SteadyMed (STDY) 10-Q 14 Aug 18 2018 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2018	Aug. 01, 2018
Document and Entity Information
Entity Registrant Name	SteadyMed Ltd.
Entity Central Index Key	1,619,087
Document Type	10-Q
Document Period End Date	Jun. 30, 2018
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		26,742,788
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q2

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2018	Dec. 31, 2017
CURRENT ASSETS:
Cash and cash equivalents	$ 21,129	$ 32,453
Other accounts receivable and prepaid expenses	340	507
Total current assets	21,469	32,960
Long term deposit	74	73
Severance pay fund	153	151
Property and equipment, net	6,134	5,307
Total assets	27,830	38,491
CURRENT LIABILITIES:
Trade payables	1,646	1,291
Other accounts payable and accrued expenses	2,829	1,465
Total current liabilities	4,475	2,756
NON-CURRENT LIABILITIES:
Accrued severance pay	211	203
Liability related to warrants	18,436	11,343
Other accounts payable	390	378
Total non-current liabilities	19,037	11,924
COMMITMENTS AND CONTINGENT LIABILITIES
SHAREHOLDERS' EQUITY:
Ordinary Shares of NIS 0.01 par value - Authorized: 50,000,000 at June 30, 2018 and December 31, 2017; Issued and outstanding: 26,742,788 at June 30, 2018 (unaudited) and 26,572,719 at December 31, 2017	69	69
Additional paid-in capital	137,049	136,117
Accumulated deficit	(132,800)	(112,375)
Total shareholders' equity	4,318	23,811
Total liabilities and shareholders' equity	$ 27,830	$ 38,491

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares	Jun. 30, 2018	Dec. 31, 2017
Ordinary Shares Disclosures
Ordinary Shares, par value per share	₪ 0.01	₪ 0.01
Ordinary Shares, shares authorized	50,000,000	50,000,000
Ordinary share, Issued shares	26,742,788	26,572,719
Ordinary Shares, shares outstanding	26,742,788	26,572,719

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017	Jun. 30, 2018	Jun. 30, 2017
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Revenues		$ 319		$ 634
Operating expenses:
Research and development	$ 3,981	3,530	$ 7,902	7,631
Sales and marketing	130	363	266	951
General and administrative	3,179	1,226	5,202	2,542
Total operating expenses	7,290	5,119	13,370	11,124
Total operating loss	7,290	4,800	13,370	10,490
Financial expenses, net	2,755	3,207	6,914	15,929
Loss before taxes on income	10,045	8,007	20,284	26,419
Taxes on income	25	139	141	287
Net loss	$ 10,070	$ 8,146	$ 20,425	$ 26,706
Net loss per share:
Basic and diluted net loss per Ordinary Share	$ 0.38	$ 0.33	$ 0.77	$ 1.20
Weighted-average number of Ordinary Shares used to compute basic and diluted net loss per share	26,596,407	24,335,774	26,584,628	22,249,391

STATEMENT OF CHANGES IN SHAREHO

STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands		Ordinary SharesRestricted share units		Ordinary Shares		Additional paid-in capitalRestricted share units	[3]	Additional paid-in capital	Receivables on account of shares		Accumulated deficit	Total
Balance, beginning at Dec. 31, 2017				$ 69				$ 136,117			$ (112,375)	$ 23,811
Balance, beginning (in shares) at Dec. 31, 2017				26,572,719
Increase (decrease) in Stockholders' Equity
Stock-based compensation								813				813
Exercise of options				$ 1	[1]			151	$ (32)	[2]		119
Exercise of options (in shares)				46,220
Exercise of warrants	[1]			$ 1								1
Exercise of warrants (in shares)				10,191
RSUs released		$ 1	[1]			$ (1)
RSUs released (in shares)		113,658
Net loss											(20,425)	(20,425)
Balance, ending at Jun. 30, 2018				$ 69				$ 137,081	$ (32)		$ (132,800)	$ 4,318
Balance, ending (in shares) at Jun. 30, 2018				26,742,788
[1]	Represents a positive amount lower than $1.
[2]	An amount of $32 was not received as of June 30, 2018.
[3]	Represents a negative amount higher than ($1).

STATEMENT OF CHANGES IN SHAREH6

STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) $ in Thousands	Jun. 30, 2018USD ($)
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Receivables on exercise of options	$ 32

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
Cash flows from operating activities:
Net loss	$ (20,425)	$ (26,706)
Adjustments required to reconcile net loss to net cash used in operating activities:
Stock-based compensation	813	477
Depreciation and impairment of property and equipment	446	386
Accrued severance pay, net	6	8
Re-evaluation of fair value of warrants to purchase Ordinary Shares	7,093	15,496
Decrease (increase) in other accounts receivable and prepaid expenses	169	(52)
Issuance costs related to warrants to purchase Ordinary Shares		441
Decrease in deferred revenue		(635)
Increase (decrease) in trade payables	355	(742)
Increase (decrease) in other accounts payable and accrued expenses	1,322	(608)
Net cash used in operating activities	(10,221)	(11,935)
Cash flows from investing activities:
Purchase of property and equipment	(1,219)	(887)
Decrease (increase) in long-term deposit	(3)	56
Net cash used in investing activities	(1,222)	(831)
Cash flows from financing activities:
Proceeds from warrants exercised		4,866
Proceeds from options exercised	119	119
Proceeds from issuance of Ordinary Shares and warrants, net of issuance costs		28,110
Net cash provided by financing activities	119	33,095
Net increase (decrease) in cash and cash equivalents	(11,324)	20,329
Cash and cash equivalents at the beginning of the period	32,453	23,215
Cash and cash equivalents at the end of the period	21,129	43,544
Supplemental disclosure of non-cash investing and financing activities:
Purchase of property and equipment	54	33
Exercise of warrants into Ordinary Shares		5,177
Cash paid during the period:
Cash paid for taxes	$ 35	$ 220

GENERAL

GENERAL	6 Months Ended
	Jun. 30, 2018
GENERAL
GENERAL	NOTE 1: - GENERAL a. SteadyMed Ltd. (the “Company” or “SteadyMed”) 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 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. A Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA took place on November 1, 2017. Management believes that the meeting was constructive and that the Company will be able to sufficiently address the FDA’s concerns. The Company revised its operating plan and is focused on re-submitting the NDA in the fourth quarter of 2018. 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 six months ended June 30, 2018, the Company incurred operating losses of $13,370 and negative cash flows from operating activities of $10,221. 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. These factors raise substantial doubt about the Company’s ability 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 April 29, 2018, the Company entered into a definitive merger agreement (the “Merger Agreement”) with United Therapeutics Corporation (“United Therapeutics”) and Daniel 24043 Acquisition Corp. Ltd., a company organized under the laws of Israel and a wholly-owned subsidiary of United Therapeutics (the “Merger Sub”), pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth therein the Merger Sub will merge with and into the Company, with the Company continuing as the surviving entity and becoming a wholly-owned, subsidiary of United Therapeutics. The transaction is valued at $216 million, including the $75 million in contingent consideration. As a result of the merger, and subject to the terms and conditions of the Merger Agreement, (a) each outstanding ordinary share of the Company (other than any shares held as treasury stock, all of which will be cancelled) will be converted into the right to receive (1) $4.46 in cash (“Closing Cash Consideration”), subject to applicable tax withholding, without interest, plus (2) one contractual contingent value right (each, a “CVR”), which will represent the right to receive $2.63 in cash (“Contingent Consideration”) upon the achievement of a milestone related to the commercialization of Trevyent® (the “Milestone”), subject to applicable tax withholding, without interest, (b) each outstanding in-the-money Company stock option, whether vested or unvested, that has not previously been exercised prior to the merger will be converted into the right to receive (1) a cash payment equal to (x) the excess, if any, of Closing Cash Consideration over the exercise price payable under such option, multiplied by (y) the total number of shares subject to such option immediately prior to the merger and (2) a number of CVRs equal to the total number of shares subject to such option immediately prior to the merger, (c) each outstanding out-of-the-money Company stock option, whether vested or unvested, that has not previously been exercised prior to the merger will be converted into the right to receive a cash payment, if and when the Milestone is achieved, equal to (x) the excess, if any, of the sum of (1) Closing Cash Consideration and (2) the Contingent Consideration actually payable per CVR over the exercise price payable under such option, multiplied by (y) the total number of shares subject to such option immediately prior to the merger (and any out-of-the-money options with an exercise price equal to or greater than $7.09 will be cancelled at the merger without any consideration payable therefor), (d) each outstanding Company restricted share unit, whether vested or unvested, will be converted into the right to receive (1) a cash payment equal to (x) the Closing Cash Consideration, multiplied by (y) the total number of shares subject to such restricted share unit and (2) a number of CVRs equal to the total number of shares subject to such restricted share unit, (e) each outstanding warrant to purchase ordinary shares of the Company, as amended, issued pursuant to subscription agreements dated April 20, 2017 will be converted into the right to receive $2.33 for each share subject to such warrant immediately prior to the merger and (f) each outstanding warrant to purchase ordinary shares of the Company, as amended, issued pursuant to subscription agreements dated July 29, 2016 will be converted into the right to receive $2.71 for each share subject to such warrant immediately prior to the merger. The closing of the merger is subject to customary closing conditions, including the expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (which expired on July 19, 2018) and the approval of the Merger Agreement by SteadyMed’s shareholders (which was obtained on July 30, 2018) (See also Note 10). Under Israeli law, the closing may not occur until at least thirty days have passed since the shareholders approved the Merger Agreement. Subjected to remaining closing conditions, the transaction is expected to close in the third quarter of 2018. 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”). During March 2018, Cardiome licensed the Canadian rights to Trevyent to Cipher Pharmaceuticals. The Company provided certain services for Cardiome 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 (the “Upfront”) 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.

UNAUDITED INTERIM CONSOLIDATED

UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS	6 Months Ended
	Jun. 30, 2018
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 June 30, 2018. Consolidated results of operations for the six and three-month periods ended June 30, 2018 and 2017 and consolidated cash flows for the six-month periods ended June 30, 2018 and 2017, have been included. The results for the six and three-month period ended June 30, 2018 are not necessarily indicative of the results that may be expected for the year ended December 31, 2018. The accompanying unaudited interim consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2017 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 30, 2018 with the SEC.

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES	6 Months Ended
	Jun. 30, 2018
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, 2017 filed with the SEC on March 30, 2018 pursuant to the Exchange Act, are applied consistently in these unaudited interim consolidated financial statements, except for: a. Revenue recognition: In May 2014, FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12, and 2016-20, respectively. Under the standard, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. The Company may enter into contracts that can include various combinations of products and services, which are generally capable of being distinct and accounted for as separate performance obligations. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted ASU 2014-09 effective January 1, 2018, using the modified retrospective transition method. The impact of the adoption of this standard on the Company’s accumulated deficit as of January 1, 2018 was nil. The Company allocates the total consideration under each arrangements to the related performance obligations using the best estimate of the standalone selling price of each distinct good or service in the contract. The Company will recognize revenues for its arrangements over time or at a point in time depending on its evaluation of when the customer obtains control of the promised goods or services. b. Recently issued and adopted accounting standards: In May 2017, the FASB issued ASU 2017-09, “Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting.” ASU 2017-09 was issued to provide clarity and reduce both 1) diversity in practice and 2) cost and complexity when applying the guidance in Topic 718 to a change in the terms or conditions of a share-based payment award. ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting under Topic 718. The Company adopted ASU 2017-09 during the first quarter of 2018. The adoption of this new guidance had no impact on the Company’s consolidated financial statements. c. New accounting standards not yet effective: 1. 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. 2. 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.

WARRANTS TO PURCHASE ORDINARY S

WARRANTS TO PURCHASE ORDINARY SHARES	6 Months Ended
	Jun. 30, 2018
WARRANTS TO PURCHASE ORDINARY SHARES
WARRANTS TO PURCHASE ORDINARY SHARES	NOTE 4: - WARRANTS TO PURCHASE ORDINARY SHARES In August 2016 and April 2017, as part of its financing rounds, the Company issued 6,554,016 and 2,515,775 warrants to purchase Ordinary Shares of the Company, nominal value NIS 0.01 per share with an exercise price of $3.5995 and $6.785 per warrant, respectively. The warrants are exercisable immediately upon issuance and may be exercised at any time prior to August 2021 and April 2022, respectively. The Company and all holders of outstanding warrants have entered into amendments to such warrants (the “Warrant Amendments”). Under the Warrant Amendments, in the event the merger is consummated by December 31, 2018, the warrants will not be assumed by United Therapeutics or Merger Sub, and instead the warrants will be cancelled and converted into the right to receive $2.33 for each share issuable upon exercise of a warrant issued in 2017 and $2.71 for each share issuable upon exercise of a warrants issued in 2016. The Warrant Amendments will terminate if the Merger is not consummated by December 31, 2018 (See also Note 1). On May 25, 2017, 1,351,766 warrants that were issued in August 2016 were exercised into ordinary shares. The Company accounted for the warrants 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. As of June 30, 2018, the Company is using both market approach and Income approach (Monte Carlo Simulation Method) in estimating the fair value of the warrants. The assumptions used under the market approach reflect the consideration to the warrants holders upon consummation of the Merger Agreement under which United Therapeutics will acquire the Company. The fair value per warrant issued in August 2016, as of June 30, 2018 and December 31, 2017 is $2.52 and $1.60, respectively. The fair value per warrant issued in April 2017, as of June 30, 2018 and December 31, 2017 is $2.13 and $1.20, respectively. The following assumptions were used in the Monte Carlo option pricing model and the fair value of the warrants. Warrants issued on August 2016: June 30, December 31, 2018 2017 Unaudited Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) Expected dividend yield (4) % % Warrants issued on April 2017: June 30, December 31, 2018 2017 Unaudited Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) Expected dividend yield (4) % % (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 June 30, 2018 and consequently during the six months periods ended June 30, 2018, the Company recorded $7,093 as a financial expense as a result of increase in the warrants’ fair value predominantly due to the terms of the amended warrant agreements. Total fair value of the warrants as of June 30, 2018, is $18,436.

FAIR VALUE MEASUREMENT

FAIR VALUE MEASUREMENT	6 Months Ended
	Jun. 30, 2018
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT	NOTE 5: - 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: Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2: Observable inputs that reflect quoted prices for identical assets or liabilities in markets that are not active; quoted prices for similar assets or liabilities in active markets; inputs other than quoted prices that are observable for the assets or liabilities; or inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3: Unobservable inputs reflecting the Company’s own assumptions incorporated in valuation techniques used to determine fair value. These assumptions are required to be consistent with market participant assumptions that are reasonably available. 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, 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: Assets: June 30, 2018 Fair value measurements Unaudited Description Fair value Level 1 Level 2 Level 3 Reverse Repurchase Agreements $ $ — $ $ — Money Market Funds — — Total financial assets $ $ $ $ — December 31, 2017 Fair value measurements Description Fair value Level 1 Level 2 Level 3 Reverse Repurchase Agreements $ $ — $ $ — Money Market Funds — — Total financial assets $ $ $ $ — Liabilities: June 30, 2018 Fair value measurements Unaudited Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) Total financial liabilities $ ) $ — $ — $ ) December 31, 2017 Fair value measurements Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) Total financial liabilities $ ) $ — $ — $ ) The following tabular presentation reflects the components of the liability associated with such warrants to purchase Ordinary Shares as of June 30, 2018: Fair value Balance at January 1, 2018 $ Increase in the fair value of the warrants (see Note 4) Balance at June 30, 2018 (unaudited) $

COMMITMENTS AND CONTINGENT LIAB

COMMITMENTS AND CONTINGENT LIABILITIES	6 Months Ended
	Jun. 30, 2018
COMMITMENTS AND CONTINGENT LIABILITIES
COMMITMENTS AND CONTINGENT LIABILITIES	NOTE 6: - COMMITMENTS AND CONTINGENT LIABILITIES a. The Company’s lease agreement for the Israeli offices expires on December 31, 2018. The Company has an option to extend the lease term for an additional three periods of twelve months each. On August 1, 2018 the Company provided a written notice to the lessor exercising the option to extend the lease term by an additional twelve months. Inc.’s lease agreement for its U.S. offices has a four-year term ending May 2019. The Company’s total future minimum aggregate lease commitments under non-cancelable operating lease agreements as of June 30, 2018 is $308 (exclusive of the extension of the Israeli offices lease term by 12 months as described above). b. During the years 2005 - 2010, the Company received grants under the royalty-bearing programs administered by the Israel Innovation Authority (the “IIA”), (previously the Office of the Chief Scientist (“OCS”)), and from the Incubator, RAD BioMed Ltd. In May 2015, the IIA 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 and all such royalties due have been paid. As of June 30, 2018, the total amount of grants received from the IIA and the Incubator, including interest, was $791 and total royalties paid were $90. In the event that intellectual property rights are deemed to be transferred out of Israel, the grants received from the IIA 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 $471 as of June 30, 2018.

SHAREHOLDERS' EQUITY

SHAREHOLDERS' EQUITY	6 Months Ended
	Jun. 30, 2018
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY	NOTE 7: - SHAREHOLDERS’ EQUITY a. Warrants: In 2012 as part of a private placement, the Company issued warrants that were originally exercisable into Convertible Preferred Shares and prior to the Company’s IPO in 2015, were automatically converted into warrants to purchase Ordinary Shares at the share par value of NIS 0.01. The majority of the warrants that were issued prior to the IPO were exercised prior to the IPO and the remaining warrants to purchase 10,191 Ordinary Shares were exercised in April 2018. b. Stock-based compensation: On June 18, 2009, a Stock Option Plan (the “2009 Plan”) was adopted by the Board of Directors of the Company. 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 and each option granted under the 2009 Plan 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 and Restated Plan”). This action was approved by the shareholders on March 1, 2015. The Amended and Restated Plan also allows the issuance of Restricted Stock Units (“RSUs”) and under the Amended and Restated 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 six months ended June 30, 2018, were as follows: Number of Weighted Weighted Aggregate options price (years) value Unaudited Options outstanding at January 1, 2018 $ $ Options exercised ) — — Options forfeited ) — — Options outstanding at end of the period Options vested at end of the period $ $ 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 six months period ended June 30, 2018 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 June 30, 2018. This amount is impacted by the changes in the fair market value of the Company’s shares. A summary of RSUs activity during the six months ended June 30, 2018, were as follows: Number of Weighted Aggregate Unaudited Unvested at January 1, 2018 $ $ RSUs vested ) RSUs forfeited ) — Unvested at end of the period $ $ 113,658 RSUs vested on June 30, 2018 and the remainder will vest on the approval of the Trevyent NDA by the FDA. On December 12, 2017, the Board of Directors reserved an additional 805,593 Ordinary Shares out of its authorized and unissued share capital for future option grants. As of June 30, 2018, the Company has 1,408,032 Ordinary Shares available for future grant under the Amended and Restated Plan. As of June 30, 2018, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $1,382, which is expected to be recognized over a weighted average period of approximately 2.12 years. The total compensation cost related to all of the Company’s equity-based awards, recognized during the six months ended June 30, 2018 and 2017 was comprised as follows: Six months ended 2018 2017 Unaudited Research and development $ $ Sales and marketing General and administrative $ $

SELECTED STATEMENTS OF OPERATIO

SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS	6 Months Ended
	Jun. 30, 2018
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, net: Six months ended 2018 2017 Unaudited Financial expenses: Reevaluation of fair value of warrants to purchase Ordinary Shares $ $ Issuance costs related to warrants to purchase Ordinary Shares — Interest expense and bank fees Foreign currency translation adjustments — Financial income: Interest income $ $ Foreign currency translation adjustments — Total financial expense, net $ $

LITIGATION

LITIGATION	6 Months Ended
	Jun. 30, 2018
LITIGATION
LITIGATION	NOTE 9: - LITIGATION a. On May 31, 2017, United Therapeutics Corporation (“United Therapeutics”) 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 Therapeutics, which expires in December 2028 and covers a method of making treprostinil, the active pharmaceutical ingredient in United Therapeutics’ 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. On November 14, the Court of Appeals upheld the PTAB ruling in our favor without issuing an opinion. On February 9, 2018, United Therapeutics filed a writ of certiorari with the U.S. Supreme Court asking for a review of the appellate ruling in view of another case pending before the Supreme Court challenging the constitutionality of IPR proceedings. On April 24, 2018, the Supreme Court ruled that IPRs are constitutional in the above pending case, and United Therapeutics has told the Company that it will withdraw the petition. b. The Company has a commercial dispute with one of its suppliers as a result of the Company’s termination of a development agreement in 2017, whereby the supplier alleges wrongful termination and certain breaches of the agreement by the Company. As of June 30, 2018, the Company believes that the claims have no merit and the dispute is in its early stages. c. Three plaintiffs, Richard Scarantino, Australia A. Hoover and Donald Skinner, have filed separate putative class action lawsuits on June 27, 2018, June 27, 2018 and June 29, 2018, respectively, each in the United States District Court for the Northern District of California, each purportedly on behalf of the shareholders of SteadyMed, against SteadyMed and its directors and each alleging, among other things, violations of sections 14(a) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 14a-9 thereunder. The complaints in these actions each seek, among other things, to enjoin the defendants from completing the previously announced proposed merger transaction by which SteadyMed will become a wholly-owned subsidiary of United Therapeutics Corporation (the “Merger”). On July 6, 2018, plaintiff Hoover filed a motion for preliminary injunction, seeking to enjoin the Merger from proceeding until certain disclosures were made to shareholders in addition to those included in the proxy statement issued in connection with the merger (the “Proxy Statement”). On July 16, 2018, SteadyMed provided certain additional disclosures in a supplement to the Proxy Statement filed with the SEC (the “Supplemental Disclosures”). On July 19, 2018 and July 20, 2018, respectively, plantiffs Skinner and Hoover filed notices of voluntary dismissal of their actions without prejudice as moot, Counsel for plantiff Scarantino has confirmed that the Supplemental Disclosures moot their claims in that action and that it will likewise be dismissed. As stated in the Supplemental Disclosures, the Supplemental Disclosures should not be taken to indicate that SteadyMed or its affiliates, officers, directors or other representatives, or any recipient of this information, considered the information contained in the Supplemental Disclosures to be material; rather, SteadyMed believes that the Proxy Statement disclosed all required material information.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	6 Months Ended
	Jun. 30, 2018
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	NOTE 10 — SUBSEQUENT EVENTS a. As described in Note 1c, the closing of the merger is subject to customary closing conditions, including the expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act which expired on July 19, 2018 and the approval by SteadyMed’s shareholders which was obtained at an Extraordinary General Meeting of the shareholders that took place on July 30, 2018. Under Israeli law, the closing may not occur until at least thirty days have passed since the shareholders approved the Merger Agreement. Subjected to remaining closing conditions, the transaction is expected to close in the third quarter of 2018.

SIGNIFICANT ACCOUNTING POLICI18

SIGNIFICANT ACCOUNTING POLICIES (Policies)	6 Months Ended
	Jun. 30, 2018
SIGNIFICANT ACCOUNTING POLICIES
Revenue recognition	a. Revenue recognition: In May 2014, FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12, and 2016-20, respectively. Under the standard, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. The Company may enter into contracts that can include various combinations of products and services, which are generally capable of being distinct and accounted for as separate performance obligations. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted ASU 2014-09 effective January 1, 2018, using the modified retrospective transition method. The impact of the adoption of this standard on the Company’s accumulated deficit as of January 1, 2018 was nil. The Company allocates the total consideration under each arrangements to the related performance obligations using the best estimate of the standalone selling price of each distinct good or service in the contract. The Company will recognize revenues for its arrangements over time or at a point in time depending on its evaluation of when the customer obtains control of the promised goods or services.
Recently issued and adopted accounting standards	b. Recently issued and adopted accounting standards: In May 2017, the FASB issued ASU 2017-09, “Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting.” ASU 2017-09 was issued to provide clarity and reduce both 1) diversity in practice and 2) cost and complexity when applying the guidance in Topic 718 to a change in the terms or conditions of a share-based payment award. ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting under Topic 718. The Company adopted ASU 2017-09 during the first quarter of 2018. The adoption of this new guidance had no impact on the Company’s consolidated financial statements.
New accounting standards not yet effective	c. New accounting standards not yet effective: 1. 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. 2. 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.

WARRANTS TO PURCHASE ORDINARY19

WARRANTS TO PURCHASE ORDINARY SHARES (Tables)	6 Months Ended
	Jun. 30, 2018
Warrants issued on August 2016
Warrants to purchase ordinary shares
Schedule of assumptions used in estimating fair value of warrants	June 30, December 31, 2018 2017 Unaudited Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) Expected dividend yield (4) % % (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
Warrants to purchase ordinary shares
Schedule of assumptions used in estimating fair value of warrants	June 30, December 31, 2018 2017 Unaudited Risk-free interest rate (1) % % Expected volatility (2) % % Expected life (in years) (3) Expected dividend yield (4) % % (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)	6 Months Ended
	Jun. 30, 2018
FAIR VALUE MEASUREMENT
Schedule of financial assets and liabilities measured at fair value on recurring basis	Assets: June 30, 2018 Fair value measurements Unaudited Description Fair value Level 1 Level 2 Level 3 Reverse Repurchase Agreements $ $ — $ $ — Money Market Funds — — Total financial assets $ $ $ $ — December 31, 2017 Fair value measurements Description Fair value Level 1 Level 2 Level 3 Reverse Repurchase Agreements $ $ — $ $ — Money Market Funds — — Total financial assets $ $ $ $ — Liabilities: June 30, 2018 Fair value measurements Unaudited Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) Total financial liabilities $ ) $ — $ — $ ) December 31, 2017 Fair value measurements Description Fair value Level 1 Level 2 Level 3 Warrants to purchase Ordinary Shares $ ) $ — $ — $ ) Total financial liabilities $ ) $ — $ — $ )
Tabular presentation of components of liability associated with warrants to purchase Ordinary Shares	Fair value Balance at January 1, 2018 $ Increase in the fair value of the warrants (see Note 4) Balance at June 30, 2018 (unaudited) $

SHAREHOLDERS' EQUITY (Tables)

SHAREHOLDERS' EQUITY (Tables)	6 Months Ended
	Jun. 30, 2018
SHAREHOLDERS' EQUITY
Schedule of stock options	Number of Weighted Weighted Aggregate options price (years) value Unaudited Options outstanding at January 1, 2018 $ $ Options exercised ) — — Options forfeited ) — — Options outstanding at end of the period Options vested at end of the period $ $
Summary of restricted share units activity	Number of Weighted Aggregate Unaudited Unvested at January 1, 2018 $ $ RSUs vested ) RSUs forfeited ) — Unvested at end of the period $ $
Schedule of total compensation cost related to all of the Company's equity-based awards	Six months ended 2018 2017 Unaudited Research and development $ $ Sales and marketing General and administrative $ $

SELECTED STATEMENTS OF OPERAT22

SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Tables)	6 Months Ended
	Jun. 30, 2018
SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Schedule of financial expense, net	Six months ended 2018 2017 Unaudited Financial expenses: Reevaluation of fair value of warrants to purchase Ordinary Shares $ $ Issuance costs related to warrants to purchase Ordinary Shares — Interest expense and bank fees Foreign currency translation adjustments — Financial income: Interest income $ $ Foreign currency translation adjustments — Total financial expense, net $ $

GENERAL (Details)

GENERAL (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2018USD ($)	Jun. 30, 2017USD ($)	Jun. 30, 2018USD ($)product	Jun. 30, 2017USD ($)
Organizational disclosures
Operating losses	$ 7,290	$ 4,800	$ 13,370	$ 10,490
Negative cash flows from operating activities			$ 10,221	$ 11,935
Products for the treatment of post-surgical and acute pain in the home setting
Organizational disclosures
Number of products in development | product			2

GENERAL - EXCLUSIVE LICENSE AND

GENERAL - EXCLUSIVE LICENSE AND SUPPLY AGREEMENT (Details) - USD ($) $ / shares in Units, $ in Thousands	Apr. 29, 2018	Jun. 28, 2015
Cardiome | Collaboration
Exclusive 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
United Therapeutics | Steady Med
Exclusive License and Supply Agreement
Transaction value	$ 216,000
Contingent consideration	$ 75,000
Acquisition share price	$ 4.46
Additional acquisition share price contingent upon commercialization of steadyMed's Trevyent Product	2.63
Maximum exercise price of options to receive consideration	7.09
Right to receive consideration for each outstanding warrant issued pursuant to 2017 subscription agreement	2.33
Right to receive consideration for each outstanding warrant issued pursuant to 2016 subscription agreement	$ 2.71

SIGNIFICANT ACCOUNTING POLICI25

SIGNIFICANT ACCOUNTING POLICIES - REVENUE RECOGNITION (Details) $ in Thousands	Jan. 01, 2018USD ($)
ASU 2014-09
Revenue recognition
Cumulative impact of accumulated deficit	$ 0

WARRANTS TO PURCHASE ORDINARY26

WARRANTS TO PURCHASE ORDINARY SHARES (Details) $ / shares in Units, $ in Thousands	May 25, 2017shares	Apr. 30, 2017₪ / sharesshares	Aug. 31, 2016₪ / sharesshares	Jun. 30, 2018USD ($)	Jun. 30, 2017USD ($)	Dec. 31, 2017₪ / shares	Jun. 30, 2018₪ / shares	Jun. 30, 2018USD ($)$ / shares	Dec. 31, 2017USD ($)$ / shares	Apr. 30, 2017$ / shares	Aug. 31, 2016$ / shares
Assumptions used in determination of fair value
Ordinary share, nominal value (in dollars per share) | ₪ / shares						₪ 0.01	₪ 0.01
Financial expense as a result of increase in warrants' fair value | $				$ 7,093	$ 15,496
Fair value of the warrants | $								$ 18,436	$ 11,343
Warrant to purchase Ordinary Shares
Assumptions used in determination of fair value
Issued of warrants into Ordinary Shares (in shares) | shares		2,515,775	6,554,016
Ordinary share, nominal value (in dollars per share) | ₪ / shares		₪ 0.01	₪ 0.01
Exercise price of warrants (in dollars per share)										$ 6.785	$ 3.5995
Financial expense as a result of increase in warrants' fair value | $				$ 7,093
Fair value of the warrants | $								$ 18,436
Warrants issued on August 2016
Assumptions used in determination of fair value
Exercise of warrants into Ordinary Shares (in shares) | shares	1,351,766
Price of warrant exercised after merger (in dollars per share)								$ 2.71
Warrants issued on August 2016 | Monte Carlo Option Pricing Model
Assumptions used in determination of fair value
Risk-free interest rate (as a percent)				2.67%		2.12%
Expected volatility (as a percent)				79.80%		76.30%
Expected life (in years)				3 years 1 month 2 days		3 years 7 months 2 days
Expected dividend yield (as a percent)				0.00%		0.00%
Fair value per warrant (in dollars)								2.52	$ 1.60
Warrants issued on April 2017
Assumptions used in determination of fair value
Price of warrant exercised after merger (in dollars per share)								2.33
Warrants issued on April 2017 | Monte Carlo Option Pricing Model
Assumptions used in determination of fair value
Risk-free interest rate (as a percent)				2.67%		2.12%
Expected volatility (as a percent)				79.80%		76.30%
Expected life (in years)				3 years 9 months 26 days		4 years 3 months 26 days
Expected dividend yield (as a percent)				0.00%		0.00%
Fair value per warrant (in dollars)								$ 2.13	$ 1.20

FAIR VALUE MEASUREMENT (Details

FAIR VALUE MEASUREMENT (Details) - USD ($) $ in Thousands	Jun. 30, 2018	Dec. 31, 2017
Liabilities:
Warrants to purchase Ordinary Shares	$ (18,436)	$ (11,343)
Recurring basis
Assets:
Reverse Repurchase Agreements	18,604	30,407
Money Market Funds	172	185
Total financial assets	18,776	30,592
Liabilities:
Warrants to purchase Ordinary Shares	(18,436)	(11,343)
Total financial liabilities	(18,436)	(11,343)
Level 1 | Recurring basis
Assets:
Money Market Funds	172	185
Total financial assets	172	185
Level 2 | Recurring basis
Assets:
Reverse Repurchase Agreements	18,604	30,407
Total financial assets	18,604	30,407
Level 3 | Recurring basis
Liabilities:
Warrants to purchase Ordinary Shares	(18,436)	(11,343)
Total financial liabilities	$ (18,436)	$ (11,343)

FAIR VALUE MEASUREMENT - WARRAN

FAIR VALUE MEASUREMENT - WARRANTS TO PURCHASE ORDINARY SHARES (Details) - Warrant to purchase Ordinary Shares $ in Thousands	6 Months Ended
	Jun. 30, 2018USD ($)
Warrants Liabilities Roll Forward
Balance, beginning of the period	$ 11,343
Increase in the fair value of the warrants (see Note 4)	7,093
Balance, end of the period	$ 18,436

COMMITMENTS AND CONTINGENT LI29

COMMITMENTS AND CONTINGENT LIABILITIES - LEASES (Details) $ in Thousands	Aug. 01, 2018	Jun. 30, 2018USD ($)period
Operating lease agreement
Total lease obligation | $		$ 308
Israel
Operating lease agreement
Number of periods to extend the lease term | period		3
Renewal lease term		12 months
Additional lease extension term per option exercised	12 months
San Ramon, California
Operating lease agreement
Lease term		4 years

COMMITMENTS AND CONTINGENT LI30

COMMITMENTS AND CONTINGENT LIABILITIES - OTHER COMMITMENTS (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2018USD ($)
Purchase obligations
Non-cancellable commitments to suppliers for purchases	$ 471
Combined OCS and Incubator, RAD Biomed Ltd
Royalties
Grants received	$ 791
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	$ 90
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	Jun. 18, 2009	Apr. 30, 2018	Dec. 31, 2015
Private placement
Stock-based compensation
Exercise price of warrants (in dollars per share)				₪ 0.01
Warrants outstanding (in shares)			10,191
2009 Plan | Stock options, all inclusive recipients
Stock-based compensation
Vesting period		3 years
Expiration period		7 years
Amended and Restated 2009 Stock Incentive Plan
Stock-based compensation
Expiration period	10 years

SHAREHOLDERS' EQUITY - OPTIONS

SHAREHOLDERS' EQUITY - OPTIONS AND RESTRICTED SHARE UNITS ROLL FORWARD (Details) - USD ($)	6 Months Ended	12 Months Ended
	Jun. 30, 2018	Dec. 31, 2017	Dec. 12, 2017
2009 Plan | Stock options, all inclusive recipients
Aggregate intrinsic value
Shares available for future grant (in shares)			805,593
Amended 2009 Stock Plan | Stock options, employees and directors
Number of options
Options outstanding at beginning of period (in shares)	2,057,862
Options exercised (in shares)	(46,220)
Options forfeited (in shares)	(136,820)
Options outstanding at end of period (in shares)	1,874,822	2,057,862
Options vested at end of period (in shares)	1,267,854
Weighted average exercise price
Options outstanding at beginning of period (in dollars per share)	$ 4.03
Options exercised (in dollars per share)	3.25
Options forfeited (in dollars per share)	3.97
Options outstanding at end of period (in dollars per share)	4.06	$ 4.03
Options vested at end of period (in dollars per share)	$ 4.20
Weighted average remaining contractual life
Weighted average remaining contractual life, Outstanding (in years)	5 years 8 months 19 days	6 years 1 month 13 days
Weighted average remaining contractual life, Vested (in years)	4 years 1 month 17 days
Aggregate intrinsic value
Aggregate intrinsic value, Outstanding	$ 1,459,000	$ 384,000
Aggregate intrinsic value, Vested	$ 904,000
Amended and Restated 2009 Stock Incentive Plan
Aggregate intrinsic value
Shares available for future grant (in shares)	1,408,032
Amended and Restated 2009 Stock Incentive Plan | Restricted share units, employees and directors
Number of restricted share units
Unvested at beginning of period (in shares)	247,095
RSUs vested	$ (113,658)
RSUs forfeited	(19,787)
Unvested at end of period (in shares)	113,650	247,095
Weighted average grant date fair value
Unvested at beginning of period (in dollars per share)	$ 3.32
RSUs vested (in dollars per share)	3.34
RSUs forfeited (in dollars per share)	3.16
Unvested at end of period (in dollars per share)	$ 3.34	$ 3.32
Aggregate intrinsic value
Aggregate intrinsic value, Unvested at beginning of period	$ 914,000
Aggregate intrinsic value, RSU's vested	511,000
Aggregate intrinsic value, RSU's forfeited
Aggregate intrinsic value, Unvested at end of the period	$ 511,000	$ 914,000

SHAREHOLDERS' EQUITY - COMPENSA

SHAREHOLDERS' EQUITY - COMPENSATION COST RELATED TO NON-VESTED STOCK OPTIONS AND RSU's (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
Stock-based compensation costs
Allocated share based compensation expense	$ 813	$ 477
Research and development
Stock-based compensation costs
Allocated share based compensation expense	189	94
Sales and marketing
Stock-based compensation costs
Allocated share based compensation expense	37	31
General and administrative
Stock-based compensation costs
Allocated share based compensation expense	587	$ 352
Stock options, all inclusive recipients
Stock-based compensation costs
Total unrecognized compensation cost related to non-vested stock option awards	$ 1,382
Weighted average period for recognition of compensation cost related to unvested stock awards	2 years 1 month 13 days

SELECTED STATEMENTS OF OPERAT34

SELECTED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017	Jun. 30, 2018	Jun. 30, 2017
Financial expenses:
Reevaluation of fair value of warrants to purchase Ordinary Shares			$ 7,093	$ 15,496
Issuance costs related to warrants to purchase Ordinary Shares				441
Interest expense and bank fees			15	15
Foreign currency translation adjustments				61
Total financial expenses			7,108	16,013
Financial income:
Interest income			184	84
Foreign currency translation adjustments			10
Total financial income			194	84
Total financial expense, net	$ 2,755	$ 3,207	$ 6,914	$ 15,929