Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 01, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | ENTERA BIO LTD. | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2023 | |
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 | 28,813,952 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
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 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 10,691 | $ 12,309 | |
Accounts receivable | 29 | 246 | |
Other current assets | 653 | 294 | |
TOTAL CURRENT ASSETS | 11,373 | 12,849 | |
NON-CURRENT ASSETS: | |||
Property and equipment, net | 136 | 139 | |
Operating lease right-of-use assets | 48 | 90 | |
Deferred income taxes | 43 | 43 | |
Funds in respect of employee rights upon retirement | 6 | 6 | |
TOTAL NON-CURRENT ASSETS | 233 | 278 | |
TOTAL ASSETS | 11,606 | 13,127 | |
CURRENT LIABILITIES: | |||
Accounts payable | 150 | 17 | |
Accrued expenses and other payables | 1,296 | 1,233 | |
Current maturities of operating lease | 48 | 91 | |
TOTAL CURRENT LIABILITIES | 1,494 | 1,341 | |
NON-CURRENT LIABILITIES: | |||
Liability for employee rights upon retirement | 32 | 32 | |
TOTAL NON-CURRENT LIABILITIES | 32 | 32 | |
TOTAL LIABILITIES | 1,526 | 1,373 | |
COMMITMENTS AND CONTINGENCIES | |||
SHAREHOLDERS' EQUITY: | |||
Ordinary Shares, NIS 0.0000769 par value: Authorized - as of March 31, 2023 and December 31, 2022, 140,010,000 shares; issued and outstanding - as of March 31, 2023 and December 31, 2022, 28,809,922 | [1] | ||
Additional paid-in capital | 107,726 | 107,210 | |
Accumulated other comprehensive income | 41 | 41 | |
Accumulated deficit | (97,687) | (95,497) | |
TOTAL SHAREHOLDERS' EQUITY | 10,080 | 11,754 | |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 11,606 | $ 13,127 | |
[1]Represents an amount less than one thousand US dollars |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parentheticals) - ₪ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 28,809,922 |
Ordinary shares, outstanding | 28,809,922 | 28,809,922 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
REVENUES | $ 0 | $ 68 |
COST OF REVENUES | 0 | 54 |
GROSS PROFIT | 0 | 14 |
OPERATING EXPENSES: | ||
Research and development | 931 | 1,690 |
General and administrative | 1,294 | 2,171 |
Other income | (13) | (12) |
TOTAL OPERATING EXPENSES | 2,212 | 3,849 |
OPERATING LOSS | 2,212 | 3,835 |
FINANCIAL INCOME, NET | (22) | (44) |
LOSS BEFORE INCOME TAX | 2,190 | 3,791 |
INCOME TAX BENEFIT | 0 | (7) |
NET LOSS | $ 2,190 | $ 3,784 |
LOSS PER SHARE BASIC | $ 0.08 | $ 0.13 |
LOSS PER SHARE DILUTED | $ 0.08 | $ 0.13 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC LOSS PER SHARE | 28,809,922 | 28,804,411 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF DILUTED LOSS PER SHARE | 28,809,922 | 28,804,411 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED 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, 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 | (3,784) | (3,784) | |
Share-based compensation | $ 0 | 964 | 0 | 0 | 964 | |
Balance (in shares) at Mar. 31, 2022 | 28,804,411 | |||||
Balance at Mar. 31, 2022 | [1] | 105,914 | 41 | (86,210) | 19,745 | |
Balance at Dec. 31, 2022 | [1] | 107,210 | 41 | (95,497) | 11,754 | |
Balance (in shares) at Dec. 31, 2022 | 28,809,922 | |||||
CHANGES DURING THE YEAR ENDED | ||||||
Net loss | $ 0 | 0 | 0 | (2,190) | (2,190) | |
Share-based compensation | $ 0 | 516 | 0 | 0 | 516 | |
Balance (in shares) at Mar. 31, 2023 | 28,809,922 | |||||
Balance at Mar. 31, 2023 | [1] | $ 107,726 | $ 41 | $ (97,687) | $ 10,080 | |
[1]Represents an amount less than one thousand U.S. dollars. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (2,190) | $ (3,784) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 14 | 16 |
Deferred income taxes | 0 | (33) |
Share-based compensation | 516 | 964 |
Finance income, net | (3) | (39) |
Changes in operating asset and liabilities: | ||
Decrease (increase) in accounts receivable | 217 | (27) |
Increase in other current assets | (359) | (1,099) |
Increase in accounts payable | 133 | 33 |
Increase (decrease) in accrued expenses and other payables | 63 | (808) |
Decrease in contract liabilities | 0 | (15) |
Net cash used in operating activities | (1,609) | (4,792) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (11) | (23) |
Net cash used in investing activities | (11) | (23) |
DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS | (1,620) | (4,815) |
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE PERIOD | 12,376 | 24,964 |
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE PERIOD | 10,756 | 20,149 |
Reconciliation in amounts on consolidated balance sheets: | ||
Cash and cash equivalents | 10,691 | 20,109 |
Restricted deposits included in other current assets | 65 | 40 |
Total cash and cash equivalents and restricted deposits | $ 10,756 | $ 20,149 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2023 | |
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 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 clinical development. Additionally, the Company intends to license its oral delivery technology to biopharmaceutical companies for use with their proprietary compounds. b. The Company's ordinary shares, NIS 0.0000769 par value per share (“ordinary shares”), have been listed on the Nasdaq Capital Market since July 2018 under the symbol “ENTX”. c. On December 10, 2018, the Company entered into a research collaboration and license agreement with Amgen (the “Amgen Agreement”) 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 had agreed to use the Company’s proprietary drug delivery platform to develop oral formulations for one preclinical large molecule program that Amgen had selected. Amgen is responsible for the clinical development, regulatory approval, manufacturing and worldwide commercialization of the programs. On May 2, 2023, the Company and Amgen agreed to terminate the Amgen Agreement in accordance with its terms, effective on such date. 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 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 an accumulated deficit in the amount of $97.7million as of March 31, 2023 and negative cash flows from operating activities. The Company's management is of the opinion that its available funds as of March 31, 2023 will allow the Company to operate under its current plans into the third quarter of 2024. This assumes the use of the Company’s capital to fund its ongoing operations, including R&D and the completion of the Phase 1 study related to the new formulation EB612. This does not include the capital required to fund the Company's proposed Phase 3 study for EB613 in osteoporosis and comparative study. 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, debt financing and strategic collaborations, as the Company will need to finance future research and development activities, general and administrative expenses and working capital through fund raising. However, there is no certainty about the Company's ability to obtain such funding. The financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023, and the consolidated results of operations, statements of changes in shareholders' equity and cash flows for the three-month periods ended March 31, 2023 and 2022. The consolidated results for the three-month period ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023. 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, 2022, as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2023. The comparative balance sheet at December 31, 2022 has been derived from the audited annual 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, adjusted to recognize the effect of a down-round feature when it is triggered, for the period divided by the weighted average number of outstanding ordinary shares during the period. c. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements adopted 1) 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 is effective for Smaller Reporting Companies (as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. The adoption of this guidance did not have material impact on the Company’s consolidated financial statements. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 3 - SHARE-BASED COMPENSATION On January 2, 2023, options to purchase an aggregate of 534,246 ordinary shares were granted to six non-executive board members with an exercise price of $0.73 per share which was the share price on the grant day. The options vest over one year in four equal quarterly installments starting on the date of grant. This grant was approved by the shareholders of the Company on October 4, 2021. The fair value of the options at the date of grant was $253. 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: Three months ended March 31, 2023 Exercise price $ 0.73 Dividend yield - Expected volatility 74 % Risk-free interest rate 3.98 % Expected life - in years 5.3 |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 3 Months Ended |
Mar. 31, 2023 | |
Supplementary Financial Statement Information [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 4 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: March 31, December 31, Accrued expenses and other payables: 2023 2022 Employees and employees related 182 154 Provision for vacation 163 146 Accrued expenses 951 933 1,296 1,233 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 5 - SUBSEQUENT EVENTS a. In April 2023, the Company entered into an amendment to its office lease agreement from 2014 to extended the period of the lease agreement for additional five years, expiring on June 30, 2028, with two options for early termination subject to a notice period. The monthly lease fee is a total of $15. b. On April 24, 2023, the Company’s Board of Directors approved the following option grants: i. Options to purchase 851,000 ordinary shares to employees, executive officers and service providers with an exercise price of $0.795 per share. ii. Options to purchase 350,000 ordinary shares to the Company’s Chief Executive Officer with an exercise price of $0.795 per share. This grant is subject to shareholders' approval. These 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. iii. Options to purchase 30,000 ordinary shares to a service provider with an exercise price of $0.795 per share. These options vest immediately at the service inception date. c. On May 2, 2023, the Company and Amgen agreed to terminate the Amgen Agreement in accordance with its terms, effective on such date. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023, and the consolidated results of operations, statements of changes in shareholders' equity and cash flows for the three-month periods ended March 31, 2023 and 2022. The consolidated results for the three-month period ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023. 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, 2022, as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2023. The comparative balance sheet at December 31, 2022 has been derived from the audited annual 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, adjusted to recognize the effect of a down-round feature when it is triggered, for the period divided by the weighted average number of outstanding ordinary shares during the period. |
Newly issued and recently adopted accounting pronouncements | c. Newly issued and recently adopted accounting pronouncements: Recently issued accounting pronouncements adopted 1) 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 is effective for Smaller Reporting Companies (as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. 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) | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value assumptions of option granted using Black-Scholes option-pricing model | Three months ended March 31, 2023 Exercise price $ 0.73 Dividend yield - Expected volatility 74 % Risk-free interest rate 3.98 % Expected life - in years 5.3 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Table) | 3 Months Ended |
Mar. 31, 2023 | |
Supplementary Financial Statement Information [Abstract] | |
Schedule of accounts payable and accrued liabilities | March 31, December 31, Accrued expenses and other payables: 2023 2022 Employees and employees related 182 154 Provision for vacation 163 146 Accrued expenses 951 933 1,296 1,233 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Detail Textuals) $ in Thousands | Mar. 31, 2023 ₪ / shares | Mar. 31, 2023 USD ($) | Dec. 31, 2022 ₪ / shares | Dec. 31, 2022 USD ($) |
General [Line Items] | ||||
Ordinary share, par value | ₪ / shares | ₪ 0.0000769 | ₪ 0.0000769 | ||
Accumulated deficit | $ | $ (97,687) | $ (95,497) |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Detail Textuals) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Significant Accounting Policies [Line Items] | ||
Number of antidilutive securities excluded from computation of earnings per share | 7,116,583 | 6,238,605 |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Detail Textuals) - Non-executive board members [Member] $ / shares in Units, $ in Thousands | Jan. 02, 2023 USD ($) $ / shares shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of options to purchase ordinary shares | shares | 534,246 |
Exercise price of options granted | $ / shares | $ 0.73 |
Vestion period | 1 year |
Fair value of options at the date of grant | $ | $ 253 |
SHARE-BASED COMPENSATION (Det_2
SHARE-BASED COMPENSATION (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ 0.73 |
Dividend yield | 0% |
Expected volatility | 74% |
Risk-free interest rate | 3.98% |
Expected life - in years | 5 years 3 months 18 days |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued expenses and other payables: | ||
Employees and employees related | $ 182 | $ 154 |
Provision for vacation | 163 | 146 |
Accrued expenses | 951 | 933 |
Accrued expenses and other payables, total | $ 1,296 | $ 1,233 |
SUBSEQUENT EVENTS (Detail Textu
SUBSEQUENT EVENTS (Detail Textuals) - Subsequent Events [Member] - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |
Apr. 24, 2023 | Apr. 30, 2023 | |
Subsequent Event [Line Items] | ||
Vestion period | 4 years | |
Employees Executive Officers And Service Providers [Member] | ||
Subsequent Event [Line Items] | ||
Number of options to purchase ordinary shares | 851,000 | |
Option to purchase, exercise price | $ 0.795 | |
Chief Executive Officer [Member] | ||
Subsequent Event [Line Items] | ||
Number of options to purchase ordinary shares | 350,000 | |
Option to purchase, exercise price | $ 0.795 | |
Service Provider [Member] | ||
Subsequent Event [Line Items] | ||
Number of options to purchase ordinary shares | 30,000 | |
Option to purchase, exercise price | $ 0.795 | |
Office Lease Agreement [Member] | ||
Subsequent Event [Line Items] | ||
Agreement term | 5 years | |
Agreement expiration date | June 30, 2028 | |
Agreement termination description | two options for early termination subject to a notice period. | |
Monthly lease fee | $ 15 | |
First Anniversary [Member] | ||
Subsequent Event [Line Items] | ||
Option to issue vesting percentage | 25% | |
Second Anniversary [Member] | ||
Subsequent Event [Line Items] | ||
Option to issue vesting percentage | 75% |