Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2017shares | |
Document Information [Line Items] | |
Entity Registrant Name | Galmed Pharmaceuticals Ltd. |
Entity Central Index Key | 1,595,353 |
Current Fiscal Year End Date | --12-31 |
Entity Filer Category | Non-accelerated Filer |
Trading Symbol | GLMD |
Document Type | 20-F |
Amendment Flag | false |
Document Period End Date | Dec. 31, 2017 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2,017 |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Common Stock, Shares Outstanding | 14,435,161 |
Consolidated Balance Sheet
Consolidated Balance Sheet - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 13,021 | $ 3,097 |
Marketable securities | 5,976 | 12,351 |
Other accounts receivable | 155 | 284 |
Total current assets | 19,152 | 15,732 |
Property and equipment, net | 491 | 718 |
Total assets | 19,643 | 16,450 |
Current liabilities | ||
Trade payables | 2,276 | 3,122 |
Other accounts payable | 1,034 | 363 |
Deferred revenue | 538 | 1,094 |
Total current liabilities | 3,848 | 4,579 |
Long-term liabilities | ||
Related parties | 0 | 267 |
Deferred revenue | 0 | 529 |
Total long-term liabilities | 0 | 796 |
Stockholders’ equity | ||
Ordinary shares, par value NIS 0.01 per share; Authorized 50,000,000 shares; Issued and outstanding: 14,435,161 shares as of December 31, 2017; 12,149,226 shares as of December 31, 2016 | 40 | 34 |
Additional paid-in capital | 92,381 | 75,446 |
Accumulated other comprehensive loss | (7) | (85) |
Accumulated deficit | (76,619) | (64,320) |
Total stockholders' equity | 15,795 | 11,075 |
Total liabilities and stockholders’ equity | $ 19,643 | $ 16,450 |
Consolidated Balance Sheet (Par
Consolidated Balance Sheet (Parenthetical) - ₪ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Ordinary shares, Par or Stated Value Per Share | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, Shares Authorized | 50,000,000 | 50,000,000 |
Ordinary shares, Shares, Issued | 14,435,161 | 12,149,226 |
Ordinary shares, Shares, Outstanding | 14,435,161 | 12,149,226 |
Consolidated Statement of Opera
Consolidated Statement of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue | $ (1,085) | $ (467) | $ 0 |
Research and development expenses | 9,650 | 14,271 | 7,629 |
General and administrative expenses | 3,799 | 3,078 | 3,246 |
Total operating loss | 12,364 | 16,882 | 10,875 |
Financial income, net | (65) | (35) | (253) |
Loss before income taxes | 12,299 | 16,847 | 10,622 |
Income taxes | 0 | 106 | 0 |
Net loss | $ 12,299 | $ 16,953 | $ 10,622 |
Basic and diluted net loss per share from continuing operations (in dollars per share) | $ 0.98 | $ 1.49 | $ 0.96 |
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share (in shares) | 12,487,349 | 11,374,653 | 11,100,453 |
Consolidated Statement of Compr
Consolidated Statement of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net loss | $ 12,299 | $ 16,953 | $ 10,622 |
Other comprehensive loss (income): | |||
Net unrealized loss (gain) on available for sale securities | (78) | (121) | 210 |
Comprehensive loss | $ 12,221 | $ 16,832 | $ 10,832 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Ordinary shares [Member] | Additional paid-in capital [Member] | Accumulated other comprehensive income (loss) [Member] | Accumulated deficit [Member] | |
Balance at Dec. 31, 2015 | $ 21,545 | $ 32 | $ 69,086 | $ (206) | $ (47,367) | |
Balance (in shares) at Dec. 31, 2015 | 11,100,453 | |||||
Stock based compensation | 1,628 | $ 0 | 1,628 | 0 | 0 | |
Issuance of Ordinary Shares | [1] | 4,479 | $ 2 | 4,477 | 0 | 0 |
Issuance of Ordinary Shares (in shares) | [1] | 933,160 | ||||
Issuance of common stock upon stock option exercises | 255 | 255 | 0 | 0 | ||
Issuance of common stock upon stock option exercises (in shares) | 115,613 | |||||
Unrealized gain from marketable securities | 121 | 0 | 121 | 0 | ||
Net loss | (16,953) | 0 | 0 | (16,953) | ||
Balance at Dec. 31, 2016 | 11,075 | $ 34 | 75,446 | (85) | (64,320) | |
Balance (in shares) at Dec. 31, 2016 | 12,149,226 | |||||
Stock based compensation | 1,394 | $ 0 | 1,394 | 0 | 0 | |
Issuance of Ordinary Shares | [1] | 15,017 | $ 5 | 15,012 | 0 | 0 |
Issuance of Ordinary Shares (in shares) | [1] | 1,874,827 | ||||
Options and Restricted stock units Exercise | 530 | $ 1 | 529 | 0 | 0 | |
Options and Restricted stock units Exercise (in Shares) | 411,108 | |||||
Unrealized gain from marketable securities | 78 | 0 | 78 | 0 | ||
Net loss | (12,299) | 0 | 0 | (12,299) | ||
Balance at Dec. 31, 2017 | $ 15,795 | $ 40 | $ 92,381 | $ (7) | $ (76,619) | |
Balance (in shares) at Dec. 31, 2017 | 14,435,161 | |||||
[1] | See also Note 9.A. |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | ||
Cash flow from operating activities | ||||
Net loss for the year | $ (12,299) | $ (16,953) | $ (10,622) | |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 239 | 169 | 50 | |
Amortization of discount/premium on marketable securities | 21 | 44 | 92 | |
Loss from realization of marketable securities | 143 | 231 | 50 | |
Linked difference of marketable securities | (167) | |||
Stock-based compensation expense | 1,394 | 1,628 | 970 | |
Changes in operating assets and liabilities: | ||||
Increase (decrease) in deferred revenue from collaboration agreement | (1,085) | 1,623 | 0 | |
Decrease (increase) in other accounts receivable | 129 | 95 | (214) | |
Increase (decrease) in trade payables | (846) | 863 | 1,384 | |
Increase in other accounts payable | 671 | 81 | 39 | |
Increase (decrease) in related party | (267) | 90 | (223) | |
Net cash used in operating activities | (12,067) | (12,129) | (8,474) | |
Cash flow from investing activities | ||||
Purchase of property and equipment | (12) | (17) | (159) | |
Proceeds from sale of property and equipment | 0 | 13 | 0 | |
Investment in securities, available for sale | (3,869) | (7,615) | (26,541) | |
Proceeds from sale of securities, available for sale | 10,325 | 13,955 | 9,594 | |
Disposal of short-term deposit | 0 | 0 | 6,000 | |
Net cash provided by (used in) investing activities | 6,444 | 6,336 | (11,106) | |
Cash flow from financing activities | ||||
Issuance of ordinary shares, net of issuance costs (*) | [1] | 15,017 | 4,479 | 0 |
Proceeds from exercise of options | 530 | 255 | 0 | |
Net cash provided by financing activities | 15,547 | 4,734 | 0 | |
Increase (decrease) in cash and cash equivalents | 9,924 | (1,059) | (19,580) | |
Cash and cash equivalents at the beginning of the year | 3,097 | 4,156 | 23,736 | |
Cash and cash equivalents at the end of the year | 13,021 | 3,097 | 4,156 | |
Cash received from interest | 202 | 382 | 473 | |
Cash paid for taxes | $ 0 | $ 106 | $ 0 | |
[1] | See also Note 9.A. |
General
General | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases. The Company was incorporated in Israel on July 31, 2013 February 2, 2014 The Company holds a wholly owned subsidiary, Galmed International Ltd., which was incorporated in Malta. Galmed International Ltd. holds a wholly owned subsidiary, Galmed Medical Research Ltd., which was incorporated in Israel and has been an inactive company since 2015 The Company also holds a wholly owned subsidiary, Galmed Research and Development Ltd., which was incorporated in Israel. The Company is a clinical-stage biopharmaceutical company with an operating history limited to pre-clinical and clinical drug development and has no approved products. To date, the Company has focused almost exclusively on developing its product candidate, Aramchol. The Company funded its research and development programs and operations to date primarily through proceeds from private placements and public offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date. As of December 31, 2017, the Company had cash and cash equivalents of $ 13.0 6.0 The Company has incurred operating losses in each year since inception. The Company's loss attributable to holders of its ordinary shares for the years ended December 31, 2015, 2016, and 2017 was approximately $ 10.6 17.0 12.3 76.6 The Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol for, and beyond its current development stage and any future commercialization Based on the Company's current operating plan, the Company's management currently estimates that its cash position will support its current clinical trial and operations through 2019. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies [Text Block] | Note 2 Significant Accounting Policies A. Basis of presentation The consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles ("U.S. GAAP"). B. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates include, but are not limited to, those related to deferred revenue, revenue recognition, stock-based compensation and indirect tax accruals, and other assumptions believed to be reasonable by management. Actual results could differ from those estimates. C. Financial statement in U.S. dollars The functional currency of the Company and its subsidiaries is in U.S dollar (the “dollar”), because the dollar is the currency of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions and balances have been re-measured to dollars in accordance with the provisions of ASC 830-10, “Foreign Currency Translation.” All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statement of operations as financial income or expenses, as appropriate. D. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: Galmed Research and Development Ltd, Galmed 2000 Inc., Galmed International Ltd., and Galmed Medical Research Ltd. All intercompany balances and transactions have been eliminated upon consolidation. E. Cash and cash equivalents Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less as of the date acquired. F. Marketable Securities Marketable securities are considered to be available for sale and are carried at fair value. Unrealized gains and losses net of tax, if any, are reported as a separate component of stockholders’ equity. The cost of marketable securities classified as available for sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other than temporary, if any, are also included in other income, net. Interest on securities classified as available for sale is included in interest income. The cost of securities sold is based on the specific identification method. For all investments in marketable securities, the Company assesses whether the impairment is other-than-temporary. If the fair value of a security is less than its amortized cost basis, an impairment is considered other-than-temporary if (i) the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security before recovery of its entire amortized cost basis, or (ii) the Company does not expect to recover the entire amortized cost of the security. If an impairment is considered other-than-temporary based on condition (i), the entire difference between the amortized cost and the fair value of the security is recognized in earnings. If an impairment is considered other-than-temporary based on condition (ii), the amount representing credit losses, defined as the difference between the present value of the cash flows expected to be collected and the amortized cost basis of the security, will be recognized in earnings, and the amount relating to all other factors will be recognized in other comprehensive income. The Company evaluates both qualitative and quantitative factors such as duration and severity of the unrealized losses, credit ratings, default and loss rates of the underlying collateral, structure and credit enhancements to determine if a credit loss may exist. Property and equipment % Office furniture and equipment 7 16 Computer software, electronic and medical equipment 15 33 Leasehold improvements 10 Impairment of long-lived assets The Company’s and its subsidiaries’ long-lived assets are reviewed for impairment in accordance with ASC 360-10, “Accounting for the Impairment or Disposal of Long-Lived Assets,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds their fair value. During 2017 and 2016, no impairment losses were identified. I. Severance pay The Company’s liability for severance pay is calculated in accordance with Israeli law, based on the most recent salary paid to each employee and the length of employment with the Company. Part of the liability is funded through individual insurance policies purchased from outside insurance companies, which are not under the Company’s control. The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33 Fair value of financial instruments The estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies. Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company could realize in a current market exchange. The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments: The carrying amounts of cash and cash equivalents, short-term bank deposits, marketable securities and trade payables approximate their fair value due to the short-term maturity of such instruments. Fair value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions used by market participants in pricing an asset or a liability. A three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: · Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets · Level 2 - Other inputs that are directly or indirectly observable in the marketplace; and · Level 3 - Unobservable inputs that are supported by little or no market activity The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. K. Accounting for stock-based compensation The Company applies ASC 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statement of operations. The Company recognizes compensation expense for the value of non-employee awards, which have graded vesting, based on the accelerated attribution method The Company recognizes compensation expenses for the value of employee awards, which have graded vesting, based on the straight-line method over the requisite service period of each of the awards, net of estimated forfeitures. The Company estimates the fair value of restricted shares based on the market price of the shares at the grant date, and estimates the fair value of stock options granted using a Black-Scholes option-pricing model The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC-718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent term. The following assumptions were used for the fiscal year 2017 and 2016 grants: dividend yield of 0.00 1.22 1.90 5 6.25 70 84 L. Deferred Revenue and Revenue Recognition We have entered into a collaboration agreement with Samil Pharm. Co., Ltd, The terms of our collaboration agreement include deliverables such as non-refundable license fees, payments based upon achievement of developmental or regulatory approval milestones, and royalties on product sales. We apply the accounting standard on revenue recognition for multiple element arrangements. The fair value of deliverables under the arrangement may be derived using a “best estimate of selling price” if vendor specific objective evidence and third-party evidence is not available. Deliverables under the arrangement will be separate units of accounting provided that (i) a delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. Performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed or deferred indefinitely until the undelivered performance obligation can be determined. We have been unable to demonstrate standalone value in our multiple element arrangements. Whenever we determine that an arrangement should be accounted for as a single unit of accounting, we determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using either a proportional performance or straight-line method. We recognize revenue under the arrangement on a straight-line basis over the period we are expected to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method, as of the period ending date. Our collaboration agreement entitles us to additional payments upon the achievement of performance-based milestones. These milestones are categorized into two types: development milestones which are generally based on the advancement of our ongoing Phase IIb ARREST trial and potential pivotal study, and regulatory milestones which are based on the approval of a new drug application in the territory in respect of the product. Milestones that are tied to regulatory approval are not considered probable of being achieved until such approval is received. Upfront payments from customers are not subject to refund if the development activities are not successful. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Although we follow detailed guidelines in measuring revenue, certain judgments affect the application of our revenue policy. For example, in connection with our existing license agreement, we have recorded in our consolidated balance sheet short-term and long-term deferred revenue based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on our current operating plan and, if our operating plan should change in the future, we may recognize a different amount of deferred revenue over the next 12-month period. Research and development expenses Research and development expenses are charged to the statement of operations as incurred. Income taxes The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the financial statements and for tax loss carry forwards. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. O. Basic and diluted net loss per share Basic net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260-10, “Earnings Per Share.” All outstanding stock options and warrants were excluded from the calculation of the diluted loss per share for the years ended December 31, 2017, 2016 and 2015, because all such securities have an anti-dilutive effect. Segment Reporting The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. Q. Comprehensive Loss The purpose of reporting comprehensive income is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. Recently issued accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. In January 2016 the FASB issued ASU 2016-01 “Recognition and Measurement of Financial Assets and Financial Liabilities”, which provides targeted improvements to the recognition, measurement, presentation and disclosure of financial assets and financial liabilities. Specific accounting areas addressed include, equity investments, financial liabilities reported under the fair value option and valuation allowance assessment resulting from unrealized losses on available-for-sale securities. The ASU also changes certain presentation and disclosure requirements for financial instruments. The Update is to be applied by means of a cumulative effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. This ASU is effective for the Company in its first quarter of fiscal year 2019. Early adoption, with certain exceptions, is not permitted. The Company is currently evaluating the effect this ASU will have on its consolidated financial statements. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which amends, among other things, the existing guidance by requiring lessees to recognize lease assets (right-to-use) and liabilities (for reasonably certain lease payments) arising from operating leases on the balance sheet. For leases with a term of twelve months or less, ASU 2016-02 permits an entity to make an accounting policy election to recognize such leases as lease expense, generally on a straight-line basis over the lease term. ASU 2016-02 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018 using a modified retrospective approach, with early adoption permitted. The Company is currently evaluating ASU 2016-02 and its impact on its consolidated financial statements. In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments Credit Losses Measurement of Credit Losses on Financial Instruments, which introduces a model based on expected losses to estimate credit losses for most financial assets and certain other instruments. In addition, for available-for-sale debt securities with unrealized losses, the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. The standard is effective for annual reporting periods beginning after December 15, 2019, with early adoption permitted for annual reporting periods beginning after December 15, 2018. Entities will apply the standard’s provisions by recording a cumulative-effect adjustment to retained earnings. The Company is evaluating the impact of the adoption on its consolidated balance sheet, results of operations, cash flows and disclosures. In August 2016, the FASB issued Accounting Standards Update No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amends ASC 230 to add and clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows. ASU 2016-15 was issued with the intent of reducing diversity in practice with respect to certain types of cash flows. ASU 2016-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. The Company is currently reviewing and evaluating this guidance and its impact on its consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASU 2014-09. Subsequently, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606), which adjusted the effective date of ASU 2014-09; ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which amends the principal-versus-agent implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies identifying performance obligations and licensing implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses implementation issues and is intended to reduce the cost and complexity of applying the new revenue standard in ASU 2014-09; ASU No. 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842): Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments (SEC Update), which codifies recent announcements by the Securities and Exchange Commission, or SEC, staff; and ASU No. 2017-14, Income StatementReporting Comprehensive Income (Topic 220), Revenue Recognition (Topic 605), and Revenue from Contracts with Customers (Topic 606) (SEC Update), which adds ASC 606-10-S25-1 as a result of SEC Release 33-10403, or collectively, the Revenue ASUs. The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers, and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017, with an option to early adopt for interim and annual periods beginning after December 15, 2016. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company adopted the new standard effective January 1, 2018 under the modified retrospective method. During the fourth quarter of 2017, the Company substantially completed its assessment of the impact that this new standard will have on its consolidated balance sheets and believes its impact will be immaterial. In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting. An entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. ASU 2017-09 is effective for annual periods beginning after December 15, 2017. The Company is currently in the process of evaluating the impact of the adoption of ASU 2017-09 on its consolidated financial statements. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2017 | |
Marketable Securities [Abstract] | |
Cash, Cash Equivalents, and Marketable Securities [Text Block] | Note 3 Marketable Securities As of December 31, 2017 Cost Basis Gross Gross Estimated (in thousands) Corporate debt securities $ 5,983 $ 7 $ (14) $ 5,976 Total Short term investments $ 5,983 $ 7 $ (14) $ 5,976 As of December 31, 2016 Cost Basis Gross Gross Estimated (in thousands) Municipals $ 1,576 $ $ (2) $ 1,574 Corporate debt securities 10,860 11 (94) 10,777 Total Short term investments $ 12,436 $ 11 $ (96) $ 12,351 The Company’s financial assets are measured at fair value on a recurring basis by level within the fair value hierarchy. All of the Company's short term investments are classified as Level 1. Other than the marketable securities, the Company doesn't have any other financial assets or financial liabilities marked to market at fair value. The contractual maturity of the above mentioned short term investments varies between less than one year to two years. The Company reviews the individual securities in its portfolio to determine whether a decline in a security’s fair value below the amortized cost basis is other-than-temporary. The Company determined that as of December 31, 2017 and 2016 there were no investments in its portfolio that were other-than-temporarily impaired. |
Other Accounts Receivable
Other Accounts Receivable | 12 Months Ended |
Dec. 31, 2017 | |
Receivables [Abstract] | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | Note 4 Other Accounts Receivable As of December 31, 2017 2016 (in thousands) Government institutions $ 55 $ 30 Prepaid expenses 100 254 $ 155 $ 284 |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment Disclosure [Text Block] | Note 5 Property and equipment, net As of December 31, 2017 2016 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 35 33 Computer software and electronic equipment 69 62 Leasehold improvements 133 130 974 962 Less - Accumulated depreciation 483 244 Net book value $ 491 $ 718 |
Deferred Revenue and Revenue Re
Deferred Revenue and Revenue Recognition | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue Disclosure [Text Block] | Note 6 Deferred Revenue and Revenue Recognition On July 28, 2016, the Company signed a Collaboration Agreement with Samil Pharm. Co., Ltd. (the “Samil”), for an exclusive, royalty-bearing license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including NASH in the Republic of Korea. Under the terms of the agreement, the Company received an up-front payment of approximately $ 2.1 6.0 The up-front payment has been recorded as deferred revenue. The deferred revenue is then amortized over the contractual period, and future milestone payments will be recognized once earned. Accordingly, during the year ended December 31, 2017, the Company recognized revenue of $ 1.1 |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | A. Balances As of December 31, 2017 and 2016, the Company had an accrual in the amount of $ 673 419 B. Transactions 1. During 2017, 2016 and 2015, the Company recorded salary expenses, stock based compensation expenses and directors’ fee to its related parties in the amount of $ 2.0 1.3 1.4 2. In April 2017, the Company granted options to purchase 20,000 4.87 97 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | Note 8 Commitments and Contingencies A. Contingencies 1. In 2002, the Company entered into an agreement with Aventis Pharma Deutschland GmbH. (“Aventis”), in which Aventis granted the Company exclusive worldwide right to commercialize an invention covered by Israeli patent application 123998 and PCT/IL99/00173, and the Company agreed to pay Aventis a royalty of 10 2. In March 2015, the Company entered into a lease agreement for its corporate headquarters. The lease has a term of four years with an option to extend the lease agreement for an additional two years 37 3. As of December 31, 2017, the Company recorded a pledge on its marketable securities in favor of its bank in the amount of approximately $ 145 B. Commitments Total Less than 1-3 years (in thousands) Facility leases $ 128 $ 104 $ 24 Purchase Obligations 2,612 2,612 - Total $ 2,740 $ 2,716 $ 24 The Company enters into contracts in the ordinary course of business with CROs for clinical trials and clinical supply manufacturing and with vendors for non-clinical research studies and other services and products for operating purposes, which generally provide for termination upon 30 days notice or less, and therefore are cancelable contracts and not included in the table above. The Company has included as purchase obligations our commitments under agreements to the extent they are quantifiable and are not cancelable. Other than as described above, the Company did not have any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies, as of December 31, 2017. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Shareholders' Equity and Share-based Payments [Text Block] | Note 9 Shareholders’ Equity A. Ordinary shares 1. Ordinary shares confer upon the holders the right to receive notice to participate and vote in general meetings of the Company and the right to receive dividends, if declared. 2. During the period of September 11, 2000 (date of inception) through 2009, a total of 4,995,837 ordinary shares were issued by the Company in consideration of $4.2 million. 3. In December 2013, upon the request of convertible-notes holders, the Company converted all of its outstanding convertible notes into 1,026,432 ordinary notes. 4. In December 2013, upon the capital-notes holders’ request, the Company converted all of its capital notes into 1,043,928 ordinary shares with a par value of NIS 0.01 per share. 5. On February 3, 2014, the Company entered into a share purchase agreement with certain of its shareholders and new investors, pursuant to which the Company issued to such existing shareholders and new investors 560,224 ordinary shares at a price per share of $3.57 for a total consideration in the amount of approximately $2 million. 6. On March 12, 2014, the Company completed an initial public offering (the “IPO”) and listed its ordinary shares on the NASDAQ Capital Market under the ticker symbol GLMD. In the IPO, the Company issued 3.3 million shares at a price of $13.50 per share (par value NIS 0.01 per share), for a total consideration of approximately $40 million, net of offering costs in the amount of approximately $4.2 million. 7. On May 31, 2016, the Company entered into a Controlled Equity Offering Sales Agreement (the "Cantor Sales Agreement") with Cantor Fitzgerald & Co., as the Company’s sales agent (“Cantor Fitzgerald”), to issue and sell, from time to time through Cantor Fitzgerald, ordinary shares having an aggregate offering price of up to $16 million. Under the Cantor Sales Agreement, the Company was entitled to sell ordinary shares by any method permitted by law and deemed to be an “at-the-market” offering, as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Company was not obligated to make any sales under the Cantor Sales Agreement. The Cantor Sales Agreement was terminated during December, 2017. As of December 31, 2017, the Company sold 1,712,369 ordinary shares under the Cantor Sales Agreement for total net proceeds of approximately $11.0 million 8. In August 2017, we sold 332,038 ordinary shares at a price of $7.10 in a registered direct offering, and in a concurrent private placement to two of our directors sold 49,295 ordinary shares at the same price. The aggregate net proceeds received from the offering was approximately $2.7 million. 9. On December 22, 2017, the Company entered into an At-the-Market Equity Offering Sales Agreement (the "Stifel Sales Agreement") with Stifel, Nicolaus & Company, Incorporated, as the Company’s sales agent (“Stifel”), to issue and sell, from time to time through Stifel, ordinary shares having an aggregate offering price of up to $35 million. Under the Stifel Sales Agreement, the Company may sell ordinary shares by any method permitted by law and deemed to be an “at-the-market” offering, as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Company is not obligated to make any sales under the Stifel Sales Agreement. As of December 31, 2017, the Company sold 714,285 ordinary shares under the Stifel Sales Agreement for total net proceeds of approximately $5.8 million. B. Stock-based compensation 1. The Company has an equity-based incentive plan, the 2013 Incentive Share Option Plan (the “2013 Plan”). As of December 31, 2017, a total of 3,090,492 shares were reserved for issuance under the 2013 Plan. The 2013 Plan, which was adopted by the Board on September 2, 2013, and approved by the Company’s shareholders on December 30, 2013 (as was amended by the Board and the Company’s shareholders on March 30, 2015 and May 11, 2015, respectively), provides for the grant of options to purchase the ordinary shares and the issuance of restricted stock units (“RSUs”) to the Company's officers, directors, employees, service providers and consultants. The 2013 Plan provides for such equity-based compensation under various and different tax regimes. 2. A summary of the status of the Company’s option plans as of December 31, 2017 and 2016 and changes during the years then ended are presented below: B. Stock-based compensation 2017 2016 Number of Weighted Number of Weighted Options outstanding at beginning 2,410,890 $ 3.80 1,753,753 $ 2.12 Granted 226,000 $ 4.86 856,500 $ 6.08 Forfeited (160,000 ) $ 6.95 (83,750 ) $ 6.00 Exercised (380,176 ) $ 1.39 (115,613 ) $ 2.22 Outstanding at end of year 2,096,714 $ 4.01 2,410,890 $ 3.39 Options exercisable at year end 1,406,074 $ 2.69 1,385,829 $ 1.38 As of December 31, 2017 and 2016, the weighted-average remaining contractual term of the outstanding and exercisable options, excluding the 38,637 Options granted in 2002 that have no expiration date, is 6.95 and 8.35 years, respectively. The weighted average grant date fair value of the options granted during the years ended December 31, 2017, 2016 and 2015 is $4.86, $3.76, and $6.48 respectively. As of December 31, 2017 a total of the 2,096,714 outstanding and exercisable options are “in the money” with aggregate intrinsic value of $11.4 million; while as of December 31, 2016 a total of 1,110,006 outstanding and exercisable options were “in the money” with aggregate intrinsic value of $3.6 million. The unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2017 and 2016 is approximately $3.1 million and $4.3 million, respectively, and is expected to be recognized over a weighted-average period of 1.87 years and 3.0 years, respectively For the years ended 2017, 2016 and 2015, the Company recorded a total of $1.4 million, $1.6 million, and $1.0 million of stock-based compensation expenses, in connection with the above mentioned option. During 2016, the Company issued a total of 78,750 RSUs. Upon vesting, each RSU will settle by the issuance of one ordinary share. The RSUs vest over four years. As of December 31, 2017, a total of 30,932 ordinary shares were issued upon vesting of 30,932 RSUs and a total of 32,348 RSUs were outstanding, while as of December 31, 2016, none of the RSUs vested and all 78,750 RSU's were outstanding. 3. For the years 2017 and 2016, with respect to the above-mentioned RSU's, the Company recorded stock-based compensation expenses in the amount of $105 thousand and $124 thousand, respectively. The unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2017 and 2016 is approximately $193 thousand and $412 thousand, respectively, and is expected to be recognized over a weighted-average period of two years and three years, respectively. |
Research and Development Expens
Research and Development Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Research and Development [Abstract] | |
Research, Development, and Computer Software Disclosure [Text Block] | Note 10 Research and Development Expenses Year ended December 31, 2017 2016 2015 (in thousands) Chemistry and formulation studies $ 820 $ 1,802 $ 1,902 Salaries 1,090 1,004 808 Stock-based compensation 585 757 111 Research and preclinical studies 684 924 637 Clinical studies 5,871 9,263 3,671 Regulatory and other expenses 600 521 500 $ 9,650 $ 14,271 $ 7,629 |
General and Administrative Expe
General and Administrative Expenses | 12 Months Ended |
Dec. 31, 2017 | |
General and Administrative Expense [Abstract] | |
General and Administrative Expenses Disclosure [Text Block] | Note 11 General and Administrative Expenses Year ended December 31, 2017 2016 2015 (in thousands) Stock-based compensation $ 809 $ 871 $ 858 Professional fees 622 683 741 Salaries and benefits 1,441 849 747 Rent and office-maintenance fees 269 303 359 Investor relations and business development expenses 460 248 457 Insurance and Other 198 124 84 $ 3,799 $ 3,078 $ 3,246 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | Note 12 Income Taxes A. General The Company is assessed for tax purposes on an unconsolidated basis. Each of the Company’s subsidiaries is subject to the tax rules prevailing in its country of incorporation. B. Corporate Taxation Israeli subsidiary: In January 2016, the Israeli corporate income tax law was amended and reduced as of January 1, 2016 to 25% (from 26.5%). In December 2016, the Israeli corporate income tax law was further amended and reduced as of January 1, 2017 to 24% and as of January 1, 2018 to 23%. On February 7, 2018, the Israeli Tax Authority issued a ruling granting the Company’s Israeli subsidiary ”Preferred Technological Enterprise” status as defined under the Encouragement of Capital Investment Law -1959 (the "Approval"). The grant of the status means that the Company’s Israeli subsidiary will be subject to a reduced Israeli corporate tax rate that will range between 6%-12% on any future taxable "technological income" which includes sales, licenses and royalties from its IP protected products . The tax ruling applies for five years until 2022 and may be extended for further periods subject to meeting certain requirements. Maltese subsidiary: Taxable income of Maltese companies is subject to tax at the rate of 35% in 2017 and 2016 (“Regular Tax Rate”). C. Net Operating Loss Carry forward As of December 31, 2017, the Company had approximately $52.5 million net-operating-loss carry forwards, consisting of approximately $12.0 million of Maltese net-operating-loss carry forwards and approximately 40.5 million Israeli net-operating-loss carry forward. Additionally, the Company had approximately $570 thousand of capital loss carry forward from the sale of marketable securities. The Maltese and the Israeli loss carry forwards have no expiration date. D. Deferred income taxes Deferred-tax assets for carry forward losses in Malta and Israel are calculated using the applicable tax rate at the time of expected realization of the carry forward losses. The Company has provided full valuation allowances in respect of deferred-tax assets. Management currently believes that it is more likely than not that those deferred taxes will not be realized in the foreseeable future. As of December 31, 2017 2016 (in thousands) Deferred tax assets Israeli subsidiary net-operating-loss carry forward $ 4,868 $ 6,003 Maltese subsidiary net-operating-loss carry forward 4,611 4,609 Israeli subsidiary capital-loss carry forward 142 407 Other reserves and allowances 12 82 Total deferred-tax assets 9,633 11,101 Valuation allowance (9,633 ) (11,101 ) Net deferred-tax assets $ $ E. Tax assessment The Israeli subsidiaries received final tax assessments through the year ended December 31, 2012. F. Effective tax expense Year ended December 31, 2017 2016 2015 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 12,299 $ 16,847 $ 10,622 Statutory tax rate 24 % 25 % 26.5 % Theoretical tax benefit 2,952 4,212 2,815 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (2,952 ) (4,212 ) (2,815 ) Tax withheld from upfront payment from Samil - 105 - Others - 1 - Actual tax expense $ - $ 106 $ - |
Significant Accounting Polici20
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | A. Basis of presentation The consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles ("U.S. GAAP"). |
Use of Estimates, Policy [Policy Text Block] | B. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates include, but are not limited to, those related to deferred revenue, revenue recognition, stock-based compensation and indirect tax accruals, and other assumptions believed to be reasonable by management. Actual results could differ from those estimates. |
Presentation Currency of Financial Statements Policy [Policy Text Block] | C. Financial statement in U.S. dollars The functional currency of the Company and its subsidiaries is in U.S dollar (the “dollar”), because the dollar is the currency of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions and balances have been re-measured to dollars in accordance with the provisions of ASC 830-10, “Foreign Currency Translation.” All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statement of operations as financial income or expenses, as appropriate. |
Consolidation, Policy [Policy Text Block] | D. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: Galmed Research and Development Ltd, Galmed 2000 Inc., Galmed International Ltd., and Galmed Medical Research Ltd. All intercompany balances and transactions have been eliminated upon consolidation. |
Cash and Cash Equivalents, Policy [Policy Text Block] | E. Cash and cash equivalents Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less as of the date acquired. |
Marketable Securities, Policy [Policy Text Block] | F. Marketable Securities Marketable securities are considered to be available for sale and are carried at fair value. Unrealized gains and losses net of tax, if any, are reported as a separate component of stockholders’ equity. The cost of marketable securities classified as available for sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other than temporary, if any, are also included in other income, net. Interest on securities classified as available for sale is included in interest income. The cost of securities sold is based on the specific identification method. For all investments in marketable securities, the Company assesses whether the impairment is other-than-temporary. If the fair value of a security is less than its amortized cost basis, an impairment is considered other-than-temporary if (i) the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security before recovery of its entire amortized cost basis, or (ii) the Company does not expect to recover the entire amortized cost of the security. If an impairment is considered other-than-temporary based on condition (i), the entire difference between the amortized cost and the fair value of the security is recognized in earnings. If an impairment is considered other-than-temporary based on condition (ii), the amount representing credit losses, defined as the difference between the present value of the cash flows expected to be collected and the amortized cost basis of the security, will be recognized in earnings, and the amount relating to all other factors will be recognized in other comprehensive income. The Company evaluates both qualitative and quantitative factors such as duration and severity of the unrealized losses, credit ratings, default and loss rates of the underlying collateral, structure and credit enhancements to determine if a credit loss may exist. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and equipment % Office furniture and equipment 7 16 Computer software, electronic and medical equipment 15 33 Leasehold improvements 10 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of long-lived assets The Company’s and its subsidiaries’ long-lived assets are reviewed for impairment in accordance with ASC 360-10, “Accounting for the Impairment or Disposal of Long-Lived Assets,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds their fair value. During 2017 and 2016, no impairment losses were identified. |
Compensation Related Costs, Policy [Policy Text Block] | I. Severance pay The Company’s liability for severance pay is calculated in accordance with Israeli law, based on the most recent salary paid to each employee and the length of employment with the Company. Part of the liability is funded through individual insurance policies purchased from outside insurance companies, which are not under the Company’s control. The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33 |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair value of financial instruments The estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies. Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company could realize in a current market exchange. The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments: The carrying amounts of cash and cash equivalents, short-term bank deposits, marketable securities and trade payables approximate their fair value due to the short-term maturity of such instruments. Fair value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions used by market participants in pricing an asset or a liability. A three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: ⋅ Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets ⋅ Level 2 - Other inputs that are directly or indirectly observable in the marketplace; and ⋅ Level 3 - Unobservable inputs that are supported by little or no market activity The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | K. Accounting for stock-based compensation The Company applies ASC 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statement of operations. The Company recognizes compensation expense for the value of non-employee awards, which have graded vesting, based on the accelerated attribution method The Company recognizes compensation expenses for the value of employee awards, which have graded vesting, based on the straight-line method over the requisite service period of each of the awards, net of estimated forfeitures. The Company estimates the fair value of restricted shares based on the market price of the shares at the grant date, and estimates the fair value of stock options granted using a Black-Scholes option-pricing model The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC-718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent term. The following assumptions were used for the fiscal year 2017 and 2016 grants: dividend yield of 0.00 1.22 1.90 5 6.25 70 84 |
Revenue Recognition, Policy [Policy Text Block] | L. Deferred Revenue and Revenue Recognition We have entered into a collaboration agreement with Samil Pharm. Co., Ltd, The terms of our collaboration agreement include deliverables such as non-refundable license fees, payments based upon achievement of developmental or regulatory approval milestones, and royalties on product sales. We apply the accounting standard on revenue recognition for multiple element arrangements. The fair value of deliverables under the arrangement may be derived using a “best estimate of selling price” if vendor specific objective evidence and third-party evidence is not available. Deliverables under the arrangement will be separate units of accounting provided that (i) a delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. Performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed or deferred indefinitely until the undelivered performance obligation can be determined. We have been unable to demonstrate standalone value in our multiple element arrangements. Whenever we determine that an arrangement should be accounted for as a single unit of accounting, we determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using either a proportional performance or straight-line method. We recognize revenue under the arrangement on a straight-line basis over the period we are expected to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method, as of the period ending date. Our collaboration agreement entitles us to additional payments upon the achievement of performance-based milestones. These milestones are categorized into two types: development milestones which are generally based on the advancement of our ongoing Phase IIb ARREST trial and potential pivotal study, and regulatory milestones which are based on the approval of a new drug application in the territory in respect of the product. Milestones that are tied to regulatory approval are not considered probable of being achieved until such approval is received. Upfront payments from customers are not subject to refund if the development activities are not successful. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Although we follow detailed guidelines in measuring revenue, certain judgments affect the application of our revenue policy. For example, in connection with our existing license agreement, we have recorded in our consolidated balance sheet short-term and long-term deferred revenue based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on our current operating plan and, if our operating plan should change in the future, we may recognize a different amount of deferred revenue over the next 12-month period. |
Research and Development Expense, Policy [Policy Text Block] | Research and development expenses Research and development expenses are charged to the statement of operations as incurred. |
Income Tax, Policy [Policy Text Block] | Income taxes The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the financial statements and for tax loss carry forwards. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. |
Earnings Per Share, Policy [Policy Text Block] | O. Basic and diluted net loss per share Basic net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260-10, “Earnings Per Share.” All outstanding stock options and warrants were excluded from the calculation of the diluted loss per share for the years ended December 31, 2017, 2016 and 2015, because all such securities have an anti-dilutive effect. |
Segment Reporting, Policy [Policy Text Block] | Segment Reporting The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. |
Comprehensive Income, Policy [Policy Text Block] | Q. Comprehensive Loss The purpose of reporting comprehensive income is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently issued accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. In January 2016 the FASB issued ASU 2016-01 “Recognition and Measurement of Financial Assets and Financial Liabilities”, which provides targeted improvements to the recognition, measurement, presentation and disclosure of financial assets and financial liabilities. Specific accounting areas addressed include, equity investments, financial liabilities reported under the fair value option and valuation allowance assessment resulting from unrealized losses on available-for-sale securities. The ASU also changes certain presentation and disclosure requirements for financial instruments. The Update is to be applied by means of a cumulative effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. This ASU is effective for the Company in its first quarter of fiscal year 2019. Early adoption, with certain exceptions, is not permitted. The Company is currently evaluating the effect this ASU will have on its consolidated financial statements. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which amends, among other things, the existing guidance by requiring lessees to recognize lease assets (right-to-use) and liabilities (for reasonably certain lease payments) arising from operating leases on the balance sheet. For leases with a term of twelve months or less, ASU 2016-02 permits an entity to make an accounting policy election to recognize such leases as lease expense, generally on a straight-line basis over the lease term. ASU 2016-02 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018 using a modified retrospective approach, with early adoption permitted. The Company is currently evaluating ASU 2016-02 and its impact on its consolidated financial statements. In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments Credit Losses Measurement of Credit Losses on Financial Instruments, which introduces a model based on expected losses to estimate credit losses for most financial assets and certain other instruments. In addition, for available-for-sale debt securities with unrealized losses, the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. The standard is effective for annual reporting periods beginning after December 15, 2019, with early adoption permitted for annual reporting periods beginning after December 15, 2018. Entities will apply the standard’s provisions by recording a cumulative-effect adjustment to retained earnings. The Company is evaluating the impact of the adoption on its consolidated balance sheet, results of operations, cash flows and disclosures. In August 2016, the FASB issued Accounting Standards Update No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amends ASC 230 to add and clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows. ASU 2016-15 was issued with the intent of reducing diversity in practice with respect to certain types of cash flows. ASU 2016-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. The Company is currently reviewing and evaluating this guidance and its impact on its consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASU 2014-09. Subsequently, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606), which adjusted the effective date of ASU 2014-09; ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which amends the principal-versus-agent implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies identifying performance obligations and licensing implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses implementation issues and is intended to reduce the cost and complexity of applying the new revenue standard in ASU 2014-09; ASU No. 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842): Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments (SEC Update), which codifies recent announcements by the Securities and Exchange Commission, or SEC, staff; and ASU No. 2017-14, Income StatementReporting Comprehensive Income (Topic 220), Revenue Recognition (Topic 605), and Revenue from Contracts with Customers (Topic 606) (SEC Update), which adds ASC 606-10-S25-1 as a result of SEC Release 33-10403, or collectively, the Revenue ASUs. The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers, and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017, with an option to early adopt for interim and annual periods beginning after December 15, 2016. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company adopted the new standard effective January 1, 2018 under the modified retrospective method. During the fourth quarter of 2017, the Company substantially completed its assessment of the impact that this new standard will have on its consolidated balance sheets and believes its impact will be immaterial. In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting. An entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. ASU 2017-09 is effective for annual periods beginning after December 15, 2017. The Company is currently in the process of evaluating the impact of the adoption of ASU 2017-09 on its consolidated financial statements. |
Significant Accounting Polici21
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Depreciation Rates for Property, Plant and Equipment [Table Text Block] | Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: % Office furniture and equipment 7 16 Computer software, electronic and medical equipment 15 33 Leasehold improvements 10 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Marketable Securities [Abstract] | |
Marketable Securities [Table Text Block] | The following table summarizes the Company’s short term investments as of December 31, 2017 and 2016. As of December 31, 2017 Cost Basis Gross Gross Estimated (in thousands) Corporate debt securities $ 5,983 $ 7 $ (14) $ 5,976 Total Short term investments $ 5,983 $ 7 $ (14) $ 5,976 As of December 31, 2016 Cost Basis Gross Gross Estimated (in thousands) Municipals $ 1,576 $ $ (2) $ 1,574 Corporate debt securities 10,860 11 (94) 10,777 Total Short term investments $ 12,436 $ 11 $ (96) $ 12,351 |
Other Accounts Receivable (Tabl
Other Accounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Receivables [Abstract] | |
Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block] | As of December 31, 2017 2016 (in thousands) Government institutions $ 55 $ 30 Prepaid expenses 100 254 $ 155 $ 284 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | As of December 31, 2017 2016 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 35 33 Computer software and electronic equipment 69 62 Leasehold improvements 133 130 974 962 Less - Accumulated depreciation 483 244 Net book value $ 491 $ 718 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contractual Obligation, Fiscal Year Maturity Schedule [Table Text Block] | The following table summarizes the Company’s significant contractual obligations at December 31, 2017: Total Less than 1-3 years (in thousands) Facility leases $ 128 $ 104 $ 24 Purchase Obligations 2,612 2,612 - Total $ 2,740 $ 2,716 $ 24 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | 2017 2016 Number of Weighted Number of Weighted Options outstanding at beginning 2,410,890 $ 3.80 1,753,753 $ 2.12 Granted 226,000 $ 4.86 856,500 $ 6.08 Forfeited (160,000 ) $ 6.95 (83,750 ) $ 6.00 Exercised (380,176 ) $ 1.39 (115,613 ) $ 2.22 Outstanding at end of year 2,096,714 $ 4.01 2,410,890 $ 3.39 Options exercisable at year end 1,406,074 $ 2.69 1,385,829 $ 1.38 |
General and Administrative Ex27
General and Administrative Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
General and Administrative Expense [Abstract] | |
General and Administrative Expenses [Table Text Block] | Year ended December 31, 2017 2016 2015 (in thousands) Stock-based compensation $ 809 $ 871 $ 858 Professional fees 622 683 741 Salaries and benefits 1,441 849 747 Rent and office-maintenance fees 269 303 359 Investor relations and business development expenses 460 248 457 Insurance and Other 198 124 84 $ 3,799 $ 3,078 $ 3,246 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | Significant components of the Company’s and its subsidiaries’ assets are as follows As of December 31, 2017 2016 (in thousands) Deferred tax assets Israeli subsidiary net-operating-loss carry forward $ 4,868 $ 6,003 Maltese subsidiary net-operating-loss carry forward 4,611 4,609 Israeli subsidiary capital-loss carry forward 142 407 Other reserves and allowances 12 82 Total deferred-tax assets 9,633 11,101 Valuation allowance (9,633 ) (11,101 ) Net deferred-tax assets $ $ |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | A reconciliation of the Company’s effective tax expense to the Company’s theoretical statutory tax benefit is as follows: Year ended December 31, 2017 2016 2015 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 12,299 $ 16,847 $ 10,622 Statutory tax rate 24 % 25 % 26.5 % Theoretical tax benefit 2,952 4,212 2,815 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (2,952 ) (4,212 ) (2,815 ) Tax withheld from upfront payment from Samil - 105 - Others - 1 - Actual tax expense $ - $ 106 $ - |
General (Details Textual)
General (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
General [Line Items] | ||||
Entity Incorporation, Date of Incorporation | Jul. 31, 2013 | |||
Operations Commenced Date | Feb. 2, 2014 | |||
Entity Incorporation, State Country Name | Israel | |||
Cash and Cash Equivalents, at Carrying Value | $ 13,021 | $ 3,097 | $ 4,156 | $ 23,736 |
Marketable Securities, Current | 6,000 | |||
Net Income (Loss), Including Portion Attributable to Noncontrolling Interest | (12,299) | (16,953) | $ (10,622) | |
Retained Earnings (Accumulated Deficit) | $ (76,619) | $ (64,320) |
Significant Accounting Polici30
Significant Accounting Policies (Details) | Dec. 31, 2017 |
Office furniture and equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 7.00% |
Office furniture and equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 16.00% |
Computer software, electronic and medical equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 15.00% |
Computer software, electronic and medical equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 33.00% |
Leasehold improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 10.00% |
Significant Accounting Polici31
Significant Accounting Policies (Details Textual) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Monthly Deposits of Employees, Percentage on Monthly Salary | 8.33% | |
Share-based Compensation Arrangement by Share-based Payment Award, Method of Measuring Cost of Award | accelerated attribution method | |
Restricted Stock [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used | Black-Scholes option-pricing model | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | 6 years 3 months |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.22% | 1.90% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 70.00% | 84.00% |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Cost Basis | $ 5,983 | $ 12,436 |
Gross Unrealized Gains | 7 | 11 |
Gross Unrealized Losses | (14) | (96) |
Estimated Fair Value | 5,976 | 12,351 |
Municipals [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cost Basis | 1,576 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (2) | |
Estimated Fair Value | 1,574 | |
Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cost Basis | 5,983 | 10,860 |
Gross Unrealized Gains | 7 | 11 |
Gross Unrealized Losses | (14) | (94) |
Estimated Fair Value | $ 5,976 | $ 10,777 |
Other Accounts Receivable (Deta
Other Accounts Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Other Accounts Receivable [Line Items] | ||
Government institutions | $ 55 | $ 30 |
Prepaid expenses | 100 | 254 |
Receivables, Net, Current | $ 155 | $ 284 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Medical equipment | $ 737 | $ 737 |
Office furniture and equipment | 35 | 33 |
Computer software and electronic equipment | 69 | 62 |
Leasehold improvements | 133 | 130 |
Property, Plant and Equipment, Gross | 974 | 962 |
Less - Accumulated depreciation | 483 | 244 |
Net book value | $ 491 | $ 718 |
Deferred Revenue and Revenue 35
Deferred Revenue and Revenue Recognition (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | ||
Jul. 28, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue Recognition, Milestone Method [Line Items] | |||
Deferred Revenue | $ 1,100 | ||
Deferred Revenue, Current | $ 538 | $ 1,094 | |
Samil Pharm. Co. Ltd [Member] | |||
Revenue Recognition, Milestone Method [Line Items] | |||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 2,100 | ||
Accrued Royalties | $ 6,000 |
Related Parties (Details Textua
Related Parties (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Stock Option [Member] | ||||
Related Party Transaction [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 226,000 | 856,500 | ||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 4.86 | $ 6.08 | ||
Chief Executive Officer [Member] | ||||
Related Party Transaction [Line Items] | ||||
Due to Related Parties | $ 673 | $ 419 | ||
Related Party Transaction, Expenses from Transactions with Related Party | $ 2,000 | $ 1,300 | $ 1,400 | |
Director [Member] | Employee Stock Option [Member] | ||||
Related Party Transaction [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 20,000 | |||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 4.87 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 97,000 |
Commitments and Contingencies37
Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2017USD ($) |
Other Commitments [Line Items] | |
Total | $ 2,740 |
Less than 1 year | 2,716 |
1-3 years | 24 |
Facility Leases [Member] | |
Other Commitments [Line Items] | |
Total | 128 |
Less than 1 year | 104 |
1-3 years | 24 |
Purchase Obligation [Member] | |
Other Commitments [Line Items] | |
Total | 2,612 |
Less than 1 year | 2,612 |
1-3 years | $ 0 |
Commitments and Contingencies38
Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended |
Mar. 31, 2015 | Dec. 31, 2017 | |
Royalty Revenue Percentage From Income | 10.00% | |
Lease Deposit Liability | $ 37 | |
Description of Lease Term | lease has a term of four years with an option to extend the lease agreement for an additional two years | |
Bank Lien On Marketable Securities | $ 145 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - Employee Stock Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of share options, Outstanding at beginning of year (in shares) | 2,410,890 | 1,753,753 |
Number of share options, Granted (in shares) | 226,000 | 856,500 |
Number of share options, Forfeited (in shares) | (160,000) | (83,750) |
Number of share options, Exercised (in shares) | (380,176) | (115,613) |
Number of share options, Outstanding at end of year (in shares) | 2,096,714 | 2,410,890 |
Number of share options, Options exercisable at year end (in shares) | 1,406,074 | 1,385,829 |
Weighted average exercise price, Options outstanding at beginning of year (in dollars per share) | $ 3.80 | $ 2.12 |
Weighted average exercise price, Granted (in dollars per share) | 4.86 | 6.08 |
Weighted average exercise Price, Forfeited (in dollars per share) | 6.95 | 6 |
Weighted average exercise price, Exercised (in dollars per share) | 1.39 | 2.22 |
Weighted average exercise price, Outstanding at end of year (in dollars per share) | 4.01 | 3.80 |
Weighted average exercise price, Options exercisable at year end (in dollars per share) | $ 2.69 | $ 1.38 |
Shareholders' Equity (Details T
Shareholders' Equity (Details Textual) $ / shares in Units, $ in Thousands | Mar. 12, 2014USD ($)$ / sharesshares | Feb. 03, 2014USD ($)$ / sharesshares | Aug. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2013₪ / sharesshares | Dec. 31, 2002shares | Dec. 31, 2009USD ($)shares | Dec. 22, 2017USD ($) | May 31, 2016USD ($) | Mar. 12, 2014₪ / shares | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Value, New Issues | [1] | $ 15,017 | $ 4,479 | ||||||||||||
Share-based Compensation | 1,394 | 1,628 | $ 970 | ||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 193 | $ 412 | |||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years | 3 years | |||||||||||||
Proceeds from Issuance or Sale of Equity | $ 2,700 | ||||||||||||||
At-The-Market Offering [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Maximum Amount Of Shares To Be Issued | $ 35,000 | $ 16,000 | |||||||||||||
Incentive Share Option Plan 2013 [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | shares | 3,090,492 | ||||||||||||||
Employee Stock Option [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 38,637 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 11 months 12 days | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 8 years 4 months 6 days | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 11,400 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 3,600 | ||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 3,100 | $ 4,300 | |||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 10 months 13 days | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 4.86 | $ 3.76 | $ 6.48 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 2,096,714 | 1,110,006 | |||||||||||||
Allocated Share-based Compensation Expense | $ 1,400 | $ 1,600 | $ 1,000 | ||||||||||||
Employee Stock Option And Restricted Stock Units [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | shares | 30,932 | 78,750 | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | shares | 32,348 | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share-based Compensation | $ 105 | $ 124 | |||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures | shares | 78,750 | ||||||||||||||
Registering Direct Placement [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Sale of Stock, Price Per Share | $ / shares | $ 7.10 | ||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | shares | 332,038 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | shares | 49,295 | ||||||||||||||
Ordinary shares [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 1,874,827 | [1] | 933,160 | [1] | 4,995,837 | ||||||||||
Stock Issued During Period, Value, New Issues | $ 5 | [1] | $ 2 | [1] | $ 4,200 | ||||||||||
Ordinary shares [Member] | IPO [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 3,300,000 | ||||||||||||||
Stock Issued During Period, Value, New Issues | $ 40,000 | ||||||||||||||
Sale of Stock, Price Per Share | (per share) | $ 13.50 | ₪ 0.01 | |||||||||||||
Payments of Stock Issuance Costs | $ 4,200 | ||||||||||||||
Ordinary shares [Member] | Cantor Sales Agreement [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 1,712,369 | ||||||||||||||
Stock Issued During Period, Value, New Issues | $ 11,000 | ||||||||||||||
Ordinary shares [Member] | Stifel Sales Agreement [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 714,285 | ||||||||||||||
Stock Issued During Period, Value, New Issues | $ 5,800 | ||||||||||||||
Ordinary shares [Member] | Shareholders and New Investors [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 560,224 | ||||||||||||||
Stock Issued During Period, Value, New Issues | $ 2,000 | ||||||||||||||
Sale of Stock, Price Per Share | $ / shares | $ 3.57 | ||||||||||||||
Ordinary shares [Member] | Convertible Notes Payable [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | shares | 1,026,432 | ||||||||||||||
Ordinary shares [Member] | Capital Notes [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | shares | 1,043,928 | ||||||||||||||
Sale of Stock, Price Per Share | ₪ / shares | ₪ 0.01 | ||||||||||||||
[1] | See also Note 9.A. |
Research and Development Expe41
Research and Development Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Research and Development Expenses [Line Items] | |||
Research and Development Expense | $ 9,650 | $ 14,271 | $ 7,629 |
Research and Development Expense [Member] | |||
Research and Development Expenses [Line Items] | |||
Chemistry and formulation studies | 820 | 1,802 | 1,902 |
Salaries | 1,090 | 1,004 | 808 |
Stock-based compensation | 585 | 757 | 111 |
Research and preclinical studies | 684 | 924 | 637 |
Clinical studies | 5,871 | 9,263 | 3,671 |
Regulatory and other expenses | 600 | 521 | 500 |
Research and Development Expense | $ 9,650 | $ 14,271 | $ 7,629 |
General and Administrative Ex42
General and Administrative Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
General and Administrative Expenses [Line Items] | |||
General and Administrative Expense | $ 3,799 | $ 3,078 | $ 3,246 |
General and Administrative Expense [Member] | |||
General and Administrative Expenses [Line Items] | |||
Stock-based compensation | 809 | 871 | 858 |
Professional fees | 622 | 683 | 741 |
Salaries and benefits | 1,441 | 849 | 747 |
Rent and office-maintenance fees | 269 | 303 | 359 |
Investor relations and business development expenses | 460 | 248 | 457 |
Insurance and Other | 198 | 124 | 84 |
General and Administrative Expense | $ 3,799 | $ 3,078 | $ 3,246 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets | ||
Capital-loss carry forward | $ 570 | |
Other reserves and allowances | 12 | $ 82 |
Total deferred-tax assets | 9,633 | 11,101 |
Valuation allowance | (9,633) | (11,101) |
Net deferred-tax assets | 0 | 0 |
Maltese Subsidiary [Member] | ||
Deferred tax assets | ||
Net-Operating-Loss Carryforward | 4,611 | 4,609 |
Israeil Subsidiary [Member] | ||
Deferred tax assets | ||
Net-Operating-Loss Carryforward | 4,868 | 6,003 |
Capital-loss carry forward | $ 142 | $ 407 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Line Items] | |||
Loss before taxes on income, as reported in the consolidated statements of operations | $ 12,299 | $ 16,847 | $ 10,622 |
Statutory tax rate | 24.00% | 25.00% | 26.50% |
Theoretical tax benefit | $ 2,952 | $ 4,212 | $ 2,815 |
Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards | (2,952) | (4,212) | (2,815) |
Tax withheld from upfront payment from Samil | 0 | 105 | 0 |
Others | 0 | 1 | 0 |
Actual tax expense | $ 0 | $ 106 | $ 0 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) $ in Thousands | Feb. 07, 2018 | Jan. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 24.00% | 25.00% | 26.50% | |||
Operating Loss Carryforwards | $ 52,500 | |||||
Deferred Tax Assets, Capital Loss Carryforwards | $ 570 | |||||
Subsequent Event [Member] | Minimum [Member] | ||||||
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 6.00% | |||||
Subsequent Event [Member] | Maximum [Member] | ||||||
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 12.00% | |||||
Israeil Subsidiary [Member] | ||||||
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 25.00% | 24.00% | ||||
Effective Income Tax Rate Reconciliation,Decrease In Federal Statutory Income Tax Rate, Percent | 26.50% | |||||
Operating Loss Carryforwards | $ 40,500 | |||||
Deferred Tax Assets, Capital Loss Carryforwards | 142 | $ 407 | ||||
Israeil Subsidiary [Member] | Scenario, Plan [Member] | ||||||
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 23.00% | |||||
Maltese Subsidiary [Member] | ||||||
Income Taxes [Line Items] | ||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% | ||||
Operating Loss Carryforwards | $ 12,000 |