Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2020shares | |
Document Information Line Items | |
Entity Registrant Name | Enlivex Therapeutics Ltd. |
Trading Symbol | ENLV |
Document Type | 20-F |
Current Fiscal Year End Date | --12-31 |
Entity Common Stock, Shares Outstanding | 14,587,934 |
Amendment Flag | false |
Entity Central Index Key | 0001596812 |
Entity Current Reporting Status | Yes |
Entity Voluntary Filers | No |
Entity Filer Category | Accelerated Filer |
Entity Well-known Seasoned Issuer | No |
Document Period End Date | Dec. 31, 2020 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | FY |
Entity Emerging Growth Company | false |
Entity Shell Company | false |
Entity File Number | 001-36578 |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 14 Einstein Street |
Entity Address, City or Town | Nes Ziona |
Entity Address, Country | IL |
Entity Address, Postal Zip Code | 7403618 |
Title of 12(b) Security | Ordinary Shares, par value of NIS 0.40 |
Security Exchange Name | NASDAQ |
Entity Interactive Data Current | Yes |
Document Accounting Standard | U.S. GAAP |
Document Annual Report | true |
Document Registration Statement | false |
Document Shell Company Report | false |
Document Transition Report | false |
Business Contact [Member] | |
Document Information Line Items | |
Entity Address, Address Line One | 14 Einstein Street |
Entity Address, City or Town | Nes Ziona |
Entity Address, Country | IL |
Entity Address, Postal Zip Code | 7403618 |
Contact Personnel Name | Mr. Oren Hershkovitz |
City Area Code | +972 |
Local Phone Number | 2.6208072 |
Contact Personnel Email Address | Oren@enlivexpharm.com |
Contact Personnel Fax Number | +972.2.6208070 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents (notes 2d, 3) | $ 5,673 | $ 3,948 |
Short term deposits (note 4) | 30,034 | 8,060 |
Prepaid expenses and other receivables | 1,164 | 913 |
Restricted cash | 79 | 100 |
Cash held with respect to CVR Agreement (notes 3,8) | 1,171 | 1,400 |
Receivables for the sale of Trehalose (note 8) | 2,000 | |
Total Current Assets | 38,121 | 16,421 |
Non-Current Assets | ||
Property and equipment, net (notes 2f, 5) | 1,481 | 648 |
Other assets (notes 2h, 6, & 9) | 756 | 491 |
Total Non-Current Assets | 2,237 | 1,139 |
TOTAL ASSETS | 40,358 | 17,560 |
Current Liabilities | ||
Accounts payable trade (note 14) | 463 | 316 |
Accrued expenses and other liabilities (note 7) | 2,738 | 2,264 |
CVR holders (note 8) | 1,171 | 3,400 |
Total Current Liabilities | 4,372 | 5,980 |
Non-Current Liabilities | ||
Other long-term Liabilities (notes 2h, 9) | 499 | 298 |
Total Non-Current Liabilities | 499 | 298 |
Commitments and Contingent Liabilities (note 10) | ||
TOTAL LIABILITIES | 4,871 | 6,278 |
SHAREHOLDERS’ EQUITY | ||
Ordinary shares of NIS 0.40 ($0.11) par value: (note 11) Authorized: 45,000,000 shares as of December 31, 2020 and 2019; Issued and outstanding:14,587,934 and 10,334,126 as of December 31, 2020 and 2019; | 1,646 | 1,151 |
Additional paid in capital | 70,361 | 37,104 |
Foreign currency translation adjustments (note 2c) | 977 | (1,300) |
Accumulated deficit | (37,497) | (25,673) |
TOTAL SHAREHOLDERS’ EQUITY | 35,487 | 11,282 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 40,358 | $ 17,560 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) | Dec. 31, 2020$ / sharesshares | Dec. 31, 2020₪ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2019₪ / sharesshares |
Statement of Financial Position [Abstract] | ||||
Common stock, par value (in Dollars per share) | (per share) | $ 0.11 | ₪ 0.40 | $ 0.11 | ₪ 0.40 |
Common stock, shares authorized | 45,000,000 | 45,000,000 | 45,000,000 | 45,000,000 |
Common stock, shares issued | 14,587,934 | 14,587,934 | 10,334,126 | 10,334,126 |
Common stock, shares outstanding | 14,587,934 | 14,587,934 | 10,334,126 | 10,334,126 |
Common stock, par value (in New Shekels per share) | (per share) | $ 0.11 | ₪ 0.40 | $ 0.11 | ₪ 0.40 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Revenues (note 2k) | |||
Operating expenses: | |||
Research and development expenses, net (notes 2l, 16a) | 6,086 | 5,604 | 4,013 |
General and administrative expenses (note 16b) | 3,699 | 3,015 | 1,286 |
Total operating expenses | 9,785 | 8,619 | 5,299 |
Operating (loss) | (9,785) | (8,619) | (5,299) |
Financial income (note 16c) | 225 | 238 | 1,060 |
Financial expenses (note 16d) | (2,264) | (1,003) | (3) |
Net (loss) | (11,824) | (9,384) | (4,242) |
Other comprehensive gain (loss) | |||
Interest on convertible notes | |||
Exchange differences arising from translating financial statements from functional to presentation currency (note 2c) | 2,277 | 951 | (748) |
Total other comprehensive gain (loss) | 2,277 | 951 | (748) |
Total comprehensive (loss) | $ (9,547) | $ (8,433) | $ (4,990) |
Basic & diluted (loss) per share (note 2p) (in Dollars per share) | $ (0.90) | $ (1.11) | $ (1.40) |
Weighted average number of shares outstanding (in Shares) | 13,169,208 | 8,649,486 | 3,509,346 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity - USD ($) $ in Thousands | Ordinary Shares | Preferred Shares | Additional paid in capital | Currency translation adjustments | Accumulated deficit | Total | |||
Balance at Dec. 31, 2017 | $ 396 | $ 465 | $ 21,182 | $ (1,503) | $ (12,047) | $ 8,493 | |||
Balance (in Shares) at Dec. 31, 2017 | 3,509,344 | 4,433,534 | |||||||
Issuance of Preferred Shares for cash consideration of $5,350 net of $156 issuance costs | $ 59 | 5,135 | 5,194 | ||||||
Issuance of Preferred Shares for cash consideration of $5,350 net of $156 issuance costs (in Shares) | 525,171 | ||||||||
Exercise of options | [1] | [1] | [1] | ||||||
Exercise of options (in Shares) | 61 | ||||||||
Stock based compensation | 1,009 | 1,009 | |||||||
Other comprehensive gain/loss | (748) | (748) | |||||||
Net loss | (4,242) | (4,242) | |||||||
Balance at Dec. 31, 2018 | $ 396 | $ 524 | 27,326 | (2,251) | (16,289) | 9,706 | |||
Balance (in Shares) at Dec. 31, 2018 | 3,509,405 | 4,958,705 | |||||||
Conversion of Preferred Shares to Ordinary Shares | $ 605 | $ (524) | (81) | ||||||
Conversion of Preferred Shares to Ordinary Shares (in Shares) | 5,479,547 | (4,958,705) | |||||||
Issuance of shares upon exercise of warrants | $ 2 | 247 | 249 | ||||||
Issuance of shares upon exercise of warrants (in Shares) | 20,348 | ||||||||
Issuance of shares for cash consideration of $8,362 net of $655 issuance costs | $ 76 | 7,631 | 7,707 | ||||||
Issuance of shares for cash consideration of $8,362 net of $655 issuance costs (in Shares) | 682,631 | ||||||||
Shares issued in conjunction with share option exercise | $ 25 | 574 | 599 | ||||||
Shares issued in conjunction with share option exercise (in Shares) | 221,641 | ||||||||
Issuance of shares in connection with the merger | $ 47 | 597 | 644 | ||||||
Issuance of shares in connection with the merger (in Shares) | 420,554 | ||||||||
Stock based compensation | 810 | 810 | |||||||
Other comprehensive gain/loss | 951 | 951 | |||||||
Net loss | (9,384) | (9,384) | |||||||
Balance at Dec. 31, 2019 | $ 1,151 | 37,104 | (1,300) | (25,673) | 11,282 | ||||
Balance (in Shares) at Dec. 31, 2019 | 10,334,126 | ||||||||
Issuance of shares and warrants for cash consideration of $26,968 net of $2,501 issuance costs | $ 382 | 24,085 | 24,467 | ||||||
Issuance of shares and warrants for cash consideration of $26,968 net of $2,501 issuance costs (in Shares) | 3,286,416 | ||||||||
Exercise of options | $ 4 | 97 | 101 | ||||||
Exercise of options (in Shares) | 37,746 | ||||||||
Exercise of warrants | $ 109 | 8,405 | 8,514 | ||||||
Exercise of warrants (in Shares) | 929,646 | ||||||||
Stock based compensation | 670 | 670 | |||||||
Other comprehensive gain/loss | 2,277 | 2,277 | |||||||
Net loss | (11,824) | (11,824) | |||||||
Balance at Dec. 31, 2020 | $ 1,646 | $ 70,361 | $ 977 | $ (37,497) | $ 35,487 | ||||
Balance (in Shares) at Dec. 31, 2020 | 14,587,934 | ||||||||
[1] | Less than $1 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Shareholders' Equity (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Stockholders' Equity [Abstract] | |||
Cash consideration | $ 26,968 | $ 8,362 | $ 5,350 |
Issuance costs | $ 2,501 | $ 655 | $ 156 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Cash flows from operating activities | ||||
Net (loss) | $ (11,824) | $ (9,384) | $ (4,242) | |
Adjustments required to reflect net cash used in operating activities: | ||||
Depreciation | 286 | 206 | 121 | |
Non-cash operating lease expense | 167 | 168 | ||
Decrease in retirement benefit obligations | (7) | |||
Loss on sale of property and equipment | 75 | |||
Share-based compensation | 670 | 810 | 1,009 | |
Changes in fair value of warrants exercisable into shares | 51 | (132) | ||
Changes in operating asset and liability items: | ||||
(Increases) decrease in prepaid expenses and other receivables | 1,823 | 318 | (423) | |
Increase (decrease) in accounts payable trade | 36 | 114 | 145 | |
Increase (decrease) in accrued expenses and other liabilities | (2,022) | 775 | 361 | |
Operating lease liabilities | (143) | (167) | ||
Net cash (used in) operating activities | (11,007) | (7,041) | (3,161) | |
Cash flows from investing activities | ||||
Purchase of property and equipment | (1,019) | (193) | (461) | |
Proceeds from sale of property and equipment | 4 | |||
Investment in short-term bank deposits, net | (19,958) | (7,714) | (40) | |
Net cash, cash equivalents and restricted cash received in the issuance of shares for the net assets of Bioblast Pharma Ltd. | 1,544 | |||
Net cash provided by (used in) investing activities | (20,977) | (6,359) | (501) | |
Cash flows from financing activities | ||||
Proceeds from issuance of shares and warrants, net | 24,467 | 7,707 | 5,194 | |
Proceeds from exercise of warrants | 8,514 | |||
Proceeds from exercise of options | 101 | 599 | [1] | |
Net cash provided by financing activities | 33,082 | 8,306 | 5,194 | |
Increase in cash, cash equivalents and restricted cash | 1,098 | (5,094) | 1,532 | |
Cash, cash equivalents and restricted cash - beginning of year | 5,524 | 9,792 | 9,032 | |
Exchange rate differences on cash, cash equivalents and restricted cash | 390 | 826 | (772) | |
Cash, cash equivalents and restricted cash - end of year | 7,012 | 5,524 | 9,792 | |
Non-cash transactions: | ||||
Warrants issued in settlement of issuance costs to a placement agent | 564 | |||
Conversion of preferred stock to ordinary shares | 525 | |||
Conversion of 6% preference on preferred shares to ordinary shares | 2,071 | |||
Issuance of ordinary shares upon exercise of warrants | 249 | |||
Issuance of shares to the former shareholders of Bioblast Pharma Ltd. | 47 | |||
Net assets acquired in the issuance of shares for the net assets of Bioblast Pharma Ltd. excluding cash, cash equivalents and restricted cash: | ||||
Assets acquired | (2,632) | |||
Less - liabilities assumed | 3,532 | |||
Net assets acquired in the issuance of shares for the net assets of Bioblast Pharma Ltd. excluding cash, cash equivalents and restricted cash | 900 | |||
Supplemental disclosures of cash flow information: | ||||
Cash paid for taxes | ||||
Cash received for interest, net | $ 160 | $ 112 | $ 138 | |
[1] | Less than $1 |
General Information
General Information | 12 Months Ended |
Dec. 31, 2020 | |
General Information [Abstract] | |
GENERAL INFORMATION | NOTE 1 – GENERAL INFORMATION a. General Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “ Company Merger As a result of the Merger, the financial statements of the Company prior to the Merger are the historical financial statements of Enlivex R&D whereas the financial statements of the Company after the Merger reflect the results of the consolidated operations. Enlivex R&D was incorporated in September 2005 under the laws of the State of Israel. The Company is a clinical stage immunotherapy company, developing Allocetra TM The Allocetra TM In January 2015, Bioblast Pharma Inc. was established in the State of Delaware as a wholly owned subsidiary of the Parent. On July 1, 2020 Bioblast Pharma Inc changed its name to Enlivex Therapeutics Inc. The Company’s ordinary shares, NIS 0.40 per share (“Ordinary Shares” or “ordinary shares”), are traded under the symbol “ENLV” on both the Nasdaq Capital Market and on the Tel Aviv Stock Exchange. b. Financial resources The Company devotes substantially all of its efforts toward research and development activities and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations. Research and development activities have required significant capital investment since the Company’s inception. The Company expects its operations to continue to require cash investment to pursue the Company’s research and development activities, including preclinical studies, formulation development, clinical trials and related drug manufacturing. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company’s has experienced net losses since its inception, and, as of December 31, 2020, had accumulated deficit of $37.5 million. The Company raised $29.5 million (before deducting placement agent fees and offering expenses) in conjunction with securities offerings during 2020 and additional $8.6 million from exercises of options and warrants. However, the Company expects to continue to incur additional losses for at least the next several years and over that period the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay part of its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses. The Company’s management and board of directors are of the opinion that its current financial resources will be sufficient to continue the development of the Company’s products for at least twelve months from the filing of the Company’s Annual Report on Form 20-F for the year ended December 31, 2020, of which these audited consolidated financial statements form a part. The Company may determine, however, to raise additional capital during such period as its Board of Directors deems prudent. The Company’s management plans to finance the Company’s operations with issuances of its equity securities and, in the longer term, revenues. There are no assurances, however, that the Company will be successful in obtaining an adequate level of financing needed for its long-term development. The Company’s ability to continue to operate in the long term is dependent upon additional financial support. Based on the Company’s current assessment, the Company does not expect any material impact on its development timeline or its liquidity due to currently ongoing COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, will depend on future developments that are highly uncertain as of the date of issuance of these consolidated financial statements. Actual results could differ from the Company’s estimates. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation The Company’s audited consolidated financial statements as of December 31, 2020 and 2019, and for each of the years in the three-year period ended December 31, 2020, have been prepared in conformity with accounting principles generally accepted in the United States (“ U.S. GAAP The financial statements have been prepared on the basis of historical cost, subject to adjustment of financial assets and liabilities to their fair value through profit or loss. The Company classifies its expenses on the statement of comprehensive loss based on the operating characteristics of such expenses. b. Use of estimates The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions, it also requires that management exercise its judgment in applying the Company’s accounting policies. The Company’s management believes that the estimates, judgments and assumptions used were reasonable based upon information available at the time they were made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts in the statements of operations during each reporting period. Actual results could differ materially from those estimates. c. Functional currency and translation to the reporting currency The functional currency of the Company is the New Israeli Shekel (“ NIS The financial statements of the Company were translated into U.S. dollars in accordance with ASC 830, “Foreign Currency Matters”. Accordingly, assets and liabilities were translated from local currencies to U.S. dollars using year end exchange rates, equity items were translated at the exchange rates of the date of the equity transaction, and income and expense items were translated at average exchange rates during the year. Gains or losses resulting from translation adjustments (which result from translating an entity’s financial statements into U.S. dollars if its functional currency is different than the U.S. dollar) are reported in other comprehensive income (loss). Balances denominated in, or linked to foreign currency are stated on the basis of the exchange rates prevailing at the balance sheet date. For foreign currency transactions included in the statement of income, the exchange rates applicable on the relevant transaction dates are used. Transaction gains or losses arising from changes in the exchange rates used in the translation of such balances are carried to financing income or expenses as applicable. The following table presents data regarding the U.S. dollar exchange rate: 2020 2019 2018 At December 31, 1 U.S. $ = NIS 3.215 NIS 3.456 NIS 3.748 Increase (decrease) during the year (7.0 )% (7.8 )% 8.1 % Average yearly exchange rates NIS 3.442 NIS 3.564 NIS 3.595 d. Cash and cash equivalents Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at acquisition. e. Restricted cash: Amounts included in restricted cash are held in interest bearing saving accounts, represent cash amounts required to be set aside by a contractual agreement for the rental of the Company’s premises and for credit cards and cash amounts required to be set aside by other contractual agreements. f. Property and equipment Property and equipment are stated at historical cost less depreciation. Assets are depreciated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: % Computers 33 Office furniture and equipment 7 Leasehold improvements 16.67 Laboratory equipment 15-33 g. Impairment of non-financial assets The long-lived assets of the Company are reviewed for impairment in accordance with ASC 360, “Property, Plant, and Equipment”, whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset with the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. During the years 2020, 2019, and 2018, no impairment losses were identified. h. Leases In accordance with ASU No. 2016-02, Leases (Topic 842), right-of-use (“ ROU Because most of the Company’s leases do not provide an implicit interest rate, the Company uses its estimated incremental borrowing rate to determine the present value of lease payments. Lease expenses for operating lease payments are recognized on a straight-line basis over the lease term, and the related ROU assets and liabilities are reduced to the present value of the remaining lease payments at the end of each period. Short-term leases (with a term of 12 months or less) are not recorded as ROU assets or liabilities in the consolidated balance sheets. The Company’s lease agreements include rental payments that adjust periodically for inflation and do not contain any material residual value guarantees or material restrictive covenants. i. Stock-based compensation The Company accounts for equity-based compensation awards to employees, directors and nonemployees based on the grant date fair value of those awards. The Company estimates the fair value of stock options using the Black-Scholes option pricing model. Forfeitures are recognized as they occur. The option pricing model requires a number of assumptions. Until the closing of the Merger, there was no market for the Company’s Ordinary Shares, consequently the Company utilized third-party valuations to estimate the fair value of its Ordinary Shares. For the estimation of the expected volatility of the Company’s share price, the Company used the historical volatility of comparable companies in the industry with characteristics similar to the Company, including stage of product development and focus on the life science industry. The expected term of options granted represents the period of time that options granted are expected to be outstanding, the company uses management’s estimates for the expected term of options due to insufficient readily available historical exercise data. The risk-free interest rate is based on the yield rates of U.S. Government Treasury Bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. j. Employee benefits The Company is required by Israeli law to make severance payments to Israeli employees upon their dismissal or termination of employment in certain circumstances. The Company operates a number of post-employment defined contribution plans. A defined contribution plan is a program that benefits an employee after termination of employment, under which the Company regularly makes fixed payments to a fund administered by a separate and independent entity so that the Company has no legal or constructive obligation to pay additional contributions if such fund does not contain sufficient assets to pay all employees the benefits to which they may be entitled relating to employee service in the current and prior periods. The fund assets are not included in the Company’s consolidated balance sheets. The Company operates pension and severance compensation plans subject to Section 14 of the Israeli Severance Pay Law. The plans are funded through payments to insurance companies or pension funds administered by trustees. In accordance with its terms, the plans meet the definition of a defined contribution plan. Short term employee benefits - Labor laws in Israel entitle every employee to vacation days, paid sick leave and recreation pay, computed annually. The Company recognizes a liability and an expense in respect of vacation and recreation pay based on the individual entitlement of each employee. k. Revenue Recognition The Company has not yet generated any revenue from product sales or otherwise. l. Research and development expenses, net Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including clinical trials, manufacturing costs, consulting fees and facilities and overhead costs. All costs associated with research and developments are expensed as incurred. As of December 31, 2020, the Company had not yet capitalized development expenses. Grants received from Israel Innovation Authority, Ministry of Industry, Trade and Labor (the “ IIA m. General and administrative General and administrative expenses consist of compensation and related benefits, including stock-based compensation, for executive and corporate personnel; professional and consulting fees; and allocated overhead such as facilities and equipment rent and maintenance, insurance costs allocated to general and administrative expenses, costs of patent applications, maintenance, depreciation expense, marketing costs, and other miscellaneous expenses which are allocated to general and administrative expense. n. Patents The Company expenses all costs associated with patents for product candidates under development as incurred. As a result of the Company’s research and development efforts, the Company is applying for a number of patents to protect proprietary technology and inventions. To date, the Company has not capitalized patent costs. The Company recorded a charge to operations of approximately $374 thousand, $120 thousand and $242 thousand for the years ended December 31, 2020, 2019 and 2018, respectively, related to patent costs. o. Income taxes The Company accounts for income taxes in accordance with ASC 740-10 “Accounting for Income Taxes”. This Statement requires the use of the liability method of accounting for income taxes, whereby deferred tax asset and liability account balances are determined based on the differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. As the Company is currently engaged primarily in development activities and is not expected to generate taxable income in the foreseeable future, the Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value. ASC 740 contains a two-step approach to recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2020, the Company recorded a liability of $682 thousand for uncertain tax positions. The Company does not expect that the amounts of uncertain tax positions will change significantly within the next year. p. Loss per share Basic loss per share is calculated based on the weighted average number of ordinary shares outstanding during each year. Diluted net loss per share is calculated based on the weighted average number of ordinary shares outstanding during each year, plus dilutive potential shares in accordance with ASC 260, “Earnings per Share.” All outstanding preferred stock, options and warrants for the years ended December 31, 2020, 2019 and 2018 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for all years presented. For the years ended December 31, 2020, 2019 and 2018, the total weighted average number of shares related to outstanding potential shares excluded from the calculations of diluted net loss per share was 3,526,214, 3,247,127 and 8,638,789, respectively. The following data show the amounts used in computing income (loss) per share and the effect on income (loss): Year ended December 31, (in thousands except share and per share data) 2020 2019 2018 Basic and diluted (loss) per share: (Loss) from continuing operations $ (11,824 ) $ (9,384 ) $ (4,242 ) Interest of 6% to Cumulative Preferred Stock - (198 ) (659 ) $ (11,824 ) $ (9,582 ) $ (4,901 ) Number of common shares at the beginning of the year 10,334,126 3,509,405 3,509,344 Weighted average number of shares issued for cash 2,603,763 518,295 - Weighted average number of shares issued in connection with the merger - 322,617 - Weighted average number of stock options exercised 21,749 80,073 2 Weighted average number of warrants exercised 209,570 15,609 - Weighted average number of shares issued in connection with conversion of Preferred Shares - 4,203,487 - Number of shares used in per share computation 13,169,208 8,649,486 3,509,346 Basic and diluted net (loss) per share $ (0.90 ) $ (1.11 ) $ (1.40 ) q. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, restricted cash and cash held with respect to CVR Agreement (as defined in Note 8). Cash and cash equivalents and restricted cash are invested in major banks in Israel. Cash held with respect to CVR Agreement is deposited in a trust account with a private investment house. Such deposits in Israel are not insured. Management believes that the financial institutions that hold the Company’s investments are financially sound and, accordingly, minimal credit risk exists with respect to these investments. The Company has no foreign exchange contracts or any other hedging arrangements. r. Fair value of financial instruments The Company applies ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), pursuant to which fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. The financial instruments presented on the balance sheet at fair value are grouped into classes with similar characteristics using the following fair value hierarchy which is determined based on the source of input used in measuring fair value: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 - inputs other than quoted prices included within level 1 that are observable either directly or indirectly. Level 3 - inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). The Company’s warrants, exercised to ordinary shares prior to the Merger in 2019, were classified as level 3 in the fair value hierarchy and measured at fair value on a recurring basis. s. Comprehensive income (loss) Comprehensive loss is the change in shareholders’ equity from transactions and other events and circumstances other than those resulting from investments by shareholders and distributions to shareholders. The Company accounts for comprehensive income (loss) in accordance with ASC 220, “Comprehensive Income”. This statement establishes standards for the reporting and display of comprehensive income (loss) and its components in a full set of general-purpose financial statements. The Company’s other comprehensive income (loss) is currently comprised of gains or losses resulting from translation adjustments which result from translating the Company’s financial statements into U.S. dollars when its functional currency is different than the U.S. dollar. t. Reclassification Certain comparative figures have been reclassified to conform to the current year presentation. Such reclassifications did not have any significant impact on the Company’s equity, net income or cash flows. u. Recently Issued Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures, the adoption of this ASU is not expected to have a material impact on its consolidated financial statements. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provides optional guidance to ease the potential burden in accounting due to reference rate reform. The guidance in this update provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments apply only to contracts and hedging relationships that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. These amendments are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into on or before December 31, 2022. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements. v. Recently Adopted Accounting Standards In August 2018, the Financial Accounting Standards Board (“ FASB In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification determines whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company adopted this standard on January 1, 2019. |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 12 Months Ended |
Dec. 31, 2020 | |
Cash and Cash Equivalents [Abstract] | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH | NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheet that sum to the total of the same such amounts shown in the statement of cash flows. December 31, (in thousands) 2020 2019 Cash held in banks $ 1,173 $ 937 Bank deposits in U.S.$ with original maturities of three months or less (annual average interest rates 0.32% and 1.8%) 4,500 3,011 Total cash and cash equivalents 5,673 3,948 Cash held with respect to CVR Agreement, see note 8 1,171 1,400 Short term restricted cash 79 100 Long-term restricted cash 89 76 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 7,012 $ 5,524 |
Short Term Deposits
Short Term Deposits | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
SHORT TERM DEPOSITS | NOTE 4 – SHORT TERM DEPOSITS December 31, (in thousands) 2020 2019 Bank deposits in U.S.$ (annual average interest rates 0.6% and 2.1%) $ 30,034 $ 8,060 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 5 – PROPERTY AND EQUIPMENT Property and equipment, net consists of the following: December 31, (in thousands) 2020 2019 Cost Laboratory equipment $ 1,256 $ 782 Computers 169 94 Office furniture & equipment 102 36 Leasehold improvements 712 152 Total cost 2,239 1,064 Accumulated depreciation Laboratory equipment 588 340 Computers 87 51 Office furniture & equipment 5 1 Leasehold improvements 78 24 Total accumulated depreciation 758 416 Depreciated cost $ 1,481 $ 648 For the years ended December 31, 2020, 2019 and 2018, depreciation expenses were $286 thousand, $206 thousand and $121 thousand, respectively. |
Other Assets
Other Assets | 12 Months Ended |
Dec. 31, 2020 | |
Other Assets [Abstract] | |
OTHER ASSETS | NOTE 6 – OTHER ASSETS December 31, (in thousands) 2020 2019 Restricted cash $ 89 $ 76 Long-term prepaid expenses 8 5 Right-of-Use assets, net 659 410 $ 756 $ 491 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES AND OTHER LIABILITIES | NOTE 7 – ACCRUED EXPENSES AND OTHER LIABILITIES December 31, (in thousands) 2020 2019 Vacation, convalescence and employees’ bonus accruals $ 684 $ 318 Employees and payroll related 352 274 Short term operating lease liabilities 203 123 Accrued expenses and other 1,499 1,549 $ 2,738 $ 2,264 |
Reverse Merger with Bioblast Ph
Reverse Merger with Bioblast Pharma Ltd. | 12 Months Ended |
Dec. 31, 2020 | |
Reverse Merger With Bioblast Pharma Disclosure [Abstract] | |
REVERSE MERGER WITH BIOBLAST PHARMA LTD. | NOTE 8 – REVERSE MERGER WITH BIOBLAST PHARMA LTD. As described in Note 1, the Merger completed between Enlivex R&D and Parent was accounted for as an issuance of shares by Enlivex R&D for the net assets of the Parent, accompanied by a recapitalization. Enlivex R&D was considered the acquirer for accounting and financial reporting purposes and acquired the assets and assumed the liabilities of the Parent, and Enlivex R&D gained control of the combined company after the merger. The annual consolidated financial statements of the Company reflect the operations of the acquirer for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the former shareholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. The annual consolidated financial statements include the accounts of the Company and its subsidiary since the effective date of the Merger and the accounts of Enlivex R&D since inception. Prior to the Merger, on February 19, 2019, the Parent sold its pre-Merger clinical development programs for “Trehalose” to Seelos Therapeutics, Inc. (“Seelos”), a clinical-stage biopharmaceutical company. Under the terms of the agreement between the Parent and Seelos, Seelos paid $1.5 million upon closing and paid an additional $2 million upon the first anniversary of the closing. Seelos has agreed to pay additional milestone payments of up to $17 million upon completion of the related clinical study for Trehalose and approval of a New Drug Application by the FDA, as well as royalties. At the closing of the Merger, the Parent, Enlivex R&D, the Parent’s pre-Merger CEO, as representative of the pre-Merger Parent’s shareholders, and a rights agent entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, the Parent’s shareholders immediately prior to the Merger received one CVR for each of the Parent’s ordinary shares held of record immediately prior to the closing of the Merger. Each CVR represents the right to receive payments based on the Parent’s pre-Merger clinical development programs. CVR holders are entitled to receive 100% of any payments up to $20 million received by the Company and 50% of any subsequent consideration in excess of such amount, in each case, net of all related transaction expenses. The estimated fair value of the total consideration of the Merger was $5,152 thousand based on the shares of the Parent outstanding on the Merger date as adjusted per the merger agreement of 420,554 multiplied by the Company’s share price of $12.25 on the date of the Merger. The excess of the fair value of the consideration paid over the fair value of the net assets acquired as detailed below was $4,508 thousand. The following summarizes the estimated fair value of the assets and liabilities acquired at the date of the merger: (in thousands) Cash and cash equivalents $ 44 Prepaid expenses and other receivables 632 Cash held with respect to CVR Agreement 1,500 Receivables for the sale of Trehalose 2,000 Trade payables (10 ) Due to CVR Holders (3,500 ) Other current liabilities (22 ) $ 644 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
LEASES | NOTE 9 – LEASES The Company elected the transition provision provided by ASU no. 2018-11, Leases (Topic 842) that allows entities to continue to apply the legacy guidance in Topic 840, Leases, including its disclosure requirements, for the comparative periods presented in the year of adoption. Accordingly, the Topic 842 disclosures below are presented only as of the year ended December 31, 2019 and not for any prior period. The Company is a party to operating leases for its corporate offices, laboratory space and vehicles. The Company’s operating leases have remaining lease terms of up to 4.75 years, some of which include options to extend the leases for up to five years. On January 1, 2019, the Company recognized $399 thousand of ROU assets and of lease liabilities on the consolidated balance sheet for operating leases. Year ended December 31, (in thousands) 2020 2019 The components of lease expense were as follows: Operating leases expenses $ 243 $ 192 Supplemental consolidated cash flow information related to operating leases follows: Cash used in operating activities $ 223 $ 188 Non-cash activity: Right of use assets obtained in exchange for new operating lease liabilities $ 398 $ 141 December 31, (in thousands) 2020 2019 Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: Other assets - Right-of-Use assets $ 920 $ 501 Accumulated amortization 261 91 Operating lease Right-of-Use assets, net $ 659 $ 410 Lease liabilities – current - Accounts payable and accrued liabilities $ 203 $ 123 Lease liabilities – noncurrent 499 298 Total operating lease liabilities $ 702 $ 421 Weighted average remaining lease term in years 3.64 3.33 Weighted average annual discount rate 11.9 % 10.7 % (in thousands) Maturities of operating lease liabilities as of December 31, 2020, were as follows: 2021 $ 258 2022 231 2023 182 2024 93 2025 53 Total undiscounted lease liability 817 Less: Imputed interest (115 ) Present value of lease liabilities $ 702 |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES a) Obligation to pay royalties to the State of Israel The Company is required to pay royalties to the State of Israel (represented by the IIA), computed on the basis of proceeds from the sale or license of products which development was supported by State grants. In accordance with the terms of the financial participation, the State is entitled to royalties on the sale or license of any product which development was supported with State participation. These royalties are generally 3% - 5% of sales until repayment of 100% of the grants (linked to the dollar) received by the Company plus annual interest at the LIBOR rate. The aggregate contingent obligation payable by the Company as of December 31, 2020 was approximately $6,303 which represents the gross amount of grants received by the Company from the IIA, including accrued interest as of December 31, 2020. As of December 31, 2020, the Company had not paid any royalties to the IIA. In March 2020, the Company submitted a grant application to the IIA for funding of its clinical development program of prevention of organ dysfunction and cytokine storms associated with COVID-19. The Company’s application for grants of NIS 1,857 thousand ($578 thousand) was approved by the IIA in April 2020 for a period commencing April 1, 2020 and ending March 31, 2021. The approved IIA funding was approximately 30% of the total expenses for the approved clinical program which was executed in Israel. In January 2020, the Company submitted a grant application to the IIA for funding of its clinical development program of prevention of cytokine storms and organ dysfunction associated with Sepsis. The Company’s application for grants of NIS 3,467 thousand ($1 , 078 thousand) was approved by the IIA in April 2020 for a period commencing April 1, 2020 and ending March 31, 2021. The approved IIA funding was approximately 30% of the total expenses for the approved clinical program which was executed in Israel. b) On September 7, 2018 the Company entered into an agreement with its Executive Chairman. Pursuant to the agreement, upon termination of the Chairman’s board service, under certain conditions defined in the agreement, the Executive Chairman will be entitled to receive an amount of up to three times his then annual base retainer plus the value of accrued benefits. As of December 31, 2020, no termination liability was accrued or paid. On June 28, 2020 the Company and the Executive Chairman signed an amendment to the agreement (the “Amendment”) awarding the Executive Chairman, upon the successful completion of a clinical trial conducted by the Company as determined in the Amendment, at any time during the first two calendar years from the date of the Amendment, a special bonus. The special bonus may only be awarded once in any financial year in respect of the successful completion of a Clinical Trial in the same financial year . |
Equity
Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
EQUITY | NOTE 11 – EQUITY a) Ordinary shares confer upon their holders the right to participate and vote in general shareholders’ meetings, to share in the distribution of dividends if declared by the Company and the right to receive assets of the Company upon its liquidation. b) On October 22, 2020, the Company entered into an at the market offering agreement (the “ Sales Agreement c) On March 5, 2020, the Company completed a registered offering pursuant to which certain investors purchased 2,093,750 ordinary shares and 2,093,750 warrants to purchase ordinary shares at a combined offering price of $8 per ordinary share and associated warrant. Net proceeds of the offering were $15,238 thousand after deducting offering expenses. The investors’ warrants are immediately exercisable for 2,093,750 ordinary shares at $9 per share, and will remain exercisable until the two-year anniversary of their date of issuance. The sale of ordinary shares and issuance of warrants qualified for equity treatment under GAAP. The respective values of the warrants and ordinary shares issued to investors were calculated using their relative fair values and classified under ordinary shares and additional paid-in capital. The warrants were valued using a Black-Scholes model with the following assumptions: estimated weighted average volatility 68.24%; weighted average risk-free interest rate of 0.67%; no dividend; and a weighted average contractual expected life of 2 years. The value ascribed to the investors’ warrants was $3,723 thousand and $13,027 thousand to the ordinary shares. In conjunction with the offerings, the Company also issued to the placement agent warrants to purchase up to 146,563 ordinary shares at an exercise price of $10 per share, such warrants have substantially the same terms as the investor warrants, except that the placement agent warrants are exercisable at a price of $10 per share. The placement agent warrants were valued at $232 thousand using a Black-Scholes model with the same assumptions used to estimate the investors’ warrants. The placement agent warrants were accounted for as additional issuance costs and classified under additional paid-in capital. d) On February 26, 2020, the Company completed a registered offering of ordinary shares pursuant to which certain investors purchased 1,000,000 ordinary shares at a price of $8 per share. Net proceeds of the offering were approximately $7,218 thousand after deducting offering expenses. In conjunction with the offering, the Company issued to the placement agent warrants to purchase up to 70,000 ordinary shares at an exercise price of $10 per share, exercisable until the five-year anniversary of their date of issuance. The warrants were valued upon issuance at $331 thousand using a Black-Scholes model with the following assumptions: estimated weighted average volatility 72%; weighted average risk-free interest rate of 1.14%; no dividend; and a weighted average contractual expected life of 5 years. The placement agent warrants were accounted for as additional issuance costs and classified under additional paid-in capital. e) Each of the Company’s warrants entitles the holder to exercise such warrant for one ordinary share and does not confer upon such holder any rights as an ordinary shareholder until such holder exercises such holder’s warrants and acquires the ordinary shares. All warrants issued in the February and March 2020 offerings may be exercisable on a “cashless” basis in certain circumstances, including while there is no effective registration statement registering the ordinary shares issuable upon exercise of the warrants until the expiry of the warrants. Such registration statement was declared effective by the SEC on June 21, 2019. All Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee of value or return. Following is a summary of changes in exercisable ordinary shares warrants during 2020: Number of Warrants Exercise price per share Issuance date Expiration date Outstanding January 1, 2020 27,016 $ 180 March 22, 2016 September 22, 2021 Issued to placement agent 70,000 $ 10 February 26, 2020 February 24, 2025 Issued to investors 2,093,750 $ 9 March 5, 2020 March 5, 2022 Issued to placement agent 146,563 $ 10 March 4, 2020 March 4, 2022 Exercised (147,646 ) $ 10 Exercised (782,000 ) $ 9 Outstanding December 31, 2020 1,407,683 f) As described in footnotes 1 and 8, on March 26, 2019, the Company completed the Merger. In connection with the Merger, all outstanding shares of Enlivex R&D were exchanged for Ordinary Shares at a rate of 0.0484 Ordinary Shares for each share of Enlivex R&D. Also prior to and in connection with the Merger, the Company effected a 1-for-8 reverse stock split and changed the total number of shares of all classes authorized to be issued to 45,000,000 with a par value of NIS 0.40 per share. All historical information presented herein has been retroactively restated to reflect the effect of the Merger exchange ratio and reverse stock split in accordance with Accounting Standards Codification Topic 260, “Earnings Per Share”. Upon consummation of the Merger, all outstanding preferred stock (4,958,705 shares) with $2,070 thousand accrued and unpaid dividends thereon were converted into 5,479,547 Ordinary Shares, and all Enlivex R&D’s outstanding warrants were converted into 20,348 Ordinary Shares. The Company incurred direct Merger-related costs totaling $655 thousand, which were recorded as a reduction to additional paid in capital. In connection with the Merger, the Company entered into substantially identical securities purchase agreements with certain private investors, pursuant to which the investors purchased an aggregate of 682,631 Ordinary Shares for a purchase price of $12.25 per share, totaling $8,362 thousand. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 12 – SHARE-BASED COMPENSATION a) Stock option plan – general In June 2019, the Company adopted the 2019 Equity Incentive Plan, under which all Ordinary Shares that remained available for future grant under all then existing plans were reserved for issuance with respect to awards that may be granted under the 2019 Equity Incentive Plan. As of December 31, 2020, 2,350,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 177,632 shares were available for future grant. Equity Incentive Plans and agreements generally expire after ten years from the date of grant. Upon termination of the optionee’s employment or other relationship with the Company, options cease vesting, vested options forfeit. Ordinary shares underlying options that are canceled or not exercised within the option term become available for future grant. b) Stock option information The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the periods indicated: Year ended December 31, 2020 2019 2018 Weighted Average Risk-free interest rate 0.46% 1.67% 2.81% Dividend yield - - - Weighted Average Volatility factor 76.32% 73.71% 74.73% Weighted Average Expected life of the options 6 5 6 The following table contains additional information concerning options granted under the existing stock-option plans: For the year ended December 31, 2020 2019 2018 Number of options Weighted average exercise price Number of options Weighted exercise price Number of Weighted average exercise price Outstanding at beginning of the year 1,625,042 $ 5.72 1,801,418 $ 4.33 1,658,778 $ 4.11 Granted 360,500 $ 4.46 158,021 $ 8.72 305,244 $ 5.85 Forfeited and expired (63,376 ) $ 6.26 (128,256 ) $ 5.24 (162,543 ) $ 4.96 Exercised (37,746 ) $ 2.69 (221,641 ) $ 2.70 (61 ) $ 2.69 Pre-merger Bioblast options - $ 15,500 $ 90.17 - $ - Outstanding at end of the year 1,884,420 $ 5.52 1,625,042 $ 5.72 1,801,418 $ 4.33 Exercisable at end of the year 1,283,193 $ 5.15 1,098,691 $ 3.71 1,026,582 $ 3.26 Following is a summary of changes in nonvested shares granted: For the year ended December 31, 2020 2019 2018 Number of options Weighted average exercise price Number of options Weighted average exercise price Number of Weighted average exercise price Balance at beginning of the year 526,351 $ 7.03 774,836 $ 5.70 885,879 $ 5.52 Granted 360,500 $ 3.86 158,021 $ 8.72 305,244 $ 5.85 Vested during the year (249,965 ) $ 6.07 (278,250 ) $ 5.21 (257,068 ) $ 4.97 Forfeited during the year (35,659 ) $ 6.24 (128,256 ) $ 5.24 (159,219 ) $ 5.16 Balance at end of the year 601,227 $ 5.93 526,351 $ 7.03 774,836 $ 5.70 The weighted-average fair value at grant date of options granted 2020, 2019 and 2018 were $2.93, $5.29 and $5.98. The total unrecognized estimated compensation cost related to non-vested stock options granted until December 31, 2020 was $1,584, which is expected to be recognized over a weighted average period of 2 years. c) Set forth below is data regarding the range of exercise prices and remaining contractual life (in years) for options outstanding at December 31, 2020: Exercise Price Number of Options Outstanding Average Remaining Contractual Life (in years) Intrinsic Value of Options Outstanding (in thousands) No. of options $ 2.69 685,992 4.51 $ 3,937,594 684,869 $ 3.66 250,000 9.34 $ 1,191,750 55,556 $ 4.68 63,000 9.25 $ 236,250 - $ 6.22 659,861 7.05 $ 1,455,922 480,634 $ 8.19 150,000 8.88 $ 36,000 37,500 $ 9.02 40,500 9.88 $ - - $ 10.12 12,126 7.93 $ - 7,274 $ 12.21 2,421 8.24 $ - 605 $ 21.4 5,020 8.57 $ - 1,255 $ 90.16 15,500 0.69 $ - 15,500 1,884,420 $ 6,857,516 1,283,193 The total intrinsic value of options exercised during 2020 was $217 thousand. d) The following table summarizes share-based compensation expenses related to grants under the Equity Incentive Plan included in the statements of operations: Year ended December 31, (in thousands) 2020 2019 2018 Research & development $ 401 $ 607 $ 862 General & administrative 269 203 147 Total $ 670 $ 810 $ 1,009 |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 13 – TAXES ON INCOME a. The Israeli corporate tax rate is 23%. b. The Company has not been assessed for tax purposes since its incorporation. Tax assessments through the year ended December 31, 2014 are deemed to be final. c. The Parent and its subsidiaries are taxed separately. As of the date of the Merger, the Parent had loss carry-forwards amounting to approximately $45.5 million deductible only against sale of assets and/or activities held by the Parent prior to the merger. As of December 31, 2020, the Parent and Enlivex R&D had losses carry-forward amounting to approximately $5.1 million and $31.4 million, respectively, deductible from future taxable income. These losses carry-forward have no expiration date. d. The components of the provision for income taxes are as follows: Year ended December 31, (in thousands) 2020 2019 2018 Current tax $ - $ - $ - Deferred tax - - - Provision for income taxes, net $ - $ - $ - e. Reconciliation of the theoretical tax expenses: Year ended December 31, (in thousands) 2020 2019 2018 Loss before taxes $ 11,824 $ 9,384 $ 4,242 Statutory tax rate 23 % 23 % 23 % Tax benefit 2,720 2,158 976 Permanent differences 642 (322 ) (237 ) Valuation allowance (3,362 ) (1,836 ) (739 ) Differences in tax rate - - - Tax expenses $ - $ - $ - f. Deferred income taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial purposes and the amounts used for income tax purposes. As of December 31, 2020, the Company had provided a full valuation allowance in respect of deferred tax assets. Management currently believes that because the Company has a history of losses, it is more likely than not that the deferred tax regarding the loss carry-forward and other temporary differences will not be realized for the foreseeable future. Components of the Company’s deferred tax liabilities and assets are as follows: Year ended December 31, (in thousands) 2020 2019 2018 Tax assets in respect of: $ $ $ Accrued employees’ and directors’ compensation 61 136 31 Research and development expenses 1,275 738 609 Net loss carry forward 8,303 4,744 2,743 Total deferred tax assets 9,639 5,618 3,383 Less - valuation allowance (9,639 ) (5,618 ) (3,383 ) Deferred tax assets $ - $ - $ - |
Balances and Transactions with
Balances and Transactions with Related Parties | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
BALANCES AND TRANSACTIONS WITH RELATED PARTIES | NOTE 14 – BALANCES AND TRANSACTIONS WITH RELATED PARTIES a) Related parties’ balances: December 31, (in thousands) 2020 2019 Key management personnel - reported in the accompanying consolidated balance sheets in Current Liabilities - Accounts payable trade $ 175 $ 79 b) Related parties’ transactions On May 12, 2019, the Company entered into a research agreement with its Chief Scientific & Medical Officer under which the executive officer undertook to perform a patients’ study according to the terms defined in the agreement. The agreement will terminate upon the completion of the study according to the study protocol and the submission of all reports and other documentation, or if earlier, upon termination by any of the parties pursuant to the terms of the agreement. In the event of early termination for any reason, the Company shall pay the executive officer the following payments: (i) the agreed remuneration for work performed in accordance with the agreement until the date of termination; and (ii) in the event that the termination is not due to a breach of the agreement by the executive officer, the Company shall reimburse the executive officer for all documented expenses arising from non-cancellable commitments incurred prior to such termination, and (iii), the balance between the aggregate amount of the remuneration and the advance (as defined below) actually paid to the executive officer, and the amount of $816 thousand, in consideration for any expenses incurred by executive officer in preparation for the study. In consideration for the executive officer’s fulfilment of his obligations, the Company has agreed to pay a fixed price for each of the activities performed as defined in the agreement. Upon entering the agreement, the Company paid the executive officer a non-refundable advance in the amount of $125 thousand. Total Research and development expenses related to this agreement and included in the Company’s consolidated statement of operations for the years ended December 31, 2020, 2019 and 2018 were $822 and $251 and $0 thousand. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENT | NOTE 15 – FAIR VALUE MEASUREMENT The Company’s financial assets measured at fair value on a recurring basis, consisted of the following types of instruments as of December 31, 2020, 2019 and 2018: December 31, 2020 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 5,673 $ 5,673 $ - $ - Short term deposits 30,034 30,034 - - Cash held with respect to CVR Agreement 1,171 1,171 Restricted cash 168 168 - - Total financial assets $ 37,046 $ 37,046 $ - $ - December 31, 2019 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 3,948 $ 3,948 $ - $ - Short term deposits 8,060 8,060 - - Cash held with respect to CVR Agreement 1,400 1,400 Restricted cash 176 176 - - Total financial assets $ 13,584 $ 13,584 $ - $ - December 31, 2018 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 9,736 $ 9,736 $ - $ - Short term deposits 40 40 Restricted cash 56 56 - - Total financial assets $ 9,832 $ 9,832 $ - $ - Warrants $ 192 $ - $ - $ 192 Total financial liabilities $ 192 $ - $ - $ 192 |
Supplementary Financial Stateme
Supplementary Financial Statement Information | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 16 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION a. Research and development expenses – net Year ended December 31, (in thousands) 2020 2019 2018 Payroll and related expenses $ 3,183 $ 2,259 $ 1,317 Research and development services 2,438 2,682 874 Materials 612 454 363 Share Based Compensation 401 607 862 Depreciation 273 198 121 Other 394 486 476 7,301 6,686 4,013 Israel Innovation Authority participation in research and development costs and royalties payable (1,215 ) (1,082 ) - $ 6,086 $ 5,604 $ 4,013 b. General and administrative expenses Year ended December 31, (in thousands) 2020 2019 2018 Payroll expenses $ 737 $ 569 $ 343 Compensation to directors 862 526 182 Professional fees 995 845 450 Office maintenance and office expenses 97 145 96 Insurance 486 243 11 Share Based Compensation 269 203 147 Other 253 484 57 $ 3,699 $ 3,015 $ 1,286 c. Financial income Year ended December 31, (in thousands) 2020 2019 2018 Interest income $ 225 $ 238 $ 138 Exchange differences, net - - 790 Net change in fair value warrants - - 132 $ 225 $ 238 $ 1,060 d. Financial expenses Year ended December 31, (in thousands) 2020 2019 2018 Issuance expenses related to warrants $ - $ - $ - Exchange differences, net 2,258 945 - Net change in fair value warrants - 51 - Bank commissions 6 7 3 $ 2,264 $ 1,003 $ 3 |
Events Subsequent to the Balanc
Events Subsequent to the Balance Sheet Date | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE | NOTE 17 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE The Company evaluated all events and transactions that occurred subsequent to the balance sheet date and prior to the date on which these financial statements were issued, and determined that the following events necessitated disclosure : 1. In January 2021, the Company submitted a new grant application to the IIA to approve expenditure of NIS 15 million ($4.7 million) of its clinical development program of prevention of cytokine storms and organ dysfunction associated with Sepsis. 2. Under the Sales Agreement, the Company received additional gross proceeds of approximately $6,339,095 from the sale of 284,317 ordinary shares at an average price per share of approximately $22.29 On February 9, 2021, the Company terminated the prospectus supplement related to the offer and sale of ordinary shares under the Sales Agreement, but the Sales Agreement remains in full force and effect. To that date, the Company had sold an aggregate of 476,983 ordinary shares under the Sales Agreement, having a gross aggregate offering price of $8,557,437 at an average price per share of approximately $17.94. 3. On February 9, 2021, the Company entered into an amended and restated underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) with respect to the offer, issuance and sale (the “Offering”) of an aggregate of 2,296,107 ordinary shares, together with an option granted to Wainwright to purchase up to 344,416 additional ordinary shares. The ordinary shares were offered to the public at a price of $20 per share. The Offering closed on February 12, 2021, on which date the Company completed the issuance of 2,296,107 ordinary shares to Wainwright at a price, including the underwriting discount but before other associated fees, of $18.60 per ordinary share before fees, as set forth in the Underwriting Agreement. In accordance with the Underwriting Agreement, the Company paid Wainwright underwriting discounts and commissions equal to 7% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering, as well as a management fee equal to 1% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering. In addition, the Company issued to Wainwright 179,501 warrants to purchase ordinary shares of the Company (the “Underwriter Warrants”). The Underwriter Warrants are exercisable for five years from commencement of the Offering and have an exercise price of $25 per ordinary share, subject to customary adjustments as provided in the Underwriter Warrants. The Company has also paid Wainwright approximately $126,000 for various expenses. The net proceeds from the Offering were approximately $42.1 million after deducting Wainwright’s fees and other estimated expenses relating to the Offering. On February 17, 2021, Wainwright exercised in part its option to purchase additional ordinary shares, and purchased 268,205 ordinary shares at a price, including the underwriting discount but before other associated fees, of $18.60 per share, as set forth in the Underwriting Agreement. 4. During February 2021, 855,813 warrants were exercised into an aggregate of 855,813 ordinary shares providing the Company with aggregate gross proceeds of $7,702. 5. During March 2021 the company signed an agreement with Mount Sinai academic health systems for Research Collaboration for the development of Allocetra in Combination with Immune Checkpoint Inhibitors. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation | a. Basis of presentation The Company’s audited consolidated financial statements as of December 31, 2020 and 2019, and for each of the years in the three-year period ended December 31, 2020, have been prepared in conformity with accounting principles generally accepted in the United States (“ U.S. GAAP The financial statements have been prepared on the basis of historical cost, subject to adjustment of financial assets and liabilities to their fair value through profit or loss. The Company classifies its expenses on the statement of comprehensive loss based on the operating characteristics of such expenses. |
Use of estimates | b. Use of estimates The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions, it also requires that management exercise its judgment in applying the Company’s accounting policies. The Company’s management believes that the estimates, judgments and assumptions used were reasonable based upon information available at the time they were made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts in the statements of operations during each reporting period. Actual results could differ materially from those estimates. |
Functional currency and translation to the reporting currency | c. Functional currency and translation to the reporting currency The functional currency of the Company is the New Israeli Shekel (“ NIS The financial statements of the Company were translated into U.S. dollars in accordance with ASC 830, “Foreign Currency Matters”. Accordingly, assets and liabilities were translated from local currencies to U.S. dollars using year end exchange rates, equity items were translated at the exchange rates of the date of the equity transaction, and income and expense items were translated at average exchange rates during the year. Gains or losses resulting from translation adjustments (which result from translating an entity’s financial statements into U.S. dollars if its functional currency is different than the U.S. dollar) are reported in other comprehensive income (loss). Balances denominated in, or linked to foreign currency are stated on the basis of the exchange rates prevailing at the balance sheet date. For foreign currency transactions included in the statement of income, the exchange rates applicable on the relevant transaction dates are used. Transaction gains or losses arising from changes in the exchange rates used in the translation of such balances are carried to financing income or expenses as applicable. The following table presents data regarding the U.S. dollar exchange rate: 2020 2019 2018 At December 31, 1 U.S. $ = NIS 3.215 NIS 3.456 NIS 3.748 Increase (decrease) during the year (7.0 )% (7.8 )% 8.1 % Average yearly exchange rates NIS 3.442 NIS 3.564 NIS 3.595 |
Cash and cash equivalents | d. Cash and cash equivalents Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at acquisition. |
Restricted cash | e. Restricted cash: Amounts included in restricted cash are held in interest bearing saving accounts, represent cash amounts required to be set aside by a contractual agreement for the rental of the Company’s premises and for credit cards and cash amounts required to be set aside by other contractual agreements. |
Property and equipment | f. Property and equipment Property and equipment are stated at historical cost less depreciation. Assets are depreciated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: % Computers 33 Office furniture and equipment 7 Leasehold improvements 16.67 Laboratory equipment 15-33 |
Impairment of non-financial assets | g. Impairment of non-financial assets The long-lived assets of the Company are reviewed for impairment in accordance with ASC 360, “Property, Plant, and Equipment”, whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset with the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. During the years 2020, 2019, and 2018, no impairment losses were identified. |
Leases | h. Leases In accordance with ASU No. 2016-02, Leases (Topic 842), right-of-use (“ ROU Because most of the Company’s leases do not provide an implicit interest rate, the Company uses its estimated incremental borrowing rate to determine the present value of lease payments. Lease expenses for operating lease payments are recognized on a straight-line basis over the lease term, and the related ROU assets and liabilities are reduced to the present value of the remaining lease payments at the end of each period. Short-term leases (with a term of 12 months or less) are not recorded as ROU assets or liabilities in the consolidated balance sheets. The Company’s lease agreements include rental payments that adjust periodically for inflation and do not contain any material residual value guarantees or material restrictive covenants. |
Stock-based compensation | i. Stock-based compensation The Company accounts for equity-based compensation awards to employees, directors and nonemployees based on the grant date fair value of those awards. The Company estimates the fair value of stock options using the Black-Scholes option pricing model. Forfeitures are recognized as they occur. The option pricing model requires a number of assumptions. Until the closing of the Merger, there was no market for the Company’s Ordinary Shares, consequently the Company utilized third-party valuations to estimate the fair value of its Ordinary Shares. For the estimation of the expected volatility of the Company’s share price, the Company used the historical volatility of comparable companies in the industry with characteristics similar to the Company, including stage of product development and focus on the life science industry. The expected term of options granted represents the period of time that options granted are expected to be outstanding, the company uses management’s estimates for the expected term of options due to insufficient readily available historical exercise data. The risk-free interest rate is based on the yield rates of U.S. Government Treasury Bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. |
Employee benefits | j. Employee benefits The Company is required by Israeli law to make severance payments to Israeli employees upon their dismissal or termination of employment in certain circumstances. The Company operates a number of post-employment defined contribution plans. A defined contribution plan is a program that benefits an employee after termination of employment, under which the Company regularly makes fixed payments to a fund administered by a separate and independent entity so that the Company has no legal or constructive obligation to pay additional contributions if such fund does not contain sufficient assets to pay all employees the benefits to which they may be entitled relating to employee service in the current and prior periods. The fund assets are not included in the Company’s consolidated balance sheets. The Company operates pension and severance compensation plans subject to Section 14 of the Israeli Severance Pay Law. The plans are funded through payments to insurance companies or pension funds administered by trustees. In accordance with its terms, the plans meet the definition of a defined contribution plan. Short term employee benefits - Labor laws in Israel entitle every employee to vacation days, paid sick leave and recreation pay, computed annually. The Company recognizes a liability and an expense in respect of vacation and recreation pay based on the individual entitlement of each employee. |
Revenue Recognition | k. Revenue Recognition The Company has not yet generated any revenue from product sales or otherwise. |
Research and development expenses, net | l. Research and development expenses, net Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including clinical trials, manufacturing costs, consulting fees and facilities and overhead costs. All costs associated with research and developments are expensed as incurred. As of December 31, 2020, the Company had not yet capitalized development expenses. Grants received from Israel Innovation Authority, Ministry of Industry, Trade and Labor (the “ IIA |
General and administrative | m. General and administrative General and administrative expenses consist of compensation and related benefits, including stock-based compensation, for executive and corporate personnel; professional and consulting fees; and allocated overhead such as facilities and equipment rent and maintenance, insurance costs allocated to general and administrative expenses, costs of patent applications, maintenance, depreciation expense, marketing costs, and other miscellaneous expenses which are allocated to general and administrative expense. |
Patents | n. Patents The Company expenses all costs associated with patents for product candidates under development as incurred. As a result of the Company’s research and development efforts, the Company is applying for a number of patents to protect proprietary technology and inventions. To date, the Company has not capitalized patent costs. The Company recorded a charge to operations of approximately $374 thousand, $120 thousand and $242 thousand for the years ended December 31, 2020, 2019 and 2018, respectively, related to patent costs. |
Income taxes | o. Income taxes The Company accounts for income taxes in accordance with ASC 740-10 “Accounting for Income Taxes”. This Statement requires the use of the liability method of accounting for income taxes, whereby deferred tax asset and liability account balances are determined based on the differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. As the Company is currently engaged primarily in development activities and is not expected to generate taxable income in the foreseeable future, the Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value. ASC 740 contains a two-step approach to recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2020, the Company recorded a liability of $682 thousand for uncertain tax positions. The Company does not expect that the amounts of uncertain tax positions will change significantly within the next year. |
Loss per share | p. Loss per share Basic loss per share is calculated based on the weighted average number of ordinary shares outstanding during each year. Diluted net loss per share is calculated based on the weighted average number of ordinary shares outstanding during each year, plus dilutive potential shares in accordance with ASC 260, “Earnings per Share.” All outstanding preferred stock, options and warrants for the years ended December 31, 2020, 2019 and 2018 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for all years presented. For the years ended December 31, 2020, 2019 and 2018, the total weighted average number of shares related to outstanding potential shares excluded from the calculations of diluted net loss per share was 3,526,214, 3,247,127 and 8,638,789, respectively. The following data show the amounts used in computing income (loss) per share and the effect on income (loss): Year ended December 31, (in thousands except share and per share data) 2020 2019 2018 Basic and diluted (loss) per share: (Loss) from continuing operations $ (11,824 ) $ (9,384 ) $ (4,242 ) Interest of 6% to Cumulative Preferred Stock - (198 ) (659 ) $ (11,824 ) $ (9,582 ) $ (4,901 ) Number of common shares at the beginning of the year 10,334,126 3,509,405 3,509,344 Weighted average number of shares issued for cash 2,603,763 518,295 - Weighted average number of shares issued in connection with the merger - 322,617 - Weighted average number of stock options exercised 21,749 80,073 2 Weighted average number of warrants exercised 209,570 15,609 - Weighted average number of shares issued in connection with conversion of Preferred Shares - 4,203,487 - Number of shares used in per share computation 13,169,208 8,649,486 3,509,346 Basic and diluted net (loss) per share $ (0.90 ) $ (1.11 ) $ (1.40 ) |
Concentrations of credit risk | q. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, restricted cash and cash held with respect to CVR Agreement (as defined in Note 8). Cash and cash equivalents and restricted cash are invested in major banks in Israel. Cash held with respect to CVR Agreement is deposited in a trust account with a private investment house. Such deposits in Israel are not insured. Management believes that the financial institutions that hold the Company’s investments are financially sound and, accordingly, minimal credit risk exists with respect to these investments. The Company has no foreign exchange contracts or any other hedging arrangements. |
Fair value of financial instruments | r. Fair value of financial instruments The Company applies ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), pursuant to which fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. The financial instruments presented on the balance sheet at fair value are grouped into classes with similar characteristics using the following fair value hierarchy which is determined based on the source of input used in measuring fair value: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 - inputs other than quoted prices included within level 1 that are observable either directly or indirectly. Level 3 - inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). The Company’s warrants, exercised to ordinary shares prior to the Merger in 2019, were classified as level 3 in the fair value hierarchy and measured at fair value on a recurring basis. |
Comprehensive income (loss) | s. Comprehensive income (loss) Comprehensive loss is the change in shareholders’ equity from transactions and other events and circumstances other than those resulting from investments by shareholders and distributions to shareholders. The Company accounts for comprehensive income (loss) in accordance with ASC 220, “Comprehensive Income”. This statement establishes standards for the reporting and display of comprehensive income (loss) and its components in a full set of general-purpose financial statements. The Company’s other comprehensive income (loss) is currently comprised of gains or losses resulting from translation adjustments which result from translating the Company’s financial statements into U.S. dollars when its functional currency is different than the U.S. dollar. |
Reclassification | t. Reclassification Certain comparative figures have been reclassified to conform to the current year presentation. Such reclassifications did not have any significant impact on the Company’s equity, net income or cash flows. |
Recently Issued Accounting Standards | u. Recently Issued Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures, the adoption of this ASU is not expected to have a material impact on its consolidated financial statements. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provides optional guidance to ease the potential burden in accounting due to reference rate reform. The guidance in this update provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments apply only to contracts and hedging relationships that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. These amendments are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into on or before December 31, 2022. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements. |
Recently Adopted Accounting Standards | v. Recently Adopted Accounting Standards In August 2018, the Financial Accounting Standards Board (“ FASB In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification determines whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company adopted this standard on January 1, 2019. |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of U.S. dollar exchange rate | 2020 2019 2018 At December 31, 1 U.S. $ = NIS 3.215 NIS 3.456 NIS 3.748 Increase (decrease) during the year (7.0 )% (7.8 )% 8.1 % Average yearly exchange rates NIS 3.442 NIS 3.564 NIS 3.595 |
Schedule of annual depreciation rates | % Computers 33 Office furniture and equipment 7 Leasehold improvements 16.67 Laboratory equipment 15-33 |
Schedule of computing income (loss) per share and the effect on income (loss) | Year ended December 31, (in thousands except share and per share data) 2020 2019 2018 Basic and diluted (loss) per share: (Loss) from continuing operations $ (11,824 ) $ (9,384 ) $ (4,242 ) Interest of 6% to Cumulative Preferred Stock - (198 ) (659 ) $ (11,824 ) $ (9,582 ) $ (4,901 ) Number of common shares at the beginning of the year 10,334,126 3,509,405 3,509,344 Weighted average number of shares issued for cash 2,603,763 518,295 - Weighted average number of shares issued in connection with the merger - 322,617 - Weighted average number of stock options exercised 21,749 80,073 2 Weighted average number of warrants exercised 209,570 15,609 - Weighted average number of shares issued in connection with conversion of Preferred Shares - 4,203,487 - Number of shares used in per share computation 13,169,208 8,649,486 3,509,346 Basic and diluted net (loss) per share $ (0.90 ) $ (1.11 ) $ (1.40 ) |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of cash, cash equivalents and restricted cash | December 31, (in thousands) 2020 2019 Cash held in banks $ 1,173 $ 937 Bank deposits in U.S.$ with original maturities of three months or less (annual average interest rates 0.32% and 1.8%) 4,500 3,011 Total cash and cash equivalents 5,673 3,948 Cash held with respect to CVR Agreement, see note 8 1,171 1,400 Short term restricted cash 79 100 Long-term restricted cash 89 76 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 7,012 $ 5,524 |
Short Term Deposits (Tables)
Short Term Deposits (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of short term deposits | December 31, (in thousands) 2020 2019 Bank deposits in U.S.$ (annual average interest rates 0.6% and 2.1%) $ 30,034 $ 8,060 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | December 31, (in thousands) 2020 2019 Cost Laboratory equipment $ 1,256 $ 782 Computers 169 94 Office furniture & equipment 102 36 Leasehold improvements 712 152 Total cost 2,239 1,064 Accumulated depreciation Laboratory equipment 588 340 Computers 87 51 Office furniture & equipment 5 1 Leasehold improvements 78 24 Total accumulated depreciation 758 416 Depreciated cost $ 1,481 $ 648 |
Other Assets (Tables)
Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Other Assets [Abstract] | |
Schedule of other assets | December 31, (in thousands) 2020 2019 Restricted cash $ 89 $ 76 Long-term prepaid expenses 8 5 Right-of-Use assets, net 659 410 $ 756 $ 491 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other liabilities | December 31, (in thousands) 2020 2019 Vacation, convalescence and employees’ bonus accruals $ 684 $ 318 Employees and payroll related 352 274 Short term operating lease liabilities 203 123 Accrued expenses and other 1,499 1,549 $ 2,738 $ 2,264 |
Reverse Merger with Bioblast _2
Reverse Merger with Bioblast Pharma Ltd. (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Reverse Merger With Bioblast Pharma Disclosure [Abstract] | |
Schedule of estimated fair value of the assets and liabilities | (in thousands) Cash and cash equivalents $ 44 Prepaid expenses and other receivables 632 Cash held with respect to CVR Agreement 1,500 Receivables for the sale of Trehalose 2,000 Trade payables (10 ) Due to CVR Holders (3,500 ) Other current liabilities (22 ) $ 644 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Schedule of operating lease expense | Year ended December 31, (in thousands) 2020 2019 The components of lease expense were as follows: Operating leases expenses $ 243 $ 192 Supplemental consolidated cash flow information related to operating leases follows: Cash used in operating activities $ 223 $ 188 Non-cash activity: Right of use assets obtained in exchange for new operating lease liabilities $ 398 $ 141 |
Schedule of operating lease related activities | December 31, (in thousands) 2020 2019 Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: Other assets - Right-of-Use assets $ 920 $ 501 Accumulated amortization 261 91 Operating lease Right-of-Use assets, net $ 659 $ 410 Lease liabilities – current - Accounts payable and accrued liabilities $ 203 $ 123 Lease liabilities – noncurrent 499 298 Total operating lease liabilities $ 702 $ 421 Weighted average remaining lease term in years 3.64 3.33 Weighted average annual discount rate 11.9 % 10.7 % (in thousands) Maturities of operating lease liabilities as of December 31, 2020, were as follows: 2021 $ 258 2022 231 2023 182 2024 93 2025 53 Total undiscounted lease liability 817 Less: Imputed interest (115 ) Present value of lease liabilities $ 702 |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Schedule of changes in exercisable ordinary shares warrants | Number of Warrants Exercise price per share Issuance date Expiration date Outstanding January 1, 2020 27,016 $ 180 March 22, 2016 September 22, 2021 Issued to placement agent 70,000 $ 10 February 26, 2020 February 24, 2025 Issued to investors 2,093,750 $ 9 March 5, 2020 March 5, 2022 Issued to placement agent 146,563 $ 10 March 4, 2020 March 4, 2022 Exercised (147,646 ) $ 10 Exercised (782,000 ) $ 9 Outstanding December 31, 2020 1,407,683 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value of stock option weighted-average assumptions | Year ended December 31, 2020 2019 2018 Weighted Average Risk-free interest rate 0.46% 1.67% 2.81% Dividend yield - - - Weighted Average Volatility factor 76.32% 73.71% 74.73% Weighted Average Expected life of the options 6 5 6 |
Schedule of options granted under the existing stock-option plans | For the year ended December 31, 2020 2019 2018 Number of options Weighted average exercise price Number of options Weighted exercise price Number of Weighted average exercise price Outstanding at beginning of the year 1,625,042 $ 5.72 1,801,418 $ 4.33 1,658,778 $ 4.11 Granted 360,500 $ 4.46 158,021 $ 8.72 305,244 $ 5.85 Forfeited and expired (63,376 ) $ 6.26 (128,256 ) $ 5.24 (162,543 ) $ 4.96 Exercised (37,746 ) $ 2.69 (221,641 ) $ 2.70 (61 ) $ 2.69 Pre-merger Bioblast options - $ 15,500 $ 90.17 - $ - Outstanding at end of the year 1,884,420 $ 5.52 1,625,042 $ 5.72 1,801,418 $ 4.33 Exercisable at end of the year 1,283,193 $ 5.15 1,098,691 $ 3.71 1,026,582 $ 3.26 |
Schedule of changes in nonvested shares granted | For the year ended December 31, 2020 2019 2018 Number of options Weighted average exercise price Number of options Weighted average exercise price Number of Weighted average exercise price Balance at beginning of the year 526,351 $ 7.03 774,836 $ 5.70 885,879 $ 5.52 Granted 360,500 $ 3.86 158,021 $ 8.72 305,244 $ 5.85 Vested during the year (249,965 ) $ 6.07 (278,250 ) $ 5.21 (257,068 ) $ 4.97 Forfeited during the year (35,659 ) $ 6.24 (128,256 ) $ 5.24 (159,219 ) $ 5.16 Balance at end of the year 601,227 $ 5.93 526,351 $ 7.03 774,836 $ 5.70 |
Schedule of exercise prices and remaining contractual life | Exercise Price Number of Options Outstanding Average Remaining Contractual Life (in years) Intrinsic Value of Options Outstanding (in thousands) No. of options $ 2.69 685,992 4.51 $ 3,937,594 684,869 $ 3.66 250,000 9.34 $ 1,191,750 55,556 $ 4.68 63,000 9.25 $ 236,250 - $ 6.22 659,861 7.05 $ 1,455,922 480,634 $ 8.19 150,000 8.88 $ 36,000 37,500 $ 9.02 40,500 9.88 $ - - $ 10.12 12,126 7.93 $ - 7,274 $ 12.21 2,421 8.24 $ - 605 $ 21.4 5,020 8.57 $ - 1,255 $ 90.16 15,500 0.69 $ - 15,500 1,884,420 $ 6,857,516 1,283,193 |
Schedule of share-based compensation expenses related to grants under the equity incentive plan | Year ended December 31, (in thousands) 2020 2019 2018 Research & development $ 401 $ 607 $ 862 General & administrative 269 203 147 Total $ 670 $ 810 $ 1,009 |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision for income taxes | Year ended December 31, (in thousands) 2020 2019 2018 Current tax $ - $ - $ - Deferred tax - - - Provision for income taxes, net $ - $ - $ - |
Schedule of reconciliation of the theoretical tax expenses | Year ended December 31, (in thousands) 2020 2019 2018 Loss before taxes $ 11,824 $ 9,384 $ 4,242 Statutory tax rate 23 % 23 % 23 % Tax benefit 2,720 2,158 976 Permanent differences 642 (322 ) (237 ) Valuation allowance (3,362 ) (1,836 ) (739 ) Differences in tax rate - - - Tax expenses $ - $ - $ - |
Schedule of deferred tax liabilities and assets | Year ended December 31, (in thousands) 2020 2019 2018 Tax assets in respect of: $ $ $ Accrued employees’ and directors’ compensation 61 136 31 Research and development expenses 1,275 738 609 Net loss carry forward 8,303 4,744 2,743 Total deferred tax assets 9,639 5,618 3,383 Less - valuation allowance (9,639 ) (5,618 ) (3,383 ) Deferred tax assets $ - $ - $ - |
Balances and Transactions wit_2
Balances and Transactions with Related Parties (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Schedule of key management personnel | December 31, (in thousands) 2020 2019 Key management personnel - reported in the accompanying consolidated balance sheets in Current Liabilities - Accounts payable trade $ 175 $ 79 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets measured at fair value on a recurring basis | December 31, 2020 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 5,673 $ 5,673 $ - $ - Short term deposits 30,034 30,034 - - Cash held with respect to CVR Agreement 1,171 1,171 Restricted cash 168 168 - - Total financial assets $ 37,046 $ 37,046 $ - $ - December 31, 2019 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 3,948 $ 3,948 $ - $ - Short term deposits 8,060 8,060 - - Cash held with respect to CVR Agreement 1,400 1,400 Restricted cash 176 176 - - Total financial assets $ 13,584 $ 13,584 $ - $ - December 31, 2018 (in thousands) Total Level 1 Level 2 Level 3 Cash and cash equivalents $ 9,736 $ 9,736 $ - $ - Short term deposits 40 40 Restricted cash 56 56 - - Total financial assets $ 9,832 $ 9,832 $ - $ - Warrants $ 192 $ - $ - $ 192 Total financial liabilities $ 192 $ - $ - $ 192 |
Supplementary Financial State_2
Supplementary Financial Statement Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of condensed income statement | Year ended December 31, (in thousands) 2020 2019 2018 Payroll and related expenses $ 3,183 $ 2,259 $ 1,317 Research and development services 2,438 2,682 874 Materials 612 454 363 Share Based Compensation 401 607 862 Depreciation 273 198 121 Other 394 486 476 7,301 6,686 4,013 Israel Innovation Authority participation in research and development costs and royalties payable (1,215 ) (1,082 ) - $ 6,086 $ 5,604 $ 4,013 Year ended December 31, (in thousands) 2020 2019 2018 Payroll expenses $ 737 $ 569 $ 343 Compensation to directors 862 526 182 Professional fees 995 845 450 Office maintenance and office expenses 97 145 96 Insurance 486 243 11 Share Based Compensation 269 203 147 Other 253 484 57 $ 3,699 $ 3,015 $ 1,286 Year ended December 31, (in thousands) 2020 2019 2018 Interest income $ 225 $ 238 $ 138 Exchange differences, net - - 790 Net change in fair value warrants - - 132 $ 225 $ 238 $ 1,060 Year ended December 31, (in thousands) 2020 2019 2018 Issuance expenses related to warrants $ - $ - $ - Exchange differences, net 2,258 945 - Net change in fair value warrants - 51 - Bank commissions 6 7 3 $ 2,264 $ 1,003 $ 3 |
General Information (Details)
General Information (Details) $ / shares in Units, $ in Thousands | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2020₪ / shares | Dec. 31, 2019USD ($)$ / shares | Dec. 31, 2019₪ / shares |
General (Textual) | ||||
Aggregate of ordinary shares (in New Shekels per share) | (per share) | $ 0.11 | ₪ 0.40 | $ 0.11 | ₪ 0.40 |
Accumulated deficit | $ (37,497) | $ (25,673) | ||
Amount raised in conjunction with securities offerings | 29,500 | |||
Additional amount raised from exercises of options and warrants | $ 8,600 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | |||
Related to its patents' costs | $ 374 | $ 120 | $ 242 |
Tax benefit, percentage | 50.00% | ||
Deferred Tax Liabilities, Gross | $ 682 | ||
Weighted average number of shares related to outstanding potential shares (in Shares) | 3,526,214 | 3,247,127 | 8,638,789 |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - Schedule of U.S. dollar exchange rate | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of U.S. dollar exchange rate [Abstract] | |||
At December 31, 1 U.S. $ = | NIS 3.215 | NIS 3.456 | NIS 3.748 |
Increase (decrease) during the year | (7.00%) | (7.80%) | 8.10% |
Average yearly exchange rates | NIS 3.442 | NIS 3.564 | NIS 3.595 |
Significant Accounting Polici_5
Significant Accounting Policies (Details) - Schedule of annual depreciation rates | Dec. 31, 2020 |
Computers [Member] | |
Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rates | 33.00% |
Office furniture and equipment [Member] | |
Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rates | 7.00% |
Leasehold improvements [Member] | |
Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rates | 16.67% |
Laboratory equipment [Member] | Minimum [Member] | |
Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rates | 15.00% |
Laboratory equipment [Member] | Maximum [Member] | |
Significant Accounting Policies (Details) - Schedule of annual depreciation rates [Line Items] | |
Annual depreciation rates | 33.00% |
Significant Accounting Polici_6
Significant Accounting Policies (Details) - Schedule of computing income (loss) per share and the effect on income (loss) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Basic and diluted (loss) per share: | |||
(Loss) from continuing operations (in Dollars) | $ (11,824) | $ (9,384) | $ (4,242) |
Interest of 6% to Cumulative Preferred Stock (in Dollars) | (198) | (659) | |
Total (in Dollars) | $ (11,824) | $ (9,582) | $ (4,901) |
Number of common shares at the beginning of the year | 10,334,126 | 3,509,405 | 3,509,344 |
Weighted average number of shares issued for cash | 2,603,763 | 518,295 | |
Weighted average number of shares issued in connection with the merger | 322,617 | ||
Weighted average number of stock options exercised | 21,749 | 80,073 | 2 |
Weighted average number of warrants exercised | 209,570 | 15,609 | |
Weighted average number of shares issued in connection with conversion of Preferred Shares | 4,203,487 | ||
Number of shares used in per share computation | 13,169,208 | 8,649,486 | 3,509,346 |
Basic and diluted net (loss) per share (in Dollars per share) | $ (0.90) | $ (1.11) | $ (1.40) |
Significant Accounting Polici_7
Significant Accounting Policies (Details) - Schedule of computing income (loss) per share and the effect on income (loss) (Parentheticals) | Dec. 31, 2020 |
Schedule of computing income (loss) per share and the effect on income (loss) [Abstract] | |
Interest to cumulative preferred stock | 6.00% |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of cash, cash equivalents and restricted cash - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of cash, cash equivalents and restricted cash [Abstract] | ||||
Cash held in banks | $ 1,173 | $ 937 | ||
Bank deposits in U.S.$ with original maturities of three months or less (annual average interest rates 0.32% and 1.8%) | 4,500 | 3,011 | ||
Total cash and cash equivalents | 5,673 | 3,948 | ||
Cash held with respect to CVR Agreement, see note 8 | 1,171 | 1,400 | ||
Short term restricted cash | 79 | 100 | ||
Long-term restricted cash | 89 | 76 | ||
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 7,012 | $ 5,524 | $ 9,792 | $ 9,032 |
Cash, Cash Equivalents and Re_4
Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of cash, cash equivalents and restricted cash (Parentheticals) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of cash, cash equivalents and restricted cash [Abstract] | ||
Annual average interest rates | 0.32% | 1.80% |
Short Term Deposits (Details) -
Short Term Deposits (Details) - Schedule of short term deposits - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of short term deposits [Abstract] | ||
Bank deposits in U.S.$ (annual average interest rates 0.6% and 2.1%) | $ 30,034 | $ 8,060 |
Short Term Deposits (Details)_2
Short Term Deposits (Details) - Schedule of short term deposits (Parentheticals) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of short term deposits [Abstract] | ||
Annual average interest rates | 0.60% | 2.10% |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expenses | $ 286 | $ 206 | $ 121 |
Property and Equipment (Detai_2
Property and Equipment (Details) - Schedule of property and equipment - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total cost | $ 2,239 | $ 1,064 |
Total accumulated depreciation | 758 | 416 |
Depreciated cost | 1,481 | 648 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total cost | 1,256 | 782 |
Total accumulated depreciation | 588 | 340 |
Computers [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total cost | 169 | 94 |
Total accumulated depreciation | 87 | 51 |
Office furniture & equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total cost | 102 | 36 |
Total accumulated depreciation | 5 | 1 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total cost | 712 | 152 |
Total accumulated depreciation | $ 78 | $ 24 |
Other Assets (Details) - Schedu
Other Assets (Details) - Schedule of other assets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of other assets [Abstract] | ||
Restricted cash | $ 89 | $ 76 |
Long-term prepaid expenses | 8 | 5 |
Right-of-Use assets, net | 659 | 410 |
Total | $ 756 | $ 491 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - Schedule of accrued expenses and other liabilities - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of accrued expenses and other liabilities [Abstract] | ||
Vacation, convalescence and employees’ bonus accruals | $ 684 | $ 318 |
Employees and payroll related | 352 | 274 |
Short term operating lease liabilities | 203 | 123 |
Accrued expenses and other | 1,499 | 1,549 |
Accrued expenses and other liabilities, Total | $ 2,738 | $ 2,264 |
Reverse Merger with Bioblast _3
Reverse Merger with Bioblast Pharma Ltd. (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | ||
Feb. 19, 2019 | Dec. 31, 2020 | Mar. 05, 2020 | |
Reverse Merger With Bioblast Pharma Disclosure [Abstract] | |||
Consideration paid | $ 1,500 | ||
Additional consideration paid | 2,000 | ||
Additional milestone payments | $ 17,000 | ||
Estimated fair value of the total considerations | $ 5,152 | ||
Adjusted per the merger agreement (in Shares) | 420,554 | ||
Share price (in Dollars per share) | $ 12.25 | $ 8 | |
Fair value of the net assets | $ 4,508 | ||
Business consideration, description | CVR holders are entitled to receive 100% of any payments up to $20 million received by the Company and 50% of any subsequent consideration in excess of such amount, in each case, net of all related transaction expenses. |
Reverse Merger with Bioblast _4
Reverse Merger with Bioblast Pharma Ltd. (Details) - Schedule of estimated fair value of the assets and liabilities $ in Thousands | Dec. 31, 2020USD ($) |
Schedule of estimated fair value of the assets and liabilities [Abstract] | |
Cash and cash equivalents | $ 44 |
Prepaid expenses and other receivables | 632 |
Cash held with respect to CVR Agreement | 1,500 |
Receivables for the sale of Trehalose | 2,000 |
Trade payables | (10) |
Due to CVR Holders | (3,500) |
Other current liabilities | (22) |
Total | $ 644 |
Leases (Details)
Leases (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Disclosure Text Block [Abstract] | |
Operating leases remaining lease terms | 4 years 9 months |
ROU assets and of lease liabilities | $ 399 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of operating lease expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
The components of lease expense were as follows: | ||
Operating leases expenses | $ 243 | $ 192 |
Supplemental consolidated cash flow information related to operating leases follows: | ||
Cash used in operating activities | 223 | 188 |
Non-cash activity: | ||
Right of use assets obtained in exchange for new operating lease liabilities | $ 398 | $ 141 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of operating lease related activities - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of operating lease related activities [Abstract] | ||
Other assets - Right-of-Use assets | $ 920 | $ 501 |
Accumulated amortization | 261 | 91 |
Operating lease Right-of-Use assets, net | 659 | 410 |
Lease liabilities – current - Accounts payable and accrued liabilities | 203 | 123 |
Lease liabilities – noncurrent | 499 | 298 |
Total operating lease liabilities | $ 702 | $ 421 |
Weighted average remaining lease term in years | 3 years 7 months 20 days | 3 years 3 months 29 days |
Weighted average annual discount rate | 11.90% | 10.70% |
2021 | $ 258 | |
2022 | 231 | |
2023 | 182 | |
2024 | 93 | |
2025 | 53 | |
Total undiscounted lease liability | 817 | |
Less: Imputed interest | (115) | |
Present value of lease liabilities | $ 702 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 28, 2020 | Mar. 31, 2020 | Jan. 31, 2020 | Dec. 31, 2020 | |
Commitments and Contingent Liabilities (Details) [Line Items] | ||||
Percentage of royalties in sales | 100.00% | |||
Aggregate contingent obligation | $ 6,303 | |||
New grant application, description | the Company submitted a grant application to the IIA for funding of its clinical development program of prevention of organ dysfunction and cytokine storms associated with COVID-19. The Company’s application for grants of NIS 1,857 thousand ($578 thousand) was approved by the IIA in April 2020 for a period commencing April 1, 2020 and ending March 31, 2021. The approved IIA funding was approximately 30% of the total expenses for the approved clinical program which was executed in Israel. | the Company submitted a grant application to the IIA for funding of its clinical development program of prevention of cytokine storms and organ dysfunction associated with Sepsis. The Company’s application for grants of NIS 3,467 thousand ($1,078 thousand) was approved by the IIA in April 2020 for a period commencing April 1, 2020 and ending March 31, 2021. The approved IIA funding was approximately 30% of the total expenses for the approved clinical program which was executed in Israel | ||
Agreement, description | The special bonus comprised of (i) a cash bonus in the amount of 100% of his annual base retainer; and (ii) 250,000 options, vesting equally over 36 months at an exercise price equal to a 25% discount. As of December 31, 2020, a special bonus was not accrued or paid. | |||
Minimum [Member] | ||||
Commitments and Contingent Liabilities (Details) [Line Items] | ||||
Percentage of royalties in sales | 3.00% | |||
Maximum [Member] | ||||
Commitments and Contingent Liabilities (Details) [Line Items] | ||||
Percentage of royalties in sales | 5.00% |
Equity (Details)
Equity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Oct. 22, 2020USD ($) | Mar. 05, 2020USD ($)$ / sharesshares | Feb. 26, 2020USD ($)$ / sharesshares | Mar. 26, 2019USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2020₪ / shares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2019₪ / sharesshares | |
Equity (Details) [Line Items] | ||||||||
Purchase of ordinary shares amount | $ | $ 25,000 | $ 2,218 | ||||||
Sales agent commission, percentage | 3.00% | |||||||
Purchase of ordinary shares | shares | 2,093,750 | 1,000,000 | 192,666 | |||||
Issuance expenses | $ | $ 207 | |||||||
Warrants to purchase shares | shares | 27,016 | |||||||
Ordinary price per share | $ / shares | $ 8 | $ 12.25 | ||||||
Net proceeds offering | $ | $ 15,238 | $ 7,218 | ||||||
Price per share | $ / shares | $ 9 | $ 8 | $ 0.0484 | |||||
Investors warrant | $ | $ 3,723 | |||||||
Common stock value | $ | $ 13,027 | |||||||
Exercise price per share | $ / shares | $ 180 | |||||||
Reverse stock split | 1-for-8 reverse stock split | |||||||
Common stock, shares authorized | shares | 45,000,000 | 45,000,000 | 45,000,000 | |||||
Common stock, par value | (per share) | $ 0.11 | ₪ 0.40 | $ 0.11 | ₪ 0.40 | ||||
Outstanding preferred stock | shares | 4,958,705 | |||||||
Issuance of Common and Preferred Stock in connection with conversion of Convertible Notes and accrued interest | $ | $ 2,070 | |||||||
Unpaid dividends to convertible stock | shares | 5,479,547 | |||||||
Conversion of warrants | shares | 20,348 | |||||||
Additional issuance costs | $ | $ 655 | |||||||
Purchase price per share | $ / shares | $ 22.29 | |||||||
Investor [Member] | ||||||||
Equity (Details) [Line Items] | ||||||||
Warrants exercisable | shares | 2,093,750 | |||||||
Placement Agent [Member] | ||||||||
Equity (Details) [Line Items] | ||||||||
Warrants to purchase shares | shares | 146,563 | |||||||
Exercise price per share | $ / shares | $ 10 | |||||||
Private Investors [Member] | ||||||||
Equity (Details) [Line Items] | ||||||||
Purchase of ordinary shares amount | $ | $ 8,362 | |||||||
Purchase of ordinary shares | shares | 682,631 | |||||||
Purchase price per share | $ / shares | $ 12.25 | |||||||
Warrant [Member] | ||||||||
Equity (Details) [Line Items] | ||||||||
Warrants to purchase shares | shares | 2,093,750 | 70,000 | ||||||
Weighted average volatility rate | 72.00% | 68.24% | ||||||
Weighted average risk-free interest rate | 1.14% | 0.67% | ||||||
Weighted average contractual expected life | 5 years | 2 years | ||||||
Exercise price per share | $ / shares | $ 10 | $ 10 | ||||||
Placement agent warrants | $ | $ 232 | |||||||
Warrant value | $ | $ 331 |
Equity (Details) - Schedule of
Equity (Details) - Schedule of changes in exercisable ordinary shares warrants | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Number of Warrants | 27,016 |
Exercise price per share | $ / shares | $ 180 |
Issuance date | Mar. 22, 2016 |
Expiration date | Sep. 22, 2021 |
Number of Warrants, Outstanding | 1,407,683 |
Issued to placement agent [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Warrants | 70,000 |
Exercise price per share | $ / shares | $ 10 |
Issuance date | Feb. 26, 2020 |
Expiration date | Feb. 24, 2025 |
Issued to investors [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Warrants | 2,093,750 |
Exercise price per share | $ / shares | $ 9 |
Issuance date | Mar. 5, 2020 |
Expiration date | Mar. 5, 2022 |
Issued to placement agent [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Warrants | 146,563 |
Exercise price per share | $ / shares | $ 10 |
Issuance date | Mar. 4, 2020 |
Expiration date | Mar. 4, 2022 |
Exercised [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise price per share | $ / shares | $ 10 |
Number of Warrants | (147,646) |
Exercised [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise price per share | $ / shares | $ 9 |
Number of Warrants | (782,000) |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-Based Compensation (Details) [Line Items] | |||
Weighted-average fair value at grant date of the options granted | $ 2.93 | $ 5.29 | $ 5.98 |
The total intrinsic value of options granted and options exercised (in Dollars) | $ 217 | ||
2019 Equity Incentive Plan [Member] | |||
Share-Based Compensation (Details) [Line Items] | |||
Authorized shares issuance to its employees, director and consultants (in Shares) | 2,350,704 | ||
Future grant share (in Shares) | 177,632 | ||
Employee Stock Option [Member] | |||
Share-Based Compensation (Details) [Line Items] | |||
Total unrecognized estimated compensation cost (in Dollars) | $ 1,584 | ||
Weighted average period | 2 years |
Share-Based Compensation (Det_2
Share-Based Compensation (Details) - Schedule of fair value of stock option weighted-average assumptions - Stock Option Plan [Member] | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-Based Compensation (Details) - Schedule of fair value of stock option weighted-average assumptions [Line Items] | |||
Weighted Average Risk-free interest rate | 0.46% | 1.67% | 2.81% |
Dividend yield | |||
Weighted Average Volatility factor | 76.32% | 73.71% | 74.73% |
Weighted Average Expected life of the options | 6 years | 5 years | 6 years |
Share-Based Compensation (Det_3
Share-Based Compensation (Details) - Schedule of options granted under the existing stock-option plans - Stock Option Plan [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options, Outstanding at beginning of the year | 1,625,042 | 1,801,418 | 1,658,778 |
Weighted average exercise price, Outstanding at beginning of the year (in Dollars per share) | $ 5.72 | $ 4.33 | $ 4.11 |
Number of options, Granted | 360,500 | 158,021 | 305,244 |
Weighted average exercise price, Granted (in Dollars per share) | $ 4.46 | $ 8.72 | $ 5.85 |
Number of options, Forfeited and expired | (63,376) | (128,256) | (162,543) |
Weighted average exercise price, Forfeited and expired (in Dollars per share) | $ 6.26 | $ 5.24 | $ 4.96 |
Number of options, Exercised | (37,746) | (221,641) | (61) |
Weighted average exercise price, Exercised (in Dollars per share) | $ 2.69 | $ 2.70 | $ 2.69 |
Number of options, Pre-merger Bioblast options | 15,500 | ||
Weighted average exercise price, Pre-merger Bioblast options (in Dollars per share) | $ 90.17 | ||
Number of options, Outstanding at end of the year | 1,884,420 | 1,625,042 | 1,801,418 |
Weighted average exercise price, Outstanding at end of the year (in Dollars per share) | $ 5.52 | $ 5.72 | $ 4.33 |
Number of options, Exercisable at end of the year | 1,283,193 | 1,098,691 | 1,026,582 |
Weighted average exercise price, Exercisable at end of the year (in Dollars per share) | $ 5.15 | $ 3.71 | $ 3.26 |
Share-Based Compensation (Det_4
Share-Based Compensation (Details) - Schedule of changes in nonvested shares granted - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of changes in nonvested shares granted [Abstract] | |||
Number of options, Balance at beginning of the year | 526,351 | 774,836 | 885,879 |
Weighted average exercise price, Balance at beginning of the year | $ 7.03 | $ 5.70 | $ 5.52 |
Number of options, Granted | 360,500 | 158,021 | 305,244 |
Weighted average exercise price, Granted | $ 3.86 | $ 8.72 | $ 5.85 |
Number of options, Vested during the year | (249,965) | (278,250) | (257,068) |
Weighted average exercise price, Vested during the year | $ 6.07 | $ 5.21 | $ 4.97 |
Number of options, Forfeited during the year | (35,659) | (128,256) | (159,219) |
Weighted average exercise price, Forfeited during the year | $ 6.24 | $ 5.24 | $ 5.16 |
Number of options, Balance at end of the year | 601,227 | 526,351 | 774,836 |
Weighted average exercise price, Balance at end of the year | $ 5.93 | $ 7.03 | $ 5.70 |
Share-Based Compensation (Det_5
Share-Based Compensation (Details) - Schedule of exercise prices and remaining contractual life $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Number of options outstanding | 1,884,420 |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 6,857,516 |
No. of options exercisable | 1,283,193 |
Exercise Price One [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 2.69 |
Number of options outstanding | 685,992 |
Average Remaining contractual Life (in years) | 4 years 6 months 3 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 3,937,594 |
No. of options exercisable | 684,869 |
Exercise Price Two [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 3.66 |
Number of options outstanding | 250,000 |
Average Remaining contractual Life (in years) | 9 years 4 months 2 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 1,191,750 |
No. of options exercisable | 55,556 |
Exercise Price Three [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 4.68 |
Number of options outstanding | 63,000 |
Average Remaining contractual Life (in years) | 9 years 3 months |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 236,250 |
No. of options exercisable | |
Exercise Price Four [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 6.22 |
Number of options outstanding | 659,861 |
Average Remaining contractual Life (in years) | 7 years 18 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 1,455,922 |
No. of options exercisable | 480,634 |
Exercise Price Five [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 8.19 |
Number of options outstanding | 150,000 |
Average Remaining contractual Life (in years) | 8 years 10 months 17 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | $ 36,000 |
No. of options exercisable | 37,500 |
Exercise Price Six [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 9.02 |
Number of options outstanding | 40,500 |
Average Remaining contractual Life (in years) | 9 years 10 months 17 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | |
No. of options exercisable | |
Exercise Price Seven [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 10.12 |
Number of options outstanding | 12,126 |
Average Remaining contractual Life (in years) | 7 years 11 months 4 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | |
No. of options exercisable | 7,274 |
Exercise Price Eight [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 12.21 |
Number of options outstanding | 2,421 |
Average Remaining contractual Life (in years) | 8 years 2 months 26 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | |
No. of options exercisable | 605 |
Exercise Price Nine [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 21.4 |
Number of options outstanding | 5,020 |
Average Remaining contractual Life (in years) | 8 years 6 months 25 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | |
No. of options exercisable | 1,255 |
Exercises Price Ten [Member] | Option [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price (in Dollars per share) | $ / shares | $ 90.16 |
Number of options outstanding | 15,500 |
Average Remaining contractual Life (in years) | 8 months 8 days |
Intrinsic Value of Options Outstanding (in Dollars) | $ | |
No. of options exercisable | 15,500 |
Share-Based Compensation (Det_6
Share-Based Compensation (Details) - Schedule of share-based compensation expenses related to grants under the equity incentive plan - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Compensation | $ 670 | $ 810 | $ 1,009 |
Research & development [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Compensation | 401 | 607 | 862 |
General & administrative [Member] | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Share-based Compensation | $ 269 | $ 203 | $ 147 |
Taxes on Income (Details)
Taxes on Income (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Taxes on Income (Details) [Line Items] | |
Israeli corporate tax rate | 23.00% |
Carry-forwards losses | $ 45.5 |
Parent [Member] | |
Taxes on Income (Details) [Line Items] | |
Carry-forwards losses | 5.1 |
Enlivex R&D [Member] | |
Taxes on Income (Details) [Line Items] | |
Carry-forwards losses | $ 31.4 |
Taxes on Income (Details) - Sch
Taxes on Income (Details) - Schedule of provision for income taxes - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of provision for income taxes [Abstract] | |||
Current tax | |||
Deferred tax | |||
Provision for income taxes, net |
Taxes on Income (Details) - S_2
Taxes on Income (Details) - Schedule of reconciliation of the theoretical tax expenses - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of reconciliation of the theoretical tax expenses [Abstract] | |||
Loss before taxes | $ 11,824 | $ 9,384 | $ 4,242 |
Statutory tax rate | 23.00% | 23.00% | 23.00% |
Tax benefit | $ 2,720 | $ 2,158 | $ 976 |
Permanent differences | 642 | (322) | (237) |
Valuation allowance | (3,362) | (1,836) | (739) |
Differences in tax rate | |||
Tax expenses |
Taxes on Income (Details) - S_3
Taxes on Income (Details) - Schedule of deferred tax liabilities and assets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Tax assets in respect of: | |||
Accrued employees’ and directors’ compensation | $ 61 | $ 136 | $ 31 |
Research and development expenses | 1,275 | 738 | 609 |
Net loss carry forward | 8,303 | 4,744 | 2,743 |
Total deferred tax assets | 9,639 | 5,618 | 3,383 |
Less - valuation allowance | (9,639) | (5,618) | (3,383) |
Deferred tax assets |
Balances and Transactions wit_3
Balances and Transactions with Related Parties (Details) - USD ($) $ in Thousands | May 12, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Related Party Transactions [Abstract] | ||||
Related parties transaction, Description | (i) the agreed remuneration for work performed in accordance with the agreement until the date of termination; and (ii) in the event that the termination is not due to a breach of the agreement by the executive officer, the Company shall reimburse the executive officer for all documented expenses arising from non-cancellable commitments incurred prior to such termination, and (iii), the balance between the aggregate amount of the remuneration and the advance (as defined below) actually paid to the executive officer, and the amount of $816 thousand, in consideration for any expenses incurred by executive officer in preparation for the study. In consideration for the executive officer’s fulfilment of his obligations, the Company has agreed to pay a fixed price for each of the activities performed as defined in the agreement. Upon entering the agreement, the Company paid the executive officer a non-refundable advance in the amount of $125 thousand. | |||
Research and development expenses | $ 822 | $ 251 | $ 0 |
Balances and Transactions wit_4
Balances and Transactions with Related Parties (Details) - Schedule of key management personnel - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of key management personnel [Abstract] | ||
Key management personnel - reported in the accompanying consolidated balance sheets in Current Liabilities - Accounts payable trade | $ 175 | $ 79 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - Schedule of financial assets measured at fair value on a recurring basis - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value Measurement (Details) - Schedule of financial assets measured at fair value on a recurring basis [Line Items] | |||
Cash and cash equivalents | $ 5,673 | $ 3,948 | $ 9,736 |
Short term deposits | 30,034 | 8,060 | 40 |
Cash held with respect to CVR Agreement | 1,171 | 1,400 | |
Restricted cash | 168 | 176 | 56 |
Total financial assets | 37,046 | 13,584 | 9,832 |
Warrants | 192 | ||
Total financial liabilities | 192 | ||
Fair Value, Inputs, Level 1 [Member] | |||
Fair Value Measurement (Details) - Schedule of financial assets measured at fair value on a recurring basis [Line Items] | |||
Cash and cash equivalents | 5,673 | 3,948 | 9,736 |
Short term deposits | 30,034 | 8,060 | 40 |
Cash held with respect to CVR Agreement | 1,171 | 1,400 | |
Restricted cash | 168 | 176 | 56 |
Total financial assets | 37,046 | 13,584 | 9,832 |
Warrants | |||
Total financial liabilities | |||
Fair Value, Inputs, Level 2 [Member] | |||
Fair Value Measurement (Details) - Schedule of financial assets measured at fair value on a recurring basis [Line Items] | |||
Cash and cash equivalents | |||
Short term deposits | |||
Cash held with respect to CVR Agreement | |||
Restricted cash | |||
Total financial assets | |||
Warrants | |||
Total financial liabilities | |||
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value Measurement (Details) - Schedule of financial assets measured at fair value on a recurring basis [Line Items] | |||
Cash and cash equivalents | |||
Short term deposits | |||
Cash held with respect to CVR Agreement | |||
Restricted cash | |||
Total financial assets | |||
Warrants | 192 | ||
Total financial liabilities | $ 192 |
Supplementary Financial State_3
Supplementary Financial Statement Information (Details) - Schedule of condensed income statement - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of condensed income statement [Abstract] | |||
Payroll and related expenses | $ 3,183 | $ 2,259 | $ 1,317 |
Research and development services | 2,438 | 2,682 | 874 |
Materials | 612 | 454 | 363 |
Share Based Compensation | 401 | 607 | 862 |
Depreciation | 273 | 198 | 121 |
Other | 394 | 486 | 476 |
Research and development expenses gross | 7,301 | 6,686 | 4,013 |
Israel Innovation Authority participation in research and development costs and royalties payable | (1,215) | (1,082) | |
Research and development expenses net | 6,086 | 5,604 | 4,013 |
Payroll expenses | 737 | 569 | 343 |
Compensation to directors | 862 | 526 | 182 |
Professional fees | 995 | 845 | 450 |
Office maintenance and office expenses | 97 | 145 | 96 |
Insurance | 486 | 243 | 11 |
Share Based Compensation | 269 | 203 | 147 |
Other | 253 | 484 | 57 |
General and administrative expenses | 3,699 | 3,015 | 1,286 |
Interest income | 225 | 238 | 138 |
Exchange differences, net | 790 | ||
Net change in fair value warrants | 132 | ||
Financial income | 225 | 238 | 1,060 |
Issuance expenses related to warrants | |||
Exchange differences, net | 2,258 | 945 | |
Net change in fair value warrants | 51 | ||
Bank commissions | 6 | 7 | 3 |
Financial expenses | $ 2,264 | $ 1,003 | $ 3 |
Events Subsequent to the Bala_2
Events Subsequent to the Balance Sheet Date (Details) $ / shares in Units, ₪ in Millions | Feb. 09, 2021USD ($)$ / sharesshares | Feb. 28, 2021USD ($)shares | Jan. 31, 2021USD ($) | Jan. 31, 2021ILS (₪) | Dec. 31, 2020USD ($)$ / sharesshares | Feb. 17, 2021$ / sharesshares | Feb. 12, 2021$ / sharesshares |
Events Subsequent to the Balance Sheet Date (Details) [Line Items] | |||||||
Gross proceeds (in Dollars) | $ | $ 6,339,095 | ||||||
Ordinary shares issued | 284,317 | ||||||
Ordinary shares price per share (in Dollars per share) | $ / shares | $ 22.29 | ||||||
Net proceeds from offering (in Dollars) | $ | $ 42,100,000 | ||||||
Subsequent Event [Member] | |||||||
Events Subsequent to the Balance Sheet Date (Details) [Line Items] | |||||||
Amount of grants expenditure | $ 4,700,000 | ₪ 15 | |||||
Gross proceeds (in Dollars) | $ | $ 7,702 | ||||||
Ordinary shares issued | 2,296,107 | 855,813 | |||||
Ordinary shares price per share (in Dollars per share) | $ / shares | $ 20 | ||||||
Underwriting agreement, description | the Company paid Wainwright underwriting discounts and commissions equal to 7% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering, as well as a management fee equal to 1% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering. In addition, the Company issued to Wainwright 179,501 warrants to purchase ordinary shares of the Company (the “Underwriter Warrants”). The Underwriter Warrants are exercisable for five years from commencement of the Offering and have an exercise price of $25 per ordinary share, subject to customary adjustments as provided in the Underwriter Warrants. The Company has also paid Wainwright approximately $126,000 for various expenses. | ||||||
Warrants exercised | 855,813 | ||||||
Wainwright [Member] | Subsequent Event [Member] | |||||||
Events Subsequent to the Balance Sheet Date (Details) [Line Items] | |||||||
Ordinary shares issued | 268,205 | 2,296,107 | |||||
Ordinary shares price per share (in Dollars per share) | $ / shares | $ 18.60 | $ 18.60 | |||||
Additional ordinary shares | 344,416 | ||||||
Sales Agreement [Member] | Subsequent Event [Member] | |||||||
Events Subsequent to the Balance Sheet Date (Details) [Line Items] | |||||||
Ordinary shares issued | 476,983 | ||||||
Ordinary shares price per share (in Dollars per share) | $ / shares | $ 17.94 | ||||||
Aggregate offering price (in Dollars) | $ | $ 8,557,437 |