Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 11, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | Intec Pharma Ltd. | |
Entity Central Index Key | 0001638381 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 | |
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 Common Stock Shares Outstanding | 35,019,479 | |
Entity File Number | 001-37521 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | L3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 14,966 | $ 39,246 |
Investment in marketable securities (Note 3) | 767 | 1,333 |
Prepaid expenses and other receivables | 2,453 | 2,986 |
TOTAL CURRENT ASSETS | 18,186 | 43,565 |
NON-CURRENT ASSETS: | ||
Other assets (Note 4b) | 4,204 | 5,431 |
Property and equipment, net (Note 4b) | 6,200 | 12,233 |
Operating lease right-of-use assets (Note 4a) | 1,687 | |
Deferred tax assets | 504 | 281 |
TOTAL NON-CURRENT ASSETS | 12,595 | 17,945 |
TOTAL ASSETS | 30,781 | 61,510 |
CURRENT LIABILITIES - | ||
Accounts payable and accruals: Trade | 4,834 | 2,849 |
Accounts payable and accruals: Other (Note 6) | 6,774 | 4,807 |
TOTAL CURRENT LIABILITIES | 11,608 | 7,656 |
LONG-TERM LIABILITIES - | ||
Non-current operating lease liabilities (Note 4a) | 1,132 | |
Other liabilities | 554 | 309 |
TOTAL LONG-TERM LIABILITIES | 1,686 | 309 |
TOTAL LIABILITIES | 13,294 | 7,965 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 4) | ||
SHAREHOLDERS' EQUITY: | ||
Ordinary shares, with no par value - authorized: 100,000,000 Ordinary Shares as of September 30, 2019 and December 31, 2018; issued and outstanding: 35,019,479 and 33,232,988 Ordinary Shares as of September 30, 2019 and December 31, 2018, respectively | 727 | 727 |
Additional paid-in capital | 199,627 | 194,642 |
Accumulated deficit | (182,867) | (141,824) |
TOTAL SHAREHOLDERS' EQUITY | 17,487 | 53,545 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 30,781 | $ 61,510 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 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 | 35,019,479 | 33,232,988 |
Ordinary shares, outstanding | 35,019,479 | 33,232,988 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
OPERATING EXPENSES: | ||||
RESEARCH AND DEVELOPMENT EXPENSES, net | $ (8,448) | $ (7,809) | $ (24,850) | $ (25,089) |
GENERAL AND ADMINISTRATIVE EXPENSES | (2,157) | (1,696) | (6,491) | (5,800) |
IMPAIRMENT OF LONG LIVED ASSETS | (9,759) | (9,759) | ||
OPERATING LOSS | (20,364) | (9,505) | (41,100) | (30,889) |
FINANCIAL INCOME (EXPENSES), net | 14 | 163 | 157 | (5) |
LOSS BEFORE INCOME TAX | (20,350) | (9,342) | (40,943) | (30,894) |
TAX BENEFIT (INCOME TAX) | (28) | 164 | (100) | (46) |
NET LOSS | $ (20,378) | $ (9,178) | $ (41,043) | $ (30,940) |
LOSS PER SHARE BASIC AND DILUTED (in dollars per share) | $ (0.61) | $ (0.28) | $ (1.23) | $ (1.01) |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE IN THOUSANDS | 33,516 | 33,226 | 33,356 | 30,505 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - 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 IN THE PERIOD ENDED SEPTEMBER 30 | ||||
Issuance of ordinary shares, net of issuance costs | 35,029 | 35,029 | ||
Issuance of ordinary shares, net of issuance costs, shares | 7,150,000 | |||
Exercise of options | 1 | 1 | ||
Exercise of options, shares | 218 | |||
Share-based compensation (Note 5b) | 2,452 | 2,452 | ||
Net loss | (30,940) | (30,940) | ||
BALANCE at Sep. 30, 2018 | $ 727 | 193,838 | (129,221) | $ 65,344 |
BALANCE (in shares) at Sep. 30, 2018 | 33,225,988 | 33,225,988 | ||
BALANCE at Jun. 30, 2018 | $ 727 | 192,987 | (120,043) | $ 73,671 |
BALANCE (in shares) at Jun. 30, 2018 | 33,225,988 | 33,225,988 | ||
CHANGES IN THE PERIOD ENDED SEPTEMBER 30 | ||||
Share-based compensation (Note 5b) | 851 | $ 851 | ||
Net loss | (9,178) | (9,178) | ||
BALANCE at Sep. 30, 2018 | $ 727 | 193,838 | (129,221) | $ 65,344 |
BALANCE (in shares) at Sep. 30, 2018 | 33,225,988 | 33,225,988 | ||
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 IN THE PERIOD ENDED SEPTEMBER 30 | ||||
Issuance of ordinary shares, net of issuance costs | 1,969 | $ 1,969 | ||
Issuance of ordinary shares, net of issuance costs, shares | 1,716,679 | |||
Exercise of options | 268 | 268 | ||
Exercise of options, shares | 69,812 | |||
Share-based compensation (Note 5b) | 2,748 | 2,748 | ||
Net loss | (41,043) | (41,043) | ||
BALANCE at Sep. 30, 2019 | $ 727 | 199,627 | (182,867) | $ 17,487 |
BALANCE (in shares) at Sep. 30, 2019 | 35,019,479 | 35,019,479 | ||
BALANCE at Jun. 30, 2019 | $ 727 | 196,871 | (162,489) | $ 35,109 |
BALANCE (in shares) at Jun. 30, 2019 | 33,302,800 | 33,302,800 | ||
CHANGES IN THE PERIOD ENDED SEPTEMBER 30 | ||||
Issuance of ordinary shares, net of issuance costs | 1,969 | $ 1,969 | ||
Issuance of ordinary shares, net of issuance costs, shares | 1,716,679 | |||
Share-based compensation (Note 5b) | 787 | 787 | ||
Net loss | (20,378) | (20,378) | ||
BALANCE at Sep. 30, 2019 | $ 727 | $ 199,627 | $ (182,867) | $ 17,487 |
BALANCE (in shares) at Sep. 30, 2019 | 35,019,479 | 35,019,479 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (41,043) | $ (30,940) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 643 | 639 |
Impairment of long lived asset | 9,759 | |
Exchange differences on cash and cash equivalents | 69 | (528) |
Right of use asset | 523 | |
Lease liability | (380) | |
Losses (gains) on marketable securities | (10) | 141 |
Share-based compensation | 2,748 | 2,452 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in prepaid expenses and other receivables | 483 | (979) |
Increase in deferred tax assets | (223) | |
Increase (decrease) in accounts payable and accruals | 3,268 | (1,734) |
Increase in other liabilities | 245 | |
Net cash used in operating activities | (23,918) | (30,949) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (791) | (2,632) |
Investment in other assets | (2,315) | (2,450) |
Proceeds from disposal (purchase) of marketable securities, net | 576 | (38) |
Net cash used in investing activities | (2,530) | (5,120) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of ordinary shares, net of issuance costs | 1,969 | 35,029 |
Proceeds from exercise of options | 268 | 1 |
Net cash provided by financing activities | 2,237 | 35,030 |
DECREASE IN CASH AND CASH EQUIVALENTS | (24,211) | (1,039) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD | 39,246 | 53,393 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (69) | 528 |
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | 14,966 | 52,882 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING ACTIVITIES: | ||
Liability with respect to property and equipment (see note 4b(1)) | 123 | 1,898 |
Liability with respect to other assets (see note 4b(2)) | 549 | 244 |
SUPPLEMENTARY DISCLOSURE OF CASH FLOW INFORMATION - | ||
Taxes paid | 50 | 31 |
Interest received | $ 315 | $ 522 |
NATURE OF OPERATIONS AND BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | NOTE 1 - NATURE OF OPERATIONS AND BASIS OF PRESENTATION: a. Nature of operations 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. In addition, 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 $9.8 million. For more details see note 4b(3). Accordingly, there is no assurance that the Company's operations will generate positive cash flows. As of September 30, 2019, the cumulative losses of the Company were approximately $182.9 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 it has adequate cash to fund its ongoing activities into the second quarter of 2020. Its ability to execute its operating plan beyond the second quarter of 2020 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, there is substantial doubt about the Company's ability to continue as a going concern within one year after the issuance date of these financial statements. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. 3) On March 1, 2019, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"). During September 2019, the Company sold 1,716,679 ordinary shares under the Sales Agreement raising a total of approximately $2.0 million (net of issuance expenses of $107 thousand). For more details see note 5a(1). b. Basis of presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("US GAAP") and S-X Article 10 for interim financial statements. Accordingly, they do not contain all information and notes required by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company's consolidated financial position as of September 30, 2019, the consolidated results of operations, changes in equity for the three and nine-month periods ended September 30, 2019 and 2018 and cash flows for the nine-month periods ended September 30, 2019 and 2018. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's annual financial statements for the year ended December 31, 2018, as filed in the 10-K on February 27, 2019. The condensed balance sheet data as of December 31, 2018 included in these unaudited condensed consolidated financial statements was derived from the audited financial statements for the year ended December 31, 2018 but does not include all disclosures required by US GAAP for annual financial statements. The results for the nine-month period ended September 30, 2019 are not necessarily indicative of the results expected for the year ending December 31, 2019. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Principles of consolidation The consolidated financial statements include the accounts of Intec and its Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. b. 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 nine 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. The marketable securities which are measures at fair value are categorized as Level 1. The carrying amount of the cash and cash equivalents, other receivable and accrued expenses and other liabilities approximates their fair value. c. Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options 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 periods presented (share data): Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 Outstanding stock options 4,156,765 3,466,482 4,314,300 3,247,927 d. Research and development expenses, net Research and development expenses, net for the three and nine-month periods ended September 30, 2019 and 2018, include participation in research and development expenses as follows: Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 U.S. dollars in thousands Participation in research and development expenses 168 92 983 550 e. Newly adopted 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 provides a number of optional practical expedients in transition. The Company has elected the 'package of practical expedients', which permits it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs for leases entered into prior to adoption of Topic 842. Additionally, the Company did not separate lease and non-lease components for all of its leases. 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 most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities. Upon adoption, the Company recognized additional operating lease liabilities, of approximately $2.2 million based on the present value of the remaining lease payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $2.2 million. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Lease expense is recognized on a straight-line basis over the lease term. The Company's leases may include variable payments based on measures that include changes in price index which are expensed as incurred and presented as operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed lease payments. 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 4a. 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 material impact on the Company's consolidated financial statements. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 - MARKETABLE SECURITIES The Company's marketable securities have a minimum of A rating by global rating agencies. These marketable securities are recorded at fair value with changes recorded in the statement of operations as "financial income, net", as the Company chose to apply the fair value option. As of September 30, 2019, and December 31, 2018, the amount of the marketable securities is approximately $0.8 million and $1.3 million, respectively. The gain, net from changes in marketable securities for the nine-month period ended September 30, 2019 amounted to approximately $10 thousand and the loss, net from changes in marketable securities for the nine-month period ended September 30, 2018 amounted to approximately $141 thousand. The gain, net from changes in marketable securities for the three-month periods ended September 30, 2019 and 2018 amounted to approximately $5 thousand and $13 thousand, respectively. |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 4 - COMMITMENTS AND CONTINGENT LIABILITIES: a. 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"). The exercise of the Extension Option may be made in the Company's sole discretion. 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 granted a bank guarantee to the lessor, which amounted to approximately $146 thousand as of September 30, 2019. The Company also leases office space in Modi'in and New York City for a short-term period. 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 three and nine month-period ended September 30, 2019 was comprised of the following: Three months Nine months 2019 2019 U.S. dollars in thousands Operating lease expense 190 576 Short-term lease expense 26 76 Variable lease expense 1 2 217 654 Supplemental information related to leases are as follows: September 30, 2019 U.S. dollars Operating lease right-of-use assets 1,685 Current Operating lease liabilities 662 Non-current operating lease liabilities 1,132 Other information: Operating cash flows from operating leases (cash paid in thousands) 563 Weighted Average Remaining Lease Term 2.65 Weighted Average Discount Rate 5.43 % Maturities of lease liabilities are as follows: Year Amount U.S. dollars 2019 (excluding the nine months ended September 30, 2019) 185 2020 728 2021 668 2022 333 Total lease payments 1,914 Less imputed interest (120 ) Total 1,794 3) ASC 840 Disclosures- The Company elected the modified retrospective transition method and included the following tables previously disclosed. Future contractual obligations under the abovementioned operating lease agreements (not including the Extension Option) as of December 31, 2018 are as follows: Year Amount U.S. dollars 2019 772 2020 721 2021 332 Total 1,825 b. 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 €8.1 million. As of September 30, 2019, and December 31, 2018, the Company transferred payments of approximately €8.1 million (approximately $9.4 million) and €7.4 million (approximately $8.6 million), respectively. In addition, as of September 30, 2019 and December 31, 2018 the Company recognized a liability in the amount of approximately €113 thousand (approximately $123 thousand) and €148 thousand (approximately $170 thousand), respectively. As of the date of the issuance of these condensed 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 intends to begin the validation and stability studies in the coming months. For more details regarding the Manufacturing Services with LTS see note 2 below. 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") in the amount of approximately €7.0 million, however such 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 September 30, 2019, the Company transferred payments of approximately €6.3 million (approximately $7.2 million) in costs of the Equipment, of which approximately €2.0 million (approximately $2.3 million) was paid during the nine-month period ended September 30, 2019 and recognized a liability in an additional amount of approximately €502 thousand (approximately $549 thousand) and as of December 31, 2018 recognized a liability of €436 thousand (approximately $499 thousand). The Company has recognized the Equipment as non-current other assets. The Agreement contains several termination rights which are expected to be included in a definitive manufacturing and supply agreement. As of September 30, 2019, the Company recognized a liability that was recorded against research and development expenses, net in the amount of approximately €3.0 million (approximately $3.3 million), for LTS's facility upgrading costs, of which €1.0 million (approximately $1.1 million) was paid in October 2019. The remaining liability balance in the amount of €2.0 million (approximately $2.2 million) will be paid to LTS only if the Company decides to not 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 The Company's long-lived assets include property, plant and 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. 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. 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. In July 2019, the Company announced top-line results from its pivotal Phase III clinical trial 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 4b(2), together "AP-CD/LD Assets, net", for impairment test. For the three and nine month period ended September 30, 2019, the Company recorded an impairment charge of approximately $9.8 million of its AP-CD/LD Assets, net, which represents the excess carrying value compared to the fair value of the AP-CD/LD Assets, net. As of September 30, 2019, the fair value of the AP-CD/LD Assets, net, is approximately $5.4 million. The impairment charge is recorded as an operating expense and was the result of both internal and external factors. 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. c. During 2019 the Company received letters (each a "Letter" and collectively the "Letters") from several of its former directors and officers. The Letters include several claims related, among others, to a purported vesting of certain options that were issued to them due to the execution by the Company of a manufacturing agreement with LTS for the production of the Company's AP-CD/LD. On July 30, 2019, the board of directors of the Company resolved that the vesting conditions have not been met. As of the date of the issuance of these condensed consolidated financial statements, the Company is yet to receive their response, and at this stage cannot assess whether a claim would be filed, and if filed, its likelihood of success. |
SHARE CAPITAL
SHARE CAPITAL | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL | NOTE 5 - SHARE CAPITAL: a. Changes in share capital 1) 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 2019, the Company sold 1,716,679 ordinary shares under the Sales Agreement at an average price of $1.21 per share for aggregate net proceeds of approximately $2.0 million, net of issuance expenses of $107 thousand. 2) During the nine-month period ended September 30, 2019, options to purchase 69,812 ordinary shares granted to employees and service providers were exercised for consideration of approximately $268 thousand. b. Share-based compensation: 1) 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 and September 2018, an increase of 2,100,000 and 1,000,000 ordinary shares, respectively, was approved by the Company's shareholders at a general meeting of shareholders. As of September 30, 2019, 175,598 shares remain available for grant under the Plan. 2) On August 22, 2019, the Company reduced the exercise price of 1,263,655 options previously granted to employees (excluding executive officers and directors) 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 and was determined based on the Black-Scholes pricing options model using the following assumptions: risk free interest rate of 1.5%, expected volatility of 99% - 122%, expected term of 2.6-4.4 years and dividend yield of: 0%. The incremental fair value of these options will be recognized over the remaining vesting period and until January 2022. 3) In the nine months ended September 30, 2019 and 2018, the Company granted options as follows: Nine months ended September 30, 2019 Number of Exercise price Vesting Expiration Employees* 1,465,000 $0.9-$7.64 3 years 7 years Directors 120,000 $4.86 3 years 7 years Nine months ended September 30, 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 5b(2), the option exercise price was adjusted to $0.44. The fair value of options granted to employees during the nine months ended September 30, 2019, and 2018 was $4.4 million and $3.1 million, respectively. The fair value of options granted to employees on the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: Nine months ended September 30 2019 2018 Value of ordinary share $1.15-$7.46 $4.20-$6.45 Dividend yield 0% 0% Expected volatility 53.32%-97.81% 45.87%-46.47% Risk-free interest rate 1.75%-2.57% 2.25%-2.73% Expected term 5 years 5 years 4) The following table illustrates the effect of share-based compensation on the statements of operations: Three months ended Nine months ended 2019 2018 2019 2018 U.S. dollars in thousands U.S. dollars in thousands Research and development expenses, net 371 459 1,538 1,315 General and administrative expenses 416 392 1,210 1,137 787 851 2,748 2,452 |
ACCOUNTS PAYABLE AND ACCRUALS -
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | 9 Months Ended |
Sep. 30, 2019 | |
Accounts payable and accruals - other [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | NOTE 6 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER: September 30, December 31, 2019 2018 U.S. dollars in thousands Expenses payable $ 4,525 $ 3,400 Current operating lease liabilities (see Note 4a) 662 - Salary and related expenses, including social security and other taxes 1,224 1,078 Accrual for vacation days and recreation pay for employees 341 309 Other 22 20 $ 6,774 $ 4,807 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Principles of consolidation | a. Principles of consolidation The consolidated financial statements include the accounts of Intec and its Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. |
Fair value measurement | b. 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 nine 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. The marketable securities which are measures at fair value are categorized as Level 1. The carrying amount of the cash and cash equivalents, other receivable and accrued expenses and other liabilities approximates their fair value. |
Loss per share | c. Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options 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 periods presented (share data): Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 Outstanding stock options 4,156,765 3,466,482 4,314,300 3,247,927 |
Research and development expenses, net | d. Research and development expenses, net Research and development expenses, net for the three and nine-month periods ended September 30, 2019 and 2018, include participation in research and development expenses as follows: Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 U.S. dollars in thousands Participation in research and development expenses 168 92 983 550 |
Newly adopted accounting pronouncements | e. Newly adopted 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 provides a number of optional practical expedients in transition. The Company has elected the 'package of practical expedients', which permits it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs for leases entered into prior to adoption of Topic 842. Additionally, the Company did not separate lease and non-lease components for all of its leases. 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 most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities. Upon adoption, the Company recognized additional operating lease liabilities, of approximately $2.2 million based on the present value of the remaining lease payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $2.2 million. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Lease expense is recognized on a straight-line basis over the lease term. The Company's leases may include variable payments based on measures that include changes in price index which are expensed as incurred and presented as operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed lease payments. 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 4a. 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 material impact on the Company's consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of anti-dilutive securities | Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 Outstanding stock options 4,156,765 3,466,482 4,314,300 3,247,927 |
Schedule of research and development expenses, net | Three months ended September 30 Nine months ended September 30 2019 2018 2019 2018 U.S. dollars in thousands Participation in research and development expenses 168 92 983 550 |
COMMITMENTS AND CONTINGENT LI_2
COMMITMENTS AND CONTINGENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease expenses and information related to leases | Lease expense for the three and nine month-period ended September 30, 2019 was comprised of the following: Three months Nine months 2019 2019 U.S. dollars in thousands Operating lease expense 190 576 Short-term lease expense 26 76 Variable lease expense 1 2 217 654 Supplemental information related to leases are as follows: September 30, 2019 U.S. dollars Operating lease right-of-use assets 1,685 Current Operating lease liabilities 662 Non-current operating lease liabilities 1,132 Other information: Operating cash flows from operating leases (cash paid in thousands) 563 Weighted Average Remaining Lease Term 2.65 Weighted Average Discount Rate 5.43 % |
Schedule of maturities of lease liabilities | Maturities of lease liabilities are as follows: Year Amount U.S. dollars 2019 (excluding the nine months ended September 30, 2019) 185 2020 728 2021 668 2022 333 Total lease payments 1,914 Less imputed interest (120 ) Total 1,794 |
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: Year Amount U.S. dollars 2019 772 2020 721 2021 332 Total 1,825 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Shareholders' Equity Note [Abstract] | |
Schedule of options granted to employees and directors | In the nine months ended September 30, 2019 and 2018, the Company granted options as follows: Nine months ended September 30, 2019 Number of Exercise price Vesting Expiration Employees* 1,465,000 $0.9-$7.64 3 years 7 years Directors 120,000 $4.86 3 years 7 years Nine months ended September 30, 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 5b(2), the option exercise price was adjusted to $0.44. |
Schedule of underlying data used for computing the fair value of the options | The fair value of options granted to employees on the date of grant was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: Nine months ended September 30 2019 2018 Value of ordinary share $1.15-$7.46 $4.20-$6.45 Dividend yield 0% 0% Expected volatility 53.32%-97.81% 45.87%-46.47% Risk-free interest rate 1.75%-2.57% 2.25%-2.73% Expected term 5 years 5 years |
Schedule of effect of share-based compensation | The following table illustrates the effect of share-based compensation on the statements of operations: Three months ended Nine months ended 2019 2018 2019 2018 U.S. dollars in thousands U.S. dollars in thousands Research and development expenses, net 371 459 1,538 1,315 General and administrative expenses 416 392 1,210 1,137 787 851 2,748 2,452 |
ACCOUNTS PAYABLE AND ACCRUALS_2
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of accounts payable and accruals - other | September 30, December 31, 2019 2018 U.S. dollars in thousands Expenses payable $ 4,525 $ 3,400 Current operating lease liabilities (see Note 4a) 662 - Salary and related expenses, including social security and other taxes 1,224 1,078 Accrual for vacation days and recreation pay for employees 341 309 Other 22 20 $ 6,774 $ 4,807 |
NATURE OF OPERATIONS AND BASI_2
NATURE OF OPERATIONS AND BASIS OF PRESENTATION (Narrative) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accumulated deficit | $ (182,867) | $ (141,824) |
Long-lived assets impairment charge | 9,800 | |
Sales Agreement [Member] | Cowen [Member] | ||
Proceeds from issuance of ordinary shares, net of issuance expenses | $ 2,000 | |
Number of shares issued | 1,716,679 | |
Issuance expenses | $ 107 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Anti-Dilutive Securities) (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Outstanding stock options [Member] | ||||
Average shares excluded from the computation of diluted net loss per share, because the effect of their inclusion in the computation would be anti-dilutive | 4,156,765 | 3,466,482 | 4,314,300 | 3,247,927 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Research and development expenses, net) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Accounting Policies [Abstract] | ||||
Participation in research and development expenses | $ 168 | $ 92 | $ 983 | $ 550 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - Newly issued accounting pronouncements [Member] $ in Thousands | Sep. 30, 2019USD ($) |
Additional lease liabilities recognized | $ 2,200 |
Recognized ROU assets | $ 2,200 |
MARKETABLE SECURITIES (Narrativ
MARKETABLE SECURITIES (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |||||
Marketable securities | $ 800 | $ 800 | $ 1,300 | ||
Gain (loss), net from changes in marketable securities | $ 5 | $ 13 | $ 10 | $ (141) |
COMMITMENTS AND CONTINGENT LI_3
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of lease expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Lease Agreements [Abstract] | ||
Operating lease expense | $ 190 | $ 576 |
Short-term lease expense | 26 | 76 |
Variable lease expense | 1 | 2 |
Total lease expense | $ 217 | $ 654 |
COMMITMENTS AND CONTINGENT LI_4
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of Supplemental information related to leases) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Lease Agreements [Abstract] | ||
Operating lease right-of-use assets | $ 1,687 | |
Current Operating lease liabilities | 662 | |
Non-current operating lease liabilities | 1,132 | |
Other information | ||
Operating cash flows from operating leases (cash paid in thousands) | $ 563 | |
Weighted Average Remaining Lease Term | 2 years 7 months 24 days | |
Weighted Average Discount Rate | 5.43% |
COMMITMENTS AND CONTINGENT LI_5
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of maturities of lease liabilities) (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Lease Agreements [Abstract] | |
2019 (excluding the nine months ended September 30, 2019) | $ 185 |
2020 | 728 |
2021 | 668 |
2022 | 333 |
Total lease payments | 1,914 |
Less imputed interest | (120) |
Total | $ 1,794 |
COMMITMENTS AND CONTINGENT LI_6
COMMITMENTS AND CONTINGENT LIABILITIES (Schedule of future contractual obligations ) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Lease Agreements [Abstract] | |
2019 | $ 772 |
2020 | 721 |
2021 | 332 |
Total | $ 1,825 |
COMMITMENTS AND CONTINGENT LI_7
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Lease Agreements) (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Lease agreements- Jerusalem [Member] | |
Bank guarantee | $ 146 |
COMMITMENTS AND CONTINGENT LI_8
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Automated Production Line) (Details) € in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Apr. 30, 2017EUR (€) | Sep. 30, 2019USD ($) | Sep. 30, 2019EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | |
Euro | Automated Production Line [Member] | |||||
Total cost of automated production line including additional components | € 8,100 | ||||
Automated Production Line [Member] | |||||
Advances payments for automated production line | $ | $ 9,400 | $ 8,600 | |||
Additional amount recognized as liability | $ | $ 123 | $ 170 | |||
Automated Production Line [Member] | Euro | |||||
Advances payments for automated production line | € 8,100 | € 7,400 | |||
Additional amount recognized as liability | € 113 | € 148 |
COMMITMENTS AND CONTINGENT LI_9
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - LTS Process Development Agreement) (Details) € in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Oct. 31, 2019USD ($) | Oct. 31, 2019EUR (€) | Dec. 31, 2018EUR (€) | Sep. 30, 2019USD ($) | Sep. 30, 2019EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | |
LTS Production equipment agreement [Member] | |||||||
Advances payments for production equipment | $ | $ 7,200 | ||||||
Advance paid for production equipment | $ | 2,300 | ||||||
Additional amount recognized as liability in respect to production equipment | $ | 549 | $ 499 | |||||
LTS Production equipment agreement [Member] | Euro | |||||||
Total cost of production equipment | € 7,000 | ||||||
Advances payments for production equipment | € 6,300 | ||||||
Advance paid for production equipment | 2,000 | ||||||
Additional amount recognized as liability in respect to production equipment | 502 | € 436 | |||||
Lohmann Therapie-Systeme [Member] | |||||||
Liability in respect to facility upgrading costs that was paid after the third quarter | $ | 3,300 | $ 1,900 | |||||
Amount of upgrading facility costs to be paid to LTS in the case that the Company decides to not continue with the project or commercialization of AP-CD/LD | $ | $ 2,200 | ||||||
Lohmann Therapie-Systeme [Member] | Euro | |||||||
Liability in respect to facility upgrading costs that was paid after the third quarter | 3,000 | € 1,650 | |||||
Amount of upgrading facility costs to be paid to LTS in the case that the Company decides to not continue with the project or commercialization of AP-CD/LD | € 2,000 | ||||||
Subsequent Event [Member] | Lohmann Therapie-Systeme [Member] | |||||||
Liability in respect to facility upgrading costs that was paid after the third quarter | $ | $ 1,100 | ||||||
Subsequent Event [Member] | Lohmann Therapie-Systeme [Member] | Euro | |||||||
Liability in respect to facility upgrading costs that was paid after the third quarter | € 1,000 |
COMMITMENTS AND CONTINGENT L_10
COMMITMENTS AND CONTINGENT LIABILITIES (Narrative - Impairment assessment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Impairment Assessment [Abstract] | ||
Impairment charge of AP-CD/LD Assets, net | $ 9,759 | $ 9,759 |
Fair value of the AP-CD/LD Assets, net | $ 5,400 |
SHARE CAPITAL (Schedule of Opt
SHARE CAPITAL (Schedule of Options Granted to Employees and Directors) (Details) - Share options [Member] - $ / shares | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | ||
Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
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 | [1] | 3 years | 3 years |
Expiration | [1] | 7 years | 7 years |
Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options granted | 120,000 | 120,000 | |
Exercise price range, maximum | $ 4.86 | $ 4.44 | |
Vesting period range | 3 years | 3 years | |
Expiration | 7 years | 7 years | |
[1] | As part of the reduction in exercise price of the options described in note 5b(2), the option exercise price was adjusted to $0.44. |
SHARE CAPITAL (Schedule of Unde
SHARE CAPITAL (Schedule of Underlying Data Used for Computing the Fair Value of the Options) (Details) - Employees [Member] - $ / shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Dividend yield | 0.00% | 0.00% |
Expected term | 5 years | 5 years |
Minimum [Member] | ||
Value of ordinary share | $ 1.15 | $ 4.20 |
Expected volatility | 53.32% | 45.87% |
Risk-free interest rate | 1.75% | 2.25% |
Maximum [Member] | ||
Value of ordinary share | $ 7.46 | $ 6.45 |
Expected volatility | 97.81% | 46.47% |
Risk-free interest rate | 2.57% | 2.73% |
SHARE CAPITAL (Schedule of effe
SHARE CAPITAL (Schedule of effect of share-based compensation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based compensation | $ 787 | $ 851 | $ 2,748 | $ 2,452 |
Research and development expenses, net [Member] | ||||
Share-based compensation | 371 | 459 | 1,538 | 1,315 |
General and administrative expenses [Member] | ||||
Share-based compensation | $ 416 | $ 392 | $ 1,210 | $ 1,137 |
SHARE CAPITAL (Narrative - Shar
SHARE CAPITAL (Narrative - Share-based Compensation) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |||||
Aug. 22, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Mar. 01, 2019 | Dec. 31, 2017 | Jul. 31, 2016 | Jan. 31, 2016 | |
Proceeds from exercise of options | $ 268 | $ 1 | |||||
Sales Agreement [Member] | Cowen [Member] | |||||||
Proceeds from issuance of ordinary shares, net of issuance expenses | $ 2,000 | ||||||
Number of shares issued | 1,716,679 | ||||||
Issuance expenses | $ 107 | ||||||
Average price per share | $ 1.21 | ||||||
Aggregate offering price under the sales agreement with cowen | $ 75,000 | ||||||
2015 Plan [Member] | |||||||
Number of ordinary shares reserved for issuance under the 2015 plan | 1,000,000 | 2,100,000 | 700,000 | 700,000 | |||
Number of shares available for grant | 175,598 | ||||||
Exercise of share options [Member] | |||||||
Number of options exercised | 69,812 | ||||||
Proceeds from exercise of options | $ 268 | ||||||
Repricing of options previously granted [Member] | |||||||
Fair value of options granted | $ 4,400 | $ 3,100 | |||||
Dividend yield | 0.00% | ||||||
Risk-free interest rate | 1.50% | ||||||
Exercise price | $ 0.44 | ||||||
Number of options granted | 1,263,655 | ||||||
Incremental fair value of options | $ 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 |
ACCOUNTS PAYABLE AND ACCRUALS_3
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Schedule of accounts payable and accruals - other) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Accounts payable and accruals - other [Abstract] | ||
Expenses payable | $ 4,525 | $ 3,400 |
Current operating lease liabilities (see Note 4a) | 662 | |
Salary and related expenses, including social security and other taxes | 1,224 | 1,078 |
Accrual for vacation days and recreation pay for employees | 341 | 309 |
Other | 22 | 20 |
Accounts payable and accruals - other | $ 6,774 | $ 4,807 |