SteadyMed (STDY) 10-Q 15 Aug 16 2016 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2016	Aug. 14, 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	Jun. 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	Q2

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2016	Dec. 31, 2015
CURRENT ASSETS:
Cash and cash equivalents	$ 17,247	$ 31,851
Restricted cash	15	323
Other accounts receivable and prepaid expenses	527	288
Total current assets	17,789	32,462
LONG-TERM DEPOSITS	121	61
SEVERANCE PAY FUND	131	124
PROPERTY AND EQUIPMENT, NET	3,303	2,583
Total assets	21,344	35,230
CURRENT LIABILITIES:
Trade payables	1,422	1,572
Current maturity of loan		230
Deferred revenue	1,330	1,705
Other accounts payable and accrued expenses	2,322	2,333
Total current liabilities	5,074	5,840
NON-CURRENT LIABILITIES:
Deferred revenues	332	426
Accrued severance pay	183	159
Other accounts payable	258	258
Total non-current liabilities	773	843
COMMITMENTS AND CONTINGENT LIABILITIES
STOCKHOLDERS' EQUITY:
Ordinary Shares of NIS 0.01 par value - Authorized: 50,000,000 at June 30, 2016 and December 31, 2015, respectively; Issued and outstanding: 13,585,810 at June 30, 2016 and December 31, 2015, respectively	34	34
Additional paid-in capital	92,194	91,814
Accumulated deficit	(76,731)	(63,301)
Total shareholders' equity	15,497	28,547
Total liabilities and shareholders' equity	$ 21,344	$ 35,230

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares	Jun. 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	13,585,810	13,585,810
Ordinary Shares, shares outstanding	13,585,810	13,585,810

CONSOLIDATED STATEMENTS OF COMP

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Revenues	$ 94		$ 469
Operating expenses:
Research and development	5,304	$ 5,429	10,268	$ 9,838
Marketing	611	285	823	507
General and administrative	1,246	1,111	2,680	2,016
Total operating expenses	7,161	6,825	13,771	12,361
Total operating loss	7,067	6,825	13,302	12,361
Financial expenses (income), net	(14)	92	(83)	(11)
Loss before taxes on income	7,053	6,917	13,219	12,350
Taxes on income	(102)	(8)	(211)	(131)
Net loss	$ 7,155	$ 6,925	$ 13,430	$ 12,481
Net loss per share:
Basic and diluted net loss per Ordinary Share	$ 0.53	$ 0.51	$ 0.99	$ 1.78
Weighted-average number of Ordinary Shares used to compute basic and diluted net loss per share	13,585,810	13,541,155	13,585,810	7,555,684

STATEMENTS OF CHANGES IN SHAREH

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - 6 months ended Jun. 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		380		380
Net loss			(13,430)	(13,430)
Balance, ending at Jun. 30, 2016	$ 34	$ 92,194	$ (76,731)	$ 15,497
Balance, ending (in shares) at Jun. 30, 2016	13,585,810

CONSOLIDATED STATEMENT OF CASH

CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015
Cash flows from operating activities:
Net loss	$ (13,430)	$ (12,481)
Adjustments required to reconcile net loss to net cash used in operating activities:
Stock-based compensation	380	214
Depreciation	289	186
Impairment of property and equipment		153
Accrued severance pay, net	16	(2)
Amortization of discount on loan	4	5
Revaluation of fair value of warrants to purchase Convertible Preferred Shares		(40)
Increase in other accounts receivable and prepaid expenses	(239)	(294)
Decrease in deferred revenue	(469)
Increase (decrease) in trade payables	(150)	698
Increase (decrease) in other accounts payable and accrued expenses	(251)	103
Net cash used in operating activities	(13,850)	(11,458)
Cash flows from investing activities:
Proceeds from maturity of investment in restricted cash	308	352
Purchase of property and equipment	(768)	(632)
Investment in other assets	(60)	(21)
Net cash used in investing activities	(520)	(301)
Cash flows from financing activities:
Proceeds from issuance of Convertible Preferred Shares and warrants, net of issuance costs		11,406
Net proceeds from issuance of equity		36,159
Proceeds from issuance of Ordinary Shares, net of underwriters' fees		1,308
Repayment of loan	(234)	(281)
Proceeds from exercise of options into Ordinary Shares		145
Net cash (used in) provided by financing activities	(234)	48,737
Net increase (decrease) in cash and cash equivalents	(14,604)	36,978
Cash and cash equivalents at the beginning of the period	31,851	6,167
Cash and cash equivalents at the end of the period	17,247	43,145
Supplemental disclosure of non-cash investing and financing activities:
Purchase of property and equipment	240	159
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 year:
Cash paid for interest	3	19
Cash paid for taxes	$ 310	$ 231

GENERAL

GENERAL	6 Months Ended
	Jun. 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 developing 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 in the foreseeable future. For the six months ended June 30, 2016, the Company incurred operating losses of $13,302 and negative cash flows from operating activities of $13,850. Until the Company has positive cash flows from operating activities, it will need to raise significant additional capital 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. There is no assurance, however, that the Company will be successful in obtaining an adequate level of financing for its long-term needs. The accompanying financial statements 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. Subsequent to the balance sheet date, the Company raised approximately $19,800 of net proceeds from sale of its ordinary shares and warrants to purchase ordinary shares in the first tranche of a private placement. These proceeds plus the Company’s existing cash and cash equivalents will provide the Company at least 12 months of capital, sufficient, among other things, to fund the filing of a New Drug Application (“NDA”) with the United States Food and Drug Administration for Trevyent® (see also Note 9). 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 completed by September 30, 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.

UNAUDITED INTERIM CONSOLIDATED

UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS	6 Months Ended
	Jun. 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 June 30, 2016. Consolidated results of operations and consolidated cash flows for the six months periods ended June 30, 2016 and 2015, have been included. The results for the six months period ended June 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	6 Months Ended
	Jun. 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	6 Months Ended
	Jun. 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	6 Months Ended
	Jun. 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 years 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. As of June 30 , 2016, the total amount of grants received from the OCS and the Incubator including interest was $729 and royalties was accrued and amounted to $35 and $5 during the year ended December 31, 2015 and six months period ended June 30, 2016, respectively. The revenues under the Agreement with Cardiome are subject to royalties under the above programs. For the six months period ended June 30 , 2016, the Company recorded an immaterial amount for royalties’ expenses. 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	6 Months Ended
	Jun. 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. On June 17, 2016, the Company’s Compensation Committee and Board of Directors approved, among other actions, grants of 320,600 options to employees to purchase the Company’s Ordinary Shares at an exercise price of $2.74 Transactions related to the grant of options to employees and directors under the Amended and Restated 2009 Stock Incentive Plan during the six months period ended June 30 , 2016 (unaudited), were as follows: Number of Weighted average exercise price Weighted average remaining contractual life Aggregate intrinsic value options $ (years) $ Options outstanding at January 1, 2016 * ) Options granted — Options expired — 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. 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 , 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 June 30 , 2016. This amount is impacted by the changes in the fair market value of the Company’s shares. As of June 30 , 2016, the Company has 427,568 Ordinary Shares available for future grant under the Amended and Restated 2009 Plan. As of June 30 , 2016, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $1,616, which is expected to be recognized over a weighted average period of approximately 2.14 years. The total compensation cost related to all of the Company’s equity-based awards, recognized during the six months period ended June 30 , 2016 and 2015 (unaudited) was comprised as follows: Six months ended June 30, 2016 2015 Unaudited Research and development $ $ Marketing General and administrative $ $

SELECTED STATEMENTS OF COMPREHE

SELECTED STATEMENTS OF COMPREHENSIVE LOSS	6 Months Ended
	Jun. 30, 2016
SELECTED STATEMENTS OF COMPREHENSIVE LOSS
SELECTED STATEMENTS OF COMPREHENSIVE LOSS	NOTE 7: - SELECTED STATEMENTS OF COMPREHENSIVE LOSS a. Financial income, net: Six months ended June 30, 2016 2015 Unaudited Interest expense and bank fees $ $ Interest income ) — Revaluation of fair value of warrants to purchase Convertible Preferred 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: Six months ended June 30, 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 six months period ended June 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.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	6 Months Ended
	Jun. 30, 2016
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS	NOTE 8:- FAIR VALUE MEASURMENTS 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, 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. The Company’s cash equivalents were comprised of money market funds and reverse repurchase agreements (RRAs) which are fully collateralized and are generally outstanding for a short period of time with maturities of less than three months from the date of purchase. The required collateral for the RRAs is either cash or U.S. Treasuries at a minimum rate of 102% of the RRAs’ principal balance. 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.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	6 Months Ended
	Jun. 30, 2016
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	NOTE 9:- SUBSEQUENT EVENTS In July 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 to the investors for an aggregate price of up to approximately $32,000 the following securities: (i) in the initial tranche, an aggregate of 6,554,016 Ordinary Shares of the Company, nominal value NIS 0.01 per share, and warrants to purchase up to 6,554,016 additional Ordinary Shares of the Company, for $3.255 per unit, 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 (i) $3.13 or (ii) 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 first tranche of the Private Placement closed on August 4, 2016, pursuant to which the Company received approximately $19,800 in net proceeds. 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. The warrants are eligible for “cashless exercise”. Therefore, these warrants are accounted and recorded as a liability according to the provisions of ASC 815-40. Placement agents for the Company received a cash fee of approximately $1.2 million. The Company is required to file a registration statement for the resale of the shares and warrant shares issued in the Private Placement within 60 days following the Closing Date and to use its reasonable best efforts to cause such registration statement to be declared effective within 75 days following the Closing Date (or 150 days following the Closing Date if the SEC determines to review the registration statement). The Company may incur liquidated damages if it does not meet the abovementioned registration obligations. As of the filing date of these interim consolidated financial statements, the registration statement has not been filed. On August 8, 2016, the Board of Directors approved an amendment to the Amended and Restated 2009 Stock Incentive Plan. The amendment moves the starting date for the 4% annual increases to the reserved pool from January 1, 2019 to January 1, 2017. The amendment will be voted upon by the shareholders at the 2016 Annual General Meeting.

SHAREHOLDERS' EQUITY (Tables)

SHAREHOLDERS' EQUITY (Tables)	6 Months Ended
	Jun. 30, 2016
SHAREHOLDERS' EQUITY
Schedule of stock options roll forward	Number of Weighted average exercise price Weighted average remaining contractual life Aggregate intrinsic value options $ (years) $ Options outstanding at January 1, 2016 * ) Options granted — Options expired — 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.
Schedule of total compensation cost related to all of the Company's equity-based awards	Six months ended June 30, 2016 2015 Unaudited Research and development $ $ Marketing General and administrative $ $

SELECTED STATEMENTS OF COMPRE17

SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Tables)	6 Months Ended
	Jun. 30, 2016
SELECTED STATEMENTS OF COMPREHENSIVE LOSS
Schedule of financial income, net	a. Six months ended June 30, 2016 2015 Unaudited Interest expense and bank fees $ $ Interest income ) — Revaluation of fair value of warrants to purchase Convertible Preferred Shares — ) Foreign currency translation adjustments ) ) $ ) $ )
Schedule of weighted average number of shares	a. Six months ended June 30, 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

GENERAL (Details)

GENERAL (Details)	1 Months Ended	3 Months Ended		6 Months Ended
	Jul. 31, 2016USD ($)	Jun. 30, 2016USD ($)	Jun. 30, 2015USD ($)	Jun. 30, 2016USD ($)product	Jun. 30, 2015USD ($)
Organizational disclosures
Operating losses		$ (7,067,000)	$ (6,825,000)	$ (13,302,000)	$ (12,361,000)
Negative cash flows from operating activities				$ 13,850,000	11,458,000
Issuance of equity
Net proceeds from issuance of equity					$ 36,159,000
Private Placement | Ordinary shares and warrants to purchase ordinary shares | Subsequent events.
Issuance of equity
Net proceeds from issuance of equity	$ 19,800,000
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	Jun. 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

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 LI22

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 LI23

COMMITMENTS AND CONTINGENT LIABILITIES - OTHER COMMITMENTS (Details) - USD ($) $ in Thousands	6 Months Ended	138 Months Ended
	Jun. 30, 2016	Jun. 30, 2016	Dec. 31, 2015
Combined OCS and Incubator, RAD Biomed Ltd
Royalties
Grants received		$ 729
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	$ 5	$ 5	$ 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	Jun. 30, 2015USD ($)	Jun. 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	Jun. 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)		427,568

SHAREHOLDERS' EQUITY - Stock 26

SHAREHOLDERS' EQUITY - Stock based compensation additional disclosures (Details) - Stock options, employees	Jun. 17, 2016$ / sharesshares
Stock-based compensation
Options granted (in shares) | shares	320,600
Options granted (in dollars per share) | $ / shares	$ 2.74

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	6 Months Ended	12 Months Ended
	Jun. 30, 2016	Dec. 31, 2015
Number of options
Options outstanding at beginning of period (in shares)	1,247,185
Options granted (in shares)	320,600
Options expired (in shares)	(600)
Options outstanding at end of period (in shares)	1,567,205	1,247,185
Options vested and expected to be vested at end of period (in shares)	1,544,330
Options vested at end of period (in shares)	756,437
Weighted average exercise price per share
Options outstanding at beginning of period (in dollars per share)	$ 4.40
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)	4.08
Options vested at end of period (in dollars per share)	$ 3.99
Weighted average remaining contractual life
Weighted average remaining contractual life, Outstanding (in years)	6 years 2 months 27 days	5 years 9 months 11 days
Weighted average remaining contractual life, Vested and expected to be vested (in years)	6 years 2 months 9 days
Weighted average remaining contractual life, Vested (in years)	4 years 2 months 9 days
Aggregate intrinsic value
Aggregate intrinsic value, Outstanding at the end of the period	$ 170
Aggregate intrinsic value, Vested and expected to be vested	160
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	6 Months Ended
	Jun. 30, 2016USD ($)
Stock-based compensation
Total unrecognized compensation cost related to non-vested stock option awards	$ 1,616
Weighted average period for recognition of compensation cost related to unvested stock awards	2 years 1 month 21 days

SHAREHOLDERS' EQUITY - COMPENSA

SHAREHOLDERS' EQUITY - COMPENSATION COST RELATED TO EQUITY-BASED AWARDS (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015
Stock-based compensation costs
Allocated share based compensation expense	$ 380	$ 214
Research and development
Stock-based compensation costs
Allocated share based compensation expense	53	50
Marketing
Stock-based compensation costs
Allocated share based compensation expense	3	4
General and administrative
Stock-based compensation costs
Allocated share based compensation expense	$ 324	$ 160

SELECTED STATEMENTS OF COMPRE30

SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2016	Jun. 30, 2015	Jun. 30, 2016	Jun. 30, 2015
Financial expense (income), net:
Interest expense and bank fees			$ 79	$ 41
Interest income			(43)
Revaluation of fair value of warrants to purchase Convertible Preferred Shares				(40)
Foreign currency translation adjustments			(119)	(12)
Financial income, net	$ (14)	$ 92	(83)	(11)
Numerator:
Net loss	$ 7,155	$ 6,925	13,430	12,481
Dividends accumulated for the period				988
Net loss available to shareholders of Ordinary shares			$ 13,430	$ 13,469
Denominator:
Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share	13,585,810	13,541,155	13,585,810	7,555,684
Preferred stock dividend rate (as a percent)				8.00%

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details)	6 Months Ended
	Jun. 30, 2016
FAIR VALUE MEASUREMENTS
Minimum collateral percentage on reverse repurchase agreements principal	102.00%

SUBSEQUENT EVENTS (Details)

SUBSEQUENT EVENTS (Details)	Aug. 04, 2016USD ($)	Jul. 31, 2016USD ($)shares	Aug. 08, 2016	Jul. 31, 2016₪ / shares	Jul. 31, 2016USD ($)$ / sharesshares	Jun. 30, 2016₪ / sharesshares	Dec. 31, 2015₪ / sharesshares	Mar. 01, 2015shares	Feb. 28, 2015shares
Subsequent events
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
Subsequent events. | Amended and Restated 2009 Stock Incentive Plan
Subsequent events
Annual increases to reserved pool with moved starting dates (as a percent)			4.00%
Private Placement | Subsequent events. | Ordinary shares and warrants to purchase ordinary shares
Subsequent events
Placement agent fees paid | $		$ 1,200,000
Private Placement | Subsequent events. | Ordinary Shares
Subsequent events
Value of shares to which the Company agreed to issue and sell under subscription agreement | $					$ 32,000,000
Private Placement | Subsequent events. | Warrant to purchase ordinary shares
Subsequent events
Exercise price of warrants (in dollars per share) | $ / shares					$ 3.5995
Private Placement | Subsequent events. | First tranche | Ordinary shares and warrants to purchase ordinary shares
Subsequent events
Number of units authorized | shares		6,554,016
Exercise price of units (in dollars per unit) | $ / shares					$ 3.255
Net proceeds from issuance of equity | $	$ 19,800
Private Placement | Subsequent events. | First tranche | Ordinary Shares
Subsequent events
Ordinary Shares, shares authorized | shares					6,554,016
Ordinary share, nominal value (in dollars per share) | ₪ / shares				₪ 0.01
Private Placement | Subsequent events. | First tranche | Warrant to purchase ordinary shares
Subsequent events
Warrants authorized (in shares) | shares					6,554,016
Private Placement | Subsequent events. | Second tranche | Ordinary Shares
Subsequent events
Value of shares to which the Company agreed to issue and sell under subscription agreement | $					$ 10,700
Price per share | $ / shares					$ 3.13