Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 29, 2020 | Jun. 30, 2019 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Intec Pharma Ltd. | ||
Entity Central Index Key | 0001638381 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2019 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Public Float | $ 121,348,153 | ||
Entity Common Stock Shares Outstanding | 52,973,580 | ||
Entity File Number | 001-37521 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation State Country Code | L3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 9,292 | $ 39,246 |
Investment in marketable securities (Note 3) | 770 | 1,333 |
Prepaid expenses and other receivables (Note 8a) | 3,683 | 2,986 |
TOTAL CURRENT ASSETS | 13,745 | 43,565 |
NON-CURRENT ASSETS: | ||
Property and equipment, net (Note 4) | 2,575 | 12,233 |
Operating lease right-of-use assets (Note 6d) | 1,243 | |
Other assets (Note 6e(2)) | 3,717 | 5,431 |
Deferred tax assets (Note 9) | 281 | |
TOTAL NON-CURRENT ASSETS | 7,535 | 17,945 |
TOTAL ASSETS | 21,280 | 61,510 |
CURRENT LIABILITIES - | ||
Accounts payable and accruals: Trade | 3,507 | 2,849 |
Accounts payable and accruals: Other (Note 8b) | 4,835 | 4,807 |
TOTAL CURRENT LIABILITIES | 8,342 | 7,656 |
LONG-TERM LIABILITIES - | ||
Operating lease liabilities (Note 6d) | 799 | |
Other liabilities (Note 9) | 604 | 309 |
TOTAL LONG-TERM LIABILITIES | 1,403 | 309 |
TOTAL LIABILITIES | 9,745 | 7,965 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 6) | ||
SHAREHOLDERS' EQUITY: | ||
Ordinary shares, with no par value - authorized: 100,000,000 as of December 31, 2019 and December 31, 2018, respectively; issued and outstanding: 35,892,209 and 33,232,988 Ordinary Shares as of December 31, 2019 and December 31, 2018, respectively | 727 | 727 |
Additional paid-in capital | 200,231 | 194,642 |
Accumulated deficit | (189,423) | (141,824) |
TOTAL SHAREHOLDERS' EQUITY | 11,535 | 53,545 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 21,280 | $ 61,510 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value (in dollar per shares) | ||
Ordinary shares, authorized | 100,000,000 | 100,000,000 |
Ordinary shares, issued | 35,892,209 | 33,232,988 |
Ordinary shares, outstanding | 35,892,209 | 33,232,988 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
OPERATING EXPENSES: | ||
RESEARCH AND DEVELOPMENT EXPENSES, net | $ (26,659) | $ (35,402) |
GENERAL AND ADMINISTRATIVE EXPENSES | (8,287) | (7,926) |
IMPAIRMENT OF LONG-LIVED ASSETS | (13,663) | |
OTHER INCOME | 1,500 | |
OPERATING LOSS | (47,109) | (43,328) |
FINANCIAL INCOME (EXPENSES), net (Note 8c) | 148 | (112) |
LOSS BEFORE INCOME TAX | (46,961) | (43,440) |
INCOME TAX (Note 9) | (638) | (103) |
NET LOSS | $ (47,599) | $ (43,543) |
LOSS PER ORDINARY SHARE - BASIC AND DILUTED (in dollars per share) | $ (1.41) | $ (1.40) |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE IN THOUSANDS | 33,776 | 31,193 |
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, 2017 | $ 727 | $ 156,356 | $ (98,281) | $ 58,802 |
BALANCE (in shares) at Dec. 31, 2017 | 26,075,770 | |||
CHANGES DURING THE YEAR | ||||
Issuance of ordinary shares, net of issuance costs (Note 7b) | 35,029 | 35,029 | ||
Issuance of ordinary shares, net of issuance costs (Note 7b) (in shares) | 7,150,000 | |||
Exercise of options by employees (Note 7c) | 30 | 30 | ||
Exercise of options by employees (Note 7c) (in shares) | 7,218 | |||
Share-based compensation (Note 7c) | 3,227 | 3,227 | ||
Net loss | (43,543) | (43,543) | ||
BALANCE at Dec. 31, 2018 | $ 727 | 194,642 | (141,824) | $ 53,545 |
BALANCE (in shares) at Dec. 31, 2018 | 33,232,988 | 33,232,988 | ||
CHANGES DURING THE YEAR | ||||
Issuance of ordinary shares, net of issuance costs (Note 7b) | 2,086 | $ 2,086 | ||
Issuance of ordinary shares, net of issuance costs (Note 7b) (in shares) | 1,944,512 | |||
Issuance of ordinary shares per equity line agreement (Note 7b) | ||||
Issuance of ordinary shares per equity line agreement (Note 7b) (in shares) | 612,520 | |||
Exercise of options by employees (Note 7c) | 282 | 282 | ||
Exercise of options by employees (Note 7c) (in shares) | 102,189 | |||
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 | 35,892,209 | 35,892,209 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (47,599) | $ (43,543) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 854 | 859 |
Impairment of long-lived assets | 13,663 | |
Exchange differences on cash and cash equivalents | 67 | 829 |
Change in right of use asset | 967 | |
Change in lease liabilities | (713) | |
Losses (gains) on marketable securities | (13) | 194 |
Share-based compensation | 3,221 | 3,227 |
Changes in operating asset and liabilities: | ||
Increase in prepaid expenses and other receivables | (747) | (1,861) |
Increase (decrease) in deferred tax assets | 281 | (281) |
Increase in accounts payable and accruals | 679 | 1,191 |
Increase in other liabilities | 295 | 309 |
Net cash used in operating activities | (29,045) | (39,076) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (921) | (4,667) |
Investment in other assets | (2,865) | (4,932) |
Proceeds from disposal of marketable securities, net | 576 | 298 |
Net cash used in investing activities | (3,210) | (9,301) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of ordinary shares, net of issuance costs | 2,086 | 35,029 |
Proceeds from exercise of options by employees | 282 | 30 |
Net cash provided by financing activities | 2,368 | 35,059 |
DECREASE IN CASH AND CASH EQUIVALENTS | (29,887) | (13,318) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR | 39,246 | 53,393 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (67) | (829) |
CASH AND CASH EQUIVALENTS AT END OF THE YEAR | 9,292 | 39,246 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING ACTIVITIES: | ||
Liability with respect to property and equipment (see note 6e(1)) | 170 | |
Liability with respect to other assets (see note 6e(2)) | 499 | |
SUPPLEMENTARY DISCLOSURE OF CASH FLOW INFORMATION: | ||
Taxes paid | 75 | 96 |
Interest received | $ 327 | $ 734 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NOTE 1 - NATURE OF OPERATIONS: General Information: 1) 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 efficiency 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, medical affairs and investor relationship activities outside of Israel. 2) The Company engages in research and development activities and has not yet generated revenues from operations. On July 22, 2019, the Company announced top-line results according to which its Phase III clinical trial for AP-CD/LD did not achieve its primary and secondary endpoints. As these results are considered a triggering event, the Company performed an impairment test on certain of its long-lived assets which resulted in an impairment charge of approximately $13.7 million. For more details see note 6e(3). Accordingly, there is no assurance that the Company's operations will generate positive cash flows. As of December 31, 2019, the cumulative losses of the Company were approximately $189.4 million. Management expects that the Company will continue to incur losses from its operations, which will result in negative cash flows from operating activities. The Company believes that, as of the date of the issuance of these consolidated financial statements, it will not have adequate cash to fund its ongoing activities beyond the second quarter of 2021 based on its current operating plan. Its ability to execute its operating plan beyond the second quarter of 2021 is dependent on its ability to obtain additional capital principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or raising capital from the public and/or private investors and/or institutional investors. The negative outcome of the Phase III clinical trial that was announced on July 22, 2019 and uncertainty regarding the Company's development programs is expected to adversely affect its ability to obtain funding and there is no assurance that it will be successful in obtaining the level of financing needed for its activities. The Company has taken measures to reduce its costs, including reducing headcount, and is continuingly evaluating measures to reduce additional costs to preserve existing capital. If the Company is unsuccessful in securing sufficient financing, it may need to curtail or cease operations. As a result of these uncertainties, there is substantial doubt about the Company's ability to continue as a going concern. 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. 3) 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 Capital Market. 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. Failure to meet these requirements could result in a delisting of the Company's ordinary shares which could negatively impact the Company's ability to raise capital. 4) On March 1, 2019, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"). As of the date of the issuance of these consolidated financial statements, the Company sold 2,775,883 ordinary shares under the Sales Agreement raising a total of approximately $2.5 million (net of issuance expenses of approximately $127 thousand) and the Company may continue to sell up to approximately $72.4 million of ordinary shares under the Sales Agreement, subject to limitations under the Baby Shelf Rule. For more details see notes 7b(2) and 10a. In addition, on February 3, 2020 the Company completed an underwritten public offering and raised a total of approximately $5.7 million (net of underwriting discounts, commissions and other offering expenses in the amount of approximately $800 thousand). For more details see note 10b. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2019 | |
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 include 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 , ", as the Company chooses to apply the fair value option. 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. As further discussed in note 6e(3), during the year ended December 31, 2019, the Company recorded an impairment loss in the amount of $13.7 million related to certain of its long-lived assets. The impairment charge is recorded as an operating expense. 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. As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the consolidated statements of operations. 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 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 years ended December 31, 2019 and 2018, include participation in research and development expenses in the amount of approximately $1.1 million and approximately $829 thousand, respectively. 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. 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. l. 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, 2019 2018 Outstanding stock options 4,325,105 3,301,669 m. 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 1: 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 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: 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. n. 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. o. 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. Commencing January 1, 2019, 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 will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Instead, the Company will continue to recognize 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 will be included in the measurement of lease payments, the ROU asset, and the lease liability for all leases entered into on or after January 1, 2019. 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"). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. 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. Topic 842 had a material impact on our consolidated balance sheets but did not have an impact on our consolidated statements of operations. The most significant impact was the recognition of $2.2 million in ROU assets and $2.2 million in lease liabilities. 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. p. Newly issued accounting pronouncements 1) In February 2016, the FASB established ASC Topic 842, "Leases" (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019 using the modified retrospective transition method and has not restated comparative periods. The new standard also provides practical expedients for an entity's ongoing accounting. Beginning in 2019, the Company changed its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard. See Note 6d. 2) In June 2018, the FASB issued ASU 2018-07, "Compensation-Stock Compensation" (Topic 718" or "ASU 2018-07") to improve the usefulness of information provided to users of financial statements while reducing cost and complexity in financial reporting and provide guidance aligning the measurement and classification for share-based payments to nonemployees with the guidance for share-based payments to employees. Under the guidance, the measurement of equity-classified nonemployee awards will be fixed at the grant date. This standard, adopted as of January 1, 2019, had no impact on the Company's consolidated financial statements. 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 as of the ASU 2019-10 issuance date 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 believe the adoption of this standard will have a material impact on its consolidated financial statements. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 - MARKETABLE SECURITIES The Company's marketable securities include 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, 2019, and 2018, the amount of the marketable securities is approximately $770 thousand and $1.3 million, respectively. The gain, net from changes in marketable securities amounted to approximately $13 thousand in 2019 and the loss, net from changes in fair value through profit or loss amounted to approximately $194 thousand in 2018. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 4 - PROPERTY AND EQUIPMENT, NET: December 31 2019 2018 U.S. dollars in thousands Cost: Computers and communications equipment $ 248 $ 237 Production and laboratory equipment 7,286 7,280 Office furniture and equipment 208 203 Leasehold improvements 2,029 2,029 Large-scale automated production line, see note 6e(1) and 6e(3) - 8,826 9,771 18,575 Less: Accumulated depreciation (7,196 ) (6,342 ) Property and equipment, net $ 2,575 $ 12,233 Depreciation expense totaled approximately $854 thousand, and approximately $859 thousand for the years ended December 31, 2019 and 2018, respectively. During the year ended December 31, 2019 the Company had impairment of large-scale automated production line in the amount of $9.6 million. For more details, see note 6e(1) and 6e(3). |
EMPLOYEE SEVERANCE BENEFITS
EMPLOYEE SEVERANCE BENEFITS | 12 Months Ended |
Dec. 31, 2019 | |
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 $610 thousand and approximately $615 thousand for the years ended December 31, 2019 and 2018, respectively. The Company expects contribution plan expenses in 2020 to amount to approximately $400 thousand. |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
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 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 will be funded by Novartis subject to the achievement of agreed milestones. In December 2019, the Company received notice from Novartis for 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 as 'Other income', which was paid in February 2020. 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. 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. As of December 31, 2019, the Company received from the IIA grants in the total amount of approximately NIS 42.3 million (approximately $11.3 million). The Company did not apply for any grants from the IIA for the years ended December 31, 2019 and 2018. 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, 2021. The lease agreement includes an option to extend the lease term until June 30, 2022 (the "extension option") which was included in the initial recognition of lease assets and liabilities as of January 1, 2019. In January 2018, the Company amended the lease agreement and added additional operational spaces and on December 31, 2019, the Company has returned these spaces to the lessor. Accordingly, as of December 31, 2019, the lease asset and operating lease liability in respect of this lease agreement have been relatively reduced. 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 $147 thousand as of December 31, 2019. The Company also leases office space in New York City and as of the date of the issuance of these consolidated financial statements, the office space lease agreement in Modi'in was ended. 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 year ended December 31, 2019 was comprised of the following: Year ended 2019 U.S. dollars in thousands Operating lease expense 743 Short-term lease expense 102 Variable lease expense 2 847 Supplemental information related to leases are as follows: December 31, 2019 U.S. dollars in thousands Operating lease right-of-use assets 1,243 Current Operating lease liabilities 544 Non-current operating lease liabilities 799 Other information: Operating cash flows from operating leases (cash paid in thousands) 743 Weighted Average Remaining Lease Term (years) 2.43 Weighted Average Discount Rate of operating leases 5.45 % Maturities of lease liabilities are as follows: Amount Year U.S. dollars in thousands 2020 599 2021 550 2022 274 Total lease payments 1,423 Less imputed interest (80 ) Total 1,343 3) ASC 840 Disclosures- The Company elected the modified retrospective transition method and included the following tables previously disclosed. The lease expenses for 2018 amounted to approximately $680 thousand. Future contractual obligations under the abovementioned operating lease agreements (not including the Extension Option) as of December 31, 2018 are as follows: Amount Year U.S. dollars in thousands 2019 772 2020 721 2021 332 Total 1,825 e. Establishment of the Commercial Scale Production Capabilities for AP-CD/LD 1) Automated Production Line In April 2017, the Company engaged with an international manufacturer for ordering a large-scale automated production line for manufacturing Accordion Pills (the "Production Line"). The total cost of the Production Line amounted to approximately €8.2 million (approximately $9.6 million). As of December 31, 2019, the Company paid in full all the consideration. As of the date of the issuance of these consolidated financial statements, the installation process and qualification studies of the Production Line at the commercial site at Lohmann Therapie-Systeme AG ("LTS") was completed and the Company has initiated the validation and stability studies. For more details regarding the Manufacturing Services with LTS, see note 6e(2) below. For the year ended December 31, 2019 the Company recorded a full impairment charge of the Production Line, for more details see note 6e(3). 2) 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. As of December 31, 2019, the Company paid in full all the consideration. The Company has recognized the Equipment as non-current other assets. As of December 31, 2019, the fair value of the Equipment is approximately $3.7 million. For the year ended December 31, 2019, the Company recorded an impairment charge of the Equipment in the amount of approximately $4.1 million. For more details, see note 6e(3) below. The Agreement contains several termination rights which are expected to be included in a definitive manufacturing and supply agreement. As of December 31, 2019, the Company recognized a liability that was recorded against research and development expenses, net in the amount of €2.0 million (approximately $2.2 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. The liability that was recorded as of December 31, 2018, was approximately €1.65 million (approximately $1.9 million). 3) Impairment Assessment 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 Production Line and Equipment net from the liability described in note 6e(2), 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/ Liability Impairment Charge Fair Value 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 No impairment of long-lived assets was recorded for the year ended December 31, 2018. 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. While management believes the assumptions used in their impairment assessment are reasonable, any changes in the actual market conditions versus the assumptions used in the model could result in a change in estimated future cash flows, which may result in an additional impairment charge on AP-CD/LD Assets, net 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 are seeking pecuniary damages of NIS 2.4 million (approximately $700 thousand) plus interest and linkage to the Israeli CPI. In addition, the plaintiffs have filed motions to obtain liens on the Company's assets to secure any future recovery. That motion was withdrawn pursuant to the court's recommendation at the conclusion of a hearing held on February 9, 2020. The Company records a provision in its financial statements to the extent that it concludes that a contingent liability is probable and the amount thereof is estimable. The Company together with its legal advisors believe that it has good defense arguments to the claims against it and filed a statement of defense to the complaint on March 8, 2020 in which it rejected all of the plaintiffs' claims. Accordingly, management assessed the likelihood of damages and concluded that no provisions are needed to be recorded within the financial statements regarding the matter disclosed in this note. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
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) In April 2018, the Company completed an underwritten public offering, pursuant to which the Company issued 6,750,000 ordinary shares at a price of $5.25 per ordinary share. In May 2018, the underwriters partially exercised their over-allotment option and purchased 400,000 additional ordinary shares. The total net proceeds were approximately $35.0 million, after deducting underwriting discounts, commissions and other offering expenses in the amount of $2.5 million. 2) On March 1, 2019, the Company entered into a Sales Agreement with 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 having an aggregate offering price of up to $75.0 million through Cowen acting as sales agent. The issuance and sale of ordinary shares by the Company under the program is being 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. During September and December 2019, the Company sold 1,944,512 ordinary shares under the Sales Agreement at an average price of $1.13 per share for aggregate net proceeds of approximately $2.1 million, net of issuance expenses of approximately $112 thousand. 3) 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 612,520 ordinary shares. 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 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 700,000 ordinary shares for grants to directors, employees and consultants. In July 2016, an increase of 700,000 ordinary shares was approved by the board of directors. In December 2017, June 2018 and December 2019, an increase of 2,100,000, 1,000,000 and 1,000,000 ordinary shares, respectively, was approved by the Company's shareholders at a general meeting of shareholders. As of December 31, 2019, 1,459,238 shares remain available for grant under the Plan. The 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 of time that granted options are expected to remain outstanding. 2) On August 22, 2019, the Company reduced the exercise price of 1,263,655 options previously granted to employees to $0.44 (determined based on the close 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 pricing options model using the following assumptions: risk free interest rate of 1.5%, expected volatility of 99% - 122%, 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, 2019 and December 31, 2018, the Company granted options to employees and directors as follows: Year ended December 31, 2019 Number of Exercise price Vesting Expiration Employees* 1,465,000 $0.9-$7.64 3 years 7 years Directors 140,000 $0.62-$4.86 3 years 7 years Year ended December 31, 2018 Number of Exercise price Vesting Expiration Employees* 1,175,000 $4.44-$6.67 3 years 7 years Directors 120,000 $4.44 3 years 7 years * As part of the reduction in exercise price of the options described in note 7c(2), the option exercise price was adjusted to $0.44. 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 2019 2018 Weighted average fair value $ 2.76 $ 2.37 The underlying data used for computing the fair value of the options are as follows: Year ended December 31 2019 2018 Value of ordinary share $0.51-$7.46 $4.20-$6.45 Dividend yield 0% 0% Expected volatility 53.32%-100.04% 45.87%-46.47% Risk-free interest rate 1.65%-2.57% 2.25%-2.73% Expected term 5 years 5 years The following table summarizes the number of options outstanding with exercise price in NIS for the years ended December 31, 2019 and December 31, 2018, and related information: Employees and directors Consultants Number of options NIS (1) Number of options NIS (1) Outstanding at January 1, 2018 349,152 30.27 8,035 0.5 Forfeited (400 ) 34.24 - - Expired (53,300 ) 45.48 - - Outstanding at December 31, 2018 295,452 27.52 8,035 0.5 Exercised (16 ) 0.5 (2,530 ) 0.5 Forfeited (85,909 ) 23.25 - - Expired (126,852 ) 21.89 (5,505 ) 0.5 Outstanding at December 31, 2019 82,675 40.60 - - The following table summarizes the number of options outstanding with exercise price in USD for the years ended December 31, 2019 and December 31, 2018, and related information: Employees and directors Number of options USD (2) Outstanding at January 1, 2018 1,872,683 5.74 Granted 1,295,000 6.01 Exercised (7,218 ) 4.14 Forfeited (22,282 ) 6.64 Expired - - Outstanding at December 31, 2018 3,138,183 5.85 Granted 1,605,000 (3) Exercised (99,643 ) (3) Forfeited (450,745 ) (3) Expired (269,900 ) 7.00 Outstanding at December 31, 2019 3,922,895 (3) (1) Weighted average price in NIS per share. (2) Weighted average price in USD per share. (3) After giving effect to the reduction in exercise price of the options described in note 7c(2). The following table summarizes information concerning outstanding and exercisable options with exercise prices in NIS as of December 31, 2019: December 31, 2019 Options outstanding Options exercisable Exercise Number of Weighted Number of Weighted 32.47-39.55 45,000 0.89 45,000 0.89 48.91 32,253 0.28 32,253 0.28 52.35 5,422 0.17 5,422 0.17 82,675 82,675 The following table summarizes information concerning outstanding and exercisable options with exercise prices in USD as of December 31, 2019: December 31, 2019 Options outstanding Options exercisable Exercise Number of Weighted Number of Weighted 0.447-0.9 1,355,451 5.65 402,398 4.50 3.526 224,478 6.38 224,478 6.38 4.14-4.47 505,466 5.93 230,540 5.60 5.19-5.46 435,000 5.85 310,001 5.95 6-6.7 697,500 6.37 466,665 6.23 7.628-7.64 505,000 6.11 - - 8.56 200,000 7.91 133,334 7.91 3,922,895 1,767,416 The aggregate intrinsic value of the total outstanding and exercisable options as of December 31, 2019, is $50 thousand and $21 thousand respectively. The following table illustrates the effect of share-based compensation on the statements of operations: Year ended December 31 2019 2018 U.S. dollars in thousands Research and development expenses, net $ 1,634 $ 1,732 General and administrative expenses 1,587 1,495 $ 3,221 $ 3,227 |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2019 | |
Supplementary Financial Statement Information [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 8 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION: Balance sheets: December 31 2019 2018 U.S. dollars in thousands a . Prepaid expenses and other receivables: Institutions $ 1,836 $ 1,683 Termination fee, Novartis (see note 6b(1)) 1,500 - Prepaid expenses 194 227 Advances to suppliers 3 728 Interest receivable 3 118 Other receivables 147 230 $ 3,683 $ 2,986 b. Accounts payable and accruals - other: Expenses payable 2,838 3,400 Salary and related expenses, including social security and other taxes 1,277 1,078 Current operating lease liabilities (see note 6d) 544 - Accrual for vacation days and recreation pay for employees 154 309 Other 22 20 $ 4,835 $ 4,807 Statements of operations: c. Financial income (expenses), net: Year ended December 31 2019 2018 U.S. dollars in thousands Financial income: Interest on cash and cash equivalents $ 330 $ 852 Gains from changes in fair value of marketable securities 13 - $ 343 $ 852 Financial expenses - Loss from changes in exchange rates $ (180 ) $ (747 ) Losses from changes in fair value of marketable securities - (194 ) Bank fees (15 ) (23 ) $ (195 ) $ (964 ) Financial income (expenses), net $ 148 $ (112 ) |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2019 | |
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 2019 and 2018 were 21%. The relevant state tax rate for 2019 and 2018 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, 2019, 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 2015. d. Losses for tax purposes carried forward to future years As of December 31, 2019, Intec had approximately $144.9 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 2019 and 2018, the Subsidiary incurred a tax expense in the amount of approximately $638 thousand and approximately $103 thousand, respectively. In 2019, the Company has provided full valuation allowance with respect to the subsidiary's share-based compensation expenses and accordingly recorded in 2019 tax expenses of $562 thousand. f. Deferred income taxes: December 31 2019 2018 U.S. dollars in thousands In respect of: Net operating loss carry forward $ 33,316 $ 24,739 Research and Development expenses 6,209 6,705 Impairment of long-lived assets 3,143 - Issuance costs 216 734 Other 1,138 787 Less—valuation allowance (44,022 ) (32,684 ) Net deferred tax assets $ - $ 281 The change in valuation allowance for the years ended December 31, 2019 and 2018 were as follows: December 31 2019 2018 U.S. dollars in thousands Balance at the beginning of the year $ 32,684 $ 22,774 Changes during the year 11,338 9,910 Balance at the end of the year $ 44,022 $ 32,684 g. Loss before income tax The components of loss before income tax are as follows: December 31 2019 2018 U.S. dollars in thousands Income (loss) before income tax: Intec $ (47,331 ) $ (43,943 ) Subsidiary 370 503 $ (46,961 ) $ (43,440 ) h. Current taxes on income The main reconciling item between the statutory tax rates of the Company and the effective rate is the share-based compensation and the provision for valuation allowance in respect of tax benefits from carryforward tax losses and issuance costs 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: December 31 2019 2018 U.S. dollars in thousands Balance at the beginning of the year $ 309 $ - Increase in uncertain tax positions for the current year 295 309 Balance at the end of the year $ 604 $ 309 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, 2019 | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2019 | NOTE 10 - EVENTS SUBSEQUENT TO DECEMBER 31, 2019: a. During January 2020, the Company sold 831,371 ordinary shares under the Sales Agreement at an average price of $0.525 per share for aggregate net proceeds of approximately $421 thousand, net of issuance expenses of approximately $15 thousand. b. In February 2020, the Company completed an underwritten public offering, pursuant to which the Company issued 15,280,000 ordinary shares, pre-funded warrants to purchase 970,000 ordinary shares and warrants to purchase 16,250,000 ordinary shares. Each pre-funded warrant was exercisable at an exercise price of $0.0001 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 were sold together at a combined price of $0.40. Each warrant shall be exercisable at an exercise price of $0.40 per share and has a term of five years from the date of issuance. The total net proceeds were approximately $5.7 million, after deducting underwriting discounts, commissions and other offering expenses in the amount of $800 thousand. c. On February 17, 2020, the board of directors approved a grant of options to purchase an aggregate of 645,000 ordinary shares to the Company's executive officers and employees. Each option shall be exercisable at an exercise price of $0.4287 per share. The options will vest over a three-year period, with one-third of the options vesting at the end of the first anniversary of the date of grant, and the remaining options vesting in eight equal quarterly installments following the first anniversary of the grant date. The options will expire seven years after the date of grant. The value of the benefit in respect of the said options, as calculated on the grant date, is approximately $127 thousand. In addition, the board of directors approved a grant of options to purchase 125,000 ordinary shares to the Company's Chief Executive Officer which shall be granted following the approval of the Company's shareholders at a general meeting of shareholders. Each option shall be exercisable at an exercise price per share equal to the average closing sale price of the Company's ordinary shares on the NASDAQ Capital Market over the 30 trading day period prior to the date of the general meeting of shareholders, or the fair market value of one of our ordinary shares on the date prior to the general meeting, whichever amount is greater. These options will vest over a three-year period, with one third of the options vesting at the end of the first anniversary of the date of grant, and the remaining options vesting in eight equal quarterly installments following the first anniversary of the grant date. The options will expire seven years after the date of grant. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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 include 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 , ", as the Company chooses to apply the fair value option. |
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. As further discussed in note 6e(3), during the year ended December 31, 2019, the Company recorded an impairment loss in the amount of $13.7 million related to certain of its long-lived assets. The impairment charge is recorded as an operating expense. |
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. As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the consolidated statements of operations. 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 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 years ended December 31, 2019 and 2018, include participation in research and development expenses in the amount of approximately $1.1 million and approximately $829 thousand, respectively. 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. |
Income taxes | k. 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 | l. 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, 2019 2018 Outstanding stock options 4,325,105 3,301,669 |
Fair value measurement | m. 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 1: 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 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: 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 | n. 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 | o. 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. Commencing January 1, 2019, 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 will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Instead, the Company will continue to recognize 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 will be included in the measurement of lease payments, the ROU asset, and the lease liability for all leases entered into on or after January 1, 2019. 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"). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. 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. Topic 842 had a material impact on our consolidated balance sheets but did not have an impact on our consolidated statements of operations. The most significant impact was the recognition of $2.2 million in ROU assets and $2.2 million in lease liabilities. 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 adopted accounting pronouncements | p. Newly issued accounting pronouncements 1) In February 2016, the FASB established ASC Topic 842, "Leases" (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019 using the modified retrospective transition method and has not restated comparative periods. The new standard also provides practical expedients for an entity's ongoing accounting. Beginning in 2019, the Company changed its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard. See Note 6d. 2) In June 2018, the FASB issued ASU 2018-07, "Compensation-Stock Compensation" (Topic 718" or "ASU 2018-07") to improve the usefulness of information provided to users of financial statements while reducing cost and complexity in financial reporting and provide guidance aligning the measurement and classification for share-based payments to nonemployees with the guidance for share-based payments to employees. Under the guidance, the measurement of equity-classified nonemployee awards will be fixed at the grant date. This standard, adopted as of January 1, 2019, had no impact on the Company's consolidated financial statements. 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 as of the ASU 2019-10 issuance date 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 believe the adoption of this standard will have a material impact on its consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
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, 2019 2018 Outstanding stock options 4,325,105 3,301,669 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | December 31 2019 2018 U.S. dollars in thousands Cost: Computers and communications equipment $ 248 $ 237 Production and laboratory equipment 7,286 7,280 Office furniture and equipment 208 203 Leasehold improvements 2,029 2,029 Large-scale automated production line, see note 6e(1) and 6e(3) - 8,826 9,771 18,575 Less: Accumulated depreciation (7,196 ) (6,342 ) Property and equipment, net $ 2,575 $ 12,233 |
COMMITMENTS AND CONTINGENT LI_2
COMMITMENTS AND CONTINGENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease expenses and information related to leases | Lease expense for the year ended December 31, 2019 was comprised of the following: Year ended 2019 U.S. dollars in thousands Operating lease expense 743 Short-term lease expense 102 Variable lease expense 2 847 Supplemental information related to leases are as follows: December 31, 2019 U.S. dollars in thousands Operating lease right-of-use assets 1,243 Current Operating lease liabilities 544 Non-current operating lease liabilities 799 Other information: Operating cash flows from operating leases (cash paid in thousands) 743 Weighted Average Remaining Lease Term (years) 2.43 Weighted Average Discount Rate of operating leases 5.45 % |
Schedule of maturities of lease liabilities | Maturities of lease liabilities are as follows: Amount Year U.S. dollars in thousands 2020 599 2021 550 2022 274 Total lease payments 1,423 Less imputed interest (80 ) Total 1,343 |
Schedule of future contractual obligations | Future contractual obligations under the abovementioned operating lease agreements (not including the Extension Option) as of December 31, 2018 are as follows: Amount Year U.S. dollars in thousands 2019 772 2020 721 2021 332 Total 1,825 |
Schedule of impairment assessment | The following table illustrates the effect of the impairment assessment on the AP-CD/LD Assets, net, as of December 31, 2019: Cost/ Liability Impairment Charge Fair Value 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, 2019 | |
Shareholders' Equity Note [Abstract] | |
Schedule of options granted to employees and directors | 3) During the years ended December 31, 2019 and December 31, 2018, the Company granted options to employees and directors as follows: Year ended December 31, 2019 Number of Exercise price Vesting Expiration Employees* 1,465,000 $0.9-$7.64 3 years 7 years Directors 140,000 $0.62-$4.86 3 years 7 years Year ended December 31, 2018 Number of Exercise price Vesting Expiration Employees* 1,175,000 $4.44-$6.67 3 years 7 years Directors 120,000 $4.44 3 years 7 years * As part of the reduction in exercise price of the options described in note 7c(2), the option exercise price was adjusted to $0.44. |
Schedule of weighted average fair value of options granted | 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 2019 2018 Weighted average fair value $ 2.76 $ 2.37 |
Schedule of underlying data used for computing the fair value of the options | Year ended December 31 2019 2018 Value of ordinary share $0.51-$7.46 $4.20-$6.45 Dividend yield 0% 0% Expected volatility 53.32%-100.04% 45.87%-46.47% Risk-free interest rate 1.65%-2.57% 2.25%-2.73% Expected term 5 years 5 years |
Schedule of number of options outstanding | The following table summarizes the number of options outstanding with exercise price in NIS for the years ended December 31, 2019 and December 31, 2018, and related information: Employees and directors Consultants Number of options NIS (1) Number of options NIS (1) Outstanding at January 1, 2018 349,152 30.27 8,035 0.5 Forfeited (400 ) 34.24 - - Expired (53,300 ) 45.48 - - Outstanding at December 31, 2018 295,452 27.52 8,035 0.5 Exercised (16 ) 0.5 (2,530 ) 0.5 Forfeited (85,909 ) 23.25 - - Expired (126,852 ) 21.89 (5,505 ) 0.5 Outstanding at December 31, 2019 82,675 40.60 - - The following table summarizes the number of options outstanding with exercise price in USD for the years ended December 31, 2019 and December 31, 2018, and related information: Employees and directors Number of options USD (2) Outstanding at January 1, 2018 1,872,683 5.74 Granted 1,295,000 6.01 Exercised (7,218 ) 4.14 Forfeited (22,282 ) 6.64 Expired - - Outstanding at December 31, 2018 3,138,183 5.85 Granted 1,605,000 (3) Exercised (99,643 ) (3) Forfeited (450,745 ) (3) Expired (269,900 ) 7.00 Outstanding at December 31, 2019 3,922,895 (3) (1) Weighted average price in NIS per share. (2) Weighted average price in USD per share. (3) After giving effect to the reduction in exercise price of the options described in note 7c(2). |
Schedule of the information concerning outstanding and exercisable options | The following table summarizes information concerning outstanding and exercisable options with exercise prices in NIS as of December 31, 2019: December 31, 2019 Options outstanding Options exercisable Exercise Number of Weighted Number of Weighted 32.47-39.55 45,000 0.89 45,000 0.89 48.91 32,253 0.28 32,253 0.28 52.35 5,422 0.17 5,422 0.17 82,675 82,675 The following table summarizes information concerning outstanding and exercisable options with exercise prices in USD as of December 31, 2019: December 31, 2019 Options outstanding Options exercisable Exercise Number of Weighted Number of Weighted 0.447-0.9 1,355,451 5.65 402,398 4.50 3.526 224,478 6.38 224,478 6.38 4.14-4.47 505,466 5.93 230,540 5.60 5.19-5.46 435,000 5.85 310,001 5.95 6-6.7 697,500 6.37 466,665 6.23 7.628-7.64 505,000 6.11 - - 8.56 200,000 7.91 133,334 7.91 3,922,895 1,767,416 |
Schedule of effect of share-based compensation | The following table illustrates the effect of share-based compensation on the statements of operations: Year ended December 31 2019 2018 U.S. dollars in thousands Research and development expenses, net $ 1,634 $ 1,732 General and administrative expenses 1,587 1,495 $ 3,221 $ 3,227 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Supplementary Financial Statement Information [Abstract] | |
Schedule of supplementary financial statement information | Balance sheets: December 31 2019 2018 U.S. dollars in thousands a . Prepaid expenses and other receivables: Institutions $ 1,836 $ 1,683 Termination fee, Novartis (see note 6b(1)) 1,500 - Prepaid expenses 194 227 Advances to suppliers 3 728 Interest receivable 3 118 Other receivables 147 230 $ 3,683 $ 2,986 b. Accounts payable and accruals - other: Expenses payable 2,838 3,400 Salary and related expenses, including social security and other taxes 1,277 1,078 Current operating lease liabilities (see note 6d) 544 - Accrual for vacation days and recreation pay for employees 154 309 Other 22 20 $ 4,835 $ 4,807 Statements of operations: c. Financial income (expenses), net: Year ended December 31 2019 2018 U.S. dollars in thousands Financial income: Interest on cash and cash equivalents $ 330 $ 852 Gains from changes in fair value of marketable securities 13 - $ 343 $ 852 Financial expenses - Loss from changes in exchange rates $ (180 ) $ (747 ) Losses from changes in fair value of marketable securities - (194 ) Bank fees (15 ) (23 ) $ (195 ) $ (964 ) Financial income (expenses), net $ 148 $ (112 ) |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred income taxes | December 31 2019 2018 U.S. dollars in thousands In respect of: Net operating loss carry forward $ 33,316 $ 24,739 Research and Development expenses 6,209 6,705 Impairment of long-lived assets 3,143 - Issuance costs 216 734 Other 1,138 787 Less—valuation allowance (44,022 ) (32,684 ) Net deferred tax assets $ - $ 281 |
Schedule of change in valuation allowance | The change in valuation allowance for the years ended December 31, 2019 and 2018 were as follows: December 31 2019 2018 U.S. dollars in thousands Balance at the beginning of the year $ 32,684 $ 22,774 Changes during the year 11,338 9,910 Balance at the end of the year $ 44,022 $ 32,684 |
Schedule of components of loss before income tax | The components of loss before income tax are as follows: December 31 2019 2018 U.S. dollars in thousands Income (loss) before income tax: Intec $ (47,331 ) $ (43,943 ) Subsidiary 370 503 $ (46,961 ) $ (43,440 ) |
Schedule of unrecognized tax benefits | The following table summarizes the activity of the Company unrecognized tax benefits: December 31 2019 2018 U.S. dollars in thousands Balance at the beginning of the year $ 309 $ - Increase in uncertain tax positions for the current year 295 309 Balance at the end of the year $ 604 $ 309 |
NATURE OF OPERATIONS (Narrative
NATURE OF OPERATIONS (Narrative) (Details) - USD ($) $ in Thousands | Feb. 03, 2020 | Mar. 01, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Accumulated Deficit | $ (189,423) | $ (141,824) | ||
Proceeds from issuance of ordinary shares, net of issuance expenses | 2,086 | 35,029 | ||
Impairment of long-live assets | $ 13,663 | |||
Sales Agreement [Member] | Cowen [Member] | ||||
Number of shares issued | 2,775,883 | |||
Proceeds from issuance of ordinary shares, net of issuance expenses | $ 2,500 | |||
Issuance expenses | 127 | |||
Sell of ordinary shares | $ 72,400 | |||
Subsequent Event [Member] | Underwritten Public Offering [Member] | ||||
Proceeds from issuance of ordinary shares, net of issuance expenses | $ 5,700 | |||
Issuance expenses | $ 800 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Annual Rates of Depreciation of Property and Equipment) (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computers and peripheral equipment [Member] | |
Rate of depreciation | 33.00% |
Production and laboratory equipment [Member] | Minimum [Member] | |
Rate of depreciation | 10.00% |
Production and laboratory equipment [Member] | Maximum [Member] | |
Rate of depreciation | 14.00% |
Office furniture and equipment | Minimum [Member] | |
Rate of depreciation | 7.00% |
Office furniture and equipment | Maximum [Member] | |
Rate of depreciation | 10.00% |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Anti-Dilutive Securities) (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
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 | 4,325,105 | 3,301,669 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Impairment of long-live assets | $ 13,663 | |
Research and development expenses [Member] | ||
Participation in research and development expenses | 1,100 | $ 829 |
Newly issued accounting pronouncements [Member] | ||
Additional lease liabilities recognized | 2,200 | |
Recognized ROU assets | $ 2,200 |
MARKETABLE SECURITIES (Narrativ
MARKETABLE SECURITIES (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | ||
Marketable securities | $ 770 | $ 1,300 |
Gain (loss), net from changes in marketable securities | $ 13 | $ (194) |
PROPERTY AND EQUIPMENT, NET (Sc
PROPERTY AND EQUIPMENT, NET (Schedule of Property and Equipment Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Cost: | $ 9,771 | $ 18,575 |
Less: Accumulated depreciation | (7,196) | (6,342) |
Property and equipment, net | 2,575 | 12,233 |
Computers and communications equipment [Member] | ||
Cost: | 248 | 237 |
Production and laboratory equipment [Member] | ||
Cost: | 7,286 | 7,280 |
Office furniture and equipment [Member] | ||
Cost: | 208 | 203 |
Leasehold improvements [Member] | ||
Cost: | 2,029 | 2,029 |
Large-scale automated production line [Member] | ||
Cost: | $ 8,826 |
PROPERTY AND EQUIPMENT, NET (Na
PROPERTY AND EQUIPMENT, NET (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Depreciation expense | $ 854 | $ 859 |
Production Line [Member] | ||
Impairment charge | $ 9,568 |
EMPLOYEE SEVERANCE BENEFITS (Na
EMPLOYEE SEVERANCE BENEFITS (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Retirement Benefits [Abstract] | ||
Severance payment expenses | $ 610 | $ 615 |
Expected deposit with respect to employee's severance benefits | $ 400 |
COMMITMENTS AND CONTINGENT LI_3
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of lease expense) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease expense | $ 743 |
Short-term lease expense | 102 |
Variable lease expense | 2 |
Total lease expense | $ 847 |
COMMITMENTS AND CONTINGENT LI_4
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of Supplemental information related to leases) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 1,243 | |
Current Operating lease liabilities | 544 | |
Non-current operating lease liabilities | 799 | |
Other information: | ||
Operating cash flows from operating leases (cash paid in thousands) | $ 743 | |
Weighted Average Remaining Lease Term (years) | 2 years 5 months 5 days | |
Weighted Average Discount Rate of operating leases | 5.45% |
COMMITMENTS AND CONTINGENT LI_5
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of maturities of lease liabilities) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 | $ 599 |
2021 | 550 |
2022 | 274 |
Total lease payments | 1,423 |
Less imputed interest | (80) |
Total | $ 1,343 |
COMMITMENTS AND CONTINGENT LI_6
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of future contractual obligations) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 772 |
2020 | 721 |
2021 | 332 |
Total | $ 1,825 |
COMMITMENTS AND CONTINGENT LI_7
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of impairment assessment) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
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 |
COMMITMENTS AND CONTINGENT LI_8
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Joint Venture and Exclusive License Agreement) (Details) | Jul. 13, 2005 |
Commitments and Contingencies Disclosure [Abstract] | |
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% |
COMMITMENTS AND CONTINGENT LI_9
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Cooperation Agreements) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Other income | $ 1,500 |
COMMITMENTS AND CONTINGENT L_10
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Grants From The IIA) (Details) ₪ in Thousands, $ in Thousands | Dec. 31, 2019USD ($) | Dec. 31, 2019ILS (₪) |
Total amount of grants received from the IIA | $ | $ 11,300 | |
NIS [Member] | ||
Total amount of grants received from the IIA | ₪ | ₪ 42,300 | |
Minimum [Member] | ||
Royalties rate | 3.00% | 3.00% |
Maximum [Member] | ||
Royalties rate | 5.00% | 5.00% |
COMMITMENTS AND CONTINGENT L_11
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Lease Agreements) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Rental expenses | $ 680 | |
Lease agreements- Jerusalem [Member] | ||
Bank guarantee | $ 147 |
COMMITMENTS AND CONTINGENT L_12
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Automated Production Line) (Details) - 1 months ended Apr. 30, 2017 - Automated Production Line [Member] € in Thousands, $ in Thousands | USD ($) | EUR (€) |
Total cost of automated production line including additional components | $ | $ 9,600 | |
Euro | ||
Total cost of automated production line including additional components | € | € 8,200 |
COMMITMENTS AND CONTINGENT L_13
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - LTS Process Development Agreement) (Details) € in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | |
LTS Production equipment agreement [Member] | ||||
Total cost of Equipment | $ 7,800 | |||
Fair value of Equipment | $ 3,700 | |||
Impairment charge | 4,100 | |||
Euro | LTS Production equipment agreement [Member] | ||||
Total cost of Equipment | € | € 6,800 | |||
Lohmann Therapie-Systeme [Member] | ||||
Additional amount recognized as liability in respect to facility upgrading costs | $ 2,200 | $ 1,900 | ||
Lohmann Therapie-Systeme [Member] | Euro | ||||
Additional amount recognized as liability in respect to facility upgrading costs | € | € 2,000 | € 1,650 |
COMMITMENTS AND CONTINGENT L_14
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Impairment Assessment) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Impairment Assessment [Abstract] | ||
Impairment charge of AP-CD/LD Assets, net | $ (13,663) |
COMMITMENTS AND CONTINGENT L_15
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - lawsuit) (Details) - 12 months ended Dec. 31, 2019 ₪ in Thousands, $ in Thousands | USD ($) | ILS (₪) |
Plaintiffs pecuniary damages | $ | $ 700 | |
NIS [Member] | ||
Plaintiffs pecuniary damages | ₪ | ₪ 2,400 |
SHARE CAPITAL (Schedule of Opt
SHARE CAPITAL (Schedule of Options Granted to Employees and Directors) (Details) - Share options [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | ||
Employees [Member] | |||
Number of options granted | [1] | 1,465,000 | 1,175,000 |
Exercise price range, minimum | [1] | $ 0.9 | $ 4.44 |
Exercise price range, maximum | [1] | $ 7.64 | $ 6.67 |
Vesting period range, maximum | [1] | 3 years | 3 years |
Expiration | [1] | 7 years | 7 years |
Directors [Member] | |||
Number of options granted | 140,000 | 120,000 | |
Exercise price range, minimum | $ 0.62 | ||
Exercise price range, maximum | $ 4.86 | $ 4.44 | |
Vesting period range, maximum | 3 years | 3 years | |
Expiration | 7 years | 7 years | |
[1] | As part of the reduction in exercise price of the options described in note 7c(2), the option exercise price was adjusted to $0.44. |
SHARE CAPITAL (Schedule of Weig
SHARE CAPITAL (Schedule of Weighted Average Fair Value of Options Granted) (Details) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Weighted average fair value of options | ||
Weighted average fair value of options granted | $ 2.76 | $ 2.37 |
SHARE CAPITAL (Schedule of Unde
SHARE CAPITAL (Schedule of Underlying Data Used for Computing the Fair Value of the Options) (Details) - Employees [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Dividend yield | 0.00% | 0.00% |
Expected term | 5 years | 5 years |
Minimum [Member] | ||
Value of ordinary share | $ 0.51 | $ 4.20 |
Expected volatility | 53.32% | 45.87% |
Risk-free interest rate | 1.65% | 2.25% |
Maximum [Member] | ||
Value of ordinary share | $ 7.46 | $ 6.45 |
Expected volatility | 100.04% | 46.47% |
Risk-free interest rate | 2.57% | 2.73% |
SHARE CAPITAL (Summary of the N
SHARE CAPITAL (Summary of the Number of Options Outstanding Under the Plan in NIS) (Details) - NIS - ₪ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | ||
Employees and Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Outstanding at beginning of period | 295,452 | 349,152 | |
Exercised | (16) | ||
Forfeited | (85,909) | (400) | |
Expired | (126,852) | (53,300) | |
Outstanding at end of period | 82,675 | 295,452 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |||
Outstanding at beginning of period | [1] | ₪ 27.52 | ₪ 30.27 |
Exercised | [1] | 0.5 | |
Forfeited | [1] | 23.25 | 34.24 |
Expired | [1] | 21.89 | 45.48 |
Outstanding at end of period | [1] | ₪ 40.60 | ₪ 27.52 |
Consultants [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Outstanding at beginning of period | 8,035 | 8,035 | |
Exercised | (2,530) | ||
Forfeited | |||
Expired | (5,505) | ||
Outstanding at end of period | 8,035 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |||
Outstanding at beginning of period | [1] | ₪ 0.5 | ₪ 0.5 |
Exercised | [1] | 0.5 | |
Forfeited | [1] | ||
Expired | [1] | 0.5 | |
Outstanding at end of period | [1] | ₪ 0.5 | |
[1] | Weighted average price in NIS per share. |
SHARE CAPITAL (Summary of the_2
SHARE CAPITAL (Summary of the Number of Options Outstanding Under the Plan in USD) (Details) - Employees and Directors [Member] - $ / shares | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||
Outstanding at beginning of period | 3,138,183 | 1,872,683 | ||
Granted | 1,605,000 | 1,295,000 | ||
Exercised | (99,643) | (7,218) | ||
Forfeited | (450,745) | (22,282) | ||
Expired | (269,900) | |||
Outstanding at end of period | 3,902,895 | 3,138,183 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ||||
Outstanding at beginning of period | [1] | $ 5.85 | $ 5.74 | |
Granted | [1] | 3.45 | [2] | 6.01 |
Exercised | [1] | 2.83 | [2] | 4.14 |
Forfeited | [1] | 4 | [2] | 6.64 |
Expired | [1] | 7 | ||
Outstanding at end of period | [1] | $ 4.13 | [2] | $ 5.85 |
[1] | Weighted average price in USD per share. | |||
[2] | After giving effect to the reduction in exercise price of the options described in note 7c(2). |
SHARE CAPITAL (Summary of the_3
SHARE CAPITAL (Summary of the Number of Options Outstanding and Options Exercisable Under the Plan in NIS) (Details) - NIS | 12 Months Ended |
Dec. 31, 2019₪ / sharesshares | |
Exercise Price 32.47 To 39.55 [Member] | |
Exercise price minimum | ₪ / shares | ₪ 32.47 |
Exercise price maximum | ₪ / shares | ₪ 39.55 |
Options outstanding, Number of options outstanding at the end of year | 45,000 |
Options outstanding, Weighted average remaining contractual life | 10 months 21 days |
Options exercisable, Number of options exercisable at the end of year | 45,000 |
Options exercisable, Weighted average remaining contractual life | 10 months 21 days |
Exercise Price 48.91 [Member] | |
Options outstanding, Exercise price per share | ₪ / shares | ₪ 48.91 |
Options outstanding, Number of options outstanding at the end of year | 32,253 |
Options outstanding, Weighted average remaining contractual life | 3 months 11 days |
Options exercisable, Number of options exercisable at the end of year | 32,253 |
Options exercisable, Weighted average remaining contractual life | 3 months 11 days |
Exercise Price 52.35 [Member] | |
Options outstanding, Exercise price per share | ₪ / shares | ₪ 52.35 |
Options outstanding, Number of options outstanding at the end of year | 5,422 |
Options outstanding, Weighted average remaining contractual life | 2 months 1 day |
Options exercisable, Number of options exercisable at the end of year | 5,422 |
Options exercisable, Weighted average remaining contractual life | 2 months 1 day |
Total [Member] | |
Options outstanding, Number of options outstanding at the end of year | 82,675 |
Options exercisable, Number of options exercisable at the end of year | 82,675 |
SHARE CAPITAL (Summary of the_4
SHARE CAPITAL (Summary of the Number of Options Outstanding and Options Exercisable Under the Plan in USD) (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Exercise Price 0.447 To 0.9 [Member] | |
Exercise price minimum | $ / shares | $ 0.447 |
Exercise price maximum | $ / shares | $ 0.9 |
Options outstanding, Number of options outstanding at the end of year | 1,335,451 |
Options outstanding, Weighted average remaining contractual life | 5 years 7 months 24 days |
Options exercisable, Number of options exercisable at the end of year | 402,398 |
Options exercisable, Weighted average remaining contractual life | 4 years 6 months |
Exercise Price 3.526 [Member] | |
Options outstanding, Exercise price per share | $ / shares | $ 3.526 |
Options outstanding, Number of options outstanding at the end of year | 224,478 |
Options outstanding, Weighted average remaining contractual life | 6 years 4 months 17 days |
Options exercisable, Number of options exercisable at the end of year | 224,478 |
Options exercisable, Weighted average remaining contractual life | 6 years 4 months 17 days |
Exercise Price 4.14 to 4.47 [Member] | |
Exercise price minimum | $ / shares | $ 4.14 |
Exercise price maximum | $ / shares | $ 4.47 |
Options outstanding, Number of options outstanding at the end of year | 505,466 |
Options outstanding, Weighted average remaining contractual life | 5 years 11 months 4 days |
Options exercisable, Number of options exercisable at the end of year | 230,540 |
Options exercisable, Weighted average remaining contractual life | 5 years 7 months 6 days |
Exercise Price 5.19 to 5.46 [Member] | |
Exercise price minimum | $ / shares | $ 5.19 |
Exercise price maximum | $ / shares | $ 5.46 |
Options outstanding, Number of options outstanding at the end of year | 435,000 |
Options outstanding, Weighted average remaining contractual life | 5 years 10 months 6 days |
Options exercisable, Number of options exercisable at the end of year | 310,001 |
Options exercisable, Weighted average remaining contractual life | 5 years 11 months 12 days |
Exercise Price 6.0 to 6.7 [Member] | |
Exercise price minimum | $ / shares | $ 6 |
Exercise price maximum | $ / shares | $ 6.7 |
Options outstanding, Number of options outstanding at the end of year | 697,500 |
Options outstanding, Weighted average remaining contractual life | 6 years 4 months 13 days |
Options exercisable, Number of options exercisable at the end of year | 466,665 |
Options exercisable, Weighted average remaining contractual life | 6 years 2 months 23 days |
Exercise Price 7.628 To 7.64 [Member] | |
Exercise price minimum | $ / shares | $ 7.628 |
Exercise price maximum | $ / shares | $ 7.64 |
Options outstanding, Number of options outstanding at the end of year | 505,000 |
Options outstanding, Weighted average remaining contractual life | 6 years 1 month 9 days |
Options exercisable, Number of options exercisable at the end of year | |
Exercise Price 8.56 [Member] | |
Options outstanding, Exercise price per share | $ / shares | $ 8.56 |
Options outstanding, Number of options outstanding at the end of year | 200,000 |
Options outstanding, Weighted average remaining contractual life | 7 years 10 months 28 days |
Options exercisable, Number of options exercisable at the end of year | 133,334 |
Options exercisable, Weighted average remaining contractual life | 7 years 10 months 28 days |
Total [Member] | |
Options outstanding, Number of options outstanding at the end of year | 3,922,895 |
Options exercisable, Number of options exercisable at the end of year | 1,767,416 |
SHARE CAPITAL (Schedule of Effe
SHARE CAPITAL (Schedule of Effect of Share-based Compensation) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based compensation | $ 3,221 | $ 3,227 |
Research and development expenses [Member] | ||
Share-based compensation | 1,634 | 1,732 |
General and administrative expenses [Member] | ||
Share-based compensation | $ 1,587 | $ 1,495 |
SHARE CAPITAL (Narrative - Shar
SHARE CAPITAL (Narrative - Share Capital) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Dec. 02, 2019 | May 31, 2018 | Apr. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 01, 2019 | |
Proceeds from issuance of ordinary shares, net of issuance costs | $ 2,086 | $ 35,029 | ||||
Sales Agreement [Member] | Cowen [Member] | ||||||
Number of share issued | 1,944,512 | |||||
Proceeds from issuance of ordinary shares, net of issuance costs | $ 2,100 | |||||
Issuance expenses | $ 112 | |||||
Aggregate offering price under the sales agreement with cowen | $ 75,000 | |||||
Average price (in dollars per share) | $ 1.13 | |||||
Purchase Agreement [Member] | ||||||
Number of shares issued to Aspire | 612,520 | |||||
Aspire's commitment to purchase aggregate amount of the Company’s ordinary shares under the purchase agreement | $ 10,000 | |||||
Underwritten Public Offering [Member] | ||||||
Number of share issued | 6,750,000 | |||||
Number of additional ordinary shares purchased by underwriters | 400,000 | |||||
Proceeds from issuance of ordinary shares, net of issuance costs | $ 35,000 | |||||
Issuance expenses | $ 2,500 | |||||
Share price (in dollars per share) | $ 5.25 |
SHARE CAPITAL (Narrative - Sh_2
SHARE CAPITAL (Narrative - Share Option Plan for Grants to Directors, Employees and Consultants) (Details) - 2015 Plan [Member] - shares | 12 Months Ended | ||||
Dec. 31, 2019 | Jun. 30, 2018 | Dec. 31, 2017 | Jul. 31, 2016 | Jan. 31, 2016 | |
Number of ordinary shares reserved for issuance under the 2015 plan | 1,000,000 | 1,000,000 | 2,100,000 | 700,000 | 700,000 |
Number of shares available for grant | 1,459,238 | ||||
Maximum term of award | 10 years |
SHARE CAPITAL (Narrative - Repr
SHARE CAPITAL (Narrative - Repricing of Options Previously Granted) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended |
Aug. 22, 2019USD ($)$ / sharesshares | |
Repricing of options previously granted [Member] | |
Dividend yield | 0.00% |
Risk-free interest rate | 1.50% |
Exercise price | $ / shares | $ 0.44 |
Number of options previously granted | shares | 1,263,655 |
Incremental fair value of options previously granted | $ 253 |
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% |
Expected term | 4 years 4 months 24 days |
Fully Vested Options [Member] | |
The incremental fair value of fully vested options previously granted | $ 62 |
SHARE CAPITAL (Narrative - Outs
SHARE CAPITAL (Narrative - Outstanding and Exercisable Options) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Share Capital Narrative - Outstanding And Exercisable Options | |
Aggregate intrinsic value of total outstanding options | $ 50 |
Aggregate intrinsic value of total exercisable options | $ 21 |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Schedule of Supplementary Balance Sheets Information) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid expenses and other receivable: | ||
Institutions | $ 1,836 | $ 1,683 |
Termination fee, Novartis (see note 6b(1)) | 1,500 | |
Prepaid expenses | 194 | 227 |
Advances to suppliers | 3 | 728 |
Interest receivable | 3 | 118 |
Other receivables | 147 | 230 |
Total prepaid expenses and other receivable | 3,683 | 2,986 |
Accounts payable and accruals - other: | ||
Expenses payable | 2,838 | 3,400 |
Salary and related expenses, including social security and other taxes | 1,277 | 1,078 |
Current operating lease liabilities (see note 6d) | 544 | |
Accrual for vacation days and recreation pay for employees | 154 | 309 |
Other | 22 | 20 |
Total accounts payable and accruals - other | $ 4,835 | $ 4,807 |
SUPPLEMENTARY FINANCIAL STATE_4
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Schedule of Supplementary Statements of Operations) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Financial income: | ||
Interest on cash and cash equivalents | $ 330 | $ 852 |
Gains from changes in fair value of marketable securities | 13 | |
Financial income | 343 | 852 |
Financial expenses - | ||
Loss from changes in exchange rates | (180) | (747) |
Losses from changes in fair value of marketable securities | (194) | |
Bank fees | (15) | (23) |
Financial expenses | (195) | (964) |
Financial income (expenses), net | $ 148 | $ (112) |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Income Taxes) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | |||
Net operating loss carry forward | $ 33,316 | $ 24,739 | |
Research and Development expenses | 6,209 | 6,705 | |
Impairment of long-lived assets | 3,143 | ||
Issuance Costs | 216 | 734 | |
Other | 1,138 | 787 | |
Less - valuation allowance | (44,022) | (32,684) | $ (22,774) |
Net deferred tax assets | $ 281 |
TAXES ON INCOME (Schedule of Ch
TAXES ON INCOME (Schedule of Change in Valuation Allowance) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Balance at the beginning of the year | $ 32,684 | $ 22,774 |
Changes during the year | 11,338 | 9,910 |
Balance at the end of the year | $ 44,022 | $ 32,684 |
TAXES ON INCOME (Components of
TAXES ON INCOME (Components of Loss Before Income Tax ) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income (loss) before income tax: | ||
Intec | $ (47,331) | $ (43,943) |
Subsidiary | 370 | 503 |
Loss before income tax | $ (46,961) | $ (43,440) |
TAXES ON INCOME (Summarizes of
TAXES ON INCOME (Summarizes of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Balance at the beginning of the year | $ 309 | |
Increase in uncertain tax positions for the current year | 295 | 309 |
Balance at the end of the year | $ 604 | $ 309 |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Net carry forward tax losses | $ 144,900 | |
Tax expenses | 638 | $ 103 |
Subsidiary [Member] | ||
Tax expenses recorded following full valuation allowance with respect to the subsidiary's share-based compensation expenses | $ 562 | |
Israel [Member] | ||
Federal statutory tax | 23.00% | |
U.S.A [Member] | ||
Relevant state tax rate | 7.00% | 7.00% |
Corporate tax rate | 21.00% | 21.00% |
EVENTS SUBSEQUENT TO DECEMBER_2
EVENTS SUBSEQUENT TO DECEMBER 31, 2019 (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 29, 2020 | Feb. 17, 2020 | Jan. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Proceeds from issuance of ordinary shares, net of issuance costs | $ 2,086 | $ 35,029 | |||
Subsequent Event [Member] | Sales Agreement [Member] | |||||
Average price (in dollars per share) | $ 0.525 | ||||
Proceeds from issuance of ordinary shares, net of issuance costs | $ 421 | ||||
Issuance expenses | $ 15 | ||||
Number of shares issued | 831,371 | ||||
Underwritten Public Offering [Member] | Subsequent Event [Member] | |||||
Proceeds from issuance of ordinary shares, net of issuance costs | $ 5,700 | ||||
Issuance expenses | $ 800 | ||||
Combined price of share and warrant (in dollars) | $ 0.40 | ||||
Number of shares issued | 15,280,000 | ||||
Number of pre-funded ordinary shares issued during the period | 970,000 | ||||
Pre-funded warrants exercise price | $ 0.0001 | ||||
Number of warrants issued | 16,250,000 | ||||
Term of the warrants | 5 years | ||||
Exercise price | $ 0.40 | ||||
Grant of options [Member] | Subsequent Event [Member] | |||||
Fair value on grant date | $ 127 | ||||
Number of options granted | 645,000 | ||||
Exercise price | $ 0.4287 | ||||
Vesting period | 3 years | ||||
Expiration | 7 years | ||||
Grant of options 1 [Member] | Subsequent Event [Member] | |||||
Additional options to be granted following the approval of the general meeting | 125,000 | ||||
Vesting period | 3 years | ||||
Expiration | 7 years |