These options have an exercise price of $2.02 per share and vest over four 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. | ||||||
Number of additional options granted to purchase ordinary shares | 500,000 | ||||||
Exercise price of options granted | $ / shares | $ 2.02 | ||||||
Vestion period | 4 years | ||||||
President of R&D [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Cash separation payment | ₪ 537,600 | $ 155,900 | |||||
Additional cash separation payment | ₪ 737,771 | $ 213,952 | |||||
President of R&D [Member] | 2021 Grant [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted to purchase ordinary shares | 100,000 | 100,000 | |||||
President of R&D [Member] | 2017 Grant [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional options granted to purchase ordinary shares | 357,500 | 357,500 | 68,750 |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued expenses and other payables: | ||
Employees and employees related | $ 182 | $ 147 |
Income tax | 20 | 134 |
Provision for vacation | 260 | 308 |
Accrued expenses | 949 | 2,212 |
Accrued expenses and other payables, total | $ 1,411 | $ 2,801 |
SUBSEQUENT EVENTS (Detail Textu
SUBSEQUENT EVENTS (Detail Textuals) - USD ($) | 3 Months Ended | |
Jul. 15, 2022 | Mar. 31, 2022 | |
Subsequent Event [Line Items] | ||
Vestion period | 4 years | |
Description of terms of share-based payment arrangement | The options vest over four 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 $147. | |
Subsequent Event [Member] | Chief Executive Officer [Member] | ||
Subsequent Event [Line Items] | ||
Number of additional options granted to purchase ordinary shares | 600,000 | |
Exercise price of options granted | $ 1.4 | |
Vestion period | 4 years | |
Description of terms of share-based payment arrangement | The options vest over four 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 applicable grant date. | |
Subsequent Event [Member] | Chief Executive Officer [Member] | Triggering event [Member] | ||
Subsequent Event [Line Items] | ||
Number of additional options granted to purchase ordinary shares | 200,000 | |
Subsequent Event [Member] | Former CEO [Member] | ||
Subsequent Event [Line Items] | ||
Number of additional options granted to purchase ordinary shares | 492,832 | |
Vestion period | 2 years | |
Number of unvested options forfeited | 821,386 | |
One-time cash termination payment | $ 411,666,670 |