Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 03, 2016 | |
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, 2016 | |
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 | 20,139,826 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 31,504 | $ 31,851 |
Restricted cash | 15 | 323 |
Other accounts receivable and prepaid expenses | 181 | 288 |
Total current assets | 31,700 | 32,462 |
LONG-TERM DEPOSITS | 123 | 61 |
SEVERANCE PAY FUND | 100 | 124 |
PROPERTY AND EQUIPMENT, NET | 3,547 | 2,583 |
Total assets | 35,470 | 35,230 |
CURRENT LIABILITIES: | ||
Current maturity of loan | 230 | |
Trade payables | 2,830 | 1,572 |
Deferred revenues | 1,279 | 1,705 |
Other accounts payable and accrued expenses | 3,269 | 2,333 |
Total current liabilities | 7,378 | 5,840 |
NON-CURRENT LIABILITIES: | ||
Deferred revenues | 107 | 426 |
Accrued severance pay | 142 | 159 |
Liability related to warrants | 11,076 | |
Other accounts payable | 258 | 258 |
Total non-current liabilities | 11,583 | 843 |
COMMITMENTS AND CONTINGENT LIABILITIES | ||
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares of NIS 0.01 par value - Authorized: 50,000,000 at September 30, 2016 and December 31, 2015, respectively; Issued and outstanding: 20,139,826 and 13,585,810 at September 30, 2016 (unaudited) and December 31, 2015, respectively | 51 | 34 |
Additional paid-in capital | 103,196 | 91,814 |
Accumulated deficit | (86,738) | (63,301) |
Total shareholders' equity | 16,509 | 28,547 |
Total liabilities and shareholders' equity | $ 35,470 | $ 35,230 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
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 | 20,139,826 | 13,585,810 |
Ordinary Shares, shares outstanding | 20,139,826 | 13,585,810 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Revenues | $ 276 | $ 439 | $ 745 | $ 439 |
Operating expenses: | ||||
Research and development | 6,044 | 4,799 | 16,312 | 14,637 |
Sales and marketing | 435 | 216 | 1,258 | 723 |
General and administrative | 1,487 | 1,308 | 4,167 | 3,324 |
Total operating expenses | 7,966 | 6,323 | 21,737 | 18,684 |
Total operating loss | 7,690 | 5,884 | 20,992 | 18,245 |
Financial expenses (income), net | 2,260 | (58) | 2,177 | (69) |
Loss before taxes on income | 9,950 | 5,826 | 23,169 | 18,176 |
Taxes on income | (56) | (115) | (268) | (246) |
Net loss | $ 10,006 | $ 5,941 | $ 23,437 | $ 18,422 |
Net loss per share: | ||||
Basic and diluted net loss per Ordinary Share | $ (0.57) | $ (0.44) | $ (1.57) | $ (2.02) |
Weighted-average number of Ordinary Shares used to compute basic and diluted net loss per share | 17,646,450 | 13,581,160 | 14,949,237 | 9,586,245 |
STATEMENTS OF CHANGES IN SHAREH
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - 9 months ended Sep. 30, 2016 - USD ($) $ in Thousands | Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total |
Balance, beginning at Dec. 31, 2015 | $ 34 | $ 91,814 | $ (63,301) | $ 28,547 |
Balance, beginning (in shares) at Dec. 31, 2015 | 13,585,810 | |||
Increase (decrease) in Stockholders' Equity | ||||
Stock-based compensation | 599 | 599 | ||
Issuance of Ordinary Shares and Warrants, net of issuance costs | $ 17 | 10,783 | 10,800 | |
Issuance of Ordinary Shares and Warrants, net of issuance costs (in shares) | 6,554,016 | |||
Net loss | (23,437) | (23,437) | ||
Balance, ending at Sep. 30, 2016 | $ 51 | $ 103,196 | $ (86,738) | $ 16,509 |
Balance, ending (in shares) at Sep. 30, 2016 | 20,139,826 |
CONSOLIDATED STATEMENT OF CASH
CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (23,437) | $ (18,422) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 599 | 382 |
Depreciation | 481 | 277 |
Impairment of property and equipment | 154 | |
Accrued severance pay, net | 6 | (2) |
Amortization of discount on loan | 4 | 8 |
Allocation of issuance costs related to warrants to purchase Ordinary Shares | 784 | |
Revaluation of fair value of warrants to purchase Convertible Preferred Shares | (40) | |
Revaluation of fair value of warrants to purchase Ordinary Shares | 1,507 | |
Decrease (increase) in other accounts receivable and prepaid expenses | 107 | (195) |
Increase (decrease) in deferred revenue | (745) | 2,561 |
Increase in trade payables | 1,258 | 655 |
Increase (decrease) in other accounts payable and accrued expenses | 650 | (632) |
Net cash used in operating activities | (18,786) | (15,254) |
Cash flows from investing activities: | ||
Proceeds from maturity of investment in restricted cash | 308 | 527 |
Purchase of property and equipment | (1,158) | (1,326) |
Investment in other assets | (62) | (21) |
Net cash used in investing activities | (912) | (820) |
Cash flows from financing activities: | ||
Proceeds from issuance of Convertible Preferred Shares and warrants, net of issuance costs | 11,406 | |
Proceeds from issuance of Ordinary Shares, net of issuance costs upon IPO | 36,159 | |
Proceeds from issuance of Ordinary Shares, net of underwriters' fees | 1,308 | |
Proceeds from issuance of Ordinary Shares and warrants, net of issuance costs | 19,585 | |
Repayment of loan | (234) | (422) |
Proceeds from exercise of options into Ordinary Shares | 145 | |
Net cash provided by financing activities | 19,351 | 48,596 |
Net increase (decrease) in cash and cash equivalents | (347) | 32,522 |
Cash and cash equivalents at the beginning of the period | 31,851 | 6,167 |
Cash and cash equivalents at the end of the period | 31,504 | 38,689 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchase of property and equipment | 286 | 109 |
Conversion of Convertible Preferred Shares into Ordinary Shares | 47,075 | |
Conversion of warrants to purchase Convertible Preferred Shares into Ordinary Shares | 5,945 | |
Non-cash deferred IPO costs | 1,463 | |
Conversion of Warrants to purchase Convertible Preferred Shares into Warrants to purchase Ordinary Shares | 87 | |
Cash paid during the period: | ||
Cash paid for interest | 3 | 25 |
Cash paid for taxes | $ 341 | $ 278 |
GENERAL
GENERAL | 9 Months Ended |
Sep. 30, 2016 | |
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”). 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 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, 2016, the Company incurred operating losses of $20,992 and negative cash flows from operating activities of $18,786. The Company’s current cash and cash equivalents are expected to support the Company’s operations into the third quarter of 2017. As a result, the Company will need to raise significant additional capital in the near term by way of a private placement of debt and/or equity and/or a secondary public offering to allow the Company to continue as a going concern. One possible source of additional capital is the $10.7 million second tranche of the Company’s private placement closed on August 2016 (detailed elsewhere in Note 1). If we meet certain milestones in 2017, we will be able to call the second tranche which would extend the Company’s funding for 12 months from the date of this quarterly report. There is no assurance, however, that the Company will be successful able to call the second tranche or in otherwise obtaining an adequate level of financing to continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. While the audit report prepared by the Company’s independent registered accounting firm for its Consolidated Financial Statements as of December 31, 2015 included a going concern explanatory paragraph, 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. Initial Public Offering: On March 19, 2015, a registration statement covering the public sale of 4,700,000 Ordinary Shares was declared effective by the U.S. Securities and Exchange Commission (“SEC”). Commencing on March 20, 2015, the Company’s Ordinary Shares began trading on the NASDAQ Stock Market operated under the ticker symbol “STDY”. On March 25, 2015, the Company closed its IPO at a price of $8.50 per share and the aggregate net proceeds received by the Company from the offering were $34,696, net of underwriting discounts and commissions and offering expenses payable by the Company. On April 22, 2015, the Company’s underwriters exercised a portion of their overallotment option pursuant to which they purchased 165,452 Ordinary Shares of the Company for $1,308, net of underwriters’ fees and commissions. Upon the closing of the IPO, all shares of the Company’s outstanding Convertible Preferred Shares were automatically converted into 7,464,320 Ordinary Shares. As of December 31, 2014, there were 711,120 outstanding warrants exercisable into Convertible Preferred Shares. Prior to the IPO, all but 10,191 warrants were exercised into Ordinary Shares. Of the exercised warrants, 295,697 were exercised for cash, and 405,232 were exercised on a cashless basis, resulting in the net exercise of 401,746 warrants (and 3,486 warrants were cancelled). Upon the closing of the IPO, the 10,191 warrants outstanding were automatically converted into warrants to purchase Ordinary Shares. d. 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”) 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. e. 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 will occur at the election of the Company following achievement by the Company of certain milestones related to its lead drug product candidate Trevyent. 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 $5,086. 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 (see also note 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 Ordinary Shares underlying the Warrants, which was declared effective by the U.S. Securities and Exchange Commission on September 21, 2016. If the Company fails to maintain the effectiveness of the registration statement, it may incur liquidated damages for each participant of up to 5% of the pro-rata purchase price of the Shares. |
UNAUDITED INTERIM CONSOLIDATED
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS | 9 Months Ended |
Sep. 30, 2016 | |
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, 2016. Consolidated results of operations and consolidated cash flows for the nine months periods ended September 30, 2016 and 2015, have been included. The results for the nine months period ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ended December 31, 2016. 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, 2015 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, 2016 with the SEC. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2016 | |
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, 2015 filed with the SEC on March 29, 2016 pursuant to the Exchange Act, are applied consistently in these unaudited interim consolidated financial statements. a. In May 2014, the FASB issued ASU 2014-09 “Revenue from Contracts with Customers (Topic 606)”, which creates a new Topic, Accounting Standards Codification Topic 606. The standard is principle-based and provides a five-step model to determine when and how revenue is recognized. The core principle of ASU 2014-09 is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In July 2015, the FASB approved the deferral of the effective date by one year. The accounting standard is now effective for annual and interim periods beginning after December 15, 2017, which for the Company is January 1, 2018, the first day of its 2018 fiscal year. In April 2016, the FASB issued ASU No. 2016-10, “Identifying Performance Obligations and Licensing” which addresses certain implementation issues that have surfaced since the issuance of ASU No. 2014-09 and provides guidance in identifying performance obligations and determining the appropriate accounting for licensing arrangements. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial statements. The final ASU permits organizations to adopt the new revenue standard early, but not before annual and interim periods beginning after December 15, 2016. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial statements. b. In February 2016, the 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 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases today. 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 Leases. The standard is effective on January 1, 2019, with early adoption permitted. The Company is currently in the process of evaluating the impact of the adoption of this standard on its consolidated financial statements. c. In March 2016, the FASB issued ASU 2016-09 “Improvements to Employee Share-Based Payment Accounting”. This ASU affects entities that issue share-based payment awards to their employees. The ASU is designed to simplify several aspects of accounting for share-based payment award transactions which include the income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and forfeiture rate calculations. ASU 2016-09 will become effective for the Company in the annual period ending August 31, 2018. Early adoption is permitted in any interim or annual period. The Company is currently in the process of evaluating the impact of the adoption of this standard on its consolidated financial statements. |
LOAN
LOAN | 9 Months Ended |
Sep. 30, 2016 | |
LOAN | |
LOAN | NOTE 4: - LOAN In February 20, 2013 (the “Closing Date”), Inc. signed a Loan and Security Agreement (“Agreement”) with a commercial bank (“Bank”) pursuant to which three-year $1,500 (“Loan”) was provided at the Closing Date. The final payment of the Loan was repaid during May 2016. As part of the Agreement, the Company issued the Bank warrants to purchase 7,332 shares of Series D Preferred Shares at an exercise price of $6.14 per Preferred D Share. The warrant has an exercise period which is the earliest of ten years after the Closing Date, consummation of a qualified IPO as determined for such warrants or the automatic conversion of Convertible Preferred Shares into Ordinary Shares as defined in the applicable articles of association. Such warrants were exercised on a cashless basis during the year ended December 31, 2015. |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 9 Months Ended |
Sep. 30, 2016 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 5: - COMMITMENTS AND CONTINGENT LIABILITIES a. The Company’s lease agreement for its Israeli offices had a 24 months term ending December 31, 2017. Inc.’s lease agreement for its U.S. offices had a four-year term ending May 2019. 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, 2016, the total amount of grants received from the OCS and the Incubator, including interest, was $759 and royalties paid and accrued was amounted to $35 and $14 during the year ended December 31, 2015 and nine months period ended September 30, 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. In October 2015, the Company filed a petition with the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office for an inter partes review of U.S. Patent No. 8,497,393 (the “‘393 Patent”) granted to United Therapeutics Corporation (“UTC”), seeking to invalidate this patent. The ‘393 Patent relates to a process for preparing prostacyclin derivatives such as treprostinil. Treprostinil is used in Trevyent. UTC filed a response to the Company’s petition in January 2016, defending the ‘393 Patent. In April 2016, the PTAB decided to institute the review of the ‘393 Patent. A final decision by the PTAB is expected in April 2017. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2016 | |
SHAREHOLDERS' EQUITY | |
SHAREHOLDERS' EQUITY | NOTE 6: - SHAREHOLDERS’ EQUITY a. On January 24, 2015, the Company signed an addendum to the Series E Convertible Preferred Share purchase agreement to raise additional funds of $11,406, net of fees and expenses. Under the addendum, the Company issued 1,445,966 Series E Convertible Preferred Shares to its existing and new investors for a price of $8.49 per share. b. On March 1, 2015, the Company affected a 7.75 for 1 forward split of its Ordinary Shares, by way of issuance and distribution of bonus shares without a change in nominal value of the Company’s outstanding Ordinary Shares. For accounting purposes, this transaction was recorded as a share split and accordingly, all Shares, warrants to purchase Convertible Preferred Shares, options to purchase Ordinary Shares and loss per share amounts have been adjusted to give retroactive effect to this Share Split for all periods presented in these consolidated financial statements. Any fractional shares resulting from the Share Split will be rounded up to the nearest whole share. In addition, the Company’s Board of Directors approved an increase the Company’s authorized Shares from 5,000,000 to 50,000,000. c. As described in Note 1c, on March 19, 2015, the Company completed its IPO by raising gross consideration of $40,000 for issuance of 4,700,000 Ordinary Shares for a price of $8.50 per share. The issuance costs in respect of the IPO transaction amounted to $5,200. d. On April 22, 2015, the Company’s underwriters exercised their overallotment option pursuant to which they purchased 165,452 Ordinary Shares of the Company for $1,308 net of underwriters’ fees and commissions. e. 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. 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 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. 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. This action was approved by the shareholders on March 1, 2015. Transactions related to the grant of options to employees and directors under the Amended and Restated 2009 Stock Incentive Plan during the nine months period ended September 30, 2016 (unaudited), were as follows: Number of Weighted Weighted Aggregate options $ (years) $ Options outstanding at January 1, 2016 * ) Options granted — Options forfeited Options outstanding at end of the period Options vested and expected to be vested at end of the period**) Options vested at end of the period — *) Represent amount less than $1. **) Equal to total options outstanding net of options expected to be forfeited. 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, 2016 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, 2016. This amount is impacted by the changes in the fair market value of the Company’s shares. As of September 30, 2016, the Company has 411,408 Ordinary Shares available for future grant under the Amended and Restated 2009 Plan. As of September 30, 2016, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $1,438, which is expected to be recognized over a weighted average period of approximately 1.95 years. The total compensation cost related to all of the Company’s equity-based awards, recognized during the nine months period ended September 30, 2016 and 2015 (unaudited) was comprised as follows: Nine months ended 2016 2015 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, 2016 | |
WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES | |
WARRANTS TO PURCHASE ORDINARY SHARES | NOTE 7: WARRANTS TO PURCHASE ORDINARY SHARES Following to Note 1e, the Warrants issued in the Private Placement are eligible also for “cashless exercise” in case the underlying Ordinary Shares are not registered for resale. In addition, the Warrants contain non-standard “full ratchet” anti-dilution protections upon issuance of securities at a price below the then-existing exercise price and are subject to certain net settlement cash feature in case of failure to timely deliver registered Ordinary Shares upon exercise. Therefore, these warrants are accounted and recorded as a liability according to the provisions of ASC 815-40, “Derivatives and Hedging - Contracts in Entity’s Own Equity” and measured using the following assumptions of the Monte Carlo option pricing model: August 4, September 30, 2016 2016 Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) 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 in the total amount of $11,076 as of September 30, 2016. Consequently, during the three and nine months periods ended September 30, 2016, the Company recorded $1,507 as a financial expense as a result of change in the warrants’ fair value. |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 9 Months Ended |
Sep. 30, 2016 | |
FAIR VALUE MEASUREMENT | |
FAIR VALUE MEASUREMENT | NOTE 8:- 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 (“MMF”) were classified as Level 1, Reverse Repurchase Agreements (“RRAs”) 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, 2016 Unaudited Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) MMFs $ $ — — RRAs $ — $ — $ $ $ $ ) December 31, 2015 Description Fair value Level 1 Level 2 Level 3 RRAs $ $ — $ $ — $ $ — $ $ — The following tabular presentation reflects the components of the liability associated with such warrants to purchase Ordinary Shares as of September 30, 2016: Fair value Balance at January 1, 2016 $ — Fair value of warrants issued to investors (see Note 1e) Revaluation of fair value of warrants to purchase Ordinary Shares (see Note 7) Balance at September 30, 2016 (unaudited) $ |
SELECTED STATEMENTS OF COMPREHE
SELECTED STATEMENTS OF COMPREHENSIVE LOSS | 9 Months Ended |
Sep. 30, 2016 | |
SELECTED STATEMENTS OF COMPREHENSIVE LOSS | |
SELECTED STATEMENTS OF COMPREHENSIVE LOSS | NOTE 9: - SELECTED STATEMENTS OF COMPREHENSIVE LOSS a. Financial expenses (income), net: Nine months ended 2016 2015 Unaudited Interest expense and bank fees $ $ Interest income ) — Revaluation of fair value of warrants to purchase Convertible Preferred Shares — ) Allocation of issuance costs related to warrants to purchase Ordinary Shares — Revaluation of fair value of warrants to purchase Ordinary Shares — Foreign currency translation adjustments ) ) $ $ ) b. The net loss and the weighted average number of shares used in computing basic and diluted net loss per share is as follows: Nine months ended 2016 2015 Unaudited Numerator: Net loss $ $ Dividends accumulated for the period (*) — Net loss available to shareholders of Ordinary shares $ $ Denominator: Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share (*) The net loss used for the computation of basic and diluted net loss per share for the nine months period ended September 30, 2015 includes the compounded dividend of eight percent per annum which shall be distributed to shareholders in case of distributable assets determined in the applicable article of association under the liquidation preference right prior to the closing of the IPO event as mentioned in Note 1c. Convertible securities such as warrants to purchase Series Preferred A2, D, E1 Shares, Series Preferred A1, A2, B, C, D, E Shares and options to grantees under the Amended and Restated 2009 Stock Incentive Plan, have not been taken into account due to their anti-dilutive effect. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2016 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 10: - SUBSEQUENT EVENTS On October 5, the Company held its 2016 Annual General Meeting of Shareholders. Among other things, the shareholders approved an amendment to the Stock Option Plan providing for the four percent (4%) automatic annual increase in the authorized number of Ordinary Shares available for future grant under the 2009 Plan to begin on January 1, 2017 instead of January 1, 2019. As a result of the Meeting, the six (6) non-employee directors of the Company also earned their automatic annual stock option grant of 3,875 Ordinary Shares. |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
SHAREHOLDERS' EQUITY | |
Schedule of stock options roll forward | Number of Weighted Weighted Aggregate options $ (years) $ Options outstanding at January 1, 2016 * ) Options granted — Options forfeited Options outstanding at end of the period Options vested and expected to be vested at end of the period**) Options vested at end of the period — *) Represent amount less than $1. **) Equal to total options outstanding net of options expected to be forfeited. |
Schedule of total compensation cost related to all of the Company's equity-based awards | Nine months ended 2016 2015 Unaudited Research and development $ $ Sales and marketing General and administrative |
WARRANTS TO PURCHASE CONVERTIBL
WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES | |
Schedule of assumptions used in estimating fair value of warrants | August 4, September 30, 2016 2016 Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) 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, 2016 | |
FAIR VALUE MEASUREMENT | |
Schedule of financial assets and liabilities measured at fair value on recurring basis | September 30, 2016 Unaudited Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) MMFs $ $ — — RRAs $ — $ — $ $ $ $ ) December 31, 2015 Description Fair value Level 1 Level 2 Level 3 RRAs $ $ — $ $ — $ $ — $ $ — |
Tabular presentation of components of liability associated with warrants to purchase Ordinary Shares | Fair value Balance at January 1, 2016 $ — Fair value of warrants issued to investors (see Note 1e) Revaluation of fair value of warrants to purchase Ordinary Shares (see Note 7) Balance at September 30, 2016 (unaudited) $ |
SELECTED STATEMENTS OF COMPRE20
SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
SELECTED STATEMENTS OF COMPREHENSIVE LOSS | |
Schedule of financial income, net | Nine months ended 2016 2015 Unaudited Interest expense and bank fees $ $ Interest income ) — Revaluation of fair value of warrants to purchase Convertible Preferred Shares — ) Allocation of issuance costs related to warrants to purchase Ordinary Shares — Revaluation of fair value of warrants to purchase Ordinary Shares — Foreign currency translation adjustments ) ) $ $ ) |
Schedule of weighted average number of shares | Nine months ended 2016 2015 Unaudited Numerator: Net loss $ $ Dividends accumulated for the period (*) — Net loss available to shareholders of Ordinary shares $ $ Denominator: Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share (*) The net loss used for the computation of basic and diluted net loss per share for the nine months period ended September 30, 2015 includes the compounded dividend of eight percent per annum which shall be distributed to shareholders in case of distributable assets determined in the applicable article of association under the liquidation preference right prior to the closing of the IPO event as mentioned in Note 1c. |
GENERAL (Details)
GENERAL (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)product | Sep. 30, 2015USD ($) | Jul. 29, 2016USD ($) | |
Organizational disclosures | |||||
Operating losses | $ (7,690) | $ (5,884) | $ (20,992) | $ (18,245) | |
Negative cash flows from operating activities | $ 18,786 | $ 15,254 | |||
Private Placement | Ordinary Shares | |||||
Organizational disclosures | |||||
Value of shares to which the Company agreed to issue and sell under subscription agreement | $ 32,000 | ||||
Private Placement | Ordinary Shares | Second tranche | |||||
Organizational disclosures | |||||
Value of shares to which the Company agreed to issue and sell under subscription agreement | $ 10,700 | ||||
Products for Treatment Of Post-Surgical And Acute Pain In Home Setting | |||||
Organizational disclosures | |||||
Number of products in development | product | 2 |
GENERAL - IPO (Details)
GENERAL - IPO (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 22, 2015 | Mar. 25, 2015 | Mar. 25, 2015 | Mar. 19, 2015 | Sep. 30, 2015 | Dec. 31, 2014 |
Initial Public Offering | ||||||
Proceeds from issuance of Ordinary Shares, net of underwriters' fees | $ 1,308 | |||||
Warrants Disclosures | ||||||
Number of Warrants for Convertible Preferred Shares exercised for cash (in shares) | 295,697 | |||||
Number of Warrants for Convertible Preferred Shares exercised on cashless basis (in shares) | 405,232 | |||||
Net number of Warrants for Convertible Preferred Shares exercised (in shares) | 401,746 | |||||
Number of Warrants for Convertible Preferred Shares cancelled (in shares) | 3,486 | |||||
Number of Warrants for Convertible Preferred Shares automatically converted into warrants for Ordinary Shares (in shares) | 10,191 | |||||
Convertible Preferred Shares | ||||||
Warrants Disclosures | ||||||
Warrants outstanding (in shares) | 10,191 | 711,120 | ||||
IPO | ||||||
Initial Public Offering | ||||||
Ordinary shares issued (in shares) | 4,700,000 | |||||
Price per share | $ 8.50 | $ 8.50 | ||||
Aggregate net proceeds received from IPO offering, net of underwriting discounts and commissions and offering expenses | $ 34,696 | |||||
Conversion of Convertible Preferred Shares into Ordinary Shares upon IPO (in shares) | 7,464,320 | |||||
Underwriters Overallotment Option Exercise | ||||||
Initial Public Offering | ||||||
Issuance of Ordinary Shares, net of underwriters fees (in shares) | 165,452 | |||||
Proceeds from issuance of Ordinary Shares, net of underwriters' fees | $ 1,308 |
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 - SUBSCRIPTION AGREEMEN
GENERAL - SUBSCRIPTION AGREEMENT (Details) $ / shares in Units, $ in Thousands | Aug. 04, 2016USD ($)director | Jul. 29, 2016₪ / shares | Sep. 30, 2016₪ / sharesshares | Jul. 29, 2016USD ($)$ / sharesshares | Dec. 31, 2015₪ / sharesshares | Mar. 01, 2015shares | Feb. 28, 2015shares |
Class of Stock [Line Items] | |||||||
Ordinary Shares, shares authorized | shares | 50,000,000 | 50,000,000 | 50,000,000 | 5,000,000 | |||
Ordinary share, nominal value (in dollars per share) | ₪ / shares | ₪ 0.01 | ₪ 0.01 | |||||
Private Placement | Ordinary Shares | |||||||
Class of Stock [Line Items] | |||||||
Value of shares to which the Company agreed to issue and sell under subscription agreement | $ 32,000 | ||||||
Private Placement | Ordinary Shares | First tranche | |||||||
Class of Stock [Line Items] | |||||||
Ordinary Shares, shares authorized | 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 to which the Company agreed to issue and sell under subscription agreement | $ 10,700 | ||||||
Price per share | $ / shares | $ 3.13 | ||||||
Private Placement | Warrant to purchase ordinary shares | |||||||
Class of Stock [Line Items] | |||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.5995 | ||||||
Private Placement | Warrant to purchase ordinary shares | First tranche | |||||||
Class of Stock [Line Items] | |||||||
Warrants authorized (in shares) | shares | 6,554,016 | ||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | |||||||
Class of Stock [Line Items] | |||||||
Maximum liquidated damages for each participant on the basis of pro-rata purchase price of Shares (as a percent) | 5.00% | ||||||
Private Placement | Ordinary shares and warrants to purchase ordinary shares | First tranche | |||||||
Class of Stock [Line Items] | |||||||
Exercise price of units (in dollars per unit) | $ / shares | $ 3.255 | ||||||
Gross proceeds from Issuance of Shares and Warrants | $ 21,333 | ||||||
Number of board members invested | director | 2 | ||||||
Issuance costs | $ 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 | $ 5,086 |
LOAN (Details)
LOAN (Details) $ / shares in Units, $ in Thousands | Feb. 20, 2013USD ($)$ / sharesshares |
Loan Agreement | |
Loan | |
Term of loan (in years) | 3 years |
Amount borrowed | $ | $ 1,500 |
Bank | Series D Preferred shares | |
Loan | |
Warrants issued to purchase preferred stock | shares | 7,332 |
Exercise price of warrant | $ / shares | $ 6.14 |
Expiration term of warrants | 10 years |
COMMITMENTS AND CONTINGENT LI26
COMMITMENTS AND CONTINGENT LIABILITIES - LEASES (Details) | Dec. 31, 2015 | May 31, 2015 |
Israel | ||
Operating lease agreement | ||
Lease term | 24 months | |
San Ramon, California | Previous Office | ||
Operating lease agreement | ||
Lease term | 4 years |
COMMITMENTS AND CONTINGENT LI27
COMMITMENTS AND CONTINGENT LIABILITIES - OTHER COMMITMENTS (Details) - USD ($) $ in Thousands | 9 Months Ended | 141 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2016 | Dec. 31, 2015 | |
Combined OCS and Incubator, RAD Biomed Ltd | |||
Royalties | |||
Grants received | $ 759 | ||
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% | ||
Accrued royalties | $ 14 | $ 14 | $ 35 |
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 - Share ca
SHAREHOLDERS' EQUITY - Share capital additional disclosures (Details) $ / shares in Units, $ in Thousands | Apr. 22, 2015USD ($)shares | Mar. 25, 2015USD ($)$ / sharesshares | Mar. 01, 2015shares | Jan. 24, 2015USD ($)$ / sharesshares | Sep. 30, 2015USD ($) | Sep. 30, 2016shares | Dec. 31, 2015shares | Feb. 28, 2015shares |
Shareholders' Deficit disclosures | ||||||||
Stock split ratio | 7.75 | |||||||
Ordinary Shares, shares authorized | shares | 50,000,000 | 50,000,000 | 50,000,000 | 5,000,000 | ||||
Proceeds from issuance of Ordinary Shares, net of underwriters' fees | $ 1,308 | |||||||
IPO | ||||||||
Shareholders' Deficit disclosures | ||||||||
Price per share | $ / shares | $ 8.50 | |||||||
Proceeds from Issuance - Initial Public Offering | $ 40,000 | |||||||
Issuance of Ordinary Shares, upon IPO (in shares) | shares | 4,700,000 | |||||||
Equity issuance costs | $ 5,200 | |||||||
Underwriters Over-Allotment Option | ||||||||
Shareholders' Deficit disclosures | ||||||||
Issuance of Ordinary Shares, net of underwriters' fees (in shares) | shares | 165,452 | |||||||
Proceeds from issuance of Ordinary Shares, net of underwriters' fees | $ 1,308 | |||||||
Series E Preferred shares | ||||||||
Shareholders' Deficit disclosures | ||||||||
Proceeds from issuance of convertible preferred shares | $ 11,406 | |||||||
Convertible Preferred Stock issued (in shares) | shares | 1,445,966 | |||||||
Price per share | $ / shares | $ 8.49 |
SHAREHOLDERS' EQUITY - STOCK BA
SHAREHOLDERS' EQUITY - STOCK BASED COMPENSATION (Details) - 2009 Plan - Stock options, all inclusive recipients - shares | Jan. 24, 2015 | Sep. 30, 2016 | Dec. 31, 2014 | Jun. 18, 2009 |
Stock-based compensation | ||||
Shares authorized for issue under the plan | 978,655 | 55,971 | ||
Vesting period | 3 years | |||
Expiration period | 7 years | |||
Additional shares authorized | 1,072,879 | |||
Shares available for future grant (in shares) | 411,408 |
SHAREHOLDERS' EQUITY - OPTIONS
SHAREHOLDERS' EQUITY - OPTIONS ROLLFORWARD (Details) - Amended and Restated 2009 Stock Incentive Plan - Stock options, employees and directors - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Number of options | ||
Options outstanding at beginning of period (in shares) | 1,247,185 | |
Options granted (in shares) | 338,620 | |
Options forfeited (in shares) | 2,440 | |
Options outstanding at end of period (in shares) | 1,583,365 | 1,247,185 |
Options vested and expected to be vested at end of period (in shares) | 1,561,617 | |
Options vested at end of period (in shares) | 878,993 | |
Weighted average exercise price per share | ||
Options outstanding at beginning of period (in dollars per share) | $ 4.40 | |
Options expired (in dollars per share) | 2.80 | |
Options outstanding at end of period (in dollars per share) | 4.06 | $ 4.40 |
Options vested and expected to be vested at end of period (in dollars per share) | 4.07 | |
Options vested at end of period (in dollars per share) | $ 4.15 | |
Weighted average remaining contractual life | ||
Weighted average remaining contractual life, Outstanding (in years) | 6 years 11 days | 5 years 9 months 11 days |
Weighted average remaining contractual life, Vested and expected to be vested (in years) | 5 years 11 months 23 days | |
Weighted average remaining contractual life, Vested (in years) | 4 years 4 months 21 days | |
Aggregate intrinsic value | ||
Aggregate intrinsic value, Outstanding at the end of the period | $ 271 | |
Aggregate intrinsic value, Vested and expected to be vested | 257 | |
Maximum | ||
Aggregate intrinsic value | ||
Aggregate intrinsic value, Outstanding at the beginning of the period | $ 1 | |
Aggregate intrinsic value, Outstanding at the end of the period | $ 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, 2016USD ($) | |
Stock-based compensation | |
Total unrecognized compensation cost related to non-vested stock option awards | $ 1,438 |
Weighted average period for recognition of compensation cost related to unvested stock awards | 1 year 11 months 12 days |
SHAREHOLDERS' EQUITY - COMPENSA
SHAREHOLDERS' EQUITY - COMPENSATION COST RELATED TO EQUITY-BASED AWARDS (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Stock-based compensation costs | ||
Allocated share based compensation expense | $ 599 | $ 382 |
Research and development | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | 90 | 82 |
Sales and marketing | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | 5 | 10 |
General and administrative | ||
Stock-based compensation costs | ||
Allocated share based compensation expense | $ 504 | $ 290 |
WARRANTS TO PURCHASE ORDINARY33
WARRANTS TO PURCHASE ORDINARY SHARES (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 04, 2016 | Sep. 30, 2016 | Sep. 30, 2016 |
Assumptions used in determination of fair value | |||
Liability related to warrants | $ 11,076 | $ 11,076 | |
Financial expense as a result of change in the warrants' fair value | 1,507 | ||
Warrant to purchase ordinary shares | |||
Assumptions used in determination of fair value | |||
Liability related to warrants | 11,076 | 11,076 | |
Financial expense as a result of change in the warrants' fair value | $ 1,507 | $ 1,507 | |
Warrant to purchase ordinary shares | Monte Carlo | |||
Assumptions used in determination of fair value | |||
Risk-free interest rate (1) | 1.03% | 1.12% | |
Expected volatility (2) | 72.70% | 70.40% | |
Expected life (in years) (3) | 5 years | 4 years 10 months 2 days | |
Expected dividend yield (4) | 0.00% | 0.00% | |
Fair value per warrant | $ 1.46 | $ 1.69 | $ 1.69 |
FAIR VALUE MEASUREMENT (Details
FAIR VALUE MEASUREMENT (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrants to purchase Ordinary Shares | $ (11,076) | |
Warrant to purchase ordinary shares | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrants to purchase Ordinary Shares | (11,076) | |
Fair Value | Recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
RRAs | 13,000 | $ 31,000 |
Total | 17,364 | 31,000 |
Fair Value | Recurring basis | MMFs | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
MMFs | 15,440 | |
Fair Value | Recurring basis | Warrant to purchase ordinary shares | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrants to purchase Ordinary Shares | (11,076) | |
Level 1 | Fair Value | Recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 15,440 | |
Level 1 | Fair Value | Recurring basis | MMFs | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
MMFs | 15,440 | |
Level 2 | Fair Value | Recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
RRAs | 13,000 | 31,000 |
Total | 13,000 | $ 31,000 |
Level 3 | Fair Value | Recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | (11,076) | |
Level 3 | Fair Value | Recurring basis | Warrant to purchase ordinary shares | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrants to purchase Ordinary Shares | $ (11,076) |
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, 2016USD ($) | |
Warrants Liabilities Roll Forward | |
Fair value of warrants issued to investors | $ 9,569 |
Revaluation of fair value of warrants to purchase Ordinary Shares | 1,507 |
Balance, Ending | $ 11,076 |
SELECTED STATEMENTS OF COMPRE36
SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Financial expenses (income), net: | ||||
Interest expense and bank fees | $ 87 | $ 36 | ||
Interest income | (59) | |||
Revaluation of fair value of warrants to purchase Convertible Preferred Shares | (40) | |||
Allocation of issuance costs related to warrants to purchase Ordinary Shares | 784 | |||
Revaluation of fair value of warrants to purchase Ordinary Shares | 1,507 | |||
Foreign currency translation adjustments | (142) | (65) | ||
Financial expenses (income), net | $ 2,260 | $ (58) | 2,177 | (69) |
Numerator: | ||||
Net loss | $ 10,006 | $ 5,941 | 23,437 | 18,422 |
Dividends accumulated for the period | 988 | |||
Net loss available to shareholders of Ordinary shares | $ 23,437 | $ 19,410 | ||
Denominator: | ||||
Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share | 17,646,450 | 13,581,160 | 14,949,237 | 9,586,245 |
Preferred stock dividend rate (as a percent) | 8.00% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent events. - Amended and Restated 2009 Stock Incentive Plan | Oct. 05, 2016directorshares |
Subsequent events | |
Automatic annual increase in authorized number of ordinary shares available for future grant under stock option plan (as a percent) | 4.00% |
Stock options, non-employee directors | |
Subsequent events | |
Number of non-employee directors earned automatic annual stock option grant | director | 6 |
Options granted (in shares) | shares | 3,875 |