Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 01, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | SteadyMed Ltd. | |
Entity Central Index Key | 1,619,087 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 26,556,052 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 37,417 | $ 23,215 |
Other accounts receivable and prepaid expenses | 706 | 167 |
Total current assets | 38,123 | 23,382 |
Long term deposits | 65 | 122 |
Severance pay fund | 139 | 105 |
Property and equipment, net | 5,593 | 4,549 |
Total assets | 43,920 | 28,158 |
CURRENT LIABILITIES: | ||
Trade payables | 1,815 | 2,704 |
Deferred revenues | 109 | 1,066 |
Other accounts payable and accrued expenses | 1,717 | 2,587 |
Total current liabilities | 3,641 | 6,357 |
NON-CURRENT LIABILITIES: | ||
Accrued severance pay | 192 | 154 |
Liability related to warrants | 10,255 | 7,078 |
Other accounts payable | 368 | 258 |
Total non-current liabilities | 10,815 | 7,490 |
COMMITMENTS AND CONTINGENT LIABILITIES | ||
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares of NIS 0.01 par value - Authorized: 50,000,000 at September 30, 2017 and December 31, 2016; Issued and outstanding: 26,556,052 and 20,139,826 at September 30, 2017 (unaudited) and December 31, 2016, respectively | 69 | 51 |
Additional paid-in capital | 135,851 | 103,430 |
Accumulated deficit | (106,456) | (89,170) |
Total shareholders' equity | 29,464 | 14,311 |
Total liabilities and shareholders' equity | $ 43,920 | $ 28,158 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Ordinary Shares Disclosures | ||
Ordinary Shares, par value per share | ₪ 0.01 | ₪ 0.01 |
Ordinary Shares, shares authorized | 50,000,000 | 50,000,000 |
Ordinary Shares, shares issued | 26,556,052 | 20,139,826 |
Ordinary Shares, shares outstanding | 26,556,052 | 20,139,826 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (INCOME) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (INCOME) | ||||
Revenues | $ 322 | $ 276 | $ 957 | $ 745 |
Operating expenses: | ||||
Research and development | 3,772 | 6,044 | 11,403 | 16,312 |
Sales and marketing | 342 | 435 | 1,293 | 1,258 |
General and administrative | 1,287 | 1,487 | 3,829 | 4,167 |
Total operating expenses | 5,401 | 7,966 | 16,525 | 21,737 |
Total operating loss | 5,079 | 7,690 | 15,568 | 20,992 |
Financial expenses (income), net | (14,170) | 2,260 | 1,760 | 2,177 |
Loss (income) before taxes on income | (9,091) | 9,950 | 17,328 | 23,169 |
Taxes on income (tax benefit) | (329) | 56 | (42) | 268 |
Net loss (income) | $ (9,420) | $ 10,006 | $ 17,286 | $ 23,437 |
Net income (loss) per share: | ||||
Basic net income (loss) per Ordinary Share | $ 0.35 | $ (0.57) | $ (0.73) | $ (1.57) |
Weighted-average number of Ordinary Shares used to compute basic net income (loss) per share | 26,556,052 | 17,646,450 | 23,700,720 | 14,949,237 |
Diluted net loss per Ordinary Share | $ (0.016) | $ (0.57) | $ (0.73) | $ (1.57) |
Weighted-average number of Ordinary Shares used to compute diluted net loss per share | 28,237,834 | 17,646,450 | 23,700,720 | 14,949,237 |
STATEMENT OF CHANGES IN SHAREHO
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY - 9 months ended Sep. 30, 2017 - USD ($) $ in Thousands | Ordinary SharesMaximum | Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total | |
Balance, beginning at Dec. 31, 2016 | $ 51 | $ 103,430 | $ (89,170) | $ 14,311 | ||
Balance, beginning (in shares) at Dec. 31, 2016 | 20,139,826 | |||||
Increase (decrease) in Stockholders' Equity (Deficit) | ||||||
Stock-based compensation | 720 | 720 | ||||
Issuance of Ordinary Shares, net | $ 14 | 21,543 | 21,557 | [1] | ||
Issuance of Ordinary Shares, net (in shares) | 5,031,550 | |||||
Exercise of options into Ordinary Shares | $ 1 | 119 | 119 | |||
Exercise of options into Ordinary Shares (in shares) | 32,910 | |||||
Exercise of warrants into Ordinary Shares | $ 4 | 4,862 | 4,866 | |||
Exercise of warrants into Ordinary Shares (in shares) | 1,351,766 | |||||
Reclassification of liability related to warrants exercised | 5,177 | 5,177 | ||||
Net loss | (17,286) | (17,286) | ||||
Balance, ending at Sep. 30, 2017 | $ 69 | $ 135,851 | $ (106,456) | $ 29,464 | ||
Balance, ending (in shares) at Sep. 30, 2017 | 26,556,052 | |||||
[1] | Gross proceeds of $30,000 net of $6,994 that were classified as warrants and $1,449 issuance costs allocated to the shares. Additional $441 of issuance costs were allocated to the warrants and recorded in the Financial expenses (income), net. |
STATEMENT OF CHANGES IN SHAREH6
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Gross proceeds from issuance of common stock | $ 30,000 |
Proceeds from issuance of warrants | 6,994 |
Issuance costs, upon issuance of Ordinary shares in a private placement | 1,449 |
Financial expenses (income), net | |
Issuance cost of warrants | $ 441 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (17,286) | $ (23,437) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 720 | 599 |
Depreciation | 588 | 481 |
Accrued severance pay, net | 4 | 6 |
Increase in fair value of warrants to purchase Ordinary Shares | 1,360 | 1,507 |
Increase (decrease) in other accounts receivable and prepaid expenses | (539) | 107 |
Allocation of issuance costs related to warrants to purchase Ordinary Shares | 441 | 784 |
Decrease in deferred revenue | (957) | (745) |
Decrease (increase) in trade payables | (1,497) | 1,258 |
Decrease (increase) in other accounts payable and accrued expenses | (792) | 654 |
Net cash used in operating activities | (17,958) | (18,786) |
Cash flows from investing activities: | ||
Proceeds from maturity of investment in restricted cash | 308 | |
Purchase of property and equipment | (992) | (1,158) |
Decrease (increase) in other assets | 57 | (62) |
Net cash used in investing activities | (935) | (912) |
Cash flows from financing activities: | ||
Repayment of loan | (234) | |
Proceeds from warrants exercised by shareholders | 4,866 | |
Proceeds from options exercise by employees | 119 | |
Proceeds from issuance of Ordinary Shares and warrants, net of issuance cost | 28,110 | 19,585 |
Net cash provided by (used in) financing activities | 33,095 | 19,351 |
Increase (decrease) in cash and cash equivalents | 14,202 | (347) |
Cash and cash equivalents at the beginning of the period | 23,215 | 31,851 |
Cash and cash equivalents at the end of the period | 37,417 | 31,504 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchase of property and equipment | 642 | 286 |
Exercise of warrants into Ordinary Shares | 5,177 | |
Cash paid during the period: | ||
Cash paid for interest | 3 | |
Cash paid for taxes | $ 237 | $ 341 |
GENERAL
GENERAL | 9 Months Ended |
Sep. 30, 2017 | |
GENERAL | |
GENERAL | NOTE 1: - GENERAL a. SteadyMed Ltd. (the “Company”) was incorporated and is located in Israel, commenced its operations on June 15, 2005 and, together with its wholly-owned subsidiary, SteadyMed Therapeutics, Inc. (“Inc.”), and Inc.’s wholly-owned subsidiary, SteadyMed U.S. Holdings, Inc. (“Holdings”), is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products in certain orphan and other well-defined high-margin specialty markets. The Company’s primary focus is to obtain approval in the United States for the sale of Trevyent® for the treatment of pulmonary arterial hypertension (“PAH”). On June 30, 2017, the Company filed a New Drug Application (“NDA”) for Trevyent, with the United States Food and Drug Administration (“FDA”). On August 28, 2017, the Company received a Refusal to File letter from the FDA, stating that based on a preliminary review of the NDA, the FDA had determined that it is not sufficiently complete to permit a substantive review. The FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. In September, the Company requested a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The meeting took place on November 1. Management believes that the meeting was constructive and that the Company will be able to sufficiently address the FDA’s concerns. The Company is awaiting the minutes from the meeting to provide further guidance and to finalize its operating plan for re-submitting the NDA and its cash utilization through resubmission and beyond. The Company is also at an earlier stage of development with two products for the treatment of post-surgical and acute pain in the home setting. Its product candidates are enabled by its proprietary PatchPump®, which is a discreet, water resistant and disposable drug administration technology that is aseptically prefilled with liquid drug at the site of manufacture and pre-programmed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously. Inc. and Holdings are located in the United States, and commenced operations on January 1, 2012 and March 25, 2015, respectively. The principal executive officers of the Company are located in the offices of Inc. and Holdings, and Inc.’s and Holdings’ principal business activities are to provide executive management, treasury and administrative support functions to the Company. b. The Company is devoting substantially all of its efforts toward research, development, regulatory approvals and marketing of Trevyent®. In the course of such activities, the Company expects operating losses for the foreseeable future. For the nine months ended September 30, 2017, the Company incurred operating losses of $15,568 and negative cash flows from operating activities of $17,958. Until the Company has positive cash flows from operating activities, it will need to raise significant additional capital by way of the exercise of the remaining outstanding warrants issued in the 2016 and 2017 private placements, another private placement of debt and/or equity and/or a secondary public offering to allow the Company to continue as a going concern. There is no assurance, however, that the Company will be successful in obtaining an adequate level of financing for its long-term needs, and therefore, there is a substantial doubt in the Company’s ability to continue as a going concern. The accompanying financial statements in this quarterly report do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. c. On June 28, 2015, the Company entered into an Exclusive License and Supply Agreement (the “Agreement”) with Cardiome Pharma Corp. and Correvio International Sárl (hereinafter collectively referred to as “Cardiome”) pursuant to which an exclusive royalty bearing license to certain of the Company’s patents relating to Trevyent® (“License”) was granted to Cardiome in order to develop and commercialize Trevyent, if approved for the treatment of PAH, in certain regions outside the United States, specifically, Europe, Canada and the Middle East (the “Regions”). The Company is obligated to perform certain services for Cardiome (“Services”) for a period of time estimated to be through the fourth quarter of 2017. Cardiome is responsible for the regulatory submissions and approvals and commercialization of Trevyent in the Regions. In addition, the Company has agreed to supply Trevyent as finished goods to Cardiome upon commercialization of Trevyent® in the Regions (“Supply Services”). Cardiome made a $3,000 upfront payment to the Company and the Agreement provides for future regulatory, third-party payor reimbursement approval and commercialization milestone payments to be achieved by Cardiome of up to $9,250 and a scaling royalty ranging from the low teens to mid-teens percent on future Trevyent sales by Cardiome in the Regions. In addition, there is a fixed price on finished goods to be supplied by the Company as part of the Supply Services. d. On July 29, 2016, the Company entered into a subscription agreement with investors for a private placement of the Company’s Ordinary Shares, pursuant to which the Company agreed to issue and sell the following securities to the investors for an aggregate price of up to approximately $32,000: (i) in the initial tranche, an aggregate of 6,554,016 Ordinary Shares of the Company, nominal value NIS 0.01 per share (the “Shares”), and warrants to purchase up to 6,554,016 additional Ordinary Shares of the Company, for $3.255 per unit (the “Warrants”), and (ii) in the second tranche, an aggregate of up to approximately $10,700 of Ordinary Shares of the Company at a purchase price equal to the higher of (x) $3.13 or (y) the average closing price of Ordinary Shares of the Company on NASDAQ over the 30 trading days immediately preceding the closing date of the second tranche (the “Private Placement”) with no warrants. The second tranche closing did not occur as the Trevyent NDA was not accepted for filing by the FDA. The first tranche of the Private Placement closed on August 4, 2016, pursuant to which the Company received gross proceeds of approximately $21,333. Two of the Company’s board members, who are also shareholders in the Company, invested a total amount of $5,133. The related issuance costs in respect of the Private Placement were $1,748. The warrants issued are exercisable immediately upon issuance and may be exercised at any time prior to August 2021 at an exercise price of $3.5995 per share. On May 25, 2017, 1,351,766 warrants were exercised (see also note 6 and 7). The Company granted to the participants certain registration rights related to the Shares and Warrants issued in this Private Placement. In connection therewith, the Company filed a registration statement for the resale of the shares and warrant shares issued in the Private Placement on September 2, 2016 which was declared effective on September 21, 2016. e. On April 20, 2017, the Company entered into a subscription agreement with investors for a private placement of the Company’s Ordinary Shares, pursuant to which the Company agreed to issue and sell to the investors for an aggregate price of up to approximately $30,000 of the following securities: (i) 5,031,550 Ordinary Shares of the Company, nominal value NIS 0.01 per share for $5.90 per share and (ii) 2,515,775 warrants to purchase additional Ordinary Shares of the Company, for $0.125 per warrant (the “2017 Private Placement”). The 2017 Private Placement closed on April 25, 2017, pursuant to which the Company received approximately $28,110, net of issuance costs of $1,890. One of the Company’s board members, who is also a shareholder in the Company, invested a total amount of $2,999. The warrants issued are exercisable immediately upon issuance and may be exercised at any time prior to April 2022 at an exercise price of $6.785 per share. The Company filed a registration statement for the resale of the shares and warrant shares issued in the Private Placement on May 24, 2017, which was declared effective on June 6, 2017. |
UNAUDITED INTERIM CONSOLIDATED
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS | 9 Months Ended |
Sep. 30, 2017 | |
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS | |
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS | NOTE 2: - UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS The accompanying unaudited interim consolidated financial statements have been prepared in accordance with Article 10 of Regulation S-X, “Interim Financial Statements” and the rules and regulations for Form 10-Q of the SEC. Pursuant to those rules and regulations, the Company has condensed or omitted certain information and footnote disclosure it normally includes in its annual consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (“US GAAP”). In the opinion of management, the Company has made all adjustments (consisting only of normal, recurring adjustments, except as otherwise indicated) considered necessary for a fair presentation of the Company’s consolidated financial position as of September 30, 2017. Consolidated results of operations and consolidated cash flows for the nine months periods ended September 30, 2017 and 2016, have been included. The results for the nine months period ended September 30, 2017 are not necessarily indicative of the results that may be expected for the year ended December 31, 2017. The accompanying Consolidated Financial Statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2016 included in the Company’s Annual Report on Form 10-K filed pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), on March 29, 2017 with the SEC. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2017 | |
SIGNIFICANT ACCOUNTING POLICIES | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 3: - SIGNIFICANT ACCOUNTING POLICIES The significant accounting policies applied in the audited annual consolidated financial statements of the Company, as disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the SEC on March 29, 2017 pursuant to the Exchange Act, are applied consistently in these unaudited interim consolidated financial statements. a. In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), which amends the existing accounting standards for revenue recognition. In August 2015, FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delays the effective date of ASU 2014-09 by one year. FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The new revenue recognition standard will be effective in the first quarter of 2018, with the option to adopt it in the first quarter of 2017. The Company currently anticipates adopting the new standard effective January 1, 2018. The new standard also permits two methods of adoption: retrospectively to each prior reporting period presented (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). In April 2016, FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. ASU 2016-10 covers two specific topics: performance obligations and licensing. This amendment includes guidance on immaterial promised goods or services, shipping or handling activities, separately identifiable performance obligations, functional or symbolic intellectual property licenses, sales-based and usage-based royalties, license restrictions (time, use, geographical) and licensing renewals. In addition, in May 2016, FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis. While the Company is still in the process of completing its assessment on the impact this guidance will have on its consolidated financial statements and related disclosures, the Company does not anticipate that the adoption of this standard will have a material impact on our financial position, results of operations or cash flows. b. In February 2016, FASB issued ASU 2016-02-Leases (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. ASC 842 supersedes the previous leases standard, ASC 840. The standard is effective on January 1, 2019, with early adoption permitted. The Company currently anticipates adopting the new standard effective January 1, 2019 and is evaluating the impact of the adoption of this standard on its consolidated financial statements. c. In March 2016, FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The amendments in ASU 2016-09 affect all entities that issue share-based payment awards to their employees and involve multiple aspects of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. The Company adopted ASU 2016-09 during the nine months ended September 30, 2017, at which time it changed its accounting policy to account for forfeitures as they occur. The change was applied on a modified retrospective basis and the impact to the cumulative effect adjustment to accumulated deficit as of January 1, 2017 is diminimus. d. In May 2017, FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting. ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company is evaluating the impact of ASU 2017-09. e. In July 2017, FASB issued ASU No. 2017-11, Earnings Per Share, Distinguishing Liabilities from Equity, Derivatives and Hedging, which changes the accounting treatment and the earnings per share calculation for certain instruments with down round features. The amendments in this update should be applied using a cumulative-effect adjustment as of the beginning of the fiscal year of adoption or retrospective adjustment to each period presented. This update is effective for annual periods beginning after December 15, 2018, and interim periods within those periods. The Company is in the process of determining the impact the adoption will have on its Consolidated Financial Statements as well as whether to early adopt the new guidance. |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 9 Months Ended |
Sep. 30, 2017 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 4: - COMMITMENTS AND CONTINGENT LIABILITIES a. On August 23, 2017, the Company extended its lease agreement for the Israeli offices by 12 months ending December 31, 2018. The company has an option to extend the lease term for an additional 3 periods of 12 month each. Inc.’s lease agreement for its U.S. offices has a four-year term ending May 2019. The Company’s total lease obligation as of September 30, 2017 is $614. b. During the years 2005- 2010, the Company received grants under the royalty-bearing programs administered by the Office of the Chief Scientist (“OCS”), and from the Incubator, RAD BioMed Ltd. In May 2015, the OCS approved the Company’s request to transfer manufacturing rights outside of Israel, noting that the Company would be required to pay an increased royalty rate without providing any specifics. Therefore, if income will be generated from the funded research program, the Company will be obligated to pay royalties on such revenue at a rate between 3% to 4% for the first three years and between 3.5% to 4.5% commencing the fourth year (based on the portion of manufacturing out of Israel while non-product related revenues are subject to the lower end of the ranges) and up to 150% to 300% of the amount received, linked to the LIBOR. The revenues under the Agreement with Cardiome are subject to royalties under the above programs. As of September 30, 2017, the total amount of grants received from the OCS and the Incubator, including interest, was $778 and royalties paid and accrued amounted to $29 and $14 during the nine months period ended September 30, 2017 and, 2016, respectively. In the event that intellectual property rights are deemed to be transferred out of Israel, the grants received from the OCS and the Incubator may become a loan to be repaid immediately at up to 600% of the grants amounts. Currently, the Company’s management believes no intellectual property has been transferred out of Israel and disclosure of the Company’s know how is made solely in connection with the transfer of manufacturing rights of the Company’s products to subcontractors. Accordingly, no provision has been recorded in such respect. c. Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. The Company had non-cancellable commitments to suppliers for purchases totaling $580 as of September 30, 2017. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2017 | |
SHAREHOLDERS' EQUITY | |
SHAREHOLDERS' EQUITY | NOTE 5: - SHAREHOLDERS’ EQUITY Stock-based compensation: On June 18, 2009, a Stock Option Plan (the “2009 Plan”) was adopted by the Board of Directors of the Company, under which options to purchase up to 55,971 Ordinary Shares were reserved. Such pool was increased over the years and as of December 31, 2014, options to purchase up to 978,655 Ordinary Shares were authorized. On January 25, 2015, the Board of Directors reserved an additional 1,072,879 Ordinary Shares out of its authorized and unissued share capital for future option grants under the 2009 Plan. The 2009 Plan was adopted in accordance with the amended sections 102 and 3(i) of Israel’s Income Tax Ordinance. Under the 2009 Plan, options to purchase Ordinary Shares of the Company may be granted to employees, advisors, directors, consultants and service providers of the Company or any subsidiary or affiliate. The default vesting schedule is up to three years, subject to the continuation of employment or service. Each option may be exercised into Ordinary Shares during a period of seven years from the date of grant, unless a different term is provided in the option agreement. On April 30, 2013, the 2013 Stock Incentive Sub Plan (the “2013 Sub Plan”) was adopted by the Board of Directors of the Company, which set forth the terms for the grant of stock awards to Inc.’s employees or US non employees. On February 20, 2015, the Company’s Board of Directors approved the replacement of the 2009 Plan and 2013 Sub Plan by adopting the Amended and Restated 2009 Stock Incentive Plan (the “Amended 2009 Plan”). This action was approved by the shareholders on March 1, 2015. Under the Amended 2009 Plan, each option may be exercised into Ordinary Shares during a period of ten years from the date of grant, unless a different term is provided in the option agreement. Transactions related to the grant of options to employees and directors under the Amended 2009 Stock Plan during the nine months ended September 30, 2017 (unaudited), were as follows: Number of Weighted Weighted Aggregate options $ (years) $ Options outstanding at January 1, 2017 (* ) Options granted Options exercised ) Options forfeited ) Options outstanding at end of the period Options vested at end of the period (*) Represent amount less than $1. The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the deemed fair value of the Company’s Ordinary Shares on the last day of the nine months period ended September 30, 2017 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2017. This amount is impacted by the changes in the fair market value of the Company’s shares. As of September 30, 2017, the Company has 1,002,882 Ordinary Shares available for future grant under the Amended 2009 Plan. As of September 30, 2017, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $1,178, which is expected to be recognized over a weighted average period of approximately 1.83 years. The total compensation cost related to all of the Company’s equity-based awards, recognized during the nine months period ended September 30, 2017 and 2016 (unaudited) was comprised as follows: The following table presents the assumptions used to estimate the fair values of the options granted in the period presented: Nine months ended September 30, 2017 Risk-free interest rate % Volatility % Expected life (in years) Dividend yield % Nine months ended 2017 2016 Unaudited Research and development $ $ Sales and marketing General and administrative $ $ |
WARRANTS TO PURCHASE ORDINARY S
WARRANTS TO PURCHASE ORDINARY SHARES | 9 Months Ended |
Sep. 30, 2017 | |
WARRANTS TO PURCHASE ORDINARY SHARES | |
WARRANTS TO PURCHASE ORDINARY SHARES | NOTE 6: - WARRANTS TO PURCHASE ORDINARY SHARES The Company accounted for the warrants, described in note 1d and 1e, according to the provisions of ASC 480 “Distinguishing Liabilities from Equity” and ASC 815-40, “Derivatives and Hedging - Contracts in Entity’s Own Equity” and due to certain terms and conditions, the warrants classified as a liability. The warrants are measured using the following assumptions of the Monte Carlo option pricing model. On May 25, 2017, 1,351,766 warrants, that were issued on August 2016, were exercised into ordinary shares for cash proceeds of $4,866 and the fair value of the warrants in the amount of $5,177 were reclassified from liability to equity. Warrants issued on August 2016: September 30, May 25, December 31, 2017 2017 2016 Risk-free interest rate (1) % % 1.5% – 1.84 % Expected volatility (2) 70.1% – 97.1 % 65.6% – 85 % 65.5% – 85.5 % Expected life (in years) (3) 3.14 – 4.59 Expected dividend yield (4) % % % Fair value per warrant: Warrants issued on April 2017: September 30, April 25, 2017 2017 Risk-free interest rate (1) % 1.82% – 1.87 % Expected volatility (2) 70.1% – 93.2 % 65.7% – 80.7 % Expected life (in years) (3) 4.73 – 5 Expected dividend yield (4) % % Fair value per warrant: (1) Risk free interest rate based on yield rates of non-index linked U.S. Federal Reserve treasury bonds. (2) Expected volatility was calculated based on actual historical share price movements of companies in the same industry over a term that is equivalent to the expected term of the warrants. (3) Expected life was based on the contractual term of the warrants. (4) Expected dividend yield was based on the fact that the Company has not paid dividends to its shareholders in the past and does not expect to pay dividends to its shareholders in the future. The Company re-measured these warrants at fair value as of the exercise date, May 25, 2017 and as of September 30, 2017 and consequently, during the nine months periods ended September 30, 2017, the Company recorded $1,360 as a financial expense as a result of increase in the warrants’ fair value. Total fair value of the warrants as of September 30, 2017, is $10,255. |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 9 Months Ended |
Sep. 30, 2017 | |
FAIR VALUE MEASUREMENT | |
FAIR VALUE MEASUREMENT | NOTE 7: - FAIR VALUE MEASUREMENT The Company applies ASC 820, “Fair Value Measurements and Disclosures”, (“ASC 820”), which defines fair value as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy is broken down into three levels based on the inputs as follows: Level 1 - Valuations based on quoted prices in active markets for identical assets that the Company has the ability to access. Valuation adjustments and block discounts are not applied to Level 1 instruments. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment. Level 2 - Valuations based on one or more quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly. Level 3 - Valuations based on inputs that are unobservable and significant to the overall fair value measurement. The availability of observable inputs can vary from investment to investment and is affected by a wide variety of factors, including, for example, the type of investment, the liquidity of markets and other characteristics particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment and the investments are categorized as Level 3. The carrying amounts of cash and cash equivalents, restricted cash, other accounts receivable, trade payables and other accounts payable and accrued expenses approximate their fair value due to the short-term maturity of such instruments. Money Market Funds were classified as Level 1, Reverse Repurchase Agreements were classified as Level 2 as the fair value is determined using a discounted cash flow model with all significant inputs derived from or corroborated with observable market data. Warrants to purchase Ordinary Shares were classified as Level 3 as the fair value is determined using a Monte Carlo option pricing model, which takes into account the anti-dilution features of the warrants and certain subjective assumptions made by Management. The Company’s financial assets and liabilities that are measured at fair value on a recurring basis, consisted of the following types of instruments as of the following dates: September 30, 2017 Unaudited Description Fair value Level 1 Level 2 Level 3 Reverse repurchase agreements $ $ — $ $ — Money market funds — — Warrants to purchase Ordinary Shares ) — — ) $ $ $ $ ) December 31, 2016 Description Fair value Level 1 Level 2 Level 3 Reverse repurchase agreements $ $ — $ $ — Money market funds — — Warrants to purchase Ordinary Shares ) — — ) $ $ $ $ ) The following tabular presentation reflects the components of the liability associated with such warrants to purchase Ordinary Shares as of September 30, 2017: Fair value Balance at January 1, 2017 $ Warrants issued to investors (see Note 1e) Warrants exercised (see Note 6) ) Increase in the fair value of the warrants (see Note 6) Balance at September 30, 2017 (unaudited) $ |
SELECTED STATEMENTS OF OPERATIO
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | 9 Months Ended |
Sep. 30, 2017 | |
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | NOTE 8: - SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Financial expenses (income), net: Nine months ended 2017 2016 Unaudited Financial expenses: Reevaluation of fair value of warrants to purchase Ordinary Shares $ $ Warrant issuance costs Interest expense and bank fees Foreign currency translation adjustments — Financial income: Interest income $ ) $ ) Foreign currency translation adjustments ) ) ) Total financial expense (income), net $ $ |
LITIGATION
LITIGATION | 9 Months Ended |
Sep. 30, 2017 | |
LITIGATION | |
LITIGATION | NOTE 9: - LITIGATION On May 31, 2017, United Therapeutics Corporation (“United”) filed a motion to appeal with the U.S. Court of Appeals for the Federal Circuit regarding a Final Written Decision of the Patent Trial and Appeal Board (the “PTAB”) for an IPR petition filed by the Company on October 21, 2015. The IPR petition sought to invalidate U.S. Patent No. 8,497,393 (the “‘393 Patent”) owned by United, which expires in December 2028 and covers a method of making treprostinil, the active pharmaceutical ingredient in United’s drug, Remodulin. The Final Written Decision for the IPR petition issued by the PTAB on March 31, 2017, found that all claims of the ‘393 Patent are not patentable. The Appellate Court heard oral arguments from the parties on November 7, 2017. |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
SHAREHOLDERS' EQUITY | |
Schedule of stock options | Number of Weighted Weighted Aggregate options $ (years) $ Options outstanding at January 1, 2017 (* ) Options granted Options exercised ) Options forfeited ) Options outstanding at end of the period Options vested at end of the period (*) Represent amount less than $1. |
Schedule of the assumptions used to estimate the fair values of the options granted | Nine months ended September 30, 2017 Risk-free interest rate % Volatility % Expected life (in years) Dividend yield % |
Schedule of total compensation cost related to all of the Company's equity-based awards | Nine months ended 2017 2016 Unaudited Research and development $ $ Sales and marketing General and administrative $ $ |
WARRANTS TO PURCHASE ORDINARY18
WARRANTS TO PURCHASE ORDINARY SHARES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Warrants issued on August 2016: | |
Schedule of assumptions used in estimating fair value of warrants | September 30, May 25, December 31, 2017 2017 2016 Risk-free interest rate (1) % % 1.5% – 1.84 % Expected volatility (2) 70.1% – 97.1 % 65.6% – 85 % 65.5% – 85.5 % Expected life (in years) (3) 3.14 – 4.59 Expected dividend yield (4) % % % Fair value per warrant: (1) Risk free interest rate based on yield rates of non-index linked U.S. Federal Reserve treasury bonds. (2) Expected volatility was calculated based on actual historical share price movements of companies in the same industry over a term that is equivalent to the expected term of the warrants. (3) Expected life was based on the contractual term of the warrants. (4) Expected dividend yield was based on the fact that the Company has not paid dividends to its shareholders in the past and does not expect to pay dividends to its shareholders in the future. |
Warrants issued on April 2017: | |
Schedule of assumptions used in estimating fair value of warrants | September 30, April 25, 2017 2017 Risk-free interest rate (1) % 1.82% – 1.87 % Expected volatility (2) 70.1% – 93.2 % 65.7% – 80.7 % Expected life (in years) (3) 4.73 – 5 Expected dividend yield (4) % % Fair value per warrant: (1) Risk free interest rate based on yield rates of non-index linked U.S. Federal Reserve treasury bonds. (2) Expected volatility was calculated based on actual historical share price movements of companies in the same industry over a term that is equivalent to the expected term of the warrants. (3) Expected life was based on the contractual term of the warrants. (4) Expected dividend yield was based on the fact that the Company has not paid dividends to its shareholders in the past and does not expect to pay dividends to its shareholders in the future. |
FAIR VALUE MEASUREMENT (Tables)
FAIR VALUE MEASUREMENT (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
FAIR VALUE MEASUREMENT | |
Schedule of financial assets and liabilities measured at fair value on recurring basis | September 30, 2017 Unaudited Description Fair value Level 1 Level 2 Level 3 Reverse repurchase agreements $ $ — $ $ — Money market funds — — Warrants to purchase Ordinary Shares ) — — ) $ $ $ $ ) December 31, 2016 Description Fair value Level 1 Level 2 Level 3 Reverse repurchase agreements $ $ — $ $ — Money market funds — — Warrants to purchase Ordinary Shares ) — — ) $ $ $ $ ) |
Tabular presentation of components of liability associated with warrants to purchase Ordinary Shares | Fair value Balance at January 1, 2017 $ Warrants issued to investors (see Note 1e) Warrants exercised (see Note 6) ) Increase in the fair value of the warrants (see Note 6) Balance at September 30, 2017 (unaudited) $ |
SELECTED STATEMENTS OF OPERAT20
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |
Schedule of financial expenses (income), net | Nine months ended 2017 2016 Unaudited Financial expenses: Reevaluation of fair value of warrants to purchase Ordinary Shares $ $ Warrant issuance costs Interest expense and bank fees Foreign currency translation adjustments — Financial income: Interest income $ ) $ ) Foreign currency translation adjustments ) ) ) Total financial expense (income), net $ $ |
GENERAL (Details)
GENERAL (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)product | Sep. 30, 2016USD ($) | |
Organizational disclosures | ||||
Operating losses | $ 5,079 | $ 7,690 | $ 15,568 | $ 20,992 |
Negative cash flows from operating activities | $ 17,958 | $ 18,786 | ||
Products for the treatment of post-surgical and acute pain in the home setting | ||||
Organizational disclosures | ||||
Number of products in development | product | 2 |
GENERAL - EXECUTIVE LICENSE AND
GENERAL - EXECUTIVE LICENSE AND SUPPLY AGREEMENT (Details) - Cardiome - Collaboration $ in Thousands | Jun. 28, 2015USD ($) |
License and supply agreement | |
Upfront payment provided for per license agreement | $ 3,000 |
Aggregate maximum milestone payments to be achieved per agreement | $ 9,250 |
Scaling royalty percentage, low end of range | low teens |
Scaling royalty percentage, high end of range | mid-teens |
GENERAL - PRIVATE PLACEMENT(Det
GENERAL - PRIVATE PLACEMENT(Details) $ / shares in Units, $ in Thousands | May 25, 2017shares | Apr. 25, 2017USD ($)director | Apr. 20, 2017₪ / sharesshares | Aug. 04, 2016USD ($)director | Jul. 29, 2016$ / item₪ / sharesshares | Sep. 30, 2017USD ($)shares | Sep. 30, 2017₪ / shares | Apr. 20, 2017USD ($)$ / sharesshares | Dec. 31, 2016₪ / shares | Jul. 29, 2016USD ($)$ / sharesshares |
Class of Stock [Line Items] | ||||||||||
Ordinary share, nominal value (in dollars per share) | ₪ / shares | ₪ 0.01 | ₪ 0.01 | ||||||||
Issuance costs, upon issuance of Ordinary shares in a private placement | $ 1,449 | |||||||||
Ordinary Shares | ||||||||||
Class of Stock [Line Items] | ||||||||||
Issuance of Ordinary Shares (in shares) | shares | 5,031,550 | |||||||||
Exercise of warrants into Ordinary Shares (in shares) | shares | 1,351,766 | |||||||||
Private Placement | Warrant to purchase Ordinary Shares | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants authorized (in warrants) | shares | 2,515,775 | |||||||||
Sale price of warrants issued ( in dollars per warrant) | $ / shares | $ 0.125 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 6.785 | $ 3.5995 | ||||||||
Exercise of warrants into Ordinary Shares (in shares) | shares | 1,351,766 | |||||||||
Private Placement | Warrant to purchase Ordinary Shares | First tranche | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants authorized (in warrants) | shares | 6,554,016 | |||||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | ||||||||||
Class of Stock [Line Items] | ||||||||||
Value of shares and warrants to which the company agreed to issue and sell | $ 30,000 | $ 32,000 | ||||||||
Gross proceeds from issuance of shares and warrants | $ 28,110 | |||||||||
Issuance costs, upon issuance of Ordinary shares in a private placement | 1,890 | |||||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | Board members | ||||||||||
Class of Stock [Line Items] | ||||||||||
Gross proceeds from issuance of shares and warrants | $ 2,999 | |||||||||
Number of board members invested | director | 1 | |||||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | First tranche | ||||||||||
Class of Stock [Line Items] | ||||||||||
Sale price per combined unit (in dollars per unit) | $ / item | 3.255 | |||||||||
Gross proceeds from issuance of shares and warrants | $ 21,333 | |||||||||
Issuance costs, upon issuance of Ordinary shares in a private placement | 1,748 | |||||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | First tranche | Board members | ||||||||||
Class of Stock [Line Items] | ||||||||||
Gross proceeds from issuance of shares and warrants | $ 5,133 | |||||||||
Number of board members invested | director | 2 | |||||||||
Private Placement | Ordinary Shares | ||||||||||
Class of Stock [Line Items] | ||||||||||
Issuance of Ordinary Shares (in shares) | shares | 5,031,550 | |||||||||
Ordinary share, nominal value (in dollars per share) | ₪ / shares | ₪ 0.01 | |||||||||
Sale price of shares issued (in dollars per share) | $ / shares | $ 5.90 | |||||||||
Private Placement | Ordinary Shares | First tranche | ||||||||||
Class of Stock [Line Items] | ||||||||||
Issuance of Ordinary Shares (in shares) | shares | 6,554,016 | |||||||||
Ordinary share, nominal value (in dollars per share) | ₪ / shares | ₪ 0.01 | |||||||||
Private Placement | Ordinary Shares | Second tranche | ||||||||||
Class of Stock [Line Items] | ||||||||||
Value of shares and warrants to which the company agreed to issue and sell | $ 10,700 | |||||||||
Sale price of shares issued (in dollars per share) | $ / shares | $ 3.13 | |||||||||
Trading days basis of shares price | 30 days |
COMMITMENTS AND CONTINGENT LI24
COMMITMENTS AND CONTINGENT LIABILITIES - LEASES (Details) $ in Thousands | Aug. 23, 2017period | May 31, 2015 | Sep. 30, 2017USD ($) |
Operating lease agreement | |||
Total lease obligation | $ | $ 614 | ||
Israel | |||
Operating lease agreement | |||
Lease extension term | 12 months | ||
Number of periods to extend the lease term | period | 3 | ||
Additional lease extension term per option exercised | 12 months | ||
San Ramon, California | |||
Operating lease agreement | |||
Lease term | 4 years |
COMMITMENTS AND CONTINGENT LI25
COMMITMENTS AND CONTINGENT LIABILITIES - OTHER COMMITMENTS (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Purchase obligations | ||
Non-cancellable commitments to suppliers for purchases | $ 580 | |
Combined OCS and Incubator, RAD Biomed Ltd | ||
Royalties | ||
Grants received | $ 778 | |
Royalties to be paid as percentage of amount received, maximum if transfer intellectual property out of Israel (as a percent) | 600.00% | |
Intellectual property transferred out of Israel | $ 0 | |
Provision for grants received which become loans to be repaid if transfer intellectual property out of Israel | $ 0 | |
OCS | ||
Royalties | ||
Royalties to be paid as percentage of amount received, minimum at base (as a percent) | 150.00% | |
Royalties to be paid as percentage of amount received, maximum at base (as a percent) | 300.00% | |
Royalty Expense | $ 29 | $ 14 |
Minimum | First three years royalty term | OCS | ||
Royalties | ||
Royalties commitment on future revenues (as a percent) | 3.00% | |
Minimum | Commencing the fourth year royalty term | OCS | ||
Royalties | ||
Royalties commitment on future revenues (as a percent) | 3.50% | |
Maximum | First three years royalty term | OCS | ||
Royalties | ||
Royalties commitment on future revenues (as a percent) | 4.00% | |
Maximum | Commencing the fourth year royalty term | OCS | ||
Royalties | ||
Royalties commitment on future revenues (as a percent) | 4.50% |
SHAREHOLDERS' EQUITY - STOCK BA
SHAREHOLDERS' EQUITY - STOCK BASED COMPENSATION (Details) - shares | Feb. 20, 2015 | Jan. 25, 2015 | Jun. 18, 2009 | Sep. 30, 2017 | Dec. 31, 2014 |
2009 Plan | Stock options, all inclusive recipients | |||||
Stock-based compensation | |||||
Shares authorized for issue under the plan | 55,971 | 978,655 | |||
Additional shares authorized | 1,072,879 | ||||
Vesting period | 3 years | ||||
Expiration period | 7 years | ||||
Amended 2009 Stock Plan | |||||
Stock-based compensation | |||||
Expiration period | 10 years | ||||
Shares available for future grant (in shares) | 1,002,882 |
SHAREHOLDERS' EQUITY - OPTIONS
SHAREHOLDERS' EQUITY - OPTIONS ROLL FORWARD (Details) - Amended 2009 Stock Plan - Stock options, employees and directors - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Number of options | ||
Options outstanding at beginning of period (in shares) | 1,689,555 | |
Options granted (in shares) | 113,107 | |
Options exercised (in shares) | (32,910) | |
Options forfeited (in shares) | (5,178) | |
Options outstanding at end of period (in shares) | 1,764,574 | 1,689,555 |
Options vested at end of period (in shares) | 1,220,705 | |
Weighted average exercise price | ||
Options outstanding at beginning of period (in dollars per share) | $ 4.02 | |
Options granted (in dollars per share) | 4.60 | |
Options exercised (in dollars per share) | 3.61 | |
Options forfeited (in dollars per share) | 3.96 | |
Options outstanding at end of period (in dollars per share) | 4.06 | $ 4.02 |
Options vested at end of period (in dollars per share) | $ 4.17 | |
Weighted average remaining contractual life | ||
Weighted average remaining contractual life, Outstanding (in years) | 5 years 7 months 24 days | 6 years 22 days |
Weighted average remaining contractual life, Vested (in years) | 4 years 4 months 21 days | |
Aggregate intrinsic value | ||
Aggregate intrinsic value, Outstanding | $ 214 | |
Aggregate intrinsic value, Outstanding, exercisable | $ 80 | |
Maximum | ||
Aggregate intrinsic value | ||
Aggregate intrinsic value, Outstanding | $ 1 |
SHAREHOLDERS' EQUITY - FAIR VAL
SHAREHOLDERS' EQUITY - FAIR VALUE ASSUMPTIONS FOR OPTIONS GRANTED (Details) - Stock options, all inclusive recipients $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Stock-based compensation | |
Total unrecognized compensation cost related to non-vested stock option awards | $ 1,178 |
Weighted average period for recognition of compensation cost related to unvested stock awards | 1 year 9 months 29 days |
Assumptions used to estimate the fair values of options granted | |
Risk-free interest rate (as a percent) | 2.07% |
Volatility (as a percent) | 86.40% |
Expected life (in years) | 5 years 10 months 13 days |
Dividend yield (as a percent) | 0.00% |
SHAREHOLDERS' EQUITY - COMPENSA
SHAREHOLDERS' EQUITY - COMPENSATION COST RELATED TO EQUITY-BASED AWARDS (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock-based compensation costs | ||
Allocated share based compensation expense | $ 720 | $ 599 |
Research and development | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | 153 | 90 |
Sales and marketing | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | 48 | 5 |
General and administrative | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | $ 519 | $ 504 |
WARRANTS TO PURCHASE ORDINARY30
WARRANTS TO PURCHASE ORDINARY SHARES (Details) - USD ($) $ / shares in Units, $ in Thousands | May 25, 2017 | Apr. 25, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Assumptions used in determination of fair value | |||||
Proceeds from warrants exercised by shareholders | $ 4,866 | ||||
Fair value adjustment for reclassification from warrant liability to equity | 5,177 | ||||
Reevaluation of fair value of warrants to purchase Ordinary Shares | 1,360 | $ 1,507 | |||
Liability related to warrants | 10,255 | $ 7,078 | |||
Warrant to purchase Ordinary Shares | Private Placement | |||||
Assumptions used in determination of fair value | |||||
Exercise of warrants into Ordinary Shares (in shares) | 1,351,766 | ||||
Proceeds from warrants exercised by shareholders | $ 4,866 | ||||
Fair value adjustment for reclassification from warrant liability to equity | $ 5,177 | ||||
Reevaluation of fair value of warrants to purchase Ordinary Shares | 1,360 | ||||
Liability related to warrants | $ 10,255 | ||||
Warrants issued on August 2016: | Monte Carlo Option Pricing Model | Private Placement | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.65% | 1.75% | |||
Expected life (in years) | 4 years 2 months 9 days | 3 years 10 months 2 days | |||
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | ||
Fair value per warrant (in dollars) | $ 3.83 | $ 1.42 | $ 1.08 | ||
Warrants issued on August 2016: | Monte Carlo Option Pricing Model | Private Placement | Minimum | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.50% | ||||
Expected volatility (as a percent) | 65.60% | 70.10% | 65.50% | ||
Expected life (in years) | 3 years 1 month 21 days | ||||
Warrants issued on August 2016: | Monte Carlo Option Pricing Model | Private Placement | Maximum | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.84% | ||||
Expected volatility (as a percent) | 85.00% | 97.10% | 85.50% | ||
Expected life (in years) | 4 years 7 months 2 days | ||||
Warrants issued on April 2017: | Monte Carlo Option Pricing Model | Private Placement | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.86% | ||||
Expected life (in years) | 4 years 6 months 26 days | ||||
Expected dividend yield (as a percent) | 0.00% | 0.00% | |||
Fair value per warrant (in dollars) | $ 2.78 | $ 1.14 | |||
Warrants issued on April 2017: | Monte Carlo Option Pricing Model | Private Placement | Minimum | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.82% | ||||
Expected volatility (as a percent) | 65.70% | 70.10% | |||
Expected life (in years) | 4 years 8 months 23 days | ||||
Warrants issued on April 2017: | Monte Carlo Option Pricing Model | Private Placement | Maximum | |||||
Assumptions used in determination of fair value | |||||
Risk-free interest rate (as a percent) | 1.87% | ||||
Expected volatility (as a percent) | 80.70% | 93.20% | |||
Expected life (in years) | 5 years |
FAIR VALUE MEASUREMENT (Details
FAIR VALUE MEASUREMENT (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
FAIR VALUE MEASUREMENT | ||
Warrants to purchase Ordinary Shares | $ (10,255) | $ (7,078) |
Fair Value | Recurring basis | ||
FAIR VALUE MEASUREMENT | ||
Reverse Repurchase Agreements | 36,405 | 13,001 |
Net financial assets (liabilities) | 26,249 | 12,378 |
Fair Value | Recurring basis | Money Market Funds | ||
FAIR VALUE MEASUREMENT | ||
Money Market Funds | 99 | 6,455 |
Fair Value | Recurring basis | Warrant to purchase Ordinary Shares | ||
FAIR VALUE MEASUREMENT | ||
Warrants to purchase Ordinary Shares | (10,255) | (7,078) |
Level 1 | Recurring basis | ||
FAIR VALUE MEASUREMENT | ||
Net financial assets (liabilities) | 99 | 6,455 |
Level 1 | Recurring basis | Money Market Funds | ||
FAIR VALUE MEASUREMENT | ||
Money Market Funds | 99 | 6,455 |
Level 2 | Recurring basis | ||
FAIR VALUE MEASUREMENT | ||
Reverse Repurchase Agreements | 36,405 | 13,001 |
Net financial assets (liabilities) | 36,405 | 13,001 |
Level 3 | Recurring basis | ||
FAIR VALUE MEASUREMENT | ||
Net financial assets (liabilities) | (10,255) | (7,078) |
Level 3 | Recurring basis | Warrant to purchase Ordinary Shares | ||
FAIR VALUE MEASUREMENT | ||
Warrants to purchase Ordinary Shares | $ (10,255) | $ (7,078) |
FAIR VALUE MEASUREMENT - WARRAN
FAIR VALUE MEASUREMENT - WARRANTS TO PURCHASE ORDINARY SHARES (Details) - Warrant to purchase Ordinary Shares $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Warrants Liabilities Roll Forward | |
Balance, beginning of the period | $ 7,078 |
Warrants issued to investors (see Note 1e) | 6,994 |
Warrants exercised (see Note 6) | (5,177) |
Increase in the fair value of the warrants (see Note 6) | 1,360 |
Balance, end of the period | $ 10,255 |
SELECTED STATEMENTS OF OPERAT33
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Financial expenses: | ||||
Reevaluation of fair value of warrants to purchase Ordinary Shares | $ 1,360 | $ 1,507 | ||
Warrant issuance costs | 441 | 784 | ||
Interest expense and bank fees | 21 | 87 | ||
Foreign currency translation adjustments | 116 | |||
Total financial expenses | 1,938 | 2,378 | ||
Financial income: | ||||
Interest income | (178) | (59) | ||
Foreign currency translation adjustments | (142) | |||
Total financial income | (178) | (201) | ||
Total financial expense (income), net | $ (14,170) | $ 2,260 | $ 1,760 | $ 2,177 |