SteadyMed (STDY) 10-Q 13 Aug 15 2015 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2015	Aug. 01, 2015
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, 2015
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		13,581,155
Document Fiscal Year Focus	2,015
Document Fiscal Period Focus	Q2

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2015	Dec. 31, 2014
CURRENT ASSETS:
Cash and cash equivalents	$ 43,145	$ 6,167
Restricted cash	675	1,026
Other accounts receivable and prepaid expenses	443	151
Total current assets	44,263	7,344
LONG-TERM LEASE DEPOSIT	69	46
SEVERANCE PAY FUND	118	99
DEFERRED IPO COSTS		1,463
PROPERTY AND EQUIPMENT, NET	1,825	1,374
Total assets	46,275	10,326
CURRENT LIABILITIES:
Current maturity of loan	506	563
Trade payables	2,848	1,991
Other accounts payable and accrued expenses	1,846	1,793
Total current liabilities	5,200	4,347
NON-CURRENT LIABILITIES:
Loan		219
Accrued severance pay	149	132
Warrants to purchase Convertible Preferred Shares		6,072
Other accounts payable	258	208
Total non-current liabilities	$ 407	$ 6,631
COMMITMENTS AND CONTINGENT LIABILITIES
CONVERTIBLE PREFERRED SHARES:
Series A1-E Preferred Shares of NIS 0.01 par value - Authorized: 8,060,923 and 0 at December 31, 2014 and June 30, 2015, respectively; Issued and outstanding: 5,895,657 and 0 at December 31, 2014 and June 30, 2015, respectively; Aggregate liquidation preference of $46,694 and 0 at December 31, 2014 and June 30, 2015, respectively;		$ 35,669
STOCKHOLDERS' EQUITY (DEFICIT):
Ordinary Shares of NIS 0.01 par value - Authorized: 30,689,077 and 50,000,000 at December 31, 2014 and June 30, 2015, respectively. Issued and outstanding: 502,224 and 13,581,155 at December 31, 2014 and June 30, 2015, respectively;	$ 34	1
Additional paid-in capital	91,445	2,008
Accumulated deficit	(50,811)	(38,330)
Total shareholders' equity (deficit)	40,668	(36,321)
Total liabilities, and shareholders? equity (deficit)	$ 46,275	$ 10,326

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical)	Jun. 30, 2015₪ / shares	Jun. 30, 2015USD ($)	Dec. 31, 2014₪ / shares	Dec. 31, 2014USD ($)
Temporary Equity Disclosures
Convertible preferred stock, par value (in ILS per share)	₪ 0.01		₪ 0.01
Convertible preferred stock, liquidation preference (in dollars) | $		$ 0		$ 46,694
Common Stock Disclosures
Common stock, par value (in ILS per share)	₪ 0.01		₪ 0.01

CONSOLIDATED BALANCE SHEETS (P4

CONSOLIDATED BALANCE SHEETS (Parenthetical 2) - shares	Jun. 30, 2015	Dec. 31, 2014
Temporary Equity Disclosures
Convertible preferred stock, shares authorized	0	8,060,923
Convertible preferred stock, shares issued	0	5,895,657
Convertible preferred stock, shares outstanding	0	5,895,657
Common Stock Disclosures
Common stock, shares authorized	50,000,000	30,689,077
Common stock, shares issued	13,581,155	502,224
Common stock, shares outstanding	13,581,155	502,224

CONSOLIDATED STATEMENTS OF COMP

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2015	Jun. 30, 2014	Jun. 30, 2015	Jun. 30, 2014
Operating expenses:
Research and development	$ 5,429	$ 3,101	$ 9,838	$ 5,352
Marketing	285	240	507	459
General and administrative	1,111	286	2,016	649
Total operating loss	6,825	3,627	12,361	6,460
Financial expenses (income), net	92	1,674	(11)	1,593
Loss before taxes on income	6,917	5,301	12,350	8,053
Taxes on income	(8)	(36)	(131)	(81)
Net loss	$ 6,925	$ 5,337	$ 12,481	$ 8,134
Net loss per share:
Basic and diluted net loss per Ordinary Share	$ 0.51	$ 12.32	$ 1.78	$ 19.06
Weighted-average number of ordinary shares used to compute basic and diluted net loss per share	13,541,155	501,828	7,555,684	501,828

STATEMENTS OF CHANGES IN SHAREH

STATEMENTS OF CHANGES IN SHAREHOLDERS' DEFICIT - 6 months ended Jun. 30, 2015 - USD ($) $ in Thousands	Common Stock	Additional paid-in capital	Deficit accumulated during the development stage	Total
Balance, beginning at Dec. 31, 2014	$ 2	$ 2,007	$ (38,330)	$ (36,321)
Balance, beginning (in shares) at Dec. 31, 2014	502,224
Increase (decrease) in Stockholders' Equity
Exercise of options into Ordinary Shares		145		145
Exercise of options into Ordinary Shares (in shares)	51,716
Conversion of Convertible Preferred Shares into Ordinary Shares upon IPO	$ 18	47,057		47,075
Conversion of Convertible Preferred Shares into Ordinary Shares upon IPO (in shares)	7,464,320
Conversion of warrants to purchase Convertible Preferred Shares into Ordinary Shares	$ 2	5,943		5,945
Conversion of warrants to purchase Convertible Preferred Shares into Ordinary Shares (in shares)	697,443
Conversion of warrants to purchase Convertible Preferred Shares into warrants to purchase Ordinary Shares		87		87
Issuance of Ordinary Shares, net of issuance costs of $5,256, upon IPO	$ 12	34,684		34,696
Issuance of Ordinary Shares, upon IPO (in shares)	4,700,000
Issuance of Ordinary Shares, net of underwriters' fees of $98		1,308		1,308
Issuance of Ordinary Shares, net of underwriters' fees (in shares)	165,452
Stock-based compensation		214		214
Net loss			(12,481)	(12,481)
Balance, ending at Jun. 30, 2015	$ 34	$ 91,445	$ (50,811)	$ 40,668
Balance, ending (in shares) at Jun. 30, 2015	13,581,155

STATEMENTS OF CHANGES IN SHARE7

STATEMENTS OF CHANGES IN SHAREHOLDERS' DEFICIT (Parenthetical) $ in Thousands	6 Months Ended
	Jun. 30, 2015USD ($)
STATEMENTS OF CHANGES IN SHAREHOLDERS' DEFICIT
Stock issuance costs	$ 5,256

CONSOLIDATED STATEMENT OF CASH

CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2015	Jun. 30, 2014
Cash flows from operating activities:
Net loss	$ (12,481)	$ (8,134)
Adjustments required to reconcile net loss to net cash used in operating activities:
Stock-based compensation	214	4
Depreciation	186	65
Impairment of property and equipment	153
Accrued severance pay, net	(2)	7
Amortization of discount on loan	5	5
Revaluation of fair value of warrant to purchase Convertible Preferred Shares	(40)	1,534
Increase in other accounts receivable and prepaid expenses	(294)	(284)
Increase in trade payables	698	751
Increase (decrease) in other accounts payable and accrued expenses	103	(28)
Net cash used in operating activities	(11,458)	(6,080)
Cash flows from investing activities:
Proceeds from maturity of investment in restricted cash	352	352
Purchases of property and equipment	(632)	(205)
Investment in other assets	(21)
Net cash (used in) provided by investing activities	(301)	147
Cash flows from financing activities:
Proceeds from issuance of Preferred Shares and warrants, net of issuance costs	11,406	19,206
Proceeds from issuance of Ordinary Shares, net of issuance costs upon IPO	36,159
Proceeds from issuance of Ordinary Shares, net of underwriter's fees	1,308
Repayment of loan	(281)	(281)
Proceeds from exercise of options into Ordinary Shares	145
Net cash provided by financing activities	48,737	18,925
Net increase in cash and cash equivalents	36,978	12,992
Cash and cash equivalents at the beginning of the period	6,167	2,072
Cash and cash equivalents at the end of the period	43,145	15,064
Supplemental disclosure of non-cash investing and financing activities
Purchase of property and equipment	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 period
Cash paid for interest	19	34
Cash paid for taxes	$ 231	$ 1

GENERAL

GENERAL	6 Months Ended
	Jun. 30, 2015
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 US 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 and administrative support functions to the Company. b. The Company had a shareholders’ equity (deficit) of $40,668 and $ (36,321) as of June 30, 2015 (unaudited) and December 31, 2014, respectively. The shareholders’ deficit as of December 31, 2014, resulted from its Convertible Preferred Shares being classified as temporary equity and the warrants to purchase Convertible Preferred Shares being classified as a non-current liability. The Convertible Preferred Shares were only redeemable upon contingent events that were not probable and the warrants included down round protection provisions. During the six months ended June 30, 2015, subsequent to the Company’s completion of its Initial Public Offering (“IPO”), the Convertible Preferred Shares and majority of the warrants to purchase Convertible Preferred Shares were converted into Ordinary Shares of the Company, par value NIS 0.01 per share (“Ordinary Shares”) and therefore classified as Shareholders’ equity (See also Note 1c). Management believes that the Company’s existing capital resources will be adequate to satisfy its expected liquidity requirements at least for the next 12 months. 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 when 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 Sarl (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 commercialize Trevyent, if approved for the treatment of PAH in certain regions outside the US, specifically Europe, Canada and the Middle East (the “Regions”). The Company is obligated to perform services over the next 18 months resulting in certain deliverables to Cardiome. Cardiome is responsible for the regulatory submissions and approvals and commercialization of Trevyent in the Regions. In addition, the Company has agreed to provide supply services to Cardiome upon commercialization of Trevyent® in the Regions (“Supply Services”). The Agreement provides for an upfront payment of $3 million $7.25 million in connection with the achievement of certain regulatory milestones by the Company, $2.0 million in connection with the achievement of a sales milestone by Cardiome, and a scaling royalty ranging from the low teens to mid-twenty percent on future Trevyent sales by Cardiome in the Regions. In addition, there is a transfer 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, 2015
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, 2015. Consolidated results of operations and consolidated cash flows for the six months ended June 30, 2015 and 2014, have been included. The results for the six months ended June 30, 2015, are not necessarily indicative of the results that may be expected for the year ended on December 31, 2015. 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, 2014 included in the Company’s prospectus filed pursuant to Rule 424(b)(4) on March 20, 2015 with the SEC.

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES	6 Months Ended
	Jun. 30, 2015
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 for the fiscal year ended December 31, 2014 included in the prospectus filed with the SEC on March 19, 2015 (“Prospectus”) pursuant to Rule 462(b) under the Securities Act of 1933, as amended (“Securities Act”), are applied consistently in these unaudited interim consolidated financial statements. a. Revenue recognition: The Company generates revenue from the Agreement described in Note 1d. Pursuant to the Agreement, the Company identified the following performance deliverables at the inception of the Agreement: (i) an exclusive royalty bearing license to certain of the Company’s patents related to Trevyent, which was transferred immediately upon signing of the Agreement, (ii) certain Services expected to be performed over a period until December 31, 2016 and (iii) Supply Services of Trevyent product upon commercialization. The Company recognizes revenue in accordance with ASC 605-25, “Multiple-Element Arrangements” pursuant to which each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable which is based on its vendor specific objective evidence (‘‘VSOE’’) if available, third party evidence (‘‘TPE’’) if VSOE is not available, or estimated selling price (‘‘ESP’’) if neither VSOE nor TPE is available. The License and Services are determined to be one unit of accounting since the License has no value to Cardiome on a stand-alone basis. The Supply Services are also determined to be a unit of accounting. The consideration allocated to the License and Services will be recognized on a straight-line basis over the performance period of the Services estimated to be December 31, 2016. Contingent payments related to milestones will be recognized immediately upon satisfaction of the milestone and contingent payments related to royalties will be recognized in the period that the related sales have occurred. Revenues from product sales will be recognized when delivery has occurred, persuasive evidence of an arrangement exists, the vendor’s fee is fixed or determinable, no future obligation exists and collectability is reasonably assumed. For the six months period ended June 30, 2015, no revenues have been recognized from the Agreement as the amount would be de minimis. b. In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers. ASU 2014-09 requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration which the entity expects to receive in exchange for those goods and services. Insurance contracts do not fall within the scope of this ASU. The effective date of ASU 2014-09 is for annual reporting periods beginning after December 15, 2017. In July 2015, the FASB decided to defer by one year the effective date of this ASU. The ASU has not yet been adopted and will not have a material impact on the Company’s financial position, cash flows or results of operations. c. In April 2015, the FASB Issued ASU 2015-03, Interest-Imputation of Interest. ASU 2015-03 reduces the complexity of disclosing debt issuance costs and debt discount and premium on the balance sheet by requiring that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The effective date of ASU 2015-03 is for interim and annual reporting periods beginning after December 15, 2015. The ASU has not yet been adopted and will not have a material impact on the Company’s financial position, cash flows or results of operations.

LOAN

LOAN	6 Months Ended
	Jun. 30, 2015
Loan
Loan	NOTE 4: - LOAN On February 20, 2013, Inc. signed a Loan and Security Agreement (“Agreement”) with a commercial bank (“Bank”) pursuant to which $1,500 (“Loan”) was provided at the closing date at a variable annual rate equal to the greater of 5.25% or the three-year constant maturity treasury rate plus 5%. From September 30, 2013, the outstanding Loan will be repaid in 32 equal installments through May 22, 2016 (“Maturity Date”). On February 15, 2015, the Agreement was amended to add Holdings as a co-borrower (collectively, Inc. and Holdings are “Borrower”). Under the Agreement, the Borrower must maintain at all times through the Maturity Date a cash balance at the lending Bank of not less than 125% of the outstanding loan principal. In addition, the Borrower is permitted to transfer cash to the Company from time to time however, at all times at least 90% of the aggregate amount of cash of the consolidated entities must be held by the Borrower. As of December 31, 2014 and June 30, 2015, the Company has met all the aforementioned financial covenants. 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 February 20, 2013, 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 AOA. Such warrants have been exercised on a cashless basis as of June 30, 2015.

WARRANTS TO PURCHASE CONVERTIBL

WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES	6 Months Ended
	Jun. 30, 2015
Warrants to purchase convertible preferred shares
Warrants to purchase convertible preferred shares	NOTE 5: - WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level to classify them for each reporting period. There have been no transfers between fair value measurements levels during the six months ended June 30, 2015. The authoritative guidance on fair value measurements establishes a consistent framework for measuring fair value on either a recurring or nonrecurring basis whereby inputs, used in valuation techniques, are assigned a hierarchical level. The following are the hierarchical levels of inputs to measure fair value: 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 Company accounts for such warrants (each of which include weighted average anti-dilution protection) as a liability according to the provisions of ASC 815-40, “Derivatives and Hedging - Contracts in Entity’s Own Equity”. The Company measures the warrants at fair value by using Monte Carlo Cliquent Option Pricing Model in each reporting period until the warrants are exercised or expired, with changes in the fair values being recognized in the Company’s statement of comprehensive loss as financial income or expense, net. The changes in Level 3 liabilities associated with warrants to purchase Convertible Preferred Shares are measured at fair value on a recurring basis. The following tabular presentation reflects the components of liability associated with warrants as of June 30, 2015 (unaudited): Fair value of warrants to purchase Convertible Preferred Shares Balance at December 31, 2014 $ Revaluation of fair value of warrants to purchase Convertible Preferred Shares ) Classification to Equity upon conversion of warrants *) ) Classification to Equity upon automatic conversion into warrants to purchase Ordinary Shares **) ) Balance at June 30, 2015 (unaudited) $ — *) 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. **) Classification of 10,191 warrants to purchase Convertible Preferred Shares converted into 10,191 warrants to purchase Ordinary Shares.

COMMITMENTS AND CONTINGENT LIAB

COMMITMENTS AND CONTINGENT LIABILITIES	6 Months Ended
	Jun. 30, 2015
Commitments and Contingencies
Commitments and Contingent Liabilities	NOTE 6: - COMMITMENTS AND CONTINGENT LIABILITIES a. The Company’s lease agreement for its Israeli offices had a 3-year term ending June 30, 2015. The lease was amended to extend the term by additional 6 months, and on July 22, 2015, the Company exercised an option to extend the lease term for an additional 24 months ending, December 31, 2018. Inc.’s lease agreement for its U.S. offices had a 17-month term ending February 28, 2015 continued on a month-to-month basis through July 31, 2015. On May 1, 2015, Inc. signed a lease agreement for new office space in San Ramon, California for a period of three years, which term was increased to four years in an amendment dated May 29, 2015. 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 4% and 4.5% up to between 150% to 300% of the amount received, linked to the LIBOR. As of June 30, 2015 the total amount of grants received from the OCS and the Incubator is $737 including interest. The revenue under the agreement with Cardiome will be subjected to royalties under these programs. 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.

SHAREHOLDERS' EQUITY (DEFICIT)

SHAREHOLDERS' EQUITY (DEFICIT)	6 Months Ended
	Jun. 30, 2015
Shareholders' Equity (Deficit)
Shareholders' Equity (Deficit)	NOTE 7: - SHAREHOLDERS’ EQUITY (DEFICIT) a. On March 1, 2015, the Company effected 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. b. On January 24, 2015, the Company signed an addendum to the Series E 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. As described in Note 1c, on March 19, 2015, the Company completed its IPO by raising gross consideration of $40 million 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 $5.2 million. c. 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. d. 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 have been 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 the shareholders on March 1, 2015. Under the Amended and Restated 2009 Stock Incentive Plan, the options 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. On July 7, 2014, the Company’s Board of Directors approved to reduce the exercise price of all outstanding options which were previously granted to certain employees at an exercise price which exceeded $3.61 per share down to $3.61 per share, representing the underlying fair value of the Ordinary Share at that date. The Company accounted for the reduction of the options’ exercise price pursuant to ASC 718 as a modification. Accordingly, additional compensation of $49 was calculated as the fair value of the modified award in excess of the fair value of the original award measured immediately before its terms have been modified based on current circumstances and recorded incremental fair value as an immediate or future expense based on the vesting schedule of the relevant options. During the year ended December 31, 2014, the Company recorded out of the aforementioned amount compensation cost of $44 as result of the above modification. During the six months ended June 30, 2015, the Company recorded an additional $4 as result of the above modification. On January 24, 2015 and June 10, 2015, the Company’s Board of Directors approved grants to employees of 248,798 and 5,813 options to purchase Ordinary Shares at an exercise price of $5.84 and $7.45 per share, respectively. The weighted average grant date fair value of options granted during the six months ended June 30, 2015 was $2.91. As of June 30, 2015, the Company has 876,788 Ordinary Shares available for future grant under the 2009 Plan. As of June 30, 2015, the total unrecognized estimated compensation cost related to non-vested stock options granted prior to that date was $1,172, which is expected to be recognized over a weighted average period of approximately 2.5 years. Transactions related to the grant of options to employees under the Amended and Restated 2009 Stock Incentive Plan during the six months ended June 30, 2015 (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, 2015 Options granted Options exercised ) Options outstanding at end of the period Options vested and expected to be vested at end of the period Exercisable 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, 2015 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, 2015. This amount is impacted by the changes in the fair market value of the Company’s shares. The total compensation cost related to all of the Company’s equity-based awards, recognized during the three and six months ended June 30, 2015 and 2014 (unaudited) was comprised as follows: Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Unaudited Research and development $ $ — $ $ Marketing *) — — General and administrative $ $ $ $ *) Represent an amount lower than $1.

SELECTED STATEMENTS OF COMPREHE

SELECTED STATEMENTS OF COMPREHENSIVE LOSS	6 Months Ended
	Jun. 30, 2015
SELECTED STATEMENTS OF COMPREHENSIVE LOSS
Selected statements of comprehensive loss	NOTE 8: - SELECTED STATEMENTS OF COMPREHENSIVE LOSS a. Financial expenses (income), net: Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Unaudited Interest expense and bank fees $ $ $ $ Revaluation of fair value of warrants to purchase Convertible Preferred Shares — ) Foreign currency translation adjustments ) $ $ $ ) $ b. The loss and the weighted average number of shares used in computing basic and diluted net loss per share is as follows: Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 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 include 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.

WARRANTS TO PURCHASE CONVERTI17

WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES (Tables)	6 Months Ended
	Jun. 30, 2015
Warrants to purchase convertible preferred shares
Components of the liability associated with the warrants	Fair value of warrants to purchase Convertible Preferred Shares Balance at December 31, 2014 $ Revaluation of fair value of warrants to purchase Convertible Preferred Shares ) Classification to Equity upon conversion of warrants *) ) Classification to Equity upon automatic conversion into warrants to purchase Ordinary Shares **) ) Balance at June 30, 2015 (unaudited) $ — *) 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. **) Classification of 10,191 warrants to purchase Convertible Preferred Shares converted into 10,191 warrants to purchase Ordinary Shares.

SHAREHOLDERS' EQUITY (DEFICIT)

SHAREHOLDERS' EQUITY (DEFICIT) (Tables)	6 Months Ended
	Jun. 30, 2015
Shareholders' Equity (Deficit)
Schedule of stock options rollforward	Number of Weighted average exercise price Weighted average remaining contractual life Aggregate intrinsic value Options $ (years) $ Options outstanding at January 1, 2015 Options granted Options exercised ) Options outstanding at end of the period Options vested and expected to be vested at end of the period Exercisable at end of the period
Schedule of total compensation cos related to all of the Company's equity-based awards	Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Unaudited Research and development $ $ — $ $ Marketing *) — — General and administrative $ $ $ $ *) Represent an amount lower than $1.

SELECTED STATEMENTS OF COMPRE19

SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Tables)	6 Months Ended
	Jun. 30, 2015
SELECTED STATEMENTS OF COMPREHENSIVE LOSS
Schedule of financial income, net	Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Unaudited Interest expense and bank fees $ $ $ $ Revaluation of fair value of warrants to purchase Convertible Preferred Shares — ) Foreign currency translation adjustments ) $ $ $ ) $
Schedule of weighted average number of shares	Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 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 include the compounded dividend of eight percent per annum which shall be distributed to shareholders in case of distributable assets determined in the applicable article of association under the liquidation preference right prior to the closing of the IPO event as mentioned in Note 1c.

GENERAL (Details)

GENERAL (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2015USD ($)product	Dec. 31, 2014USD ($)
General
Number of products in development	2
Shareholders' equity (deficit) | $	$ 40,668	$ (36,321)

GENERAL (Details 2)

GENERAL (Details 2) - 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
Aggregate net proceeds received from IPO offering, net of underwriting discounts and commissions and offering expenses					$ 34,696
Issuance of Ordinary Shares, net of underwriters? fees (in shares)	165,452
Proceeds From Issuance of Ordinary Shares, Net of Underwriters' Fees	$ 1,308				$ 1,308
Warrants Disclosures
Warrants outstanding (in shares)				10,191		711,120
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
IPO
Initial Public Offering
Common stock issued (in shares)		4,700,000
Share Price (in dollars 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

GENERAL (Details 3)

GENERAL (Details 3) - Jun. 28, 2015 - Cardiome - Collaboration - USD ($) $ in Thousands	Total
License and supply agreement
Period of time over which reporting entity is required to perform services per agreement	18 months
Upfront payment provided for per license agreement	$ 3,000
Payment in connection with achievement of certain regulatory milestones	7,250
Payment in connection with achievement of sales milestone	$ 2,000
Scaling royalty percentage, low end of range
Scaling royalty percentage, high end of range

SIGNIFICANT ACCOUNTING POLICI23

SIGNIFICANT ACCOUNTING POLICIES (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2015USD ($)
Cardiome | Collaboration
Revenue recognition
Royalty revenue	$ 0

LOAN (Details)

LOAN (Details) - Feb. 20, 2013 $ / shares in Units, $ in Thousands	USD ($)installment$ / sharesshares
Loan Agreement
Loan
Amount borrowed | $	$ 1,500
Minimum variable annual rate	5.25%
Variable rate basis	three-year constant maturity treasury rate
Basis spread on variable rate	5.00%
Number of installments for repayment | installment	32
Minimum percentage of outstanding loan principal to be maintained as cash balance	125.00%
Percentage of aggregate amount of cash of consolidated entities to be held by entity that signed debt agreement	90.00%
Bank | Series D preferred stock
Loan
Warrants issued to purchase preferred stock | shares	7,332
Exercise price of warrants	$ 6.14
Expiration term of warrants	10 years

WARRANTS TO PURCHASE CONVERTI25

WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2015USD ($)
Fair value disclosures
Transfers in (out) of level 3 fair value measurements	$ 0
Balance, beginning	6,072
Revaluation of fair value of warrants to purchase Convertible Preferred Shares	(40)
Classification to Equity upon conversion of warrants	(5,945)
Classification to Equity upon automatic conversion into warrants to purchase Ordinary Shares	$ (87)

WARRANTS TO PURCHASE CONVERTI26

WARRANTS TO PURCHASE CONVERTIBLE PREFERRED SHARES (Details 2) - shares	Mar. 25, 2015	Mar. 19, 2015	Dec. 31, 2014
Warrants Disclosures
Warrants outstanding (in shares)		10,191	711,120
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

COMMITMENTS AND CONTINGENT LI27

COMMITMENTS AND CONTINGENT LIABILITIES (Details)	May. 01, 2015	Sep. 30, 2013	Jul. 01, 2012
Israel
Operating lease agreement
Lease term			3 years
Lease extension term			6 months
Additional lease extension term per option exercised			24 months
San Ramon, California | Previous Office
Operating lease agreement
Lease term		17 months
San Ramon, California | New Office
Operating lease agreement
Lease term	3 years
Lease extension term	4 years

COMMITMENTS AND CONTINGENT LI28

COMMITMENTS AND CONTINGENT LIABILITIES (Details 2) - Jun. 30, 2015 - USD ($) $ in Thousands	Total	Total
Combined OCS and Incubator, RAD Biomed Ltd
Royalties
Grants received		$ 737
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%
Minimum | OCS
Royalties
Royalties commitment on future revenues (as a percent)	4.00%
Maximum | OCS
Royalties
Royalties commitment on future revenues (as a percent)	4.50%

SHAREHOLDERS' EQUITY (DEFICIT29

SHAREHOLDERS' EQUITY (DEFICIT) (Details) $ / shares in Units, $ in Thousands	Mar. 01, 2015	Jan. 24, 2015USD ($)$ / sharesshares
SHAREHOLDERS' Equity (Deficit)
Stock split ratio	7.75
Series E preferred stock
SHAREHOLDERS' Equity (Deficit)
Proceeds from Issuance of Convertible Preferred Stock | $		$ 11,406
Convertible Preferred Stock issued (in shares) | shares		1,445,966
Share Price (in dollars per share)		$ 8.49

SHAREHOLDERS' EQUITY (DEFICIT30

SHAREHOLDERS' EQUITY (DEFICIT) (Details 2) - USD ($) $ / shares in Units, $ in Thousands	Apr. 22, 2015	Mar. 25, 2015	Mar. 25, 2015	Jun. 30, 2015
Initial Public Offering
Stock issuance costs				$ 5,256
Proceeds From Issuance of Ordinary Shares, Net of Underwriters' Fees	$ 1,308			$ 1,308
Issuance of Ordinary Shares, net of underwriters? fees (in shares)	165,452
IPO
Initial Public Offering
Gross consideration from issuance of Ordinary Shares			$ 40,000
Common stock issued (in shares)		4,700,000
Share Price (in dollars per share)		$ 8.50	$ 8.50
Stock issuance costs			$ 5,200
Underwriters Overallotment Option Exercise
Initial Public Offering
Proceeds From Issuance of Ordinary Shares, Net of Underwriters' Fees	$ 1,308
Issuance of Ordinary Shares, net of underwriters? fees (in shares)	165,452

SHAREHOLDERS' EQUITY (DEFICIT31

SHAREHOLDERS' EQUITY (DEFICIT) (Details 3) - Stock options - shares	Feb. 20, 2015	Jan. 24, 2015	Jun. 30, 2015	Dec. 31, 2014	Jun. 18, 2009
2009 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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
Amended And Restated 2009 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expiration period	10 years

SHAREHOLDERS' EQUITY (DEFICIT32

SHAREHOLDERS' EQUITY (DEFICIT) (Details 4) - Stock options - USD ($)	Jun. 10, 2015	Jan. 24, 2015	Jul. 07, 2014	Jun. 30, 2015	Dec. 31, 2014
Stock-based compensation
Threshold limit for reduction in exercise price (in dollars per share)			$ 3.61
Additional compensation due to fair value modification			$ 49,000
Compensation cost recorded from modification of equity-based arrangements				$ 4,000	$ 44,000
Options granted (in shares)	5,813	248,798		254,611
Exercise price, options granted (in dollars per share)	$ 7.45	$ 5.84		$ 5.88
Weighted average grant-date fair value of options granted (in dollars per share)				$ 2.91
Total unrecognized compensation cost related to non-vested stock option awards				$ 1,172,000
Weighted average period for recognition of compensation cost related to unvested stock awards				2 years 6 months
2009 Plan
Stock-based compensation
Shares available for future grant (in shares)				876,788

SHAREHOLDERS EQUITY (DEFICIT) (

SHAREHOLDERS EQUITY (DEFICIT) (Details 5) - Stock options - USD ($) $ / shares in Units, $ in Thousands	Jun. 10, 2015	Jan. 24, 2015	Jun. 30, 2015	Dec. 31, 2014
Number of options
Options outstanding at beginning of 2015			919,744
Options granted (in shares)	5,813	248,798	254,611
Options exercised			(51,716)
Options outstanding at end of period			1,122,639	919,744
Options vested and expected to be vested at end of period			1,106,348
Exercisable at end of period			465,271
Weighted average exercise price per share
Options outstanding at beginning of 2015 (in dollars per share)			$ 3.54
Exercise price, options granted (in dollars per share)	$ 7.45	$ 5.84	5.88
Options exercised (in dollars per share)			2.86
Options outstanding at end of period ( in dollars per share)			4.10	$ 3.54
Options vested and expected to be vested at end of period (in dollars per share)			4.63
Exercisable at end of period (in dollars per share)			$ 4.82
Weighted average remaining contractual term
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2			5 years 5 months 23 days	5 years 8 months 1 day
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2			5 years 5 months 23 days	5 years 8 months 1 day
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1			5 years 5 months 19 days
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestExercisableWeightedAverageRemainingContractualTerm1			4 years 7 months 2 days
Aggregate intrinsic value
Aggregate intrinsic value, Outstanding at the beginning of the period			$ 2,183
Aggregate intrinsic value, Outstanding at the end of the period			1,506	$ 2,183
Aggregate intrinsic value, Vested and expected to be vested			1,487
Aggregate intrinsic value, Exercisable			$ 821

SHAREHOLDERS' EQUITY (DEFICIT34

SHAREHOLDERS' EQUITY (DEFICIT) (Details 6) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2015	Jun. 30, 2014	Jun. 30, 2015	Jun. 30, 2014
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Allocated share based compensation expense	$ 123	$ 2	$ 214	$ 4
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Allocated share based compensation expense	26		50	1
Marketing
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Allocated share based compensation expense			4
Selling, general and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Allocated share based compensation expense	$ 97	$ 2	$ 160	$ 3

SELECTED STATEMENTS OF COMPRE35

SELECTED STATEMENTS OF COMPREHENSIVE LOSS (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2015	Jun. 30, 2014	Jun. 30, 2015	Jun. 30, 2014
Financial expense (income), net:
Interest expense and bank fees	$ 15	$ 23	$ 41	$ 41
Revaluation of fair value of warrant to purchase Convertible Preferred Shares		1,647	(40)	1,534
Foreign currency translation adjustments	77	4	(12)	18
Financial expenses (income), net	92	1,674	(11)	1,593
Numerator:
Net loss	6,925	5,337	12,481	8,134
Dividends accumulated for the period		845	988	1,432
Net loss available to shareholders of Ordinary shares	$ 6,925	$ 6,182	$ 13,469	$ 9,566
Denominator:
Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share	13,541,155	501,828	7,555,684	501,828
Preferred stock dividend rate (as a percent)			8.00%