Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 12, 2021 | Jun. 30, 2020 | |
Document Information Line Items | |||
Entity Registrant Name | INTEC PHARMA LTD. | ||
Trading Symbol | NTEC | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 4,502,578 | ||
Entity Public Float | $ 19,549,537 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001638381 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-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 Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-37521 | ||
Entity Address, Country | IL | ||
Entity Incorporation, State or Country Code | L3 | ||
Entity Tax Identification Number | 00-0000000 | ||
Entity Address, Address Line One | 12 Hartom Street Har Hotzvim | ||
Entity Address, City or Town | Jerusalem | ||
Entity Address, Postal Zip Code | 9777512 | ||
Title of 12(b) Security | Ordinary Shares, no par value | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
City Area Code | +972-2 | ||
Local Phone Number | 586-4657 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 14,671 | $ 9,292 |
Investment in marketable securities (Note 3) | 770 | |
Prepaid expenses and other receivables (Note 8a) | 297 | 3,683 |
TOTAL CURRENT ASSETS | 14,968 | 13,745 |
NON-CURRENT ASSETS: | ||
Property and equipment, net (Note 4) | 1,394 | 2,575 |
Operating lease right-of-use assets (Note 6d) | 817 | 1,243 |
Other assets (Note 6e(1)) | 3,717 | 3,717 |
TOTAL NON-CURRENT ASSETS | 5,928 | 7,535 |
TOTAL ASSETS | 20,896 | 21,280 |
CURRENT LIABILITIES - | ||
Accounts payable and accruals: Trade | 368 | 3,507 |
Other (Note 8b) | 4,966 | 4,835 |
TOTAL CURRENT LIABILITIES | 5,334 | 8,342 |
LONG-TERM LIABILITIES: | ||
Operating lease liabilities (Note 6d) | 338 | 799 |
Other liabilities (Note 9) | 691 | 604 |
TOTAL LONG-TERM LIABILITIES | 1,029 | 1,403 |
TOTAL LIABILITIES | 6,363 | 9,745 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 6) | ||
SHAREHOLDERS’ EQUITY: | ||
Ordinary shares, with no par value - authorized: 17,500,000 and 5,000,000 Ordinary Shares as of December 31, 2020 and December 31, 2019, respectively; issued and outstanding: 4,321,296 and 1,811,431 Ordinary Shares as of December 31, 2020 and December 31, 2019, respectively | 727 | 727 |
Additional paid-in capital | 217,357 | 200,231 |
Accumulated deficit | (203,551) | (189,423) |
TOTAL SHAREHOLDERS’ EQUITY | 14,533 | 11,535 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 20,896 | $ 21,280 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, authorized | 17,500,000 | 5,000,000 |
Ordinary shares, issued | 4,321,296 | 1,811,431 |
Ordinary shares, outstanding | 4,321,296 | 1,811,431 |
Ordinary shares, par value (in Dollars per share) |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
OPERATING EXPENSES: | ||
RESEARCH AND DEVELOPMENT EXPENSES, net | $ (6,740) | $ (26,659) |
GENERAL AND ADMINISTRATIVE EXPENSES | (7,089) | (8,287) |
IMPAIRMENT OF LONG-LIVED ASSETS (Note 6e(2)) | (13,663) | |
OTHER INCOME | 1,500 | |
OPERATING LOSS | (13,829) | (47,109) |
FINANCIAL INCOME (EXPENSES), net (Note 8c) | (175) | 148 |
LOSS BEFORE INCOME TAX | (14,004) | (46,961) |
INCOME TAX (Note 9) | (124) | (638) |
NET LOSS | $ (14,128) | $ (47,599) |
LOSS PER ORDINARY SHARE - BASIC AND DILUTED (in Dollars per share) | $ (4.08) | $ (28.18) |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE IN THOUSANDS (in Shares) | 3,461 | 1,689 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary Shares | Additional paid-in capital | Accumulated Deficit | Total |
BALANCE at Dec. 31, 2018 | $ 727 | $ 194,642 | $ (141,824) | $ 53,545 |
BALANCE (in Shares) at Dec. 31, 2018 | 1,678,469 | |||
CHANGES DURING 2019: | ||||
Issuance of ordinary shares, net of issuance costs (Note 7b(1)) | 2,086 | 2,086 | ||
Issuance of ordinary shares, net of issuance costs (Note 7b(1)) (in Shares) | 97,226 | |||
Issuance of ordinary shares per equity line agreement (Note 7b(2)) | ||||
Issuance of ordinary shares per equity line agreement (Note 7b(2)) (in Shares) | 30,626 | |||
Exercise of options by employees (Note 7c) | 282 | 282 | ||
Exercise of options by employees (Note 7c) (in Shares) | 5,110 | |||
Share-based compensation (Note 7c) | 3,221 | 3,221 | ||
Net loss | (47,599) | (47,599) | ||
BALANCE at Dec. 31, 2019 | $ 727 | 200,231 | (189,423) | 11,535 |
BALANCE (in Shares) at Dec. 31, 2019 | 1,811,431 | |||
CHANGES DURING 2019: | ||||
Issuance of ordinary shares, net of issuance costs (Note 7b(1)) | 421 | 421 | ||
Issuance of ordinary shares, net of issuance costs (Note 7b(1)) (in Shares) | 41,569 | |||
Issuance of ordinary shares and warrants, net of issuance costs (Note 7b(3)) | 5,692 | 5,692 | ||
Issuance of ordinary shares and warrants, net of issuance costs (Note 7b(3)) (in Shares) | 812,500 | |||
Issuance of ordinary shares and warrants, net of issuance costs (Note 7b(4)) | 4,426 | 4,426 | ||
Issuance of ordinary shares and warrants, net of issuance costs (Note 7b(4)) (in Shares) | 814,598 | |||
Issuance of ordinary shares and pre-funded warrants, net of issuance costs (Note 7b(6)) | 4,599 | 4,599 | ||
Issuance of ordinary shares and pre-funded warrants, net of issuance costs (Note 7b(6)) (in Shares) | 356,250 | |||
Exercise of pre-funded warrants (Note 7b(6)) | 71 | 71 | ||
Exercise of pre-funded warrants (Note 7b(6)) (in Shares) | 356,250 | |||
Exercise of warrants (Note 7b(3) and 7b(4)) | 769 | 769 | ||
Exercise of warrants (Note 7b(3) and 7b(4)) (in Shares) | 128,698 | |||
Share-based compensation (Note 7c) | 1,148 | 1,148 | ||
Net loss | (14,128) | (14,128) | ||
BALANCE at Dec. 31, 2020 | $ 727 | $ 217,357 | $ (203,551) | $ 14,533 |
BALANCE (in Shares) at Dec. 31, 2020 | 4,321,296 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (14,128) | $ (47,599) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,203 | 854 |
Impairment of long-lived assets | 13,663 | |
Exchange differences on cash and cash equivalents | (162) | 67 |
Change in right of use asset | 509 | 967 |
Change in lease liabilities | (492) | (713) |
Gains on marketable securities | (2) | (13) |
Share-based compensation | 1,148 | 3,221 |
Changes in operating asset and liabilities: | ||
Decrease (increase) in prepaid expenses and other receivables | 3,386 | (747) |
Decrease in deferred tax assets | 281 | |
Increase (decrease) in accounts payable and accruals | (3,060) | 679 |
Increase in other liabilities | 87 | 295 |
Net cash used in operating activities | (11,511) | (29,045) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (22) | (921) |
Investment in other assets | (2,865) | |
Proceeds from disposal of marketable securities | 772 | 576 |
Net cash provided by (used in) investing activities | 750 | (3,210) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of ordinary shares, net of issuance costs | 421 | 2,086 |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (Note 7b(3)) | 5,692 | |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (Note 7b(4)) | 4,426 | |
Proceeds from issuance of ordinary shares and pre-funded warrants, net of issuance costs (Note 7b(6)) | 4,599 | |
Proceeds from exercise of pre-funded warrants (Note 7b(6)) | 71 | |
Proceeds from exercise of warrants (Note 7b(3) and 7b(4)) | 769 | |
Proceeds from exercise of options by employees | 282 | |
Net cash provided by financing activities | 15,978 | 2,368 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 5,217 | (29,887) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR | 9,292 | 39,246 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 162 | (67) |
CASH AND CASH EQUIVALENTS AT END OF THE YEAR | 14,671 | 9,292 |
SUPPLEMENTARY DISCLOSURE OF CASH FLOW INFORMATION: | ||
Taxes paid | 9 | 75 |
Interest received | 39 | 327 |
SUPPLEMENTARY DISCLOSURE OF NON-CASH FINANCING ACTIVITIES: | ||
Acquisition of right-of-use assets by means of lease liabilities | $ 83 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NOTE 1 - NATURE OF OPERATIONS: a. Intec Pharma Ltd. (“Intec”) is engaged in the development of proprietary technology which enables the gastric retention of certain drugs. The technology is intended to significantly improve the efficacy of the drugs and substantially reduce their side-effects or the effective doses. Intec is a limited liability public company incorporated in Israel. Intec’s ordinary shares are traded on the NASDAQ Capital Market (“NASDAQ”). In September 2017, Intec incorporated a wholly-owned subsidiary in the United States of America in the State of Delaware – Intec Pharma Inc. (the “Subsidiary”, together with Intec - “the Company”). The Subsidiary was incorporated mainly to provide Intec executive and management services, including business development and investor relationship activities outside of Israel. On March 15, 2021, the Company entered into an Agreement and Plan of Merger and Reorganization (the "Merger Agreement") with Intec Parent, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“Intec Parent”) that was incorporated in March 2021, Dillon Merger Subsidiary, Inc., a Delaware corporation and a wholly-owned subsidiary of Intec Parent (“Merger Sub”) that was incorporated in March 2021, Domestication Merger Sub Ltd., an Israeli company and a wholly-owned subsidiary of Intec Parent (the “Domestication Merger Sub”) that was incorporated in March 2021 and Decoy Biosystems, Inc., a Delaware corporation (“Decoy”). Under the terms of the Merger Agreement, following the merger of the Domestication Merger Sub with and into the Company, with the Company being the surviving entity and a wholly-owned subsidiary of Intec Parent (the “Domestication Merger”), and subject to satisfaction of additional closing conditions, the Merger Sub will merge with and into Decoy, with Decoy being the surviving entity and a wholly-owned subsidiary of Intec Parent (the “Merger”). For more details see note 10c. b. The Company engages in research and development activities and has not yet generated revenues from operations. On July 22, 2019, The Company believes that it has adequate cash to fund its ongoing activities through the completion of the Merger and into the first quarter of 2022. However, changes may occur that would cause the Company to consume its existing cash prior to that time, including the costs to consummate the Merger. Prior to closing of the Merger, the Company agreed, among other things, that it would use commercially reasonable efforts to enter into one or more agreements providing for the sale, transfer or assignment or that it would otherwise take steps related to the divestment or disposal and satisfaction of liabilities of the Company’s Accordion Pill business, to be effected immediately after closing. Although the Company has entered into the Merger Agreement and intends to consummate the Merger, there is no assurance that it will be able to successfully complete the Merger on a timely basis, or at all. If, for any reason, the Merger is not consummated and the Company is unable to continue to operate its ongoing activities or identify and complete an alternative strategic transaction like the Merger, the Company may be required to dissolve and liquidate its assets. In such case, the Company would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left to distribute to its shareholders after paying its debts and other obligations and setting aside funds for reserves. In addition, the COVID-19 pandemic, that has spread globally, has resulted in significant financial market volatility and uncertainty in the past year. Many countries around the world, including in Israel and the United States, have implemented significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions on travel and the movement of people, and other material limitations on the conduct of business. The Company has implemented remote working and work place protocols for its employees in accordance with government requirements. The implementation of measures to prevent the spread of COVID-19 pandemic have resulted in disruptions to the Company’s partnering efforts which depend, in part, on attendance at in-person meetings, industry conferences and other events. It is not possible at this time to estimate the full impact that COVID-19 could have on the Company’s operation, as the impact will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat its impact. As of the date of issuance of these consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity, or results of operations is uncertain. As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of these financial statements. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. c. On September 3, 2019, the Company was notified by NASDAQ that it was not in compliance with the minimum bid price requirements for continued listing on the NASDAQ. The notification provided that the Company had 180 calendar days, or until March 2, 2020, to regain compliance. On March 3, 2020, the Company was notified that it is eligible for an additional 180 calendar day period, or until August 31, 2020, to regain compliance. As a result of tolling of compliance periods by NASDAQ, on April 17, 2020, the Company was notified that the term to regain compliance was extended until November 13, 2020. The Company implemented a 1-for-20 reverse share split of its outstanding ordinary shares that was effective for NASDAQ purposes at the open of business on October 30, 2020, which resulted in the Company regaining compliance with the minimum bid price requirement. As a result of the reverse share split, every 20 outstanding ordinary shares was combined into one ordinary share. All fractional shares created by the reverse share split were rounded up to the nearest whole share. The number of authorized shares was proportionately reduced from 350,000,000 ordinary shares to 17,500,000 ordinary shares. The reverse share split decreased the Company’s outstanding ordinary shares from 78,964,492 shares to 3,965,046 shares as of that date. All share and per share amounts in these consolidated financial statements have been retroactively adjusted to reflect the reverse share split. d. The Company’s effective “shelf” registration statement on Form S-3 is under General Instruction I.B.6 to Form S-3, or the Baby Shelf Rule. The amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the ordinary shares held by non-affiliates of the Company. |
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 financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (‘U.S. GAAP’). b. Principles of consolidation The consolidated financial statements include the accounts of Intec and its Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from those estimates. As applicable to these financial statements, the most significant estimates and assumptions relate to the impairment assessment on certain long-lived assets and fair value of share-based compensation. d. Functional and presentation currency The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of Intec and the Subsidiary are conducted. Accordingly, the functional currency of the Company is the dollar. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for transactions — exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. e. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. f. Marketable securities The Company’s marketable securities included bonds issued by the State of Israel and corporate bonds with a minimum of A rating by global rating agencies. These assets are recorded at fair value with changes recorded in the statement of operations as “financial income , g. Property and equipment: 1) Property and equipment are stated at cost, net of accumulated depreciation. 2) The Company’s property and equipment are depreciated by the straight-line method on the basis of their estimated useful lives. Annual rates of depreciation are as follows: % Computers and peripheral equipment 33 Production and laboratory equipment 10-14 Office furniture and equipment 7-10 Leasehold improvements are depreciated by the straight-line method over the shorter of the expected lease term and the estimated useful life of the improvements. h. Impairment of long-lived assets The Company’s long-lived assets include property, equipment and long-term other assets. The Company evaluates its long-lived assets for impairment in accordance with ASC 360, whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. When necessary, the Company calculates the undiscounted value of the projected cash flows associated with the asset, or asset group, and compares this estimated amount to the carrying amount. If any of its long-lived assets are considered to be impaired, the amount of impairment to be recognized is the excess of the carrying amount of the assets over its fair value. Estimates of future cash flows and timing of events for evaluating long-lived assets for impairment are based upon management’s assumptions and market conditions. Changes in assumptions or market conditions could result in a change in estimated future cash flows and the likelihood of materially different reported results. No impairment on long-lived assets was recorded for the year ended December 31, 2020. During the year ended December 31, 2019, the Company recorded an impairment loss related to certain of its long-lived assets in the amount of $13.7 million. The impairment charge is recorded as an operating expense. For more details, see note 6e(2). i. Share-based compensation The Company accounts for employees’ and directors’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. Performance based awards are expensed over the vesting period when the achievement of performance criteria is probable. The Company has elected to recognize forfeitures as they occur. j. 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 and professional services. All costs associated with research and developments are expensed as incurred. Grants received from the Israel Innovation Authority, formerly known as the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor (the “IIA”), were recognized when the grant becomes receivable, provided there was reasonable assurance that the Company will comply with the conditions attached to the grant and there was reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred, see note 6c. Research and development expenses, net for the year ended December 31, 2019, include participation in research and development expenses in the amount of approximately $1.1 million. The Company had no participation in research and development expenses for the year ended December 31, 2020. Clinical trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations under contracts with clinical research organizations (CROs). The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided. The Company’s objective is to reflect the appropriate trial expense in the consolidated financial statements by matching the appropriate expenses with the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments are recorded as other assets, which will be recognized as expenses as services are rendered. k. Loss contingencies: The Company may become involved, from time to time, in various lawsuits and legal proceedings which arise in the ordinary course of business. The Company records accruals for loss contingencies to the extent that it concludes their occurrence is probable and that the related liabilities are estimable. l. Income taxes: 1) Deferred taxes Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future. 2) Uncertainty in income taxes The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. m. Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the year divided by the weighted average number of ordinary shares outstanding during the year. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive. The following share options were excluded from the calculation of diluted loss per ordinary share because their effect would have been anti-dilutive for the years presented (share data): December 31 2020 2019 Outstanding stock options 237,288 216,255 Warrants 948,044 - n. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. o. Concentration of credit risks Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, marketable securities and certain receivables. The Company deposits cash and cash equivalents with highly rated financial institutions (Israeli banks). In addition, all marketable securities carry a high rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. p. Leases The Company is a lessee in several noncancelable operating leases primarily for office and operational spaces and vehicles. The Company currently has no finance leases. The Company accounts for leases in accordance with ASC Topic 842, “Leases”. The Company determines if an arrangement is a lease at inception. Right-of-use, or ROU, assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date. Operating lease ROU assets are presented as operating lease right of use assets on the consolidated balance sheets. The current portion of operating lease liabilities is included in other current liabilities and the long-term portion is presented separately as operating lease liabilities on the consolidated balance sheets. Lease expense is recognized on a straight-line basis for operating leases. The Company’s leases may include variable payments based on measures that include changes in price index. Change to index based variable lease payments is expensed in the period of the change. Variable lease payments are presented as operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company does not recognize ROU assets or lease liabilities. Instead, the Company recognizes the lease payments for those leases in profit or loss on a straight-line basis over the lease term. The Company’s lease terms may include options of the Company as the lessee to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability if it is reasonably certain that it will exercise that option. Because the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company has lease agreements with lease and non-lease components and has elected the practical expedient to combine lease and non-lease components for all underlying classes of assets. All fixed payments of non-lease components are included in the measurement of lease payments, the ROU asset, and the lease liability. All variable payments for non-lease components and executory costs will be recognized and disclosed as variable lease payments. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Topic 842 provides for a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. q. Newly issued accounting pronouncements New accounting pronouncements effective in future periods Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies will have an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company meets the definition of an SRC and is adopting the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial statements but does not expect that the adoption of this standard will have a material impact on its consolidated financial statements. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 - MARKETABLE SECURITIES The Company’s marketable securities included bonds issued by the State of Israel and corporate bonds with a minimum of A rating by global rating agencies. These assets are recorded as fair value with changes recorded in the statement of operations as “financial income, net”, as the Company chose to apply the fair value option. These assets are categorized as Level 1. As of December 31, 2020, the Company had no marketable securities. As of December 2019, the amount of the marketable securities is approximately $770 thousand. The gain, net from changes in marketable securities for the years ended December 31, 2020 and 2019 amounted to approximately $2 thousand and $13 thousand, respectively. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2020 | |
PROPERTY AND EQUIPMENT, NET | NOTE 4 - PROPERTY AND EQUIPMENT, NET: December 31 2020 2019 U.S. dollars in thousands Cost: Computers and communications equipment $ 259 $ 248 Production and laboratory equipment 7,297 7,286 Office furniture and equipment 208 208 Leasehold improvements 2,029 2,029 9,793 9,771 Less: Accumulated depreciation (8,399 ) (7,196 ) Property and equipment, net $ 1,394 $ 2,575 Depreciation expense totaled approximately $1,203 thousand, and approximately $854 thousand for the years ended December 31, 2020 and 2019, respectively. |
EMPLOYEE SEVERANCE BENEFITS
EMPLOYEE SEVERANCE BENEFITS | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
EMPLOYEE SEVERANCE BENEFITS | NOTE 5 - EMPLOYEE SEVERANCE BENEFITS The Company is required by Israeli law to make severance payments to Israeli employees upon dismissal or upon termination of employment in certain other 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 separate and independent entity so that the Company has no legal or constructive obligation to pay additional contributions if the fund does not hold sufficient assets to pay all employees the benefits relating to employee service in the current and prior periods. The fund assets are not included in the Company’s financial position. 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, as defined above. Contribution plan expenses totaled approximately $360 thousand and approximately $610 thousand for the years ended December 31, 2020 and 2019, respectively. The Company expects contribution plan expenses in 2021 to amount to approximately $400 thousand. |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 6 - COMMITMENTS AND CONTINGENT LIABILITIES: a. Joint venture and exclusive license agreement In June 2000, the Company engaged in a joint venture and exclusive license agreement with Yissum Research and Development Company, owned by the Hebrew University of Jerusalem (“Yissum”). Under the license agreement, the Company has been granted a perpetual and exclusive license to develop, manufacture and market products globally, which are based directly or indirectly on a patent owned by Yissum and based on the intellectual property that has been created as a result of the research that has been conducted by Yissum and financed by the Company under the license agreement. The Company is entitled to grant sub-licenses to third parties and said sub-licenses may be perpetual, and any sublicensee thereunder will not be required to assume any undertaking towards Yissum. Under the license agreement, the Company committed to act for the future development of products that are based on Yissum’s patent and on the initial research activity that was undertaken under the license agreement (the “Products”). Several pending patents have resulted from the development work done by the Company, on its behalf or on behalf of the Company and Yissum jointly. Further, the Company assumed in the license agreement all costs of submitting and managing patent applications, as well as maintaining pending and granted patents. In accordance with an amendment to the license agreement dated July 13, 2005 (which reduced royalty rates), and in exchange for the license, the Company agreed to pay 3% royalties on its overall net income (as defined in the license agreement) from the sale of the Products, to Yissum from the time of the first commercial sale. Furthermore, the Company agreed to pay 15% royalties on sub-licenses on any payment or benefit whatsoever that the Company may receive from sub-licenses. As of the date of issuance of these consolidated financial statements, the Company has not yet begun to sell its product candidates and has not yet granted sub-licenses to any party, and, accordingly, no obligation has yet to arise to pay royalties in accordance with the license agreement. The parties are entitled to cancel the license agreement in the following cases: (a) the appointment of a liquidator or a receiver or the submission of an application for liquidation in relation to the other party, which is not cancelled within 180 days; (b) attachment proceedings, debt collecting agency proceedings and similar proceedings in connection with a significant portion of the other party’s assets; (c) the liquidation or bankruptcy of the other party; or (d) a significant breach that is not cured within 30 days from the time notice is given. If the license agreement is cancelled except in the case of its cancellation as a result of a breach by Yissum, the rights that were granted under the license will return to Yissum. In accordance with the license agreement, the agreement will remain in force until the later of the expiry of the last patent that partially underlies the Products on a global basis or 15 years from the time of the first commercial sale under the license agreement. b. Cooperation agreements As part of its operations, the Company entered into feasibility agreements with multinational companies for the development of products that combine the Company’s proprietary Accordion Pill platform technology with certain drugs for the treatment of various indications. These agreements sometimes include a mutual possibility of entering into negotiations for the acquisition of a future license for the commercial use of the products that are being developed by the multinational companies under the feasibility agreements. In addition, the multinational companies agreed to reimburse the Company for its expenses, based on milestones that are detailed in the feasibility agreements. This funding is recognized in the statements of operations as a deduction from research and development expenses, as they are incurred. 1) In December 2020, the Company entered into cannabinoid research collaboration agreement with GW Research Limited (“GW”) to explore using the Accordion Pill platform for an undisclosed research program. 2) In May 2019, the Company entered into a research collaboration agreement with Merck Sharp & Dohme (“Merck”) for the development of a custom-designed Accordion Pill for one of Merck’s proprietary compounds. Under the agreement, the Company’s activities will be funded by Merck subject to the achievement of agreed milestones. In October 2020, the Company entered into a new research collaboration agreement with Merck for another compound. 3) In January 2018, the Company entered into a feasibility and option agreement with Novartis Pharmaceuticals (“Novartis”) to explore using the Accordion Pill platform for a proprietary Novartis compound. Under the agreement and the research plan, the Company’s activities were to be funded by Novartis subject to the achievement of agreed milestones. In December 2019, the Company received notice from Novartis of the termination of the agreement, since this program no longer meets Novartis’ mid to long-term strategic goals. Novartis agreed to pay to the Company $1.5 million on conclusion of the program. The Company recorded this amount in the statements of operations for the year ended December 31, 2019 as ‘Other income’, which was paid in February 2020. c. Grants from the IIA The Company has received grants from the IIA for research and development funding and therefore is subject to the provisions of the Israeli Law for the Encouragement of Research, Development and Technological Innovation in the Industry and the regulations and guidelines thereunder (the “Innovation Law”, formerly known as the Law for the Encouragement of Research and Development in Industry). Under the Innovation Law, the rate of royalties varies between 3% to 5% computed based on the revenues from the products that their development was also funded by grants from the IIA. Such commitment is up to the amount of grants received (dollar linked), plus interest at annual rate based on LIBOR. Pursuant to the Innovation Law there are restrictions regarding intellectual property and manufacturing outside of Israel, unless approval is received, and additional payments are made to the IIA. At the time the Company received the grants, successful development of the program was not assured and, accordingly, no liability has been recognized in the financial statements. In February 2018, the Company received an approval from the IIA to manufacture its AP-CD/LD product outside of Israel. As such, the royalties to the IIA will be paid at an increased rate and up to an increased cap amount of three times the total amount of the IIA grants, plus interest accrued thereon, depending on the manufacturing volume to be performed outside Israel. The Company received from the IIA grants in the total amount of approximately NIS 42.3 million (approximately $11.3 million) for research and development programs in the years 2009 through 2016. T he Company d. Lease Agreements: 1) The Company is a tenant under a lease agreement in respect of offices and operational spaces in Jerusalem until June 30, 2022. Rent payments are denominated in NIS and linked to the Israeli CPI. To secure the Company’s obligations to the lease agreement in Jerusalem, the Company has granted a bank guarantee to the lessor, which amounted to approximately $157 thousand and $147 thousand approximately as of December 31, 2020 and 2019, respectively. 2) The Company has entered into operating lease agreements for vehicles used by its employees. The lease periods are generally for three years and the payments are linked to the Israeli CPI. To secure the terms of the lease agreements, the Company has made certain prepayments to the leasing company, representing approximately three months of lease payments. Lease expense for the years ended December 31, 2020 and 2019 was comprised of the following: Year ended December 31 2020 2019 U.S. dollars in thousands Operating lease expense $ 501 $ 743 Short-term lease expense 15 102 Variable lease expense - 2 $ 516 $ 847 Supplemental information related to leases are as follows: December 31 2020 2019 U.S. dollars in thousands Operating lease right-of-use assets $ 817 $ 1,243 Current Operating lease liabilities 596 544 Non-current operating lease liabilities $ 338 $ 799 Other information: Operating cash flows from operating leases (cash paid in thousands) $ 547 $ 743 Weighted Average Remaining Lease Term (years) 1.59 2.43 Weighted Average Discount Rate of operating leases 5.40 % 5.45 % Maturities of lease liabilities are as follows: Year Amount U.S. dollars in thousands 2021 625 2022 329 2023 22 Total lease payments 976 Less imputed interest (42 ) Total 934 e. Establishment of the Commercial Scale Production Capabilities for AP-CD/LD: 1) LTS Process Development Agreement In December 2018, the Company entered into a Process Development Agreement for Manufacturing Services with LTS for the manufacture of AP-CD/LD (the “Agreement”). Under the Agreement, the Company will bear the costs incurred by LTS to acquire the production equipment for AP-CD/LD (“Equipment”) which amounted to approximately €6.8 million (approximately $7.8 million), and this amount will later be reimbursed to the Company by LTS in the form of a reduction in the purchase price of the AP-CD/LD product. The Company paid in full all the consideration. The Company has recognized the Equipment as non-current other assets. In 2019, the Company performed an impairment assessment on certain of its long-lived assets which resulted an impairment charge of the Equipment in the amount of approximately $4.1 million. As of December 31, 2019, the fair value of the Equipment was approximately $3.7 million. As of December 31, 2020, the Company performed an impairment assessment on the Equipment which determined that there is no need to record an additional impairment charge of the Equipment. For more details, see note 6e(2) below. The Agreement also contains several termination rights , including, among others, in the cases of bankruptcy, breach by either party, change of control of either of the parties, or the sale or licensing by us of the Accordion Pill to a third party, and as of December 31, 2020 and 2019, the Company has a liability in the amount of €2.0 million (as of December 31, 2020 approximately $2.45 million) for LTS’s facility upgrading costs. This liability will be paid to LTS only if the Company decides not to continue with the project or commercialization of AP-CD/LD. 2) Impairment Assessment (i) On July 22, 2019, the Company announced top-line results from its pivotal Phase III clinical for AP-CD/LD for the treatment of advanced Parkinson’s which did not meet its target endpoints. The Company determined that the Phase III clinical trial results constituted a triggering event that required the Company to evaluate its large-scale automated production line for manufacturing Accordion Pills (the “Production Line”) and Equipment net from the liability described in note 6e(1), together “AP-CD/LD Assets, net” for impairment test. For the year ended December 31, 2019, the Company recorded an impairment charge of approximately $13.7 million of its AP-CD/LD Assets, net which represents excess carrying value compared to the fair value of the AP-CD/LD Assets, net. The following table illustrates the effect of the impairment assessment on the AP-CD/LD Assets, net, as of December 31, 2019: Cost/ Impairment Charge Fair U.S. dollars in thousands Production Line $ 9,568 $ (9,568 ) $ - Equipment 7,812 (4,095 ) 3,717 Liability for LTS’s facility upgrading costs (2,244 ) - (2,244 ) AP-CD/LD Assets, net $ 15,136 $ (13,663 ) $ 1,473 The fair value was determined using the discounted cash flow method (level 3) which utilized significant estimates and assumptions surrounding the amount and timing of the projected net cash flows, which includes the probability of out-licensing the AP-CD/LD program to a third-party, the probability of obtaining FDA approval, the expected impact of competition, the discount rate, which seeks to reflect the various risks inherent in the projected cash flows, and the tax rate. (ii) As of December 31, 2020, the Company performed an additional impairment assessment on its Equipment since the uncertainty that the Company will initiate operation for commercial manufacturing in the foreseeable future. Based on this assessment, as of December 31, 2020, the fair value of the Equipment was higher than its net book value and no impairment was recorded for the year ended December 31, 2020. As of December 31, 2020, the net book value of the Equipment is approximately $3.7 million. The fair value was determined using a combination of market approach and cost approach (level 3). This method utilized significant estimates and assumptions which include adjustments to the historical cost that derived from brokers or manufacturers who are active in the used equipment market and other relevant market data. While management believes the assumptions used in their impairment assessments are reasonable, any changes in the actual market conditions versus the assumptions used in the models could result in a change in estimated future cash flows, which may result in an additional impairment charge on Equipment in the future. f. Lawsuit In December 2019, two former directors and officers (the “plaintiffs”) filed a statement of claim with the Jerusalem District Labor Court alleging breach of contract related to a purported vesting of certain options issued to the plaintiffs pursuant to the execution of the LTS Agreement and further alleging payments due for unredeemed vacation days. The plaintiffs sought pecuniary damages of NIS 2.4 million (as of December 31, 2020 approximately $750 thousand) plus interest and linkage to the Israeli CPI. On February 17, 2021, the Company entered into a settlement agreement (the "Settlement Agreement") with each of the plaintiffs, pursuant to which the Company agreed to pay to each plaintiff NIS 400 thousand (approximately $125 thousand) in cash (the "Settlement Amount") in return for the complete settlement of all past and future claims by each plaintiff. The Settlement Amount was recorded under accounts payable and accruals as of December 31, 2020. On February 18, 2021, the Jerusalem District Labor Court agreed to dismiss the case. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2020 | |
SHARE CAPITAL | NOTE 7 - SHARE CAPITAL: a. Rights of the Company’s ordinary shares Each ordinary share is entitled to one vote. The holders of ordinary shares are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. Since its inception, the Company has not declared any dividends. b. Changes in share capital: 1) On March 1, 2019, the Company entered into a Sales Agreement with Cowen and Company, LLC (“Cowen”) which provides that, upon the terms and subject to the conditions and limitations in the Sales Agreement, the Company may elect from time to time, to offer and sell ordinary shares through an “at-the-market” equity offering program through Cowen acting as sales agent. The issuance and sale of ordinary shares by the Company under the offering program was made pursuant to the Company’s effective “shelf” registration statement on Form S-3 filed with the SEC on March 1, 2019 and declared effective on March 28, 2019, as amended by a prospectus supplement filed on March 13, 2020. On May 4, 2020, the Company terminated the prospectus supplement, but the sales agreement remains in full force and effect. During September and December 2019, the Company sold 97,226 ordinary shares under the Sales Agreement at an average price of $22.6 per share for aggregate net proceeds of approximately $2.1 million, net of issuance expenses of approximately $112 thousand. During January 2020, the Company sold 41,569 ordinary shares under the Sales Agreement at an average price of $10.50 per share for aggregate net proceeds of approximately $421 thousand, net of issuance expenses of approximately $15 thousand. 2) On December 2, 2019, the Company entered into an ordinary shares purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (Aspire Capital) which provides that, upon the terms and subject to the conditions and limitations in the Purchase agreement, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of the Company’s ordinary shares over the 30-month term of the Purchase Agreement. The Company will control the timing and amount of sales of the Company’s ordinary shares to Aspire Capital. In consideration for entering into the Purchase Agreement, the Company issued to Aspire Capital 30,626 ordinary shares. 3) On February 3, 2020, the Company completed an underwritten public offering, pursuant to which the Company issued 764,000 ordinary shares, pre-funded warrants to purchase 48,500 ordinary shares and warrants to purchase 812,500 ordinary shares. Each pre-funded warrant was exercisable at an exercise price of $0.002 per share. All the pre-funded warrants were exercised following the closing of the offering. Each ordinary share and warrant or pre-funded warrant and warrant was sold together at a combined price of $8.00. Each warrant shall is exercisable at an exercise price of $8.00 per share and has a term of five years from the date of issuance. The Company concluded that the warrants are classified as equity, since they meet all criteria for equity classification. The total net proceeds were approximately $5.7 million, after deducting underwriting discounts, commissions and other offering expenses in the amount of $800 thousand. In June and July 2020, warrants to purchase 44,625 ordinary shares were exercised for consideration of $357 thousand. As of December 31, 2020, warrants to purchase 767,875 ordinary shares remained outstanding. In February 2021, warrants to purchase 20,000 ordinary shares were exercised for consideration of $160 thousand. 4) On May 6, 2020, the Company completed a registered direct offering, pursuant to which the Company sold and issued to certain institutional investors 814,598 ordinary shares at a purchase price per share of $6.138. In addition, in a concurrent private placement, the Company also sold and issued to the purchasers in the offering unregistered warrants to purchase 407,299 ordinary shares. Each warrant is exercisable at an exercise price of $4.90 per share and has a term of five and one-half years from the date of issuance. The Company concluded that the warrants are classified as equity, since they meet all criteria for equity classification. The total net proceeds were approximately $4.5 million, after deducting placement agent and other offering expenses in the amount of approximately $500 thousand. In July 2020, warrants to purchase 84,073 ordinary shares were exercised for consideration of approximately $412 thousand. As of December 31, 2020, warrants to purchase 323,226 ordinary shares remained outstanding. In February 2021, warrants to purchase 162,500 ordinary shares were exercised for consideration of $796 thousand. 5) On July 15, 2020, the Company increased its authorized share capital from 5,000,000 ordinary shares to 17,500,000 ordinary shares. 6) On August 10, 2020, the Company completed a registered direct offering, pursuant to which the Company sold and issued to Aspire Capital Fund LLC (Aspire Capital), 356,250 ordinary shares at a purchase price per share of $7.022. In addition, the Company also sold and issued to Aspire Capital pre-funded warrants to purchase 356,250 ordinary shares at a purchase price per share of $6.822. Each pre-funded warrant was exercisable at an exercise price of $0.20 per share. The pre-funded warrants were exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full. The Company concluded that the pre-funded warrants are classified as equity, since they meet all criteria for equity classification. The total net proceeds were approximately $4.6 million, after deducting commitment fee and other offering expenses in the amount of approximately $330 thousand. In December 2020, the pre-funded warrants were exercised in full for consideration of approximately $71 thousand. The total net proceeds were approximately $4.7 million, after deducting offering expenses. c. Share-based compensation: 1) In September 2005, the Company’s board of directors approved a share option plan for grants to directors, employees and consultants (the “2005 Plan”). The 2005 plan expired in September 2015. In January 2016, the Company’s board of directors approved a new option plan (the “2015 Plan”). Originally, the maximum number of ordinary shares reserved for issuance under the 2015 Plan was 35,000 ordinary shares for grants to directors, employees and consultants. In July 2016, an increase of 35,000 ordinary shares was approved by the board of directors. In December 2017, June 2018 and December 2019, an increase of 105,000, 50,000 and 50,000 ordinary shares, respectively, was approved by the Company’s shareholders at a general meeting of shareholders. In July 2020, the Company’s shareholders approved a further increase of 175,000 ordinary shares. As of December 31, 2020, 181,027 shares remain available for grant under the Plan. The 2015 Plan is designed to enable the Company to grant options to purchase ordinary shares under various and different tax regimes including, without limitation: pursuant and subject to Section 102 of the Israeli Tax Ordinance and pursuant and subject to Section 3(i) of the Israeli Tax Ordinance. The awards may be exercised after vesting and in accordance with vesting schedules which will be determined by the Company’s board of directors for each grant. The maximum term of the awards is 10 years. The fair value of each option granted under the 2015 Plan is estimated using the Black-Scholes option pricing method. Expected volatility is based on the Company’s historical volatility. The risk-free interest rate was determined on the basis of the yield rates to maturity of unlinked government bonds bearing a fixed interest rate, whose maturity dates correspond to the expected exercise dates of the options. The Company’s management uses the contractual term or its expectations, as applicable, of each option as its expected life. The expected term of the options granted represents the period that granted options are expected to remain outstanding. 2) On August 22, 2019, the Company reduced the exercise price of 63,183 options previously granted to employees (excluding executive officers and directors) to $8.94 (determined based on the closing price of the Company’s ordinary shares on NASDAQ on August 21, 2019). The total incremental fair value of these options amounted to $253 thousand and was determined based on the Black-Scholes pricing options model using the following assumptions: risk free interest rate of 1.5%, expected volatility of 99% - 122%, expected term of 2.6-4.4 years and dividend yield of 0%. The incremental fair value of the fully vested options as of August 22, 2019 in the amount of $62 thousand was recognized immediately. The remaining incremental fair value will be recognized over the remaining vesting period and until January 2022. 3) During the years ended December 31, 2020 and December 31, 2019, the Company granted options to employees and directors as follows: Year ended December 31, 2020 Number of options granted Exercise Vesting Expiration Employees 85,000 $ 6.15-$8.57 1.29-3 years 7 years Directors 10,000 $ 6.15 3 years 7 years Year ended December 31, 2019 Number of options granted Exercise price range Vesting Expiration Employees 73,250 $ 8.94-$152.8 3 years 7 years Directors 7,000 $ 12.4-$97.2 3 years 7 years The weighted average fair value of options granted during the years was generally estimated by using the Black-Scholes option-pricing model as follows: Year ended December 31 2020 2019 Weighted average fair value $ 4.38 $ 55.28 The underlying data used for computing the fair value of the options are as follows: Year ended December 31 2020 2019 Value of ordinary share $5.60-$6.20 $10.2-$149.2 Dividend yield 0% 0% Expected volatility 102.58%-110.4% 53.32%-100.04% Risk-free interest rate 0.28%-1.42% 1.65%-2.57% Expected term 5 years 5 years The following table summarizes the number of options outstanding with exercise price in NIS, which were granted under the 2005 Plan, for the years ended December 31, 2020 and December 31, 2019, and related information: Employees and directors Consultants Number of options NIS (1) Number of options NIS (1) Outstanding at January 1, 2019 14,773 550.4 402 10.0 Exercised (1 ) 10.0 (127 ) 10.0 Forfeited (4,295 ) 465.0 - - Expired (6,343 ) 437.8 (275 ) 10.0 Outstanding at December 31, 2019 4,134 812.0 - - Forfeited - - - - Expired (4,134 ) 812.0 - - Outstanding at December 31, 2020 - - - - The following table summarizes the number of options outstanding with exercise price in USD, which were granted under the 2015 Plan, for the years ended December 31, 2020 and December 31, 2019, and related information: Employees and directors Number of options USD (2) Outstanding at January 1, 2019 156,909 117.0 Granted 80,250 69.0 Exercised (4,982 ) 56.6 Forfeited (22,537 ) 80.0 Expired (13,495 ) 140.0 Outstanding at December 31, 2019 196,145 82.6 Granted 95,000 7.09 Forfeited (18,249 ) 39.47 Expired (9,816 ) 41.18 Outstanding at December 31, 2020 263,080 59.87 (1) Weighted average price in NIS per share. (2) Weighted average price in USD per share. The following table summarizes information concerning outstanding and exercisable options with exercise prices in USD as of December 31, 2020: December 31, 2020 Options outstanding Options exercisable Exercise price per share (USD) Number of options outstanding at the end of year Weighted average remaining contractual life Number of options exercisable at the end of year Weighted average remaining contractual life 6.15-6.67 60,750 6.64 - - 8.58-8.94 60,416 4.93 28,810 3.91 11.1-18.0 21,000 5.71 8,668 5.71 70.52 11,224 5.37 11,224 5.37 82.8-89.3 20,440 5.05 14,692 4.95 97.2 4,000 5.49 1,996 5.49 103.8-109.2 21,750 4.85 21,188 4.87 120.0-122.0 11,542 0.60 11,542 0.60 134.0 19,000 6.95 19,000 6.95 152.6-152.8 22,958 4.42 14,207 3.98 171.2 10,000 6.91 10,000 6.91 263,080 141,327 As of December 31, 2020, the total outstanding and exercisable options have no intrinsic value. The following table illustrates the effect of share-based compensation on the statements of operations: Year ended December 31 2020 2019 U.S. dollars in thousands Research and development expenses, net $ 289 $ 1,634 General and administrative expenses 859 1,587 $ 1,148 $ 3,221 |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2020 | |
Supplementary Financial Statement Information [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 8 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: a. Prepaid expenses and other receivable: December 31 2020 2019 U.S. dollars in thousands Institutions $ 25 $ 1,836 Termination fee, Novartis (see note 6b(1)) - 1,500 Prepaid expenses 212 194 Advances to suppliers - 3 Interest receivable - 3 Other receivables 60 147 $ 297 $ 3,683 b. Accounts payable and accruals - other: Expenses payable 2,859 2,838 Salary and related expenses, including social security and other taxes 1,057 1,277 Current operating lease liabilities (see note 6d) 596 544 Accrual for vacation days and recreation pay for employees 180 154 Other 274 22 $ 4,966 $ 4,835 Statements of operations: c. Financial income (expenses), net: Year ended December 31 2020 2019 U.S. dollars in thousands Financial income: Interest on cash and cash equivalents $ 39 $ 330 Gains from changes in fair value of marketable securities 2 13 $ 41 $ 343 Financial expenses - Loss from changes in exchange rates $ (206 ) $ (180 ) Bank fees (10 ) (15 ) $ (216 ) $ (195 ) Financial income (expenses), net $ (175 ) $ 148 |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 9 - TAXES ON INCOME: a. Tax rates: 1) Income from Israel is taxed according to the Israeli tax laws. Capital gains are taxed at the standard corporate tax rate. Israeli tax rate relevant to the Company is 23%. For tax benefits in Israel see note b below. 2) Income of the subsidiary is taxed according to the federal tax laws in the US and the relevant state laws. The relevant U.S. statutory tax rates for 2020 and 2019 were 21%. The relevant state tax rate for 2020 and 2019 was approximately 7%. The U.S. Tax Cuts and Jobs Act (“Tax Act”) was enacted on December 22, 2017 and introduced significant changes to U.S. income tax law. Effective in 2018, the Tax Act reduced the U.S. federal statutory tax rate from 35% to 21% and created new taxes on certain foreign-sourced earnings and certain related-party payments, which are referred to as the global intangible low-taxed income tax and the base erosion tax, respectively. b. Tax benefits under the Law for the Encouragement of Capital Investments, 1959 in Israel (the “ECI Law”) Under the ECI Law, Intec may be entitled to tax benefits, by virtue of its status as a “Benefited Enterprise”, which was awarded to Intec in October 2007. Intec received the status of a “plant under establishment” in Development Area A in a tax-exempt track, subject to compliance with the applicable requirements by the Law. As of December 31, 2020, Intec has not yet generated operating income that will allow it to benefit from the tax benefits under the ECI Law. The tax benefits under the ECI Law will apply for a period of up to ten years from the first year in which taxable income will be generated and are scheduled to expire at the end of 2023. c. Tax assessments Intec has tax assessments that are considered to be final through tax year 2016. d. Losses for tax purposes carried forward to future years As of December 31, 2020, Intec had approximately $173.6 million of net carry forward tax losses which are available to reduce future taxable income with no limited period of use. e. Subsidiary tax expenses During 2020 and 2019, the Subsidiary incurred a tax expense in the amount of approximately $124 thousand and approximately $638 thousand, respectively. In 2020 and 2019, the Company has provided full valuation allowance with respect to the subsidiary's share-based compensation expenses and accordingly recorded in 2020 and 2019 tax expenses of approximately $87 thousand and approximately $562 thousand, respectively. f. Deferred income taxes: December 31 2020 2019 U.S. dollars in thousands In respect of: Net operating loss carry forward $ 39,924 $ 33,316 Research and Development expenses 2,910 6,209 Impairment of long-lived assets 3,143 3,143 Issuance costs 274 216 Other 1,246 1,138 Less—valuation allowance (47,497 ) (44,022 ) Net deferred tax assets $ - $ - The change in valuation allowance for the years ended December 31, 2020 and 2019 were as follows: Year ended December 31 2020 2019 U.S. dollars in thousands Balance at the beginning of the year $ 44,022 $ 32,684 Changes during the year 3,475 11,338 Balance at the end of the year $ 47,497 $ 44,022 g. Loss before income tax: The components of loss before income tax are as follows: Year ended December 31 2020 2019 U.S. dollars in thousands Income (loss) before income tax: Intec $ (14,180 ) $ (47,331 ) Subsidiary 176 370 $ (14,004 ) $ (46,961 ) h. Current taxes on income The main reconciling item between the statutory tax rates of the Company and the effective rate is the provision for valuation allowance in respect of tax benefits from carryforward tax losses and research and development expenses due to the uncertainty of the realization of such tax benefits. i. ASC No. 740, Income Taxes, requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of the effective tax rate and consequently, affect the operating results of the Company. The following table summarizes the activity of the Company unrecognized tax benefits: Year ended December 31 2020 2019 U.S. dollars in thousands Balance at the beginning of the year $ 604 $ 309 Increase in uncertain tax positions for the current year 87 295 Balance at the end of the year $ 691 $ 604 The Company does not expect unrecognized tax expenses to change significantly over the next 12 months. |
EVENTS SUBSEQUENT TO DECEMBER 3
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 | 12 Months Ended |
Dec. 31, 2020 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 | NOTE 10 - EVENTS SUBSEQUENT TO DECEMBER 31, 2020: a. In February 2021, warrants to purchase 182,500 ordinary shares were exercised for consideration of approximately $956 thousand. b. In February 2021, the Company entered into a non-binding term sheet for the sale or license of the AP-CD/LD program to an undisclosed third party and are currently negotiating the terms of a definitive agreement. There is no assurance that this will result in a definitive agreement. c. On March 15, 2021, the Company entered into a Merger Agreement with Intec Parent, Merger Sub, Domestication Merger Sub, and Decoy, pursuant to which, following the Domestication Merger, and upon satisfaction of additional closing conditions, the Merger Sub will merge with and into Decoy, with Decoy being the surviving entity and a wholly owned subsidiary of Intec Parent. If the Merger is completed then the business of Decoy will become the business of Intec Parent. Under the exchange ratio formula in the Merger Agreement, without taking into consideration the effect of the respective levels of cash and liabilities of each of the Company and Decoy, which will result in an adjustment to such exchange ratio, following the closing of the Merger (the “Closing”), the former Decoy securityholders immediately before the Merger are expected to own approximately 75% of the aggregate number of the outstanding securities of Intec Parent (based on a valuation of $30 million), and the securityholders of the Company immediately before the Domestication Merger are expected to own approximately 25% of the aggregate number of the outstanding securities of Intec Parent (based on a valuation of $10 million), calculated on a fully-diluted basis. The actual allocation will be subject to adjustment based on, among other things, Decoy’s and the Company’s net cash balance (including, in the case of the Company, any proceeds from any disposition of the Company’s Accordion Pill business), subject to certain exceptions. As further described below, the Closing is also conditioned on completion of the Domestication Merger and on a financing by the Company or Intec Parent, which will dilute securityholders of both the Company and Decoy on a pro-rata basis. The Merger Agreement contains customary representations, warranties and covenants made by each of the Company and Decoy, including covenants relating to (i) the conduct of their respective businesses prior to the Closing, (ii) the preparation and filing of a registration statement on Form S-4 registering the Merger Shares and the shares of Intec Parent Common Stock to be issued in connection with the Domestication Merger (the “Registration Statement”) and the preparation and/or filing, as applicable, of a proxy statement/information statement for the special meeting or approval by written consent, as applicable, of shareholders of each of the Company and Decoy, (iii) holding a meeting or approval by written consent, as applicable, of shareholders of each of the Company and Decoy to obtain their requisite approvals in connection with the Domestication Merger and Merger, as applicable, including, among other approvals, the approval by the Company’s shareholders of the issuance of the Merger Shares, and (iv) subject to certain exceptions, the recommendation of the board of directors of each party to the Merger Agreement to its shareholders that such approvals be given. Consummation of the Merger is subject to certain closing conditions, including, among other things, (i) consummation of the Domestication Merger, (ii) approval of certain matters related to the Merger by the shareholders of the Company and approval of the Merger by the stockholders of Decoy, (iii) the effectiveness of the Registration Statement, (iv) the continued listing of the Company’s ordinary shares on the Nasdaq Capital Market (and following the Domestication Merger, the shares of Intec Parent Common Stock) and the authorization for listing on the Nasdaq Capital Market of the Merger Shares, (v) the receipt of a tax ruling from the Israel Tax Authority with respect to the Domestication Merger, (vi) disposition of the Company’s Accordion Pill business, as further described below, and (vii) a closing financing by the Company or Intec Parent such that upon Closing of the Merger (taking account of the proceeds to be received with respect to such financing), the combined net cash of Intec Parent shall be not less than $30 million and not more than $50 million, and which represents an agreed minimum valuation derived from the Exchange Ratio for Intec Parent following the Closing. The Merger Agreement requires the Company to convene a shareholders’ meeting for purposes of obtaining the necessary shareholder approvals required in connection with the Merger. The Merger Agreement contains certain termination rights for both the Company and Decoy, including, but not limited to, the right of the Company and Decoy to terminate the Merger Agreement by mutual written consent or if a court of competent jurisdiction or other Governmental Body (as defined in the Merger Agreement) has issued a final and nonappealable order, decree or ruling, or has taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Merger. In addition, either the Company or Decoy may terminate the Merger Agreement if the Merger is not consummated on or before the date that is 155 days following the delivery of the Decoy audited financial statements for the fiscal years ended December 31, 2020 and 2019, which date may be extended in certain circumstances. In connection with the termination of the Merger Agreement, under specified circumstances, Decoy may be required to pay to the Company a break-up fee of $1,000,000, or the Company may be required to pay to Decoy a reverse break-up fee of $1,000,000 and forfeit a deposit in the amount of $350,000 in favor of Decoy to cover transaction expenses. As set forth in the Merger Agreement, prior to the date of the closing date (the “Closing Date”), the Company shall re-domesticate as a Delaware corporation by merging with and into the Domestication Merger Sub, with the Company surviving the merger and becoming a wholly-owned subsidiary of Intec Parent. In connection with the Domestication Merger, all the Company’s ordinary shares, having no par value per share (the “Intec Israel Shares”), outstanding immediately prior to the Domestication Merger, will convert, on a one-for-one basis, into shares of Intec Parent Common Stock and all options and warrants to purchase Intec Israel Shares outstanding immediately prior to the Domestication Merger will be exchanged for equivalent securities of Intec Parent. In accordance with the terms of the Merger Agreement, the Company agreed that prior to the Closing Date it would use commercially reasonable efforts to enter into one or more agreements providing for the sale, transfer or assignment, or that it would otherwise take steps related to the divestment or disposal and satisfaction of liabilities of, the Company’s Accordion Pill business, to be effected immediately after the Closing. |
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 financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (‘U.S. GAAP’). |
Principles of consolidation | b. Principles of consolidation The consolidated financial statements include the accounts of Intec and its Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. |
Use of estimates in the preparation of financial statements | c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from those estimates. As applicable to these financial statements, the most significant estimates and assumptions relate to the impairment assessment on certain long-lived assets and fair value of share-based compensation. |
Functional and presentation currency | d. Functional and presentation currency The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of Intec and the Subsidiary are conducted. Accordingly, the functional currency of the Company is the dollar. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for transactions — exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. |
Cash and cash equivalents | e. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. |
Marketable securities | f. Marketable securities The Company’s marketable securities included bonds issued by the State of Israel and corporate bonds with a minimum of A rating by global rating agencies. These assets are recorded at fair value with changes recorded in the statement of operations as “financial income , |
Property and equipment | g. Property and equipment: 1) Property and equipment are stated at cost, net of accumulated depreciation. 2) The Company’s property and equipment are depreciated by the straight-line method on the basis of their estimated useful lives. Annual rates of depreciation are as follows: % Computers and peripheral equipment 33 Production and laboratory equipment 10-14 Office furniture and equipment 7-10 Leasehold improvements are depreciated by the straight-line method over the shorter of the expected lease term and the estimated useful life of the improvements. |
Impairment of long-lived assets | h. Impairment of long-lived assets The Company’s long-lived assets include property, equipment and long-term other assets. The Company evaluates its long-lived assets for impairment in accordance with ASC 360, whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. When necessary, the Company calculates the undiscounted value of the projected cash flows associated with the asset, or asset group, and compares this estimated amount to the carrying amount. If any of its long-lived assets are considered to be impaired, the amount of impairment to be recognized is the excess of the carrying amount of the assets over its fair value. Estimates of future cash flows and timing of events for evaluating long-lived assets for impairment are based upon management’s assumptions and market conditions. Changes in assumptions or market conditions could result in a change in estimated future cash flows and the likelihood of materially different reported results. No impairment on long-lived assets was recorded for the year ended December 31, 2020. During the year ended December 31, 2019, the Company recorded an impairment loss related to certain of its long-lived assets in the amount of $13.7 million. The impairment charge is recorded as an operating expense. For more details, see note 6e(2). |
Share-based compensation | i. Share-based compensation The Company accounts for employees’ and directors’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. Performance based awards are expensed over the vesting period when the achievement of performance criteria is probable. The Company has elected to recognize forfeitures as they occur. |
Research and development expenses, net | j. 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 and professional services. All costs associated with research and developments are expensed as incurred. Grants received from the Israel Innovation Authority, formerly known as the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor (the “IIA”), were recognized when the grant becomes receivable, provided there was reasonable assurance that the Company will comply with the conditions attached to the grant and there was reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred, see note 6c. Research and development expenses, net for the year ended December 31, 2019, include participation in research and development expenses in the amount of approximately $1.1 million. The Company had no participation in research and development expenses for the year ended December 31, 2020. Clinical trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations under contracts with clinical research organizations (CROs). The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided. The Company’s objective is to reflect the appropriate trial expense in the consolidated financial statements by matching the appropriate expenses with the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments are recorded as other assets, which will be recognized as expenses as services are rendered. |
Loss contingencies | k. Loss contingencies: The Company may become involved, from time to time, in various lawsuits and legal proceedings which arise in the ordinary course of business. The Company records accruals for loss contingencies to the extent that it concludes their occurrence is probable and that the related liabilities are estimable. |
Income taxes | l. Income taxes: 1) Deferred taxes Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future. 2) Uncertainty in income taxes The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. |
Loss per share | m. Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the year divided by the weighted average number of ordinary shares outstanding during the year. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive. The following share options were excluded from the calculation of diluted loss per ordinary share because their effect would have been anti-dilutive for the years presented (share data): December 31 2020 2019 Outstanding stock options 237,288 216,255 Warrants 948,044 - |
Fair value measurement | n. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. |
Concentration of credit risks | o. Concentration of credit risks Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, marketable securities and certain receivables. The Company deposits cash and cash equivalents with highly rated financial institutions (Israeli banks). In addition, all marketable securities carry a high rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. |
Leases | p. Leases The Company is a lessee in several noncancelable operating leases primarily for office and operational spaces and vehicles. The Company currently has no finance leases. The Company accounts for leases in accordance with ASC Topic 842, “Leases”. The Company determines if an arrangement is a lease at inception. Right-of-use, or ROU, assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date. Operating lease ROU assets are presented as operating lease right of use assets on the consolidated balance sheets. The current portion of operating lease liabilities is included in other current liabilities and the long-term portion is presented separately as operating lease liabilities on the consolidated balance sheets. Lease expense is recognized on a straight-line basis for operating leases. The Company’s leases may include variable payments based on measures that include changes in price index. Change to index based variable lease payments is expensed in the period of the change. Variable lease payments are presented as operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company does not recognize ROU assets or lease liabilities. Instead, the Company recognizes the lease payments for those leases in profit or loss on a straight-line basis over the lease term. The Company’s lease terms may include options of the Company as the lessee to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability if it is reasonably certain that it will exercise that option. Because the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company has lease agreements with lease and non-lease components and has elected the practical expedient to combine lease and non-lease components for all underlying classes of assets. All fixed payments of non-lease components are included in the measurement of lease payments, the ROU asset, and the lease liability. All variable payments for non-lease components and executory costs will be recognized and disclosed as variable lease payments. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Topic 842 provides for a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. |
Newly issued accounting pronouncements | q. Newly issued accounting pronouncements New accounting pronouncements effective in future periods Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies will have an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company meets the definition of an SRC and is adopting the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial statements but does not expect that the adoption of this standard will have a material impact on its consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of annual rates of depreciation of property and equipment | % Computers and peripheral equipment 33 Production and laboratory equipment 10-14 Office furniture and equipment 7-10 |
Schedule of anti-dilutive securities | December 31 2020 2019 Outstanding stock options 237,288 216,255 Warrants 948,044 - |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of property and equipment | December 31 2020 2019 U.S. dollars in thousands Cost: Computers and communications equipment $ 259 $ 248 Production and laboratory equipment 7,297 7,286 Office furniture and equipment 208 208 Leasehold improvements 2,029 2,029 9,793 9,771 Less: Accumulated depreciation (8,399 ) (7,196 ) Property and equipment, net $ 1,394 $ 2,575 |
COMMITMENTS AND CONTINGENT LI_2
COMMITMENTS AND CONTINGENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of operating lease expenses and information related to leases | Year ended December 31 2020 2019 U.S. dollars in thousands Operating lease expense $ 501 $ 743 Short-term lease expense 15 102 Variable lease expense - 2 $ 516 $ 847 December 31 2020 2019 U.S. dollars in thousands Operating lease right-of-use assets $ 817 $ 1,243 Current Operating lease liabilities 596 544 Non-current operating lease liabilities $ 338 $ 799 Operating cash flows from operating leases (cash paid in thousands) $ 547 $ 743 Weighted Average Remaining Lease Term (years) 1.59 2.43 Weighted Average Discount Rate of operating leases 5.40 % 5.45 % |
Schedule of maturities of lease liabilities | Year Amount U.S. dollars in thousands 2021 625 2022 329 2023 22 Total lease payments 976 Less imputed interest (42 ) Total 934 |
Schedule of impairment assessment | Cost/ Impairment Charge Fair U.S. dollars in thousands Production Line $ 9,568 $ (9,568 ) $ - Equipment 7,812 (4,095 ) 3,717 Liability for LTS’s facility upgrading costs (2,244 ) - (2,244 ) AP-CD/LD Assets, net $ 15,136 $ (13,663 ) $ 1,473 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of options granted to employees and directors | Year ended December 31, 2020 Number of options granted Exercise Vesting Expiration Employees 85,000 $ 6.15-$8.57 1.29-3 years 7 years Directors 10,000 $ 6.15 3 years 7 years Year ended December 31, 2019 Number of options granted Exercise price range Vesting Expiration Employees 73,250 $ 8.94-$152.8 3 years 7 years Directors 7,000 $ 12.4-$97.2 3 years 7 years |
Schedule of weighted average fair value of options granted | Year ended December 31 2020 2019 Weighted average fair value $ 4.38 $ 55.28 |
Schedule of underlying data used for computing the fair value of the options | Year ended December 31 2020 2019 Value of ordinary share $5.60-$6.20 $10.2-$149.2 Dividend yield 0% 0% Expected volatility 102.58%-110.4% 53.32%-100.04% Risk-free interest rate 0.28%-1.42% 1.65%-2.57% Expected term 5 years 5 years |
Schedule of number of options outstanding | Employees and directors Consultants Number of options NIS (1) Number of options NIS (1) Outstanding at January 1, 2019 14,773 550.4 402 10.0 Exercised (1 ) 10.0 (127 ) 10.0 Forfeited (4,295 ) 465.0 - - Expired (6,343 ) 437.8 (275 ) 10.0 Outstanding at December 31, 2019 4,134 812.0 - - Forfeited - - - - Expired (4,134 ) 812.0 - - Outstanding at December 31, 2020 - - - - Employees and directors Number of options USD (2) Outstanding at January 1, 2019 156,909 117.0 Granted 80,250 69.0 Exercised (4,982 ) 56.6 Forfeited (22,537 ) 80.0 Expired (13,495 ) 140.0 Outstanding at December 31, 2019 196,145 82.6 Granted 95,000 7.09 Forfeited (18,249 ) 39.47 Expired (9,816 ) 41.18 Outstanding at December 31, 2020 263,080 59.87 |
Schedule of the information concerning outstanding and exercisable options | December 31, 2020 Options outstanding Options exercisable Exercise price per share (USD) Number of options outstanding at the end of year Weighted average remaining contractual life Number of options exercisable at the end of year Weighted average remaining contractual life 6.15-6.67 60,750 6.64 - - 8.58-8.94 60,416 4.93 28,810 3.91 11.1-18.0 21,000 5.71 8,668 5.71 70.52 11,224 5.37 11,224 5.37 82.8-89.3 20,440 5.05 14,692 4.95 97.2 4,000 5.49 1,996 5.49 103.8-109.2 21,750 4.85 21,188 4.87 120.0-122.0 11,542 0.60 11,542 0.60 134.0 19,000 6.95 19,000 6.95 152.6-152.8 22,958 4.42 14,207 3.98 171.2 10,000 6.91 10,000 6.91 263,080 141,327 |
Schedule of effect of share-based compensation | Year ended December 31 2020 2019 U.S. dollars in thousands Research and development expenses, net $ 289 $ 1,634 General and administrative expenses 859 1,587 $ 1,148 $ 3,221 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Supplementary Financial Statement Information [Abstract] | |
Schedule of supplementary financial statement information | December 31 2020 2019 U.S. dollars in thousands Institutions $ 25 $ 1,836 Termination fee, Novartis (see note 6b(1)) - 1,500 Prepaid expenses 212 194 Advances to suppliers - 3 Interest receivable - 3 Other receivables 60 147 $ 297 $ 3,683 b. Accounts payable and accruals - other: Expenses payable 2,859 2,838 Salary and related expenses, including social security and other taxes 1,057 1,277 Current operating lease liabilities (see note 6d) 596 544 Accrual for vacation days and recreation pay for employees 180 154 Other 274 22 $ 4,966 $ 4,835 Year ended December 31 2020 2019 U.S. dollars in thousands Financial income: Interest on cash and cash equivalents $ 39 $ 330 Gains from changes in fair value of marketable securities 2 13 $ 41 $ 343 Financial expenses - Loss from changes in exchange rates $ (206 ) $ (180 ) Bank fees (10 ) (15 ) $ (216 ) $ (195 ) Financial income (expenses), net $ (175 ) $ 148 |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred income taxes | December 31 2020 2019 U.S. dollars in thousands In respect of: Net operating loss carry forward $ 39,924 $ 33,316 Research and Development expenses 2,910 6,209 Impairment of long-lived assets 3,143 3,143 Issuance costs 274 216 Other 1,246 1,138 Less—valuation allowance (47,497 ) (44,022 ) Net deferred tax assets $ - $ - |
Schedule of change in valuation allowance | Year ended December 31 2020 2019 U.S. dollars in thousands Balance at the beginning of the year $ 44,022 $ 32,684 Changes during the year 3,475 11,338 Balance at the end of the year $ 47,497 $ 44,022 |
Schedule of components of loss before income tax | Year ended December 31 2020 2019 U.S. dollars in thousands Income (loss) before income tax: Intec $ (14,180 ) $ (47,331 ) Subsidiary 176 370 $ (14,004 ) $ (46,961 ) |
Schedule of unrecognized tax benefits | Year ended December 31 2020 2019 U.S. dollars in thousands Balance at the beginning of the year $ 604 $ 309 Increase in uncertain tax positions for the current year 87 295 Balance at the end of the year $ 691 $ 604 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) - (Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Oct. 30, 2020 | Dec. 31, 2019 | |
Accumulated deficit (in Dollars) | $ (203,551) | $ (189,423) | |
Reverse Share Split [Member] | |||
Reverse share split, description | 1-for-20 reverse share split | ||
Authorized ordinary shares before the reverse share split | 350,000,000 | ||
Authorized ordinary shares post the reserve share split | 17,500,000 | ||
Outstanding ordinary shares before the reserve share split | 78,964,492 | ||
Outstanding ordinary shares post the reverse share split | 3,965,046 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Details) - (Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Impairment of long-lived assets | ||
Impairment on long-lived assets | $ 0 | $ 13.7 |
Research and development expenses, net | ||
Participation in research and development expenses | $ 0 | $ 1.1 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details) - Schedule of annual rates of depreciation of property and equipment | 12 Months Ended |
Dec. 31, 2020 | |
Computers and peripheral equipment [Member] | Minimum [Member] | |
Rate of depreciation | 33.00% |
Production and laboratory equipment [Member] | |
Rate of depreciation | 10.00% |
Production and laboratory equipment [Member] | Maximum [Member] | |
Rate of depreciation | 14.00% |
Office furniture and equipment [Member] | |
Rate of depreciation | 7.00% |
Office furniture and equipment [Member] | Maximum [Member] | |
Rate of depreciation | 10.00% |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Details) - Schedule of anti-dilutive securities - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Outstanding stock options [Member] | ||
Shares excluded from the computation of diluted net loss per share, because the effect of their inclusion in the computation would be anti-dilutive | 237,288 | 216,255 |
Warrants [Member] | ||
Shares excluded from the computation of diluted net loss per share, because the effect of their inclusion in the computation would be anti-dilutive | 948,044 |
MARKETABLE SECURITIES (Details)
MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | ||
Marketable securities | $ 770 | |
Gain, net from changes in marketable securities | $ 2 | $ 13 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 1,203 | $ 854 |
PROPERTY AND EQUIPMENT, NET (_2
PROPERTY AND EQUIPMENT, NET (Details) - Schedule of property and equipment - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Cost | $ 9,793 | $ 9,771 |
Less: Accumulated depreciation | (8,399) | (7,196) |
Property and equipment, net | 1,394 | 2,575 |
Computers and communications equipment [Member] | ||
Cost | 259 | 248 |
Production and laboratory equipment [Member] | ||
Cost | 7,297 | 7,286 |
Office furniture and equipment [Member] | ||
Cost | 208 | 208 |
Leasehold improvements [Member] | ||
Cost | $ 2,029 | $ 2,029 |
EMPLOYEE SEVERANCE BENEFITS (De
EMPLOYEE SEVERANCE BENEFITS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | ||
Severance payment expenses | $ 360 | $ 610 |
Expected deposit with respect to employee's severance benefits | $ 400 |
COMMITMENTS AND CONTINGENT LI_3
COMMITMENTS AND CONTINGENT LIABILITIES (Details) ₪ in Thousands, $ in Thousands | 12 Months Ended | ||||||
Dec. 31, 2020USD ($) | Dec. 31, 2020ILS (₪) | Dec. 31, 2020EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | Jul. 13, 2005 | |
Joint Venture and Exclusive License Agreement [Member] | |||||||
Royalties rate paid based on the overall net income from the sale of the products | 3.00% | ||||||
Royalties rate paid based on sub-licenses on any payment or benefit whatsoever that may receive from sub-licenses | 15.00% | ||||||
Cooperation Agreements - Termination Fee from Novartis [Member] | |||||||
Other income | $ 1,500 | ||||||
Grants from the IIA [Member] | |||||||
Total amount of grants received from the IIA | $ 11,300 | ₪ 42,300 | |||||
Grants from the IIA [Member] | Minimum [Member] | |||||||
Royalties rate | 3.00% | ||||||
Grants from the IIA [Member] | Maximum [Member] | |||||||
Royalties rate | 5.00% | ||||||
Lease Agreements- Jerusalem [Member] | |||||||
Bank guarantee | $ 157 | 147 | |||||
LTS Process Development Agreement [Member] | |||||||
Total cost of the equipment | $ 7,800 | € 6,800 | |||||
Impairment charge | 4,100 | ||||||
Fair value of equipment | 3,700 | ||||||
Additional amount recognized as liability in respect to facility upgrading costs | 2,450 | € 2,000 | |||||
Impairment Assessment [Member] | |||||||
Impairment charge of AP-CD/LD Assets, net | $ 13,700 | ||||||
Net book value of equipment | 3,700 | ||||||
Lawsuit [Member] | |||||||
Plaintiffs pecuniary damages | 750 | 2,400 | |||||
Settlement amount to each plaintiff | $ 125 | ₪ 400 |
COMMITMENTS AND CONTINGENT LI_4
COMMITMENTS AND CONTINGENT LIABILITIES (Details) - Schedule of operating lease expenses and information related to leases - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating lease expense | $ 501 | $ 743 |
Short-term lease expense | 15 | 102 |
Variable lease expense | 2 | |
Total lease expense | 516 | 847 |
Operating lease right-of-use assets | 817 | 1,243 |
Non-current operating lease liabilities | 338 | 799 |
Supplemental information related to leases | ||
Operating lease right-of-use assets | 817 | 1,243 |
Current Operating lease liabilities | 596 | 544 |
Non-current operating lease liabilities | 338 | 799 |
Other information | ||
Operating cash flows from operating leases (cash paid in thousands) | $ 547 | $ 743 |
Weighted Average Remaining Lease Term (years) | 1 year 7 months 2 days | 2 years 5 months 4 days |
Weighted Average Discount Rate of operating leases | 5.40% | 5.45% |
COMMITMENTS AND CONTINGENT LI_5
COMMITMENTS AND CONTINGENT LIABILITIES (Details) - Schedule of maturities of lease liabilities $ in Thousands | Dec. 31, 2020USD ($) |
Schedule of maturities of lease liabilities [Abstract] | |
2021 | $ 625 |
2022 | 329 |
2023 | 22 |
Total lease payments | 976 |
Less imputed interest | (42) |
Total | $ 934 |
COMMITMENTS AND CONTINGENT LI_6
COMMITMENTS AND CONTINGENT LIABILITIES (Details) - Schedule of impairment assessment $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Production Line [Member] | |
Cost/Liability | $ 9,568 |
Impairment charge | (9,568) |
Fair value | |
Equipment [Member] | |
Cost/Liability | 7,812 |
Impairment charge | (4,095) |
Fair value | 3,717 |
Liability for LTS’s facility upgrading costs [Member] | |
Cost/Liability | (2,244) |
Impairment charge | |
Fair value | (2,244) |
AP-CD/LD Assets, net [Member] | |
Cost/Liability | 15,136 |
Impairment charge | (13,663) |
Fair value | $ 1,473 |
SHARE CAPITAL (Details)
SHARE CAPITAL (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 10, 2020 | May 06, 2020 | Feb. 03, 2020 | Feb. 28, 2021 | Feb. 28, 2021 | Jul. 31, 2020 | Jan. 31, 2020 | Dec. 02, 2019 | Aug. 22, 2019 | Jul. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 15, 2020 | Jun. 30, 2018 | Dec. 31, 2017 | Jul. 31, 2016 | Jan. 31, 2016 |
Proceeds from issuance of ordinary shares, net of issuance costs (in Dollars) | $ 421 | $ 2,086 | |||||||||||||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (in Dollars) | 5,692 | ||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | 769 | ||||||||||||||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (in Dollars) | 4,426 | ||||||||||||||||
Proceeds from issuance of ordinary shares and pre-funded warrants, net of issuance costs (in Dollars) | 4,599 | ||||||||||||||||
Proceeds from exercise of pre-funded warrants (in Dollars) | $ 71 | ||||||||||||||||
2015 Plan [Member] | |||||||||||||||||
Number of ordinary shares reserved for issuance under the 2015 plan | 175,000 | 175,000 | 50,000 | 50,000 | 105,000 | 35,000 | 35,000 | ||||||||||
Number of shares available for grant | 181,027 | ||||||||||||||||
Maximum term of award | 10 years | ||||||||||||||||
Increase in authorized share capital [Member] | |||||||||||||||||
Authorized ordinary shares before the increase in authorized share capital | 5,000,000 | ||||||||||||||||
Authorized ordinary shares post the increase in authorized share capital | 17,500,000 | ||||||||||||||||
Purchase agreement with Aspire | |||||||||||||||||
Aspire's commitment to purchase aggregate amount of the Company’s ordinary shares under the purchase agreement (in Dollars) | $ 10,000 | ||||||||||||||||
Number of shares issued to Aspire | 30,626 | ||||||||||||||||
Cowen [Member] | Sales Agreement [Member] | |||||||||||||||||
Number of shares issued | 41,569 | 97,226 | |||||||||||||||
Average price per share (in Dollars per share) | $ 10.50 | $ 22.6 | |||||||||||||||
Proceeds from issuance of ordinary shares, net of issuance costs (in Dollars) | $ 421 | $ 2,100 | |||||||||||||||
Issuance expenses (in Dollars) | $ 15 | $ 112 | |||||||||||||||
Exercise of warrants [Member] | Subsequent Event [Member] | |||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | $ 956 | ||||||||||||||||
Repricing of options previously granted [Member] | |||||||||||||||||
Number of options previously granted | 63,183 | ||||||||||||||||
Exercise price (in Dollars per share) | $ 8.94 | ||||||||||||||||
Total incremental fair value of options previously granted (in Dollars) | $ 253 | ||||||||||||||||
Risk-free interest rate | 1.50% | ||||||||||||||||
Dividend yield | 0.00% | ||||||||||||||||
The incremental fair value of fully vested options previously granted (in Dollars) | $ 62 | ||||||||||||||||
Repricing of options previously granted [Member] | Minimum [Member] | |||||||||||||||||
Expected volatility | 99.00% | ||||||||||||||||
Expected term | 2 years 7 months 6 days | ||||||||||||||||
Repricing of options previously granted [Member] | Maximum [Member] | |||||||||||||||||
Expected volatility | 122.00% | ||||||||||||||||
Underwritten Public Offering [Member] | |||||||||||||||||
Number of shares issued | 764,000 | ||||||||||||||||
Issuance expenses (in Dollars) | $ 800 | ||||||||||||||||
Number of pre-funded warrants issued | 48,500 | ||||||||||||||||
Number of warrants issued | 812,500 | ||||||||||||||||
Pre-funded warrants exercise price (in Dollars per share) | $ 0.002 | ||||||||||||||||
Combined price of share and warrant (in Dollars per share) | 8 | ||||||||||||||||
Exercise price (in Dollars per share) | $ 8 | ||||||||||||||||
Term of the warrants | 5 years | ||||||||||||||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (in Dollars) | $ 5,700 | ||||||||||||||||
Outstanding warrants | 767,875 | ||||||||||||||||
Underwritten Public Offering [Member] | Exercise of warrants [Member] | |||||||||||||||||
Number of warrants exercised | 44,625 | ||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | $ 357 | ||||||||||||||||
Underwritten Public Offering [Member] | Exercise of warrants [Member] | Subsequent Event [Member] | |||||||||||||||||
Number of warrants exercised | 20,000 | ||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | $ 160 | ||||||||||||||||
Registered Direct Offering and Concurrent Private Placement [Member] | |||||||||||||||||
Number of shares issued | 814,598 | ||||||||||||||||
Issuance expenses (in Dollars) | $ 500 | ||||||||||||||||
Number of warrants issued | 407,299 | ||||||||||||||||
Exercise price (in Dollars per share) | $ 4.90 | ||||||||||||||||
Outstanding warrants | 323,226 | ||||||||||||||||
Purchase price (in Dollars per share) | $ 6.138 | ||||||||||||||||
Term of the warrants | five and one-half | ||||||||||||||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs (in Dollars) | $ 4,500 | ||||||||||||||||
Registered Direct Offering and Concurrent Private Placement [Member] | Exercise of warrants [Member] | |||||||||||||||||
Number of warrants exercised | 84,073 | ||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | $ 412 | ||||||||||||||||
Registered Direct Offering and Concurrent Private Placement [Member] | Exercise of warrants [Member] | Subsequent Event [Member] | |||||||||||||||||
Number of warrants exercised | 162,500 | ||||||||||||||||
Proceeds from exercise of warrants (in Dollars) | $ 796 | ||||||||||||||||
Registered Direct Offering [Member] | Aspire Capital Fund LLC [Member] | |||||||||||||||||
Number of shares issued | 356,250 | ||||||||||||||||
Issuance expenses (in Dollars) | $ 330 | ||||||||||||||||
Number of pre-funded warrants issued | 356,250 | ||||||||||||||||
Exercise price (in Dollars per share) | $ 0.20 | ||||||||||||||||
Purchase price (in Dollars per share) | 7.022 | ||||||||||||||||
Purchase price of pre-funded warrants (in Dollars per share) | $ 6.822 | ||||||||||||||||
Proceeds from issuance of ordinary shares and pre-funded warrants, net of issuance costs (in Dollars) | $ 4,600 | ||||||||||||||||
Proceeds from exercise of pre-funded warrants (in Dollars) | $ 71 | ||||||||||||||||
Proceeds from issuance of ordinary shares and pre-funded warrants including the exercise of pre-funded warrants, net of issuance costs (in Dollars) | $ 4,700 |
SHARE CAPITAL (Details) - Sched
SHARE CAPITAL (Details) - Schedule of options granted to employees and directors - Share options [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Employees [Member] | ||
Number of options granted (in Shares) | 85,000 | 73,250 |
Exercise price range, minimum (in Dollars per share) | $ 6.15 | $ 8.94 |
Exercise price range, maximum (in Dollars per share) | $ 8.57 | $ 152.8 |
Vesting period range, minimum | 1 year 3 months 14 days | |
Vesting period range, maximum | 3 years | 3 years |
Expiration | 7 years | 7 years |
Directors [Member] | ||
Number of options granted (in Shares) | 10,000 | 7,000 |
Exercise price range, minimum (in Dollars per share) | $ 12.4 | |
Exercise price range, maximum (in Dollars per share) | $ 6.15 | $ 97.2 |
Vesting period range, maximum | 3 years | 3 years |
Expiration | 7 years | 7 years |
SHARE CAPITAL (Details) - Sch_2
SHARE CAPITAL (Details) - Schedule of weighted average fair value of options granted - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of weighted average fair value of options granted [Abstract] | ||
Weighted average fair value | $ 4.38 | $ 55.28 |
SHARE CAPITAL (Details) - Sch_3
SHARE CAPITAL (Details) - Schedule of underlying data used for computing the fair value of the options - Employees [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Dividend yield | 0.00% | 0.00% |
Expected term | 5 years | 5 years |
Minimum [Member] | ||
Value of ordinary share (in Dollars per share) | $ 5.60 | $ 10.2 |
Expected volatility | 102.58% | 53.32% |
Risk-free interest rate | 0.28% | 1.65% |
Maximum [Member] | ||
Value of ordinary share (in Dollars per share) | $ 6.20 | $ 149.2 |
Expected volatility | 110.40% | 100.04% |
Risk-free interest rate | 1.42% | 2.57% |
SHARE CAPITAL (Details) - Sch_4
SHARE CAPITAL (Details) - Schedule of number of options outstanding | 12 Months Ended | ||||
Dec. 31, 2020$ / sharesshares | Dec. 31, 2020₪ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2019₪ / sharesshares | ||
Employees and directors [Member] | 2005 Plan [Member] | |||||
Outstanding at beginning of period | 4,134 | 4,134 | 14,773 | 14,773 | |
Outstanding at beginning of period (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 812 | ₪ 550.4 | ||
Exercised | (1) | (1) | |||
Exercised (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 10 | |||
Forfeited | (4,295) | (4,295) | |||
Forfeited (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 465 | |||
Expired | (4,134) | (4,134) | (6,343) | (6,343) | |
Expired (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 812 | ₪ 437.8 | ||
Outstanding at end of period | 4,134 | 4,134 | |||
Outstanding at end of period (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 812 | |||
Employees and directors [Member] | 2015 Plan [Member] | |||||
Outstanding at beginning of period | 196,145 | 196,145 | 156,909 | 156,909 | |
Outstanding at beginning of period (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 82.6 | $ 117 | ||
Granted | 95,000 | 95,000 | 80,250 | 80,250 | |
Granted (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 7.09 | $ 69 | ||
Exercised | (4,982) | (4,982) | |||
Exercised (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 56.6 | |||
Forfeited | (18,249) | (18,249) | (22,537) | (22,537) | |
Forfeited (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 39.47 | $ 80 | ||
Expired | (9,816) | (9,816) | (13,495) | (13,495) | |
Expired (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 41.18 | $ 140 | ||
Outstanding at end of period | 263,080 | 263,080 | 196,145 | 196,145 | |
Outstanding at end of period (in New Shekels per share and Dollars per share) | $ / shares | [2] | $ 59.87 | $ 82.6 | ||
Consultants [Member] | 2005 Plan [Member] | |||||
Outstanding at beginning of period | 402 | 402 | |||
Outstanding at beginning of period (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 10 | |||
Exercised | (127) | (127) | |||
Exercised (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 10 | |||
Forfeited | |||||
Forfeited (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ||||
Expired | (275) | (275) | |||
Expired (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ₪ 10 | |||
Outstanding at end of period | |||||
Outstanding at end of period (in New Shekels per share and Dollars per share) | ₪ / shares | [1] | ||||
[1] | Weighted average price in NIS per share. | ||||
[2] | Weighted average price in USD per share. |
SHARE CAPITAL (Details) - Sch_5
SHARE CAPITAL (Details) - Schedule of the information concerning outstanding and exercisable options | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Exercise price per share - range 6.15-6.67 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 6.15 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 6.67 |
Options outstanding, Number of options outstanding at the end of year | 60,750 |
Options outstanding, Weighted average remaining contractual life | 6 years 7 months 20 days |
Options exercisable, Number of options exercisable at the end of year | |
Exercise price per share - range 8.58-8.94 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 8.58 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 8.94 |
Options outstanding, Number of options outstanding at the end of year | 60,416 |
Options outstanding, Weighted average remaining contractual life | 4 years 11 months 4 days |
Options exercisable, Number of options exercisable at the end of year | 28,810 |
Options exercisable, Weighted average remaining contractual life | 3 years 10 months 28 days |
Exercise price per share - range 11.1-18.0 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 11.1 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 18 |
Options outstanding, Number of options outstanding at the end of year | 21,000 |
Options outstanding, Weighted average remaining contractual life | 5 years 8 months 15 days |
Options exercisable, Number of options exercisable at the end of year | 8,668 |
Options exercisable, Weighted average remaining contractual life | 5 years 8 months 15 days |
Exercise price per share - 70.52 [Member] | |
Options outstanding, Exercise price per share (in Dollars per share) | $ / shares | $ 70.52 |
Options outstanding, Number of options outstanding at the end of year | 11,224 |
Options outstanding, Weighted average remaining contractual life | 5 years 4 months 13 days |
Options exercisable, Number of options exercisable at the end of year | 11,224 |
Options exercisable, Weighted average remaining contractual life | 5 years 4 months 13 days |
Exercise price per share - range 82.8-89.3 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 82.8 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 89.3 |
Options outstanding, Number of options outstanding at the end of year | 20,440 |
Options outstanding, Weighted average remaining contractual life | 5 years 18 days |
Options exercisable, Number of options exercisable at the end of year | 14,692 |
Options exercisable, Weighted average remaining contractual life | 4 years 11 months 12 days |
Exercise price per share - 97.2 [Member] | |
Options outstanding, Exercise price per share (in Dollars per share) | $ / shares | $ 97.2 |
Options outstanding, Number of options outstanding at the end of year | 4,000 |
Options outstanding, Weighted average remaining contractual life | 5 years 5 months 26 days |
Options exercisable, Number of options exercisable at the end of year | 1,996 |
Options exercisable, Weighted average remaining contractual life | 5 years 5 months 26 days |
Exercise price per share - range 103.8-109.2 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 103.8 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 109.2 |
Options outstanding, Number of options outstanding at the end of year | 21,750 |
Options outstanding, Weighted average remaining contractual life | 4 years 10 months 6 days |
Options exercisable, Number of options exercisable at the end of year | 21,188 |
Options exercisable, Weighted average remaining contractual life | 4 years 10 months 13 days |
Exercise price per share - range 120.0-122.0 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 120 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 122 |
Options outstanding, Number of options outstanding at the end of year | 11,542 |
Options outstanding, Weighted average remaining contractual life | 7 months 6 days |
Options exercisable, Number of options exercisable at the end of year | 11,542 |
Options exercisable, Weighted average remaining contractual life | 7 months 6 days |
Exercise price per share - 134.0 [Member] | |
Options outstanding, Exercise price per share (in Dollars per share) | $ / shares | $ 134 |
Options outstanding, Number of options outstanding at the end of year | 19,000 |
Options outstanding, Weighted average remaining contractual life | 6 years 11 months 12 days |
Options exercisable, Number of options exercisable at the end of year | 19,000 |
Options exercisable, Weighted average remaining contractual life | 6 years 11 months 12 days |
Exercise price per share - range 152.6-152.8 [Member] | |
Exercise price per share, minimum (in Dollars per share) | $ / shares | $ 152.6 |
Exercise price per share, maximum (in Dollars per share) | $ / shares | $ 152.8 |
Options outstanding, Number of options outstanding at the end of year | 22,958 |
Options outstanding, Weighted average remaining contractual life | 4 years 5 months 1 day |
Options exercisable, Number of options exercisable at the end of year | 14,207 |
Options exercisable, Weighted average remaining contractual life | 3 years 11 months 23 days |
Exercise price per share - 171.2 [Member] | |
Options outstanding, Exercise price per share (in Dollars per share) | $ / shares | $ 171.2 |
Options outstanding, Number of options outstanding at the end of year | 10,000 |
Options outstanding, Weighted average remaining contractual life | 6 years 10 months 28 days |
Options exercisable, Number of options exercisable at the end of year | 10,000 |
Options exercisable, Weighted average remaining contractual life | 6 years 10 months 28 days |
Total [Member] | |
Options outstanding, Number of options outstanding at the end of year | 263,080 |
Options exercisable, Number of options exercisable at the end of year | 141,327 |
SHARE CAPITAL (Details) - Sch_6
SHARE CAPITAL (Details) - Schedule of effect of share-based compensation - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based compensation | $ 1,148 | $ 3,221 |
Research and development expenses, net [Member] | ||
Share-based compensation | 289 | 1,634 |
General and administrative expenses [Member] | ||
Share-based compensation | $ 859 | $ 1,587 |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Details) - Schedule of supplementary financial statement information - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Prepaid expenses and other receivable: | ||
Institutions | $ 25 | $ 1,836 |
Termination fee, Novartis (see note 6b(1)) | 1,500 | |
Prepaid expenses | 212 | 194 |
Advances to suppliers | 3 | |
Interest receivable | 3 | |
Other receivables | 60 | 147 |
Total prepaid expenses and other receivable | 297 | 3,683 |
Accounts payable and accruals - other: | ||
Expenses payable | 2,859 | 2,838 |
Salary and related expenses, including social security and other taxes | 1,057 | 1,277 |
Current operating lease liabilities (see note 6d) | 596 | 544 |
Accrual for vacation days and recreation pay for employees | 180 | 154 |
Other | 274 | 22 |
Total accounts payable and accruals - other | 4,966 | 4,835 |
Financial income: | ||
Interest on cash and cash equivalents | 39 | 330 |
Gains from changes in fair value of marketable securities | 2 | 13 |
Financial income | 41 | 343 |
Financial expenses - | ||
Loss from changes in exchange rates | (206) | (180) |
Bank fees | (10) | (15) |
Financial expenses | (216) | (195) |
Financial income (expenses), net | $ (175) | $ 148 |
TAXES ON INCOME (Details)
TAXES ON INCOME (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net carry forward tax losses (in Dollars) | $ 173,600 | ||
Tax expenses (in Dollars) | 124 | $ 638 | |
Subsidiary [Member] | |||
Tax expenses recorded following full valuation allowance with respect to the subsidiary's share-based compensation expenses (in Dollars) | $ 87 | $ 562 | |
Israel [Member] | |||
Federal statutory tax | 23.00% | ||
U.S.A [Member] | |||
Federal statutory tax | 21.00% | 21.00% | |
Relevant state tax rate | 7.00% | 7.00% | |
U.S.A [Member] | Maximum [Member] | |||
Federal statutory tax | 35.00% | ||
U.S.A [Member] | Minimum [Member] | |||
Federal statutory tax | 21.00% |
TAXES ON INCOME (Details) - Sch
TAXES ON INCOME (Details) - Schedule of deferred income taxes - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
In respect of: | |||
Net operating loss carry forward | $ 39,924 | $ 33,316 | |
Research and Development expenses | 2,910 | 6,209 | |
Impairment of long-lived assets | 3,143 | 3,143 | |
Issuance costs | 274 | 216 | |
Other | 1,246 | 1,138 | |
Less—valuation allowance | (47,497) | (44,022) | $ (32,684) |
Net deferred tax assets |
TAXES ON INCOME (Details) - S_2
TAXES ON INCOME (Details) - Schedule of change in valuation allowance - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of change in valuation allowance [Abstract] | ||
Balance at the beginning of the year | $ 44,022 | $ 32,684 |
Changes during the year | 3,475 | 11,338 |
Balance at the end of the year | $ 47,497 | $ 44,022 |
TAXES ON INCOME (Details) - S_3
TAXES ON INCOME (Details) - Schedule of components of loss before income tax - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of components of loss before income tax [Abstract] | ||
Intec | $ (14,180) | $ (47,331) |
Subsidiary | 176 | 370 |
Loss before income tax | $ (14,004) | $ (46,961) |
TAXES ON INCOME (Details) - S_4
TAXES ON INCOME (Details) - Schedule of unrecognized tax benefits - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of unrecognized tax benefits [Abstract] | ||
Balance at the beginning of the year | $ 604 | $ 309 |
Increase in uncertain tax positions for the current year | 87 | 295 |
Balance at the end of the year | $ 691 | $ 604 |
EVENTS SUBSEQUENT TO DECEMBER_2
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 (Details) - Subsequent Event [Member] - USD ($) | Mar. 15, 2021 | Feb. 28, 2021 |
Merger Agreement [Member] | ||
Share exchange ratio in the merger for the former Decoy securityholders, which is subject to adjustment based on, among other things, Decoy’s and the Company’s net cash balance | 75.00% | |
Decoy's estimated valuation that is the basis of the share exchange ratio calculation | $ 30,000,000 | |
Share exchange ratio in the merger for the securityholders of the Company, which is subject to adjustment based on, among other things, Decoy’s and the Company’s net cash balance | 25.00% | |
Company's estimated valuation that is the basis of the share exchange ratio calculation | $ 10,000,000 | |
The minimum combined net cash of Intec Parent | 30,000,000 | |
The maximum combined net cash of Intec Parent | 50,000,000 | |
The break-up fee that the Company or Decoy may be require to pay in connection with the termination of the Merger, under specified circumstances | 1,000,000 | |
The Company's deposit in favor of Decoy that may be forfeit in connection with the termination of the Merger, under specified circumstances | $ 350,000 | |
Exercise of warrants [Member] | ||
Number of warrants issued (in Shares) | 182,500 | |
Proceeds from exercise of warrants | $ 956,000 |